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Sample records for anticoagulation point-of-care testing

  1. Optical sensing of anticoagulation status: Towards point-of-care coagulation testing.

    Directory of Open Access Journals (Sweden)

    Diane M Tshikudi

    Full Text Available Anticoagulant overdose is associated with major bleeding complications. Rapid coagulation sensing may ensure safe and accurate anticoagulant dosing and reduce bleeding risk. Here, we report the novel use of Laser Speckle Rheology (LSR for measuring anticoagulation and haemodilution status in whole blood. In the LSR approach, blood from 12 patients and 4 swine was placed in disposable cartridges and time-varying intensity fluctuations of laser speckle patterns were measured to quantify the viscoelastic modulus during clotting. Coagulation parameters, mainly clotting time, clot progression rate (α-angle and maximum clot stiffness (MA were derived from the clot viscoelasticity trace and compared with standard Thromboelastography (TEG. To demonstrate the capability for anticoagulation sensing in patients, blood samples from 12 patients treated with warfarin anticoagulant were analyzed. LSR clotting time correlated with prothrombin and activated partial thromboplastin time (r = 0.57-0.77, p<0.04 and all LSR parameters demonstrated good correlation with TEG (r = 0.61-0.87, p<0.04. To further evaluate the dose-dependent sensitivity of LSR parameters, swine blood was spiked with varying concentrations of heparin, argatroban and rivaroxaban or serially diluted with saline. We observed that anticoagulant treatments prolonged LSR clotting time in a dose-dependent manner that correlated closely with TEG (r = 0.99, p<0.01. LSR angle was unaltered by anticoagulation whereas TEG angle presented dose-dependent diminution likely linked to the mechanical manipulation of the clot. In both LSR and TEG, MA was largely unaffected by anticoagulation, and LSR presented a higher sensitivity to increased haemodilution in comparison to TEG (p<0.01. Our results establish that LSR rapidly and accurately measures the response of various anticoagulants, opening the opportunity for routine anticoagulation monitoring at the point-of-care or for patient self-testing.

  2. Point-of-Care Coagulation Tests Monitoring of Direct Oral Anticoagulants and Their Reversal Therapy: State of the Art.

    Science.gov (United States)

    Iapichino, Giacomo E; Bianchi, Paolo; Ranucci, Marco; Baryshnikova, Ekaterina

    2017-06-01

    Direct oral anticoagulants (DOACs) exert similar anticoagulant effects to vitamin K antagonists and are increasingly used worldwide. Nevertheless, an evidence-based approach to patients receiving DOACs when any unplanned urgent surgery or bleeding (either spontaneous or traumatic) occurs is still missing. In this review, we investigate the role of point-of-care coagulation tests when other, more specific tests are not available. Indeed, thromboelastography and activated clotting time can detect dabigatran-induced coagulopathy, while their accuracy is limited for apixaban and rivaroxaban, mostly in cases of low drug plasma concentrations. These tests can also be used to guide the reversal of DOAC-induced coagulopathy providing a quick, before-and-after picture in case of therapeutic use of hemostatic compounds. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  3. Good quality of oral anticoagulation treatment in general practice using international normalised ratio point of care testing

    DEFF Research Database (Denmark)

    Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent

    2015-01-01

    collected retrospectively for a period of six months. For each patient, time in therapeutic range (TTR) was calculated and correlated with practice and patient characteristics using multilevel linear regression models. RESULTS: We identified 447 patients in warfarin treatment in the 20 practices using POCT......INTRODUCTION: Oral anticoagulation treatment (OACT) with warfarin is common in general practice. Increasingly, international normalised ratio (INR) point of care testing (POCT) is being used to manage patients. The aim of this study was to describe and analyse the quality of OACT with warfarin...

  4. Good quality of oral anticoagulation treatment in general practice using international normalised ratio point of care testing

    DEFF Research Database (Denmark)

    Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent

    2015-01-01

    INTRODUCTION: Oral anticoagulation treatment (OACT) with warfarin is common in general practice. Increasingly, international normalised ratio (INR) point of care testing (POCT) is being used to manage patients. The aim of this study was to describe and analyse the quality of OACT with warfarin...... in general practice in the Capital Region of Denmark using INR POCT. METHODS: A total of 20 general practices, ten single-handed and ten group practices using INR POCT, were randomly selected to participate in the study. Practice organisation and patient characteristics were recorded. INR measurements were...... collected retrospectively for a period of six months. For each patient, time in therapeutic range (TTR) was calculated and correlated with practice and patient characteristics using multilevel linear regression models. RESULTS: We identified 447 patients in warfarin treatment in the 20 practices using POCT...

  5. Good quality of oral anticoagulation treatment in general practice using international normalised ratio point of care testing

    DEFF Research Database (Denmark)

    Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent

    2015-01-01

    INTRODUCTION: Oral anticoagulation treatment (OACT)with warfarin is common in general practice. Increasingly,international normalised ratio (INR) point of care testing(POCT) is being used to manage patients. The aim of thisstudy was to describe and analyse the quality of OACT withwarfarin...... in general practice in the Capital Region of Denmarkusing INR POCT. METHODS: A total of 20 general practices, ten singlehandedand ten group practices using INR POCT, were randomlyselected to participate in the study. Practice organisationand patient characteristics were recorded. INRmeasurements were...... collected retrospectively for a periodof six months. For each patient, time in therapeutic range(TTR) was calculated and correlated with practice and patientcharacteristics using multilevel linear regressionmodels. RESULTS: We identified 447 patients in warfarin treatmentin the 20 practices using POCT...

  6. Point-of-Care Testing of Coagulation in Patients Treated With Non-Vitamin K Antagonist Oral Anticoagulants.

    Science.gov (United States)

    Ebner, Matthias; Peter, Andreas; Spencer, Charlotte; Härtig, Florian; Birschmann, Ingvild; Kuhn, Joachim; Wolf, Martin; Winter, Natalie; Russo, Francesca; Zuern, Christine S; Blumenstock, Gunnar; Ziemann, Ulf; Poli, Sven

    2015-10-01

    Specific coagulation assays for non-vitamin K antagonist oral anticoagulants (NOAC) are relatively slow and often lack availability. Although specific point-of-care tests (POCT) are currently not available, NOAC are known to affect established coagulation POCT. This study aimed at determining the diagnostic accuracy of the CoaguChek POCT to rule out relevant concentrations of rivaroxaban, apixaban, and dabigatran in real-life patients. We consecutively enrolled 60 ischemic stroke patients newly started on NOAC treatment and obtained blood samples at 6 prespecified time points. Samples were tested using the CoaguChek POCT, laboratory-based coagulation assays (prothrombin time and activated partial thromboplastin time, anti-Xa test and Hemoclot), and liquid chromatography-tandem mass spectrometry for direct determination of NOAC concentrations. Three hundred fifty-six blood samples were collected. The CoaguChek POCT strongly correlated (r=0.82 P<0.001) with rivaroxaban concentrations but did not accurately detect dabigatran or apixaban. If used to estimate the presence of low rivaroxaban concentrations, POCT was superior to predictions based on normal prothrombin time and activated partial thromboplastin time values even if sensitive reagents were used. POCT-results≤1.0 predicted rivaroxaban concentrations<32 and <100 ng/mL with a specificity of 90% and 96%, respectively. If anti-Xa test is not available, we propose the use of the CoaguChek POCT to guide thrombolysis decisions after individual risk assessment in rivaroxaban-treated patients having acute ischemic stroke. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02371044. © 2015 American Heart Association, Inc.

  7. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants.

    Science.gov (United States)

    Ebner, Matthias; Birschmann, Ingvild; Peter, Andreas; Spencer, Charlotte; Härtig, Florian; Kuhn, Joachim; Blumenstock, Gunnar; Zuern, Christine S; Ziemann, Ulf; Poli, Sven

    2017-02-15

    Point-of-care testing (POCT) of coagulation has been proven to be of great value in accelerating emergency treatment. Specific POCT for direct oral anticoagulants (DOAC) is not available, but the effects of DOAC on established POCT have been described. We aimed to determine the diagnostic accuracy of Hemochron® Signature coagulation POCT to qualitatively rule out relevant concentrations of apixaban, rivaroxaban, and dabigatran in real-life patients. We enrolled 68 patients receiving apixaban, rivaroxaban, or dabigatran and obtained blood samples at six pre-specified time points. Coagulation testing was performed using prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (aPTT), and activated clotting time (ACT+ and ACT-low range) POCT cards. For comparison, laboratory-based assays of diluted thrombin time (Hemoclot) and anti-Xa activity were conducted. DOAC concentrations were determined by liquid chromatography-tandem mass spectrometry. Four hundred and three samples were collected. POCT results of PT/INR and ACT+ correlated with both rivaroxaban and dabigatran concentrations. Insufficient correlation was found for apixaban. Rivaroxaban concentrations at 95% specificity at PT/INR POCT ≤1.0 and ≤1.1 and ACT+ POCT ≤120 and ≤130 s. Dabigatran concentrations at 95% specificity at PT/INR POCT ≤1.1 and ≤1.2 and ACT+ POCT ≤100 s. Hemochron® Signature POCT can be a fast and reliable alternative for guiding emergency treatment during rivaroxaban and dabigatran therapy. It allows the rapid identification of a relevant fraction of patients that can be treated immediately without the need to await the results of much slower laboratory-based coagulation tests. Unique identifier, NCT02371070 . Retrospectively registered on 18 February 2015.

  8. Point-of-Care Testing.

    Science.gov (United States)

    Goble, Joseph A; Rocafort, Patrick T

    2017-04-01

    This article provides an overview of the current use of point-of-care testing (POCT) and its utility for patients' self-management of chronic disease states. Pharmacists utilize POCT to provide rapid laboratory diagnostic results as a monitoring tool in the management of their patients and in order to improve medication outcomes. Considerations for the transition to use of POCT in the home to further improve disease management and improve health care cost-effectiveness are discussed. Devices available for home use include those suitable for management of diabetes mellitus, hypertension, congestive heart failure, and anticoagulation. Many of these devices include software capabilities enabling patients to share important health information with health care providers using a computer. Limitations and challenges surrounding implementation of home POCT for patients include reliability of instrumentation, ability to coordinate data collection, necessary training requirements, and cost-effectiveness. Looking forward, the successful integration of POCT into the homes of patients is contingent on a concerted effort made by all members of the health care team.

  9. Point-of-Care Testing: General Aspects.

    Science.gov (United States)

    Ferreira, Carlos E S; Guerra, Joao C C; Slhessarenko, Natasha; Scartezini, Marileia; Franca, Carolina N; Colombini, Marjorie P; Berlitz, Fernando; Machado, Antonia M O; Campana, Gustavo A; Faulhaber, Adriana C L; Galoro, Cesar A; Dias, Claudia M; Shcolnik, Wilson; Martino, Marines D V; Cesar, Katia R; Sumita, Nairo M; Mendes, Maria E; Faulhaber, Marcelo H W; Pinho, Joao R R; Barbosa, Ismar V; Batista, Marcelo C; Khawali, Cristina; Pariz, Vitor M; Andriolo, Adagmar

    2018-01-01

    Point-of-Care Testing (POCT) has been highlighted in the health care sector in recent decades. On the other hand, due to its low demand, POCT is at a disadvantage compared to conventional equipment, since its cost is inversely proportional to the volume of use. In addition, for the implementation of POCT to succeed, it is essential to rely on the work of a multidisciplinary team. The awareness of health professionals of the importance of each step is perhaps the critical success factor. The trend towards the continuous advancement of the use of POCT and the great potential of its contributions reinforce the need to implement quality management tools, including performance indicators, to ensure their results. This review presents some advantages and disadvantages concerning POCT and the real need to use it. A worldwide call for the availability of easy-to-use health technologies that are increasingly closer to the final user is one of the main reasons for this focus.

  10. Point-of-care testing INR: an overview.

    Science.gov (United States)

    Barcellona, Doris; Fenu, Lara; Marongiu, Francesco

    2017-05-01

    Oral anticoagulant therapies with the anti-vitamin K drugs (AVK), warfarin, acenocoumarol and phenprocoumon, are employed in primary and secondary anti-thrombotic prophylaxis in patients with venous thromboembolism, atrial fibrillation and cardiac mechanical valves. However, a monitoring test such as the International Normalized Ratio (INR) is required. The periodic monitoring of this therapy entails discomfort for the patients. Telemedicine and telecare can provide significant aid in the management of this therapy allowing patients to perform the test at home or anywhere else with a portable device, i.e. point-of-care testing (POCT), and to send the result to a thrombosis (TC) via web. Patients can receive dose adjustment sent back by the TC. The effectiveness of this type of management is equal or superior to the traditional AVK monitoring in terms of hemorrhagic and thrombotic events. Analysis of the costs with a horizon of 10 years reveals that both self-testing and self-management are cost-effective. The aim of this overview is to describe the pros and cons of the use of POCT as an alternative in the monitoring of AVK. In particular, description of the POCT, decentralization, quality of the therapy, safety and costs will be examined.

  11. Critical Care Glucose Point-of-Care Testing.

    Science.gov (United States)

    Narla, S N; Jones, M; Hermayer, K L; Zhu, Y

    Maintaining blood glucose concentration within an acceptable range is a goal for patients with diabetes mellitus. Point-of-care glucose meters initially designed for home self-monitoring in patients with diabetes have been widely used in the hospital settings because of ease of use and quick reporting of blood glucose information. They are not only utilized for the general inpatient population but also for critically ill patients. Many factors affect the accuracy of point-of-care glucose testing, particularly in critical care settings. Inaccurate blood glucose information can result in unsafe insulin delivery which causes poor glucose control and can be fatal. Healthcare professionals should be aware of the limitations of point-of-care glucose testing. This chapter will first introduce glucose regulation in diabetes mellitus, hyperglycemia/hypoglycemia in the intensive care unit, importance of glucose control in critical care patients, and pathophysiological variables of critically ill patients that affect the accuracy of point-of-care glucose testing. Then, we will discuss currently available point-of-care glucose meters and preanalytical, analytical, and postanalytical sources of variation and error in point-of-care glucose testing. © 2016 Elsevier Inc. All rights reserved.

  12. Business models & business cases for point-of-care testing

    NARCIS (Netherlands)

    Staring, A.J.; Meertens, L. O.; Sikkel, N.

    2016-01-01

    Point-Of-Care Testing (POCT) enables clinical tests at or near the patient, with test results that are available instantly or in a very short time frame, to assist caregivers with immediate diagnosis and/or clinical intervention. The goal of POCT is to provide accurate, reliable, fast, and

  13. Point-of-care testing of activated clotting time in the ICU: is it relevant?

    Science.gov (United States)

    Brown, Ellenora; Clarke, Jody; Edward, Karen-leigh; Giandinoto, Jo-Ann

    Over the past 50 years there have been significant advances in both the clinical techniques and equipment used in the intensive care environment. One traditionally used point-of-care test is activated clotting time (ACT), a coagulation test primarily used during cardiopulmonary bypass surgery to monitor the anticoagulation effects of heparin. The ACT test has since emerged into the intensive care environment to guide clinical assessment and management of haemostasis in postoperative cardiac patients. The aim of this integrative systematic review was to critique the available research evaluating the effectiveness of ACT point-of-care testing in the intensive care unit for adult patients following cardiopulmonary bypass and cardiac surgery and any impacts this may have on nursing care. A systematic search of Medline, CINAHL and PubMed was undertaken. The search identified five research papers reporting on the use of ACT point-of-care testing in the intensive care unit for adult cardiac surgical patients. Meta-analysis was not performed due to the lack of homogeneity between the papers included. There was a lack of clear evidence for the use of the ACT point-of-care test after cardiac surgery in the intensive care environment. This review has highlighted that conventional laboratory tests are generally more accurate and reliable than this point-of-care test in guiding nursing care management.

  14. Intraoperative point-of-care testing | Von Rahden | Southern African ...

    African Journals Online (AJOL)

    Point-of-care devices offer an increasing number of analytical tests more quickly than laboratory analysis, but clinicians must be aware of the limitations of these devices, especially for critical threshold-level decisions. Glucometers are susceptible to a wide range of errors, and only a few haemoglobin-measuring devices ...

  15. Point of Care Testing | Amponsah | African Journal of Anaesthesia ...

    African Journals Online (AJOL)

    Point of Care Testing (POCT) tries to eliminate some if not all the delays mentioned above because of the shorter turnaround time. This paper discusses how POCT can be started in health facilities, the protocol, the guidelines and the training of personnel who will be involved in the process. Some of the equipment involved ...

  16. Responsibilities in point-of-care testing. An institutional perspective.

    Science.gov (United States)

    Lamb, L S

    1995-10-01

    The development of "user-friendly" laboratory analyzers, combined with the need for rapid assessment of critical care patients, has led to the performance of in vitro diagnostic testing at the point of care. This strategy has been well received by most physicians who desire rapid turnaround times for laboratory tests, especially in the critical care areas. Since the primary care-giver in most critical care units is the registered nurse, much point-of-care testing has been delegated to nursing personnel. This has resulted in questions of authority, responsibility, regulation, and conflict resolution. These areas are discussed along with alternative strategies, such as vacuum transport, stat and/or satellite laboratories, unit-based phelebotomists, or "super techs," designed to achieve the goals of bedside or near-bedside testing in the critical care setting.

  17. Multiplexed Point-of-Care Testing - xPOCT.

    Science.gov (United States)

    Dincer, Can; Bruch, Richard; Kling, André; Dittrich, Petra S; Urban, Gerald A

    2017-08-01

    Multiplexed point-of-care testing (xPOCT), which is simultaneous on-site detection of different analytes from a single specimen, has recently gained increasing importance for clinical diagnostics, with emerging applications in resource-limited settings (such as in the developing world, in doctors' offices, or directly at home). Nevertheless, only single-analyte approaches are typically considered as the major paradigm in many reviews of point-of-care testing. Here, we comprehensively review the present diagnostic systems and techniques for xPOCT applications. Different multiplexing technologies (e.g., bead- or array-based systems) are considered along with their detection methods (e.g., electrochemical or optical). We also address the unmet needs and challenges of xPOCT. Finally, we critically summarize the in-field applicability and the future perspectives of the presented approaches. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. Point-of-care testing: applications of 3D printing.

    Science.gov (United States)

    Chan, Ho Nam; Tan, Ming Jun Andrew; Wu, Hongkai

    2017-08-08

    Point-of-care testing (POCT) devices fulfil a critical need in the modern healthcare ecosystem, enabling the decentralized delivery of imperative clinical strategies in both developed and developing worlds. To achieve diagnostic utility and clinical impact, POCT technologies are immensely dependent on effective translation from academic laboratories out to real-world deployment. However, the current research and development pipeline is highly bottlenecked owing to multiple restraints in material, cost, and complexity of conventionally available fabrication techniques. Recently, 3D printing technology has emerged as a revolutionary, industry-compatible method enabling cost-effective, facile, and rapid manufacturing of objects. This has allowed iterative design-build-test cycles of various things, from microfluidic chips to smartphone interfaces, that are geared towards point-of-care applications. In this review, we focus on highlighting recent works that exploit 3D printing in developing POCT devices, underscoring its utility in all analytical steps. Moreover, we also discuss key advantages of adopting 3D printing in the device development pipeline and identify promising opportunities in 3D printing technology that can benefit global health applications.

  19. Gas-generating reactions for point-of-care testing.

    Science.gov (United States)

    Liu, Dan; Tian, Tian; Chen, Xiaofeng; Lei, Zhichao; Song, Yanling; Shi, Yuanzhi; Ji, Tianhai; Zhu, Zhi; Yang, Liu; Yang, Chaoyong

    2018-03-12

    Gas generation-based measurement is an attractive alternative approach for POC (Point-of-care) testing, which relies on the amount of generated gas to detect the corresponding target concentrations. In gas generation-based POC testing, the integration of a target recognition component and a catalyzed gas-generating reaction initiated by the target introduction can lead to greatly amplified signals, which can be highly sensitive measured via distance readout or simple hand-held devices. More importantly, numerous gas-generating reactions are environment-friendly since their products such as oxygen and nitrogen are nontoxic and odourless, which makes gas generation-based POC testing safe and secure for inexperienced staff. Researchers have demonstrated that gas generation-based measurements enable the rapid and highly sensitive POC detection of a variety of analytes. In this review, we focus on the recent developments in gas generation-based POC testing systems. The common types of gas-generating reactions are first listed and the translation of gas signals to different signal readouts for POC testing are then summarized, including distance readouts and hand-held devices. Moreover, we introduce gas bubbles as actuators to power microfluidic devices. We finally provide the applications and future perspective of gas generation-based POC testing systems.

  20. Point-of-care lactate testing in emergency room

    Directory of Open Access Journals (Sweden)

    Darinka Purg

    2014-04-01

    Full Text Available Lactate is a product of anaerobic metabolism, which can be used to detect the critically ill. Rapid recognition, early appropriate treatment and control of treatment success are paramount in that population. Lactate levels need to be available as soon as possible if they are to be of assistance at the bedside. Point-of-care analyzers enable rapid determination of lactate. The role of point-of-care lactate analyzers in the treatment of the critically ill, different analysis techniques and limitations of point-of-care lactate analyzers are presented. The use of point-of-care lactate analyzers is demonstrated in two cases of patients with sepsis. The first patient is a 73-year-old female, where point-of-care lactate was determined immediately. Septic shock with multi-organ failure developed. She was successfully treated and discharged after 14 days to home care. The second patient is a 62-year old male, where elevated lactate was detected after three hours. The patient died after a total of 5 months of treatment in the intensive care unit. Lactate can be an important tool in early recognition and treatment of the critically ill.

  1. Ammonia concentrations in canine whole blood, EDTA-anticoagulated whole blood, and plasma measured by use of a point-of-care ammonia meter.

    Science.gov (United States)

    Odunayo, Adesola; Tobias, Karen M; Okafor, Chika C; Flatland, Bente

    2017-11-01

    OBJECTIVE To investigate the use of canine whole blood (WB) for measurement of ammonia concentration by use of a point-of-care ammonia meter and to compare results of measuring ammonia concentrations in WB, EDTA-anticoagulated WB, and plasma. ANIMALS 40 client-owned dogs. PROCEDURES A blood sample (2 mL) was obtained from each dog. One drop of WB was immediately applied to a test strip for evaluation with an ammonia meter. The remainder of the blood sample was placed in an EDTA-containing tube, and 1 drop of EDTA-anticoagulated WB was applied to a test strip. The remaining EDTA-anticoagulated WB sample was centrifuged, and the plasma was harvested and placed on ice. One drop of plasma was applied to a test strip; the remainder of the plasma sample was transported on ice and used for ammonia measurement with a reference laboratory instrument. All samples were tested within 1 hour after sample collection. Results were evaluated to detect significant differences in ammonia concentration. RESULTS Ammonia concentrations did not differ significantly between WB and EDTA-anticoagulated WB and between plasma samples measured with the meter and reference laboratory instrument. However, median ammonia concentration was significantly higher in plasma than in WB or EDTA-anti-coagulated WB. CONCLUSIONS AND CLINICAL RELEVANCE Anticoagulant-free WB was a valid sample for measurement by use of the ammonia meter. Plasma samples had higher ammonia concentrations than did WB samples. Results for each sample type should be interpreted by use of specimen- and method-specific reference intervals.

  2. RNI Point-of-care test (POCT: esperança ou ilusão? Point-of-care test (POCT INR: hope or illusion?

    Directory of Open Access Journals (Sweden)

    Luci Maria Sant'Ana Dusse

    2012-06-01

    , INR point-of-care test (POCT INR, is the main test of this new proposal. This test has great potential benefit in situations where the quick INR results influences clinical decision making, as in acute ischemic stroke, before surgical procedures and during cardiac surgery. The INR POCT has the potential to be used for self-monitoring of oral anticoagulation in patients under anticoagulant therapy. However, the precision and accuracy of INR POCT still need to be enhanced to increase effectiveness and efficiency of the test. Additionally, the RDC / ANVISA Number 302 makes clear that the POCT testing must be supervised by the technical manager of the Clinical Laboratory in the pre-analytical, analytical and post-analytical. In practice, the Clinical Laboratory does not participate in the implementation of POCT testing or release of the results. Clinicians have high expectation with the incorporation of INR POCT in clinical practice, despite the limitations of this method. These professionals are willing to train the patient to perform the test, but are not legally responsible for the quality of it and are not prepared for the maintenance of equipment. The definition of who is in charge for the test must be one to ensure the quality control.

  3. Embedding new technologies in practice ? a normalization process theory study of point of care testing

    OpenAIRE

    Jones, Caroline H. D.; Glogowska, Margaret; Locock, Louise; Lasserson, Daniel S.

    2016-01-01

    Background Many point of care diagnostic technologies are available which produce results within minutes, and offer the opportunity to deliver acute care out of hospital settings. Increasing access to diagnostics at the point of care could increase the volume and scope of acute ambulatory care. Yet these technologies are not routinely used in many settings. We aimed to explore how point of care testing is used in a setting where it has become ?normalized? (embedded in everyday practice), in o...

  4. Point-of-care C-reactive protein testing in Febrile Children in General Practice

    NARCIS (Netherlands)

    M. Montenij (Miriam); M.H. ten Brinke (Majolein); J. van Brakel (Jocelyn); Y.B. de Rijke (Yolanda); M.Y. Berger (Marjolein)

    2006-01-01

    markdownabstract__Background:__ Point-of-care testing for C-reactive protein (CRP) may be helpful in differentiating viral from bacterial infection. Such a device should give results comparable to laboratory testing. The aim was to evaluate two point-of-care CRP tests (Nycocard and QuikRead) in

  5. Point of Care Testing Services Delivery: Policy Analysis using a ...

    African Journals Online (AJOL)

    Background: For many years, all or majority of laboratory testing was performed in central laboratories. This was necessary due to complexity of testing. However, with computer technology and the need to reduce turnaround time of results, testing has emerged from the laboratory to the patient's bedside, pharmacy, ...

  6. Evaluating point-of-care testing for glycosylated haemoglobin in ...

    African Journals Online (AJOL)

    The HbA1c test result was entered into the patient record; the patient was then managed according to the usual guidelines and practice at the health facility. No attempt was made to provide additional training in the management of diabetes and interpretation of the HbA1c test. The technical quality of the POC machine was ...

  7. Evaluation of point-of-care tests for detecting microalbuminuria in ...

    African Journals Online (AJOL)

    , indicates renal damage and is recognised as a risk factor for the progression of renal and cardiovascular disease. Several international scientific bodies recommend microalbuminuria screening. Point-of-care testing (POCT) of ...

  8. Embedding new technologies in practice - a normalization process theory study of point of care testing.

    Science.gov (United States)

    Jones, Caroline H D; Glogowska, Margaret; Locock, Louise; Lasserson, Daniel S

    2016-10-19

    Many point of care diagnostic technologies are available which produce results within minutes, and offer the opportunity to deliver acute care out of hospital settings. Increasing access to diagnostics at the point of care could increase the volume and scope of acute ambulatory care. Yet these technologies are not routinely used in many settings. We aimed to explore how point of care testing is used in a setting where it has become 'normalized' (embedded in everyday practice), in order to inform future adoption and implementation in other settings. We used normalization process theory to guide our case study approach. We used a single case study design, choosing a community based ambulatory care unit where point of care testing is used routinely. A focused ethnographic approach was taken, including non-participant observation of all activities related to point of care testing, and semi-structured interviews, with all clinical staff involved in point of care testing at the unit. Data were analysed thematically, guided by normalization process theory. Fourteen days of observation and six interviews were completed. Staff had a shared understanding of the purpose, value and benefits of point of care testing, believing it to be integral to the running of the unit. They organised themselves as a team to ensure that point of care testing worked effectively; and one key individual led a change in practice to ensure more consistency and trust in procedures. Staff assessed point of care testing as worthwhile for the unit, their patients, and themselves in terms of job satisfaction and knowledge. Potential barriers to adoption of point of care testing were evident (including lack of trust in the accuracy of some results compared to laboratory testing; and lack of ease of use of some aspects of the equipment); but these did not prevent point of care testing from becoming embedded, because the importance and value attributed to it were so strong. This case study offers insights

  9. A Novel Field-Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis

    Science.gov (United States)

    2016-10-01

    AWARD NUMBER: W81XWH-14-2-0195. Log Number: PR130282 TITLE: A Novel Field-Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis ...SUBTITLE A Novel Field-Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT...14. ABSTRACT Leishmaniasis is caused by the protozoan Leishmania and is generally transmitted by the bite of sand flies of the genus Lutzomyia or

  10. Evaluating point-of-care testing for glycosylated haemoglobin in ...

    African Journals Online (AJOL)

    The DCA Vantage Analyzer (Siemens, Germany) for POC testing was introduced at the intervention sites for 12 months. Patients were randomly selected from the diabetes register at the intervention (n=300) and control (n=300) sites, respectively, and data were collected from patient records at baseline and 12 months.

  11. Internal quality control in point-of-care testing: where's the evidence?

    Science.gov (United States)

    Holt, Helen; Freedman, Danielle B

    2016-03-01

    ISO 22870 standards require protocols for performance of internal quality control for all point-of-care testing devices and training of users in its theory and practice. However, the unique setting of point-of-care testing (i.e. processes conducted by non-scientific users) means that laboratory internal quality control programmes do not easily translate to point-of-care testing. In addition, while the evidence base for internal quality control within the laboratory has been increasing, the equivalent literature surrounding point-of-care testing is very limited. This has led to wide variation in what is considered acceptable practice for internal quality control at the point of care. Indeed, it has been demonstrated that internal quality control is an area of deficiency in point-of-care testing. Internal quality control protocols used at point-of-care testing should be defined based on risk management. The protocol will therefore be dependent on analyser complexity and availability of inbuilt system checks, the risk associated with release of an incorrect patient result as well as frequency of use. The emphasis should be on designing an effective internal quality control protocol as opposed to the inherent tendency of introducing high-frequency quality control. Typically a simple pass or fail criterion is used for internal quality control in point-of-care testing based on whether internal quality control results fall within assigned ranges. While simply taught, such criteria can require broad internal quality control ranges to decrease the probability of false rejection (also reducing the probability of error detection). Customized internal quality control ranges, two-tier acceptance systems and assay-specific internal quality control can be used to improve error detection rates. © The Author(s) 2016.

  12. Training of nurses in point-of-care testing: a systematic review of the literature.

    Science.gov (United States)

    Liikanen, Eeva; Lehto, Liisa

    2013-08-01

    To review and describe the training of nurses in point-of care testing. Point-of-care tests are usually carried out by nurses. They are used in many healthcare units. Through training, nurses are able to improve their competence in performing point-of-care testing. Systematic review. A literature search of electronic data was undertaken in autumn 2011 using CINAHL, The Cochrane Library, Medline (Ovid) and Scopus databases. From the available literature, six specific initiatives were analysed. The studies were performed on three continents and in five healthcare settings. The three interventions were related to glucose point-of-care testing. The training approaches involved seven aspects. The interventions were diverse, broad and multifaceted, but they appeared to be successful. The strength of the interventions lay in the involvement of laboratory staff. Quantitative synthesis of the data was not undertaken because of different designs for the studies. Training can improve nurses' competence, and many methods are available. There are very few studies of training nurses in point-of-care testing, although in-depth descriptions of interventions in different settings would be valuable. Nurses can be trained using a variety of methods in different healthcare settings. To save resources, especially in large hospitals and sparsely populated areas, distance learning is worth considering. However if training is delivered with the support of laboratory professionals, nurses subsequently perform good-quality point-of-care testing. © 2013 John Wiley & Sons Ltd.

  13. Chlamydia and gonorrhoea point-of-care testing in Australia: where should it be used?

    Science.gov (United States)

    Natoli, Lisa; Guy, Rebecca J; Shephard, Mark; Donovan, Basil; Fairley, Christopher K; Ward, James; Regan, David G; Hengel, Belinda; Maher, Lisa

    2015-03-01

    Background Diagnoses of chlamydia and gonorrhoea have increased steadily in Australia over the past decade. Testing and treatment is central to prevention and control but in some settings treatment may be delayed. Testing at the point of care has the potential to reduce these delays. We explored the potential utility of newly available accurate point-of-care tests in various clinical settings in Australia. In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with sexual health, primary care, remote Aboriginal health and laboratory expertise. Participants reported that point-of-care testing would have greatest benefit in remote Aboriginal communities where prevalence of sexually transmissible infections is high and treatment delays are common. Some suggested that point-of-care testing could be useful in juvenile justice services where young Aboriginal people are over-represented and detention periods may be brief. Other suggested settings included outreach (where populations may be homeless, mobile or hard to access, such as sex workers in the unregulated sex industry and services that see gay, bisexual and other men who have sex with men). Point-of-care testing could also improve the consumer experience and facilitate increased testing for sexually transmissible infections among people with HIV infection between routine HIV-management visits. Some participants disagreed with the idea of introducing point-of-care testing to urban services with easy access to pathology facilities. Participants felt that point-of-care testing may enhance pathology service delivery in priority populations and in particular service settings. Further research is needed to assess test performance, cost, acceptability and impact.

  14. Point-of-Care Hemoglobin A1c Testing: An Evidence-Based Analysis.

    Science.gov (United States)

    2014-01-01

    The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control for the management of this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements. To review the correlation between point-of-care HbA1c testing and laboratory HbA1c measurement in patients with diabetes in clinical settings. The literature search included studies published between January 2003 and June 2013. Search terms included glycohemoglobin, hemoglobin A1c, point of care, and diabetes. Studies were included if participants had diabetes; if they compared point-of-care HbA1c devices (licensed by Health Canada and available in Canada) with laboratory HbA1c measurement (reference method); if they performed point-of-care HbA1c testing using capillary blood samples (finger pricks) and laboratory HbA1c measurement using venous blood samples within 7 days; and if they reported a correlation coefficient between point-of-care HbA1c and laboratory HbA1c results. Three point-of-care HbA1c devices were reviewed in this analysis: Bayer's A1cNow+, Bio-Rad's In2it, and Siemens' DCA Vantage. Five observational studies met the inclusion criteria. The pooled results showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement (correlation coefficient, 0.967; 95% confidence interval, 0.960-0.973). Outcomes were limited to the correlation coefficient, as this was a commonly reported measure of analytical performance in the literature. Results should be interpreted with caution due to risk of bias related to selection of participants, reference standards, and the multiple steps involved in POC HbA1c testing. Moderate quality evidence showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement. Five

  15. A systematic evaluation of immunoassay point-of-care testing to define impact on patients' outcomes.

    Science.gov (United States)

    Pecoraro, Valentina; Banfi, Giuseppe; Germagnoli, Luca; Trenti, Tommaso

    2017-07-01

    Background Point-of-care testing has been developed to provide rapid test results. Most published studies focus on analytical performance, neglecting its impact on patient outcomes. Objective To review the analytical performance and accuracy of point-of-care testing specifically planned for immunoassay and to evaluate the impact of faster results on patient management. Methods A search of electronic databases for studies reporting immunoassay results obtained in both point-of-care testing and central laboratory scenarios was performed. Data were extracted concerning the study details, and the methodological quality was assessed. The analytical characteristics and diagnostic accuracy of six points-of-care testing: troponin, procalcitonin, parathyroid hormone, brain natriuretic peptide, C-reactive protein and neutrophil gelatinase-associated lipocalin were evaluated. Results A total of 116 scientific papers were analysed. Studies measuring procalcitonin, parathyroid hormone and neutrophil gelatinase-associated lipocalin reported a limited impact on diagnostic decisions. Seven studies measuring C-reactive protein claimed a significant reduction of antibiotic prescription. Several authors evaluated brain natriuretic peptide or troponin reporting faster decision-making without any improvement in clinical outcome. Forty-four per cent of studies reported analytical data, showing satisfactory correlations between results obtained through point-of-care testing and central laboratory setting. Half of studies defined the diagnostic accuracy of point-of-care testing as acceptable for troponin (median sensitivity and specificity: 74% and 94%, respectively), brain natriuretic peptide (median sensitivity and specificity: 82% and 88%, respectively) and C-reactive protein (median sensitivity and specificity 85%). Conclusions Point-of-care testing immunoassay results seem to be reliable and accurate for troponin, brain natriuretic peptide and C-reactive protein. The satisfactory

  16. Point-of-Care Hemoglobin A1c Testing: A Budget Impact Analysis.

    Science.gov (United States)

    Chadee, A; Blackhouse, G; Goeree, R

    2014-01-01

    The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control as part of managing this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements. To estimate the budget impact of point-of-care HbA1c testing to replace laboratory HbA1c measurement for monitoring glycemic control in patients with diabetes in 2013/2014. This analysis compared the average testing cost of 3 point-of-care HbA1c devices licensed by Health Canada and available on the market in Canada (Bayer's A1cNow+, Siemens's DCA Vantage, and Bio Rad's In2it), with that of the laboratory HbA1c reference method. The cost difference between point-of-care HbA1c testing and laboratory HbA1c measurement was calculated. Costs and the corresponding range of net impact were estimated in sensitivity analyses. The total annual costs of laboratory HbA1c measurement and point-of-care HbA1c testing for 2013/2014 were $91.5 million and $86.8 million, respectively. Replacing all laboratory HbA1c measurements with point-of-care HbA1c testing would save approximately $4.7 million over the next year. Savings could be realized by the health care system at each level that point-of-care HbA1c testing is substituted for laboratory HbA1c measurement. If physician fees were excluded from the analysis, the health care system would incur a net impact from using point-of-care HbA1c testing instead of laboratory A1c measurement. Point-of-care HbA1c technology is already in use in the Ontario health care system, but the current uptake is unclear. Knowing the adoption rate and market share of point-of-care HbA1c technology would allow for a more accurate estimate of budget impact. Replacing laboratory HbA1c measurement with point-of-care HbA1c testing or using point-of-care HbA1c testing in

  17. Point-of-care D-dimer testing in emergency departments.

    Science.gov (United States)

    Marquardt, Udo; Apau, Daniel

    2015-09-01

    Overcrowding and prolonged patient stays in emergency departments (EDs) affect patients' experiences and outcomes, and increase healthcare costs. One way of addressing these problems is through using point-of-care blood tests, laboratory testing undertaken near patient locations with rapidly available results. D-dimer tests are used to exclude venous thromboembolism (VTE), a common presentation in EDs, in low-risk patients. However, data on the effects of point-of-care D-dimer testing in EDs and other urgent care settings are scarce. This article reports the results of a literature review that examined the benefits to patients of point-of-care D-dimer testing in terms of reduced turnaround times (time to results), and time to diagnosis, discharge or referral. It also considers the benefits to organisations in relation to reduced ED crowding and increased cost effectiveness. The review concludes that undertaking point-of-care D-dimer tests, combined with pre-test probability scores, can be a quick and safe way of ruling out VTE and improving patients' experience.

  18. C-reactive protein point-of-care testing and associated antibiotic prescribing

    NARCIS (Netherlands)

    Minnaard, Margaretha C.; van de Pol, Alma C.; Hopstaken, Rogier M.; van Delft, Sanne; Broekhuizen, Berna D. L.; Verheij, Theo J. M.; de Wit, Niek J.

    Background. In clinical trials, the potential of point-of-care (POC) C-reactive protein (CRP) tests was demonstrated in decreasing antibiotic prescribing in adults with acute cough in general practice, but effects of implementation are unknown. Objective. To determine the overall effect of POC CRP

  19. Trends in miniaturized total analysis systems for point-of-care testing in clinical chemistry

    NARCIS (Netherlands)

    Tudos, Anna J.; Besselink, G.A.J.; Schasfoort, Richardus B.M.

    2001-01-01

    A currently emerging approach enables more widespread monitoring of health parameters in disease prevention and biomarker monitoring. Miniaturisation provides the means for the production of small, fast and easy-to-operate devices for reduced-cost healthcare testing at the point-of-care (POC) or

  20. The universe of ANA testing: a case for point-of-care ANA testing.

    Science.gov (United States)

    Konstantinov, Konstantin N; Rubin, Robert L

    2017-12-01

    Testing for total antinuclear antibodies (ANA) is a critical tool for diagnosis and management of autoimmune diseases at both the primary care and subspecialty settings. Repurposing of ANA from a test for lupus to a test for any autoimmune condition has driven the increase in ANA requests. Changes in ANA referral patterns include early or subclinical autoimmune disease detection in patients with low pre-test probability and use of negative ANA results to rule out underlying autoimmune disease. A positive result can lead to further diagnostic considerations. Currently, ANA tests are performed in centralized laboratories; an alternative would be ANA testing at the clinical point-of-care (POC). By virtue of its near real-time data collection capability, low cost, and ease of use, we believe the POC ANA has the potential to enable a new paradigm shift in autoimmune serology testing.

  1. A Laboratory-Based Evaluation of Four Rapid Point-of-Care Tests for Syphilis

    Science.gov (United States)

    Causer, Louise M.; Kaldor, John M.; Fairley, Christopher K.; Donovan, Basil; Karapanagiotidis, Theo; Leslie, David E.; Robertson, Peter W.; McNulty, Anna M.; Anderson, David; Wand, Handan; Conway, Damian P.; Denham, Ian; Ryan, Claire; Guy, Rebecca J.

    2014-01-01

    Background Syphilis point-of-care tests may reduce morbidity and ongoing transmission by increasing the proportion of people rapidly treated. Syphilis stage and co-infection with HIV may influence test performance. We evaluated four commercially available syphilis point-of-care devices in a head-to-head comparison using sera from laboratories in Australia. Methods Point-of-care tests were evaluated using sera stored at Sydney and Melbourne laboratories. Sensitivity and specificity were calculated by standard methods, comparing point-of-care results to treponemal immunoassay (IA) reference test results. Additional analyses by clinical syphilis stage, HIV status, and non-treponemal antibody titre were performed. Non-overlapping 95% confidence intervals (CI) were considered statistically significant differences in estimates. Results In total 1203 specimens were tested (736 IA-reactive, 467 IA-nonreactive). Point-of-care test sensitivities were: Determine 97.3%(95%CI:95.8–98.3), Onsite 92.5%(90.3–94.3), DPP 89.8%(87.3–91.9) and Bioline 87.8%(85.1–90.0). Specificities were: Determine 96.4%(94.1–97.8), Onsite 92.5%(90.3–94.3), DPP 98.3%(96.5–99.2), and Bioline 98.5%(96.8–99.3). Sensitivity of the Determine test was 100% for primary and 100% for secondary syphilis. The three other tests had reduced sensitivity among primary (80.4–90.2%) compared to secondary syphilis (94.3–98.6%). No significant differences in sensitivity were observed by HIV status. Test sensitivities were significantly higher among high-RPR titre (RPR≥8) (range: 94.6–99.5%) than RPR non-reactive infections (range: 76.3–92.9%). Conclusions The Determine test had the highest sensitivity overall. All tests were most sensitive among high-RPR titre infections. Point-of-care tests have a role in syphilis control programs however in developed countries with established laboratory infrastructures, the lower sensitivities of some tests observed in primary syphilis suggest these would

  2. Point-of-care hemoglobin testing for postmortem diagnosis of anemia.

    Science.gov (United States)

    Na, Joo-Young; Park, Ji Hye; Choi, Byung Ha; Kim, Hyung-Seok; Park, Jong-Tae

    2018-03-01

    An autopsy involves examination of a body using invasive methods such as dissection, and includes various tests using samples procured during dissection. During medicolegal autopsies, the blood carboxyhemoglobin concentration is commonly measured using the AVOXimeter® 4000 as a point-of-care test. When evaluating the body following hypovolemic shock, characteristics such as reduced livor mortis or an anemic appearance of the viscera can be identified, but these observations arequite subjective. Thus, a more objective test is required for the postmortem diagnosis of anemia. In the present study, the AVOXimeter® 4000 was used to investigate the utility of point-of-care hemoglobin testing. Hemoglobin tests were performed in 93 autopsy cases. The AVOXimeter® 4000 and the BC-2800 Auto Hematology Analyzer were used to test identical samples in 29 of these cases. The results of hemoglobin tests performed with these two devices were statistically similar (r = 0.969). The results of hemoglobin tests using postmortem blood were compared with antemortem test results from medical records from 31 cases, and these results were similar. In 13 of 17 cases of death from internal hemorrhage, hemoglobin levels were lower in the cardiac blood than in blood from the affected body cavity, likely due to compensatory changes induced by antemortem hemorrhage. It is concluded that blood hemoglobin testing may be useful as a point-of-care test for diagnosing postmortem anemia.

  3. Accuracy of point-of-care HbA1c testing in pregnant women.

    Science.gov (United States)

    Culliney, Katherine; McCowan, Lesley M E; Okesene-Gafa, Karaponi; Murphy, Rinki; Rowan, Janet; Taylor, Rennae S; Mckinlay, Christopher J D

    2018-02-22

    In New Zealand, it is recommended that all pregnant women have a haemoglobin A1c (HbA1c) test performed with their booking antenatal bloods to identify previously unrecognised diabetes. However, screening rates in some groups are low. Use of a point-of-care device may improve compliance with screening. To assess the accuracy of the COBAS b101 point-of-care system referenced against a laboratory method, for measurement of HbA1c levels in pregnant women. Convenience sample of 40 obese pregnant women enrolled in a clinical trial. HbA1c was assayed in paired capillary and venous whole blood samples using the COBAS b101 point-of-care system and Primus Ultra2 high performance liquid chromatography laboratory analyser, respectively. The accuracy of the point-of-care system was assessed by Bland-Altman analysis. The mean (SD) laboratory HbA1c was 35.9 (2.0) mmol/mol. The COBAS b101 point-of-care system, compared with the laboratory reference method, had a small negative bias for HbA1c (-1.0 mmol/mol, 95% CI -2.0 to -0.03, P = 0.03) and relatively wide 95% limits of agreement (-7.2 to 5.1 mmol/mol). In conclusion, we found that in pregnancy, the COBAS b101 point-of-care system has a small negative bias and modest point accuracy for HbA1c. When used to screen for previously unrecognised diabetes in pregnancy, appropriate COBAS b101 HbA1c point-of-care HbA1c thresholds for a negative and positive result are 7 mmol/mol below and 5 mmol/mol above the clinical threshold, respectively. Values between these limits should be confirmed by laboratory testing. © 2018 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  4. Validation of capillary blood analysis and capillary testing mode on the epoc Point of Care system

    Directory of Open Access Journals (Sweden)

    Jing Cao

    2017-12-01

    Full Text Available Background: Laboratory test in transport is a critical component of patient care, and capillary blood is a preferred sample type particularly in children. This study evaluated the performance of capillary blood testing on the epoc Point of Care Blood Analysis System (Alere Inc. Methods: Ten fresh venous blood samples was tested on the epoc system under the capillary mode. Correlation with GEM 4000 (Instrumentation Laboratory was examined for Na+, K+, Cl-, Ca2+, glucose, lactate, hematocrit, hemoglobin, pO2, pCO2, and pH, and correlation with serum tested on Vitros 5600 (Ortho Clinical Diagnostics was examined for creatinine. Eight paired capillary and venous blood was tested on epoc and ABL800 (Radiometer for the correlation of Na+, K+, Cl-, Ca2+, glucose, lactate, hematocrit, hemoglobin, pCO2, and pH. Capillary blood from 23 apparently healthy volunteers was tested on the epoc system to assess the concordance to reference ranges used locally. Results: Deming regression correlation coefficients for all the comparisons were above 0.65 except for ionized Ca2+. Accordance of greater than 85% to the local reference ranges were found in all assays with the exception of pO2 and Cl-. Conclusion: Data from this study indicates that capillary blood tests on the epoc system provide comparable results to reference method for these assays, Na+, K+, glucose, lactate, hematocrit, hemoglobin, pCO2, and pH. Further validation in critically ill patients is needed to implement the epoc system in patient transport. Impact of the study: This study demonstrated that capillary blood tests on the epoc Point of Care Blood Analysis System give comparable results to other chemistry analyzers for major blood gas and critical tests. The results are informative to institutions where pre-hospital and inter-hospital laboratory testing on capillary blood is a critical component of patient point of care testing. Keywords: Epoc, Capillary, Transport, Blood gas, Point of care

  5. Validation of a novel point of care testing device for sickle cell disease.

    Science.gov (United States)

    Kanter, Julie; Telen, Marilyn J; Hoppe, Carolyn; Roberts, Christopher L; Kim, Jason S; Yang, Xiaoxi

    2015-09-16

    Sickle cell disease is one of the most common inherited blood disorders. Universal screening and early intervention have significantly helped to reduce childhood mortality in high-resource countries. However, persons living in low-resource settings are often not diagnosed until late childhood when they present with clinical symptoms. In addition, confirmation of disease in affected individuals in the urgent care setting is limited in both high- and low-resource areas, often leading to delay in treatment. All of the current diagnostic methods rely on advanced laboratory systems and are often prohibitively expensive and time-consuming in low-resource settings. To address this need, the Sickle SCAN™ test has been developed to diagnose sickle cell disease and sickle cell trait at the point of care without electricity or advanced equipment. This study was conducted to evaluate and validate the diagnostic accuracy of the Sickle SCAN™ test, a novel point of care test for sickle cell disease. Thus, we describe the laboratory testing and clinical validation of the Sickle SCAN™ test in individuals >1 year of age using capillary blood. The Sickle SCAN™ test was created using advanced, qualitative lateral flow technology using capillary blood to identify the presence of hemoglobin A, S, and C allowing for detection of results with the naked eye. Laboratory testing using venous blood demonstrated 99 % sensitivity and 99 % specificity for the diagnosis of HbSS, HbAS, HbSC, HbAC, and HbAA. Seventy-one subjects underwent capillary blood sampling at the point of care for further validation. This test detected the correct A, S, and C presence with an overall diagnostic accuracy of 99 % at the bedside. The Sickle SCAN™ test has the potential to significantly impact the diagnosis and treatment for sickle cell disease worldwide as well as enhance genetic counseling at the point of care. Further validation testing will be conducted in newborns in resource-poor settings in

  6. Essential aspects of external quality assurance for point-of-care testing

    OpenAIRE

    Stavelin, Anne; Sandberg, Sverre

    2017-01-01

    External quality assurance (EQA) or proficiency testing for point-of-care (POC) testing is in principle similar to EQA for larger hospital laboratories, but the participants are different. The participants are usually health care personnel with little or no knowledge of laboratory medicine. The implication of this is that the EQA provider has to a) convince the participants that participation in EQA schemes are important, b) be able to circulate materials with reasonable time intervals, c) pr...

  7. Toward point-of-care testing for JAK2 V617F mutation on a microchip.

    Science.gov (United States)

    Wang, Hua; Liu, Weiwei; Zhang, Xinju; Xu, Xiao; Kang, Zhihua; Li, Shibao; Wu, Zhiyuan; Yang, Zhiliu; Yao, Bo; Guan, Ming

    2015-09-04

    Molecular genetics now plays a crucial role in diagnosis, the identification of prognostic markers, and monitoring of hematological malignancies. Demonstration of acquired changes such as the JAK2 V617F mutation within myeloproliferative neoplasms (MPN) has quickly moved from a research setting to the diagnostic laboratory. Microfluidics-based assays can reduce the assay time and sample/reagent consumption and enhance the reaction efficiency; however, no current assay has integrated isothermal amplification for point-of-care MPN JAK2 V617F mutation testing with a microchip. In this report, an integrated microchip that performs the whole human blood genomic DNA extraction, loop-mediated isothermal nucleic acid amplification (LAMP) and visual detection for point-of-care genetic mutation testing is demonstrated. This method was validated on DNA from cell lines as well as on whole blood from patients with MPN. The results were compared with those obtained by unlabeled probe melting curve analysis. This chip enjoys a high accuracy, operability, and cost/time efficiency within 1h. All these benefits provide the chip with a potency toward a point-of-care genetic analysis. All samples identified as positive by unlabeled probe melting curve analysis (n=27) proved positive when tested by microchip assay. None of the 30 negative controls gave false positive results. In addition, a patient with polycythemia vera diagnosed as being JAK2 V617F-negative by unlabeled probe melting curve analysis was found to be positive by the microchip. This microchip would possibly be very attractive in developing a point-of-care platform for quick preliminary diagnosis of MPN or other severe illness in resource-limited settings. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Validation of capillary blood analysis and capillary testing mode on the epoc Point of Care system.

    Science.gov (United States)

    Cao, Jing; Edwards, Rachel; Chairez, Janette; Devaraj, Sridevi

    2017-12-01

    Laboratory test in transport is a critical component of patient care, and capillary blood is a preferred sample type particularly in children. This study evaluated the performance of capillary blood testing on the epoc Point of Care Blood Analysis System (Alere Inc). Ten fresh venous blood samples was tested on the epoc system under the capillary mode. Correlation with GEM 4000 (Instrumentation Laboratory) was examined for Na+, K+, Cl-, Ca2+, glucose, lactate, hematocrit, hemoglobin, pO2, pCO2, and pH, and correlation with serum tested on Vitros 5600 (Ortho Clinical Diagnostics) was examined for creatinine. Eight paired capillary and venous blood was tested on epoc and ABL800 (Radiometer) for the correlation of Na+, K+, Cl-, Ca2+, glucose, lactate, hematocrit, hemoglobin, pCO2, and pH. Capillary blood from 23 apparently healthy volunteers was tested on the epoc system to assess the concordance to reference ranges used locally. Deming regression correlation coefficients for all the comparisons were above 0.65 except for ionized Ca2+. Accordance of greater than 85% to the local reference ranges were found in all assays with the exception of pO2 and Cl-. Data from this study indicates that capillary blood tests on the epoc system provide comparable results to reference method for these assays, Na+, K+, glucose, lactate, hematocrit, hemoglobin, pCO2, and pH. Further validation in critically ill patients is needed to implement the epoc system in patient transport. This study demonstrated that capillary blood tests on the epoc Point of Care Blood Analysis System give comparable results to other chemistry analyzers for major blood gas and critical tests. The results are informative to institutions where pre-hospital and inter-hospital laboratory testing on capillary blood is a critical component of patient point of care testing.

  9. A critical appraisal of point-of-care coagulation testing in critically ill patients.

    Science.gov (United States)

    Levi, M; Hunt, B J

    2015-11-01

    Derangement of the coagulation system is a common phenomenon in critically ill patients, who may present with severe bleeding and/or conditions associated with a prothrombotic state. Monitoring of this coagulopathy can be performed with conventional coagulation assays; however, point-of-care tests have become increasingly attractive, because not only do they yield a more rapid result than clinical laboratory testing, but they may also provide a more complete picture of the condition of the hemostatic system. There are many potential areas of study and applications of point-of-care hemostatic testing in critical care, including patients who present with massive blood loss, patients with a hypercoagulable state (such as in disseminated intravascular coagulation), and monitoring of antiplatelet treatment for acute arterial thrombosis, mostly acute coronary syndromes. However, the limitations of near-patient hemostatic testing has not been fully appreciated, and are discussed here. The currently available evidence indicates that point-of-care tests may be applied to guide appropriate blood product transfusion and the use of hemostatic agents to correct the hemostatic defect or to ameliorate antithrombotic treatment. Disappointingly, however, only in cardiac surgery is there adequate evidence to show that application of near-patient thromboelastography leads to an improvement in clinically relevant outcomes, such as reductions in bleeding-related morbidity and mortality, and cost-effectiveness. More research is required to validate the utility and cost-effectiveness of near-patient hemostatic testing in other areas, especially in traumatic bleeding and postpartum hemorrhage. © 2015 International Society on Thrombosis and Haemostasis.

  10. Point-of-care testing in India: missed opportunities to realize the true potential of point-of-care testing programs.

    Science.gov (United States)

    Engel, Nora; Ganesh, Gayatri; Patil, Mamata; Yellappa, Vijayashree; Vadnais, Caroline; Pai, Nitika Pant; Pai, Madhukar

    2015-12-14

    The core objective of any point-of-care (POC) testing program is to ensure that testing will result in an actionable management decision (e.g. referral, confirmatory test, treatment), within the same clinical encounter (e.g. POC continuum). This can but does not have to involve rapid tests. Most studies on POC testing focus on one specific test and disease in a particular healthcare setting. This paper describes the actors, technologies and practices involved in diagnosing major diseases in five Indian settings - the home, community, clinics, peripheral laboratories and hospitals. The aim was to understand how tests are used and fit into the health system and with what implications for the POC continuum. The paper reports on a qualitative study including 78 semi-structured interviews and 13 focus group discussions with doctors, nurses, patients, lab technicians, program officers and informal providers, conducted between January and June 2013 in rural and urban Karnataka, South India. Actors, diseases, tests and diagnostic processes were mapped for each of the five settings and analyzed with regard to whether and how POC continuums are being ensured. Successful POC testing hardly occurs in any of the five settings. In hospitals and public clinics, most of the rapid tests are used in laboratories where either the single patient encounter advantage is not realized or the rapidity is compromised. Lab-based testing in a context of manpower and equipment shortages leads to delays. In smaller peripheral laboratories and private clinics with shorter turn-around-times, rapid tests are unavailable or too costly. Here providers find alternative measures to ensure the POC continuum. In the home setting, patients who can afford a test are not/do not feel empowered to use those devices. These results show that there is much diagnostic delay that deters the POC continuum. Existing rapid tests are currently not translated into treatment decisions rapidly or are not available where

  11. A Novel Field Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis

    Science.gov (United States)

    2015-10-01

    equivalent of ᝺ parasites in spiked clinical specimens. We will compare the analytical sensitivity and specificity of RPA-LF with qPCR using a broad panel of...AWARD NUMBER: W81XWH-14-2-0196 TITLE: A Novel Field-Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis PRINCIPAL INVESTIGATOR... Diagnostic Test for Cutaneous Leishmaniasis 5b. GRANT NUMBER W81XWH-14-2-0196 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER LT Robert

  12. Rapid point-of-care breath test for biomarkers of breast cancer and abnormal mammograms.

    Directory of Open Access Journals (Sweden)

    Michael Phillips

    Full Text Available BACKGROUND: Previous studies have reported volatile organic compounds (VOCs in breath as biomarkers of breast cancer and abnormal mammograms, apparently resulting from increased oxidative stress and cytochrome p450 induction. We evaluated a six-minute point-of-care breath test for VOC biomarkers in women screened for breast cancer at centers in the USA and the Netherlands. METHODS: 244 women had a screening mammogram (93/37 normal/abnormal or a breast biopsy (cancer/no cancer 35/79. A mobile point-of-care system collected and concentrated breath and air VOCs for analysis with gas chromatography and surface acoustic wave detection. Chromatograms were segmented into a time series of alveolar gradients (breath minus room air. Segmental alveolar gradients were ranked as candidate biomarkers by C-statistic value (area under curve [AUC] of receiver operating characteristic [ROC] curve. Multivariate predictive algorithms were constructed employing significant biomarkers identified with multiple Monte Carlo simulations and cross validated with a leave-one-out (LOO procedure. RESULTS: Performance of breath biomarker algorithms was determined in three groups: breast cancer on biopsy versus normal screening mammograms (81.8% sensitivity, 70.0% specificity, accuracy 79% (73% on LOO [C-statistic value], negative predictive value 99.9%; normal versus abnormal screening mammograms (86.5% sensitivity, 66.7% specificity, accuracy 83%, 62% on LOO; and cancer versus no cancer on breast biopsy (75.8% sensitivity, 74.0% specificity, accuracy 78%, 67% on LOO. CONCLUSIONS: A pilot study of a six-minute point-of-care breath test for volatile biomarkers accurately identified women with breast cancer and with abnormal mammograms. Breath testing could potentially reduce the number of needless mammograms without loss of diagnostic sensitivity.

  13. Systems Engineering and Point of Care Testing: Report from the NIBIB POCT/Systems Engineering Workshop.

    Science.gov (United States)

    Stahl, James E; McGowan, Heather; DiResta, Ellen; Gaydos, Charlotte A; Klapperich, Catherine; Parrish, John; Korte, Brenda

    2015-03-01

    The first part of this manuscript is an introduction to systems engineering and how it may be applied to health care and point of care testing (POCT). Systems engineering is an interdisciplinary field that seeks to better understand and manage changes in complex systems and projects as whole. Systems are sets of interconnected elements which interact with each other, are dynamic, change over time and are subject to complex behaviors. The second part of this paper reports on the results of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) workshop exploring the future of point of care testing and technologies and the recognition that these new technologies do not exist in isolation. That they exist within ecosystems of other technologies and systems; and these systems influence their likelihood of success or failure and their effectiveness. In this workshop, a diverse group of individuals from around the country, from disciplines ranging from clinical care, engineering, regulatory affairs and many others to members of the three major National Institutes of Health (NIH) funded efforts in the areas the Centers for POCT for sexually transmitted disease, POCT for the future of Cancer Care, POCT primary care research network, gathered together for a modified deep dive workshop exploring the current state of the art, mapping probable future directions and developing longer term goals. The invitees were broken up into 4 thematic groups: Home, Outpatient, Public/shared space and Rural/global. Each group proceeded to explore the problem and solution space for point of care tests and technology within their theme. While each thematic area had specific challenges, many commonalities also emerged. This effort thus helped create a conceptual framework for POCT as well as identifying many of the challenges for POCT going forward. Four main dimensions were identified as defining the functional space for both point of care testing and treatment, these are

  14. Tracking the progress of HIV: the impact of point-of-care tests on antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    Reid SD

    2013-09-01

    Full Text Available Steven D Reid, Sarah J Fidler, Graham S Cooke Department of Infectious Diseases, St Mary's Hospital, Imperial College London, London, UK Abstract: It is now around 30 years since the discovery of HIV, the virus that causes AIDS. More than 70 million people have been infected in that time and around 35 million have died. The majority of those currently living with HIV/AIDS are in low- and middle-income countries, with sub-Saharan Africa bearing a disproportionate burden of the global disease. In high-income countries, the introduction of antiretroviral therapy (ART has drastically reduced the morbidity and mortality associated with HIV. Patients on ART are now predicted to have near-normal life expectancy and the role of treatment is increasingly recognized in preventing new infections. In low- and middle-income countries, treatment is now more widely available and around half of those who need ART are currently receiving it. Early diagnosis of HIV is essential if ART is to be optimally implemented. Lab-based diagnostics for screening, diagnosis, treatment initiation, and the monitoring of treatment efficacy are critical in managing the disease and reducing the number of new infections each year. The introduction of point-of-care HIV rapid tests has transformed the epidemic, particularly in low- and middle-income countries. For the first time, these point-of-care tests allow for the rapid identification of infected individuals outside the laboratory who can undergo counseling and treatment and, in the case of pregnant women, allow the timely initiation of ART to reduce the risk of vertical transmission. Although survival is markedly improved with ART even in the absence of laboratory monitoring, long-term management of people living with HIV on ART, and their partners, is essential to ensure successful viral suppression. The burden of disease in many resource-poor settings with high HIV prevalence has challenged the ability of local laboratories

  15. Current status and future prospects of point-of-care testing around the globe.

    Science.gov (United States)

    Abel, Gyorgy

    2015-01-01

    In the past half-century, routine central laboratory testing has become increasingly automated and efficient. The majority of clinical chemistry, immunochemistry and hematology testing are performed using high throughput instrumentation, with sophisticated automation. Microbiology, immunohematology and molecular diagnostic testing are also becoming increasingly automated. Recent challenges in healthcare demand new diagnostic solutions worldwide. Point-of-care testing (POCT) offers considerable advantages over central laboratory testing, such as fast and simple specimen handling, and simpler sample requirement (no additives and mostly blood from finger stick; and urine). No transportation is required, and POCT delivers short turnaround time of approximately 5-15 min. In recent years, POCT has gained ground worldwide. In advanced healthcare systems, POCT may be beneficial if health or cost-benefits can be established. In resource-poor countries, POCT may be the only means of delivering advanced testing for epidemiologically important diseases, such as tuberculosis of HIV infection.

  16. The Role of Pharmacists and Pharmacy Education in Point-of-Care Testing.

    Science.gov (United States)

    Kehrer, James P; James, Deborah E

    2016-10-25

    Point-of-care testing (POCT) is defined as laboratory testing conducted close to the site of patient care. Although performed originally primarily by clinical staff for acute conditions, recent advances in technology have made such testing possible for disease screening and prevention across a wide range of conditions in virtually any setting, and often by individuals with little or no training. With the ongoing evolution in POCT, numerous concerns have arisen about the quality and accuracy of the tests, comparability between multiple tests for the same endpoint, interpretation of test results, and whether and how results should be used for therapeutic decisions and included in a patient's medical record. The pharmacist is well-positioned to manage and interpret POCT performed outside of the usual clinical settings. However, educational and regulatory changes are needed to enable pharmacists to take on this emerging activity effectively.

  17. Evaluation of a pharmacist-managed lipid clinic that uses point-of-care lipid testing.

    Science.gov (United States)

    Gerrald, Katherine R; Dixon, Dave L; Barnette, Debra J; Williams, Virginia G

    2010-01-01

    Hyperlipidemia is a significant, modifiable risk factor for developing coronary heart disease. Low-density lipoprotein cholesterol (LDL-C) goal achievement has improved overall, but many high-risk patients remain above the desired LDL-C goals. Published data have demonstrated the ability of pharmacist-managed lipid clinics to improve lipid management in a variety of clinical settings. This observational analysis aimed to report the impact of a newly developed hospital-based, outpatient lipid clinic by the use of point-of-care testing on LDL-C goal attainment. A retrospective, observational analysis was conducted from February 2007 to December 2008. The primary outcome measure was the change in the proportion of patients who achieved their LDL-C goal at the end of the observation period compared with baseline. A total of 81 patients met study inclusion criteria. Mean duration of follow-up was 9.0 ± 4.9 (SD) months. At the end of the observation period, 82.9% of patients achieved their LDL-C goal compared with 55.3% at baseline (P used point-of-care testing to obtain lipid results for making therapy adjustments during the face-to-face visit. Copyright © 2010 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  18. Essential aspects of external quality assurance for point-of-care testing.

    Science.gov (United States)

    Stavelin, Anne; Sandberg, Sverre

    2017-02-15

    External quality assurance (EQA) or proficiency testing for point-of-care (POC) testing is in principle similar to EQA for larger hospital laboratories, but the participants are different. The participants are usually health care personnel with little or no knowledge of laboratory medicine. The implication of this is that the EQA provider has to a) convince the participants that participation in EQA schemes are important, b) be able to circulate materials with reasonable time intervals, c) produce feedback reports that are understandable, and d) offer help and guidance to the participants when needed. It is also important that EQA for POC testing e) address the pre-examination, the examination and the post-examination processes, and f) that schemes for measurement procedures using interval or ordinal scale are offered. The aim of the present paper is to highlight important issues of these essential aspects of EQA for POC testing.

  19. Microbiological point of care testing before antibiotic prescribing in primary care

    DEFF Research Database (Denmark)

    Haldrup, Steffen; Thomsen, Reimar W; Bro, Flemming

    2017-01-01

    BACKGROUND: Point-of-care testing (POCT) in primary care may improve rational antibiotic prescribing. We examined use of POCT in Denmark, including patient- and general practitioner (GP)-related predictors. METHODS: We linked nationwide health care databases to assess POCT use (C-reactive protein...... (CRP), group A streptococcal (GAS) antigen swabs, bacteriological cultures, and urine test strips) per 1,000 overall GP consultations, 2004-2013. We computed odds ratios (OR) of POCT in patients prescribed antibiotics according to patient and GP age and sex, GP practice type, location, and workload....... RESULTS: The overall use of POCT in Denmark increased by 45.8% during 2004-2013, from 147.2 per 1,000 overall consultations to 214.8. CRP tests increased by 132%, bacteriological cultures by 101.7% while GAS swabs decreased by 8.6%. POCT preceded 28% of antibiotic prescriptions in 2004 increasing to 44...

  20. Review of point-of-care testing and biomarkers of cardiovascular diseases in emergency and prehospital medicine.

    Science.gov (United States)

    Claret, Pierre-Géraud; Bobbia, Xavier; Roger, Claire; Sebbane, Mustapha; de La Coussaye, Jean-Emmanuel

    2015-10-01

    Medical reasoning must be constructed on clinical evidence-based biology and follow a process of a priori assumptions. The introduction of a solution of point-of-care testing must result from any work involving clinicians, biologists, and administration. Several solutions of point-of-care testing allow the dosage of cardiac enzymes (CPK, myoglobin, and troponin) or BNP in less than half an hour time. The point-of-care testing saves time in obtaining the results earlier. It seems to allow timesaving on the overall care of the patient and the duration of his stay in the emergency department. By its technique and the relevance of its results, point-of-care testing is suitable for prehospital use.

  1. Clinical value of drugs of abuse point of care testing in an emergency department setting.

    Science.gov (United States)

    Lager, P S; Attema-de Jonge, M E; Gorzeman, M P; Kerkvliet, L E; Franssen, E J F

    2018-01-01

    Toxicology screening tests for drugs-of-abuse and therapeutic drugs in urine (TST-U) are often used to assess whether a patient's clinical condition can be explained by the use of drugs-of-abuse (DOA) and/or therapeutic drugs. TST-U have clinical value when they support clinical decision making by influencing diagnosis and patient care. We aim to quantify the influence of TST-U results on diagnosis and patient care in an emergency department. Our secondary objective is to identify specific patients for which a TST-U is most warranted or mostly unhelpful. This prospective observational study was performed at the emergency department of a middle-sized urban teaching hospital. A point of care TST-U has been used in this department for three years. When a TST-U is considered indicated by a physician, the influence of the TST-U result on diagnosis and patient care is quantified before and after the test results are available, by means of a questionnaire. Urgency and complaints upon admission have also been registered. Of 100 TST-U results 37% were reported having a substantial influence on diagnosis and 25% on patient care. TST-U had a substantial influence on diagnosis in 48% of patients with decreased consciousness, 47% of patients with psychiatric symptoms and in 47% of patients with "other" complaints. In this last category patients with neurological symptoms benefited most. In patients who were already suspected to be intoxicated, only 18% of the TST-U results had substantial influence on diagnosis. The use of point of care TST-U in an Emergency Department helps physicians to understand the clinical condition of a patient. They influence the way a patient is treated to a lesser extent. These tests are most helpful in patients with decreased consciousness, psychiatric or neurological symptoms and mostly unhelpful in patients who, upon admission, are already known to be intoxicated.

  2. OLED Hybrid Integrated Polymer Microfluidic Biosensing for Point of Care Testing

    Directory of Open Access Journals (Sweden)

    Ashwin Acharya

    2015-09-01

    Full Text Available This paper reports a microfluidic platform with external hybrid integration of an organic light emitting diode (OLED as an excitation source. This device can be used as a simple and cost effective biosensing element. The device is capable of rapid in-situ detection of biological elements such as sensing of interaction of antigen with fluorescent tagged antibody conjugates. These portable microfluidic systems have great potential for use an OLED in a single chip with very high accuracy and sensitivity for various point-of-care (POC diagnosis and lab on a chip (LOC applications, as the miniaturization of the biosensor is essential for handling smaller sample volumes in order to achieve high throughput. The biosensing element was successfully tested to detect anti-sheep IgG conjugates tagged to Alexafluor using a fluorescence based immunoassay method.

  3. Review of Commercially Available Microfluidic Materials and Fabricating Techniques for Point of Care Testing

    Directory of Open Access Journals (Sweden)

    Luck EREKU

    2016-07-01

    Full Text Available During the last two decades silicon and MEMs technology had been the mainstay of early microfluidic devices. However, recent times have brought into focus the need for low cost and readily available materials capable of achieving the expected microfluidics physical and chemical requirements. Also what mentioning is the rapid improvement in microfabrication technology over the years, which has significantly aided new and cheaper ways to produce microfluidic Point-Of-Care-Testing devices commercially or for research purposes. This review article discusses the usefulness of a wide range of available materials and their unique properties suitability in microfluidic applications. Likewise, advantages and drawbacks of manufacturing procedures and outputs of different fabrication methods are also brought into focus.

  4. Advances in paper-based sample pretreatment for point-of-care testing.

    Science.gov (United States)

    Tang, Rui Hua; Yang, Hui; Choi, Jane Ru; Gong, Yan; Feng, Shang Sheng; Pingguan-Murphy, Belinda; Huang, Qing Sheng; Shi, Jun Ling; Mei, Qi Bing; Xu, Feng

    2017-06-01

    In recent years, paper-based point-of-care testing (POCT) has been widely used in medical diagnostics, food safety and environmental monitoring. However, a high-cost, time-consuming and equipment-dependent sample pretreatment technique is generally required for raw sample processing, which are impractical for low-resource and disease-endemic areas. Therefore, there is an escalating demand for a cost-effective, simple and portable pretreatment technique, to be coupled with the commonly used paper-based assay (e.g. lateral flow assay) in POCT. In this review, we focus on the importance of using paper as a platform for sample pretreatment. We firstly discuss the beneficial use of paper for sample pretreatment, including sample collection and storage, separation, extraction, and concentration. We highlight the working principle and fabrication of each sample pretreatment device, the existing challenges and the future perspectives for developing paper-based sample pretreatment technique.

  5. Point-of-Care Testing in Community Pharmacies: Keys to Success From Pennsylvania Pharmacists.

    Science.gov (United States)

    Steltenpohl, Emily A; Barry, Brandon K; Coley, Kim C; McGivney, Melissa S; Olenak, Julie L; Berenbrok, Lucas A

    2017-01-01

    Clinical Laboratory Improvement Amendments (CLIA)-waived tests allow for quick, accurate, and noninvasive laboratory testing. Community pharmacists utilize CLIA-waived tests to provide clinical services such as point-of-care (POC) testing to help manage chronic disease and acute illness. To identify key themes in the successful delivery of POC testing services by community pharmacists in Pennsylvania. An initial search identified 51 Pennsylvania pharmacies with a CLIA waiver. Of these, five independent pharmacies met inclusion criteria, three of which completed interviews. The remaining 38 chain pharmacies were represented by three interviews. In total, five key themes were identified as essential to POC testing services: (1) utilize state resources and professional connections to navigate federal and state regulations, (2) establish relationships with physician partners (3) offer tests that are meaningful to patients and their physicians, (4) evaluate financial impact, workflow adaptations, and marketing approaches when implementing POC testing services, and (5) focus on individualized attention and convenience of community pharmacy-based POC testing to improve patient satisfaction. Successful POC testing services in community pharmacy practice rely on utilizing resources, partnering with known physicians, selecting meaningful tests for patients, and analyzing finances, workflow, and marketing to provide individualized attention and convenient care.

  6. Primary care clinicians' attitudes towards point-of-care blood testing: a systematic review of qualitative studies.

    Science.gov (United States)

    Jones, Caroline H D; Howick, Jeremy; Roberts, Nia W; Price, Christopher P; Heneghan, Carl; Plüddemann, Annette; Thompson, Matthew

    2013-08-14

    Point-of-care blood tests are becoming increasingly available and could replace current venipuncture and laboratory testing for many commonly used tests. However, at present very few have been implemented in most primary care settings. Understanding the attitudes of primary care clinicians towards these tests may help to identify the barriers and facilitators to their wider adoption. We aimed to systematically review qualitative studies of primary care clinicians' attitudes to point-of-care blood tests. We systematically searched Medline, Embase, ISI Web of Knowledge, PsycINFO and CINAHL for qualitative studies of primary care clinicians' attitudes towards point-of-care blood tests in high income countries. We conducted a thematic synthesis of included studies. Our search identified seven studies, including around two hundred participants from Europe and Australia. The synthesis generated three main themes: the impact of point-of-care testing on decision-making, diagnosis and treatment; impact on clinical practice more broadly; and impact on patient-clinician relationships and perceived patient experience. Primary care clinicians believed point-of-care testing improved diagnostic certainty, targeting of treatment, self-management of chronic conditions, and clinician-patient communication and relationships. There were concerns about test accuracy, over-reliance on tests, undermining of clinical skills, cost, and limited usefulness. We identified several perceived benefits and barriers regarding point-of-care tests in primary care. These imply that if point-of-care tests are to become more widely adopted, primary care clinicians require evidence of their accuracy, rigorous testing of the impact of introduction on patient pathways and clinical practice, and consideration of test funding.

  7. Challenges of development and implementation of point of care pharmacogenetic testing.

    Science.gov (United States)

    Haga, Susanne B

    2016-09-01

    Just as technology was the underlying driver of the sequencing of the human genome and subsequent generation of volumes of genome sequence data from healthy and affected individuals, animal, plant, and microbial species alike, so too will technology revolutionize diagnostic testing. One area of intense interest is the use of genetic data to inform decisions regarding drug selection and drug dosing, known as pharmacogenetic (PGx) testing, to improve likelihood of successful treatment outcomes with minimal risks. This commentary will provide an overview of implementation research of PGx testing, the benefits of point-of-care (POC) testing and overview of POC testing platforms, available PGx tests, and barriers and facilitators to the development and integration of POC-PGx testing into clinical settings. Sources include the published literature, and databases from the Centers for Medicaid and Medicare Services, Food and Drug Administration. Expert commentary: The utilization of POC PGx testing may enable more routine test use, but the development and implementation of such tests will face some barriers before personalized medicine is available to every patient. In particular, provider training, availability of clinical decision supports, and connectivity will be key areas to facilitate routine use.

  8. Compounding diagnostic delays: a qualitative study of point-of-care testing in South Africa.

    Science.gov (United States)

    Engel, Nora; Davids, Malika; Blankvoort, Nadine; Pai, Nitika Pant; Dheda, Keertan; Pai, Madhukar

    2015-04-01

    Successful point-of-care (POC) testing (completion of test-and-treat cycle in one patient encounter) has immense potential to reduce diagnostic and treatment delays, and improve patient and public health outcomes. We explored what tests are done and how in public/private, rural/urban hospitals and clinics in South Africa and whether they can ensure successful POC testing. This qualitative research study examined POC testing across major diseases in Cape Town, Durban and Eastern Cape. We conducted 101 semi-structured interviews and seven focus group discussions with doctors, nurses, community health workers, patients, laboratory technicians, policymakers, hospital managers and diagnostic manufacturers. In South Africa, diagnostics are characterised by a centralised system. Most tests conducted on the spot can be made to work successfully as POC tests. The majority of public/private clinics and smaller hospitals send samples via couriers to centralised laboratories and retrieve results the same way, via internet, fax or phone. The main challenge to POC testing lies in transporting samples and results, while delays risk patient loss from diagnostic/treatment pathways. Strategies to deal with associated delays create new problems, such as artificially prolonged turnaround times, strains on human resources and quality of testing, compounding additional diagnostic and treatment delays. For POC testing to succeed, particular characteristics of diagnostic ecosystems and adaptations of professional practices to overcome associated challenges must be taken into account. © 2014 John Wiley & Sons Ltd.

  9. Barriers to Point-of-Care Testing in India: Results from Qualitative Research across Different Settings, Users and Major Diseases

    Science.gov (United States)

    Engel, Nora; Ganesh, Gayatri; Patil, Mamata; Yellappa, Vijayashree; Pant Pai, Nitika; Vadnais, Caroline; Pai, Madhukar

    2015-01-01

    Background Successful point-of-care testing, namely ensuring the completion of the test and treat cycle in the same encounter, has immense potential to reduce diagnostic and treatment delays, and impact patient outcomes. However, having rapid tests is not enough, as many barriers may prevent their successful implementation in point-of-care testing programs. Qualitative research on diagnostic practices may help identify such barriers across different points of care in health systems. Methods In this exploratory qualitative study, we conducted 78 semi-structured interviews and 13 focus group discussions in an urban and rural area of Karnataka, India, with healthcare providers (doctors, nurses, specialists, traditional healers, and informal providers), patients, community health workers, test manufacturers, laboratory technicians, program managers and policy-makers. Participants were purposively sampled to represent settings of hospitals, peripheral labs, clinics, communities and homes, in both the public and private sectors. Results In the Indian context, the onus is on the patient to ensure successful point-of-care testing across homes, clinics, labs and hospitals, amidst uncoordinated providers with divergent and often competing practices, in settings lacking material, money and human resources. We identified three overarching themes affecting point-of-care testing: the main theme is ‘relationships’ among providers and between providers and patients, influenced by the cross-cutting theme of ‘infrastructure’. Challenges with both result in ‘modified practices’ often favouring empirical (symptomatic) treatment over treatment guided by testing. Conclusions Even if tests can be conducted on the spot and infrastructure challenges have been resolved, relationships among providers and between patients and providers are crucial for successful point-of-care testing. Furthermore, these barriers do not act in isolation, but are interlinked and need to be examined

  10. Barriers to Point-of-Care Testing in India: Results from Qualitative Research across Different Settings, Users and Major Diseases.

    Science.gov (United States)

    Engel, Nora; Ganesh, Gayatri; Patil, Mamata; Yellappa, Vijayashree; Pant Pai, Nitika; Vadnais, Caroline; Pai, Madhukar

    2015-01-01

    Successful point-of-care testing, namely ensuring the completion of the test and treat cycle in the same encounter, has immense potential to reduce diagnostic and treatment delays, and impact patient outcomes. However, having rapid tests is not enough, as many barriers may prevent their successful implementation in point-of-care testing programs. Qualitative research on diagnostic practices may help identify such barriers across different points of care in health systems. In this exploratory qualitative study, we conducted 78 semi-structured interviews and 13 focus group discussions in an urban and rural area of Karnataka, India, with healthcare providers (doctors, nurses, specialists, traditional healers, and informal providers), patients, community health workers, test manufacturers, laboratory technicians, program managers and policy-makers. Participants were purposively sampled to represent settings of hospitals, peripheral labs, clinics, communities and homes, in both the public and private sectors. In the Indian context, the onus is on the patient to ensure successful point-of-care testing across homes, clinics, labs and hospitals, amidst uncoordinated providers with divergent and often competing practices, in settings lacking material, money and human resources. We identified three overarching themes affecting point-of-care testing: the main theme is 'relationships' among providers and between providers and patients, influenced by the cross-cutting theme of 'infrastructure'. Challenges with both result in 'modified practices' often favouring empirical (symptomatic) treatment over treatment guided by testing. Even if tests can be conducted on the spot and infrastructure challenges have been resolved, relationships among providers and between patients and providers are crucial for successful point-of-care testing. Furthermore, these barriers do not act in isolation, but are interlinked and need to be examined as such. Also, a test alone has only limited power

  11. Point-of-care testing for chlamydia and gonorrhoea: implications for clinical practice.

    Directory of Open Access Journals (Sweden)

    Lisa Natoli

    Full Text Available Point-of-care (POC testing for chlamydia (CT and gonorrhoea (NG offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings.In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise.Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection.The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines.

  12. Point-of-Care Testing for Chlamydia and Gonorrhoea: Implications for Clinical Practice

    Science.gov (United States)

    Natoli, Lisa; Maher, Lisa; Shephard, Mark; Hengel, Belinda; Tangey, Annie; Badman, Steven G.; Ward, James; Guy, Rebecca J.

    2014-01-01

    Objectives Point-of-care (POC) testing for chlamydia (CT) and gonorrhoea (NG) offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs) in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings. Methods In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise. Results Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection. Conclusions The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines. PMID:24956111

  13. A Systematic Review of Point of Care Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis

    Directory of Open Access Journals (Sweden)

    Sasha Herbst de Cortina

    2016-01-01

    Full Text Available Objectives. Systematic review of point of care (POC diagnostic tests for sexually transmitted infections: Chlamydia trachomatis (CT, Neisseria gonorrhoeae (NG, and Trichomonas vaginalis (TV. Methods. Literature search on PubMed for articles from January 2010 to August 2015, including original research in English on POC diagnostics for sexually transmitted CT, NG, and/or TV. Results. We identified 33 publications with original research on POC diagnostics for CT, NG, and/or TV. Thirteen articles evaluated test performance, yielding at least one test for each infection with sensitivity and specificity ≥90%. Each infection also had currently available tests with sensitivities <60%. Three articles analyzed cost effectiveness, and five publications discussed acceptability and feasibility. POC testing was acceptable to both providers and patients and was also demonstrated to be cost effective. Fourteen proof of concept articles introduced new tests. Conclusions. Highly sensitive and specific POC tests are available for CT, NG, and TV, but improvement is possible. Future research should focus on acceptability, feasibility, and cost of POC testing. While pregnant women specifically have not been studied, the results available in nonpregnant populations are encouraging for the ability to test and treat women in antenatal care to prevent adverse pregnancy and neonatal outcomes.

  14. Stressful point-of-care rapid testing for human immunodeficiency virus, hepatitis C virus, and syphilis.

    Science.gov (United States)

    Reynolds, Grace L; Fisher, Dennis G; Brocato, Jo; van Otterloo, Lucy; Khahlil, Khaloud; Huckabay, Loucine

    2017-09-01

    Even with technological advances in point-of-care rapid testing for HIV, hepatitis, and syphilis, individuals may still find the experience of submitting to testing, and receiving results, to be stressful. Participants completed the rapid test experience questionnaires to assess stress both prior to and after the specimen collection. Participants completed the risk behavior assessment, the coping strategies indicator, and the Barratt impulsivity scale. Participants chose which rapid tests they wanted using a list administered via computer. Logistic regression analysis was used to model self-reported stress prior to testing and after testing. A total of 1097 individuals completed testing. Individuals who scored high on avoidance reported a stressful experience at pretest (OR = 1.15, CI = 1.04, 1.26) while higher educational attainment was associated with no stress at both time points. Injection drug users, avoidant, and impulsive individuals experience stress either before or after rapid testing. Education appears to be protective against stressful testing.

  15. Quality assurance for HIV point-of-care testing and treatment monitoring assays

    Science.gov (United States)

    Sandstrom, Paul; Denny, Thomas N.; Hurlston, Mackenzie; Ball, Terry B.; Peeling, Rosanna W.; Boeras, Debrah I.

    2016-01-01

    In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of people infected with HIV to become aware of their status, access antiretroviral therapies and ultimately be virally suppressed. To achieve these goals, countries may need to scale up point-of-care (POC) testing in addition to strengthening central laboratory services. While decentralising testing increases patient access to diagnostics, it presents many challenges with regard to training and assuring the quality of tests and testing. To ensure synergies, the London School of Hygiene & Tropical Medicine held a series of consultations with countries with an interest in quality assurance and their implementing partners, and agreed on an external quality assessment (EQA) programme to ensure reliable results so that the results lead to the best possible care for HIV patients. As a result of the consultations, EQA International was established, bringing together EQA providers and implementers to develop a strategic plan for countries to establish national POC EQA programmes and to estimate the cost of setting up and maintaining the programme. With the dramatic increase in the number of proficiency testing panels required for thousands of POC testing sites across Africa, it is important to facilitate technology transfer from global EQA providers to a network of regional EQA centres in Africa for regional proficiency testing panel production. EQA International will continue to identify robust and cost-effective EQA technologies for quality POC testing, integrating novel technologies to support sustainable country-owned EQA programmes in Africa. PMID:28879133

  16. Evaluating operational specifications of point-of-care diagnostic tests: a standardized scorecard.

    Directory of Open Access Journals (Sweden)

    Jonathan D Lehe

    Full Text Available The expansion of HIV antiretroviral therapy into decentralized rural settings will increasingly require simple point-of-care (POC diagnostic tests that can be used without laboratory infrastructure and technical skills. New POC test devices are becoming available but decisions around which technologies to deploy may be biased without systematic assessment of their suitability for decentralized healthcare settings. To address this, we developed a standardized, quantitative scorecard tool to objectively evaluate the operational characteristics of POC diagnostic devices. The tool scores devices on a scale of 1-5 across 30 weighted characteristics such as ease of use, quality control, electrical requirements, shelf life, portability, cost and service, and provides a cumulative score that ranks products against a set of ideal POC characteristics. The scorecard was tested on 19 devices for POC CD4 T-lymphocyte cell counting, clinical chemistry or hematology testing. Single and multi-parameter devices were assessed in each of test categories. The scores across all devices ranged from 2.78 to 4.40 out of 5. The tool effectively ranked devices within each category (p0.80; p<0.001. Use of this tool enables the systematic evaluation of diagnostic tests to facilitate product selection and investment in appropriate technology. It is particularly relevant for countries and testing programs considering the adoption of new POC diagnostic tests.

  17. Quality assurance for HIV point-of-care testing and treatment monitoring assays.

    Science.gov (United States)

    Meyers, Adrienne F A; Sandstrom, Paul; Denny, Thomas N; Hurlston, Mackenzie; Ball, Terry B; Peeling, Rosanna W; Boeras, Debrah I

    2016-01-01

    In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of people infected with HIV to become aware of their status, access antiretroviral therapies and ultimately be virally suppressed. To achieve these goals, countries may need to scale up point-of-care (POC) testing in addition to strengthening central laboratory services. While decentralising testing increases patient access to diagnostics, it presents many challenges with regard to training and assuring the quality of tests and testing. To ensure synergies, the London School of Hygiene & Tropical Medicine held a series of consultations with countries with an interest in quality assurance and their implementing partners, and agreed on an external quality assessment (EQA) programme to ensure reliable results so that the results lead to the best possible care for HIV patients. As a result of the consultations, EQA International was established, bringing together EQA providers and implementers to develop a strategic plan for countries to establish national POC EQA programmes and to estimate the cost of setting up and maintaining the programme. With the dramatic increase in the number of proficiency testing panels required for thousands of POC testing sites across Africa, it is important to facilitate technology transfer from global EQA providers to a network of regional EQA centres in Africa for regional proficiency testing panel production. EQA International will continue to identify robust and cost-effective EQA technologies for quality POC testing, integrating novel technologies to support sustainable country-owned EQA programmes in Africa.

  18. HIV Point-of-Care Testing in Canadian Settings: A Scoping Review.

    Science.gov (United States)

    Minichiello, Alexa; Swab, Michelle; Chongo, Meck; Marshall, Zack; Gahagan, Jacqueline; Maybank, Allison; Hot, Aurélie; Schwandt, Michael; Gaudry, Sonia; Hurley, Oliver; Asghari, Shabnam

    2017-01-01

    HIV point-of-care testing (POCT) was approved for use in Canada in 2005 and provides important public health benefits by providing rapid screening results rather than sending a blood sample to a laboratory and waiting on test results. Access to test results soon after testing (or during the same visit) is believed to increase the likelihood that individuals will receive their results and improve access to confirmatory testing and linkages to care. This paper reviews the literature on the utilization of HIV POCT across Canadian provinces. We searched OVID Medline, Embase, EBM Reviews, PsycINFO, CINAHL, and 20 electronic grey literature databases. All empirical studies investigating HIV POCT programs in Canada published in French or English were included. Searches of academic databases identified a total of 6,091 records. After removing duplicates and screening for eligibility, 27 records were included. Ten studies are peer-reviewed articles, and 17 are grey literature reports. HIV POCT in Canada is both feasible and accepted by Canadians. It is preferred to conventional HIV testing (ranging from 81.1 to 97%), and users are highly satisfied with the testing process (ranging between 96 and 100%). The majority of studies demonstrate that HIV POCT is feasible, preferred, and accepted by diverse populations in Canada. Losses to follow-up and linkage rates are also good. However, more research is needed to understand how best to scale up HIV POCT in contexts that currently have very limited or no access to testing.

  19. The introduction of syphilis point of care tests in resource limited settings.

    Science.gov (United States)

    Marks, Michael; Mabey, David Cw

    2017-04-01

    Syphilis remains an important and preventable cause of stillbirth and neonatal mortality. About 1 million women with active syphilis become pregnant each year. Without treatment, 25% of them will deliver a stillborn baby and 33% a low birth weight baby with an increased chance of dying in the first month of life. Adverse pregnancy outcomes due to syphilis can be prevented by screening pregnant women, and treating those who test positive with a single dose of penicillin before 28 weeks' gestation. Areas covered: This manuscript covers the impact of syphilis on pregnancy outcome, the diagnosis of syphilis, with a special focus on point of care (POC) tests, and challenges to the introduction of POC tests, and their potential impact on the control and prevention of syphilis in resource limited settings. Expert commentary: POC tests for syphilis are available which meet the ASSURED criteria, and could make syphilis screening accessible to all women anywhere in the world who attend an antenatal clinic. High quality dual POC tests for HIV and syphilis could ensure that well-funded programmes for the prevention of mother to child transmission of HIV can contribute towards increased coverage of antenatal syphilis screening, and prevent more than 300,000 adverse pregnancy outcomes due to syphilis annually. Alongside investment to increase availability of syphilis POC tests, operational research is needed to understand how best to improve screening of pregnant women and to translate test availability into improved pregnancy outcomes.

  20. The laboratory information float, time-based competition, and point-of-care testing.

    Science.gov (United States)

    Friedman, B A

    1994-01-01

    A new term, the laboratory information float, should be substituted for turnaround-time when evaluating the performance of the clinical laboratory because it includes the time necessary to make test results both available (ready to use) and accessible (easy to use) to clinicians ordering tests. The laboratory information float can be greatly reduced simply by telescoping the analytic phase of laboratory testing into the preanalytic phase. Significant costs are incurred by such a change, some of which can be reduced by developing a mobile clinical laboratory (sometimes referred to as a "lab-on-a-slab" or "rolling thunder") to transport the analytic devices directly to patient care units. The mobile clinical laboratory should be equipped with an integrated personal computer that can communicate continuously with the host laboratory information system and achieve some semblance of continuous flow processing despite test performance in point-of-care venues. Equipping clinicians with palmtop computers will allow the mobile clinician to access test results and order tests on the run. Such devices can be easily configured to operate in a passive mode, accessing relevant information automatically instead of forcing clinicians to query the laboratory information system periodically for the test results necessary to render care to their patients. The laboratory information float of the year 2,000 will surely be measured in minutes through the judicious deployment of relevant technology such as mobile clinical laboratories and palmtop computers.

  1. Comparison of Result Times Between Urine and Whole Blood Point-of-care Pregnancy Testing.

    Science.gov (United States)

    Gottlieb, Michael; Wnek, Kristopher; Moskoff, Jordan; Christian, Errick; Bailitz, John

    2016-07-01

    Point-of-care (POC) pregnancy testing is commonly performed in the emergency department (ED). One prior study demonstrated equivalent accuracy between urine and whole blood for one common brand of POC pregnancy testing. Our study sought to determine the difference in result times when comparing whole blood versus urine for the same brand of POC pregnancy testing. We conducted a prospective, observational study at an urban, academic, tertiary care hospital comparing the turnaround time between order and result for urine and whole blood pregnancy tests collected according to standard protocol without intervention from the investigators. After the blood was collected, the nurse would place three drops onto a Beckman Coulter ICON 25 Rapid HCG bedside pregnancy test and set a timer for 10 minutes. At the end of the 10 minutes, the result and time were recorded on an encoded data sheet and not used clinically. The same make and model analyzer was also used for urine tests in the lab located within the ED. The primary outcome was the difference in mean turnaround time between whole blood in the ED and urine testing in the adjacent lab results. Concordance between samples was assessed as a secondary outcome. 265 total patients were included in the study. The use of whole blood resulted in a mean time savings of 21 minutes (95% CI 16-25 minutes) when compared with urine (ptesting may reduce the total result turnaround time without significant changes in accuracy in this single-center study.

  2. A Novel Quantum Dots-Based Point of Care Test for Syphilis

    Science.gov (United States)

    Yang, Hao; Li, Ding; He, Rong; Guo, Qin; Wang, Kan; Zhang, Xueqing; Huang, Peng; Cui, Daxiang

    2010-05-01

    One-step lateral flow test is recommended as the first line screening of syphilis for primary healthcare settings in developing countries. However, it generally shows low sensitivity. We describe here the development of a novel fluorescent POC (Point Of Care) test method to be used for screening for syphilis. The method was designed to combine the rapidness of lateral flow test and sensitiveness of fluorescent method. 50 syphilis-positive specimens and 50 healthy specimens conformed by Treponema pallidum particle agglutination (TPPA) were tested with Quantum Dot-labeled and colloidal gold-labeled lateral flow test strips, respectively. The results showed that both sensitivity and specificity of the quantum dots-based method reached up to 100% (95% confidence interval [CI], 91-100%), while those of the colloidal gold-based method were 82% (95% CI, 68-91%) and 100% (95% CI, 91-100%), respectively. In addition, the naked-eye detection limit of quantum dot-based method could achieve 2 ng/ml of anti-TP47 polyclonal antibodies purified by affinity chromatography with TP47 antigen, which was tenfold higher than that of colloidal gold-based method. In conclusion, the quantum dots were found to be suitable for labels of lateral flow test strip. Its ease of use, sensitiveness and low cost make it well-suited for population-based on-the-site syphilis screening.

  3. Niche point-of-care endocrine testing - Reviews of intraoperative parathyroid hormone and cortisol monitoring.

    Science.gov (United States)

    Chen, Li-Sheng; Singh, Ravinder J

    2018-03-01

    Point-of-care (POC) testing, which provides quick test results in near-patient settings with easy-to-use devices, has grown continually in recent decades. Among near-patient and on-site tests, rapid intraoperative and intra-procedural assays are used to quickly deliver critical information and thereby improve patient outcomes. Rapid intraoperative parathyroid hormone (ioPTH) monitoring measures postoperative reduction of parathyroid hormone (PTH) to predict surgical outcome in patients with primary hyperparathyroidism, and therefore contributes to the change of parathyroidectomy to a minimally invasive procedure. In this review, recent progress in applying ioPTH monitoring to patients with secondary and tertiary hyperparathyroidism and other testing areas is discussed. In-suite cortisol monitoring facilitates the use of adrenal vein sampling (AVS) for the differential diagnosis of primary aldosteronism and adrenocorticotropic hormone (ACTH)-independent Cushing syndrome. In clinical and psychological research settings, POC testing is also useful for rapidly assessing cortisol in plasma and saliva samples as a biomarker of stress. Careful resource utilization and coordination among stakeholders help to determine the best approach for implementing cost-effective POC testing. Technical advances in integrating appropriate biosensors with microfluidics-based devices hold promise for future real-time POC cortisol monitoring.

  4. Validity of Point-of-Care Testing with Mission Plus Hemoglobin in Detecting Anemia

    Directory of Open Access Journals (Sweden)

    S Maria Awaluddin

    2015-06-01

    Full Text Available Background: Point-of-care testing, POCT, was widely used to assess hemoglobin status before proceeding with the confirmation test. Our study aimed to assess the validity of Mission® Plus Hb in detecting hemoglobin levels in a general population compared with a standard laboratory hematology analyser as the gold standard. Methods: Two types of samples, capillary and venous blood, were collected from all respondents by trained nurses. Both blood samples were tested using Mission® Plus while the remaining venous blood in EDTA test tubes was sent to the reference laboratory. Results: A total of 622 respondents participated in this study, 75% of them females. The mean Hb tested from capillary blood using Mission® Plus Hb was 11.80±2.02g/dl. For venous blood, the mean Hb concentrations using Mission® Plus Hb and Sysmex XE-2100 hematology analyser were 12.16±1.84g/dl and 13.07±1.87g/dl, respectively. Sensitivity and specificity in detecting anemia from venous samples were 98.8% and 73.4% respectively. Positive Predictive Value (PPV was 58.5%, while Negative Predictive Value (NPV was 99.4%. Conclusion: The findings of moderate PPV should alert the programme managers to the importance of a confirmatory test following screening using Mission® Plus Hb.

  5. C-reactive protein point-of-care testing and associated antibiotic prescribing.

    Science.gov (United States)

    Minnaard, Margaretha C; van de Pol, Alma C; Hopstaken, Rogier M; van Delft, Sanne; Broekhuizen, Berna D L; Verheij, Theo J M; de Wit, Niek J

    2016-08-01

    In clinical trials, the potential of point-of-care (POC) C-reactive protein (CRP) tests was demonstrated in decreasing antibiotic prescribing in adults with acute cough in general practice, but effects of implementation are unknown. To determine the overall effect of POC CRP testing on antibiotic prescribing rate in general practice. In an observational study, GPs were instructed to use POC CRP in adults with acute cough following current guidelines. After routine history taking and physical examination, they reported whether they intended to prescribe antibiotics ('pre-test decision'). They reported their revised decision after receiving the POC CRP test result ('post-test decision'). Primary outcome was the percentage of patients in whom the GP changed his or her decision to prescribe antibiotics. Secondary outcome was the difference between 'pre-test' and 'post-test' antibiotic prescribing % at group level. A total of 40 GPs enrolled 939 patients, 78% of whom were tested for CRP. GPs changed their decision after POC CRP testing in 200 patients (27%). Antibiotic prescribing before and after CRP testing did not differ ('pre-test' 31%, 'post-test' 28%; 95% confidence interval of difference -7 to 1). In 41% of the tested patients, the indication for testing was in accordance with the guidelines. POC CRP influenced GPs to change their decision about antibiotic prescribing in patients with acute cough. POC CRP testing does not reduce overall antibiotic prescribing by GPs who already have a low antibiotic prescribing rate. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. Validation of G6PD Point-of-Care Tests among Healthy Volunteers in Yangon, Myanmar.

    Directory of Open Access Journals (Sweden)

    Nwe Nwe Oo

    Full Text Available Primaquine and other 8-amnoquinoline based anti-malarials can cause haemolysis in subjects with glucose-6-phosphate dehydrogenase (G6PD deficiency. Correct diagnosis of G6PD status in patients is crucial for safe treatment of both relapsing stages of Plasmodium vivax and transmitting forms of Plasmodium falciparum. Lack of suitable point-of-care tests has hampered a much needed wide use of primaquine for malaria elimination. In this study we have assessed the performances of two qualitative tests, the fluorescent spot test (FST and the G6PD CareStart test (CST, against the gold standard quantitative spectrophotometric assay in a population of 1000 random adult healthy volunteers living in Yangon, Myanmar. The prevalence of G6PD deficiency in the Bamar, Karen and in the whole sample set was 6.6% (10.1% in males, 9.2% (21.0% in males and 6.8% (11.1% in males respectively. The FST and CST showed comparable performances with sensitivity over 95% and specificity over 90%, however for cases with severe G6PD activity the FTS had improved performance. If used with a conservative interpretation of the signal, the CareStart test has the potential to be used in the field and, by allowing a wider use of primaquine, to help malaria elimination.

  7. A Novel Molecular Test to Diagnose Canine Visceral Leishmaniasis at the Point of Care

    Science.gov (United States)

    Castellanos-Gonzalez, Alejandro; Saldarriaga, Omar A.; Tartaglino, Lilian; Gacek, Rosana; Temple, Elissa; Sparks, Hayley; Melby, Peter C.; Travi, Bruno L.

    2015-01-01

    Dogs are the principal reservoir hosts of zoonotic visceral leishmaniasis (VL) but current serological methods are not sensitive enough to detect all subclinically infected animals, which is crucial to VL control programs. Polymerase chain reaction (PCR) methods have greater sensitivity but require expensive equipment and trained personnel, impairing its implementation in endemic areas. We developed a diagnostic test that uses isothermal recombinase polymerase amplification (RPA) to detect Leishmania infantum. This method was coupled with lateral flow (LF) reading with the naked eye to be adapted as a point-of-care test. The L. infantum RPA-LF had an analytical sensitivity similar to real time-PCR, detecting DNA of 0.1 parasites spiked in dog blood, which was equivalent to 40 parasites/mL. There was no cross amplification with dog or human DNA or with Leishmania braziliensis, Leishmania amazonensis, or Trypanosoma cruzi. The test also amplified Leishmania donovani strains (N = 7). In a group of clinically normal dogs (N = 30), RPA-LF detected more subclinical infections than rK39 strip test, a standard serological method (50% versus 13.3% positivity, respectively; P = 0.005). Also, RPA-LF detected L. infantum in noninvasive mucosal samples of dogs with a sensitivity comparable to blood samples. This novel molecular test may have a positive impact in leishmaniasis control programs. PMID:26240156

  8. Point-of-care testing for respiratory viruses in adults: The current landscape and future potential.

    Science.gov (United States)

    Brendish, Nathan J; Schiff, Hannah F; Clark, Tristan W

    2015-11-01

    Respiratory viruses are responsible for a large proportion of acute respiratory illness in adults as well as children, and are associated with a huge socio-economic burden worldwide. Development of accurate point-of-care tests (POCT) for respiratory viruses has been listed as a priority by the World Health Organisation and replacing the current paradigm of empirical antimicrobial use with directed use is a listed goal of the movement for reduction in antimicrobial resistance. POCTs for respiratory viruses have previously been limited by the poor sensitivity of antigen detection based tests and by a limited range of detectable viruses. Highly accurate molecular platforms are now able to test for a comprehensive range of viruses, can be operated by non-laboratory staff and can generate a result in approximately 1 h, making them potentially deployable as POCTs. The potential clinical benefits of POC testing for respiratory viruses in adults include a reduction in unnecessary antibiotic use, improved antiviral prescribing for influenza and rationalisation of isolation facilities. We review here the burden of disease, the currently available molecular platforms with potential for POCT use and the existing evidence for clinical and economic benefits of testing for respiratory viruses in adults. Copyright © 2015 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

  9. Impact of point-of-care CD4 testing on linkage to HIV care: a systematic review.

    Science.gov (United States)

    Wynberg, Elke; Cooke, Graham; Shroufi, Amir; Reid, Steven D; Ford, Nathan

    2014-01-01

    Point-of-care testing for CD4 cell count is considered a promising way of reducing the time to eligibility assessment for antiretroviral therapy (ART) and of increasing retention in care prior to treatment initiation. In this review, we assess the available evidence on the patient and programme impact of point-of-care CD4 testing. We searched nine databases and two conference sites (up until 26 October 2013) for studies reporting patient and programme outcomes following the introduction of point-of-care CD4 testing. Where appropriate, results were pooled using random-effects methods. Fifteen studies, mainly from sub-Saharan Africa, were included for review, providing evidence for adults, adolescents, children and pregnant women. Compared to conventional laboratory-based testing, point-of-care CD4 testing increased the likelihood of having CD4 measured [odds ratio (OR) 4.1, 95% CI 3.5-4.9, n=2] and receiving a CD4 result (OR 2.8, 95% CI 1.5-5.6, n=6). Time to being tested was significantly reduced, by a median of nine days; time from CD4 testing to receiving the result was reduced by as much as 17 days. Evidence for increased treatment initiation was mixed. The results of this review suggest that point-of-care CD4 testing can increase retention in care prior to starting treatment and can also reduce time to eligibility assessment, which may result in more eligible patients being initiated on ART.

  10. Sensitivity and specificity of point-of-care rapid combination syphilis-HIV-HCV tests.

    Directory of Open Access Journals (Sweden)

    Kristen L Hess

    Full Text Available New rapid point-of-care (POC tests are being developed that would offer the opportunity to increase screening and treatment of several infections, including syphilis. This study evaluated three of these new rapid POC tests at a site in Southern California.Participants were recruited from a testing center in Long Beach, California. A whole blood specimen was used to evaluate the performance of the Dual Path Platform (DPP Syphilis Screen & Confirm, DPP HIV-Syphilis, and DPP HIV-HCV-Syphilis rapid tests. The gold-standard comparisons were Treponema pallidum passive particle agglutination (TPPA, rapid plasma reagin (RPR, HCV enzyme immunoassay (EIA, and HIV-1/2 EIA.A total of 948 whole blood specimens were analyzed in this study. The sensitivity of the HIV tests ranged from 95.7-100% and the specificity was 99.7-100%. The sensitivity and specificity of the HCV test were 91.8% and 99.3%, respectively. The treponemal-test sensitivity when compared to TPPA ranged from 44.0-52.7% and specificity was 98.7-99.6%. The non-treponemal test sensitivity and specificity when compared to RPR was 47.8% and 98.9%, respectively. The sensitivity of the Screen & Confirm test improved to 90.0% when cases who were both treponemal and nontreponemal positive were compared to TPPA+/RPR ≥ 1 ∶ 8.The HIV and HCV on the multi-infection tests showed good performance, but the treponemal and nontreponemal tests had low sensitivity. These results could be due to a low prevalence of active syphilis in the sample population because the sensitivity improved when the gold standard was limited to those more likely to be active cases. Further evaluation of the new syphilis POC tests is required before implementation into testing programs.

  11. Point-of-Care Hemoglobin/Hematocrit Testing: Comparison of Methodology and Technology.

    Science.gov (United States)

    Maslow, Andrew; Bert, Arthur; Singh, Arun; Sweeney, Joseph

    2016-04-01

    Point-of-care (POC) testing allows rapid assessment of hemoglobin (Hgb) and hematocrit (Hct) values. This study compared 3 POC testing devices--the Radical-7 pulse oximeter (Radical-7, Neuchȃtel, Switzerland), the i-STAT (Abbott Point of Care, Princeton, NJ), and the GEM 4000 (Instrumentation Laboratory, Bedford, MA)--to the hospital reference device, the UniCel DxH 800 (Beckman Coulter, Brea, CA) in cardiac surgery patients. Prospective study. Tertiary care cardiovascular center. Twenty-four consecutive elective adult cardiac surgery patients. Hgb and Hct values were measured using 3 POC devices (the Radical-7, i-STAT, and GEM 4000) and a reference laboratory device (UniCel DxH 800). Data were collected simultaneously before surgery, after heparin administration, after heparin reversal with protamine, and after sternal closure. Data were analyzed using bias analyses. POC testing data were compared with that of the reference laboratory device. Hgb levels ranged from 6.8 to 15.1 g/dL, and Hct levels ranged from 20.1% to 43.8%. The overall mean bias was lowest with the i-STAT (Hct, 0.22%; Hgb 0.05 g/dL) compared with the GEM 4000 (Hct, 2.15%; Hgb, 0.63 g/dL) and the Radical-7 (Hgb 1.16 g/dL). The range of data for the i-STAT and Radical-7 was larger than that with the GEM 4000, and the pattern or slopes changed significantly with the i-STAT and Radical-7, whereas that of the GEM 4000 remained relatively stable. The GEM 4000 demonstrated a consistent overestimation of laboratory data, which tended to improve after bypass and at lower Hct/Hgb levels. The i-STAT bias changed from overestimation to underestimation, the latter in the post-cardiopulmonary bypass period and at lower Hct/Hgb levels. By contrast, the Radical-7 biases increased during the surgical procedure and in the lower ranges of Hgb. Important clinical differences and limitations were found among the 3 POC testing devices that should caution clinicians from relying on these data as sole determinants of

  12. Cost-effectiveness of point-of-care testing for dehydration in the pediatric ED.

    Science.gov (United States)

    Whitney, Rachel E; Santucci, Karen; Hsiao, Allen; Chen, Lei

    2016-08-01

    Acute gastroenteritis (AGE) and subsequent dehydration account for a large proportion of pediatric emergency department (PED) visits. Point-of-care (POC) testing has been used in conjunction with clinical assessment to determine the degree of dehydration. Despite the wide acceptance of POC testing, little formal cost-effective analysis of POC testing in the PED exists. We aim to examine the cost-effectiveness of using POC electrolyte testing vs traditional serum chemistry testing in the PED for children with AGE. This was a cost-effective analysis using data from a randomized control trial of children with AGE. A decision analysis model was constructed to calculate cost-savings from the point of view of the payer and the provider. We used parameters obtained from the trial, including cost of testing, admission rates, cost of admission, and length of stay. Sensitivity analyses were performed to evaluate the stability of our model. Using the data set of 225 subjects, POC testing results in a cost savings of $303.30 per patient compared with traditional serum testing from the point of the view of the payer. From the point-of-view of the provider, POC testing results in consistent mean savings of $36.32 ($8.29-$64.35) per patient. Sensitivity analyses demonstrated the stability of the model and consistent savings. This decision analysis provides evidence that POC testing in children with gastroenteritis-related moderate dehydration results in significant cost savings from the points of view of payers and providers compared to traditional serum chemistry testing. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Implementation of point-of-care testing in a general internal medicine practice: A confirmation study.

    Science.gov (United States)

    Lewandrowski, Elizabeth-Lee; Yeh, Sunu; Baron, Jason; Benjamin Crocker, J; Lewandrowski, Kent

    2017-10-01

    In a previous study we reported on the impact of point-of-care testing (POCT) on practice efficiency in an academic primary care practice that was established to develop new models of care delivery. Here we report a follow-on confirmation study in a more typical primary care practice in the community. In this observational study with a retrospective comparison analysis we measured metrics of practice efficiency on two patient cohorts: those that did not receive POCT and those that did. In the patient cohort that received POCT there was a 99% reduction in letters to patients (ptests per visit (p=0.044) and a 38% reduction in follow-up visits due to abnormal test results (p=0.178). Financial analysis including testing costs, revenues and efficiency gains to the practice demonstrated a net financial benefit of $11.90-14.74 per patient visit. Our data confirm the earlier published findings that POCT can improve metrics of practice efficiency in a primary care practice. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. A point-of-care chemistry test for reduction of turnaround and clinical decision time.

    Science.gov (United States)

    Lee, Eui Jung; Shin, Sang Do; Song, Kyoung Jun; Kim, Seong Chun; Cho, Jin Seong; Lee, Seung Chul; Park, Ju Ok; Cha, Won Chul

    2011-06-01

    Our study compared clinical decision time between patients managed with a point-of-care chemistry test (POCT) and patients managed with the traditional central laboratory test (CLT). This was a randomized controlled multicenter trial in the emergency departments (EDs) of 5 academic teaching hospitals. We randomly assigned patients to POCT or CLT stratified by the Emergency Severity Index. A POCT chemistry analyzer (Piccolo; Abaxis, Inc, Union City, Calif), which is able to test liver panel, renal panel, pancreas enzymes, lipid panel, electrolytes, and blood gases, was set up in each ED. Primary and secondary end point was turnaround time and door-to-clinical-decision time. The total 2323 patients were randomly assigned to the POCT group (n = 1167) or to the CLT group (n = 1156). All of the basic characteristics were similar in the 2 groups. The turnaround time (median, interquartile range [IQR]) of the POCT group was shorter than that of the CLT group (14, 12-19 versus 55, 45-69 minutes; P CLT group (46, 33-61 versus 86, 68-107 minutes; P CLT group (P CLT. Copyright © 2011 Elsevier Inc. All rights reserved.

  15. Evaluation of point-of-care testing of C-reactive protein in forensic autopsy cases.

    Science.gov (United States)

    Soejima, Mikiko; Koda, Yoshiro

    2014-04-01

    We assessed the technical performance and robustness of the point-of-care test for C-reactive protein (CRP) NycoCard CRP for use in forensic autopsy cases. The results of 17 of 39 cadaver blood samples that had CRP in the range effectively measured by the NycoCard (5-120mg/l) correlated well (r=0.99) with those of quantitative latex agglutination immunoassay (turbidimetry), and the out-of-range NycoCard results were fully consistent with those obtained by turbidimetry. For the ten sera whose CRP >120mg/l according to NycoCard, a significant correlation (r=0.98) was observed between values multiplied by the dilution ratio and those of turbidimetry. No significant differences were observed after a freeze-thaw procedure. In addition, CRP results using recombinant human CRP spiked with hemoglobin up to 80g/l were not significantly different from the unspiked results in PBS. The test allows reliable and cost-effective on-site measurement of CRP from a small volume of serum (5μl) with simple equipment. This semi-quantification method of CRP should be useful for diagnosis during autopsy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  16. Surface enhanced Raman spectroscopy (SERS) for in vitro diagnostic testing at the point of care

    Science.gov (United States)

    Marks, Haley; Schechinger, Monika; Garza, Javier; Locke, Andrea; Coté, Gerard

    2017-06-01

    Point-of-care (POC) device development is a growing field that aims to develop low-cost, rapid, sensitive in-vitro diagnostic testing platforms that are portable, self-contained, and can be used anywhere - from modern clinics to remote and low resource areas. In this review, surface enhanced Raman spectroscopy (SERS) is discussed as a solution to facilitating the translation of bioanalytical sensing to the POC. The potential for SERS to meet the widely accepted "ASSURED" (Affordable, Sensitive, Specific, User-friendly, Rapid, Equipment-free, and Deliverable) criterion provided by the World Health Organization is discussed based on recent advances in SERS in vitro assay development. As SERS provides attractive characteristics for multiplexed sensing at low concentration limits with a high degree of specificity, it holds great promise for enhancing current efforts in rapid diagnostic testing. In outlining the progression of SERS techniques over the past years combined with recent developments in smart nanomaterials, high-throughput microfluidics, and low-cost paper diagnostics, an extensive number of new possibilities show potential for translating SERS biosensors to the POC.

  17. Laser-induced fluorescence detection platform for point-of-care testing

    Science.gov (United States)

    Berner, Marcel; Hilbig, Urs; Schubert, Markus B.; Gauglitz, Günter

    2017-08-01

    Point-of-care testing (POCT) devices for continuous low-cost monitoring of critical patient parameters require miniaturized and integrated setups for performing quick high-sensitivity analyses, away from central clinical laboratories. This work presents a novel and promising laser-induced fluorescence platform for measurements in direct optical test formats that leads towards such powerful POCT devices based on fluorescence-labeled immunoassays. Ultimate sensitivity of thin film photodetectors, integrated with microfluidics, and a comprehensive optimization of all system components aim at low-level signal detection in the targeted biosensor application. The setup acquires fluorescence signals from the volume of a microfluidic channel. An innovative sandwiching process forms a flow channel in the microfluidic chips by embedding laser-cut double-sided adhesive tapes. The custom fit of amorphous silicon based photodiode arrays to the geometry of the flow channel enables miniaturization, fully adequate for POCT devices. A free-beam laser excitation with line focus provides excellent alignment stability, allows for easy and reliable swapping of the disposable microfluidic chips, and therewith greatly improves the ease of use of the resulting integrated device. As a proof-of-concept of this novel in-volume measurement approach, the limit of detection for the dye DY636-COOH in pure water as a model fluorophore is examined and found to be 26 nmol l-1 .

  18. Surface enhanced Raman spectroscopy (SERS for in vitro diagnostic testing at the point of care

    Directory of Open Access Journals (Sweden)

    Marks Haley

    2017-06-01

    Full Text Available Point-of-care (POC device development is a growing field that aims to develop low-cost, rapid, sensitive in-vitro diagnostic testing platforms that are portable, self-contained, and can be used anywhere – from modern clinics to remote and low resource areas. In this review, surface enhanced Raman spectroscopy (SERS is discussed as a solution to facilitating the translation of bioanalytical sensing to the POC. The potential for SERS to meet the widely accepted “ASSURED” (Affordable, Sensitive, Specific, User-friendly, Rapid, Equipment-free, and Deliverable criterion provided by the World Health Organization is discussed based on recent advances in SERS in vitro assay development. As SERS provides attractive characteristics for multiplexed sensing at low concentration limits with a high degree of specificity, it holds great promise for enhancing current efforts in rapid diagnostic testing. In outlining the progression of SERS techniques over the past years combined with recent developments in smart nanomaterials, high-throughput microfluidics, and low-cost paper diagnostics, an extensive number of new possibilities show potential for translating SERS biosensors to the POC.

  19. Point-of-care blood ketone testing: screening for diabetic ketoacidosis at the emergency department.

    Science.gov (United States)

    Charles, R A; Bee, Y M; Eng, P H K; Goh, S Y

    2007-11-01

    We piloted the use of a blood beta-hydroxybutyrate meter as a point-of-care testing in an emergency department (ED) to establish its role in distinguishing ketosis/ketoacidosis from simple hyperglycaemia, and develop guidelines for its use in the ED. 111 consecutive patients presenting with capillary glucose levels exceeding 14 mmol/L had a simultaneous blood ketone measurement at triage. This was correlated with clinical diagnosis, venous bicarbonate levels and urine ketone testing. The median beta-hydroxybutyrate levels was 5.7 (range 4.3-6.0) mmol/L for patients with diabetic ketoacidosis (DKA) and 0.1 (0.0-3.2) mmol/L for the remaining patients. Only 47.7 percent could provide urine samples in the ED. A blood ketone result of 3.5 mmol/L yielded 100 percent specificity and sensitivity for the diagnosis of DKA. This is a useful tool that allows clinicians to immediately distinguish between simple hyperglycaemia and potentially life-threatening ketotic states. We formulated simple guidelines for its utilisation in an ED setting.

  20. Point of care blood ketone testing of diabetic patients in the emergency department.

    Science.gov (United States)

    Bektas, Firat; Eray, Oktay; Sari, Ramazan; Akbas, Halide

    2004-08-01

    The aim of our study was to determine the utility of point-of-care blood ketone testing in diabetic patients presenting to the emergency department. In this prospective, observational clinical study, patients with known or newly diagnosed diabetes mellitus presenting to our tertiary care university emergency department with any nontrauma related medical complaint and a high fingerstick glucose (> or =200 mg/dL) were eligible for inclusion. Capillary blood beta-hydroxybutyrate (beta-HBA), venous blood beta-HBA level, venous blood glucose level, arterial blood gas analysis, and urine ketone dipstickstick were measured in each patient as primary outcome measures. Of the 479 diabetic patients presenting during the study period, a total of 139 diabetic patients with high capillary blood glucose level (> or =200 mg/dL) and a positive capillary blood beta-HBA (> or =0.1 mmol/L) were included in the study. Hyperketonemia (> or =0.42 mmol/L) was found in 48 of these patients by Sigma Diagnostics reference testing (diabetic ketosis in 35%). The calculated blood pH was less than 7.3 in 18 of these 48 patients (ketoacidosis in 31%). Capillary and venous blood beta-hydroxybutyrate levels were not statistically different from each other (P = 0.824). There was a positive correlation between capillary and venous blood beta-HBA levels (r = 0.488, P urine ketone dipstick testing and capillary blood ketone testing in determining diabetic ketoacidosis were 66% and 78%, and 72% and 82%; and in determining hyperketonemia (both in diabetic ketosis and diabetic ketoacidosis) were 82% and 54%, and 91% and 56%, respectively. A rapid, bedside capillary blood ketone test for beta-HBA can accurately measure blood concentrations of beta-HBA in diabetic patients in an emergency department setting. This device can be used as a reliable diagnostic test to detect emergency metabolic problems in diabetic patients, such as diabetic ketosis or ketoacidosis.

  1. A miniaturised image based fluorescence detection system for point-of-care-testing of cocaine abuse

    Science.gov (United States)

    Walczak, Rafał; Krüger, Jan; Moynihan, Shane

    2015-08-01

    In this paper, we describe a miniaturised image-based fluorescence detection system and demonstrate its viability as a highly sensitive tool for point-of-care-analysis of drugs of abuse in human sweat with a focus on monitor individuals for drugs of abuse. Investigations of miniaturised and low power optoelectronic configurations and methodologies for real-time image analysis were successfully carried out. The miniaturised fluorescence detection system was validated against a reference detection system under controlled laboratory conditions by analysing spiked sweat samples in dip stick and then strip with sample pad. As a result of the validation studies, a 1 ng mL-1 limit of detection of cocaine in sweat and full agreement of test results with the reference detection system can be reported. Results of the investigations open the way towards a detection system that integrates a hand-held fluorescence reader and a wearable skinpatch, and which can collect and in situ analyse sweat for the presence of cocaine at any point for up to tenths hours.

  2. Point of care testing: Knowledge and utilization amongst Doctors in Government hospitals in Edo State, Nigeria.

    Science.gov (United States)

    Onovughakpo-Sakpa, E O; Osemwenkha, S O; Adewolu, O F; Okhimamhe, A F

    2015-01-01

    The study assessed the knowledge and utilization of point of care testing (POCT) amongst doctors in two health facilities in Edo State, Nigeria. A descriptive cross-sectional study was carried out using a multistage sampling technique. Data were collected from 174 doctors in both centers using a 25 item structured questionnaire which was analyzed using SPSS version 20.0. The mean age of respondents was 31.26±2.14 years with 120 (69.0%) males and 54 (31.0%) females (male: female=2.2:1). Knowledge of POCT and utilization of POCT devices was good in 50.6% and 32.2% of respondents respectively. Utilization of POCT correlated significantly with knowledge of POCT (r=0.67, P<0.001) and availability of POCT devices (r=0.43, P<0.001). There was statistically significant association between utilization of POCT devices and Hospital (χ2=9.95, P=0.002); job designation (χ2=10.03, P=0.018) and availability of POCT devices (χ2=6.80, P=0.001). However, no statistically significant relationship was found between utilization of POCT devices and sex (χ2=0.23, P=0.629). Promotion of POCT's utilization with regulation, training of doctors and establishment of regulatory framework/assessment teams will help improve healthcare services and achieve more beneficial outcomes. That way, POCT that is faster could be better.

  3. Nanobody-Based Apolipoprotein E Immunosensor for Point-of-Care Testing.

    Science.gov (United States)

    Ren, Xiang; Yan, Junrong; Wu, Dan; Wei, Qin; Wan, Yakun

    2017-09-22

    Alzheimer's disease (AD) biomarkers can reflect the neurochemical indicators used to estimate the risk in clinical nephrology. Apolipoprotein E (ApoE) is an early biomarker for AD in clinical diagnosis. In this research, through bactrian camel immunization, lymphocyte isolation, RNA extraction, and library construction, ApoE-specific Nbs with high affinity were successfully separated from an immune phage display nanobody library. Herein, a colorimetric immunosensor was developed for the point-of-care testing of ApoE by layer-by-layer nanoassembly techniques and novel nanobodies (Nbs). Using highly oriented Nbs as the capture and detection antibodies, an on-site immunosensor was developed by detecting the mean gray value of fade color due to the glutaraldehyde@3-aminopropyltrimethoxysilane oxidation by H 2 O 2 . The detection limit of AopE is 0.42 pg/mL, and the clinical analysis achieves a good performance. The novel easily operated immunosensor may have potential application in the clinical diagnosis and real-time monitoring for AD.

  4. Towards a point-of-care strip test to diagnose sickle cell anemia.

    Directory of Open Access Journals (Sweden)

    Meaghan Bond

    Full Text Available A rapid test to identify patients with sickle cell disease could have important benefits in low-resource settings. Sickle cell anemia (SCA affects about 300,000 newborns each year, the majority of whom are born in sub-Saharan Africa. Low-cost therapies are available to treat SCA, but most countries in sub-Saharan Africa lack robust neonatal screening programs needed to identify patients in need of treatment. To address this need, we developed and evaluated a competitive lateral flow assay that identifies patients with SCA (genotype HbSS in 15 minutes using undiluted whole blood. A small volume of blood (0.5 μL- 3 μL is mixed with antibody-coated blue latex beads in a tube and applied to the strip. Strips are then placed in a well of running buffer and allowed to run for 10 minutes. Laboratory evaluation with samples containing different proportions of hemoglobin A (HbA and hemoglobin S (HbS indicated that the test should enable identification of SCA patients but not persons with sickle cell trait (SCT. We evaluated the test using 41 samples from individuals with SCA, SCT, and normal blood. With visual inspection or quantitative analysis, we found a 98% accuracy when differentiating SCA from normal and SCT samples as a group (90% sensitivity and 100% specificity for identifying SCA. This work demonstrates important steps towards making a lateral flow test for hemoglobinopathies more appropriate for point-of-care use; further work is needed before the test is appropriate for clinical use.

  5. Point-of-care testing improves diabetes management in a primary care clinic in South Africa.

    Science.gov (United States)

    Motta, Lara A; Shephard, Mark D S; Brink, Julie; Lawson, Stefan; Rheeder, Paul

    2017-06-01

    Diabetes is a major health problem in South Africa. DiabCare Africa found just 47% of diabetes patients had a hemoglobin A1c (HbA1c) test for their management in the previous year. Patients attending an urban diabetes clinic near Johannesburg, run by Project HOPE, accessed HbA1c (and urine albumin:creatinine ratio) point-of-care testing (POCT) as part of a quality-assured international program called ACE (Analytical and Clinical Excellence). Patients who had two or more HbA1c POC tests from 2012 to 2014 were assessed to determine their change in glycaemic control. The mean (±SD) HbA1c in this group of diabetes patients (n=131) fell significantly from 9.7%±2.4 (83mmol/mol) at their first POCT measurement to 8.4%±2.4 (68mmol/mmol/mol) at their most recent POCT measurement (paired t-test ptest was 15 months. The number of diabetes patients achieving optimal glycaemic control (HbA1c≤6.5-7.5% [48-58mmol/mol) increased by 125%, while the number with very poor glycaemic control (HbA1c>10% [86mmol/mol]) halved. An association was observed between degree of glycaemic control and increasing albuminuria in this cohort. POCT has promoted change in clinical practice by facilitating greater accessibility to HbA1c testing. Copyright © 2017 Primary Care Diabetes Europe. All rights reserved.

  6. Microbiological point of care testing before antibiotic prescribing in primary care: considerable variations between practices.

    Science.gov (United States)

    Haldrup, Steffen; Thomsen, Reimar W; Bro, Flemming; Skov, Robert; Bjerrum, Lars; Søgaard, Mette

    2017-01-26

    Point-of-care testing (POCT) in primary care may improve rational antibiotic prescribing. We examined use of POCT in Denmark, including patient- and general practitioner (GP)-related predictors. We linked nationwide health care databases to assess POCT use (C-reactive protein (CRP), group A streptococcal (GAS) antigen swabs, bacteriological cultures, and urine test strips) per 1,000 overall GP consultations, 2004-2013. We computed odds ratios (OR) of POCT in patients prescribed antibiotics according to patient and GP age and sex, GP practice type, location, and workload. The overall use of POCT in Denmark increased by 45.8% during 2004-2013, from 147.2 per 1,000 overall consultations to 214.8. CRP tests increased by 132%, bacteriological cultures by 101.7% while GAS swabs decreased by 8.6%. POCT preceded 28% of antibiotic prescriptions in 2004 increasing to 44% in 2013. The use of POCT varied more than 5-fold among individual practices, from 54.9 to 394.7 per 1,000 consultations in 2013. POCT use varied substantially with patient age, and males were less likely to receive POCT than females (adjusted OR = 0.75, 95% CI 0.74-0.75) driven by usage of urine test strips among females (18% vs. 7%). Odds of POCT were higher among female GPs and decreased with higher GP age, with lowest usage among male GPs >60 years. GP urban/rural location and workload had little impact. GPs use POCT increasingly with the highest use among young female GPs. In 2013, 44% of all antibiotic prescriptions were preceded by POCT but testing rates vary greatly across individual GPs.

  7. Care model design for E-health : Integration of point-of-care testing at Dutch general practices

    NARCIS (Netherlands)

    Verhees, Bart; van Kuijk, Kees; Simonse, W.L.

    2018-01-01

    Point-of-care testing (POCT)—laboratory tests performed with new mobile devices and online technologies outside of the central laboratory—is rapidly outpacing the traditional laboratory test market, growing at a rate of 12 to 15% each year. POCT impacts the diagnostic process of care providers by

  8. Quality assuring HIV point of care testing using whole blood samples.

    Science.gov (United States)

    Dare-Smith, Raellene; Badrick, Tony; Cunningham, Philip; Kesson, Alison; Badman, Susan

    2016-08-01

    The Royal College of Pathologists Australasia Quality Assurance Programs (RCPAQAP), have offered dedicated external quality assurance (EQA) for HIV point of care testing (PoCT) since 2011. Prior to this, EQA for these tests was available within the comprehensive human immunodeficiency virus (HIV) module. EQA testing for HIV has typically involved the supply of serum or plasma, while in the clinic or community based settings HIV PoCT is generally performed using whole blood obtained by capillary finger-stick collection. RCPAQAP has offered EQA for HIV PoCT using stabilised whole blood since 2014. A total of eight surveys have been undertaken over a period of 2 years from 2014 to 2015. Of the 962 responses received, the overall consensus rate was found to be 98% (941/962). A total of 21 errors were detected. The majority of errors were attributable to false reactive HIV p24 antigen results (9/21, 43%), followed by false reactive HIV antibody results (8/21, 38%). There were 4/21 (19%) false negative HIV antibody results and no false negative HIV p24 antigen results reported. Overall performance was observed to vary minimally between surveys, from a low of 94% up to 99% concordant. Encouraging levels of testing proficiency for HIV PoCT are indicated by these data, but they also confirm the need for HIV PoCT sites to participate in external quality assurance programs to ensure the ongoing provision of high quality patient care. Copyright © 2016 Royal College of Pathologists of Australasia. All rights reserved.

  9. Point of care testing of phospholipase A2 group IIA for serological diagnosis of rheumatoid arthritis

    Science.gov (United States)

    Liu, Nathan J.; Chapman, Robert; Lin, Yiyang; Mmesi, Jonas; Bentham, Andrew; Tyreman, Matthew; Abraham, Sonya; Stevens, Molly M.

    2016-02-01

    Secretory phospholipase A2 group IIA (sPLA2-IIA) was examined as a point of care marker for determining disease activity in rheumatoid (RA) and psoriatic (PsA) arthritis. Serum concentration and activity of sPLA2-IIA were measured using in-house antibodies and a novel point of care lateral flow device assay in patients diagnosed with varying severities of RA (n = 30) and PsA (n = 25) and found to correlate strongly with C-reactive protein (CRP). Levels of all markers were elevated in patients with active RA over those with inactive RA as well as both active and inactive PsA, indicating that sPLA2-IIA can be used as an analogue to CRP for RA diagnosis at point of care.Secretory phospholipase A2 group IIA (sPLA2-IIA) was examined as a point of care marker for determining disease activity in rheumatoid (RA) and psoriatic (PsA) arthritis. Serum concentration and activity of sPLA2-IIA were measured using in-house antibodies and a novel point of care lateral flow device assay in patients diagnosed with varying severities of RA (n = 30) and PsA (n = 25) and found to correlate strongly with C-reactive protein (CRP). Levels of all markers were elevated in patients with active RA over those with inactive RA as well as both active and inactive PsA, indicating that sPLA2-IIA can be used as an analogue to CRP for RA diagnosis at point of care. Electronic supplementary information (ESI) available. See DOI: 10.1039/c5nr08423g

  10. ASVCP guidelines: quality assurance for point-of-care testing in veterinary medicine.

    Science.gov (United States)

    Flatland, Bente; Freeman, Kathleen P; Vap, Linda M; Harr, Kendal E

    2013-12-01

    Point-of-care testing (POCT) refers to any laboratory testing performed outside the conventional reference laboratory and implies close proximity to patients. Instrumental POCT systems consist of small, handheld or benchtop analyzers. These have potential utility in many veterinary settings, including private clinics, academic veterinary medical centers, the community (eg, remote area veterinary medical teams), and for research applications in academia, government, and industry. Concern about the quality of veterinary in-clinic testing has been expressed in published veterinary literature; however, little guidance focusing on POCT is available. Recognizing this void, the ASVCP formed a subcommittee in 2009 charged with developing quality assurance (QA) guidelines for veterinary POCT. Guidelines were developed through literature review and a consensus process. Major recommendations include (1) taking a formalized approach to POCT within the facility, (2) use of written policies, standard operating procedures, forms, and logs, (3) operator training, including periodic assessment of skills, (4) assessment of instrument analytical performance and use of both statistical quality control and external quality assessment programs, (5) use of properly established or validated reference intervals, (6) and ensuring accurate patient results reporting. Where possible, given instrument analytical performance, use of a validated 13s control rule for interpretation of control data is recommended. These guidelines are aimed at veterinarians and veterinary technicians seeking to improve management of POCT in their clinical or research setting, and address QA of small chemistry and hematology instruments. These guidelines are not intended to be all-inclusive; rather, they provide a minimum standard for maintenance of POCT instruments in the veterinary setting. © 2013 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

  11. Point-of-care testing to promote cardiovascular disease risk assessment: A proof of concept study.

    Science.gov (United States)

    Karmali, Kunal N; Brown, Tiffany; Sanchez, Thomas; Long, Timothy; Persell, Stephen D

    2017-09-01

    Updated cholesterol guidelines emphasize multivariable cardiovascular disease (CVD) risk estimation to guide treatment decision-making in primary prevention. This study tested the preliminary feasibility, acceptability and efficacy of point-of-care testing (POCT) and quantitative CVD risk assessment in high-risk adults to increase guideline-recommended statin use in primary prevention. Participants were aged 40-75 years, without CVD or diabetes mellitus, and potentially-eligible for consideration of statins based on estimated 10-year CVD risk from last-measured risk factor levels in the electronic health record. We performed POCT to facilitate quantitative CVD risk assessment with the Pooled Cohort Equations immediately before a scheduled primary care provider (PCP) visit. Outcomes were: physician documentation of a CVD risk discussion and statin prescription on the study date. We also assessed acceptability of the intervention through structured questionnaire. We recruited 18 participants (8 from an academic practice and 10 from a federally-qualified health clinic). After the intervention, 83% of participants discussed CVD risk with their PCP, 47% received a statin recommendation from their PCP, and 29% received a new statin prescription during the PCP visit. Participants reported high levels of satisfaction with the intervention. This study demonstrates that in initial testing pre-visit POCT and quantitative CVD risk assessment appears to be a feasible and acceptable intervention that may promote guideline-recommended statin initiation in primary prevention. Future research with an adequately powered trial is warranted to determine the effectiveness of this approach in clinical practice.

  12. Brazilian Program For HIV Point-Of-Care Test Evaluation: A Decade’s Experience

    Directory of Open Access Journals (Sweden)

    Orlando da Costa Ferreira Jr.

    2017-11-01

    Full Text Available The point-of-care tests (POCTs for HIV diagnosis have been widely used in Brazil in order to expand and to allow HIV diagnosis outside health units including remote areas, such as the Amazon region. In order to guarantee the quality of HIV diagnostics based on rapid tests, the Brazilian Ministry of Health (MoH implemented the HIV POCT Evaluation Program. This study compiles the Brazilian experience acquired over the last 13 years conducting the HIV POCT Evaluation Program.   Methods and Findings The selection of tests was based on the interest of manufacturers to qualify for the MoH tenders. Each round was performed with fresh whole blood and oral fluid samples, always including HIV positive and negative ones. In addition to the POCT, every sample was submitted to a reference testing protocol, based on an immunoassay followed by Western blot. The POCTs were evaluated for clinical sensitivity, clinical specificity, assay operational characteristics, detection of HIV-2 antibodies, sensitivity to subtypes panels; and sensitivity to seroconversion panels. Since its implementation in 2003, the POCT evaluation protocol has undergone some modifications aiming to improve and simplify the evaluation process, to know: (i  for HIV-positive samples, perform EIA and Western blot only if the POCT is non-reactive; (ii reduction from 800 to 600 HIV negative samples; (iii increase from one to three subtype panels (including HIV-2 samples; and (iv inclusion of seroconversion panel. We evaluated six tests, four of which met the sensitivity criteria of 99.5%: BD Chek™ HIV Multi-test (whole blood, HIV 1/2 Colloidal Gold (whole blood, OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test (whole blood and oral fluid and TR DPP HIV-1/2 (whole blood, plasma and oral fluid. Regarding other evaluated criteria, all assays met the requirements.   Conclusions The successful Brazilian policy on POCT use for HIV infection diagnosis includes the evaluation of the POCT itself in

  13. Point-of-care creatinine testing in patients receiving contrast-enhanced computed tomography scan.

    Science.gov (United States)

    Bargnoux, Anne-Sophie; Beaufils, Olivier; Oguike, Maryse; Lopasso, Aurélie; Dupuy, Anne-Marie; Sebbane, Mustapha; Badiou, Stéphanie; Fesler, Pierre; Cristol, Jean-Paul

    2018-03-01

    The aim of this study was to evaluate the creatinine assay on the ABL800 FLEX© blood gas analyzer for the screening of pre-existing renal impairment before radiographic contrast administration in the emergency department (ED), by comparing it with standard practice using central laboratory blood testing. The evaluation comprised two elements. The first, conducted in the central laboratory, focused on the analytical performance of the ABL800 creatinine assay. This included assessment of imprecision and accuracy by comparison with central laboratory standard creatinine assay. We also compared ABL 800 estimated glomerular filtration rate (eGFR) and 99m Tc-DTPA measured GFR (mGFR). The second part, conducted in ED sought to determine the impact that implementation of the creatinine at the point-of-care (POC) has on the timeframe in which ED patients are submitted for computed tomography scan (CT). The ABL800 enzymatic creatinine assay met the National Kidney Disease Education Program acceptance criteria for imprecision and showed good agreement with the isotope dilution mass spectrometry-traceable Roche enzymatic assay used in the central laboratory. Furthermore, ABL800 eGFR was in total agreement with mGFR by a reference method. The implementation of POC testing creatinine in the ED significantly reduced patient waiting times for contrast enhanced CT (1.73[0.75-3.01] vs 2.57 [1.53-3.48] hours, for period with and without ABL800 respectively, p=0.04). The ABL800 assay is comparable with central laboratory reference method in terms of analytical performance and superior in terms of turnaround time. Implementation of creatinine at POC reduces delay results, potentially allowing ED clinical staff to make more rapid clinical decisions and reduce patient waiting time. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. The cost-utility of point-of-care troponin testing to diagnose acute coronary syndrome in primary care

    NARCIS (Netherlands)

    Kip, Michelle M.A.; Koffijberg, Hendrik; Moesker, Marco J.; IJzerman, Maarten J.; Kusters, Ron

    2017-01-01

    Background: The added value of using a point-of-care (POC) troponin test in primary care to rule out acute coronary syndrome (ACS) is debated because test sensitivity is inadequate early after symptom onset. This study investigates the potential cost-utility of diagnosing ACS by a general

  15. Point-of-care urine tests for smoking status and isoniazid treatment monitoring in adult patients.

    Directory of Open Access Journals (Sweden)

    Ioana Nicolau

    Full Text Available Poor adherence to isoniazid (INH preventive therapy (IPT is an impediment to effective control of latent tuberculosis (TB infection. TB patients who smoke are at higher risk of latent TB infection, active disease, and TB mortality, and may have lower adherence to their TB medications. The objective of our study was to validate IsoScreen and SmokeScreen (GFC Diagnostics, UK, two point-of-care tests for monitoring INH intake and determining smoking status. The tests could be used together in the same individual to help identify patients with a high-risk profile and provide a tailored treatment plan that includes medication management, adherence interventions, and smoking cessation programs.200 adult outpatients attending the TB and/or the smoking cessation clinic were recruited at the Montreal Chest Institute. Sensitivity and specificity were measured for each test against the corresponding composite reference standard. Test reliability was measured using kappa statistic for intra-rater and inter-rater agreement. Univariate and multivariate logistic regression models were used to explore possible covariates that might be related to false-positive and false-negative test results. IsoScreen had a sensitivity of 93.2% (95% confidence interval [CI] 80.3, 98.2 and specificity of 98.7% (94.8, 99.8. IsoScreen had intra-rater agreement (kappa of 0.75 (0.48, 0.94 and inter-rater agreement of 0.61 (0.27, 0.90. SmokeScreen had a sensitivity of 69.2% (56.4, 79.8, specificity of 81.6% (73.0, 88.0, intra-rater agreement of 0.77 (0.56, 0.94, and inter-rater agreement of 0.66 (0.42, 0.88. False-positive SmokeScreen tests were strongly associated with INH treatment.IsoScreen had high validity and reliability, whereas SmokeScreen had modest validity and reliability. SmokeScreen tests did not perform well in a population receiving INH due to the association between INH treatment and false-positive SmokeScreen test results. Development of the next generation Smoke

  16. HIV-1 Drug Resistance Mutations: Potential Applications for Point-of-Care Genotypic Resistance Testing.

    Directory of Open Access Journals (Sweden)

    Soo-Yon Rhee

    Full Text Available The increasing prevalence of acquired and transmitted HIV-1 drug resistance is an obstacle to successful antiretroviral therapy (ART in the low- and middle-income countries (LMICs hardest hit by the HIV-1 pandemic. Genotypic drug resistance testing could facilitate the choice of initial ART in areas with rising transmitted drug resistance (TDR and enable care-providers to determine which individuals with virological failure (VF on a first- or second-line ART regimen require a change in treatment. An inexpensive near point-of-care (POC genotypic resistance test would be useful in settings where the resources, capacity, and infrastructure to perform standard genotypic drug resistance testing are limited. Such a test would be particularly useful in conjunction with the POC HIV-1 viral load tests that are currently being introduced in LMICs. A POC genotypic resistance test is likely to involve the use of allele-specific point mutation assays for detecting drug-resistance mutations (DRMs. This study proposes that two major nucleoside reverse transcriptase inhibitor (NRTI-associated DRMs (M184V and K65R and four major NNRTI-associated DRMs (K103N, Y181C, G190A, and V106M would be the most useful for POC genotypic resistance testing in LMIC settings. One or more of these six DRMs was present in 61.2% of analyzed virus sequences from ART-naïve individuals with intermediate or high-level TDR and 98.8% of analyzed virus sequences from individuals on a first-line NRTI/NNRTI-containing regimen with intermediate or high-level acquired drug resistance. The detection of one or more of these DRMs in an ART-naïve individual or in a individual with VF on a first-line NRTI/NNRTI-containing regimen may be considered an indication for a protease inhibitor (PI-containing regimen or closer virological monitoring based on cost-effectiveness or country policy.

  17. Medication History versus Point-of-Care Platelet Activity Testing in Patients with Intracerebral Hemorrhage.

    Science.gov (United States)

    Maas, Matthew B; Naidech, Andrew M; Kim, Minjee; Batra, Ayush; Manno, Edward M; Sorond, Farzaneh A; Prabhakaran, Shyam; Liotta, Eric M

    2018-05-01

    We evaluated whether reduced platelet activity detected by point-of-care (POC) testing is a better predictor of hematoma expansion and poor functional outcomes in patients with intracerebral hemorrhage (ICH) than a history of antiplatelet medication exposure. Patients presenting with spontaneous ICH were enrolled in a prospective observational cohort study that collected demographic, clinical, laboratory, and radiographic data. We measured platelet activity using the PFA-100 (Siemens AG, Germany) and VerifyNow-ASA (Accumetrics, CA) systems on admission. We performed univariate and adjusted multivariate analyses to assess the strength of association between those measures and (1) hematoma growth at 24 hours and (2) functional outcomes measured by the modified Rankin Scale (mRS) at 3 months. We identified 278 patients for analysis (mean age 65 ± 15, median ICH score 1 [interquartile range 0-2]), among whom 164 underwent initial neuroimaging within 6 hours of symptom onset. Univariate association with hematoma growth was stronger for antiplatelet medication history than POC measures, which was confirmed in multivariable models (β 3.64 [95% confidence interval [CI] 1.02-6.26], P = .007), with a larger effect size measured in the under 6-hour subgroup (β 7.20 [95% CI 3.35-11.1], P < .001). Moreover, antiplatelet medication history, but not POC measures of platelet activity, was independently associated with poor outcome at 3 months (mRS 4-6) in the under 6-hour subgroup (adjusted OR 3.6 [95% CI 1.2-11], P = .023). A history of antiplatelet medication use better identifies patients at risk for hematoma growth and poor functional outcomes than POC measures of platelet activity after spontaneous ICH. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  18. Construction of effective disposable biosensors for point of care testing of nitrite.

    Science.gov (United States)

    Monteiro, Tiago; Rodrigues, Patrícia R; Gonçalves, Ana Luisa; Moura, José J G; Jubete, Elena; Añorga, Larraitz; Piknova, Barbora; Schechter, Alan N; Silveira, Célia M; Almeida, M Gabriela

    2015-09-01

    In this paper we aim to demonstrate, as a proof-of-concept, the feasibility of the mass production of effective point of care tests for nitrite quantification in environmental, food and clinical samples. Following our previous work on the development of third generation electrochemical biosensors based on the ammonia forming nitrite reductase (ccNiR), herein we reduced the size of the electrodes' system to a miniaturized format, solved the problem of oxygen interference and performed simple quantification assays in real samples. In particular, carbon paste screen printed electrodes (SPE) were coated with a ccNiR/carbon ink composite homogenized in organic solvents and cured at low temperatures. The biocompatibility of these chemical and thermal treatments was evaluated by cyclic voltammetry showing that the catalytic performance was higher with the combination acetone and a 40°C curing temperature. The successful incorporation of the protein in the carbon ink/solvent composite, while remaining catalytically competent, attests for ccNiR's robustness and suitability for application in screen printed based biosensors. Because the direct electrochemical reduction of molecular oxygen occurs when electroanalytical measurements are performed at the negative potentials required to activate ccNiR (ca.-0.4V vs Ag/AgCl), an oxygen scavenging system based on the coupling of glucose oxidase and catalase activities was successfully used. This enabled the quantification of nitrite in different samples (milk, water, plasma and urine) in a straightforward way and with small error (1-6%). The sensitivity of the biosensor towards nitrite reduction under optimized conditions was 0.55 A M(-1) cm(-2) with a linear response range 0.7-370 μM. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. Prevalence of HIV infection and acceptability of point-of-care testing in a Canadian inner-city emergency department.

    Science.gov (United States)

    Stenstrom, Rob; Ling, Daphne; Grafstein, Eric; Barrios, Rolando; Sherlock, Chris; Gustafson, Reka; Osati, Farzaneh; Poureslami, Iraj; Anis, Aslam

    2016-10-20

    The objective of this study was to estimate the seroprevalence of HIV infection and the acceptability of point-of-care HIV testing in an innercity Canadian emergency department. We conducted a prospective cohort study in an urban tertiary care emergency department between August 2009 and January 2011. Randomly selected patients were enrolled using probabilistic sampling based on patient volumes. Inclusion criteria were age 19-75 years and ability to provide informed consent. Patients who were intoxicated or in extremis were excluded. After informed consent and brief pre-test counselling, participants' HIV status was obtained using the INSTI HIV-1/HIV-2 Antibody Test. Participants completed a questionnaire on HIV risk behaviours and satisfaction with emergency department HIV testing. Participants with a positive result or those having other blood tests received confirmatory Western blot testing. HIV-positive participants were offered immediate referral to an HIV specialty clinic. A total of 2,077 patients were approached, and 1,402 (67.5%) agreed to participate. Participants' mean age was 43.3 years, and 58.4% of participants were male. The HIV antibody seroprevalence based on the point-of-care test was 65/1,402 (4.6%; 95% confidence interval: 3.5%-5.8%). No new diagnoses of HIV were identified in our cohort. Patient satisfaction with point-of-care HIV testing was high (mean satisfaction score 9.6/10). On the basis of a rapid, point-of-care HIV antibody test, the seroprevalence rate of HIV in an inner city emergency department was 4.6%. Point-of-care testing in the emergency department is acceptable, and patients' satisfaction with the testing procedure was high.

  20. 78 FR 73553 - Prospective Grant of Exclusive License: Development of Cripto-1 Point of Care (POC) Tests and...

    Science.gov (United States)

    2013-12-06

    ... Exclusive License: Development of Cripto-1 Point of Care (POC) Tests and Kits for the Detection of Colon and Rectal Cancer, Breast Cancer, and Lung Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice... rectal cancer, breast cancer, and lung cancer. DATES: Only written comments and/or applications for a...

  1. Innovative technologies for point-of-care testing of viral hepatitis in low-resource and decentralized settings.

    Science.gov (United States)

    Duchesne, L; Lacombe, K

    2018-02-01

    According to the Global Burden of Diseases, chronic viral hepatitis B and C are one of the most challenging global health conditions that rank among the first causes of morbidity and mortality worldwide. Low- and middle-income countries are particularly affected by the health burden associated with HBV or HCV infection. One major gap in efficiently addressing the issue of viral hepatitis is universal screening. However, the costs and chronic lack of human resources for using traditional screening strategies based on serology and molecular biology preclude any scaling-up. Point-of-care tests have been deemed a powerful potential solution to fill the current diagnostics gap in low-resource and decentralized settings. Despite high interest resulting from their development in recent years, very few point-of-care devices have reached the market. Scaling down and automating all testing steps in 1 single device (eg, sample preparation, detection and readout) is indeed challenging. But innovations in multiple disciplines such as nanotechnologies, microfluidics, biosensors and synthetic biology have led to the creation of chip-sized laboratory systems called "lab-on-a-chip" devices. This review aims to explain how these innovations can overcome technological barriers that usually arise for each testing step while developing integrated point-of-care tests. Point-of-care test prototypes rarely meet the requirements for mass production, which also hinders their large-scale production. In addition to logistical hurdles, legal and economic constraints specific to the commercialization of in vitro diagnostics, which have also participated in the low transfer of innovative point-of-care tests to the field, are discussed. © 2017 John Wiley & Sons Ltd.

  2. Roll-to-roll, shrink-induced superhydrophobic surfaces for antibacterial applications, enhanced point-of-care detection, and blood anticoagulation

    Science.gov (United States)

    Nokes, Jolie McLane

    Superhydrophobic (SH) surfaces are desirable because of their unique anti-wetting behavior. Fluid prefers to bead up (contact angle >150°) and roll off (contact angle hysteresis micro- and nanostructure features trap air pockets. Fluid only adheres to the peaks of the structures, causing minimal adhesion to the surface. Here, shrink-induced SH plastics are fabricated for a plethora of applications, including antibacterial applications, enhanced point-of-care (POC) detection, and reduced blood coagulation. Additionally, these purely structural SH surfaces are achieved in a roll-to-roll (R2R) platform for scalable manufacturing. Because their self-cleaning and water resistant properties, structurally modified SH surfaces prohibit bacterial growth and obviate bacterial chemical resistance. Antibacterial properties are demonstrated in a variety of SH plastics by preventing gram-negative Escherichia coli (E. coli) bacterial growth >150x compared to flat when fluid is rinsed and >20x without rinsing. Therefore, a robust and stable means to prevent bacteria growth is possible. Next, protein in urine is detected using a simple colorimetric output by evaporating droplets on a SH surface. Contrary to evaporation on a flat surface, evaporation on a SH surface allows fluid to dramatically concentrate because the weak adhesion constantly decreases the footprint area. On a SH surface, molecules in solution are confined to a footprint area 8.5x smaller than the original. By concentrating molecules, greater than 160x improvements in detection sensitivity are achieved compared to controls. Utility is demonstrated by detecting protein in urine in the pre-eclampsia range (150-300microgmL -1) for pregnant women. Further, SH surfaces repel bodily fluids including blood, urine, and saliva. Importantly, the surfaces minimize blood adhesion, leading to reduced blood coagulation without the need for anticoagulants. SH surfaces have >4200x and >28x reduction of blood residue area and

  3. Point-of-Care Testing for Anemia, Diabetes, and Hypertension: A Pharmacy-Based Model in Lima, Peru.

    Science.gov (United States)

    Saldarriaga, Enrique M; Vodicka, Elisabeth; La Rosa, Sayda; Valderrama, Maria; Garcia, Patricia J

    Prevention and control of chronic diseases is a high priority for many low- and middle-income countries. This study evaluated the feasibility and acceptability of training pharmacy workers to provide point-of-care testing for 3 chronic diseases-hypertension, diabetes, and anemia-to improve disease detection and awareness through private pharmacies. We developed a multiphase training curriculum for pharmacists and pharmacy technicians to build capacity for identification of risk factors, patient education, point-of-care testing, and referral for abnormal results. We conducted a pre-post evaluation with participants and evaluated results using Student t test for proportions. We conducted point-of-care testing with pharmacy clients and evaluated acceptability by patient characteristics (age, gender, and type of patient) using multiple logistic regression. In total, 72 pharmacy workers (66%) completed the full training curriculum. Pretest scores indicated that pharmacists had more knowledge and skills in chronic disease risk factors, patient education, and testing than pharmacy technicians. All participants improved their knowledge and skills after the training, and post-test scores indicated that pharmacy technicians achieved the same level of competency as pharmacists (P test during the study; 53% completed the acceptability survey. Nearly 100% thought the pharmacy could provide faster results, faster and better attention, and better access to basic screening for hypertension, diabetes, and anemia than a traditional health center. Fast service was very important: 41% ranked faster results and 30% ranked faster attention as the most important factor for receiving diagnostic testing in the pharmacy. We found that it is both feasible for pharmacies and acceptable to clients to train pharmacy workers to provide point-of-care testing for anemia, diabetes, and hypertension. This innovative approach holds potential to increase early detection of risk factors and bolster

  4. The usefulness of point-of-care (POC) tests in screening elevated glucose and ketone body levels postmortem

    OpenAIRE

    Walta, Anna-Mari; Keltanen, Terhi; Lindroos, Katarina; Sajantila, Antti

    2016-01-01

    The aim was to evaluate the performance of point-of-care (POC) tests in detecting glucose and ketone bodies in postmortem (PM) samples and to assess the usefulness of POC tests in sample screening for more precise analyses. Glucose and ketone body, beta-hydroxybutyrate (BHB), were measured from vitreous humor (VH) in 52 autopsy cases with a POC blood glucose monitoring device (BGMD). In addition glucose and ketone bodies, acetone (Ac) and acetoacetate (AcAc), were measured from urine samples ...

  5. Transillumination test: A bedside aid for differentiating meningocele from myelomeningocele: Point of care testing

    Directory of Open Access Journals (Sweden)

    Aakash Pandita

    2015-01-01

    Full Text Available Transillumination test is a bedside and simple technique to illuminate the body cavity by transmission of light through the cavity. Transillumination test is used in a variety of conditions like hydrocele, Hydrocephalus, pneumoperitonium and pneumothorax in neonatology. We describe use of transillumination for differentiating meningocele and myelomeningocele.

  6. Keratoconus Progression in Patients With Allergy and Elevated Surface Matrix Metalloproteinase 9 Point-of-Care Test.

    Science.gov (United States)

    Mazzotta, Cosimo; Traversi, Claudio; Mellace, Pierfrancesco; Bagaglia, Simone A; Zuccarini, Silvio; Mencucci, Rita; Jacob, Soosan

    2017-10-04

    To assess keratoconus (KC) progression in patients with allergies who also tested positive to surface matrix metalloproteinase 9 (MMP-9) point-of-care test. Prospective comparative study including 100 stage I-II keratoconic patients, mean age 16.7±4.6 years. All patients underwent an anamnestic questionnaire for concomitant allergic diseases and were screened with the MMP-9 point-of-care test. Patients were divided into two groups: patients KC with allergies (KC AL) and patients KC without allergies (KC NAL). Severity of allergy was established by papillary subtarsal response grade and KC progression assessed by Scheimpflug corneal tomography, corrected distance visual acuity (CDVA) measurement in a 12-month follow-up. The KC AL group included 52 patients and the KC NAL group 48. In the KC AL group, 42/52 of patients (81%) were positive to MMP-9 point-of-care test versus two positive patients in the KC NAL group (4%). The KC AL group data showed a statistically significant decrease of average CDVA, from 0.155±0.11 to 0.301±0.2 logarithm of the minimum angle of resolution (Paverage. The KC NAL group revealed a slight KC progression without statistically significant changes. Pearson correlation test showed a high correlation between Kmax worsening and severity of PSR in the KC AL group. The study demonstrated a statistically significant progression of KC in patients with concomitant allergies, positive to MMP-9 point-of-care test versus negative. A high correlation between severity of allergy and KC progression was documented.

  7. Decentralized lab testing. A collaborative approach to point of care testing.

    Science.gov (United States)

    Miller, C M; Niznik, C; Springer, J; Pauly, S

    1995-01-01

    What is involved in setting up and managing a decentralized laboratory testing program at a hospital? What elements are involved in making such a program a success? Multidepartmental and multidisciplinary cooperation and communication are the keys to implementing a cost-effective, user-friendly system that assures quality patient care and operator competence.

  8. Review of the cultural safety of a national Indigenous point-of-care testing program for diabetes management.

    Science.gov (United States)

    Shephard, Mark; O'Brien, Christopher; Burgoyne, Anthony; Croft, Jody; Garlett, Trevor; Barancek, Kristina; Halls, Heather; McAteer, Bridgit; Motta, Lara; Shephard, Anne

    2016-01-01

    In Australia, Aboriginal and Torres Strait Islander people have approximately three-fold higher rates of diabetes than non-Indigenous Australians. Point-of-care testing, where pathology tests are conducted close to the patient, with results available during the patient consultation, can potentially deliver several benefits for both the Indigenous client and the health professional team involved in their care. Currently, point-of-care testing for diabetes management is being conducted in over 180 Aboriginal and Torres Strait Islander Medical Services as part of a national program called Quality Assurance for Aboriginal and Torres Strait Islander Medical Services (QAAMS). The cultural safety of the Program was reviewed by sourcing the views of the QAAMS Indigenous Leaders Team in a focus group setting and by surveying the point-of-care testing operators enrolled in QAAMS, via an electronic questionnaire. The current study confirms that QAAMS remains a culturally safe program that fills a permanent and positive niche within the Indigenous health sector. The study demonstrates that QAAMS provides a convenient and accessible 'one-stop' pathology service for Indigenous clients with diabetes and empowers Aboriginal Health Workers to have a direct role in the care of their diabetes clients.

  9. Extended Gate Field-Effect Transistor Biosensors for Point-Of-Care Testing of Uric Acid.

    Science.gov (United States)

    Guan, Weihua; Reed, Mark A

    2017-01-01

    An enzyme-free redox potential sensor using off-chip extended-gate field effect transistor (EGFET) with a ferrocenyl-alkanethiol modified gold electrode has been used to quantify uric acid concentration in human serum and urine. Hexacyanoferrate (II) and (III) ions are used as redox reagent. The potentiometric sensor measures the interface potential on the ferrocene immobilized gold electrode, which is modulated by the redox reaction between uric acid and hexacyanoferrate ions. The device shows a near Nernstian response to uric acid and is highly specific to uric acid in human serum and urine. The interference that comes from glucose, bilirubin, ascorbic acid, and hemoglobin is negligible in the normal concentration range of these interferents. The sensor also exhibits excellent long term reliability and is regenerative. This extended gate field effect transistor based sensor is promising for point-of-care detection of uric acid due to the small size, low cost, and low sample volume consumption.

  10. NT-proBNP on Cobas h 232 in point-of-care testing

    DEFF Research Database (Denmark)

    Gils, Charlotte; Ramanathan, R.; Breindahl, T.

    2015-01-01

    Background. NT-proBNP may be useful for ruling out heart failure in primary health care. In this study we examined the analytical quality of NT-proBNP in primary health care on the Cobas h 232 point-of-care instrument compared with measurements performed in a hospital laboratory. Materials...... and methods. Blood samples requested for NT-proBNP were collected in primary health care (n = 95) and in a hospital laboratory (n = 107). NT-proBNP was measured on-site on Cobas h 232 instruments both in primary health care centres and at the hospital laboratory and all samples were also analyzed...... with a comparison method at the hospital. Precision, trueness, accuracy, and lot-variation were determined at different concentration levels and evaluated according to acceptance criteria. Furthermore user-friendliness was assessed by questionnaires. Results. For Cobas h 232 repeatability CV was 8...

  11. Point-of-Care Testing for Infectious Diseases: Past, Present, and Future.

    Science.gov (United States)

    Kozel, Thomas R; Burnham-Marusich, Amanda R

    2017-08-01

    Point-of-care (POC) diagnostics provide rapid actionable information for patient care at the time and site of an encounter with the health care system. The usual platform has been the lateral flow immunoassay. Recently, emerging molecular diagnostics have met requirements for speed, low cost, and ease of use for POC applications. A major driver for POC development is the ability to diagnose infectious diseases at sites with a limited infrastructure. The potential use in both wealthy and resource-limited settings has fueled an intense effort to build on existing technologies and to generate new technologies for the diagnosis of a broad spectrum of infectious diseases. Copyright © 2017 American Society for Microbiology.

  12. Point-of-care testing facilitates screening and treatment for anaemia in women and children in rural Pakistan.

    Science.gov (United States)

    McCormack, Tessa; Ayub, Rukhsana; Aziz, Faisal; Motta, Lara; Spaeth, Brooke; Shephard, Mark

    2017-11-06

    To use point-of-care testing to screen and facilitate treatment for anaemia and to establish an estimate of the prevalence of anaemia in the local population. An uncontrolled before and after study design was used to evaluate the effectiveness of the intervention on the anaemia status of participants. This study took place in a rural mountain community (population approximately 1000) in the Haripur district in northern Pakistan. Women of child-bearing age (15-49 years) and children (12-14 years) were included in this study. The intervention included point-of-care testing for haemoglobin, treatment with mebendazole and oral iron supplementation, and an education campaign about anaemia delivered by community health workers and medical students. The main outcome measure was an increase in blood haemoglobin over the study period. A secondary outcome measure was a positive change in anaemia status or classification post-intervention. Anaemia was initially detected in 64 (53%) women and 15 (47%) children. The mean haemoglobin concentration increased significantly (P Point-of-care testing used for the detection of anaemia in this rural community helped to identify the burden of disease and to reduce this significantly by way of rapid diagnosis, education and immediate medical intervention. © 2017 National Rural Health Alliance Inc.

  13. Making HIV testing work at the point of care in South Africa: a qualitative study of diagnostic practices.

    Science.gov (United States)

    Engel, Nora; Davids, Malika; Blankvoort, Nadine; Dheda, Keertan; Pant Pai, Nitika; Pai, Madhukar

    2017-06-17

    Point of care testing promises to reduce delays in diagnosing and initiating treatment for infectious diseases such as Human Immuno-deficiency Virus (HIV). In South Africa, decentralized HIV testing with rapid tests offers important lessons for point of care testing programs. Yet, little is known about the strategies of providers and clients to make HIV testing successful in settings short of equipment, human resources and space. We aimed at examining these strategies. This paper is based on a larger qualitative study of diagnostic practices across major diseases and actors in homes, clinics, communities, hospitals and laboratories in South Africa. We conducted 101 semi-structured interviews and 7 focus group discussions with doctors, nurses, community health workers, patients, laboratory technicians, policymakers, hospital managers and manufacturers between September 2012 and June 2013 in Durban, Cape Town and Eastern Cape. The topics explored included diagnostic processes and challenges, understanding of diagnosis, and visions of ideal tests. For this paper, the data on HIV testing processes in clinics, communities and hospitals was used. Strategies to make HIV testing work at point of care involve overcoming constraints in equipment, spaces, human resources and workload and actively managing diagnostic processes. We grouped these strategies into subthemes: maintaining relationships, adapting testing guidelines and practices to stock-outs, to physical space, and to different clients, turning the test into a tool to reach another aim and turning the testing process into a tool to enhance adherence. These adaptive strategies are locally negotiated solutions, often ad-hoc, depending on personal commitment, relationships, human resources, physical space and referral systems. In the process, testing is redefined and repurposed. Not all of these repurposing acts are successful in ensuring a timely diagnosis. Some lead to disruptions, unnecessary testing or delays with

  14. A reliable and easy to transport quality control method for chlamydia and gonorrhoea molecular point of care testing.

    Science.gov (United States)

    Badman, S G; Causer, L M; Guy, R; Wand, H; Donovan, B; Tabrizi, S N; Speers, D; Shephard, M D; Vallely, A; Whiley, D

    2018-04-01

    Quality control (QC) is an essential component of point-of-care testing programs. In the context of a randomised-controlled trial (TTANGO) using GeneXpert (Xpert) Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) point-of-care testing in remote areas of Australia, we aimed to develop and utilise a stable positive control material. Bacterial cultures of CT and NG were resuspended together to provide cycle threshold (C t ) values of approximately 25 cycles for both CT and NG when tested on the Xpert CT/NG assay. These positive control suspensions were dried in aliquots, heat inactivated, and then provided to 12 participating health services as research-only QC samples in kit form. At each service, a QC sample was resuspended and tested each month on the Xpert. QC results, including Xpert C t values, were analysed from each site over 30 months and we calculated costs per QC sample. Overall, at 12 health services there were 89 QC samples tested (average of 8 tests per site per year). Mean C t values for the 89 controls samples were 25.25 cycles (SD = 1.15) for CT, 24.04 cycles (SD = 1.400) for one NG target and 23.35 cycles (SD = 1.55) for the other NG target. No significant differences in C t value for CT or NG controls were observed over a trial period of 30 months. Positive QC samples for research use in a trial of a molecular point-of-care assay were inexpensive to produce and stable when stored at 2-8°C. For routine use, additional requirements such as meeting National Association of Testing Authority (NATA) regulations and Therapeutic Goods Administration (TGA) approval will need to be achieved. Copyright © 2017 Royal College of Pathologists of Australasia. All rights reserved.

  15. The social role of C-reactive protein point-of-care testing to guide antibiotic prescription in Northern Thailand.

    Science.gov (United States)

    Haenssgen, Marco J; Charoenboon, Nutcha; Althaus, Thomas; Greer, Rachel C; Intralawan, Daranee; Lubell, Yoel

    2018-04-01

    New and affordable point-of-care testing (POCT) solutions are hoped to guide antibiotic prescription and to help limit antimicrobial resistance (AMR)-especially in low- and middle-income countries where resource constraints often prevent extensive diagnostic testing. Anthropological and sociological research has illuminated the role and impact of rapid point-of-care malaria testing. This paper expands our knowledge about the social implications of non-malarial POCT, using the case study of a C-reactive-protein point-of-care testing (CRP POCT) clinical trial with febrile patients at primary-care-level health centres in Chiang Rai province, northern Thailand. We investigate the social role of CRP POCT through its interactions with (a) the healthcare workers who use it, (b) the patients whose routine care is affected by the test, and (c) the existing patient-health system linkages that might resonate or interfere with CRP POCT. We conduct a thematic analysis of data from 58 purposively sampled pre- and post-intervention patients and healthcare workers in August 2016 and May 2017. We find widespread positive attitudes towards the test among patients and healthcare workers. Patients' views are influenced by an understanding of CRP POCT as a comprehensive blood test that provides specific diagnosis and that corresponds to notions of good care. Healthcare workers use the test to support their negotiations with patients but also to legitimise ethical decisions in an increasingly restrictive antibiotic policy environment. We hypothesise that CRP POCT could entail greater patient adherence to recommended antibiotic treatment, but it could also encourage riskier health behaviour and entail potentially adverse equity implications for patients across generations and socioeconomic strata. Our empirical findings inform the clinical literature on increasingly propagated point-of-care biomarker tests to guide antibiotic prescriptions, and we contribute to the anthropological and

  16. Performance evaluation of the point-of-care SAMBA I and II HIV-1 Qual whole blood tests.

    Science.gov (United States)

    Ritchie, Allyson V; Goel, Neha; Sembongi, Hiroshi; Lehga, Jesse; Farleigh, Laura E; Edemaga, Daniel; Wisniewski, Craig A; Lee, Helen H

    2016-11-01

    The SAMBA HIV-1 Qual Whole Blood Test is a nucleic acid-based amplification assay for the qualitative detection of HIV-1 in whole blood of adults or infants. The test can be run on either the semi-automated SAMBA I system for clinical use or the fully automated, including readout, SAMBA II system for point-of-care use in resource-limited settings. We have assessed the performance characteristics of the SAMBA HIV-1 Qual Whole Blood Test on SAMBA I and SAMBA II. The limit of detection obtained for the two tests were 518IU/ml and 399copies/ml on SAMBA I and 457IU/ml and 433copies/ml on SAMBA II. Test specificity on both systems was 100% with a panel of 503 HIV-1 negative samples. Evaluation of test reproducibility showed 100% concordance with expected gold standard results as well as 100% agreement between operators, days, and runs as well as within runs on both SAMBA I and SAMBA II. Our results thus show that the SAMBA HIV-1 Qual Whole Blood Test performs equivalently on SAMBA I and SAMBA II, and also suggest that the test is suitable for implementation in medium-throughput clinical facilities (SAMBA I) or low-throughput point-of-care (POC) settings (SAMBA II) in resource-poor regions. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  17. International definition of a point-of-care test in family practice: a modified e-Delphi procedure.

    Science.gov (United States)

    Schols, Angel M R; Dinant, Geert-Jan; Hopstaken, Rogier; Price, Christopher P; Kusters, Ron; Cals, Jochen W L

    2018-01-29

    The use of point-of-care tests (POCTs) in family practice is increasing, and the term POCT is often used in medical literature and clinical practice. Yet, no widely supported definition by several professional fields exists. To reach consensus on an international definition of a POCT in family practice. We performed a modified international e-Delphi procedure of four rounds among expert panel members from different professional backgrounds-family practitioners, laboratory specialists, policymakers, researchers and manufacturers. Of 27 panel members from seven different countries, 26 participated in all rounds. Most panel members were active in POCT research or policymaking and 70% worked in family medicine. After choosing important components, structuring of answers and feedback, the following definition was chosen as the best or second best definition by 81% of panel members: a point-of-care test in family practice is a test to support clinical decision making, which is performed by a qualified member of the practice staff nearby the patient and on any part of the patient's body or its derivatives, during or very close to the time of consultation, to help the patient and physician to decide upon the best suited approach, and of which the results should be known at the time of the clinical decision making. The definition emerging from this study can inform family practitioners, laboratory specialists, policymakers and manufacturers on the most widely supported and recognized definition and could act as a clear starting point for the organization and execution of professional point-of-care testing in family practice worldwide. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. Providing HIV results via SMS one day after testing: more popular than rapid point-of-care tests.

    Science.gov (United States)

    Davies, Stephen C; Koh, Andrew; Lindsay, Heather E; Fulton, Richard B; Fernando, Suran L

    2017-06-01

    An inner Sydney sexual health service introduced the option to gay and bisexual men of receiving a negative HIV result by SMS to mobile phone one business day after venipuncture (rapid SMS). Men could also choose one of the other options: a point-of-care-test (POCT), by phone, or in-person (clinicians could also require in-person). We followed-up patients choosing the rapid SMS method to ascertain their satisfaction. During 12 months, 473 men had 591 HIV tests. Of these tests, 5.4% were POCTs, 9.1% were in-person, 24% were by phone, and 62% were rapid SMS. HIV POCTs declined from being 22% of result methods in the pre-study period to 5.4% during the rapid SMS intervention period (odds ratio 0.20, 95% CI 0.13-0.32, P SMS was sent by the next business day in 95% of cases; 96% of men were satisfied; and 95% would choose this method for their next test. Of 77 men who previously had an HIV POCT, 56 (73%) elected a rapid SMS result rather than having another POCT. The higher accuracy of conventional serology was commonly expressed as the reason for choosing rapid SMS for results.

  19. Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial.

    Science.gov (United States)

    Karkouti, Keyvan; Callum, Jeannie; Wijeysundera, Duminda N; Rao, Vivek; Crowther, Mark; Grocott, Hilary P; Pinto, Ruxandra; Scales, Damon C

    2016-10-18

    Cardiac surgery is frequently complicated by coagulopathic bleeding that is difficult to optimally manage using standard hemostatic testing. We hypothesized that point-of-care hemostatic testing within the context of an integrated transfusion algorithm would improve the management of coagulopathy in cardiac surgery and thereby reduce blood transfusions. We conducted a pragmatic multicenter stepped-wedge cluster randomized controlled trial of a point-of-care-based transfusion algorithm in consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at 12 hospitals from October 6, 2014, to May 1, 2015. Following a 1-month data collection at all participating hospitals, a transfusion algorithm incorporating point-of-care hemostatic testing was sequentially implemented at 2 hospitals at a time in 1-month intervals, with the implementation order randomly assigned. No other aspects of care were modified. The primary outcome was red blood cell transfusion from surgery to postoperative day 7. Other outcomes included transfusion of other blood products, major bleeding, and major complications. The analysis adjusted for secular time trends, within-hospital clustering, and patient-level risk factors. All outcomes and analyses were prespecified before study initiation. Among the 7402 patients studied, 3555 underwent surgery during the control phase and 3847 during the intervention phase. Overall, 3329 (45.0%) received red blood cells, 1863 (25.2%) received platelets, 1645 (22.2%) received plasma, and 394 (5.3%) received cryoprecipitate. Major bleeding occurred in 1773 (24.1%) patients, and major complications occurred in 740 (10.2%) patients. The trial intervention reduced rates of red blood cell transfusion (adjusted relative risk, 0.91; 95% confidence interval, 0.85-0.98; P=0.02; number needed to treat, 24.7), platelet transfusion (relative risk, 0.77; 95% confidence interval, 0.68-0.87; Ppoint-of-care hemostatic testing within the context of an integrated

  20. Diagnostic accuracy of point-of-care tests for hepatitis C virus infection: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Mehnaaz Sultan Khuroo

    Full Text Available Point-of-care tests provide a plausible diagnostic strategy for hepatitis C infection in economically impoverished areas. However, their utility depends upon the overall performance of individual tests.A literature search was conducted using the metasearch engine Mettā, a query interface for retrieving articles from five leading medical databases. Studies were included if they employed point-of-care tests to detect antibodies of hepatitis C virus and compared the results with reference tests. Two reviewers performed a quality assessment of the studies and extracted data for estimating test accuracy.Thirty studies that had evaluated 30 tests fulfilled the inclusion criteria. The overall pooled sensitivity, specificity, positive likelihood-ratio, negative likelihood-ratio and diagnostic odds ratio for all tests were 97.4% (95% CI: 95.9-98.4, 99.5% (99.2-99.7, 80.17 (55.35-116.14, 0.03 (0.02-0.04, and 3032.85 (1595.86-5763.78, respectively. This suggested a high pooled accuracy for all studies. We found substantial heterogeneity between studies, but none of the subgroups investigated could account for the heterogeneity. Genotype diversity of HCV had no or minimal influence on test performance. Of the seven tests evaluated in the meta-regression model, OraQuick had the highest test sensitivity and specificity and showed better performance than a third generation enzyme immunoassay in seroconversion panels. The next highest test sensitivities and specificities were from TriDot and SDBioline, followed by Genedia and Chembio. The Spot and Multiplo tests produced poor test sensitivities but high test specificities. Nine of the remaining 23 tests produced poor test sensitivities and specificities and/or showed poor performances in seroconversion panels, while 14 tests had high test performances with diagnostic odds ratios ranging from 590.70 to 28822.20.Performances varied widely among individual point-of-care tests for diagnosis of hepatitis C virus

  1. The reliability of point-of-care prothrombin time testing. A comparison of CoaguChek S and XS INR measurements with hospital laboratory monitoring.

    LENUS (Irish Health Repository)

    Ryan, F

    2010-02-01

    The development of point-of-care (POC) testing devices enables patients to test their own international normalized ratio (INR) at home. However, previous studies have shown that when compared with clinical laboratory values, statistically significant differences may occur between the two methods of INR measurement. The aim of this study was to evaluate the accuracy of the CoaguChek S and XS POC meters relative to clinical laboratory measurements. As part of a randomized, crossover patient self-testing (PST) study at Cork University Hospital, patients were randomized to 6 months PST or 6 months routine care by the anticoagulation management service. During the PST arm of the study, patients measured their INR at home using the CoaguChek S or XS POC meter. External quality control was performed at enrollment, 2 months and 4 months by comparing the POC measured INR with the laboratory determined value. One hundred and fifty-one patients provided 673 paired samples. Good correlation was shown between the two methods of determination (r = 0.91), however, statistically significant differences did occur. A Bland-Altman plot illustrated good agreement of INR values between 2.0 and 3.5 INR units but there was increasing disagreement as the INR rose above 3.5. Eighty-seven per cent of all dual measurements were within the recommended 0.5 INR units of each other. This study adds to the growing evidence that POC testing is a reliable and safe alternative to hospital laboratory monitoring but highlights the importance of external quality control when these devices are used for monitoring oral anticoagulation.

  2. Point-of-care testing for HIV in an Irish prison setting: results from three major Irish prisons.

    Science.gov (United States)

    Bannan, Ciaran L; Lynch, Pamela A; Conroy, Emmett P; O'Dea, Siobhan; Surah, Saloni; Betts-Symonds, Graham; Lyons, Fiona E

    2016-10-01

    HIV is more prevalent in the prison population compared to the general population. Prison inmates are at an increased risk of blood-borne infections. Considerable stigma has been documented amongst inmates with HIV infection. In collaboration with the schools, healthcare facilities, prison authorities and inmate Irish Red Cross groups in Wheatfield, Cloverhill and Mountjoy prisons in Dublin, Ireland, the Department of Genito Urinary Medicine and Infectious Diseases at St James' Hospital in Dublin developed a campaign for raising awareness of HIV, educating inmates about HIV and tackling HIV stigma. Following this campaign, large-scale point-of-care testing for HIV was offered over a short period. In total, 741 inmates were screened for HIV. One inmate tested positive for HIV. We experienced a large number of invalid test results, requiring formal laboratory serum testing, and a small number of false positive results. Large-scale point-of-care testing in the Irish prison setting is acceptable and achievable. © The Author(s) 2016.

  3. C-reactive protein point-of-care testing in acutely ill children: a mixed methods study in primary care.

    Science.gov (United States)

    Van den Bruel, Ann; Jones, Caroline; Thompson, Matthew; Mant, David

    2016-04-01

    Point-of-care C-reactive protein (CRP) testing of adults with acute respiratory infection in primary care reduces antibiotic prescribing by 22%. The acceptability and impact of CRP testing in children is unknown To determine the acceptability and impact of CRP testing in acutely ill children. Mixed methods study comprising an observational cohort with a nested randomised controlled trial and embedded qualitative study. Children presenting with an acute illness to general practice out-of-hours services; children with a temperature ≥38°C were randomised in the nested trial; parents and clinical staff were invited to the qualitative study. Informed consent rates; parental and staff views on testing. Consent to involvement in the study was obtained for 200/297 children (67.3%, 95% CI 61.7% to 72.6%); the finger-prick test might have been a contributory factor for 63 of the 97 children declining participation but it was cited as a definite factor in only 10 cases. None of the parents or staff raised concerns about the acceptability of testing, describing the pain caused as minor and transient. General practitioner views on the utility of the CRP test were inconsistent. CRP point-of-care testing in children is feasible in primary care and is likely to be acceptable. However, it will not reduce antibiotic prescribing and hospital referrals until general practitioners accept its diagnostic value in children. ISRCTN 69736109. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. Performance of 4 Point-of-Care Screening Tests for Feline Leukemia Virus and Feline Immunodeficiency Virus.

    Science.gov (United States)

    Levy, J K; Crawford, P Cynda; Tucker, S J

    2017-03-01

    More than 3 million cats in the United States are infected with FeLV or FIV. The cornerstone of control is identification and segregation of infected cats. To compare test performance with well-characterized clinical samples of currently available FeLV antigen/FIV antibody combination test kits. Surplus serum and plasma from diagnostic samples submitted by animal shelters, diagnostic laboratories, veterinary clinics, and cat research colonies. None of the cats had been vaccinated against FIV. The final sample set included 146 FeLV+, 154 FeLV-, 94 FIV+, and 97 FIV- samples. Prospective, blind comparison to a gold standard: Samples were evaluated in 4 different point-of-care tests by ELISA antigen plate tests (FeLV) and virus isolation (FIV) as the reference standards. All test results were visually read by 2 blinded observers. Sensitivity and specificity, respectively, for FeLV were SNAP ® (100%/100%), WITNESS ® (89.0%/95.5%), Anigen ® (91.8%/95.5%), and VetScan ® (85.6%/85.7%). Sensitivity and specificity for FIV were SNAP ® (97.9%/99.0%), WITNESS ® (94.7%/100%), Anigen ® (96.8%/99.0%), and VetScan ® (91.5%/99.0%). The SNAP ® test had the best performance for FeLV, but there were no significant differences for FIV. In typical cat populations with seroprevalence of 1-5%, a majority of positive results reported by most point-of-care test devices would be false-positives. This could result in unnecessary segregation or even euthanasia. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  5. External quality assurance for HIV point-of-care testing in Africa: A collaborative country-partner approach to strengthen diagnostic services

    Directory of Open Access Journals (Sweden)

    Debrah I. Boeras

    2016-10-01

    Full Text Available It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing.

  6. External quality assurance for HIV point-of-care testing in Africa: A collaborative country-partner approach to strengthen diagnostic services.

    Science.gov (United States)

    Boeras, Debrah I; Peeling, Rosanna W

    2016-01-01

    It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing.

  7. From water analytics to the point-of-care-testing. Biosensors for the quantitative analysis in different matrices; Von der Wasseranalytik bis zum Point-of-Care-Testing. Biosensoren zur quantitativen Analyse in verschiedenen Matrices

    Energy Technology Data Exchange (ETDEWEB)

    Albrecht, C.; Gauglitz, G. [Tuebingen Univ. (DE). Inst. fuer Physikalische und Theoretische Chemie (IPTC)

    2008-03-15

    In many ranges of control analytics, a continuous monitoring is increasingly necessary. Classical methods such as gas chromatography or HPLC enable a sensitive proof of analytes. However, these classical methods are not suitable for high flow rates. Biosensors fulfill the requirements of a fast, economical and sensitive detection. Under this aspect, the authors of the contribution under consideration report on biosensors for the automated employment with the quantitative measurement in different matrices. The modular structure of the used surface chemistry permits a flexible adjustment to extern conditions. Thus a high stability of the sensitive, biological layer is to be achieved. The potential of the technology is pointed out on the basis of three applications to the measurement in water, cow's milk and human serum (point-of-care-testing).

  8. Sensitivity of a point of care tick-test for the development of Lyme borreliosis

    NARCIS (Netherlands)

    Sprong, H.; Leeuwen, van A.D.; Fonville, M.; Harms, M.; Vliet, van A.J.H.; Pelt, van W.; Ferreira, J.A.; Wijngaard, van den C.C.

    2013-01-01

    Background: A commercially available self-test for the detection of Borrelia burgdorferi sensu lato in ticks was evaluated for its ability to predict erythema migrans formation. Findings: The self-test was performed on 127 Ixodes ricinus from 122 humans that reported tick bites at enrolment and

  9. Field trial evaluation of the performances of point-of-care tests for screening G6PD deficiency in Cambodia.

    Directory of Open Access Journals (Sweden)

    Arantxa Roca-Feltrer

    Full Text Available User-friendly, accurate, point-of-care rapid tests to detect glucose-6-phosphate dehydrogenase deficiency (G6PDd are urgently needed at peripheral level to safely recommend primaquine for malaria elimination.The CareStart G6PD RDT (AccessBio, New Jersey, USA, a novel rapid diagnostic test and the most commonly used test, the fluorescent spot test (FST were assessed against the quantitatively measured G6PD enzyme activity for detecting G6PDd. Subjects were healthy males and non-pregnant females aged 18 years or older residing in six villages in Pailin Province, western Cambodia.Of the 938 subjects recruited, 74 (7.9% were severe and moderately severe G6PD deficient (enzyme activity <30%, mostly in male population; population median G6PD activity was 12.0 UI/g Hb. The performances of the CareStart G6PD RDT and the FST, according to different cut-off values used to define G6PDd were very similar. For the detection of severe and moderately severe G6PDd (enzyme activity < 30%, < 3.6 UI/g Hb in males and females, sensitivity and negative (normal status predictive value were 100% for both point-of-care tools. When the G6PDd cut-off value increased (from < 40% to < 60%, the sensitivity for both PoCs decreased: 93.3% to 71.7% (CareStart G6PD RDT, p = 10(-6 and 95.5% to 73.2% (FST, p = 10(-6 while the specificity for both PoCs remained similar: 97.4% to 98.3% (CareStart G6PD RDT, p = 0.23 and 98.7% to 99.6% (FST, p = 0.06. The cut-off values for classifying individuals as normal were 4.0 UI/g Hb and 4.3 UI/g Hb for the CareStart G6PD RDT and the FST, respectively.The CareStart G6PD RDT reliably detected moderate and severe G6PD deficient individuals (enzyme activity <30%, suggesting that this novel point-of-care is a promising tool for tailoring appropriate primaquine treatment for malaria elimination by excluding individuals with severe G6PDd for primaquine treatment.

  10. Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital

    Directory of Open Access Journals (Sweden)

    Charlotte Oris

    2018-03-01

    Conclusion: Our results met standard requirements and the 12 analyzers were assessed as suitable for point-of-care testing in services of academic medical centers, as exemplified at Clermont-Ferrand hospital.

  11. Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.

    Directory of Open Access Journals (Sweden)

    Christopher D Pilcher

    Full Text Available Current laboratory and point-of-care tests for HIV detect different analytes and use different sample types. Some have fast turnaround times (<1 hour. We investigated how HIV test choice could impact case finding by testing programs.We analyzed 21,234 consecutive HIV tests with venous blood obtained by San Francisco HIV testing programs from 2003 to 2008. For a subset, oral fluid (n = 6446 or fingerstick blood (n = 8127 samples were also obtained for rapid testing. In all cases, HIV status was determined using an HIV antibody-plus-RNA test algorithm. We assessed how the screening antibody tests performed individually versus the gold standard of the full algorithm. We then evaluated the potential ability of other tests (including new tests to detect more cases, by re-testing all specimens that had negative/discrepant antibody results on initial screening.The antibody-RNA algorithm identified 58 acute and 703 established HIV infection cases. 1(st-generation (Vironostika and 3(rd-generation (Genetic Systems immunoassays had 92 and 96 percent sensitivity, respectively. The Oraquick rapid test had clinical sensitivity of only 86 percent on oral fluid samples, but 92 percent on finger-stick blood. Newer 4(th-generation, antigen-antibody combo rapid immunoassay (ARCHITECT detected HIV in 87 percent of all the acute cases that had been missed by one of the previous screening assays. A point-of-care 4(th generation antigen-antibody combo rapid test (Determine detected about 54 percent of such acute cases.Our study suggests that some rapid antibody blood tests will give similar case detection to laboratory antibody tests, but that oral fluid testing greatly reduces ability to detect HIV. New 4(th-generation combo tests can detect the majority of acute infections detectable by HIV RNA but with rapid results. Using these tests as a primary screening assay in high-risk HIV testing programs could reduce or eliminate the need for HIV RNA testing.

  12. Point of care testing of fecal calprotectin as a substitute for routine laboratory analysis

    DEFF Research Database (Denmark)

    Hejl, Julie; Theede, Klaus; Møllgren, Brian

    2018-01-01

    Objectives Fecal calprotectin (FC) is widely used to monitor the activity of inflammatory bowel disease (IBD) and to tailor medical treatment to disease activity. Laboratory testing of fecal samples may have a turnaround time of 1–2 weeks, whereas FC home testing allows results within hours...... and thus enables a rapid response to clinical deterioration. Design and methods Fifty-five stool samples were analyzed by the IBDoc® Calprotectin Home Testing kit and the BÜHLMANN fCAL® turbo assay on a Roche Cobas 6000 c501. The correlation between the assays was assessed using Spearman's Rho correlation...... coefficient and the intermediate imprecision of both assays was calculated. Results We found a strong correlation coefficient of 0.887 between FC measured on IBDoc® and the laboratory assay BÜHLMANN fCAL® turbo. The coefficients of variation (CVs) at three different FC levels were in the range 2...

  13. Evaluation of a point-of-care immunoassay test kit 'StrongStep' for cryptococcal antigen detection.

    Directory of Open Access Journals (Sweden)

    Edward Mpoza

    Full Text Available HIV-associated cryptococcal meningitis is the leading cause of adult meningitis in Sub-Saharan Africa, accounting for 15%-20% of AIDS-attributable mortality. The development of point-of-care assays has greatly improved the screening and diagnosis of cryptococcal disease. We evaluated a point-of-care immunoassay, StrongStep (Liming Bio, Nanjing, Jiangsu, China lateral flow assay (LFA, for cryptococcal antigen (CrAg detection in cerebrospinal fluid (CSF and plasma.We retrospectively tested 143 CSF and 77 plasma samples collected from HIV-seropositive individuals with suspected meningitis from 2012-2016 in Uganda. We prospectively tested 90 plasma samples collected from HIV-seropositive individuals with CD4 cell count <100 cells/μL from 2016-2017 as part of a cryptococcal antigenemia screening program. The StrongStep CrAg was tested against a composite reference standard of positive Immy CrAg LFA (Immy, Norman, OK, USA or CSF culture with statistical comparison by McNemar's test.StrongStep CrAg had a 98% (54/55 sensitivity and 90% (101/112 specificity in plasma (P = 0.009, versus reference standard. In CSF, the StrongStep CrAg had 100% (101/101 sensitivity and 98% (41/42 specificity (P = 0.99. Adjusting for the cryptococcal antigenemia prevalence of 9% in Uganda and average cryptococcal meningitis prevalence of 37% in Sub-Saharan Africa, the positive predictive value of the StrongStep CrAg was 50% in plasma and 96% in CSF.We found the StrongStep CrAg LFA to be a sensitive assay, which unfortunately lacked specificity in plasma. In lower prevalence settings, a majority of positive results from blood would be expected to be false positives.

  14. Rapid prototyping of centrifugal microfluidic modules for point of care blood testing

    CSIR Research Space (South Africa)

    Madzivhandila, Phophi

    2016-11-01

    Full Text Available We present modular centrifugal microfluidic devices that enable a series of blood tests to be performed towards a full blood count. The modular approach allows for rapid prototyping of device components in a generic format to complete different...

  15. Point of Care Testing/Central Laboratory Analysis of Glucose and ...

    African Journals Online (AJOL)

    Prompt diagnosis of electrolytes and acid-base abnormalities in diabetic emergencies, and quick intervention is the key to a good outcome. In the Third world, there is a delay in reporting of central laboratory results due to a mirage of problems. POCT testing has been shown to be valuable in the management of diabetic ...

  16. HIV-1 Drug Resistance Mutations: Potential Applications for Point-of-Care Genotypic Resistance Testing

    NARCIS (Netherlands)

    Rhee, Soo-Yon; Jordan, Michael R.; Raizes, Elliot; Chua, Arlene; Parkin, Neil; Kantor, Rami; van Zyl, Gert U.; Mukui, Irene; Hosseinipour, Mina C.; Frenkel, Lisa M.; Ndembi, Nicaise; Hamers, Raph L.; Rinke de Wit, Tobias F.; Wallis, Carole L.; Gupta, Ravindra K.; Fokam, Joseph; Zeh, Clement; Schapiro, Jonathan M.; Carmona, Sergio; Katzenstein, David; Tang, Michele; Aghokeng, Avelin F.; de Oliveira, Tulio; Wensing, Annemarie M. J.; Gallant, Joel E.; Wainberg, Mark A.; Richman, Douglas D.; Fitzgibbon, Joseph E.; Schito, Marco; Bertagnolio, Silvia; Yang, Chunfu; Shafer, Robert W.

    2015-01-01

    The increasing prevalence of acquired and transmitted HIV-1 drug resistance is an obstacle to successful antiretroviral therapy (ART) in the low- and middle-income countries (LMICs) hardest hit by the HIV-1 pandemic. Genotypic drug resistance testing could facilitate the choice of initial ART in

  17. HIV-1 drug resistance mutations : Potential applications for point-of-care Genotypic resistance testing

    NARCIS (Netherlands)

    Rhee, Soo Yon; Jordan, Michael R.; Raizes, Elliot; Chua, Arlene; Parkin, Neil; Kantor, Rami; Van Zy, Gert U.; Mukui, Irene; Hosseinipour, Mina C.; Frenkel, Lisa M.; Ndembi, Nicaise; Hamers, Raph L.; De Wit, Tobias F Rinke; Wallis, Carole L.; Gupta, Ravindra K.; Fokam, Joseph; Zeh, Clement; Schapiro, Jonathan M.; Carmona, Sergio; Katzenstein, David; Tang, Michele; Aghokeng, Avelin F.; De Oliveira, Tulio; Wensing, Annemarie M J; Gallant, Joel E.; Wainberg, Mark A.; Richman, Douglas D.; Fitzgibbon, Joseph E.; Schito, Marco; Bertagnolio, Silvia; Yang, Chunfu; Shafer, Robert W.

    2015-01-01

    The increasing prevalence of acquired and transmitted HIV-1 drug resistance is an obstacle to successful antiretroviral therapy (ART) in the low- and middle-income countries (LMICs) hardest hit by the HIV-1 pandemic. Genotypic drug resistance testing could facilitate the choice of initial ART in

  18. Rapid, high sensitivity, point-of-care test for cardiac troponin based on optomagnetic biosensor

    NARCIS (Netherlands)

    Dittmer, W.U.; Evers, T.H.; Hardeman, W.M.; Huijnen-Keur, W.M.; Kamps, R.; De Kievit, P.; Neijzen, J.H.M.; Sijbers, M.J.J.; Nieuwenhuis, J.H.; Hefti, M.H.; Dekkers, D.; Martens, M.

    2010-01-01

    BACKGROUND: We present a handheld integrated device based on a novel magnetic-optical technology for the sensitive detection of cardiactroponin I, a biomarker for the positive diagnosis of myocardial infarct, in a finger-prick blood sample. The test can be performed with a turn-around time of 5

  19. A Novel Field-Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis

    Science.gov (United States)

    2016-10-01

    extractor at the POC or FTA Whatman filter paper specially designed to improve DNA preservation and purification at POC. Aim 1: To optimize the analytical...patients in order to perform species-specific identification by Nested Real Time PCR FRET probes- based. In addition, as part of a training workshop...LF test using a DNA mini-extractor vs. Whatman FTA filter paper utilizing dermal tissues spiked with Leishmania grown in the lab 1-3 80

  20. Qualitative point-of-care D-dimer testing compared with quantitative D-dimer testing in excluding pulmonary embolism in primary care

    NARCIS (Netherlands)

    Lucassen, W. A. M.; Erkens, P. M. G.; Geersing, G. J.; Büller, H. R.; Moons, K. G. M.; Stoffers, H. E. J. H.; van Weert, H. C. P. M.

    2015-01-01

    General practitioners can safely exclude pulmonary embolism (PE) by using the Wells PE rule combined with D-dimer testing. To compare the accuracy of a strategy using the Wells rule combined with either a qualitative point-of-care (POC) D-dimer test performed in primary care or a quantitative

  1. Rapid and point-of-care tests for the diagnosis of Trichomonas vaginalis in women and men.

    Science.gov (United States)

    Gaydos, Charlotte A; Klausner, Jeffrey D; Pai, Nitika Pant; Kelly, Helen; Coltart, Cordelia; Peeling, Rosanna W

    2017-12-01

    Trichomonasvaginalis (TV) is a highly prevalent parasitic infection worldwide. It is associated with many adverse reproductive health outcomes. Many infections are asymptomatic and syndromic management leads to underdetection of TV. Traditional methods of TV detection such as wet preparation are insensitive. New rapid, point-of-care (POC) tests can enhance the diagnosis of trichomoniasis. The authors reviewed the literature and discuss older POC tests for TV detection, as well as the OSOM lateral flow test, the AmpliVue test, the Solana test and the GeneXpert test as well as the limitations of wet preparation and culture for detection of TV. The OSOM test is easy to perform, compared with other POC tests, and is Clinical Laboratory Improvement Amendments (CLIA)-waived, equipment-free, has sensitivities of 83%-86% compared with nucleic acid amplification tests (NAATs) and can be performed in 15 min. The AmpliVue and the Solana tests are not CLIA waived and require small pieces of equipment. They are molecular amplified assays and can be completed in TV test for women and men is a moderately complex test, requires a small platform and can be performed in women and one is available for detection of TV in men. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  2. Ensuring the Quality of Point-of-Care Testing in a Large and Decentralized Ambulatory Care Setting.

    Science.gov (United States)

    Arboleda, Valerie A; Garner, Omai B

    2017-10-01

    In this project, we assessed the breadth, quality, trends, and outcomes of point-of-care (POC) testing and regulatory compliance in 200 University of California, Los Angeles (UCLA) Health system outpatient clinics. We retrospectively extracted clinic POC test orders, results, and e-prescription data from the UCLA electronic health record over a 1-year period. Over 100,000 total tests were performed, encompassing 10 POC tests. Initially, 40% of clinics did not have complete licensure, but after implementation of the POC team, this metric improved to 100% licensure within 6 months. Most clinics used two or fewer POC tests, resulted fewer than 200 tests per year, and performed little to no external quality control measures. Our data analytics approach showed that peak POC testing occurred in January 2015, driven by influenza and urinalysis testing, and that both the testing and resulting clinical decision making do not routinely follow society guidelines. This decentralization of laboratory testing presents challenges to ensuring quality POC testing. Optimization and analysis of informatics data allow for the identification of POC test utilization trends, areas of improvement for clinical workflows, and increased education on national guidelines. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  3. Point-of-care testing of HbA1c in diabetes care and preventable hospital admissions

    DEFF Research Database (Denmark)

    Kristensen, Troels; Rose Olsen, Kim

    Background: Point-of-care testing (POCT) of HbA1c may result in improved diabetic control, better patient outcomes and enhanced clinical efficiency with fewer patient visits and subsequent reductions in hospitalizations and costs. In 2008, the Danish regulators agreed to create a new tariff...... for the remuneration of POCT of HbA1c in primary care. Aim: The aim of this study is to assess whether there is an association between the use of POCT of HbA1c and preventable hospital admissions among diabetes patients in general practice. Method: We apply logistic regression analyses to examine whether......, socioeconomic covariates, municipality classifications and case mix measure in terms of the charlson index and costs of care in primary care and secondary care. Results: There was a significant link between POCT of HbA1c among diabetes patients in general practice and an ACSC-measure of preventable out...

  4. Point-of-care testing of HbA1c in diabetes care and preventable hospital admissions

    DEFF Research Database (Denmark)

    Kristensen, Troels; Rose Olsen, Kim; Skovsgaard, Christian

    Background: Point-of-care testing (POCT) of HbA1c may result in improved diabetic control, better patient outcomes and enhanced clinical efficiency with fewer patient visits and subsequent reductions in hospitalizations and costs. In 2008, the Danish regulators agreed to create a new tariff...... for the remuneration of POCT of HbA1c in primary care. Aim: The aim of this study is to assess whether there is an association between the use of POCT of HbA1c and preventable hospital admissions among diabetes patients in general practice. Method: We apply logistic regression analyses to examine whether...... there is a link between preventable hospital admissions and POCT of HbA1c in general practice. Preventable hospital admissions were assessed through the ambulatory care sensitive conditions (ACSCs) classification of hospital admissions. We include independent variables such as gender, age, ethnicity...

  5. Hydrophobic marking line used to eliminate the edge effect in a microfluidic point-of-care testing device

    Science.gov (United States)

    Jingmin, Li; Xia, Li; Ziyang, Liu; Chao, Liang; Chong, Liu

    2017-01-01

    The traversal rate for the liquid medium near a point-of-care testing (POCT) device microfluidic channel edge is faster than that through the body of the channel, which makes the fluid front meniscus becomes concave rather than convex or flat. The concave front is unwished due to its influences on quantitative analysis accuracy and the possibility to generate air bubbles. Here, a unique method, named hydrophobic marking line, is demonstrated. This method used a soft pen with hydrophobic ink to draw two lines along the edges of the channel of a POCT device. Results have shown that the marking lines will eliminate the edge effects and generate convex liquid front. The curvature of the liquid front can be changed by adjusting the marking line width or ink solutions.

  6. Potential point of care tests (POCTs) for maternal health in Peru, perspectives of pregnant women and their partners.

    Science.gov (United States)

    Bayer, Angela M; Najarro, Lizzete; Zevallos, Mercedes; García, Patricia J

    2014-01-16

    Globally, no qualitative studies have explored the perspectives of women and their partners about the integration of technology - and specifically diagnostic testing technologies - into antenatal care. The study objective was to describe the demand side for pregnancy-related diagnostic tests from the perspective of Peruvian consumers, including female and male community members, by engaging participants about their awareness of and care-seeking for pregnancy-related diagnostic tests and their preferred characteristics and testing conditions for pregnancy-related point-of-care diagnostic tests (POCTs). Sixty-seven mothers and fathers of children under one from the peri-urban coast and the peri-urban and rural highlands and jungle of Peru participated in ten focus groups. Participants think that pregnancy-related diagnostic tests are important and they and their fellow community members are committed to ensuring that pregnant women receive the tests they need. Participants expressed clear demands for pregnancy-related POCTs, including important characteristics for the tests themselves (certification, rapid, reliable results) and for test implementation (well-trained, personable good communicators as test administrators at well-equipped, convenient testing sites). Participants emphasized the importance of short waiting times and explained that many people have some ability to pay for POCTs, particularly if they are innovative, rapid or multiplex. Engaging future POCT users as consumers who are able to make key decisions about the development and implementation of pregnancy-related POCTs is valuable and informative.

  7. Lactate point-of-care testing for acidosis: Cross-comparison of two devices with routine laboratory results

    Directory of Open Access Journals (Sweden)

    Remco van Horssen

    2016-04-01

    Full Text Available Objectives: Lactate is a major parameter in medical decision making. During labor, it is an indicator for fetal acidosis and immediate intervention. In the Emergency Department (ED, rapid analysis of lactate/blood gas is crucial for optimal patient care. Our objectives were to cross-compare-for the first time-two point-of-care testing (POCT lactate devices with routine laboratory results using novel tight precision targets and evaluate different lactate cut-off concentrations to predict metabolic acidosis. Design and methods: Blood samples from the delivery room (n=66 and from the ED (n=85 were analyzed on two POCT devices, the StatStrip-Lactate (Nova Biomedical and the iSTAT-1 (CG4+ cassettes, Abbott, and compared to the routine laboratory analyzer (ABL-735, Radiometer. Lactate concentrations were cross-compared between these analyzers. Results: The StatStrip correlated well with the ABL-735 (R=0.9737 and with the iSTAT-1 (R=0.9774 for lactate in umbilical cord blood. Lactate concentrations in ED samples measured on the iSTAT-1 and ABL-735 showed a correlation coefficient of R=0.9953. Analytical imprecision was excellent for lactate and pH, while for pO2 and pCO2 the coefficient of variation was relatively high using the iSTAT-1. Conclusion: Both POCT devices showed adequate analytical performance to measure lactate. The StatStrip can indicate metabolic acidosis in 1 μl blood and will be implemented at the delivery room. Keywords: Lactate, Point-of-care testing, Blood gas, Fetal acidosis

  8. The Utility of Point-of-Care Testing at Emergency Department Triage by Nurses in Simulated Scenarios.

    Science.gov (United States)

    Pines, Jesse M; Zocchi, Mark S; Buchanan, Mary Elizabeth; Shah, Manish N; Travers, Debbie

    We developed and tested simulated patient scenarios to assess how normal or abnormal point-of-care (POC) test results at triage change prioritization decisions. This was a cross-sectional study where our team developed simulated scenarios and presented them to triage nurses from 3 academic medical centers. Twenty-four scenarios were constructed on the basis of 12 clinical indications from a protocol previously developed by our team. In each scenario, nurses were presented with 2 patients with the same Emergency Severity Index Version 4 (ESI v.4; Agency for Healthcare Research and Quality, Rockville, MD) triage level (Level 2 or Level 3). One of the patients met the inclusion criteria for POC testing under the protocol (cases), whereas the other patient did not (controls). Nurses were asked which of the 2 patients to prioritize first in 3 separate rounds: first without any POC test results, once with abnormal POC test results for case patients, and once with normal POC test results for case patients. Prioritization decisions that changed on the basis of abnormal POC results were defined as "up-triage" and prioritization decisions that changed on the basis of normal results were defined as "down-triage." A total of 39 nurses completed 468 scenarios. In scenarios without any POC test results, 42.3% of case patients were prioritized first. When POC test results were abnormal, 71.6% of cases were prioritized first. When POC test results were normal, 32.7% of case patients were prioritized first. An abnormal POC test resulted in up-triage in 32.5% of the scenarios. When POC test results were normal, there was down-triage in 18.6% of the scenarios. Up- and down-triage rates varied considerably by scenario and clinical indication. Point-of-care testing at emergency department triage results in reasonably high rates of up- and down-triage in simulated scenarios; however, POC tests for specific indications appear to be more useful than others.

  9. Successful Integration of Hepatitis C Virus Point-of-Care Tests into the Denver Metro Health Clinic

    Directory of Open Access Journals (Sweden)

    A. Jewett

    2013-01-01

    Full Text Available Background. The Centers for Disease Control and Prevention (CDC recommends testing and linkage to care for persons most likely infected with hepatitis C virus (HCV, including persons with human immunodeficiency virus. We explored facilitators and barriers to integrating HCV point-of-care (POC testing into standard operations at an urban STD clinic. Methods. The OraQuick HCV rapid antibody test was integrated at the Denver Metro Health Clinic (DMHC. All clients with at least one risk factor were offered the POC test. Research staff conducted interviews with clients (three HCV positive and nine HCV negative. Focus groups were conducted with triage staff, providers, and linkage-to-care counselors. Results. Clients were pleased with the ease of use and rapid return of results from the HCV POC test. Integrating the test into this setting required more time but was not overly burdensome. While counseling messages were clear to staff, clients retained little knowledge of hepatitis C infection or factors related to risk. Barriers to integrating the HCV POC test into clinic operations were loss to follow-up and access to care. Conclusion. DMHC successfully integrated HCV POC testing and piloted a HCV linkage-to-care program. Providing testing opportunities at STD clinics could increase identification of persons with HCV infection.

  10. A smartphone-based system for the automated management of point-of-care test results in hospitals.

    Science.gov (United States)

    Jang, Dasom; Shin, Soo-Yong; Seo, Dong-Woo; Joo, Segyeong; Huh, Soo-Jin

    2015-04-01

    Managing test results is an important issue in hospitals because of the increasing use of point-of-care testing (POCT). Here, we propose a smartphone-based system for automatically managing POCT test results. We developed the system to provide convenience to the medical staffs. The system recognizes the patient identification or prescription number of the test by reading barcodes and provides a countdown to indicate when the results will be ready. When the countdown in finished, a picture of the test result is transferred to the electronic medical record server using the Health Level 7 protocol. Human immunodeficiency virus (HIV) kits were selected in this research because HIV is a life-threatening infectious virus, especially for the medical staff who treat undiagnosed patients. The performance of the system was verified from a survey of the users. The performance of the system was tested at the emergency room (ER) for 10 months using commercially available POCT kits for detecting HIV. The survey showed that, in total, 80% and 0% of users reported positive or negative feedback, respectively. The staff also reported that the system reduced total processing time by approximately 32 min, in addition to reducing workload. The developed automated management system was successfully tested at an ER for 10 months. The survey results show that the system is effective and that medical staff members who used the system are satisfied with using the system at the ER.

  11. Utilization of influenza and streptococcal pharyngitis point-of-care testing in the community pharmacy practice setting.

    Science.gov (United States)

    Klepser, Donald G; Klepser, Michael E; Smith, Jaclyn K; Dering-Anderson, Allison M; Nelson, Maggie; Pohren, Lauren E

    2018-04-01

    One way to reduce the complications and costs of influenza like illness and pharyngitis is to improve access to testing and treatment in early stages of infection. Pharmacy-based screening and treatment of group A streptococcus (GAS) infection and influenza has the potential to improve patient care and population health. To improve patient care and population health, the objective of this retrospective study was to assess if a previously validated service model could be implemented by pharmacy chains without mandated standardization. Researchers utilized a certificate program to provide initial training to pharmacists and shared templates from previous validated models. Pharmacy companies were responsible for navigation of all implementation within their company. Researchers analyzed the de-identified data from patients seeking point-of-care testing from the participating pharmacies. Participating pharmacies reported 661 visits for adult (age 18 and over) patients tested for influenza for GAS pharyngitis. For the GAS patients, 91 (16.9%) tested positive. For the Influenza patients, 22.9% tested positive and 64 (77.1%) testing negative. Access to care was improved as patients presented to the visit outside normal clinic hours for 38% of the pharmacy visits, and 53.7% did not have a primary care provider. A collaborative care model for managing patients with symptoms consistent with influenza or group A streptococcus can be successfully implemented, and improve access to care outside of normal clinic hours and for those without a regular primary care provider. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Point-of-Care Testing for Cryptococcal Disease among Hospitalized Human Immunodeficiency virus–Infected Adults in Ethiopia

    Science.gov (United States)

    Mamuye, Admasu Tenna; Bornstein, Ethan; Temesgen, Obsie; Blumberg, Henry M.; Kempker, Russell R.

    2016-01-01

    In a cross-sectional study among hospitalized human immunodeficiency virus (HIV)–infected patients in Ethiopia, we sought to determine the rates and predictors of cryptococcal disease and evaluate the test performance of a recently introduced point-of-care test for Cryptococcus neoformans detection in various biological samples. We tested serum, urine, and fingerstick blood samples from each patient with a cryptococcal antigen lateral flow assay (CRAG LFA; Immuno Mycologic Inc., Norman, OK). Cerebrospinal fluid was collected at the discretion of the treating physician. Logistic regression was used to identify risk factors for a positive test result. Agreement between different sample types was also assessed. Among 198 hospitalized HIV-infected patients with a median CD4 count of 93 cells/mm3, 18 patients (9.1%) had a positive serum CRAG LFA. Of these, 16 (8.1%) had confirmed cryptococcal meningitis (CM), all of whom had a positive fingerstick blood LFA result. There was a very high agreement between CRAG LFA tests in serum and fingerstick blood samples (κ = 0.97, 95% confidence interval [CI] = 0.91–1.00); this was higher than that between serum and urine samples (κ = 0.76, 95% CI = 0.58–0.93). A CD4 count cryptococcal disease, our study demonstrated that the use of the LFA on fingerstick whole blood is less invasive, and an effective method for CM case finding among hospitalized patients with HIV. PMID:27527636

  13. Preanalytical conditions of point-of-care testing in the intensive care unit are decisive for analysis reliability.

    Science.gov (United States)

    Auvet, Adrien; Espitalier, Fabien; Grammatico-Guillon, Leslie; Nay, Mai-Anh; Elaroussi, Djilali; Laffon, Marc; Andres, Christian R; Legras, Annick; Ehrmann, Stephan; Dequin, Pierre-François; Gendrot, Chantal; Guillon, Antoine

    2016-12-01

    Point-of-care testing (POCT) systems enable a wide range of tests to be rapidly performed at the bedside and have attracted increasing interest in the intensive care unit (ICU). However, previous studies comparing the concordance of POCT with central laboratory testing have reported divergent findings. Most reported studies on POCT reliability have focused on analyzer performance rather than the preanalytical phase. The aim of this study was to assess the reliability of results provided by point-of-care analyzers according to the organization of the care units and the preanalytical process. In three adult critical care units, 491 paired blood samples were analyzed for hemoglobin, potassium, and sodium concentrations by blood gas analyzers (identical reference) and the central laboratory. The clinical significance of agreement was assessed using Bland-Altman plots. A quality improvement program was then implemented to improve the preanalytical POCT process for one ICU where there was poor agreement. A second comparison was performed on 278 paired blood samples in this unit. Biases were clinically nonsignificant for potassium and sodium concentrations for all tested critical care units, relative to the reference method. However, biases [limits of agreements] for hemoglobin analyses were clearly affected by the preanalytical process: -3 [-6; 1] g/L in the operating room, -5 [-28; 17] g/L in a 10-bed ICU, and -19 [-64; 27] g/L in a 37-bed ICU. The quality approach was implemented in the 37-bed ICU and led to corrective actions that: (1) reduced the time for the POCT preanalytical phase; (2) implemented a checklist to validate the preanalytical conditions; (3) used technical innovations. The improvement of the preanalytical process resulted in a substantial decrease of the bias for hemoglobin concentration measurements: -3 [-10; 5] g/L in the 37-bed ICU. We clearly demonstrate that an identical analyzer can provide results of varying quality depending on the local

  14. Cost-effectiveness of point-of-care C-reactive protein testing to inform antibiotic prescribing decisions

    Science.gov (United States)

    Oppong, Raymond; Jit, Mark; Smith, Richard D; Butler, Christopher C; Melbye, Hasse; Mölstad, Sigvard; Coast, Joanna

    2013-01-01

    Background Point-of-care C-reactive protein (POCCRP) is a biomarker of inflammation that offers clinicians a rapid POC test to guide antibiotic prescribing decisions for acute cough and lower respiratory tract infections (LRTI). However, evidence that POCCRP is cost-effective is limited, particularly outside experimental settings. Aim To assess the cost-effectiveness of POCCRP as a diagnostic tool for acute cough and LRTI from the perspective of the health service. Design and setting Observational study of the presentation, management, and outcomes of patients with acute cough and LRTI in primary care settings in Norway and Sweden. Method Using hierarchical regression, data were analysed in terms of the effect on antibiotic use, cost, and patient outcomes (symptom severity after 7 and 14 days, time to recovery, and EQ-5D), while controlling for patient characteristics (self-reported symptom severity, comorbidities, and health-related quality of life) at first attendance. Results POCCRP testing is associated with non-significant positive reductions in antibiotic prescribing (P = 0.078) and increased cost (P = 0.092). Despite the uncertainty, POCCRP testing is also associated with a cost per quality-adjusted life year (QALY) gain of €9391. At a willingness-to-pay threshold of €30 000 per QALY gained, there is a 70% probability of CRP being cost-effective. Conclusion POCCRP testing is likely to provide a cost-effective diagnostic intervention both in terms of reducing antibiotic prescribing and in terms of QALYs gained. PMID:23834883

  15. Use of point-of-care tests among general practitioners: a cross-sectional study in Saxony, Germany.

    Science.gov (United States)

    Frese, Thomas; Steger, Kathleen; Deutsch, Tobias; Schmid, Gordian L; Sandholzer, Hagen

    2016-01-01

    There is little knowledge about the use of point-of-care (POC) tests among general practitioners (GPs). The aim of this study was to determine which POC tests are known and used by GPs and how they estimate the usefulness of those tests. The use of POC tests among GPs and university-associated general practitioners who teach undergraduates (GPTUs) was elucidated. Differences between GPs working in urban and rural areas were also investigated. The knowledge, utilisation and usefulness (as estimated by the responders) of 27 POC tests were assessed with a self-designed questionnaire in a random sample of GPs (n=244) and GPTUs (n=48) in Saxony, Germany. A total of 63 GPs and 31 GPTUs (response rates 26.5% and 64.6%, respectively) responded. No relevant difference between GPs and GPTUs was found. The GPs were familiar with 22.5±4.5 (mean ± standard deviation) of the laboratory parameters, the GPTUs with 22.9±4.3 (p=0.427). The amount of recognised POC tests was 11.6±4.9 vs 12.4±5.5 (GPs vs GPTUs; p=0.441). The amount of utilised POC tests was 5.5±2.3 vs 6.0±2.5 (GPs vs GPTUs; p=0.431). Rural GPs were familiar with more POC tests than urban GPs (mean number of tests (rural vs urban): 13.3±5.5 vs 10.6±4.4; p=0.011), but there was no difference in the amount of utilised POC tests. Twelve of the 27 POC tests were estimated as useful by more than 50% of the responders who answered this item. Only a limited number of rapid tests are estimated as useful and are used by GPs in Saxony.

  16. Field evaluation of HIV point-of-care testing for early infant diagnosis in Cape Town, South Africa.

    Science.gov (United States)

    Dunning, Lorna; Kroon, Max; Hsiao, Nei-Yuan; Myer, Landon

    2017-01-01

    Early infant HIV diagnosis (EID) coverage and uptake remains challenging. Point-of-care (POC) testing may improve access and turn-around-times, but, while several POC technologies are in development there are few data on their implementation in the field. We conducted an implementation study of the Alere q Detect POC system for EID at two public sector health facilities in Cape Town. HIV-exposed neonates undergoing routine EID testing at a large maternity hospital and a primary care clinic received both laboratory-based HIV PCR testing per local protocols and a POC test. We analysed the performance of POC versus laboratory testing, and conducted semi-structured interviews with providers to assess acceptability and implementation issues. Overall 478 specimens were taken: 311 tests were performed at the obstetric hospital (median child age, 1 days) and 167 six-week tests in primary care (median child age, 42 days). 9.0% of all tests resulted in an error with no differences by site; most errors resolved with retesting. POC was more sensitive (100%; lower 95% CI, 39.8%) and specific (100%, lower 95% CI, 98%) among older children tested in primary care compared with birth testing in hospital (90.0%, 95% CI, 55.5-99.8% and 100.0%, lower 95% CI, 98.4%, respectively). Negative predictive value was high (>99%) at both sites. In interviews, providers felt the device was simple to use and facilitated decision-making in the management of infants. However, many wanted clarity on the cause of errors on the POC device to help guide repeat testing. POC EID testing performs well in field implementation in health care facilities and appears highly acceptable to health care providers.

  17. Uptake of Community-Based Peer Administered HIV Point-of-Care Testing: Findings from the PROUD Study.

    Directory of Open Access Journals (Sweden)

    Lisa Lazarus

    Full Text Available HIV prevalence among people who inject drugs (PWID in Ottawa is estimated at about 10%. The successful integration of peers into outreach efforts and wider access to HIV point-of-care testing (POCT create opportunities to explore the role of peers in providing HIV testing. The PROUD study, in partnership with Ottawa Public Health (OPH, sought to develop a model for community-based peer-administered HIV POCT.PROUD draws on community-based participatory research methods to better understand the HIV risk environment of people who use drugs in Ottawa. From March-October 2013, 593 people who reported injecting drugs or smoking crack cocaine were enrolled through street-based recruitment. Trained peer or medical student researchers administered a quantitative survey and offered an HIV POCT (bioLytical INSTI test to participants who did not self-report as HIV positive.550 (92.7% of the 593 participants were offered a POCT, of which 458 (83.3% consented to testing. Of those participants, 74 (16.2% had never been tested for HIV. There was no difference in uptake between testing offered by a peer versus a non-peer interviewer (OR = 1.05; 95% CI = 0.67-1.66. Despite testing those at high risk for HIV, only one new reactive test was identified.The findings from PROUD demonstrate high uptake of community-based HIV POCT. Peers were able to successfully provide HIV POCT and reach participants who had not previously been tested for HIV. Community-based and peer testing models provide important insights on ways to scale-up HIV prevention and testing among people who use drugs.

  18. Care Model Design for E-Health: Integration of Point-of-Care Testing at Dutch General Practices

    Directory of Open Access Journals (Sweden)

    Bart Verhees

    2017-12-01

    Full Text Available Point-of-care testing (POCT—laboratory tests performed with new mobile devices and online technologies outside of the central laboratory—is rapidly outpacing the traditional laboratory test market, growing at a rate of 12 to 15% each year. POCT impacts the diagnostic process of care providers by yielding high efficiency benefits in terms of turnaround time and related quality improvements in the reduction of errors. However, the implementation of this disruptive eHealth technology requires the integration and transformation of diagnostic services across the boundaries of healthcare organizations. Research has revealed both advantages and barriers of POCT implementations, yet to date, there is no business model for the integration of POCT within general practice. The aim of this article is to contribute with a design for a care model that enables the integration of POCT in primary healthcare. In this research, we used a design modelling toolkit for data collection at five general practices. Through an iterative design process, we modelled the actors and value transactions, and designed an optimized care model for the dynamic integration of POCTs into the GP’s network of care delivery. The care model design will have a direct bearing on improving the integration of POCT through the connectivity and norm guidelines between the general practice, the POC technology, and the diagnostic centre.

  19. The clinical situation of point-of-care testing and its future development at the emergency department in Shanghai.

    Science.gov (United States)

    Leong, Waiian; Chen, Lianxiang; Yu, Ping; Wei, Bohua; Wang, Cuicui; Ying, Yilin; Jiang, Jie; Tong, Jianjing; Zhu, Dingliang; Ye, Jing; Lu, Yiming

    2014-12-01

    We assessed the efficiency of point-of-care (POC) tests in the emergency department (ED) by comparing them with the international standard. We recorded the turnaround times (TATs) for processing laboratory biomarkers to assess laboratory efficiency from 17 EDs in national/regional hospitals. We also compared patient components between national and regional hospitals. Although the 17 enrolled hospitals expanded their EDs, they contained only five POC machines among them. The P50 (P25, P75) of the TATs for POC tests was 47 min (39, 55.5 min) for cardiac troponin T, which was much longer than the international standard (30 min). The TATs of other cardiac biomarkers were also longer than 30 min. The low efficiency of TATs for POC tests was a common feature in both regional and national hospitals (p > 0.05). Myocardial infarction was diagnosed in 61% of investigated ED patients who visited national hospitals, which is more frequently than those diagnosed at regional hospitals (46%, p administrative management of EDs. This issue should be addressed in the next version of the medical reform policy. © 2014 Society for Laboratory Automation and Screening.

  20. Syphilis screening among 27,150 pregnant women in South Chinese rural areas using point-of-care tests.

    Directory of Open Access Journals (Sweden)

    Li-Gang Yang

    Full Text Available To determine the prevalence and correlates of syphilis among pregnant women in rural areas of South China.Point-of-care syphilis testing was provided at 71 health facilities in less developed, rural areas of Guangdong Province. Positive samples were confirmed at a local referral center by toluidine red unheated serum tests (TRUST and Treponema pallidum particle agglutination (TPPA tests.Altogether 27,150 pregnant women in rural Guangdong were screened for syphilis. 106 (0.39% syphilis cases were diagnosed, of which 78 (73.6% received treatment for syphilis. Multivariate analysis revealed that older pregnant women (31-35 years old, aOR 2.7, 95% CI 0.99-7.32; older than 35 years old, aOR 5.9, 95% CI 2.13-16.34 and those with a history of adverse pregnant outcomes (aOR 3.64, 95% CI 2.30-5.76 were more likely to be infected with syphilis.A high prevalence of syphilis exists among pregnant women living in rural areas of South China. Enhanced integration of syphilis screening with other routine women's health services (OB GYN, family planning may be useful for controlling China's syphilis epidemic.

  1. Care Model Design for E-Health: Integration of Point-of-Care Testing at Dutch General Practices.

    Science.gov (United States)

    Verhees, Bart; van Kuijk, Kees; Simonse, Lianne

    2017-12-21

    Point-of-care testing (POCT)-laboratory tests performed with new mobile devices and online technologies outside of the central laboratory-is rapidly outpacing the traditional laboratory test market, growing at a rate of 12 to 15% each year. POCT impacts the diagnostic process of care providers by yielding high efficiency benefits in terms of turnaround time and related quality improvements in the reduction of errors. However, the implementation of this disruptive eHealth technology requires the integration and transformation of diagnostic services across the boundaries of healthcare organizations. Research has revealed both advantages and barriers of POCT implementations, yet to date, there is no business model for the integration of POCT within general practice. The aim of this article is to contribute with a design for a care model that enables the integration of POCT in primary healthcare. In this research, we used a design modelling toolkit for data collection at five general practices. Through an iterative design process, we modelled the actors and value transactions, and designed an optimized care model for the dynamic integration of POCTs into the GP's network of care delivery. The care model design will have a direct bearing on improving the integration of POCT through the connectivity and norm guidelines between the general practice, the POC technology, and the diagnostic centre.

  2. Simple Approaches to Minimally-Instrumented, Microfluidic-Based Point-of-Care Nucleic Acid Amplification Tests

    Science.gov (United States)

    Mauk, Michael G.; Song, Jinzhao; Liu, Changchun; Bau, Haim H.

    2018-01-01

    Designs and applications of microfluidics-based devices for molecular diagnostics (Nucleic Acid Amplification Tests, NAATs) in infectious disease testing are reviewed, with emphasis on minimally instrumented, point-of-care (POC) tests for resource-limited settings. Microfluidic cartridges (‘chips’) that combine solid-phase nucleic acid extraction; isothermal enzymatic nucleic acid amplification; pre-stored, paraffin-encapsulated lyophilized reagents; and real-time or endpoint optical detection are described. These chips can be used with a companion module for separating plasma from blood through a combined sedimentation-filtration effect. Three reporter types: Fluorescence, colorimetric dyes, and bioluminescence; and a new paradigm for end-point detection based on a diffusion-reaction column are compared. Multiplexing (parallel amplification and detection of multiple targets) is demonstrated. Low-cost detection and added functionality (data analysis, control, communication) can be realized using a cellphone platform with the chip. Some related and similar-purposed approaches by others are surveyed. PMID:29495424

  3. The role of point-of-care blood testing for ketones in the diagnosis of diabetic ketoacidosis.

    Science.gov (United States)

    Coetzee, Ankia; Hoffmann, Mariza; Ascott-Evans, Brynne H

    2015-09-14

    Urine dipstick testing for ketones is widely used when diabetic ketoacidosis (DKA) is suspected in patients with hyperglycaemia. If urinary ketones are positive, patients are referred for further management--often inappropriately, as the test is a poor surrogate for plasma ketones. Plasma beta-hydroxybutyrate (β-OHB) levels>3 mmol/L are diagnostic of DKA, while levelsL are insignificant. To evaluate a hand-held electrochemical (point-of-care testing; POCT) ketone monitor and compare it with the gold-standard manual enzymatic method (MEM) for detection of plasma ketones. In a prospective and comparative study, we evaluated the measurement of β-OHB by means of POCT and the MEM in 61 consecutive samples from patients with suspected DKA at Tygerberg and Karl Bremer hospitals, Cape Town, South Africa. Capillary (for POCT) and plasma samples (for the MEM) were obtained simultaneously and compared for accuracy. Precision was assessed with control samples. The POCT method was precise (coefficient of variation 3 mmol/L and L), the total allowable error (bias+imprecision) was not exceeded. Patients will therefore still be classified correctly. The POCT method had a sensitivity of 100% and specificity of 89% for DKA (β-OHB>3 mmol/L), while at levelsL sensitivity was 100% and specificity 87.5%. The POCT device provides an accurate and precise result and can be used as an alternative to the MEM in the diagnosis of DKA.

  4. Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test.

    Science.gov (United States)

    Jani, Ilesh V; Meggi, Bindiya; Mabunda, Nédio; Vubil, Adolfo; Sitoe, Nadia E; Tobaiwa, Ocean; Quevedo, Jorge I; Lehe, Jonathan D; Loquiha, Osvaldo; Vojnov, Lara; Peter, Trevor F

    2014-09-01

    To evaluate the accuracy of a point-of-care (POC) nucleic acid-based test (NAT) for early infant HIV diagnosis (EID) in primary health clinics in Mozambique. POC and laboratory NAT EID tests were conducted on matched blood samples collected from 827 HIV-exposed infants younger than 18 months who were enrolled consecutively at 4 periurban primary health clinics and the central hospital in Maputo. Lancet heel draw blood collected by nurses was tested on site for HIV-1/-2 RNA on the Alere HIV NAT POC device and also used to create dried blood spots for later laboratory EID testing on the Roche Cobas Taqman/Ampliprep instrument. Results were used to determine the sensitivity, specificity, and agreement between the POC and laboratory NAT EID tests. The sensitivity and specificity of POC NAT EID testing were 98·5% (95% confidence interval (CI): 91.7 to 99.9, n = 65) and 99·9% (95% CI: 99.3 to 100, n = 762), respectively, compared with laboratory EID tests. Overall agreement was high (Cohen kappa = 0·981; 95% CI: 0.96 to 1.00). Positive (98·5%; 95% CI: 96·3 to 100) and negative 99.9% (95% CI: 99.7 to 100) test agreement was also high. Primary health care nurses accurately performed POC NAT EID testing within primary health care clinics. On-site nucleic acid-based EID testing is technically feasible in clinic settings and could be used in efforts to improve access to pediatric HIV antiretroviral treatment.

  5. Consumer perceptions of and willingness-to-pay for point-of-care testing services in the community pharmacy.

    Science.gov (United States)

    Hohmeier, Kenneth C; Loomis, Benjamin; Gatwood, Justin

    2018-04-01

    Point-of-care testing (POCT) is a specialty of laboratory medicine that occurs at the bedside or near the patient when receiving health services. Despite its clinical utility, POCT implementation in the community pharmacy setting is slow due to uncertainty about the market for this novel service and remuneration for services rendered. To identify 1) demographics and 2) willingness-to-pay preferences of the market niche of consumers who prefer to receive POCT services in the community pharmacy. A sample of 188 participants matched to the U.S. population were surveyed in February of 2016 utilizing a self-explicated conjoint analysis survey model. Age groups differed between the community pharmacy consumer niche and the entire sample. The largest age group of the pharmacy niche consumer group were between 20 and 34 years old. Of those who preferred the community pharmacy setting to receive POCT services, 75% indicated they would be willing to pay $50 or more compared to 79% of the entire sample who preferred to pay $50 or less. There exists a latent and niche group of consumers interested in community pharmacy provided POCT services. This market niche is younger, and in general willing-to-pay more than the general population for these tests. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Variation in point-of-care testing of HbA1c in diabetes care general practice

    DEFF Research Database (Denmark)

    Kristensen, Troels

    2016-01-01

    Background and Aims Point-of-care testing (POCT) for HbA1c may result in improved diabetic control, better patient outcomes and enhanced clinical efficiency with fewer patient visits and subsequent reductions in costs. In 2008, the Danish regulators agreed to create a new fee for the remuneration...... of POCT of HbA1c in primary care. The aim of this study is to describe and analyze the variation in use of POCT of HbA1c among diabetes patients in Danish general practice and municipalities. Method We use register data from the year 2011 to define a population of 172,906 diabetes patients. The POCT fee...... is used to measure the amount of POCT of HbA1c among diabetes patients. Next we apply descriptive statistics to analyze variation in the prevalence of POCT versus laboratory testing at patient, clinic and municipality level. We include patient characteristics such as gender, age, socioeconomic markers...

  7. The implementation of an external quality assurance method for point- of- care tests for HIV and syphilis in Tanzania.

    Science.gov (United States)

    Smit, Pieter W; Mabey, David; van der Vlis, Thomas; Korporaal, Hans; Mngara, Julius; Changalucha, John; Todd, Jim; Peeling, Rosanna W

    2013-11-09

    External quality assurance (EQA) programmes, which are routinely used in laboratories, have not been widely implemented for point-of- care tests (POCTs). A study was performed in ten health centres in Tanzania, to implement the use of dried blood spots (DBS) as an EQA method for HIV and syphilis (POCTs). DBS samples were collected for retesting at a reference laboratory and the results compared to the POCT results obtained at the clinic. In total, 2341 DBS samples were collected from 10 rural health facilities over a period of nine months, of which 92.5% were correctly collected and spotted. The EQA method was easily implemented by healthcare workers under routine conditions in Northern Tanzania. For HIV, 967 out of 972 samples (99.5%) were concordant between DBS and POCT results. For syphilis, the sensitivity of syphilis tests varied between clinics with a median of 96% (25th and 75th quartile; 95-98%). The specificity of syphilis POCT was consistent compared to laboratory based test using DBS, with a median of 96% (25th and 75th quartiles; 95-98%). Overall, the quality of testing varied at clinics and EQA results can be used to identify clinics where healthcare workers require remedial training, suggesting the necessity for stringent quality assurance programmes for POC testing. As Tanzania embarks on scaling up HIV and syphilis testing, DBS can be a useful and robust tool to monitor the quality of testing performed by healthcare workers and trigger corrective action to ensure accuracy of test results.

  8. The cost-utility of point-of-care troponin testing to diagnose acute coronary syndrome in primary care.

    Science.gov (United States)

    Kip, Michelle M A; Koffijberg, Hendrik; Moesker, Marco J; IJzerman, Maarten J; Kusters, Ron

    2017-08-02

    The added value of using a point-of-care (POC) troponin test in primary care to rule out acute coronary syndrome (ACS) is debated because test sensitivity is inadequate early after symptom onset. This study investigates the potential cost-utility of diagnosing ACS by a general practitioner (GP) when a POC troponin test is available versus GP assessment only. A patient-level simulation model was developed, representing a hypothetical cohort of the Dutch population (>35 years) consulting the GP with chest complaints. All health related consequences as well as cost consequences were included. Both symptom duration, selection of patients in whom the POC troponin test is performed, and test performance at different time points were incorporated. Health outcomes were expressed as Quality-Adjusted Life Years (QALYs). The main outcome parameters involve the effect of POC troponin testing on (in)correct hospital referrals, QALYs, and costs. The POC troponin strategy decreases the referral rate in non-ACS patients from 38.46% to 31.85%. Despite a small increase in non-referral among ACS patients from 0.22% to 0.27%, the overall health effect is negligible. Costs will decrease with €77.25/patient (95% CI €-126.81 to €-33.37). The POC troponin strategy is likely cost-saving, by reducing hospital referrals. The small increase in missed ACS patients can be partly explained by conservative assumptions used in the analysis. Besides, current developments in POC troponin tests will likely further improve their diagnostic performance. Therefore, future prospective studies are warranted to investigate whether those developments make the POC troponin test to a safe and cost-effective diagnostic tool for diagnosing ACS in general practices.

  9. Point-of-Care Testing in Bathhouses: A Narrative Inquiry into the Experience of Receiving a Positive Preliminary HIV Test Result.

    Science.gov (United States)

    Genoway, Shyla; Caine, Vera; Singh, Ameeta E; Estefan, Andrew

    2016-01-01

    With a call to increase the accessibility of HIV testing, point-of-care testing for HIV is being readily adopted, but little attention has been paid to the experiences of people being tested at HIV point-of-care sites. Some testing environments, such as bathhouses, promote testing for HIV in higher-risk groups. In this narrative inquiry study we explored the experiences of people testing positive for HIV through point-of-care while at a bathhouse. Three narrative threads for reconsidering the practice were identified: (a) seeing complexities, understanding testing decisions in relation to time, place, and social context; (b) recognizing the impact and significance of secret and silent stories; and (c) tentative and tension-filled connections to care. It is important to understand testing experiences across time, place, and in diverse social contexts. These experiences are embedded within the larger life histories of people and raise questions about adequate support, follow-up, and counseling. Copyright © 2016 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

  10. Detection of antibiotic resistance is essential for gonorrhoea point-of-care testing: a mathematical modelling study.

    Science.gov (United States)

    Fingerhuth, Stephanie M; Low, Nicola; Bonhoeffer, Sebastian; Althaus, Christian L

    2017-07-26

    Antibiotic resistance is threatening to make gonorrhoea untreatable. Point-of-care (POC) tests that detect resistance promise individually tailored treatment, but might lead to more treatment and higher levels of resistance. We investigate the impact of POC tests on antibiotic-resistant gonorrhoea. We used data about the prevalence and incidence of gonorrhoea in men who have sex with men (MSM) and heterosexual men and women (HMW) to calibrate a mathematical gonorrhoea transmission model. With this model, we simulated four clinical pathways for the diagnosis and treatment of gonorrhoea: POC test with (POC+R) and without (POC-R) resistance detection, culture and nucleic acid amplification tests (NAATs). We calculated the proportion of resistant infections and cases averted after 5 years, and compared how fast resistant infections spread in the populations. The proportion of resistant infections after 30 years is lowest for POC+R (median MSM: 0.18%, HMW: 0.12%), and increases for culture (MSM: 1.19%, HMW: 0.13%), NAAT (MSM: 100%, HMW: 99.27%), and POC-R (MSM: 100%, HMW: 99.73%). Per 100 000 persons, NAAT leads to 36 366 (median MSM) and 1228 (median HMW) observed cases after 5 years. Compared with NAAT, POC+R averts more cases after 5 years (median MSM: 3353, HMW: 118). POC tests that detect resistance with intermediate sensitivity slow down resistance spread more than NAAT. POC tests with very high sensitivity for the detection of resistance are needed to slow down resistance spread more than by using culture. POC with high sensitivity to detect antibiotic resistance can keep gonorrhoea treatable longer than culture or NAAT. POC tests without reliable resistance detection should not be introduced because they can accelerate the spread of antibiotic-resistant gonorrhoea.

  11. Optimization of an Optical Inspection System Based on the Taguchi Method for Quantitative Analysis of Point-of-Care Testing

    Directory of Open Access Journals (Sweden)

    Chia-Hsien Yeh

    2014-09-01

    Full Text Available This study presents an optical inspection system for detecting a commercial point-of-care testing product and a new detection model covering from qualitative to quantitative analysis. Human chorionic gonadotropin (hCG strips (cut-off value of the hCG commercial product is 25 mIU/mL were the detection target in our study. We used a complementary metal-oxide semiconductor (CMOS sensor to detect the colors of the test line and control line in the specific strips and to reduce the observation errors by the naked eye. To achieve better linearity between the grayscale and the concentration, and to decrease the standard deviation (increase the signal to noise ratio, S/N, the Taguchi method was used to find the optimal parameters for the optical inspection system. The pregnancy test used the principles of the lateral flow immunoassay, and the colors of the test and control line were caused by the gold nanoparticles. Because of the sandwich immunoassay model, the color of the gold nanoparticles in the test line was darkened by increasing the hCG concentration. As the results reveal, the S/N increased from 43.48 dB to 53.38 dB, and the hCG concentration detection increased from 6.25 to 50 mIU/mL with a standard deviation of less than 10%. With the optimal parameters to decrease the detection limit and to increase the linearity determined by the Taguchi method, the optical inspection system can be applied to various commercial rapid tests for the detection of ketamine, troponin I, and fatty acid binding protein (FABP.

  12. Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

    Science.gov (United States)

    Cross, Robert W.; Boisen, Matthew L.; Millett, Molly M.; Nelson, Diana S.; Oottamasathien, Darin; Hartnett, Jessica N.; Jones, Abigal B.; Goba, Augustine; Momoh, Mambu; Fullah, Mohamed; Bornholdt, Zachary A.; Fusco, Marnie L.; Abelson, Dafna M.; Oda, Shunichiro; Brown, Bethany L.; Pham, Ha; Rowland, Megan M.; Agans, Krystle N.; Geisbert, Joan B.; Heinrich, Megan L.; Kulakosky, Peter C.; Shaffer, Jeffrey G.; Schieffelin, John S.; Kargbo, Brima; Gbetuwa, Momoh; Gevao, Sahr M.; Wilson, Russell B.; Saphire, Erica Ollmann; Pitts, Kelly R.; Khan, Sheik Humarr; Grant, Donald S.; Geisbert, Thomas W.; Branco, Luis M.; Garry, Robert F.

    2016-01-01

    Background. Ebola virus disease (EVD) is a severe viral illness caused by Ebola virus (EBOV). The 2013–2016 EVD outbreak in West Africa is the largest recorded, with >11 000 deaths. Development of the ReEBOV Antigen Rapid Test (ReEBOV RDT) was expedited to provide a point-of-care test for suspected EVD cases. Methods. Recombinant EBOV viral protein 40 antigen was used to derive polyclonal antibodies for RDT and enzyme-linked immunosorbent assay development. ReEBOV RDT limits of detection (LOD), specificity, and interference were analytically validated on the basis of Food and Drug Administration (FDA) guidance. Results. The ReEBOV RDT specificity estimate was 95% for donor serum panels and 97% for donor whole-blood specimens. The RDT demonstrated sensitivity to 3 species of Ebolavirus (Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus) associated with human disease, with no cross-reactivity by pathogens associated with non-EBOV febrile illness, including malaria parasites. Interference testing exhibited no reactivity by medications in common use. The LOD for antigen was 4.7 ng/test in serum and 9.4 ng/test in whole blood. Quantitative reverse transcription–polymerase chain reaction testing of nonhuman primate samples determined the range to be equivalent to 3.0 × 105–9.0 × 108 genomes/mL. Conclusions. The analytical validation presented here contributed to the ReEBOV RDT being the first antigen-based assay to receive FDA and World Health Organization emergency use authorization for this EVD outbreak, in February 2015. PMID:27587634

  13. SAMBA HIV semiquantitative test, a new point-of-care viral-load-monitoring assay for resource-limited settings.

    Science.gov (United States)

    Ritchie, Allyson V; Ushiro-Lumb, Ines; Edemaga, Daniel; Joshi, Hrishikesh A; De Ruiter, Annemiek; Szumilin, Elisabeth; Jendrulek, Isabelle; McGuire, Megan; Goel, Neha; Sharma, Pia I; Allain, Jean-Pierre; Lee, Helen H

    2014-09-01

    Routine viral-load (VL) testing of HIV-infected individuals on antiretroviral therapy (ART) is used to monitor treatment efficacy. However, due to logistical challenges, implementation of VL has been difficult in resource-limited settings. The aim of this study was to evaluate the performance of the SAMBA semi-Q (simple amplification-based assay semiquantitative test for HIV-1) in London, Malawi, and Uganda. The SAMBA semi-Q can distinguish between patients with VLs above and below 1,000 copies/ml. The SAMBA semi-Q was validated with diluted clinical samples and blinded plasma samples collected from HIV-1-positive individuals. SAMBA semi-Q results were compared with results from the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 test, v2.0. Testing of 96 2- to 10-fold dilutions of four samples containing HIV-1 subtype C as well as 488 samples from patients in the United Kingdom, Malawi, and Uganda yielded an overall accuracy for the SAMBA semi-Q of 99% (95% confidence interval [CI], 93.8 to 99.9%) and 96.9% (95% CI 94.9 to 98.3%), respectively, compared to to the Roche test. Analysis of VL data from patients in Malawi and Uganda showed that the SAMBA cutoff of 1,000 copies/ml appropriately distinguished treated from untreated individuals. Furthermore, analysis of the viral loads of 232 patients on ART in Malawi and Uganda revealed similar patterns for virological control, defined as either SAMBA cutoff) or SAMBA semi-Q has adequate concurrency with the gold standard measurements for viral load. This test can allow VL monitoring of patients on ART at the point of care in resource-limited settings. Copyright © 2014 Ritchie et al.

  14. Cellphone-based hand-held microplate reader for point-of-care ELISA testing (Conference Presentation)

    Science.gov (United States)

    Berg, Brandon; Cortazar, Bingen; Tseng, Derek; Ozkan, Haydar; Feng, Steve; Wei, Qingshan; Chan, Raymond Y.; Burbano, Jordi; Farooqui, Qamar; Lewinski, Michael; Di Carlo, Dino; Garner, Omai B.; Ozcan, Aydogan

    2016-03-01

    Enzyme-linked immunosorbent assay (ELISA) in a microplate format has been a gold standard first-line clinical test for diagnosis of various diseases including infectious diseases. However, this technology requires a relatively large and expensive multi-well scanning spectrophotometer to read and quantify the signal from each well, hindering its implementation in resource-limited-settings. Here, we demonstrate a cost-effective and handheld smartphone-based colorimetric microplate reader for rapid digitization and quantification of immunoserology-related ELISA tests in a conventional 96-well plate format at the point of care (POC). This device consists of a bundle of 96 optical fibers to collect the transmitted light from each well of the microplate and direct all the transmission signals from the wells onto the camera of the mobile-phone. Captured images are then transmitted to a remote server through a custom-designed app, and both quantitative and qualitative diagnostic results are returned back to the user within ~1 minute per 96-well plate by using a machine learning algorithm. We tested this mobile-phone based micro-plate reader in a clinical microbiology lab using FDA-approved mumps IgG, measles IgG, and herpes simplex virus IgG (HSV-1 and HSV-2) ELISA tests on 1138 remnant patient samples (roughly 50% training and 50% testing), and achieved an overall accuracy of ~99% or higher for each ELISA test. This handheld and cost-effective platform could be immediately useful for large-scale vaccination monitoring in low-infrastructure settings, and also for other high-throughput disease screening applications at POC.

  15. Potential for Pharmacy-Public Health Collaborations Using Pharmacy-Based Point-of-Care Testing Services for Infectious Diseases.

    Science.gov (United States)

    Gubbins, Paul O; Klepser, Michael E; Adams, Alex J; Jacobs, David M; Percival, Kelly M; Tallman, Gregory B

    Health care professionals must continually identify collaborative ways to combat antibiotic resistance while improving community health and health care delivery. Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived point-of-care (POC) testing (POCT) services for infectious disease conducted in community pharmacies provide a means for pharmacists to collaborate with prescribers and/or public health officials combating antibiotic resistance while improving community health and health care delivery. To provide a comprehensive literature review that explores the potential for pharmacists to collaborate with public health professionals and prescribers using pharmacy-based CLIA-waived POCT services for infectious diseases. Comprehensive literature review. PubMed and Google Scholar were searched for manuscripts and meeting abstracts for the following key words: infectious disease, community pharmacy, rapid diagnostic tests, rapid assay, and POC tests. All relevant manuscripts and meeting abstracts utilizing POCT in community pharmacies for infectious disease were reviewed. Information regarding the most contemporary evidence regarding CLIA-waived POC infectious diseases tests for infectious diseases and their use in community pharmacies was synthesized to highlight and identify opportunities to develop future collaborations using community pharmacy-based models for such services. Evidence demonstrates that pharmacists in collaboration with other health care professionals can leverage their knowledge and accessibility to provide CLIA-waived POCT services for infectious diseases. Testing for influenza may augment health departments' surveillance efforts, help promote rationale antiviral use, and avoid unnecessary antimicrobial therapy. Services for human immunodeficiency virus infection raise infection status awareness, increase access to health care, and facilitate linkage to appropriate care. Testing for group A streptococcal pharyngitis may curb inappropriate

  16. Variation in Point-of-Care Testing of HbA1c in Diabetes Care in General Practice

    DEFF Research Database (Denmark)

    Kristensen, Troels; Waldorff, Frans Boch; Nexøe, Jørgen

    2017-01-01

    Background: Point-of-care testing (POCT) of HbA1c may result in improved diabetic control, better patient outcomes, and enhanced clinical efficiency with fewer patient visits and subsequent reductions in costs. In 2008, the Danish regulators created a framework agreement regarding a new fee......-for-service fee for the remuneration of POCT of HbA1c in general practice. According to secondary research, only the Capital Region of Denmark has allowed GPs to use this new incentive for POCT. The aim of this study is to use patient data to characterize patients with diabetes who have received POCT of HbA1c...... and analyze the variation in the use of POCT of HbA1c among patients with diabetes in Danish general practice. Methods: We use register data from the Danish Drug Register, the Danish Health Service Register and the National Patient Register from the year 2011 to define a population of 44,981 patients...

  17. Pen-on-paper strategy for point-of-care testing: Rapid prototyping of fully written microfluidic biosensor.

    Science.gov (United States)

    Li, Zedong; Li, Fei; Xing, Yue; Liu, Zhi; You, Minli; Li, Yingchun; Wen, Ting; Qu, Zhiguo; Ling Li, Xiao; Xu, Feng

    2017-12-15

    Paper-based microfluidic biosensors have recently attracted increasing attentions in point-of-care testing (POCT) territories benefiting from their affordable, accessible and eco-friendly features, where technologies for fabricating such biosensors are preferred to be equipment free, easy-to-operate and capable of rapid prototyping. In this work, we developed a pen-on-paper (PoP) strategy based on two custom-made pens, i.e., a wax pen and a conductive-ink pen, to fully write paper-based microfluidic biosensors through directly writing both microfluidic channels and electrodes. Particularly, the proposed wax pen is competent to realize one-step fabrication of wax channels on paper, as the melted wax penetrates into paper during writing process without any post-treatments. The practical applications of the fabricated paper-based microfluidic biosensors are demonstrated by both colorimetric detection of Salmonella typhimurium DNA with detection limit of 1nM and electrochemical measurement of glucose with detection limit of 1mM. The developed PoP strategy for making microfluidic biosensors on paper characterized by true simplicity, prominent portability and excellent capability for rapid prototyping shows promising prospect in POCT applications. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. A simple and inexpensive point-of-care test for hepatitis B surface antigen detection: serological and molecular evaluation.

    Science.gov (United States)

    Gish, R G; Gutierrez, J A; Navarro-Cazarez, N; Giang, K; Adler, D; Tran, B; Locarnini, S; Hammond, R; Bowden, S

    2014-12-01

    Early identification of chronic hepatitis B is important for optimal disease management and prevention of transmission. Cost and lack of access to commercial hepatitis B surface antigen (HBsAg) immunoassays can compromise the effectiveness of HBV screening in resource-limited settings and among marginalized populations. High-quality point-of-care (POC) testing may improve HBV diagnosis in these situations. Currently available POC HBsAg assays are often limited in sensitivity. We evaluated the NanoSign(®) HBs POC chromatographic immunoassay for its ability to detect HBsAg of different genotypes and with substitutions in the 'a' determinant. Thirty-seven serum samples from patients with HBV infection, covering HBV genotypes A-G, were assessed for HBsAg titre with the Roche Elecsys HBsAg II quantification assay and with the POC assay. The POC assay reliably detected HBsAg at a concentration of at least 50 IU/mL for all genotypes, and at lower concentrations for some genotypes. Eight samples with substitutions in the HBV 'a' determinant were reliably detected after a 1/100 dilution. The POC strips were used to screen serum samples from 297 individuals at risk for HBV in local clinical settings (health fairs and outreach events) in parallel with commercial laboratory HBsAg testing (Quest Diagnostics EIA). POC testing was 73.7% sensitive and 97.8% specific for detection of HBsAg. Although the POC test demonstrated high sensitivity over a range of genotypes, false negatives were frequent in a clinical setting. Nevertheless, the POC assay offers advantages for testing in both developed and resource-limited countries due to its low cost (0.50$) and immediately available results. © 2014 John Wiley & Sons Ltd.

  19. Evaluating Laboratory Performance on Point-of-Care Glucose Testing with Six Sigma Metric for 151 Institutions in China.

    Science.gov (United States)

    Fei, Yang; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo

    2015-10-01

    The aim of this study was to use Six Sigma(SM) (Motorola Trademark Holdings, Libertyville, IL) techniques to analyze the quality of point-of-care (POC) glucose testing measurements quantitatively and to provide suggestions for improvement. In total, 151 laboratories in China were included in this investigation in 2014. Bias and coefficient of variation were collected from an external quality assessment and an internal quality control program, respectively, for POC glucose testing organized by the National Center for Clinical Laboratories. The σ values and the Quality Goal Index were used to evaluate the performance of POC glucose meters. There were 27, 30, 57, and 37 participants in the groups using Optium Xceed™ (Abbott Diabetes Care, Alameda, CA), Accu-Chek(®) Performa (Roche, Basel, Switzerland), One Touch Ultra(®) (Abbott), and "other" meters, respectively. The median of the absolute value of percentage difference varied among different lots and different groups. Among all the groups, the Abbott One Touch Ultra group had the smallest median of absolute value of percentage difference except for lot 201411, whereas the "other" group had the largest median in all five lots. More than 85% of participate laboratories satisfied the total allowable error (TEa) requirement in International Organization for Standardization standard 15197:2013, and 85.43% (129/151) of laboratories obtained intralaboratory coefficient of variations less than 1/3TEa. However, Six Sigma techniques suggested that 41.72% (63/151) to 65.56% (99/151) of the laboratories needed to improve their POC glucose testing performance, in either precision, trueness, or both. Laboratories should pay more attention on the practice of POC glucose testing and take actions to improve their performance. Only in this way can POC glucose testing really function well in clinical practice.

  20. A multi-center field study of two point-of-care tests for circulating Wuchereria bancrofti antigenemia in Africa

    Science.gov (United States)

    Chesnais, Cédric B.; Awaca-Uvon, Naomi-Pitchouna; Bolay, Fatoma K.; Boussinesq, Michel; Fischer, Peter U.; Gankpala, Lincoln; Meite, Aboulaye; Missamou, François; Pion, Sébastien D.

    2017-01-01

    Background The Global Programme to Eliminate Lymphatic Filariasis uses point-of-care tests for circulating filarial antigenemia (CFA) to map endemic areas and for monitoring and evaluating the success of mass drug administration (MDA) programs. We compared the performance of the reference BinaxNOW Filariasis card test (ICT, introduced in 1997) with the Alere Filariasis Test Strip (FTS, introduced in 2013) in 5 endemic study sites in Africa. Methodology The tests were compared prior to MDA in two study sites (Congo and Côte d'Ivoire) and in three sites that had received MDA (DRC and 2 sites in Liberia). Data were analyzed with regard to % positivity, % agreement, and heterogeneity. Models evaluated potential effects of age, gender, and blood microfilaria (Mf) counts in individuals and effects of endemicity and history of MDA at the village level as potential factors linked to higher sensitivity of the FTS. Lastly, we assessed relationships between CFA scores and Mf in pre- and post-MDA settings. Principal findings Paired test results were available for 3,682 individuals. Antigenemia rates were 8% and 22% higher by FTS than by ICT in pre-MDA and in post-MDA sites, respectively. FTS/ICT ratios were higher in areas with low infection rates. The probability of having microfilaremia was much higher in persons with CFA scores >1 in untreated areas. However, this was not true in post-MDA settings. Conclusions/Significance This study has provided extensive new information on the performance of the FTS compared to ICT in Africa and it has confirmed the increased sensitivity of FTS reported in prior studies. Variability in FTS/ICT was related in part to endemicity level, history of MDA, and perhaps to the medications used for MDA. These results suggest that FTS should be superior to ICT for mapping, for transmission assessment surveys, and for post-MDA surveillance. PMID:28892473

  1. Clinical Validation of a Point-of-Care Multiplexed In Vitro Immunoassay Using Monoclonal Antibodies (the MSD Influenza Test) in Four Hospitals in Vietnam

    NARCIS (Netherlands)

    van Doorn, H. Rogier; Kinh, Nguyen Van; Tuan, Ha Manh; Tuan, Tran Anh; Minh, Ngo Ngoc Quang; Bryant, Juliet E.; Hang, Vu thi Ty; Uyen, Le thi Tham; Thinh, Le Quoc; Anh, Tran thi Ngoc; Lan, Nguyen Phu Huong; Trung, Nguyen Vu; Taylor, Walter; Merson, Laura; Wertheim, Heiman F. L.; Farrar, Jeremy; Wolbers, Marcel; Chau, Nguyen Van Vinh; de Jong, Menno D.

    2012-01-01

    Point-of-care (POC) diagnostic tests for influenza can considerably shorten the time to clinical decision making. An investigational POC test based on a multiplexed immunoassay was developed by Meso Scale Diagnostics, LLC (MSD), with the objective to make a more sensitive rapid test that can also

  2. Simple and inexpensive point-of-care tests improve diagnosis of vaginal infections in resource constrained settings

    Science.gov (United States)

    Madhivanan, Purnima; Krupp, Karl; Hardin, Jill; Karat, Chitra; Klausner, Jeffrey D.; Reingold, Arthur L.

    2013-01-01

    Summary OBJECTIVE Bacterial vaginosis (BV) and Trichomonas vaginalis infection (TV) have been associated with adverse birth outcomes and increased risk for HIV. We compare the performance of simple inexpensive point-of-care (POC) tests to laboratory diagnosis and syndromic management of BV and TV in poor settings. METHODS Between November 2005 and March 2006, 898 sexually active women attending two reproductive health clinics in Mysore, India were recruited into a cohort study investigating the relationship between vaginal flora and HSV-2 infection. Participants were interviewed and screened for reproductive tract infections. Laboratory tests included serology for HSV-2; cultures for TV, Candida sp., and Neisseria gonorrhoeae; Gram stains; and two POC tests: vaginal pH; and Whiff test. RESULTS Of the 898 participants, 411 [45.7%, 95% confidence interval (95% CI): 42.4–49.0%] had any laboratory diagnosed vaginal infection. BV was detected in 165 women (19.1%, 95%CI: 16.5–21.9%) using Nugent score. TV was detected in 76 women (8.5%, 95%CI: 6.7–10.4%) using culture. Among the entire study population, POC correctly detected 82% of laboratory diagnosed BV cases, and 83% of laboratory diagnosed TV infections. Among women with complaints of vulval itching, burning, abnormal vaginal discharge, and/or sores (445/898), POC correctly detected 83% (60 of 72 cases) of laboratory diagnosed BV cases vs. 40% (29 of 72 cases) correctly managed using the syndromic approach (P inexpensive and practical, but also significantly more sensitive than the syndromic management approach, resulting in less overtreatment. PMID:19392745

  3. Analytic laboratory performance of a point of care urine culture kit for diagnosis and antibiotic susceptibility testing.

    Science.gov (United States)

    Bongard, E; Frimodt-Møller, N; Gal, M; Wootton, M; Howe, R; Francis, N; Goossens, H; Butler, C C

    2015-10-01

    Currently available point-of-care (POC) diagnostic tests for managing urinary tract infections (UTIs) in general practice are limited by poor performance characteristics, and laboratory culture generally provides results only after a few days. This laboratory evaluation compared the analytic performance of the POC UK Flexicult(™) (Statens Serum Institut) (SSI) urinary kit for quantification, identification and antibiotic susceptibility testing and routine UK National Health Service (NHS) urine processing to an advanced urine culture method. Two hundred urine samples routinely submitted to the Public Health Wales Microbiology Laboratory were divided and: (1) analysed by routine NHS microbiological tests as per local laboratory standard operating procedures, (2) inoculated onto the UK Flexicult(™) SSI urinary kit and (3) spiral plated onto Colorex Orientation UTI medium (E&O Laboratories Ltd). The results were evaluated between the NHS and Flexicult(™ )methods, and discordant results were compared to the spiral plating method. The UK Flexicult(™) SSI urinary kit was compared to routine NHS culture for identification of a pure or predominant uropathogen at ≥ 10(5) cfu/mL, with a positive discordancy rate of 13.5% and a negative discordancy rate of 3%. The sensitivity and specificity were 86.7% [95% confidence interval (CI) 73.8-93.7] and 82.6% (95% CI 75.8-87.7), respectively. The UK Flexicult(™) SSI urinary kit was comparable to routine NHS urine processing in identifying microbiologically positive UTIs in this laboratory evaluation. However, the number of false-positive samples could lead to over-prescribing of antibiotics in clinical practice. The Flexicult(™) SSI kit could be useful as a POC test for UTIs in primary care but further pragmatic evaluations are necessary.

  4. Results from 15years of quality surveillance for a National Indigenous Point-of-Care Testing Program for diabetes.

    Science.gov (United States)

    Shephard, Mark; Shephard, Anne; McAteer, Bridgit; Regnier, Tamika; Barancek, Kristina

    2017-12-01

    Diabetes is a major health problem for Australia's Aboriginal and Torres Strait Islander peoples. Point-of-care testing for haemoglobin A1c (HbA1c) has been the cornerstone of a long-standing program (QAAMS) to manage glycaemic control in Indigenous people with diabetes and recently, to diagnose diabetes. The QAAMS quality management framework includes monthly testing of quality control (QC) and external quality assurance (EQA) samples. Key performance indicators of quality include imprecision (coefficient of variation [CV%]) and percentage acceptable results. This paper reports on the past 15years of quality testing in QAAMS and examines the performance of HbA1c POC testing at the 6.5% cut-off recommended for diagnosis. The total number of HbA1c EQA results submitted from 2002 to 2016 was 29,093. The median imprecision for EQA testing by QAAMS device operators averaged 2.81% (SD 0.50; range 2.2 to 3.9%) from 2002 to 2016 and 2.44% (SD 0.22; range 2.2 to 2.9%) from 2009 to 2016. No significant difference was observed between the median imprecision achieved in QAAMS and by Australasian laboratories from 2002 to 2016 (p=0.05; two-tailed paired t-test) and from 2009 to 2016 (p=0.17; two-tailed paired t-test). For QC testing from 2009 to 2016, imprecision averaged 2.5% and 3.0% for the two levels of QC tested. Percentage acceptable results averaged 90% for QA testing from 2002 to 2016 and 96% for QC testing from 2009 to 2016. The DCA Vantage was able to measure a patient and an EQA sample with an HbA1c value close to 6.5% both accurately and precisely. HbA1c POC testing in QAAMS has remained analytically sound, matched the quality achieved by Australasian laboratories and met profession-derived analytical goals for 15years. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  5. Impact and Cost-Effectiveness of Point-Of-Care CD4 Testing on the HIV Epidemic in South Africa.

    Directory of Open Access Journals (Sweden)

    Alastair Heffernan

    Full Text Available Rapid diagnostic tools have been shown to improve linkage of patients to care. In the context of infectious diseases, assessing the impact and cost-effectiveness of such tools at the population level, accounting for both direct and indirect effects, is key to informing adoption of these tools. Point-of-care (POC CD4 testing has been shown to be highly effective in increasing the proportion of HIV positive patients who initiate ART. We assess the impact and cost-effectiveness of introducing POC CD4 testing at the population level in South Africa in a range of care contexts, using a dynamic compartmental model of HIV transmission, calibrated to the South African HIV epidemic. We performed a meta-analysis to quantify the differences between POC and laboratory CD4 testing on the proportion linking to care following CD4 testing. Cumulative infections averted and incremental cost-effectiveness ratios (ICERs were estimated over one and three years. We estimated that POC CD4 testing introduced in the current South African care context can prevent 1.7% (95% CI: 0.4% - 4.3% of new HIV infections over 1 year. In that context, POC CD4 testing was cost-effective 99.8% of the time after 1 year with a median estimated ICER of US$4,468/DALY averted. In healthcare contexts with expanded HIV testing and improved retention in care, POC CD4 testing only became cost-effective after 3 years. The results were similar when, in addition, ART was offered irrespective of CD4 count, and CD4 testing was used for clinical assessment. Our findings suggest that even if ART is expanded to all HIV positive individuals and HIV testing efforts are increased in the near future, POC CD4 testing is a cost-effective tool, even within a short time horizon. Our study also illustrates the importance of evaluating the potential impact of such diagnostic technologies at the population level, so that indirect benefits and costs can be incorporated into estimations of cost-effectiveness.

  6. Impact and Cost-Effectiveness of Point-Of-Care CD4 Testing on the HIV Epidemic in South Africa.

    Science.gov (United States)

    Heffernan, Alastair; Barber, Ella; Thomas, Ranjeeta; Fraser, Christophe; Pickles, Michael; Cori, Anne

    2016-01-01

    Rapid diagnostic tools have been shown to improve linkage of patients to care. In the context of infectious diseases, assessing the impact and cost-effectiveness of such tools at the population level, accounting for both direct and indirect effects, is key to informing adoption of these tools. Point-of-care (POC) CD4 testing has been shown to be highly effective in increasing the proportion of HIV positive patients who initiate ART. We assess the impact and cost-effectiveness of introducing POC CD4 testing at the population level in South Africa in a range of care contexts, using a dynamic compartmental model of HIV transmission, calibrated to the South African HIV epidemic. We performed a meta-analysis to quantify the differences between POC and laboratory CD4 testing on the proportion linking to care following CD4 testing. Cumulative infections averted and incremental cost-effectiveness ratios (ICERs) were estimated over one and three years. We estimated that POC CD4 testing introduced in the current South African care context can prevent 1.7% (95% CI: 0.4% - 4.3%) of new HIV infections over 1 year. In that context, POC CD4 testing was cost-effective 99.8% of the time after 1 year with a median estimated ICER of US$4,468/DALY averted. In healthcare contexts with expanded HIV testing and improved retention in care, POC CD4 testing only became cost-effective after 3 years. The results were similar when, in addition, ART was offered irrespective of CD4 count, and CD4 testing was used for clinical assessment. Our findings suggest that even if ART is expanded to all HIV positive individuals and HIV testing efforts are increased in the near future, POC CD4 testing is a cost-effective tool, even within a short time horizon. Our study also illustrates the importance of evaluating the potential impact of such diagnostic technologies at the population level, so that indirect benefits and costs can be incorporated into estimations of cost-effectiveness.

  7. Alterations in rotation thromboelastometry (ROTEM®) parameters: point-of-care testing vs analysis after pneumatic tube system transport.

    Science.gov (United States)

    Martin, J; Schuster, T; Moessmer, G; Kochs, E F; Wagner, K J

    2012-10-01

    Thromboelastometry as point-of-care (POC) testing enables the analysis of the clotting process at the bedside, providing rapid results to guide haemostatic therapy. However, POC testing utilizes medical staff who are managing critically ill patients, as non-laboratory personnel may not be sufficiently trained to run the devices. To resolve these problems, thromboelastometry can be performed in the central laboratory and rapid transport of samples can be accomplished via a pneumatic tube system (PTS). This study compares thromboelastometry parameters of blood samples analysed immediately with those analysed after PTS transport. In patients with normal haemostasis, two arterial blood samples were collected from each patient (n=92) in citrated plastic tubes to investigate the assays INTEM (n=35), EXTEM (n=27), and FIBTEM (n=30). One blood sample was analysed immediately, the other sample after PTS transport. Thromboelastometry was performed using a single ROTEM(®) device. The mean clot firmness values were significantly lower for PTS samples in both the INTEM (-0.7 mm cf. -1.1 mm) and EXTEM (-1.4 cf. -1.7 mm) assays. INTEM coagulation time (CT) was significantly lower in PTS samples with a mean difference of -13 s. EXTEM CT was significantly higher in PTS samples with a mean difference of +3.9 s. Thromboelastometry parameters of blood samples analysed after PTS transport are significantly altered compared with those analysed immediately. However, in patients with normal haemostasis, the alterations were small and without clinical consequence, implying that analysis after PTS transport is an acceptable alternative to prompt analysis at the bedside. Further studies should focus on patients with impaired haemostasis.

  8. The usefulness of point-of-care (POC) tests in screening elevated glucose and ketone body levels postmortem.

    Science.gov (United States)

    Walta, Anna-Mari; Keltanen, Terhi; Lindroos, Katarina; Sajantila, Antti

    2016-09-01

    The aim was to evaluate the performance of point-of-care (POC) tests in detecting glucose and ketone bodies in postmortem (PM) samples and to assess the usefulness of POC tests in sample screening for more precise analyses. Glucose and ketone body, β-hydroxybutyrate (BHB), were measured from vitreous humor (VH) in 52 autopsy cases with a POC blood glucose monitoring device (BGMD). In addition glucose and ketone bodies, acetone (Ac) and acetoacetate (AcAc), were measured from urine samples in another set of 59 cases with semi-quantitative stick tests. The results were compared to the concentration in VH measured with validated methods (values ≥ 7mmol/l indicate possible hyperglycemia and total ketone body levels ≥ 3mmol/l ketoacidosis). The sensitivity for glucose with the BGMD was 1.0 and specificity 0.94 when the threshold value for the meter to predict elevated glucose was set to ≥ 10mmol/l. The correlation between the BGMD and the validated method was strong (R(2)=0.89). For detecting ketoacidosis, the BGMD had a sensitivity of 1.0 and specificity of 0.73, when the threshold value was set to 2.5mmol/l. The urine stick test presented a sensitivity of 0.89 and specificity of 0.90 for detecting elevated VH glucose concentration. The sensitivity and specificity for the stick test to detect cases with possible ketoacidosis were 0.84 and 0.68, respectively. According to the results, BGMD can be reliably applied for sample screening, although more samples need to be analyzed for delineating the correct threshold values. In the case of glucose, the urine stick tests could be indicative in detecting cases with VH glucose ≥ 10mmol/l. For predicting possible ketoacidosis with elevated VH total ketone bodies, the stick test is not reliable as the test presented both false-positive and -negative results. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. Sexual health risks, service use, and views of rapid point-of-care testing among men who have sex with men attending saunas: a cross-sectional survey.

    Science.gov (United States)

    Horwood, Jeremy; Ingle, Suzanne M; Burton, David; Woodman-Bailey, Adam; Horner, Paddy; Jeal, Nikki

    2016-03-01

    Guidelines highlight the need to increase HIV testing among men who have sex with men (MSM) and novel point-of-care testing provides new possibilities for delivery of care. However, it is unclear how point-of-care testing should be used to best effect. This study aimed to increase understanding of sexual risk-taking behaviour, service use, and attitudes to point-of-care testing among MSM sauna clients. Data were collected within two saunas for MSM in south west England using a self-completion survey (n = 134). Though this sample of MSM sauna clients are at high risk of acquiring a sexually transmitted infection, the testing frequency among the majority of those reporting unprotected anal intercourse is not in keeping with national guidelines. For almost all participants the introduction of rapid point-of-care testing for both genital and blood-borne infection was likely to increase testing and for the majority NHS specialist services was the preferred setting. © The Author(s) 2016.

  10. ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study.

    Science.gov (United States)

    Broadhurst, Mara Jana; Kelly, John Daniel; Miller, Ann; Semper, Amanda; Bailey, Daniel; Groppelli, Elisabetta; Simpson, Andrew; Brooks, Tim; Hula, Susan; Nyoni, Wilfred; Sankoh, Alhaji B; Kanu, Santigi; Jalloh, Alhaji; Ton, Quy; Sarchet, Nicholas; George, Peter; Perkins, Mark D; Wonderly, Betsy; Murray, Megan; Pollock, Nira R

    2015-08-29

    At present, diagnosis of Ebola virus disease requires transport of venepuncture blood to field biocontainment laboratories for testing by real-time RT-PCR, resulting in delays that complicate patient care and infection control efforts. Therefore, an urgent need exists for a point-of-care rapid diagnostic test for this disease. In this Article, we report the results of a field validation of the Corgenix ReEBOV Antigen Rapid Test kit. We performed the rapid diagnostic test on fingerstick blood samples from 106 individuals with suspected Ebola virus disease presenting at two clinical centres in Sierra Leone. Adults and children who were able to provide verbal consent or assent were included; we excluded patients with haemodynamic instability and those who were unable to cooperate with fingerstick or venous blood draw. Two independent readers scored each rapid diagnostic test, with any disagreements resolved by a third. We compared point-of-care rapid diagnostic test results with clinical real-time RT-PCR results (RealStar Filovirus Screen RT-PCR kit 1·0; altona Diagnostics GmbH, Hamburg, Germany) for venepuncture plasma samples tested in a Public Health England field reference laboratory (Port Loko, Sierra Leone). Separately, we performed the rapid diagnostic test (on whole blood) and real-time RT-PCR (on plasma) on 284 specimens in the reference laboratory, which were submitted to the laboratory for testing from many clinical sites in Sierra Leone, including our two clinical centres. In point-of-care testing, all 28 patients who tested positive for Ebola virus disease by RT-PCR were also positive by fingerstick rapid diagnostic test (sensitivity 100% [95% CI 87·7-100]), and 71 of 77 patients who tested negative by RT-PCR were also negative by the rapid diagnostic test (specificity 92·2% [95% CI 83·8-97·1]). In laboratory testing, all 45 specimens that tested positive by RT-PCR were also positive by the rapid diagnostic test (sensitivity 100% [95% CI 92·1

  11. Point-of-care lactate testing for sepsis at presentation to health care: a systematic review of patient outcomes.

    Science.gov (United States)

    Morris, Elizabeth; McCartney, David; Lasserson, Daniel; Van den Bruel, Ann; Fisher, Rebecca; Hayward, Gail

    2017-12-01

    Lactate is measured in hospital settings to identify patients with sepsis and severe infections, and to guide initiation of early treatment. Point-of-care technology could facilitate measurement of lactate by clinicians in the community. However, there has been little research into its utility in these environments. To investigate the effect of using point-of-care lactate at presentation to health care on mortality and other clinical outcomes, in patients presenting with acute infections. Studies comparing the use of point-of-care lactate to usual care in initial patient assessment at presentation to health care were identified using a maximally sensitive search strategy of six electronic databases. Two independent authors screened 3063 records for eligibility, and extracted data from eligible studies. Quality assessment for observational studies was performed using the ROBINS-I tool. Eight studies were eligible for inclusion (3063 patients). Seven studies were recruited from emergency departments, and one from a pre-hospital aeromedical setting. Five studies demonstrated a trend towards reduced mortality with point-of-care lactate; three studies achieved statistical significance. One study demonstrated a significant reduction in length of hospital stay, although another did not find any significant difference. Two studies demonstrated a significant reduction in time to treatment for antibiotics and intravenous fluids. This review identifies an evidence gap - there is no high-quality evidence to support the use of point-of-care lactate in community settings. There are no randomised controlled trials (RCTs) and no studies in primary care. RCT evidence from community settings is needed to evaluate this potentially beneficial diagnostic technology. © British Journal of General Practice 2017.

  12. Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy.

    Science.gov (United States)

    Zorzi, Antonella; Cordioli, Maddalena; Gios, Lorenzo; Del Bravo, Paola; Toskin, Igor; Peeling, Rosanna W; Blondeel, Karel; Cornaglia, Giuseppe; Kiarie, James; Ballard, Ronald; Mirandola, Massimo

    2017-12-01

    The incidence of HIV and syphilis among men who have sex with men (MSM) in Europe has recently increased. Rapid point-of-care tests (POCTs) for syphilis can improve access to screening. The purpose of this study was to evaluate the performance of two syphilis POCTs compared with laboratory tests among MSM. The study was undertaken in Verona, Italy. Asymptomatic MSM, potentially exposed to syphilis, were enrolled prospectively. The POCTs evaluated were SD Bioline Syphilis 3.0 and Chembio DPP Syphilis Screen & Confirm Assay on both serum and fingerprick blood. The results of the POCTs were read by the naked eye by two independent readers and their concordance assessed. A total of 289 MSM were enrolled in the study. Based on laboratory tests, 35 MSM (12.1%) were TPPA-positive alone and 16 (5.5%) were both Treponema pallidum particle agglutination test (TPPA) and rapid plasma reagin (RPR)-positive. The specificities of both POCTs were above 99% on both serum and fingerstick blood specimens, while sensitivities varied considerably. The sensitivity of the SD Bioline test was lower on fingerprick blood (51.4% and 54.3%, readers 1 and 2, respectively) compared with that on serum (80.0% and 82.9%). In contrast, the Chembio test exhibited similar sensitivity values for serum and fingerprick samples (57.7% and 64.0% on serum vs 65.4% and 69.2% on fingerprick for the treponemal component; 63.6% on both samples by both readers for the non-treponemal component). The positive predictive value ranged between 100% and 93.9% for the treponemal component of both syphilis POCTs, but was lower (76.3%-100%)%) for the non-treponemal component of the Chembio POCT. The negative predictive value surpassed 90% for both tests on both samples. The agreement between readers was very high (>99%). The diagnostic performance of the syphilis POCTs was lower than expected; however, considering the prevalence of syphilis among MSM, POCTs should be recommended to improve syphilis detection among MSM

  13. An integrated paper-based sample-to-answer biosensor for nucleic acid testing at the point of care.

    Science.gov (United States)

    Choi, Jane Ru; Hu, Jie; Tang, Ruihua; Gong, Yan; Feng, Shangsheng; Ren, Hui; Wen, Ting; Li, XiuJun; Wan Abas, Wan Abu Bakar; Pingguan-Murphy, Belinda; Xu, Feng

    2016-02-07

    With advances in point-of-care testing (POCT), lateral flow assays (LFAs) have been explored for nucleic acid detection. However, biological samples generally contain complex compositions and low amounts of target nucleic acids, and currently require laborious off-chip nucleic acid extraction and amplification processes (e.g., tube-based extraction and polymerase chain reaction (PCR)) prior to detection. To the best of our knowledge, even though the integration of DNA extraction and amplification into a paper-based biosensor has been reported, a combination of LFA with the aforementioned steps for simple colorimetric readout has not yet been demonstrated. Here, we demonstrate for the first time an integrated paper-based biosensor incorporating nucleic acid extraction, amplification and visual detection or quantification using a smartphone. A handheld battery-powered heating device was specially developed for nucleic acid amplification in POC settings, which is coupled with this simple assay for rapid target detection. The biosensor can successfully detect Escherichia coli (as a model analyte) in spiked drinking water, milk, blood, and spinach with a detection limit of as low as 10-1000 CFU mL(-1), and Streptococcus pneumonia in clinical blood samples, highlighting its potential use in medical diagnostics, food safety analysis and environmental monitoring. As compared to the lengthy conventional assay, which requires more than 5 hours for the entire sample-to-answer process, it takes about 1 hour for our integrated biosensor. The integrated biosensor holds great potential for detection of various target analytes for wide applications in the near future.

  14. Comparison of noninvasive and invasive point-of-care testing methods with reference method for hemoglobin measurement.

    Science.gov (United States)

    Avcioglu, Gamze; Nural, Cemil; Yilmaz, Fatma Meriç; Baran, Pervin; Erel, Özcan; Yilmaz, Gülsen

    2017-08-23

    Rapid and practical point-of-care testing (POCT) devices become more popular, especially in blood donation centers for determining predonation hemoglobin (Hb) concentrations. The purpose of this study was to evaluate accordance between the POCT methods and the venous method as the reference to Hb screening. A total of 353 subjects with no known significant health problems were included in the study. Hb screening was performed by two different POCT methods, a noninvasive method (Haemospect, MBR, Germany) and an invasive method (HemoControl, EKF Diagnostic, Germany), and a venous method as the reference (Sysmex XE-2100, Sysmex Europe, Germany). The obtained results were compared. The sensitivity and the specificity values of the invasive POCT method (83.3%, 87.9%) were higher than the noninvasive POCT method (66.7%, 77.1%). The Bland-Altman analysis was evaluated for both sexes and the bias of the noninvasive POCT method of the males (-0.97 g/dL) was higher than the bias of the invasive POCT method of the males (-0.07 g/dL). We found a better correlation between the invasive POCT method (r = .908) compared with the venous method than the noninvasive POCT method (r = .634). Predonation Hb measurements must be performed with accurate, precise, and practical methods. Although the noninvasive POCT method was practical and painless, it had lower levels of specificity and sensitivity, and more false deferral and pass rates than the invasive POCT method. The POCT methods agreeable to the venous method as the reference might be suitable for Hb screening especially for centers of excessive numbers of blood donation. © 2017 Wiley Periodicals, Inc.

  15. Design and Realization of Integrated Management System for Data Interoperability between Point-of-Care Testing Equipment and Hospital Information System.

    Science.gov (United States)

    Park, Ki Sang; Heo, Hyuk; Choi, Young Keun

    2013-09-01

    The purpose of this study was to design an integrated data management system based on the POCT1-A2, LIS2-A, LIS2-A2, and HL7 standard to ensure data interoperability between mobile equipment, such as point-of-care testing equipment and the existing hospital data system, its efficiency was also evaluated. The method of this study was intended to design and realize a data management system which would provide a solution for the problems that occur when point-of-care testing equipment is introduced to existing hospital data, after classifying such problems into connectivity, integration, and interoperability. This study also checked if the data management system plays a sufficient role as a bridge between the point-of-care testing equipment and the hospital information system through connection persistence and reliability testing, as well as data integration and interoperability testing. In comparison with the existing system, the data management system facilitated integration by improving the result receiving time, improving the collection rate, and by enabling the integration of disparate types of data into a single system. And it was found out that we can solve the problems related to connectivity, integration and interoperability through generating the message in standardized types. It is expected that the proposed data management system, which is designed to improve the integration point-of-care testing equipment with existing systems, will establish a solid foundation on which better medical service may be provided by hospitals by improving the quality of patient service.

  16. Barriers to hospital-based clinical adoption of point-of-care testing (POCT): A systematic narrative review.

    Science.gov (United States)

    Quinn, Alistair D; Dixon, Dorian; Meenan, Brian J

    2016-01-01

    Recent advances in areas such as biomarker discovery and microfluidic device fabrication have allowed clinical testing to be moved ever closer to the site of patient care. The development of a range of point-of-care testing (POCT) devices that seek to provide the clinician with diagnostic test results more rapidly offer the opportunity to enhance the quality of care for the individual patient and the population at large. However, there are indications that, notwithstanding advances in the technologies that underpin the utility of POCT, their clinical uptake and utilization is less than might be expected. Moreover, the nature and relative importance of the barriers identified as being impediments to their more widespread adoption are not well understood. This article reports the findings from a systematic narrative review of published literature sources over the period 2000 to January 2014 to identify and categorize the various barriers to adoption of POCT devices within the clinical environment. Data from a total of six electronic bibliographic databases were accessed and these searches were supplemented by scrutinizing the reference lists within the key articles identified. A set of 49 key articles were assessed in detail and from these four specific categories of barrier to adoption of POCT were identified. Identification and categorization of these barriers, along with an assessment of their significance to clinical practice, is seen as necessary for developing real solutions to ensure appropriate and effective POCT uptake. The most prevalent categories were those associated with the economics of adoption and quality assurance and regulatory issues, each which were reflected in 65% of the literature articles reviewed. Device performance and data management issues were cited in 51% of the publications. Staff and operational issues were found within 35% of articles. The most significant barriers identified concerned higher cost per test of POCT in comparison to

  17. Antenatal syphilis screening using point-of-care testing in Sub-Saharan African countries: a cost-effectiveness analysis.

    Directory of Open Access Journals (Sweden)

    Andreas Kuznik

    2013-11-01

    Full Text Available Untreated syphilis in pregnancy is associated with adverse clinical outcomes for the infant. Most syphilis infections occur in sub-Saharan Africa (SSA, where coverage of antenatal screening for syphilis is inadequate. Recently introduced point-of-care syphilis tests have high accuracy and demonstrate potential to increase coverage of antenatal screening. However, country-specific cost-effectiveness data for these tests are limited. The objective of this analysis was to evaluate the cost-effectiveness and budget impact of antenatal syphilis screening for 43 countries in SSA and estimate the impact of universal screening on stillbirths, neonatal deaths, congenital syphilis, and disability-adjusted life years (DALYs averted.The decision analytic model reflected the perspective of the national health care system and was based on the sensitivity (86% and specificity (99% reported for the immunochromatographic strip (ICS test. Clinical outcomes of infants born to syphilis-infected mothers on the end points of stillbirth, neonatal death, and congenital syphilis were obtained from published sources. Treatment was assumed to consist of three injections of benzathine penicillin. Country-specific inputs included the antenatal prevalence of syphilis, annual number of live births, proportion of women with at least one antenatal care visit, per capita gross national income, and estimated hourly nurse wages. In all 43 sub-Saharan African countries analyzed, syphilis screening is highly cost-effective, with an average cost/DALY averted of US$11 (range: US$2-US$48. Screening remains highly cost-effective even if the average prevalence falls from the current rate of 3.1% (range: 0.6%-14.0% to 0.038% (range: 0.002%-0.113%. Universal antenatal screening of pregnant women in clinics may reduce the annual number of stillbirths by up to 64,000, neonatal deaths by up to 25,000, and annual incidence of congenital syphilis by up to 32,000, and avert up to 2.6 million

  18. Performance evaluation of point-of-care test for detection of Cryptosporidium stool antigen in children and HIV infected adults.

    Science.gov (United States)

    Shimelis, Techalew; Tadesse, Endale

    2014-05-16

    Gastro-enteritis is associated with significant morbidity and mortality in patients with HIV/AIDS and children, and Cryptosporidium is the most important parasite implicated. To date, several commercial companies have developed simple and rapid point-of-care tests for the detection of Cryptosporidium infection; however, information is scarce regarding their diagnostic significance in Ethiopia. This study aimed at evaluating the performance of a rapid diagnostic test (RDT) for the detection of Cryptosporidium stool antigen. A hospital-based cross-sectional study was conducted in Hawassa University Hospital, southern Ethiopia from May to November 2013. Faecal samples were collected from a total of 100 children and 250 HIV infected individuals with diarrhea or CD4 T-cell count lower than 200 cells/μl. Specimens were processed using direct, formol-ether concentration and modified Ziehl-Neelsen techniques for diagnosis of Cryptosporidium and other parasites. One hundred faecal samples (50 positives for Cryptosporidium, 35 positives for other parasites and 15 negatives for any intestinal parasites) were tested using the CoproStrip™Cryptosporidium kit (Savyon Diagnostics Ltd, Israel). Test parameters were calculated using microscopy of the modified Ziehl-Neelsen stained stool smear as reference method. The performance of the RDT was first compared to routine microscopic analysis (examination ≤10 min). The CoproStrip™Cryptosporidium RDT correctly detected 31 of 42 positive samples and 49 of 50 negative samples (i.e., 11 false negatives and 1 false positive). Sensitivity, specificity, PPV, NPV and accuracy were calculated to be 74, 98, 97, 84 and 88%, respectively. Upon thorough microscopic analysis (examination >10 min), 8 more samples with very low oocyst density were found. However, these were missed by the kit and lower the sensitivity and NPV to 62 and 72%, respectively. No cross-reactivity was observed with any of the helminthic or other protozoan parasites

  19. Advancing prevention of sexually transmitted infections through point-of-care testing: target product profiles and landscape analysis.

    Science.gov (United States)

    Toskin, Igor; Murtagh, Maurine; Peeling, Rosanna W; Blondeel, Karel; Cordero, Joanna; Kiarie, James

    2017-12-01

    Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing. Since 2014, the WHO Department of Reproductive Health and Research, in collaboration with technical partners, has completed four landscape analyses of promising diagnostics for use at or near the point of patient care to detect syphilis, Neisseria gonorrhoeae , Chlamydia trachomatis , Trichomonas vaginalis and the human papillomavirus. The analyses comprised a literature review and interviews. Two International Technical Consultations on STI POCTs (2014 and 2015) resulted in the development of target product profiles (TPP). Experts in STI microbiology, laboratory diagnostics, clinical management, public health and epidemiology participated in the consultations with representation from all WHO regions. The landscape analysis identified diagnostic tests that are either available on the market, to be released in the near future or in the pipeline. The TPPs specify 28 analytical and operational characteristics of POCTs for use in different populations for surveillance, screening and case management. None of the tests that were identified in the landscape analysis met all of the targets of the TPPs. More efforts of the global health community are needed to accelerate access to affordable quality-assured STI POCTs, particularly in low- and middle-income countries, by supporting the development of new diagnostic platforms as well as strengthening the validation and implementation of existing diagnostics according to internationally endorsed standards and the best available evidence. © World Health Organization 2017. Licensee BMJ Publishing Group Limited. This is an open access article distributed under the terms of the Creative Commons Attribution IGO

  20. Loop-Mediated Isothermal Amplification for Laboratory Confirmation of Buruli Ulcer Disease-Towards a Point-of-Care Test.

    Directory of Open Access Journals (Sweden)

    Marcus Beissner

    2015-11-01

    Full Text Available As the major burden of Buruli ulcer disease (BUD occurs in remote rural areas, development of point-of-care (POC tests is considered a research priority to bring diagnostic services closer to the patients. Loop-mediated isothermal amplification (LAMP, a simple, robust and cost-effective technology, has been selected as a promising POC test candidate. Three BUD-specific LAMP assays are available to date, but various technical challenges still hamper decentralized application. To overcome the requirement of cold-chains for transport and storage of reagents, the aim of this study was to establish a dry-reagent-based LAMP assay (DRB-LAMP employing lyophilized reagents.Following the design of an IS2404 based conventional LAMP (cLAMP assay suitable to apply lyophilized reagents, a lyophylization protocol for the DRB-LAMP format was developed. Clinical performance of cLAMP was validated through testing of 140 clinical samples from 91 suspected BUD cases by routine assays, i.e. IS2404 dry-reagent-based (DRB PCR, conventional IS2404 PCR (cPCR, IS2404 qPCR, compared to cLAMP. Whereas qPCR rendered an additional 10% of confirmed cases and samples respectively, case confirmation and positivity rates of DRB-PCR or cPCR (64.84% and 56.43%; 100% concordant results in both assays and cLAMP (62.64% and 52.86% were comparable and there was no significant difference between the sensitivity of the assays (DRB PCR and cPCR, 86.76%; cLAMP, 83.82%. Likewise, sensitivity of cLAMP (95.83% and DRB-LAMP (91.67% were comparable as determined on a set of 24 samples tested positive in all routine assays.Both LAMP formats constitute equivalent alternatives to conventional PCR techniques. Provided the envisaged availability of field friendly DNA extraction formats, both assays are suitable for decentralized laboratory confirmation of BUD, whereby DRB-LAMP scores with the additional advantage of not requiring cold-chains. As validation of the assays was conducted in a third

  1. Clinical Decision Support and Optional Point of Care Testing of Renal Function for Safe Use of Antibiotics in Elderly Patients : A Retrospective Study in Community Pharmacy Practice

    NARCIS (Netherlands)

    Heringa, Mette; Floor-Schreudering, Annemieke; De Smet, Peter A G M; Bouvy, Marcel L

    2017-01-01

    OBJECTIVE: The aim was to investigate the management of drug therapy alerts on safe use of antibiotics in elderly patients with (potential) renal impairment and the contribution of optional creatinine point of care testing (PoCT) in community pharmacy practice. METHODS: Community pharmacists used a

  2. Point of Care Ultrasound

    DEFF Research Database (Denmark)

    Dietrich, Christoph F; Goudie, Adrian; Chiorean, Liliana

    2017-01-01

    Over the last decade, the use of portable ultrasound scanners has enhanced the concept of point of care ultrasound (PoC-US), namely, "ultrasound performed at the bedside and interpreted directly by the treating clinician." PoC-US is not a replacement for comprehensive ultrasound, but rather allow...... and critical care medicine, cardiology, anesthesiology, rheumatology, obstetrics, neonatology, gynecology, gastroenterology and many other applications. In the future, PoC-US will be more diverse than ever and be included in medical student training.......Over the last decade, the use of portable ultrasound scanners has enhanced the concept of point of care ultrasound (PoC-US), namely, "ultrasound performed at the bedside and interpreted directly by the treating clinician." PoC-US is not a replacement for comprehensive ultrasound, but rather allows...

  3. More Than Just Accuracy: A Novel Method to Incorporate Multiple Test Attributes in Evaluating Diagnostic Tests Including Point of Care Tests.

    Science.gov (United States)

    Thompson, Matthew; Weigl, Bernhard; Fitzpatrick, Annette; Ide, Nicole

    2016-01-01

    Current frameworks for evaluating diagnostic tests are constrained by a focus on diagnostic accuracy, and assume that all aspects of the testing process and test attributes are discrete and equally important. Determining the balance between the benefits and harms associated with new or existing tests has been overlooked. Yet, this is critically important information for stakeholders involved in developing, testing, and implementing tests. This is particularly important for point of care tests (POCTs) where tradeoffs exist between numerous aspects of the testing process and test attributes. We developed a new model that multiple stakeholders (e.g., clinicians, patients, researchers, test developers, industry, regulators, and health care funders) can use to visualize the multiple attributes of tests, the interactions that occur between these attributes, and their impacts on health outcomes. We use multiple examples to illustrate interactions between test attributes (test availability, test experience, and test results) and outcomes, including several POCTs. The model could be used to prioritize research and development efforts, and inform regulatory submissions for new diagnostics. It could potentially provide a way to incorporate the relative weights that various subgroups or clinical settings might place on different test attributes. Our model provides a novel way that multiple stakeholders can use to visualize test attributes, their interactions, and impacts on individual and population outcomes. We anticipate that this will facilitate more informed decision making around diagnostic tests.

  4. Design and Testing of an EHR-Integrated, Busulfan Pharmacokinetic Decision Support Tool for the Point-of-Care Clinician.

    Directory of Open Access Journals (Sweden)

    Susan M. Abdel-Rahman

    2016-03-01

    Full Text Available BACKGROUND: Busulfan demonstrates a narrow therapeutic index for which clinicians routinely employ therapeutic drug monitoring (TDM. However, operationalizing TDM can be fraught with inefficiency. We developed and tested software encoding a clinical decision support tool (DST that is embedded into our electronic health record (EHR and designed to streamline the TDM process for our oncology partners. METHODS: Our development strategy was modeled based on the features associated with successful DSTs. An initial Requirements Analysis was performed to characterize tasks, information flow, user needs, and system requirements to enable push/pull from the EHR. Back-end development was coded based on the algorithm used when manually performing busulfan TDM. The code was independently validated in MATLAB using 10,000 simulated patient profiles. A 296-item heuristic checklist was used to guide design of the front-end user interface. Content experts and end-users (n=28 were recruited to participate in traditional usability testing under an IRB approved protocol. RESULTS: Decision support software was developed to systematically walk the point-of-care clinician through the TDM process. The system is accessed through the EHR which transparently imports all of the requisite patient data. Data are visually inspected and then curve fit using a model-dependent approach. Quantitative goodness-of-fit are converted to single tachometer where green alerts the user that the model is strong, yellow signals caution and red indicates that there may be a problem with the fitting. Override features are embedded to permit application of a model-independent approach where appropriate. Simulations are performed to target a desired exposure or dose as entered by the clinician and the DST pushes the user approved recommendation back into the EHR. Usability testers were highly satisfied with our DST and quickly became proficient with the software.CONCLUSIONS: With early and

  5. Diagnosing acute HIV infection at point of care: a retrospective analysis of the sensitivity and specificity of a fourth-generation point-of-care test for detection of HIV core protein p24.

    Science.gov (United States)

    Fitzgerald, Naomi; Cross, Maria; O'Shea, Siobhan; Fox, Julie

    2017-03-01

    Detection of acute HIV infection is vital in preventing onward transmission. HIV point-of-care testing (POCT) has improved uptake of HIV testing but has been limited to third-generation assays, which only detect chronic HIV infection. Previous evaluation of the fourth-generation Alere Determine HIV-1/2 Ag/Ab Combo POCT showed only 50% sensitivity for HIV core protein p24 (p24 antigen) detection, which is suboptimal for diagnosis of acute HIV infection with limited advantage over third-generation POCT. We aimed to assess the sensitivity of the new Alere HIV Combo POCT to detect acute HIV infection. Stored samples in samples already identified as p24-positive using standard-of-care fourth-generation assays were randomly selected alongside groups of antibody-positive samples and HIV-negative samples. Each sample was tested using the new Alere POCT according to manufacturer's instructions. Sensitivity and specificity were then calculated. The Alere HIV Combo POCT test demonstrated 88% sensitivity 95% CI (78% to 98%) and 100% specificity 95% CI (99.7% to 100%) for detection of p24 antigen. This new POCT shows improved sensitivity for detection of p24 antigen and may be of value for clinical use in detecting acute HIV infection. Further evaluation of its use in a clinical setting is still required. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  6. Point-of-care diagnostic tests for childhood urinary-tract infection: phase-contrast microscopy for bacteria, stick testing, and counting white blood cells.

    Science.gov (United States)

    Coulthard, Malcolm G; Nelson, Andrew; Smith, Terry; Perry, John D

    2010-09-01

    To evaluate point-of-care testing for childhood urinary-tract infections (UTI). Point-of-care testing of prospectively collected sequential paired urines was compared with quantitative culture after serial dilution in 203 children, of whom 36 had UTIs. Proportionate reduction in uncertainty (PRU) plots were used to compare between methods and with published values. Phase-contrast microscopy for bacteria, as with culturing a single urine and using a threshold of 10(5) bacteria/ml, was 100% sensitive, making it powerful to rule UTIs out. The specificity was slightly lower than urine culture (0.860 vs 0.925) except in girls >9 years where vaginal Lactobacillus contamination reduced it to 0.61, but this increased to 0.81 when 'urethral stream' urines were collected. Nitrite positivity is highly specific at 0.985, making it powerful at ruling UTIs in, but its low sensitivity (0.61) makes it unsafe to rule UTIs out. A PRU plot of 16 previous studies confirmed this. Though the presence of urinary white blood cells (WBC) correlates with UTI, whether tested by point-of-care of laboratory microscopy or by stick testing, the coefficient of determination is too low to make them clinically useful, alone or combined with nitrite analysis. Seventeen other studies confirmed this. Phase-contrast microscopy can rule out UTIs as reliably as urine culture but is immediate, which may be clinically important. To interpret positive results reliably, girls >9 years must collect a 'urethral stream' urine. While nitrite positivity is useful to rule UTIs in, negative results are unreliable. Urinary WBC testing has little value.

  7. Sensitivity and specificity of a rapid point-of-care test for active yaws: a comparative study.

    Science.gov (United States)

    Ayove, Telek; Houniei, Wendy; Wangnapi, Regina; Bieb, Sibauk V; Kazadi, Walter; Luke, Lisol-Nirau; Manineng, Clement; Moses, Penias; Paru, Raymond; Esfandiari, Javan; Alonso, Pedro L; de Lazzari, Elisa; Bassat, Quique; Mabey, David; Mitjà, Oriol

    2014-07-01

    To eradicate yaws, national control programmes use the Morges strategy (initial mass treatment and biannual resurveys). The resurvey component is designed to actively detect and treat remaining yaws cases and is initiated on the basis of laboratory-supported reactive non-treponemal serology (using the rapid plasma reagin [RPR] test). Unfortunately, the RPR test is available rarely in yaws-endemic areas. We sought to assess a new point-of-care assay-the Dual Path Platform (DPP) syphilis assay, which is based on simultaneous detection of antibodies to treponemal and non-treponemal antigens-for guiding use of antibiotics for yaws eradication. A secondary goal was to ascertain at what timepoint the DPP assay line reverted to negative after treatment. 703 children (aged 1-18 years) with suspected clinical yaws living in two remote, yaws-endemic villages in Papua New Guinea were enrolled. Clinical suspicion of yaws was established according to a WHO pictorial guide. We obtained blood samples from all patients. We calculated the sensitivity and specificity of the DPP assay for detection of antibodies to treponemal (T1) and non-treponemal (T2) antigens and compared values against those obtained with standard laboratory tests (the Treponema pallidum haemagglutination assay [TPHA] and the RPR test). We followed up a subsample of children with dually positive serology (T1 and T2) to monitor changes in DPP optical density (using an automatic reader) at 3 and 6 months. This trial is registered with ClinicalTrials.gov, number NCT01841203. Of 703 participants, 389 (55%) were reactive for TPHA, 305 (43%) for the RPR test, and 287 (41%) for both TPHA and the RPR test. The DPP T1 (treponemal) assay had a sensitivity of 88·4% (95% CI 84·8-91·4) and specificity of 95·2% (92·2-97·3). The DPP T2 (non-treponemal) assay had a sensitivity of 87·9% (83·7-91·3) and specificity of 92·5% (89·4-94·9). In subgroup analyses, sensitivities and specificities did not differ according to

  8. Laboratory Evaluation of a Smartphone-Based Electronic Reader of Rapid Dual Point-of-Care Tests for Antibodies to Human Immunodeficiency Virus and Treponema pallidum Infections.

    Science.gov (United States)

    Herbst de Cortina, Sasha; Bristow, Claire C; Humphries, Romney; Vargas, Silver Keith; Konda, Kelika A; Caceres, Carlos F; Klausner, Jeffrey D

    2017-07-01

    Dual point-of-care tests for antibodies to human immunodeficiency virus (HIV) and Treponema pallidum allow for same-day testing and treatment and have been demonstrated to be cost-effective in preventing the adverse outcomes of HIV infection and syphilis. By recording and transmitting data as they are collected, electronic readers address challenges related to the decentralization of point-of-care testing. We evaluated a smartphone-based electronic reader using 201 sera tested with 2 dual rapid tests for detection of antibodies to HIV and T. pallidum in Los Angeles, USA, and Lima, Peru. Tests were read both visually and with the electronic reader. Enzyme immunoassay followed by Western blot and T. pallidum particle agglutination were the reference tests for HIV and T. pallidum, respectively. The sensitivities of the 2 rapid tests for detection of HIV were 94.1% and 97.0% for electronic readings. Both tests had a specificity of 100% for detection of HIV by electronic reading. The sensitivities of the 2 rapid tests for detection of T. pallidum were 86.5% and 92.4% for electronic readings. The specificities for detection of T. pallidum were 99.1% and 99.0% by electronic reading. There were no significant differences between the accuracies of visual and electronic readings, and the performance did not differ between the 2 study sites. Our results show the electronic reader to be a promising option for increasing the use of point-of-care testing programs.

  9. Point-of-Care Platforms

    Science.gov (United States)

    Gauglitz, Günter

    2014-06-01

    Point-of-care applications are gaining increasing interest in clinical diagnostics and emergency applications. Biosensors are used to monitor the biomolecular interaction process between a disease biomarker and a recognition element such as a reagent. Essential are the quality and selectivity of the recognition elements and assay types used to improve sensitivity and to avoid nonspecific interactions. In addition, quality measures are influenced by the detection principle and the evaluation strategies. For these reasons, this review provides a survey and validation of recognition elements, assays, and various types of detection methods for point-of-care testing (POCT) platforms. Common applications of clinical parameters are discussed and considered. In this ever-changing field, a snapshot of current applications is needed. We provide such a snapshot by way of a table including literature citations and also discuss these applications in more detail throughout.

  10. Point-of-care procalcitonin test to reduce antibiotic exposure in patients hospitalized with acute exacerbation of COPD

    DEFF Research Database (Denmark)

    Corti, Caspar; Fally, Markus; Fabricius-Bjerre, Andreas

    2016-01-01

    BACKGROUND: This study was conducted to investigate whether point-of-care (POC) procalcitonin (PCT) measurement can reduce redundant antibiotic treatment in patients hospitalized with acute exacerbation of COPD (AECOPD). METHODS: One-hundred and twenty adult patients admitted with AECOPD were...... in the PCT-arm vs 8.5 (IQR 1-11) days in the control arm (P=0.0169, Wilcoxon) for the intention-to-treat population. The proportion of patients using antibiotics for ≥5 days within the 28-day follow-up was 41.9% (PCT-arm) vs 67.2% (P=0.006, Fisher's exact) in the intention-to-treat population. For the per...... no apparent difference. CONCLUSION: Our study shows that the implementation of a POC PCT-guided algorithm can be used to substantially reduce antibiotic exposure in patients hospitalized with AECOPD, with no apparent harm....

  11. Scaling Up HIV Testing in an Academic Emergency Department: An Integrated Testing Model with Rapid Fourth-Generation and Point-of-Care Testing.

    Science.gov (United States)

    Signer, Danielle; Peterson, Stephen; Hsieh, Yu-Hsiang; Haider, Somiya; Saheed, Mustapha; Neira, Paula; Wicken, Cassie; Rothman, Richard E

    2016-01-01

    We evaluated two approaches for implementing routine HIV screening in an inner-city, academic emergency department (ED). These approaches differed by staffing model and type of HIV testing technology used. The programmatic outcomes assessed included the total number of tests performed, proportion of newly identified HIV-positive patients, and proportion of newly diagnosed individuals who were linked to care. This study examined specific outcomes for two distinct, successive approaches to implementing HIV screening in an inner-city, academic ED, from July 2012 through June 2013 (Program One), and from August 2013 through July 2014 (Program Two). Program One used a supplementary staff-only HIV testing model with point-of-care (POC) oral testing. Program Two used a triage-integrated, nurse-driven HIV testing model with fourth-generation blood and POC testing, and an expedited linkage-to-care process. During Program One, 6,832 eligible patients were tested for HIV with a rapid POC oral HIV test. Sixteen patients (0.2%) were newly diagnosed with HIV, of whom 13 were successfully linked to care. During Program Two, 8,233 eligible patients were tested for HIV, of whom 3,124 (38.0%) received a blood test and 5,109 (62.0%) received a rapid POC test. Of all patients tested in Program Two, 29 (0.4%) were newly diagnosed with HIV, four of whom had acute infections and 27 of whom were successfully linked to care. We found a statistically significant difference in the proportion of the eligible population tested-8,233 of 49,697 (16.6%) in Program Two and 6,832 of 46,818 (14.6%) in Program One. These differences from Program One to Program Two corresponded to increases in testing volume (n=1,401 tests), number of patients newly diagnosed with HIV (n=13), and proportion of patients successfully linked to care (from 81.0% to 93.0%). Integrating HIV screening into the standard triage workflow resulted in a higher proportion of ED patients being tested for HIV as compared with the

  12. Expanded HIV Testing and Linkage to Care: Conventional vs. Point-of-Care Testing and Assignment of Patient Notification and Linkage to Care to an HIV Care Program.

    Science.gov (United States)

    Bares, Sara; Eavou, Rebecca; Bertozzi-Villa, Clara; Taylor, Michelle; Hyland, Heather; McFadden, Rachel; Shah, Sachin; Pho, Mai T; Walter, James; Badlani, Sameer; Schneider, John; Prachand, Nik; Benbow, Nanette; Pitrak, David

    2016-01-01

    The University of Chicago Medicine (UCM) led the Expanded Testing and Linkage to Care (X-TLC) program for disproportionately affected populations on the South Side of Chicago. The X-TLC program aimed to expand routine HIV testing to high-prevalence communities with disproportionately affected populations (i.e., minority men and women, men who have sex with men, and intravenous drug users) according to CDC guidelines at multiple clinical sites. The X-TLC program used standard blood-based laboratory testing vs. point-of-care rapid testing or rapid laboratory testing with point-of-care results notification. Site coordinators and the linkage-to-care coordinator at UCM oversaw testing, test notification, and linkage to care. From February 1, 2011, through December 31, 2013, the X-TLC program completed 75,345 HIV tests on 67,153 unique patients. Of the total tests, 48,044 (63.8%) were performed on patients who self-identified as African American and 6,606 (8.8%) were performed on patients who self-identified as Hispanic. Of the 67,153 patients tested, 395 (0.6%) tested positive and 176 (0.3%) were previously unaware of their HIV-positive status. Seroprevalence was even higher for EDs, where 127 of 12,957 patients tested positive for HIV (1.0% seroprevalence), than for other patient care sites, including for new diagnoses, where 50 of 12,957 patients tested positive for HIV (0.4% seroprevalence). Of the 176 newly diagnosed patients, 166 of 173 (96.0%) patients who were still alive when testing was complete received their test results, and 148 of the 166 patients who were eligible for care (89.0%) were linked to care. Patients linked to X-TLC physicians did well with respect to the continuum of care: 77 of 123 (62.6%) patients achieved HIV viral load of care for HIV patients diagnosed at community sites. HIV screening and linkage to care can be accomplished by incorporating standard testing for HIV into routine medical care.

  13. Estimating the value of point-of-care HPV testing in three low- and middle-income countries: a modeling study.

    Science.gov (United States)

    Campos, Nicole G; Tsu, Vivien; Jeronimo, Jose; Mvundura, Mercy; Kim, Jane J

    2017-11-25

    Where resources are available, the World Health Organization recommends cervical cancer screening with human papillomavirus (HPV) DNA testing and subsequent treatment of HPV-positive women with timely cryotherapy. Newer technologies may facilitate a same-day screen-and-treat approach, but these testing systems are generally too expensive for widespread use in low-resource settings. To assess the value of a hypothetical point-of-care HPV test, we used a mathematical simulation model of the natural history of HPV and data from the START-UP multi-site demonstration project to estimate the health benefits and costs associated with a shift from a 2-visit approach (requiring a return visit for treatment) to 1-visit HPV testing (i.e., screen-and-treat). We estimated the incremental net monetary benefit (INMB), which represents the maximum additional lifetime cost per woman that could be incurred for a new point-of-care HPV test to be cost-effective, depending on expected loss to follow-up between visits (LTFU) in a given setting. For screening three times in a lifetime at 100% coverage of the target population, when LTFU was 10%, the INMB of the 1-visit relative to the 2-visit approach was I$13 in India, I$36 in Nicaragua, and I$17 in Uganda. If LTFU was 30% or greater, the INMB values for the 1-visit approach in all countries was equivalent to or exceeded total lifetime costs associated with screening three times in a lifetime. At a LTFU level of 70%, the INMB of the 1-visit approach was I$127 in India, I$399 in Nicaragua, and I$121 in Uganda. These findings indicate that point-of-care technology for cervical cancer screening may be worthy of high investment if linkage to treatment can be assured, particularly in settings where LTFU is high.

  14. Existential Threat or Dissociative Response? Examining Defensive Avoidance of Point-of-Care Testing Devices Through a Terror Management Theory Framework.

    Science.gov (United States)

    Dunne, Simon; Gallagher, Pamela; Matthews, Anne

    2015-01-01

    Using a terror management theory framework, this study investigated if providing mortality reminders or self-esteem threats would lead participants to exhibit avoidant responses toward a point-of-care testing device for cardiovascular disease risk and if the nature of the device served to diminish the existential threat of cardiovascular disease. One hundred and twelve participants aged 40-55 years completed an experimental questionnaire. Findings indicated that participants were not existentially threatened by established terror management methodologies, potentially because of cross-cultural variability toward such methodologies. Highly positive appraisals of the device also suggest that similar technologies may beneficially affect the uptake of screening behaviors.

  15. Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited Setting.

    Science.gov (United States)

    Ondiek, Johnson; Namukaya, Zikulah; Mtapuri-Zinyowera, Sekesai; Balkan, Suna; Elbireer, Ali; Ushiro Lumb, Ines; Kiyaga, Charles; Goel, Neha; Ritchie, Allyson; Ncube, Patience; Omuomu, Kenneth; Ndiege, Kenneth; Kekitiinwa, Adeodata; Mangwanya, Douglas; Fowler, Mary G; Nadala, Lou; Lee, Helen

    2017-10-01

    Early diagnosis of HIV-1 infection and the prompt initiation of antiretroviral therapy are critical to achieving a reduction in the morbidity and mortality of infected infants. The Simple AMplification-Based Assay (SAMBA) HIV-1 Qual Whole Blood Test was developed specifically for early infant diagnosis and prevention of mother-to-child transmission programs implemented at the point-of-care in resource-limited settings. We have evaluated the performance of this test run on the SAMBA I semiautomated platform with fresh whole blood specimens collected from 202 adults and 745 infants in Kenya, Uganda, and Zimbabwe. Results were compared with those obtained with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 assay as performed with fresh whole blood or dried blood spots of the same subjects, and discrepancies were resolved with alternative assays. The performance of the SAMBA and CAP/CTM assays evaluated at 5 laboratories in the 3 countries was similar for both adult and infant samples. The clinical sensitivity, specificity, positive predictive value, and negative predictive value for the SAMBA test were 100%, 99.2%, 98.7%, and 100%, respectively, with adult samples, and 98.5%, 99.8%, 99.7%, and 98.8%, respectively, with infant samples. Our data suggest that the SAMBA HIV-1 Qual Whole Blood Test would be effective for early diagnosis of HIV-1 infection in infants at point-of-care settings in sub-Saharan Africa.

  16. Pushing the limits of chemistry point-of-care testing for the management of patients under investigation for Ebola virus disease.

    Science.gov (United States)

    LeBlanc, Jason J; Heinstein, Charles; MacDonald, James; Gallant, Roy; Roberts, Catherine; Jackson, Colleen; Lou, Amy; Nassar, Bassam A; Hatchette, Todd F

    2016-03-01

    With the recent outbreak in West Africa, hospitals worldwide have been developing protocols for suspect of cases of Ebola virus disease. Patients with Ebola virus disease present with a severe gastroenteritis leading to dehydration and electrolyte abnormalities and as such, routine chemistry analysis is essential for patient management. While point-of-care testing can be used with additional precautions for rapid chemistry analyses in a laboratory setting, significant delays could ensue before specimens arrive to the laboratory. This study evaluated the stability of eight chemistry analytes up to 4 h post-collection. Blood was collected by venipuncture from 20 healthy volunteers and tested at times 0, 30, 60, 90, 120 and 240 h. Approximately 100 µl of blood was dispensed into a CHEM 8+Cartridge and processed on a model 300 i-STAT 1 Analyzer (Abbott Point of Care Inc.) and ANOVA was used to assess statistical significant difference from the initial time point. While the manufacturer recommends testing within 30 min of collection, no significant variation was observed for most analytes with time points extending up to 4 h. In contrast, glucose concentrations decreased significantly (P testing could still be used, taking into account the collection time and the average rate of decrease. © The Author(s) 2015.

  17. Biomarkers as point-of-care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care.

    Science.gov (United States)

    Aabenhus, Rune; Jensen, Jens-Ulrik S; Jørgensen, Karsten Juhl; Hróbjartsson, Asbjørn; Bjerrum, Lars

    2014-11-06

    Background Acute respiratory infections (ARIs) are by far the most common reason for prescribing an antibiotic in primary care, even though the majority of ARIs are of viral or non-severe bacterial aetiology. Unnecessary antibiotic use will, in many cases, not be beneficial to the patients' recovery and expose them to potential side effects. Furthermore, as a causal link exists between antibiotic use and antibiotic resistance, reducing unnecessary antibiotic use is a key factor in controlling this important problem. Antibiotic resistance puts increasing burdens on healthcare services and renders patients at risk of future ineffective treatments, in turn increasing morbidity and mortality from infectious diseases. One strategy aiming to reduce antibiotic use in primary care is the guidance of antibiotic treatment by use of a point-of-care biomarker. A point-of-care biomarker of infection forms part of the acute phase response to acute tissue injury regardless of the aetiology (infection, trauma and inflammation) and may in the correct clinical context be used as a surrogate marker of infection,possibly assisting the doctor in the clinical management of ARIs.Objectives To assess the benefits and harms of point-of-care biomarker tests of infection to guide antibiotic treatment in patients presenting with symptoms of acute respiratory infections in primary care settings regardless of age.Search methods We searched CENTRAL (2013, Issue 12), MEDLINE (1946 to January 2014), EMBASE (2010 to January 2014), CINAHL (1981 to January 2014), Web of Science (1955 to January 2014) and LILACS (1982 to January 2014).Selection criteria We included randomised controlled trials (RCTs) in primary care patients with ARIs that compared use of point-of-care biomarkers with standard of care. We included trials that randomised individual patients as well as trials that randomised clusters of patients(cluster-RCTs).Two review authors independently extracted data on the following outcomes: i

  18. Is point of care testing in Irish hospitals ready for the laboratory modernisation process? An audit against the current national Irish guidelines.

    LENUS (Irish Health Repository)

    O'Kelly, R A

    2013-04-11

    BACKGROUND: The Laboratory modernisation process in Ireland will include point of care testing (POCT) as one of its central tenets. However, a previous baseline survey showed that POCT was under-resourced particularly with respect to information technology (IT) and staffing. AIMS: An audit was undertaken to see if POCT services had improved since the publication of National Guidelines and if such services were ready for the major changes in laboratory medicine as envisaged by the Health Service Executive. METHODS: The 15 recommendations of the 2007 Guidelines were used as a template for a questionnaire, which was distributed by the Irish External Quality Assessment Scheme. RESULTS: Thirty-nine of a possible 45 acute hospitals replied. Only a quarter of respondent hospitals had POCT committees, however, allocation of staff to POCT had doubled since the first baseline survey. Poor IT infrastructure, the use of unapproved devices, and low levels of adverse incident reporting were still major issues. CONCLUSIONS: Point of care testing remains under-resourced, despite the roll out of such devices throughout the health service including primary care. The present high standards of laboratory medicine may not be maintained if the quality and cost-effectiveness of POCT is not controlled. Adherence to national Guidelines and adequate resourcing is essential to ensure patient safety.

  19. Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital.

    Science.gov (United States)

    Oris, Charlotte; Clavel, Yoan; Jabaudon, Matthieu; Pialat, Annick; Mohamed, Hadj Abdelkader; Lioret, Frédérique; Sapin, Vincent; Bouvier, Damien

    2018-03-01

    Blood gas analyzers are o0.ften integrated into point-of-care testing provisions. International standards (ISO 22870 and 15189) as adapted to French COFRAC regulations make accreditation of point-ofta-care testintag obligatory. We installed and assessed 12 GEM PREMIER 4000 analyzers for pH, p CO 2 , p O 2 , Na + , K + , Cl - , Ca 2+ , lactate, hemoglobin and oxyhemoglobin (O 2 Hb) at Clermont-Ferrand Hospital. These instruments were distributed across 11 care sites in the hospital. Precision was studied at two control levels for each parameter. Comparisons between GEM analyzers were performed (on 30 samples) for pH, p CO 2 , p O 2 , Na + , K + , Cl - , Ca 2+ , lactate, hemoglobin and O 2 Hb; and between GEM analyzers and the central laboratory for Na + , K + , Cl - , Ca 2+ and hemoglobin (on 30-50 samples). Uncertainty in measurement (UM) was evaluated with an approach using reproducibility and accuracy data. The coefficients of variation (CVs) were in line with recommendations, except for the repeatability CV for p O 2 . All CVs were below 4%. All comparisons complied with recommendations. Uncertainties of measurement were also validated. Our results met standard requirements and the 12 analyzers were assessed as suitable for point-of-care testing in services of academic medical centers, as exemplified at Clermont-Ferrand hospital.

  20. Co-creation of market expansion in point-of-care testing in the United States: Industry leadership perspectives on the community pharmacy segment.

    Science.gov (United States)

    Hohmeier, Kenneth C; McDonough, Sharon L K; Wang, Junling

    Point-of-care testing (POCT) is a specialty of laboratory medicine that occurs at the bedside or near the patient when receiving health services. Despite its established clinical utility and consumer demand in the community pharmacy, the implementation of POCT within this setting has remained modest for a variety of reasons. One possible solution to this problem is the concept of co-creation - the partnership between consumer and manufacturer in the development of value for a service or device. Using the theoretical underpinning of co-creation, this study aimed to investigate perceptions of point-of-care-testing (POCT) industry leadership on the community pharmacy market in the United States to uncover reasons for limited implementation within community pharmacies. Participants were recruited for this study through the use of snowball sampling. A series of semi-structured interviews were conducted with the participants via telephone. Interviews were recorded, transcribed, and entered into a qualitative analysis software program to summarize the data. Five key themes were uncovered: gaps in understanding, areas of positive impact, barriers to implementation, facilitators of implementation, and community pharmacy - a potential major player. Through uncovering gaps in perceptions, it may be possible to leverage the U.S. pharmacy industry's size, potential for scalability, and ease of patient access to further patient care. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. The effectiveness of computer reminders versus postal reminders for improving quality assessment for point-of-care testing in primary care

    DEFF Research Database (Denmark)

    Siersma, Volkert; Kousgaard, Marius Brostrøm; Reventlow, Susanne

    2015-01-01

    Rationale, aims and objectives: This study aimed to evaluate the relative effectiveness of electronic and postal reminders for increasing adherence to the quality assurance programme for the international normalized ratio (INR) point-of-care testing (POCT) device inprimary care. Methods: All 213...... (Postal) if they did not perform a split test to check the quality of their INR POCT for each calendar month. The adherence of the practices was tracked during the subsequent 8 months subdivided into two 4-month periods both without intervention. Outcomes were measures of split test procedure adherence....... Results: Both interventions were associated with an increase in adherence to the split test procedure – a factor 6.00 [95% confidence interval (CI) 4.46–7.72] and 8.22 [95% CI5.87–11.52] for ComRem and Postal, respectively – but there is no evidence that one of the interventions was more effective than...

  2. Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care.

    Science.gov (United States)

    Goel, Neha; Ritchie, Allyson V; Mtapuri-Zinyowera, Sekesai; Zeh, Clement; Stepchenkova, Tetiana; Lehga, Jesse; De Ruiter, Annemiek; Farleigh, Laura E; Edemaga, Daniel; So, Rosario; Sembongi, Hiroshi; Wisniewski, Craig; Nadala, Lourdes; Schito, Marco; Lee, Helen

    2017-06-01

    Although access to antiretroviral therapy for HIV infection is increasing in resource-poor countries, viral load testing for monitoring of treatment efficacy remains limited, expensive, and confined to centralized laboratories. The SAMBA HIV-1 Semi-Q Test is a nucleic acid-based amplification assay developed for viral load monitoring performed on either the semi-automated SAMBA I system for laboratory use or the fully automated SAMBA II system for point-of care use. We have assessed the performance characteristics of the SAMBA HIV-1 Semi-Q Test on SAMBA I and SAMBA II systems according to the Common Technical Specifications of the European Community's 98/79 In Vitro Diagnostic Medical Devices Directive. The sensitivity, specificity, reproducibility, and viral subtype coverage of the test were similar on the SAMBA I and SAMBA II platforms. The clinical performance on the SAMBA I system was compared with the Roche CAP/CTM assay and evaluated in-house with 130 patient specimens from London as well as in the field with 390 specimens in Kenya and Zimbabwe. The overall concordance between the SAMBA and CAP/CTM assays was 98.1%. The clinical performance of the test on the SAMBA II platform in comparison with the Abbott HIV-1 RealTime Assay was evaluated in-house with 150 specimens from Ukraine, yielding a concordance of 98.0%. The results thus show that the SAMBA HIV-1 Semi-Q Test performs equivalently on SAMBA I and SAMBA II, and they suggest that the test is suitable for implementation at the point-of-care in resource-poor regions where viral load testing is desperately needed but often unavailable. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. The clinical and economic impact of point-of-care CD4 testing in mozambique and other resource-limited settings: a cost-effectiveness analysis.

    Science.gov (United States)

    Hyle, Emily P; Jani, Ilesh V; Lehe, Jonathan; Su, Amanda E; Wood, Robin; Quevedo, Jorge; Losina, Elena; Bassett, Ingrid V; Pei, Pamela P; Paltiel, A David; Resch, Stephen; Freedberg, Kenneth A; Peter, Trevor; Walensky, Rochelle P

    2014-09-01

    Point-of-care CD4 tests at HIV diagnosis could improve linkage to care in resource-limited settings. Our objective is to evaluate the clinical and economic impact of point-of-care CD4 tests compared to laboratory-based tests in Mozambique. We use a validated model of HIV testing, linkage, and treatment (CEPAC-International) to examine two strategies of immunological staging in Mozambique: (1) laboratory-based CD4 testing (LAB-CD4) and (2) point-of-care CD4 testing (POC-CD4). Model outcomes include 5-y survival, life expectancy, lifetime costs, and incremental cost-effectiveness ratios (ICERs). Input parameters include linkage to care (LAB-CD4, 34%; POC-CD4, 61%), probability of correctly detecting antiretroviral therapy (ART) eligibility (sensitivity: LAB-CD4, 100%; POC-CD4, 90%) or ART ineligibility (specificity: LAB-CD4, 100%; POC-CD4, 85%), and test cost (LAB-CD4, US$10; POC-CD4, US$24). In sensitivity analyses, we vary POC-CD4-specific parameters, as well as cohort and setting parameters to reflect a range of scenarios in sub-Saharan Africa. We consider ICERs less than three times the per capita gross domestic product in Mozambique (US$570) to be cost-effective, and ICERs less than one times the per capita gross domestic product in Mozambique to be very cost-effective. Projected 5-y survival in HIV-infected persons with LAB-CD4 is 60.9% (95% CI, 60.9%-61.0%), increasing to 65.0% (95% CI, 64.9%-65.1%) with POC-CD4. Discounted life expectancy and per person lifetime costs with LAB-CD4 are 9.6 y (95% CI, 9.6-9.6 y) and US$2,440 (95% CI, US$2,440-US$2,450) and increase with POC-CD4 to 10.3 y (95% CI, 10.3-10.3 y) and US$2,800 (95% CI, US$2,790-US$2,800); the ICER of POC-CD4 compared to LAB-CD4 is US$500/year of life saved (YLS) (95% CI, US$480-US$520/YLS). POC-CD4 improves clinical outcomes and remains near the very cost-effective threshold in sensitivity analyses, even if point-of-care CD4 tests have lower sensitivity/specificity and higher cost than published

  4. The clinical and economic impact of point-of-care CD4 testing in mozambique and other resource-limited settings: a cost-effectiveness analysis.

    Directory of Open Access Journals (Sweden)

    Emily P Hyle

    2014-09-01

    Full Text Available Point-of-care CD4 tests at HIV diagnosis could improve linkage to care in resource-limited settings. Our objective is to evaluate the clinical and economic impact of point-of-care CD4 tests compared to laboratory-based tests in Mozambique.We use a validated model of HIV testing, linkage, and treatment (CEPAC-International to examine two strategies of immunological staging in Mozambique: (1 laboratory-based CD4 testing (LAB-CD4 and (2 point-of-care CD4 testing (POC-CD4. Model outcomes include 5-y survival, life expectancy, lifetime costs, and incremental cost-effectiveness ratios (ICERs. Input parameters include linkage to care (LAB-CD4, 34%; POC-CD4, 61%, probability of correctly detecting antiretroviral therapy (ART eligibility (sensitivity: LAB-CD4, 100%; POC-CD4, 90% or ART ineligibility (specificity: LAB-CD4, 100%; POC-CD4, 85%, and test cost (LAB-CD4, US$10; POC-CD4, US$24. In sensitivity analyses, we vary POC-CD4-specific parameters, as well as cohort and setting parameters to reflect a range of scenarios in sub-Saharan Africa. We consider ICERs less than three times the per capita gross domestic product in Mozambique (US$570 to be cost-effective, and ICERs less than one times the per capita gross domestic product in Mozambique to be very cost-effective. Projected 5-y survival in HIV-infected persons with LAB-CD4 is 60.9% (95% CI, 60.9%-61.0%, increasing to 65.0% (95% CI, 64.9%-65.1% with POC-CD4. Discounted life expectancy and per person lifetime costs with LAB-CD4 are 9.6 y (95% CI, 9.6-9.6 y and US$2,440 (95% CI, US$2,440-US$2,450 and increase with POC-CD4 to 10.3 y (95% CI, 10.3-10.3 y and US$2,800 (95% CI, US$2,790-US$2,800; the ICER of POC-CD4 compared to LAB-CD4 is US$500/year of life saved (YLS (95% CI, US$480-US$520/YLS. POC-CD4 improves clinical outcomes and remains near the very cost-effective threshold in sensitivity analyses, even if point-of-care CD4 tests have lower sensitivity/specificity and higher cost than published

  5. Point-of-care testing for coagulation function: CoaguChek®XS System versus standard laboratory testing in pediatric patients with normal and abnormal coagulation function.

    Science.gov (United States)

    Kako, Hiromi; Raman, Vidya T; Tumin, Dmitry; Rice, Julie; Tobias, Joseph D

    2017-06-01

    Intraoperative abnormalities of coagulation function may occur for various reasons. In most scenarios, treatment is directed by laboratory parameters. Unfortunately, standard laboratory testing may take 1-2 h. The purpose of the current study was to evaluate a point-of-care testing device (CoaguChek ® XS System) in pediatric patients. Patients ranging in age from 2 to 18 years, undergoing posterior spinal fusion (PSF) or cardiac surgery using cardiopulmonary bypass (CPB) were eligible for inclusion. After CPB and/or the surgical procedure, 2.8 ml of blood was obtained and simultaneously tested on both the standard laboratory apparatus and the CoaguChek ® XS System. The study cohort consisted of 100 patients (50 PSF and 50 cardiac cases) with 13 cases excluded, leaving 87 patients (49 PSF and 38 cardiac cases) for analysis. In PSF cases, reference laboratory international normalized ratio (INR) ranged from 0.98 to 1.77 while CoaguChek ® XS INR ranged from 1.0 to 1.3. The correlation coefficient was 0.69. The results of the Bland-Altman analysis showed a bias of 0.09, precision of 0.1, and 95% limits of agreement ranging from -0.11 to 0.28. In cardiac cases, reference INR ranged from 1.68 to 14.19, while CoaguChek ® XS INR ranged from 1.4 to 7.9. The correlation coefficient was 0.35. The results of the Bland-Altman analysis showed a bias of -1.8, precision of 2.1, and 95% limits of agreement ranging from -6.0 to 2.4. INR values obtained from CoaguChek ® XS showed a moderate correlation with reference laboratory values within the normal range. However, in the presence of coagulopathy, the discrepancy was significantly greater, thereby making the CoaguChek ® XS clinically unreliable.

  6. Point -of -care testing (POCT) in molecular diagnostics: Performance evaluation of GeneXpert HCV RNA test in diagnosing and monitoring of HCV infection.

    Science.gov (United States)

    Gupta, Ekta; Agarwala, Pragya; Kumar, Guresh; Maiwall, Rakhi; Sarin, Shiv Kumar

    2017-03-01

    Molecular testing at the point-of-care may turn out to be game changer for HCV diagnosis and treatment monitoring, through increased sensitivity, reduced turnaround time, and ease of performance. One such assay GeneXpert ® has recently been released. Comparative analysis between performances of GeneXpert ® and Abbott HCV-RNA was done. 174 HCV infected patients were recruited and, one time plasma samples from 154 patients and repeated samples from 20 patients, obtained at specific treatment time-points (0, 4, 12 and 24) weeks were serially re-tested on Xpert ® . Genotype 3 was the commonest, seen in 80 (66%) of the cases, genotype 1 in 34 (28.3%), genotype 4 in 4 (3.3%) and genotypes 2 and 5 in 1 (0.8%) each. Median HCV RNA load was 4.69 log 10 (range: 0-6.98log 10 ) IU/ml. Overall a very good correlation was seen between the two assays (R 2 =0.985), concordance of the results between the assays was seen in 138 samples (89.6%). High and low positive standards were tested ten times on Xpert ® to evaluate the precision and the coefficient of variation was 0.01 for HPC and 0.07 for the LPC. Monitoring of patients on two different regimes of treatment, pegylated interferon plus ribavirin and sofosbuvir plus ribavirin was done by both the systems at baseline, 4, 12 and 24 weeks. Perfect correlation between the assays in the course of therapy at different treatment time- point in genotypes 3 and 1 was seen. The study demonstrates excellent performance of the Xpert ® HCV assay in viral load assessment and in treatment course monitoring consistency. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Next generation blood tests for detecting tuberculosis at the point-of-care: Overcoming challenges in product development

    Directory of Open Access Journals (Sweden)

    R McNerney

    2015-01-01

    Full Text Available To control tuberculosis (TB, it is necessary to detect the disease and provide effective treatment to avert its progression and to interrupt any onward transmission from infectious pulmonary cases. Traditional diagnostic methods rely on the detection of the Mycobacterium tuberculosis (MTB bacilli in clinical samples such as sputum. Testing is usually done on patients that have been coughing for some time, when transmission is likely to have already occurred. The impact of the GeneXpert MTB/RIF assay has so far had a limited impact on TB control because of its high cost and limited accessibility. A number of follow-up nucleic acid amplification technologies are being evaluated, but they also rely on testing for the presence of the bacteria in sputum. Diagnosing extra-pulmonary disease and TB in children remains very difficult and tests are needed that detect all forms of the disease. For developing countries with a high burden of TB, technology is needed that is robust, affordable and will avoid diagnostic delay; the tests must be readily accessible to the community without waiting for patients to self-refer to a TB testing clinic. Compromises may be needed between accuracy and access where a rapid imperfect test that can be used to test people in their community will have more benefit than a more perfect test that is not accessible. Traditional serological tests have failed for TB because of the complexity of the disease, but by testing for multiple markers, sensitivity and specificity can be improved and it is possible to differentiate latent infection and active disease. Examples of new assays that have the potential to change TB control shall be provided. The challenge now is to develop, manufacture, and distribute detection platforms that are safe, robust and affordable. Recent studies have revealed the market for TB diagnostics to be fragmented and small. Consultation with manufacturers has revealed that access to finance, management of

  8. Comparative evaluation of commercially available point-of-care heartworm antigen tests using well-characterized canine plasma samples.

    Science.gov (United States)

    Starkey, Lindsay A; Bowles, Joy V; Payton, Mark E; Blagburn, Byron L

    2017-11-09

    Dirofilaria immitis is a worldwide parasite that is endemic in many parts of the United States. There are many commercial assays available for the detection of D. immitis antigen, one of which was modified and has reentered the market. Our objective was to compare the recently reintroduced Witness® Heartworm (HW) Antigen test Kit (Zoetis, Florham Park, NJ) and the SNAP® Heartworm RT (IDEXX Laboratories, Inc., Westbrook, ME) to the well-based ELISA DiroChek® Heartworm Antigen Test Kit (Zoetis, Florham Park, NJ). Canine plasma samples were either received at the Auburn Diagnostic Parasitology Laboratory from veterinarians submitting samples for additional heartworm testing (n = 100) from 2008 to 2016 or purchased from purpose-bred beagles (n = 50, presumed negative) in 2016. Samples were categorized as "positive," "borderline" or "negative" using our established spectrophotometric cutoff value with the DiroChek® assay when a sample was initially received and processed. Three commercially available heartworm antigen tests (DiroChek®, Witness® HW, and SNAP® RT) were utilized for simultaneous testing of the 150 samples in random order as per their package insert with the addition of spectrophotometric optical density (OD) readings of the DiroChek® assay. Any samples yielding discordant test results between assays were further evaluated by heat treatment of plasma and retesting. Chi-square tests for the equality of proportions were utilized for statistical analyses. Concordant results occurred in 140/150 (93.3%) samples. Discrepant results occurred in 10/150 samples tested (6.6%): 9/10 occurring in the borderline heartworm (HW) category and 1/10 occurring in the negative HW category. The sensitivity and specificity of each test compared to the DiroChek® read by spectrophotometer was similar to what has been reported previously (Witness®: sensitivity 97.0% [94.1-99.4%], specificity 96.4% [95.5-100.0%]; SNAP® RT: sensitivity 90.9% [78.0-100.0%], specificity

  9. Biomarkers as point-of-care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care

    DEFF Research Database (Denmark)

    Aabenhus, Rune; Jensen, Jens Ulrik Stæhr; Jørgensen, Karsten Juhl

    2014-01-01

    ' recovery and expose them to potential side effects. Furthermore, as a causal link exists between antibiotic use and antibiotic resistance, reducing unnecessary antibiotic use is a key factor in controlling this important problem. Antibiotic resistance puts increasing burdens on healthcare services...... the benefits and harms of point-of-care biomarker tests of infection to guide antibiotic treatment in patients presenting with symptoms of acute respiratory infections in primary care settings regardless of age. SEARCH METHODS: We searched CENTRAL (2013, Issue 12), MEDLINE (1946 to January 2014), EMBASE (2010...... and the statistically significant test for subgroup differences between the three RCTs and three cluster-RCTs suggest that the results of the meta-analysis on antibiotic use should be interpreted with caution and the pooled effect estimate (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.66 to 0.92; I(2) statistic...

  10. Approaching a diagnostic point-of-care test for pediatric tuberculosis through evaluation of immune biomarkers across the clinical disease spectrum

    DEFF Research Database (Denmark)

    Jenum, Synne; Dhanasekaran, S; Lodha, Rakesh

    2016-01-01

    The World Health Organization (WHO) calls for an accurate, rapid, and simple point-of-care (POC) test for the diagnosis of pediatric tuberculosis (TB) in order to make progress "Towards Zero Deaths". Whereas the sensitivity of a POC test based on detection of Mycobacterium tuberculosis (MTB......) is likely to have poor sensitivity (70-80% of children have culture-negative disease), host biomarkers reflecting the on-going pathological processes across the spectrum of MTB infection and disease may hold greater promise for this purpose. We analyzed transcriptional immune biomarkers direct ex......-vivo and translational biomarkers in MTB-antigen stimulated whole blood in 88 Indian children with intra-thoracic TB aged 6 months to 15 years, and 39 asymptomatic siblings. We identified 12 biomarkers consistently associated with either clinical groups "upstream" towards culture-positive TB on the TB disease spectrum...

  11. NMP22 BladderChek Test: point-of-care technology with life- and money-saving potential.

    Science.gov (United States)

    Tomera, Kevin M

    2004-11-01

    A new, relatively obscure tumor marker assay, the NMP22 BladderChek Test (Matritech, Inc.), represents a paradigm shift in the diagnosis and management of urinary bladder cancer (transitional cell carcinoma). Specifically, BladderChek should be employed every time a cystoscopy is performed, with corresponding changes in the diagnostic protocol and the guidelines of the American Urological Association for the diagnosis and management of bladder cancer. Currently, cystoscopy is the reference standard and NMP22 BladderChek Test in combination with cystoscopy improves the performance of cystoscopy. At every stage of disease, BladderChek provides a higher sensitivity for the detection of bladder cancer than cytology, which now represents the adjunctive standard of care. Moreover, BladderChek is four-times more sensitive than cytology and is available at half the cost. Early detection of bladder cancer improves prognosis, quality of life and survival. BladderChek may be analogous to the prostate-specific antigen test and eventually expand beyond the urologic setting into the primary care setting for the testing of high-risk patients characterized by smoking history, occupational exposures or age.

  12. Comparative evaluation of commercially available point-of-care heartworm antigen tests using well-characterized canine plasma samples

    Directory of Open Access Journals (Sweden)

    Lindsay A. Starkey

    2017-11-01

    Full Text Available Abstract Background Dirofilaria immitis is a worldwide parasite that is endemic in many parts of the United States. There are many commercial assays available for the detection of D. immitis antigen, one of which was modified and has reentered the market. Our objective was to compare the recently reintroduced Witness® Heartworm (HW Antigen test Kit (Zoetis, Florham Park, NJ and the SNAP® Heartworm RT (IDEXX Laboratories, Inc., Westbrook, ME to the well-based ELISA DiroChek® Heartworm Antigen Test Kit (Zoetis, Florham Park, NJ. Methods Canine plasma samples were either received at the Auburn Diagnostic Parasitology Laboratory from veterinarians submitting samples for additional heartworm testing (n = 100 from 2008 to 2016 or purchased from purpose-bred beagles (n = 50, presumed negative in 2016. Samples were categorized as “positive,” “borderline” or “negative” using our established spectrophotometric cutoff value with the DiroChek® assay when a sample was initially received and processed. Three commercially available heartworm antigen tests (DiroChek®, Witness® HW, and SNAP® RT were utilized for simultaneous testing of the 150 samples in random order as per their package insert with the addition of spectrophotometric optical density (OD readings of the DiroChek® assay. Any samples yielding discordant test results between assays were further evaluated by heat treatment of plasma and retesting. Chi-square tests for the equality of proportions were utilized for statistical analyses. Results Concordant results occurred in 140/150 (93.3% samples. Discrepant results occurred in 10/150 samples tested (6.6%: 9/10 occurring in the borderline heartworm (HW category and 1/10 occurring in the negative HW category. The sensitivity and specificity of each test compared to the DiroChek® read by spectrophotometer was similar to what has been reported previously (Witness®: sensitivity 97.0% [94.1–99.4%], specificity 96.4% [95.5–100

  13. 13[C]-urea breath test as a novel point-of-care biomarker for tuberculosis treatment and diagnosis.

    Directory of Open Access Journals (Sweden)

    Mandeep S Jassal

    Full Text Available BACKGROUND: Pathogen-specific metabolic pathways may be detected by breath tests based on introduction of stable isotopically-labeled substrates and detection of labeled products in exhaled breath using portable infrared spectrometers. METHODOLOGY/PRINCIPAL FINDINGS: We tested whether mycobacterial urease activity could be utilized in such a breath test format as the basis of a novel biomarker and diagnostic for pulmonary TB. Sensitized New-Zealand White Rabbits underwent bronchoscopic infection with either Mycobacterium bovis or Mycobacterium tuberculosis. Rabbits were treated with 25 mg/kg of isoniazid (INH approximately 2 months after infection when significant cavitary lung pathology was present. [(13C] urea was instilled directly into the lungs of intubated rabbits at selected time points, exhaled air samples analyzed, and the kinetics of delta(13CO(2 formation were determined. Samples obtained prior to inoculation served as control samples for background (13CO(2 conversion in the rabbit model. (13CO(2, from metabolic conversion of [(13C]-urea by mycobacterial urease activity, was readily detectable in the exhaled breath of infected rabbits within 15 minutes of administration. Analyses showed a rapid increase in the rate of (13CO(2 formation both early in disease and prior to treatment with INH. Following INH treatment, all evaluable rabbits showed a decrease in the rate of (13CO(2 formation. CONCLUSIONS/SIGNIFICANCE: Urea breath testing may provide a useful diagnostic and biomarker assay for tuberculosis and for treatment response. Future work will test specificity for M. tuberculosis using lung-targeted dry powder inhalation formulations, combined with co-administering oral urease inhibitors together with a saturating oral dose of unlabeled urea, which would prevent the delta(13CO(2 signal from urease-positive gastrointestinal organisms.

  14. Early diagnosis of celiac disease in IgA deficient children: contribution of a point-of-care test.

    Science.gov (United States)

    Bienvenu, Francoise; Anghel, Silvia I; Besson Duvanel, Cécile; Guillemaud, Julien; Garnier, Lorna; Renosi, Florian; Lachaux, Alain; Bienvenu, Jacques

    2014-11-06

    The serological diagnosis of celiac disease (CD) often relies on the presence of anti-tissue transglutaminase (tTG) IgA autoantibodies. Patients suffering from selective IgA deficiency (IgAD) are often not aware of their IgA deficiency and are tested as CD negative, delaying considerably the diagnosis. The detection of IgG against deamidated gliadin peptides (DGP) has high specificity and better sensitivity than IgG anti-tTG. A multi-analytic lateral-flow immunochromatographic assay (CD-LFIA) based on the detection of IgA and IgG anti-DGP and total IgA was shown to have a good diagnostic accuracy for CD. The aim of this study was to evaluate the clinical accuracy of its use in children suffering from IgAD. 45 IgAD children ranging from 1.1 to 17.4 years and suspected of CD or having high CD risk factors were referred from outpatient clinics located in the area of Rhone-Alpes (France) to the Hospices Civils de Lyon, Paediatric Hospital-Gastroenterology-Hepatology- Nutrition Department for further CD investigations. The CD investigations, including the sample collection, were performed within the Paediatric Hospital-Gastroenterology-Hepatology- Nutrition Department, and the serological testing was performed at the Lyon-Sud Hospital-Immunology Laboratory. The diagnosis of CD was based on IgG anti-tTG serology, biopsy results and patient follow-up. The serum samples were retrospectively tested on the CD-LFIA test. A total of eight (8) patients were diagnosed as new CD. All were correctly identified by the CD-LFIA. The test yielded four (4) false positive results. Two patients with positive IgG anti-tTG were negative on CD-LFIA, but were classified as CD negative based on biopsy results and patient follow-up. The remaining 33 patients were found negative by both methods. The specificity and sensitivity of CD-LFIA was of 89.2% [74.6-97.0] and of 100% [63.1-100] respectively. The negative predictive value (NPV) was of 100% [89.4-100], and the Likelihood Ratio for Negative

  15. Validation of two point-of-care tests against standard lab measures of NO in saliva and in serum.

    Science.gov (United States)

    Modi, Ashwin; Morou-Bermudez, Evangelia; Vergara, Jose; Patel, Rakesh P; Nichols, Alexandria; Joshipura, Kaumudi

    2017-04-01

    Nitric oxide (NO) is an endogenous signaling molecule, which plays important roles in cardiometabolic health. A significant source of NO is dietary nitrate (NO 3 ), which is initially metabolized by oral bacteria into nitrite (NO 2 - ) and is subsequently converted into NO once digested in the acidic gastric environment. Inexpensive non-invasive tests for measuring nitrite from saliva have been developed as a means for individuals to monitor their NO bioavailability. However, few studies exist in the literature validating and comparing these products with standard lab assays. The objective of this study was to validate two commonly used commercial strips: Nitric Oxide Test Strips (Berkeley Test) and Nitric Oxide Indicator Strips (Neogenesis) against standard lab measures for saliva and serum nitrite/nitrate. A stratified random sample of 20 non-smoking, overweight or obese participants between 40 to 65 years of age, were selected for this study from the baseline data of the San Juan Overweight Adults Longitudinal Study (SOALS). There was a significant correlation between the measures from the two nitrite-detecting-strips after controlling for the stratification variables (metabolic syndrome, and mouthwash use) (r = 0.75). Measurements from both strips correlated significantly with salivary nitrite levels (r = 0.76 for Berkeley strips; r = 0.59 for Neogenesis). Neither of the strips had a significant correlation with the levels of saliva nitrate, serum nitrite and serum nitrate. In conclusion, commercially available Berkeley and Neogenesis strips provide a reasonable surrogate for salivary, but not for systemic nitrite levels. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Early diagnosis of celiac disease in IgA deficient children: contribution of a point-of-care test

    OpenAIRE

    Bienvenu, Francoise; Anghel, Silvia I; Besson Duvanel, C?cile; Guillemaud, Julien; Garnier, Lorna; Renosi, Florian; Lachaux, Alain; Bienvenu, Jacques

    2014-01-01

    Background The serological diagnosis of celiac disease (CD) often relies on the presence of anti-tissue transglutaminase (tTG) IgA autoantibodies. Patients suffering from selective IgA deficiency (IgAD) are often not aware of their IgA deficiency and are tested as CD negative, delaying considerably the diagnosis. The detection of IgG against deamidated gliadin peptides (DGP) has high specificity and better sensitivity than IgG anti-tTG. A multi-analytic lateral-flow immunochromatographic assa...

  17. Access to Point-of-Care Tests Reduces the Prescription of Antibiotics Among Antibiotic-Requesting Subjects With Respiratory Tract Infections

    DEFF Research Database (Denmark)

    Llor, C.; Bjerrum, Lars; Munck, Anders

    2014-01-01

    BACKGROUND: General practitioners (GPs) often feel uncomfortable when patients request an antibiotic when there is likely little benefit. This study evaluates the effect of access to point-of-care tests on decreasing the prescription of antibiotics in respiratory tract infections in subjects who...... explicitly requested an antibiotic prescription. METHODS: Spanish GPs registered all cases of respiratory tract infections over a 3-week period before and after an intervention undertaken in 2008 and 2009. Patients with acute sinusitis, pneumonia, and exacerbations of COPD were excluded. Two types...... tract infections were included, of whom 344 (1.4%) requested antibiotic prescribing. Antibiotics were more frequently prescribed to subjects requesting them compared with those who did not (49.1% vs 18.5%, P

  18. Effect of point-of-care susceptibility testing in general practice on appropriate prescription of antibiotics for patients with uncomplicated urinary tract infection

    DEFF Research Database (Denmark)

    Holm, Anne; Cordoba, Gloria; Møller Sørensen, Tina

    2017-01-01

    OBJECTIVES: To investigate the effect of adding point-of-care (POC) susceptibility testing to POC culture on appropriate use of antibiotics as well as clinical and microbiological cure for patients with suspected uncomplicated urinary tract infection (UTI) in general practice. DESIGN: Open......, individually randomised controlled trial. SETTING: General practice. PARTICIPANTS: Women with suspected uncomplicated UTI, including elderly patients above 65, patients with recurrent UTI and patients with diabetes. The sample size calculation predicted 600 patients were needed. INTERVENTIONS: Flexicult SSI-Urinary...... the infecting pathogen was susceptible or a second line if a first line could not be used or (2) patient without UTI: not to prescribe an antibiotic. UTI was defined by typical symptoms and significant growth in a reference urine culture performed at one of two external laboratories. SECONDARY OUTCOMES...

  19. Field Evaluation of Performance of Alere and Cepheid Qualitative HIV Assays for Pediatric Point-of-Care Testing in an Academic Hospital in Soweto, South Africa.

    Science.gov (United States)

    Murray, Tanya Y; Sherman, Gayle G; Nakwa, Firdose; MacLeod, William B; Sipambo, Nosisa; Velaphi, Sithembiso; Carmona, Sergio

    2017-11-01

    Point-of-care (POC) technologies for HIV diagnosis in infants have the potential to overcome logistical challenges that delay treatment initiation and prevent improvements in morbidity and mortality. This study aimed to evaluate the performance of two POC technologies against the current standard-of-care (SOC) laboratory-based assay in South Africa, when operated by nurses in a hospital environment. Children performed, which yielded a simulated sensitivity of 0.9904 (interquartile range [IQR], 0.9808 to 0.9904) and a specificity of 0.9954 (IQR, 0.9954 to 1.0). This study confirmed that both POC technologies can be successfully used outside the laboratory environment to yield precise sensitivity/specificity values for pediatric, including neonatal, HIV testing. Copyright © 2017 American Society for Microbiology.

  20. Self-driven filter-based blood plasma separator microfluidic chip for point-of-care testing

    International Nuclear Information System (INIS)

    Madadi, Hojjat; Casals-Terré, Jasmina; Mohammadi, Mahdi

    2015-01-01

    There is currently a growing need for lab-on-a-chip devices for use in clinical analysis and diagnostics, especially in the area of patient care. The first step in most blood assays is plasma extraction from whole blood. This paper presents a novel, self-driven blood plasma separation microfluidic chip, which can extract more than 0.1 μl plasma from a single droplet of undiluted fresh human blood (∼5 μl). This volume of blood plasma is extracted from whole blood with high purity (more than 98%) in a reasonable time frame (3 to 5 min), and without the need for any external force. This would be the first step towards the realization of a single-use, self-blood test that does not require any external force or power source to deliver and analyze a fresh whole-blood sample, in contrast to the existing time-consuming conventional blood analysis. The prototypes are manufactured in polydimethylsiloxane that has been modified with a strong nonionic surfactant (Silwet L-77) to achieve hydrophilic behavior. The main advantage of this microfluidic chip design is the clogging delay in the filtration area, which results in an increased amount of extracted plasma (0.1 μl). Moreover, the plasma can be collected in one or more 10 μm-deep channels to facilitate the detection and readout of multiple blood assays. This high volume of extracted plasma is achieved thanks to a novel design that combines maximum pumping efficiency without disturbing the red blood cells’ trajectory through the use of different hydrodynamic principles, such as a constriction effect and a symmetrical filtration mode. To demonstrate the microfluidic chip’s functionality, we designed and fabricated a novel hybrid microdevice that exhibits the benefits of both microfluidics and lateral flow immunochromatographic tests. The performance of the presented hybrid microdevice is validated using rapid detection of thyroid stimulating hormone within a single droplet of whole blood. (paper)

  1. Laboratory Tests Turnaround Time in Outpatient and Emergency Patients in Nigeria: Results of A Physician Survey on Point of Care Testing

    Directory of Open Access Journals (Sweden)

    Bolodeoku J

    2017-05-01

    Full Text Available Laboratory analytical turnaround time is a well-recognised indicator of how well a laboratory is performing and is sometimes regarded as the benchmark for laboratory performance. Methods: Total 104 doctors in public and private health institutions in Nigeria, spread across all six geo-political zones participated in survey requesting information on their experience with laboratory turnaround times in emergency situations (emergency room, special care baby unit, intensive care unit, dialysis unit and outpatient situations (general medicine and diabetes. Results: The average turnaround time in hours was 5.12, 8.35, 7.32 and 8.33 for the emergency room, special care baby unit, intensive care unit and dialysis unit, respectively. For the outpatient situations, the average turnaround time in hours was 10.74 and 15.70 hours for the diabetes and general medical outpatients. The median range (hours and modal range (hours for: the emergency room was 2-4 and <2; the special care baby unit was 4-8 and 4-8; the intensive care unit was 2-4 and 2-4; the dialysis unit was 4-8 and 4-8. The median range (hours and modal range (hours for: the general outpatient clinic was 12-24 and 12-24; the diabetic clinic was 4-8 and 12-24 hours. Conclusion: These turnaround time results are quite consistent with published data from other countries. However, there is some measure of improvement that is required in some areas to reduce the laboratory turnaround in the emergency situations. This could be overcome with the introduction of more point of care testing devices into emergency units.

  2. Dry Eye Profiles in Patients with a Positive Elevated Surface Matrix Metalloproteinase 9 Point-of-Care Test Versus Negative Patients.

    Science.gov (United States)

    Lanza, Nicole L; McClellan, Allison L; Batawi, Hatim; Felix, Elizabeth R; Sarantopoulos, Konstantinos D; Levitt, Roy C; Galor, Anat

    2016-04-01

    To compare dry eye (DE) symptoms and signs in subjects who tested positive versus those who tested negative for ocular surface matrix metalloproteinase 9 (MMP-9) using the InflammaDry point-of-care test (RPS, Sarasota, FL). In this cross-sectional study, individuals seen in the Miami Veterans Affairs eye clinic with DE symptoms, as evidenced by DE questionnaire 5 (DEQ5) ≥6, were given standardized questionnaires to assess DE symptoms and ocular and non-ocular pain complaints. Also, a complete evaluation was conducted to measure ocular surface signs of DE. MMP-9 testing was performed using the InflammaDry once in each eye, per the manufacturer's instructions. The main outcome measure was a comparison of DE symptoms and signs in MMP-9 positive versus negative subjects. Of 128 subjects, 50 (39%) were positive for MMP-9 for InflammaDry testing in either eye. No statistically significant differences in mental health indices, DE symptoms, or ocular surface signs were seen in subjects based on MMP-9 status. In our population, there was no difference in the DE profile by both symptoms and signs between those testing positive versus negative for MMP-9 on the ocular surface. This suggests that clinical exam alone cannot predict patients with clinically significant inflammation. Published by Elsevier Inc.

  3. Health care workers' perceptions of point-of-care testing in a low-income country-A qualitative study in Southwestern Uganda.

    Directory of Open Access Journals (Sweden)

    Reza Rasti

    Full Text Available Point-of-care (POC tests have become increasingly available and more widely used in recent years. They have been of particular importance to low-income settings, enabling them with clinical capacities that had previously been limited. POC testing programs hold a great potential for significant improvement in low-income health systems. However, as most POC tests are developed in high-income countries, disengagement between developers and end-users inhibit their full potential. This study explores perceptions of POC test end-users in a low-income setting, aiming to support the development of novel POC tests for low-income countries.A qualitative study was conducted in Mbarara District, Southwestern Uganda, in October 2014. Fifty health care workers were included in seven focus groups, comprising midwives, laboratory technicians, clinical and medical officers, junior and senior nurses, and medical doctors. Discussions were audio-recorded and transcribed verbatim. Transcripts were coded through a data-driven approach for qualitative content analysis.Nineteen different POC tests were identified as currently being in use. While participants displayed being widely accustomed to and appreciative of the use of POC tests, they also assessed the use and characteristics of current tests as imperfect. An ideal POC test was characterized as being adapted to local conditions, thoughtfully implemented in the specific health system, and capable of improving the care of patients. Tests for specific medical conditions were requested. Opinions differed with regard to the ideal distribution of POC tests in the local health system.POC tests are commonly used and greatly appreciated in this study setting. However, there are dissatisfactions with current POC tests and their use. To maximize benefit, stakeholders need to include end-user perspectives in the development and implementation of POC tests. Insights from this study will influence our ongoing efforts to

  4. Feasibility and acceptability of point of care HIV testing in community outreach and GUM drop-in services in the North West of England: A programmatic evaluation

    Directory of Open Access Journals (Sweden)

    Jelliman Pauline

    2011-06-01

    Full Text Available Abstract Background In Liverpool, injecting drug users (IDUs, men-who-have-sex-with-men (MSM and UK Africans experience a disproportionate burden of HIV, yet services do not reach out to these groups and late presentations continue. We set out to: increase testing uptake in targeted marginalized groups through a community and genitourinary medicine (GUM-based point of care testing (POCT programme; and conduct a process evaluation to examine service provider inputs and document service user perceptions of the programme. Methods Mixed quantitative, qualitative and process evaluation methods were used. Service providers were trained to use fourth generation rapid antibody/antigen HIV tests. Existing outreach services incorporated POCT into routine practice. Clients completed a semi-structured questionnaire and focus group discussions (FGDs were held with service providers. Results Between September 2009 and June 2010, 953 individuals underwent POCT (GUM: 556 [59%]; community-based sites: 397 [42%]. Participants in the community were more likely to be male (p = 0.028, older (p Conclusions Community and GUM clinic-based POCT for HIV was feasible and acceptable to clients and service providers in a low prevalence setting. It successfully reached target groups, many of whom would not have otherwise tested. We recommend POCT be considered among strategies to increase the uptake of HIV testing among groups who are currently underserved.

  5. Sneltesten in de huisartspraktijk: Huidig gebruik en behoefte aan testen in de toekomst [Point-of-care testing in family practices: present use and need for tests in the future

    NARCIS (Netherlands)

    Cals, J.W.L.; Schols, A.M.R.; van Weert, H.C.P.M.; Stevens, F.; Zeijen, C.G.I.P.; Holtman, G.; Lucassen, W.A.M.; Berger, M.Y.

    2014-01-01

    OBJECTIVE: To provide insight into the current use, future needs, and attitudes towards point-of-care testing among Dutch family practitioners. DESIGN: Cross-sectional online survey. METHOD: We performed a survey among 2129 Dutch family practitioners. We asked respondents to report on the current

  6. Validation of a Point-of-Care Circulating Cathodic Antigen Urine Cassette Test for Schistosoma mansoni Diagnosis in the Sahel, and Potential Cross-Reaction in Pregnancy.

    Science.gov (United States)

    Greter, Helena; Krauth, Stefanie J; Ngandolo, Bongo N R; Alfaroukh, Idriss O; Zinsstag, Jakob; Utzinger, Jürg

    2016-02-01

    On the shores of Lake Chad, schistosomiasis among mobile pastoralists was investigated in a field laboratory. Point-of-care circulating cathodic antigen (POC-CCA) cassette test, reagent strip, and filtration were conducted on urine samples. Fresh stool samples were subjected to the Kato-Katz technique, and fixed samples were examined with an ether-concentration method at a reference laboratory. POC-CCA urine cassette tests revealed a Schistosoma mansoni prevalence of 6.9%, compared with only 0.5% by stool microscopy. Three pregnant women with otherwise negative urine and stool testing had positive POC-CCA. This observation raises concern of cross-reactivity in pregnancy. Hence, two pregnant women in Switzerland with no history of schistosomiasis were subjected to POC-CCA and one tested positive. Our data suggest that POC-CCA can be performed under extreme Sahelian conditions (e.g., temperatures > 40°C), and it is more sensitive than stool microscopy for S. mansoni diagnosis. However, potential cross-reactivity in pregnancy needs further investigation. © The American Society of Tropical Medicine and Hygiene.

  7. Utilization and Effectiveness of Desmopressin Acetate After Cardiac Surgery Supplemented With Point-of-Care Hemostatic Testing: A Propensity-Score-Matched Analysis.

    Science.gov (United States)

    Orlov, David; McCluskey, Stuart A; Callum, Jeannie; Rao, Vivek; Moreno, Jacobo; Karkouti, Keyvan

    2017-06-01

    To explore the utilization pattern and hemostatic effectiveness of desmopressin acetate (DDAVP) supplemented with point-of-care (POC) hemostatic testing in contemporary cardiac surgery. Retrospective, observational study. Single quaternary care university hospital. The study comprised 2,468 consecutive patients undergoing cardiac surgery-1,237 before and 1,231 after the introduction of POC testing. The incidence of DDAVP administration during the year before (2012) and after (2013) the initiation of POC-based viscoelastic (ROTEM; Tem International GmBH, Munich, Germany) and platelet function (Plateletworks; Helena Laboratories, Beaumont, TX) testing was determined. Propensity-score matching was used to examine the association between DDAVP administration and major bleeding during each time period. DDAVP was administered more than twice as often after POC implementation (41% v 20%, ptesting. After adjusting for matched data, DDAVP administration was associated with 1.70 (95% confidence interval 1.25-2.32, ptesting, respectively. Clinicians should be cognizant of the potential for increased use of DDAVP despite limited evidence of benefit in contemporary cardiac anesthesia practice supplemented with POC-based hemostatic testing. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Feasibility and Field Performance of a Simultaneous Syphilis and HIV Point-of-Care Test Based Screening Strategy in at Risk Populations in Edmonton, Canada

    Directory of Open Access Journals (Sweden)

    Joshua Bergman

    2013-01-01

    Full Text Available Few studies have evaluated the feasibility of delivering syphilis point-of-care (POC testing in outreach (nonclinical settings in resource rich countries. The objectives of the study were to evaluate the feasibility and diagnostic performance of performing both HIV and syphilis POC testing in outreach settings and to document new cases identified in the study population. 1,265 outreach testing visits were offered syphilis and HIV POC testing and 81.5% (n=1,031 consented to testing. In our population, the SD Bioline 3.0 Syphilis Test had a sensitivity of 85.3% [CI (68.9–95.0], specificity of 100.0% [CI (99.6–100.0], positive predictive value (PPV of 100.0% [CI (88.1–100.0], and negative predictive value (NPV of 99.5% [CI (98.9–99.8]. Test characteristics for the INSTI HIV-1/HIV-2 Antibody Test had a 100.0% sensitivity [CI (39.8–100.00], 99.8 specificity [CI (99.3–100], 66.7% PPV [CI (22.3–95.7], and 100.0% NPV [CI (99.6–100.0]. Four new cases of syphilis and four new HIV cases were diagnosed. In summary, at risk population seeking STI testing found POC tests to be acceptable, the POC tests performed well in outreach settings, and new cases of syphilis and HIV were identified and linked to treatment and care.

  9. Auditing the use and assessing the clinical utility of microscopy as a point-of-care test for Neisseria gonorrhoeae in a Sexual Health clinic.

    Science.gov (United States)

    Mensforth, Sarah; Thorley, Nicola; Radcliffe, Keith

    2018-02-01

    We assessed whether urethral microscopy was performed as per clinic protocol for male clinic attendees reporting contact with Neisseria gonorrhoeae (GC), urethral symptoms or given a diagnosis of epididymo-orchitis (EO) over a 12-month period (9732 patients). Prevalence of gonorrhoea in the contacts, urethral symptoms and EO groups was 50, 12.7 and 1.6%, respectively. Microscopy was performed reliably for contacts (96%), those with discharge/dysuria with evidence of urethritis on examination (98%), but not those with EO (43%). We explored the clinical utility of microscopy as a point-of-care test for identifying urethral GC in each subgroup, using the APTIMA Combo 2 CT/GC nucleic acid amplification test as the comparator (1710 patients). Sensitivity of microscopy for each subgroup was good; there was no statistical difference between subgroup sensitivity using Fisher's exact test. Microscopy is valuable to ensure prompt diagnosis and contact tracing. All GC contacts were treated 'epidemiologically'; however, half of GC contacts did not have GC. Microscopy identified the majority of GC cases, including amongst contacts (71% of heterosexual contacts, 66% of contacts reporting sex with men). We propose that epidemiological treatment for GC contacts should be reconsidered on the grounds of antibiotic stewardship, favouring use of microscopy to guide treatment decisions.

  10. A wireless point-of-care testing system for the detection of neuron-specific enolase with microfluidic paper-based analytical devices.

    Science.gov (United States)

    Fan, Yan; Liu, Juntao; Wang, Yang; Luo, Jinping; Xu, Huiren; Xu, Shengwei; Cai, Xinxia

    2017-09-15

    Neuron-specific enolase (NSE) had clinical significance on diagnosis, staging, monitoring effect and judging prognosis of small cell lung cancer. Thus, there had a growing demand for the on-site testing of NSE. Here, a wireless point-of-care testing (POCT) system with electrochemical measurement for NSE detection was developed and verified. The wireless POCT system consisted of microfluidic paper-based analytical devices (μPADs), electrochemical detector and Android's smartphone. Differential pulse voltammetry (DPV) measurement was adopted by means of electrochemical detector which including a potentiostat and current-to-voltage converter. μPADs were modified with nanocomposites synthesized by Amino functional graphene, thionine and gold nanoparticles (NH 2 -G/Thi/AuNPs) as immunosensors for NSE detection. Combined with μPADs, the performance of the wireless POCT system was evaluated. The peak currents showed good linear relationship of the logarithm of NSE concentration ranging from 1 to 500ngmL -1 with the limit of detection (LOD) of 10pgmL -1 . The detection results were automatically stored in EEPROM memory and could be displayed on Android's smartphone through Bluetooth in real time. The detection results were comparable to those measured by a commercial electrochemical workstation. The wireless POCT system had the potential for on-site testing of other tumor markers. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Considerations for point-of-care diagnostics: evaluation of acridine orange staining and postprocessing methods for a three-part leukocyte differential test

    Science.gov (United States)

    Powless, Amy J.; Conley, Roxanna J.; Freeman, Karan A.; Muldoon, Timothy J.

    2017-03-01

    There exists a broad range of techniques that can be used to classify and count white blood cells in a point-of-care (POC) three-part leukocyte differential test. Improvements in lenses, light sources, and cameras for image-based POC systems have renewed interest in acridine orange (AO) as a contrast agent, whereby subpopulations of leukocytes can be differentiated by colorimetric analysis of AO fluorescence emission. We evaluated the effect on test accuracy using different AO staining and postprocessing methods in the context of an image-based POC colorimetric cell classification scheme. Thirty blood specimens were measured for percent cell counts using our POC system and a conventional hematology analyzer for comparison. Controlling the AO concentration used during whole-blood staining, the incubation time with AO, and the colorimetric ratios among the three population of leukocytes yielded a percent deviation of 0.706%, -1.534%, and -0.645% for the lymphocytes, monocytes, and granulocytes, respectively. Overall, we demonstrated that a redshift in AO fluorescence was observed at elevated AO concentrations, which lead to reproducible inaccuracy of cell counts. This study demonstrates there is a need for a strict control of the AO staining and postprocessing methods to improve test accuracy in these POC systems.

  12. External quality assurance with dried tube specimens (DTS) for point-of-care syphilis and HIV tests: experience in an indigenous populations screening programme in the Brazilian Amazon.

    Science.gov (United States)

    Benzaken, Adele Schwartz; Bazzo, Maria Luiza; Galban, Enrique; Pinto, Ione Conceição Pereira; Nogueira, Christiane Lourenço; Golfetto, Lisléia; Benzaken, Nina Schwartz; Sollis, Kimberly A; Mabey, David; Peeling, Rosanna W

    2014-02-01

    The availability of point-of-care (POC) tests for infectious diseases has revolutionised the provision of healthcare for remote rural populations without access to laboratories. However, quality assurance for POC tests has been largely overlooked. We have evaluated the use and stability of dry tube specimens (DTS) for External Quality Assurance (EQA) for HIV and syphilis screening in remote indigenous populations in the Amazon region of Brazil. All healthcare workers (HCWs) participating in the community-screening were trained. We used HIV and syphilis DTS panels developed by the reference laboratory, containing samples with negative and positive results at different antibody concentrations, for both infections. DTS panels were distributed to HCWs in the communities for reconstitution and testing using POC HIV and syphilis tests. The results of testing were sent to the reference laboratory for marking and remedial action taken where necessary. In total 268 HCWs tested 1607 samples for syphilis and 1608 samples for HIV. Results from HCWs showed a concordance rate of 90% for syphilis and 93% for HIV (κ coefficients of 0.74 and 0.78, respectively) with reference laboratories. Most false negatives were in samples of very low antibody concentration. DTS syphilis specimens produced the expected results after storage at 2-8°C or at 18-24°C for up to 3 weeks. The results show that POC tests for syphilis and HIV give valid results in environments where traditional tests do not work, but errors in the interpretation of POC test results were identified by the EQA programme using DTS. EQA using DTS can help to improve the quality of screening programmes using POC tests in remote regions.

  13. Evaluating point-of-care testing for glycosylated haemoglobin in public sector primary care facilities in the Western Cape, South Africa.

    Science.gov (United States)

    Mash, R; Ugoagwu, A; Vos, C; Rensburg, M; Erasmus, R

    2016-12-01

    Diabetes mellitus contributes significantly to the burden of disease in South Africa (SA). Monitoring of glycaemic control with glycosylated haemoglobin (HbA1c) is recommended, even though current laboratory-based testing does not support immediate clinical decision-making. To evaluate the costs and consequences for quality of care by introducing point-of-care (POC) testing for HbA1c for patients with type 2 diabetes at community health centres in Cape Town, SA. A quasi-experimental study was conducted at two control and two intervention sites in the same sub-district. The DCA Vantage Analyzer (Siemens, Germany) for POC testing was introduced at the intervention sites for 12 months. Patients were randomly selected from the diabetes register at the intervention (n=300) and control (n=300) sites, respectively, and data were collected from patient records at baseline and 12 months. Focus group interviews were performed at the intervention sites. Technical quality and cost implications were evaluated. POC testing was feasible, easy to integrate into the organisation of care, resulted in more immediate feedback to patients (p<0.001) and patients appeared more satisfied. POC testing did not improve test coverage, treatment intensification, counselling or glycaemic control. There was an incremental cost of ZAR2 110 per 100 tests. Compliance with quality control was poor, although control tests showed good reliability. This study does not support the introduction of POC testing for HbA1c in public sector primary care practice in the current context. POC testing should be evaluated further in combination with interventions to overcome clinical inertia and strengthen primary healthcare.

  14. Agreement of Point-of-Care Capillary Glycated Hemoglobin Levels with Conventional Screening Tests for Diabetes Mellitus in a Canadian First Nations Population.

    Science.gov (United States)

    Mackenzie-Feder, Jessica; Jin, Andrew; Seccombe, David W; Sirrs, Sandra; Neufeld, Carolyne; Dawson, Keith G

    2016-06-01

    1) How closely do capillary glycated hemoglobin (A1C) levels agree with venous A1C levels? 2) How well do venous A1C levels agree with plasma glucose for diagnosis of diabetes in this population? The Seabird Island mobile diabetes clinic screened people not known to have diabetes by using finger-prick capillary A1C levels with point-of-care analysis according to the Siemens/Bayer DCA 2000 system. Clients then went to a clinical laboratory for confirmatory testing for venous A1C levels, fasting plasma glucose (FPG) and plasma glucose 2 hours after 75 g oral glucose load (2hPG). A reference laboratory compared the DCA 2000 and the clinical laboratory's Roche Integra 800CTS system to the National Glycohemoglobin Standardization Program Diabetes Control and Complications Trial (DCCT) reference. 1) In the reference laboratory, DCA 2000 and Integra 800CTS both agreed very closely with the DCCT standard. In the field, capillary glycated hemoglobin percent (A1C) % was biased, underestimating venous A1C % by a mean of 0.19 (p<0.001). The margin of error of bias-adjusted capillary A1C % was ±0.36 for 95% of the time, compared to ±0.27 for venous A1C%. 2) By linear regression, we found FPG 7.0 mmol/L and 2hPG 11.1 mmol/L predicted mean venous A1C levels very close to 6.5%, with no significant bias. Point-of-care capillary A1C did not perform as well in the field as in the laboratory, but the bias is correctible, and the margin of error is small enough that the test is clinically useful. In this population, venous A1C levels ≥6.5% agree closely with the FPG and 2hPG thresholds to diagnose diabetes; ethnic-specific adjustment of the venous A1C threshold is not necessary. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

  15. Screening for impaired renal function in outpatients before iodinated contrast injection: Comparing the Choyke questionnaire with a rapid point-of-care-test

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    Too, C.W., E-mail: toochowwei@gmail.com [Department of Diagnostic Radiology, Singapore General Hospital, Outram Road, Singapore 169608 (Singapore); Ng, W.Y., E-mail: ng.wai.yoong@sgh.com.sg [Department of Pathology, Singapore General Hospital, 20 College Road, Academia, Singapore 169856 (Singapore); Tan, C.C., E-mail: tan.chin.chong@sgh.com.sg [Department of Diagnostic Radiology, Singapore General Hospital, Outram Road, Singapore 169608 (Singapore); Mahmood, M.I., E-mail: muhd.illyyas.mahmood@sgh.com.sg [Department of Diagnostic Radiology, Singapore General Hospital, Outram Road, Singapore 169608 (Singapore); Tay, K.H., E-mail: tay.kiang.hiong@sgh.com.sg [Department of Diagnostic Radiology, Singapore General Hospital, Outram Road, Singapore 169608 (Singapore)

    2015-07-15

    Highlights: • Iodinated intravenous contrast carries a low risk of contrast induced nephropathy (CIN). • Patients with eGFR less than 45 mL/min/1.73 m{sup 2} are particularly at risk for CIN. • The Choyke questionnaire is used to screen for impaired renal function in outpatients. • Choyke questionnaire is a good screening tool for eGFR less than 45 mL/min/1.73 m{sup 2}. • Point of care test (POCT) for serum creatinine can reduce waiting time. - Abstract: Rationale and purpose: To determine the usefulness of the Choyke questionnaire with a creatinine point-of-care test (POCT) to detect impaired renal function amongst outpatients receiving intravenous iodinated contrast in a tertiary centre. Materials and methods: Between July and December 2012, 1361 outpatients had their serum creatinine determined by POCT and answered the Chokye questionnaire just before their examination. Results: Four hundred and eighty (35.2%) patients had at least one ‘Yes’ response. Forty-four patients (3.2%) had estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m{sup 2} and 14 patients (1.0%) have eGFR <45 mL/min/1.73 m{sup 2}. Sensitivity, specificity, positive predictive value and negative predictive value of the Choyke criteria in detecting patients with eGFR <60 mL/min/1.73 m{sup 2} are respectively: 65.9%, 65.8%, 6.0% and 98.3% and to detect eGFR <45 mL/min/1.73 m{sup 2}: 92.9%, 65.3%, 2.7% and 99.9%. Only ‘Yes’ responses to ‘Have you ever been told you have renal problems?’ and ‘Do you have diabetes mellitus?’ were statistically significant in predicting eGFR <45 mL/min/1.73 m{sup 2}, with odds ratio 98.7 and 4.4 respectively. Conclusion: The Choyke questionnaire has excellent sensitivity and moderate-to-good specificity in detecting patients with <45 mL/min/1.73 m{sup 2}, below this level it has been shown that risk of contrast induced nephropathy increases significantly, making it an effective screening tool. Also the use of POCT can potentially

  16. Impact on ART initiation of point-of-care CD4 testing at HIV diagnosis among HIV-positive youth in Khayelitsha, South Africa.

    Science.gov (United States)

    Patten, Gabriela E M; Wilkinson, Lynne; Conradie, Karien; Isaakidis, Petros; Harries, Anthony D; Edginton, Mary E; De Azevedo, Virginia; van Cutsem, Gilles

    2013-07-04

    Despite the rapid expansion of antiretroviral therapy (ART) programmes in developing countries, pre-treatment losses from care remain a challenge to improving access to treatment. Youth and adolescents have been identified as a particularly vulnerable group, at greater risk of loss from both pre-ART and ART care. Point-of-care (POC) CD4 testing has shown promising results in improving linkage to ART care. In Khayelitsha township, South Africa, POC CD4 testing was implemented at a clinic designated for youth aged 12-25 years. We assessed whether there was an associated reduction in attrition between HIV testing, assessment for eligibility and ART initiation. A before-and-after observational study was conducted using routinely collected data. These were collected on patients from May 2010 to April 2011 (Group A) when baseline CD4 count testing was performed in a laboratory and results were returned to the clinic within two weeks. Same-day POC CD4 testing was implemented in June 2011, and data were collected on patients from August 2011 to July 2012 (Group B). A total of 272 and 304 youth tested HIV-positive in Group A and Group B, respectively. Group B patients were twice as likely to have their ART eligibility assessed compared to Group A patients: 275 (90%) vs. 183 (67%) [relative risk (RR)=2.4, 95% CI: 1.8-3.4, ptesting and ART initiation was reduced from 36 to 28 days (p=0.6). POC CD4 testing significantly improved assessment for ART eligibility. The improvement in the proportion initiating ART and the reduction in time to initiation was not significant due to sample size limitations. POC CD4 testing reduced attrition between HIV-testing and assessment of ART eligibility. Strategies to improve uptake of ART are needed, possibly by improving patient support for HIV-positive youth immediately after diagnosis.

  17. Public health implications of molecular point-of-care testing for chlamydia and gonorrhoea in remote primary care services in Australia: a qualitative study.

    Science.gov (United States)

    Natoli, L; Guy, R J; Shephard, M; Whiley, D; Tabrizi, S N; Ward, J; Regan, D G; Badman, S G; Anderson, D A; Kaldor, J; Maher, L

    2015-04-28

    With accurate molecular tests now available for diagnosis of chlamydia and gonorrhoea (Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG)) at the point-of-care (POC), we aimed to explore the public health implications (benefits and barriers) of their integration into remote primary care in Australia. Qualitative interviews were conducted with a purposively selected group of 18 key informants reflecting sexual health, primary care, remote Aboriginal health and laboratory expertise. Participants believed that POC testing may decrease community prevalence of sexually transmitted infections (STIs), and associated morbidity by reducing the time to treatment and infectious period and expediting partner notification. Also, POC testing could improve acceptability of STI testing, increase testing coverage and result in more targeted prescribing, thereby minimising the risk of antibiotic resistance. Conversely, some felt the immediacy of diagnosis could deter certain young people from being tested. Participants also noted that POC testing may reduce the completeness of communicable disease surveillance data given the current dependence on reporting from pathology laboratories. Others expressed concern about the need to maintain and improve the flow of NG antibiotic sensitivity data, already compromised by the shift to nucleic acid-based testing. This is particularly relevant to remote areas where culture viability is problematic. Results indicate a high level of support from clinicians and public health practitioners for wider access to CT/NG POC tests citing potential benefits, including earlier, more accurate treatment decisions and reductions in ongoing transmission. However, the data also highlight the need for new systems to avoid adverse impact on disease surveillance. Australian and New Zealand Clinical Trials Registry: ACTRN12613000808741. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  18. How can point-of-care HbA1c testing be integrated into UK primary care consultations? - A feasibility study.

    Science.gov (United States)

    Hirst, J A; Stevens, R J; Smith, I; James, T; Gudgin, B C; Farmer, A J

    2017-08-01

    Point-of-care (POC) HbA1c testing gives a rapid result, allowing testing and treatment decisions to take place in a single appointment. Trials of POC testing have not been shown to improve HbA1c, possibly because of how testing was implemented. This study aimed to identify key components of POC HbA1c testing and determine strategies to optimise implementation in UK primary care. This cohort feasibility study recruited thirty patients with type 2 diabetes and HbA1c>7.5% (58mmol/mol) into three primary care clinics. Patients' clinical care included two POC HbA1c tests over six months. Data were collected on appointment duration, clinical decisions, technical performance and patient behaviour. Fifty-three POC HbA1c consultations took place during the study; clinical decisions were made in 30 consultations. Five POC consultations with a family doctor lasted on average 11min and 48 consultations with nurses took on average 24min. Five POC study visits did not take place in one clinic. POC results were uploaded to hospital records from two clinics. In total, sixty-three POC tests were performed, and there were 11 cartridge failures. No changes in HbA1c or patient behaviour were observed. HbA1c measurement with POC devices can be effectively implemented in primary care. This work has identified when these technologies might work best, as well as potential challenges. The findings can be used to inform the design of a pragmatic trial to implement POC HbA1c testing. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  19. Diagnostic accuracy of a prototype point-of-care test for ocular Chlamydia trachomatis under field conditions in The Gambia and Senegal.

    Directory of Open Access Journals (Sweden)

    Emma M Harding-Esch

    2011-08-01

    Full Text Available The clinical signs of active trachoma are often present in the absence of ocular Chlamydia trachomatis infection in low prevalence and mass treated settings. Treatment decisions are currently based on the prevalence of clinical signs, and this may result in the unnecessary distribution of mass antibiotic treatment. We aimed to evaluate the diagnostic accuracy of a prototype point-of-care (POC test, developed for field diagnosis of ocular C. trachomatis, in low prevalence settings of The Gambia and Senegal.Three studies were conducted, two in The Gambia and one in Senegal. Children under the age of 10 years were screened for the clinical signs of trachoma. Two ocular swabs were taken from the right eye. The first swab was tested by the POC test in the field and the result independently graded by two readers. The second swab was tested for the presence of C. trachomatis by Amplicor Polymerase Chain Reaction. In Senegal, measurements of humidity and temperature in the field were taken. A total of 3734 children were screened, 950 in the first and 1171 in the second Gambian study, and 1613 in Senegal. The sensitivity of the prototype POC test ranged between 33.3-67.9%, the specificity between 92.4-99.0%, the positive predictive value between 4.3-21.0%, and the negative predictive value between 98.0-99.8%. The rate of false-positives increased markedly at temperatures above 31.4°C and relative humidities below 11.4%.In its present format, this prototype POC test is not suitable for field diagnosis of ocular C. trachomatis as its specificity decreases in hot and dry conditions: the environment in which trachoma is predominantly found. In the absence of a suitable test for infection, trachoma diagnosis remains dependent on clinical signs. Under current WHO recommendations, this is likely resulting in the continued mass treatment of non-infected communities.

  20. "I Do Feel Like a Scientist at Times": A Qualitative Study of the Acceptability of Molecular Point-Of-Care Testing for Chlamydia and Gonorrhoea to Primary Care Professionals in a Remote High STI Burden Setting.

    Science.gov (United States)

    Natoli, Lisa; Guy, Rebecca J; Shephard, Mark; Causer, Louise; Badman, Steven G; Hengel, Belinda; Tangey, Annie; Ward, James; Coburn, Tony; Anderson, David; Kaldor, John; Maher, Lisa

    2015-01-01

    Point-of-care tests for chlamydia (CT) and gonorrhoea (NG) could increase the uptake and timeliness of testing and treatment, contribute to improved disease control and reduce reproductive morbidity. The GeneXpert (Xpert CT/NG assay), suited to use at the point-of-care, is being used in the TTANGO randomised controlled trial (RCT) in 12 remote Australian health services with a high burden of sexually transmissible infections (STIs). This represents the first ever routine use of a molecular point-of-care diagnostic for STIs in primary care. The purpose of this study was to explore the acceptability of the GeneXpert to primary care staff in remote Australia. In-depth qualitative interviews were conducted with 16 staff (registered or enrolled nurses and Aboriginal Health Workers/Practitioners) trained and experienced with GeneXpert testing. Interviews were digitally-recorded and transcribed verbatim prior to content analysis. Most participants displayed positive attitudes, indicating the test was both easy to use and useful in their clinical context. Participants indicated that point-of-care testing had improved management of STIs, resulting in more timely and targeted treatment, earlier commencement of partner notification, and reduced follow up efforts associated with client recall. Staff expressed confidence in point-of-care test results and treating patients on this basis, and reported greater job satisfaction. While point-of-care testing did not negatively impact on client flow, several found the manual documentation processes time consuming, suggesting that improved electronic connectivity and test result transfer between the GeneXpert and patient management systems could overcome this. Managing positive test results in a shorter time frame was challenging for some but most found it satisfying to complete episodes of care more quickly. In the context of a RCT, health professionals working in remote primary care in Australia found the GeneXpert highly acceptable

  1. Evaluation of a novel point-of-care cryptococcal antigen test on serum, plasma, and urine from patients with HIV-associated cryptococcal meningitis.

    Science.gov (United States)

    Jarvis, Joseph N; Percival, Ann; Bauman, Sean; Pelfrey, Joy; Meintjes, Graeme; Williams, G Ntombomzi; Longley, Nicky; Harrison, Thomas S; Kozel, Thomas R

    2011-11-01

    Many deaths from cryptococcal meningitis (CM) may be preventable through early diagnosis and treatment. An inexpensive point-of-care (POC) assay for use with urine or a drop of blood would facilitate early diagnosis of cryptococcal infection in resource-limited settings. We compared cryptococcal antigen (CRAG) concentrations in plasma, serum, and urine from patients with CM, using an antigen-capture assay for glucuronoxylomannan (GXM) and a novel POC dipstick test. GXM concentrations were determined in paired serum, plasma, and urine from 62 patients with active or recent CM, using a quantitative sandwich enzyme-linked immunosorbent assay (ELISA). A dipstick lateral-flow assay developed using the same monoclonal antibodies for the sandwich ELISA was tested in parallel. Correlation coefficients were calculated using Spearman rank test. All patients had detectable GXM in serum, plasma, and urine using the quantitative ELISA. Comparison of paired serum and plasma showed identical results. There were strong correlations between GXM levels in serum/urine (r(s) = 0.86; P < .001) and plasma/urine (r(s) = 0.85; P < .001). Levels of GXM were 22-fold lower in urine than in serum/plasma. The dipstick test was positive in serum, plasma, and urine in 61 of 62 patients. Dipstick titers correlated strongly with ELISA. Correlations between the methods were 0.93 (P < .001) for serum, 0.94 (P < .001) for plasma, and 0.94 (P < .001) for urine. This novel dipstick test has the potential to markedly improve early diagnosis of CM in many settings, enabling testing of urine in patients presenting to health care facilities in which lumbar puncture, or even blood sampling, is not feasible.

  2. Pulsatile plasma filtration and cell-free DNA amplification using a water-head-driven point-of-care testing chip.

    Science.gov (United States)

    Lee, Yonghun; Kim, Dong-Min; Li, Zhenglin; Kim, Dong-Eun; Kim, Sung-Jin

    2018-03-13

    We demonstrate a microfiltration chip that separates blood plasma by using water-head-driven pulsatile pressures rather than any external equipment and use it for on-chip amplification of nucleic acids. The chip generates pulsatile pressures to significantly reduce filter clogging without hemolysis, and consists of an oscillator, a plasma-extraction pump, and filter units. The oscillator autonomously converts constant water-head pressure to pulsatile pressure, and the pump uses the pulsatile pressure to extract plasma through the filter. Because the pulsatile pressure can periodically clear blood cells from the filter surface, filter clogging can be effectively reduced. In this way, we achieve plasma extraction with 100% purity and 90% plasma recovery at 15% hematocrit. During a 10 min period, the volume of plasma extracted was 43 μL out of a 243 μL extraction volume at 15% hematocrit. We also studied the influence of the pore size and diameter of the filter, blood loading volume, oscillation period, and hematocrit level on the filtration performance. To demonstrate the utility of our chip for point-of-care testing (POCT) applications, we successfully implemented on-chip amplification of a nucleic acid (miDNA21) in plasma filtered from blood. We expect our chip to be useful not only for POCT applications but also for other bench-top analysis tools using blood plasma.

  3. A point-of-care testing system with Love-wave sensor and immunogold staining enhancement for early detection of lung cancer.

    Science.gov (United States)

    Zou, Yingchang; Zhang, Xi; An, Chao; Ran, Chunxue; Ying, Kejing; Wang, Ping

    2014-12-01

    It has been reported that detection of exhaled breath condensate (EBC) is available for studies of pulmonary diseases, especially lung disease. In order to detect lung cancer (LC) at early stage, a point-of-care testing system suitable for measurement of tumor markers in EBC is developed. The assay, based on gold nanoparticle sandwich immunoassay and subsequent gold staining, was performed on a Love-wave sensor packaged inside a chip cartridge. Benefit from high sensitivity of Love-wave sensor, oriented immobilization of coating antibodies and immunogold staining enhancement, the present immunosensor could provide a sensitive, specific and rapid measurement. Carcinoembryonic antigen (CEA), neuron specific enolase (NSE) and squamous cell carcinoma antigen (SCC) in EBC collected from 17 patients with LC and 13 healthy volunteers were detected by this system. Results were compared with commercial chemiluminescence immunoassay and showed high correlation between two methods. Additionally, it revealed significantly statistical differences existing between two groups of subjects. These results indicate that the present system is suitable for detection of tumor markers in EBC and could be used as assistant tools for early detection of LC.

  4. A fully integrated distance readout ELISA-Chip for point-of-care testing with sample-in-answer-out capability.

    Science.gov (United States)

    Liu, Dan; Li, Xingrui; Zhou, Junkai; Liu, Shibo; Tian, Tian; Song, Yanling; Zhu, Zhi; Zhou, Leiji; Ji, Tianhai; Yang, Chaoyong

    2017-10-15

    Enzyme-linked immunosorbent assay (ELISA) is a popular laboratory technique for detection of disease-specific protein biomarkers with high specificity and sensitivity. However, ELISA requires labor-intensive and time-consuming procedures with skilled operators and spectroscopic instrumentation. Simplification of the procedures and miniaturization of the devices are crucial for ELISA-based point-of-care (POC) testing in resource-limited settings. Here, we present a fully integrated, instrument-free, low-cost and portable POC platform which integrates the process of ELISA and the distance readout into a single microfluidic chip. Based on manipulation using a permanent magnet, the process is initiated by moving magnetic beads with capture antibody through different aqueous phases containing ELISA reagents to form bead/antibody/antigen/antibody sandwich structure, and finally converts the molecular recognition signal into a highly sensitive distance readout for visual quantitative bioanalysis. Without additional equipment and complicated operations, our integrated ELISA-Chip with distance readout allows ultrasensitive quantitation of disease biomarkers within 2h. The ELISA-Chip method also showed high specificity, good precision and great accuracy. Furthermore, the ELISA-Chip system is highly applicable as a sandwich-based platform for the detection of a variety of protein biomarkers. With the advantages of visual analysis, easy operation, high sensitivity, and low cost, the integrated sample-in-answer-out ELISA-Chip with distance readout shows great potential for quantitative POCT in resource-limited settings. Copyright © 2017. Published by Elsevier B.V.

  5. A Low-Cost Point-of-Care Testing System for Psychomotor Symptoms of Depression Affecting Standing Balance: A Preliminary Study in India

    Directory of Open Access Journals (Sweden)

    Arindam Dutta

    2013-01-01

    Full Text Available The World Health Organization estimated that major depression is the fourth most significant cause of disability worldwide for people aged 65 and older, where depressed older adults reported decreased independence, poor health, poor quality of life, functional decline, disability, and increased chronic medical problems. Therefore, the objectives of this study were (1 to develop a low-cost point-of-care testing system for psychomotor symptoms of depression and (2 to evaluate the system in community dwelling elderly in India. The preliminary results from the cross-sectional study showed a significant negative linear correlation between balance and depression. Here, monitoring quantitative electroencephalography along with the center of pressure for cued response time during functional reach tasks may provide insights into the psychomotor symptoms of depression where average slope of the Theta-Alpha power ratio versus average slope of baseline-normalized response time may be a candidate biomarker, which remains to be evaluated in our future clinical studies. Once validated, the biomarker can be used for monitoring the outcome of a comprehensive therapy program in conjunction with pharmacological interventions. Furthermore, the frequency of falls can be monitored with a mobile phone-based application where the propensity of falls during the periods of psychomotor symptoms of depression can be investigated further.

  6. Performance of the CareStart™ G6PD deficiency screening test, a point-of-care diagnostic for primaquine therapy screening.

    Science.gov (United States)

    Kim, Saorin; Nguon, Chea; Guillard, Bertrand; Duong, Socheat; Chy, Sophy; Sum, Sarorn; Nhem, Sina; Bouchier, Christiane; Tichit, Magali; Christophel, Eva; Taylor, Walter R J; Baird, John Kevin; Menard, Didier

    2011-01-01

    Development of reliable, easy-to-use, rapid diagnostic tests (RDTs) to detect glucose-6-phosphate dehydrogenase (G6PD) deficiency at point of care is essential to deploying primaquine therapies as part of malaria elimination strategies. We assessed a kit under research and development called CareStart™ G6PD deficiency screening test (Access Bio, New Jersey, USA) by comparing its performance to quantitative G6PD enzyme activity using a standardized spectrophotometric method ('gold standard'). Blood samples (n = 903) were collected from Cambodian adults living in Pailin province, western Cambodia. G6PD enzyme activities ranged from 0 to 20.5 U/g Hb (median 12.0 U/g Hg). Based on a normal haemoglobin concentration and wild-type G6PD gene, the normal values of G6PD enzymatic activity for this population was 3.6 to 20.5 U/g Hg (95(th) percentiles from 5.5 to 17.2 U/g Hg). Ninety-seven subjects (10.7%) had G6PD deficiency screening test was 0.68 and 1.0, respectively. Its detection threshold was <2.7 U/g Hg, well within the range of moderate and severe enzyme deficiencies. Thirteen subjects (1.4%, 12 males and 1 female) with G6PD enzyme activities <2 U/g Hg were falsely classified as "normal" by RDT. This experimental RDT test here evaluated outside of the laboratory for the first time shows real promise, but safe application of it will require lower rates of falsely "normal" results.

  7. Clinical validation of a point-of-care multiplexed in vitro immunoassay using monoclonal antibodies (the MSD influenza test) in four hospitals in Vietnam.

    Science.gov (United States)

    van Doorn, H Rogier; Kinh, Nguyen van; Tuan, Ha Manh; Tuan, Tran Anh; Minh, Ngo Ngoc Quang; Bryant, Juliet E; Hang, Vu thi Ty; Uyen, Le thi Tham; Thinh, Le Quoc; Anh, Tran thi Ngoc; Lan, Nguyen Phu Huong; Trung, Nguyen Vu; Taylor, Walter; Merson, Laura; Wertheim, Heiman F L; Farrar, Jeremy; Wolbers, Marcel; Chau, Nguyen van Vinh; de Jong, Menno D

    2012-05-01

    Point-of-care (POC) diagnostic tests for influenza can considerably shorten the time to clinical decision making. An investigational POC test based on a multiplexed immunoassay was developed by Meso Scale Diagnostics, LLC (MSD), with the objective to make a more sensitive rapid test that can also subtype influenza A viruses (1977 H1, H3, and H5). Between February and November 2010, we conducted a prospective multicenter study at four hospitals in Vietnam and compared the performance of this test to that of the WHO/CDC real-time reverse transcriptase PCR (RT-PCR) on nasal and throat swab specimens from patients presenting with influenza-like illness. Five hundred sixty-three adults and children with a median age of 25 months were enrolled. Sensitivity and specificity of the test with combined results from nasal and throat swab samples were 74.0% (131/177) and 99.7% (351/352), respectively, compared to RT-PCR. The POC test was as sensitive for influenza virus B as for influenza virus A (74.4% [64/86] versus 73.6% [67/91]). The positivity rate was associated with lower cycle threshold values (a marker for higher viral loads), sample type (73.6% for nasal swab versus 52.4% for throat swab), and younger age. A total of 210 (18.7%) out of 1,126 MSD tests failed, and for 34 (6%) of patients, both test samples failed (these were excluded from the performance analysis). Subtyping could be assessed only for influenza virus A/H3N2, as 1977 H1N1 was not circulating at the time and no H5N1-infected patients were enrolled, and was successful only in 9/54 patients infected with H3 influenza virus who had a positive POC test result for influenza virus A. This novel POC test provided highly sensitive detection of influenza viruses A and B compared to the reported sensitivities of other rapid tests. However, 18.7% of tests failed for technical reasons and subtyping for H3 was poor. Drawbacks to the technology include the requirement for a dedicated reader instrument and the need for

  8. Assessment of platelet function in healthy cats in response to commonly prescribed antiplatelet drugs using three point-of-care platelet function tests.

    Science.gov (United States)

    Ho, Kimberly K; Abrams-Ogg, Anthony Cg; Wood, R Darren; O'Sullivan, M Lynne; Kirby, Gordon M; Blois, Shauna L

    2017-06-01

    Objectives The objective was to determine if decreased platelet function could be detected after treatment with aspirin and/or clopidogrel in healthy cats using three point-of-care platelet function tests that evaluate platelet function by different methods: Multiplate (by impedance), Platelet Function Analyzer 100 (by mechanical aperture closure) and Plateletworks (by platelet counting). Methods Thirty-six healthy cats were randomly assigned to receive one of three oral treatments over an 8 day period: (1) aspirin 5 mg q72h; (2) aspirin 20.25 mg q72h; or (3) clopidogrel 18.75 mg q24h. Cats treated with 5 and 20.25 mg aspirin also received clopidogrel on days 4-8. Platelet aggregation in response to adenosine diphosphate and collagen ± arachidonic acid was assessed on days 1 (baseline), 4 and 8. Aspirin and clopidogrel metabolites were measured by high-performance liquid chromatography. Platelet function in response to treatment was analyzed by ANCOVA, linear regression and Spearman correlation. Results The only solitary aspirin effect was detected using Plateletworks with collagen in cats treated with 20.25 mg. The only effect detected by Multiplate was using arachidonic acid in cats treated with both aspirin 20.25 mg and clopidogrel. All clopidogrel treatment effects were detected by Platelet Function Analyzer 100, Plateletworks (adenosine diphosphate) and Plateletworks (collagen). Drug metabolites were present in all cats, but concentrations were minimally correlated to platelet function test results. Conclusions and relevance Platelet Function Analyzer 100 and Plateletworks using adenosine diphosphate ± collagen agonists may be used to detect decreased platelet function in response to clopidogrel treatment. Either aspirin is not as effective an antiplatelet drug as clopidogrel, or the tests used were not optimal to measure aspirin effect. Cats with heart disease are commonly prescribed antiplatelet drugs to decrease the risk of aortic thromboembolism

  9. Point-of-care estimation of haemoglobin concentration in neonates ...

    African Journals Online (AJOL)

    Objective. The HemoCue is a point-of-care analytical system for haemoglobin concentration (Hb) measurement. Point-of-care testing has been validated in hospitals and outpatient departments to assist with urgent patient management by providing rapid laboratory test results. Method. In this prospective study we compared ...

  10. Comparison between point-of-care dermatophyte test medium and mycology laboratory culture for diagnosis of dermatophytosis in dogs and cats.

    Science.gov (United States)

    Kaufmann, Ronnie; Blum, Shlomo E; Elad, Daniel; Zur, Gila

    2016-08-01

    Point-of-care Dermatophyte Test Medium (PoC-DTM) is a diagnostic procedure to rule in/rule out dermatophytosis in veterinary clinics. To evaluate the performance of PoC-DTM in the clinic compared to DTM plate culture in a mycology laboratory and to compare results obtained by general practitioners and referral clinicians. Hair samples were collected from 47 cats and 54 dogs with suspected dermatophytosis and from nine healthy controls (seven cats and two dogs). This was a multicentre blinded study. In one group (65 suspected cases, 9 healthy controls), PoC-DTM results were evaluated by clinicians in a referral clinic (SP group) who examined the colony morphology macroscopically and microscopically. In the other group (36 suspected cases) PoC-DTM results were evaluated by clinicians from general practice for colour change only, with no macroscopic or microscopic examination (GP group). All hair samples were also cultured on DTM plates in a mycology laboratory. Laboratory culture was considered the gold standard for comparison. Agreements between tests were 97% (two false positive; κ = 0.839) and 80.6% (five false positives and two false negatives; κ = 0.466) in the SP and GP groups, respectively. This difference between groups was significant (P = 0.024). When applying macroscopic and microscopic evaluation of the colony, PoC-DTM is accurate for diagnosing dermatophytes with only a 3% chance of error. However, when macroscopic and microscopic examination is not included there is significant (19.4%) chance for an incorrect diagnosis. © 2016 ESVD and ACVD.

  11. Scaling Down to Scale Up: A Health Economic Analysis of Integrating Point-of-Care Syphilis Testing into Antenatal Care in Zambia during Pilot and National Rollout Implementation.

    Directory of Open Access Journals (Sweden)

    Katharine D Shelley

    Full Text Available Maternal syphilis results in an estimated 500,000 stillbirths and neonatal deaths annually in Sub-Saharan Africa. Despite the existence of national guidelines for antenatal syphilis screening, syphilis testing is often limited by inadequate laboratory and staff services. Recent availability of inexpensive rapid point-of-care syphilis tests (RST can improve access to antenatal syphilis screening. A 2010 pilot in Zambia explored the feasibility of integrating RST within prevention of mother-to-child-transmission of HIV services. Following successful demonstration, the Zambian Ministry of Health adopted RSTs into national policy in 2011. Cost data from the pilot and 2012 preliminary national rollout were extracted from project records, antenatal registers, clinic staff interviews, and facility observations, with the aim of assessing the cost and quality implications of scaling up a successful pilot into a national rollout. Start-up, capital, and recurrent cost inputs were collected, including costs of extensive supervision and quality monitoring during the pilot. Costs were analysed from a provider's perspective, incremental to existing antenatal services. Total and unit costs were calculated and a multivariate sensitivity analysis was performed. Our accompanying qualitative study by Ansbro et al. (2015 elucidated quality assurance and supervisory system challenges experienced during rollout, which helped explain key cost drivers. The average unit cost per woman screened during rollout ($11.16 was more than triple the pilot unit cost ($3.19. While quality assurance costs were much lower during rollout, the increased unit costs can be attributed to several factors, including higher RST prices and lower RST coverage during rollout, which reduced economies of scale. Pilot and rollout cost drivers differed due to implementation decisions related to training, supervision, and quality assurance. This study explored the cost of integrating RST into

  12. Diagnostic accuracy of point-of-care testing for acute coronary syndromes, heart failure and thromboembolic events in primary care: a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Diemand Albert

    2011-03-01

    Full Text Available Abstract Background Evidence of the clinical benefit of 3-in-1 point-of-care testing (POCT for cardiac troponin T (cTnT, N-terminal pro-brain natriuretic peptide (NT-proBNP and D-dimer in cardiovascular risk stratification at primary care level for diagnosing acute coronary syndromes (ACS, heart failure (HF and thromboembolic events (TE is very limited. The aim of this study is to analyse the diagnostic accuracy of POCT in primary care. Methods Prospective multicentre controlled trial cluster-randomised to POCT-assisted diagnosis and conventional diagnosis (controls. Men and women presenting in 68 primary care practices in Zurich County (Switzerland with chest pain or symptoms of dyspnoea or TE were consecutively included after baseline consultation and working diagnosis. A follow-up visit including confirmed diagnosis was performed to determine the accuracy of the working diagnosis, and comparison of working diagnosis accuracy between the two groups. Results The 218 POCT patients and 151 conventional diagnosis controls were mostly similar in characteristics, symptoms and pre-existing diagnoses, but differed in working diagnosis frequencies. However, the follow-up visit showed no statistical intergroup difference in confirmed diagnosis frequencies. Working diagnoses overall were significantly more correct in the POCT group (75.7% vs 59.6%, p = 0.002, as were the working diagnoses of ACS/HF/TE (69.8% vs 45.2%, p = 0.002. All three biomarker tests showed good sensitivity and specificity. Conclusion POCT confers substantial benefit in primary care by correctly diagnosing significantly more patients. Trial registration DRKS: DRKS00000709

  13. Enhancing the Usability of an Optical Reader System to Support Point-of-Care Rapid Diagnostic Testing: An Iterative Design Approach.

    Science.gov (United States)

    Hohenstein, Jess; O'Dell, Dakota; Murnane, Elizabeth L; Lu, Zhengda; Erickson, David; Gay, Geri

    2017-11-21

    In today's health care environment, increasing costs and inadequate medical resources have created a worldwide need for more affordable diagnostic tools that are also portable, fast, and easy to use. To address this issue, numerous research and commercial efforts have focused on developing rapid diagnostic technologies; however, the efficacy of existing systems has been hindered by usability problems or high production costs, making them infeasible for deployment in at-home, point-of-care (POC), or resource-limited settings. The aim of this study was to create a low-cost optical reader system that integrates with any smart device and accepts any type of rapid diagnostic test strip to provide fast and accurate data collection, sample analysis, and diagnostic result reporting. An iterative design methodology was employed by a multidisciplinary research team to engineer three versions of a portable diagnostic testing device that were evaluated for usability and overall user receptivity. Repeated design critiques and usability studies identified a number of system requirements and considerations (eg, software compatibility, biomatter contamination, and physical footprint) that we worked to incrementally incorporate into successive system variants. Our final design phase culminated in the development of Tidbit, a reader that is compatible with any Wi-Fi-enabled device and test strip format. The Tidbit includes various features that support intuitive operation, including a straightforward test strip insertion point, external indicator lights, concealed electronic components, and an asymmetric shape, which inherently signals correct device orientation. Usability testing of the Tidbit indicates high usability for potential user communities. This study presents the design process, specification, and user reception of the Tidbit, an inexpensive, easy-to-use, portable optical reader for fast, accurate quantification of rapid diagnostic test results. Usability testing suggests

  14. Household point of care CD4 testing and isoniazid preventive therapy initiation in a household TB contact tracing programme in two districts of South Africa.

    Science.gov (United States)

    Page-Shipp, Liesl; Lewis, James J; Velen, Kavindhran; Senoge, Sedikanelo; Zishiri, Elizabeth; Popane, Flora; Chihota, Violet N; Clark, Dave; Churchyard, Gavin J; Charalambous, Salome

    2018-01-01

    In South Africa, TB household contact tracing provides an opportunity for increased TB and HIV case finding. We aimed to determine the effect of two new potential interventions for TB contact tracing programmes: Point of Care CD4 (PoC CD4) on HIV linkage to care and household Isoniazid Preventive Therapy (IPT) provision on uptake and retention of IPT. A pragmatic, three-arm, cluster-randomized trial was undertaken. TB Household contacts were randomised to 3 arms: 1) Standard of Care TB and HIV testing (SOC); 2) SOC with POC CD4 for those testing HIV positive; 3) SOC with POC CD4 and IPT for eligible household members. Linkage to care within 90 days was assessed either through patient visits (at 10 weeks and 6 months) or via telephonic contact. 2,243 index TB patients and 3,012 contacts (64,3% female, median age 30 years) were enrolled. On self-report, 26(1.2%) were currently receiving TB treatment and 1816 (60.3%) reported a prior HIV test. HIV testing uptake was 34.7% in the SoC arm, 40.2% in the PoC CD4 arm (RR1.16, CI 0.99-1.36, p-value = 0.060) and 39.9% in the PoC CD4 + HH-IPT arm (RR = 1.15, CI 0.99-1.35, p-value = 0.075). Linkage to care within 3 months was 30.8% in the SoC arm and 42.1% in the POC CD4 arms (RR 1.37; CI: 0.68-2.76, p-value = 0.382). 20/21 contacts (95.2%) initiated IPT in the PoC CD4 + HH-IPT arm, compared to 3/20 (15.0%) in the PoC CD4 arm (p = 0.004; p-value from Fisher's exact test TB with an overall yield of TB of 0.5% (95% CI: 0.3%, 0.8%). Household PoC CD4 testing and IPT initiation is feasible. There was only weak evidence that PoCCD4 led to a small increase in HCT uptake and no evidence for an increase in linkage-to-care. IPT initiation and completion was increased by the household intervention. Although feasible, these interventions had low impact due to the low uptake of HIV testing in households.

  15. Point-of-care-testing of standing posture with Wii balance board and Microsoft Kinect during transcranial direct current stimulation: a feasibility study.

    Science.gov (United States)

    Dutta, Arindam; Chugh, Sanjay; Banerjee, Alakananda; Dutta, Anirban

    2014-01-01

    Non-invasive brain stimulation (NIBS) is a promising tool for facilitating motor function. NIBS therapy in conjunction with training using postural feedback may facilitate physical rehabilitation following posture disorders (e.g., Pusher Syndrome). The objectives of this study were, 1) to develop a low-cost point-of-care-testing (POCT) system for standing posture, 2) to investigate the effects of anodal tDCS on functional reach tasks using the POCT system. Ten community-dwelling elderly (age >50 years) subjects evaluated the POCT system for standing posture during functional reach tasks where their balance score on Berg Balance Scale was compared with that from Center-of-Mass (CoM) - Center-of-Pressure (CoP) posturography. Then, in a single-blind, sham-controlled study, five healthy right-leg dominant subjects (age: 26.4 ± 5.3 yrs) were evaluated using the POCT system under two conditions - with anodal tDCS of primary motor representations of right tibialis anterior muscle and with sham tDCS. The maximum CoP-CoM lean-angle was found to be well correlated with the BBS score in the elderly subjects The anodal tDCS strongly (p = 0.0000) affected the maximum CoP excursions but not the return reaction time in healthy. It was concluded that the CoM-CoP lean-line could be used for posture feedback and monitoring during tDCS therapy in conjunction with balance training exercises.

  16. A New Method for Blood NT-proBNP Determination Based on a Near-infrared Point of Care Testing Device with High Sensitivity and Wide Scope.

    Science.gov (United States)

    Zhang, Xiao Guang; Shu, Yao Gen; Gao, Ju; Wang, Xuan; Liu, Li Peng; Wang, Meng; Cao, Yu Xi; Zeng, Yi

    2017-06-01

    To develop a rapid, highly sensitive, and quantitative method for the detection of NT-proBNP levels based on a near-infrared point-of-care diagnostic (POCT) device with wide scope. The lateral flow assay (LFA) strip of NT-proBNP was first prepared to achieve rapid detection. Then, the antibody pairs for NT-proBNP were screened and labeled with the near-infrared fluorescent dye Dylight-800. The capture antibody was fixed on a nitrocellulose membrane by a scribing device. Serial dilutions of serum samples were prepared using NT-proBNP-free serum series. The prepared test strips, combined with a near-infrared POCT device, were validated by known concentrations of clinical samples. The POCT device gave the output of the ratio of the intensity of the fluorescence signal of the detection line to that of the quality control line. The relationship between the ratio value and the concentration of the specimen was plotted as a work curve. The results of 62 clinical specimens obtained from our method were compared in parallel with those obtained from the Roche E411 kit. Based on the log-log plot, the new method demonstrated that there was a good linear relationship between the ratio value and NT-proBNP concentrations ranging from 20 pg/mL to 10 ng/mL. The results of the 62 clinical specimens measured by our method showed a good linear correlation with those measured by the Roche E411 kit. The new LFA detection method of NT-proBNP levels based on the near-infrared POCT device was rapid and highly sensitive with wide scope and was thus suitable for rapid and early clinical diagnosis of cardiac impairment. Copyright © 2017 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

  17. The role of point-of-care tests in antibiotic stewardship for urinary tract infections in a resource-limited setting on the Thailand-Myanmar border.

    Science.gov (United States)

    Chalmers, Lauren; Cross, Jessica; Chu, Cindy S; Phyo, Aung Pyae; Trip, Margreet; Ling, Clare; Carrara, Verena; Watthanaworawit, Wanitda; Keereecharoen, Lily; Hanboonkunupakarn, Borimas; Nosten, François; McGready, Rose

    2015-10-01

    Published literature from resource-limited settings is infrequent, although urinary tract infections (UTI) are a common cause of outpatient presentation and antibiotic use. Point-of-care test (POCT) interpretation relates to antibiotic use and antibiotic resistance. We aimed to assess the diagnostic accuracy of POCT and their role in UTI antibiotic stewardship. One-year retrospective analysis in three clinics on the Thailand-Myanmar border of non-pregnant adults presenting with urinary symptoms. POCT (urine dipstick and microscopy) were compared to culture with significant growth classified as pure growth of a single organism >10(5)  CFU/ml. In 247 patients, 82.6% female, the most common symptoms were dysuria (81.2%), suprapubic pain (67.8%) and urinary frequency (53.7%). After excluding contaminated samples, UTI was diagnosed in 52.4% (97/185); 71.1% (69/97) had a significant growth on culture, and >80% of these were Escherichia coli (20.9% produced extended-spectrum β-lactamase (ESBL)). Positive urine dipstick (leucocyte esterase ≥1 and/or nitrate positive) compared against positive microscopy (white blood cell >10/HPF, bacteria ≥1/HPF, epithelial cells sensitivity (99% vs. 57%) but a lower specificity (47% vs. 89%), respectively. Combined POCT resulted in the best sensitivity (98%) and specificity (81%). Nearly one in ten patients received an antimicrobial to which the organism was not fully sensitive. One rapid, cost-effective POCT was too inaccurate to be used alone by healthcare workers, impeding antibiotic stewardship in a high ESBL setting. Appropriate prescribing is improved with concurrent use and concordant results of urine dipstick and microscopy. © 2015 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

  18. Different influences of hematocrit on the results of two Point-Of-Care platelet function tests, the VerifyNow assay and multiple electrode platelet aggregometry.

    Science.gov (United States)

    Kim, Yun Gi; Suh, Jung-Won; Park, Jin Joo; Oh, Il-Young; Yoon, Chang-Hwan; Cho, Young-Seok; Youn, Tae-Jin; Chae, In-Ho; Choi, Dong-Ju

    2014-01-01

    Previous studies have reported a considerable association between the VerifyNow (Accumetrics, San Diego, CA, USA) P2Y12 assay results and hematocrit. No reports, however, have described an association between the multiple electrode platelet aggregometry (MEA; Dynabyte, Munich, Germany) adenosine diphosphate (ADP) assay results and hematocrit. This study was conducted to evaluate the influence of hematocrit on the results of 2 different point-of-care platelet function tests. A total of 462 consecutive patients who were undergoing percutaneous coronary intervention were enrolled. Platelet function was evaluated with both the VerifyNow P2Y12 and MEA ADP assays. Anemic patients (n = 152, 32.9%) demonstrated a significantly higher rate of cardiac death, myocardial infarction, and stroke (5.3% vs. 2.3%, p = 0.046) during the follow-up (median: 18.8 months). Although the VerifyNow P2Y12 assay results demonstrated a significant inverse correlation with hematocrit (r = -0.409, phematocrit (r = 0.039, p = 0.401). In the multivariate analysis, anemia was an independent predictor of high on-treatment platelet reactivity, defined as a VerifyNow P2Y12 reaction unit level of ≥252.5 (odds ratio = 2.21, 95% confidence interval = 1.39-3.52; p = 0.001). Importantly, this association was independent of an intrinsic change in platelet reactivity as measured by the MEA ADP assay. Adjusting for the influence of hematocrit improved the strength of the correlation between the VerifyNow P2Y12 and MEA ADP assay results. Hematocrit significantly influenced the VerifyNow P2Y12 assay results, a phenomenon that was presumably in-vitro. Hematocrit level should therefore be considered when interpreting results of the VerifyNow P2Y12 assay.

  19. Effect of point-of-care susceptibility testing in general practice on appropriate prescription of antibiotics for patients with uncomplicated urinary tract infection: a diagnostic randomised controlled trial.

    Science.gov (United States)

    Holm, Anne; Cordoba, Gloria; Møller Sørensen, Tina; Rem Jessen, Lisbeth; Frimodt-Møller, Niels; Siersma, Volkert; Bjerrum, Lars

    2017-10-16

    To investigate the effect of adding point-of-care (POC) susceptibility testing to POC culture on appropriate use of antibiotics as well as clinical and microbiological cure for patients with suspected uncomplicated urinary tract infection (UTI) in general practice. Open, individually randomised controlled trial. General practice. Women with suspected uncomplicated UTI, including elderly patients above 65, patients with recurrent UTI and patients with diabetes. The sample size calculation predicted 600 patients were needed. Flexicult SSI-Urinary Kit was used for POC culture and susceptibility testing and ID Flexicult was used for POC culture only. Primary outcome: appropriate antibiotic prescribing on the day after consultation defined as either (1) patient with UTI: to prescribe a first-line antibiotic to which the infecting pathogen was susceptible or a second line if a first line could not be used or (2) patient without UTI: not to prescribe an antibiotic. UTI was defined by typical symptoms and significant growth in a reference urine culture performed at one of two external laboratories. clinical cure on day five according to a 7-day symptom diary and microbiological cure on day 14. Logistic regression models taking into account clustering within practices were used for analysis. 20 general practices recruited 191 patients for culture and susceptibility testing and 172 for culture only. 63% of the patients had UTI and 12% of these were resistant to the most commonly used antibiotic, pivmecillinam. Patients randomised to culture only received significantly more appropriate treatment (OR: 1.44 (95% CI 1.03 to 1.99), p=0.03). There was no significant difference in clinical or microbiological cure. Adding POC susceptibility testing to POC culture did not improve antibiotic prescribing for patients with suspected uncomplicated UTI in general practice. Susceptibility testing should be reserved for patients at high risk of resistance and complications. NCT02323087

  20. Cryptococcal antigen screening by lay cadres using a rapid test at the point of care: A feasibility study in rural Lesotho.

    Directory of Open Access Journals (Sweden)

    Fernanda Rick

    Full Text Available Cryptococcal meningitis is one of the leading causes of death among people with HIV in Africa, primarily due to delayed presentation, poor availability and high cost of treatment. Routine cryptococcal antigen (CrAg screening of patients with a CD4 count less than 100 cells/mm3, followed by pre-emptive therapy if positive, might reduce mortality in high prevalence settings. Using the cryptococcal antigen (CrAg lateral flow assay (LFA, screening is possible at the point of care (POC. However, critical shortages of health staff may limit adoption. This study investigates the feasibility of lay counsellors conducting CrAg LFA screening in rural primary care clinics in Lesotho.From May 2014 to June 2015, individuals who tested positive for HIV were tested for CD4 count and those with CD4 <100 cells/mm3 were screened with CrAg LFA. All tests were performed by lay counsellors. CrAg-positive asymptomatic patients received fluconazole, while symptomatic patients were referred to hospital. Lay counsellors were trained and supervised by a laboratory technician and counsellor activity supervisor. Additionally, nurses and doctors were trained on CrAg screening and appropriate treatment.During the study period, 1,388 people were newly diagnosed with HIV, of whom 129 (9% presented with a CD4 count <100 cells/mm3. Of these, 128 (99% were screened with CrAg LFA and 14/128 (11% tested positive. Twelve of the 14 (86% were asymptomatic, and received outpatient fluconazole. All commenced ART with a median time to initiation of 15.5 days [IQR: 14-22]. Of the asymptomatic patients, nine (75% remained asymptomatic after a median time of 5 months [IQR; 3-6] of follow up. One (8% became co-infected with tuberculosis and died and two were transferred out. The two patients with symptomatic cryptococcal meningitis (CM were referred to hospital, where they later died.CrAg LFA screening by lay counsellors followed by pre-emptive fluconazole treatment for asymptomatic cases

  1. Does use of point-of-care testing improve cost-effectiveness of the NHS Health Check programme in the primary care setting? A cost-minimisation analysis.

    Science.gov (United States)

    El-Osta, Austen; Woringer, Maria; Pizzo, Elena; Verhoef, Talitha; Dickie, Claire; Ni, Melody Z; Huddy, Jeremy R; Soljak, Michael; Hanna, George B; Majeed, Azeem

    2017-08-15

    To determine if use of point of care testing (POCT) is less costly than laboratory testing to the National Health Service (NHS) in delivering the NHS Health Check (NHSHC) programme in the primary care setting. Observational study and theoretical mathematical model with microcosting approach. We collected data on NHSHC delivered at nine general practices (seven using POCT; two not using POCT). We recruited nine general practices offering NHSHC and a pathology services laboratory in the same area. We conducted mathematical modelling with permutations in the following fields: provider type (healthcare assistant or nurse), type of test performed (total cholesterol with either lab fasting glucose or HbA1c), cost of consumables and variable uptake rates, including rate of non-response to invite letter and rate of missed [did not attend (DNA)] appointments. We calculated total expected cost (TEC) per 100 invites, number of NHSHC conducted per 100 invites and costs for completed NHSHC for laboratory and POCT-based pathways. A univariate and probabilistic sensitivity analysis was conducted to account for uncertainty in the input parameters. We collected data on cost, volume and type of pathology services performed at seven general practices using POCT and a pathology services laboratory. We collected data on response to the NHSHC invitation letter and DNA rates from two general practices. TEC of using POCT to deliver a routine NHSHC is lower than the laboratory-led pathway with savings of £29 per 100 invited patients up the point of cardiovascular disease risk score presentation. Use of POCT can deliver NHSHC in one sitting, whereas the laboratory pathway offers patients several opportunities to DNA appointment. TEC of using POCT to deliver an NHSHC in the primary care setting is lower than the laboratory-led pathway. Using POCT minimises DNA rates associated with laboratory testing and enables completion of NHSHC in one sitting. © Article author(s) (or their employer

  2. Design, development and evaluation of rK28-based point-of-care tests for improving rapid diagnosis of visceral leishmaniasis.

    Directory of Open Access Journals (Sweden)

    Sowmya Pattabhi

    simplifying VL disease confirmation at the point-of-care.

  3. Antenatal syphilis screening using point-of-care testing in low- and middle-income countries in Asia and Latin America: a cost-effectiveness analysis.

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    Andreas Kuznik

    Full Text Available Untreated syphilis in pregnancy is associated with adverse clinical outcomes to the infant. In low- and middle-income countries in Asia and Latin America, 20%-30% of women are not tested for syphilis during pregnancy. We evaluated the cost-effectiveness of increasing the coverage for antenatal syphilis screening in 11 Asian and 20 Latin American countries, using a point-of-care immunochromatographic strip (ICS test.The decision analytical cost-effectiveness models reported incremental costs per disability-adjusted life years (DALYs averted from the perspectives of the national health care payer. Clinical outcomes were stillbirths, neonatal deaths, and congenital syphilis. DALYs were computed using WHO disability weights. Costs included the ICS test, three injections of benzathine penicillin, and nurse wages. Country-specific inputs included the antenatal prevalence of syphilis and the proportion of women in the antenatal care setting that are screened for syphilis infection as reported in the 2014 WHO baseline report on global sexually transmitted infection surveillance. Country-specific data on the annual number of live births, proportion of women with at least one antenatal care visit, and per capita gross national income were also included in the model.The incremental cost/DALY averted of syphilis screening is US$53 (range: US$10-US$332; Prob<1*per capita GDP=99.71% in Asia and US$60 (range: US$5-US$225; Prob<1*per capita GDP=99.77% in Latin America. Universal screening may reduce the annual number of stillbirths by 20,344 and 4,270, neonatal deaths by 8,201 and 1,721, cases of congenital syphilis by 10,952 and 2,298, and avert 925,039 and 197,454 DALYs in the aggregate Asian and Latin American panel, respectively.Antenatal syphilis screening is highly cost-effective in all the 11 Asian and 20 Latin American countries assessed. Our findings support the decision to expand syphilis screening in countries with currently low screening rates or

  4. Quantitative influenza follow-up testing (QIFT--a novel biomarker for the monitoring of disease activity at the point-of-care.

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    Xi Chen

    Full Text Available BACKGROUND: Influenza infections induce considerable disease burden in young children. Biomarkers for the monitoring of disease activity at the point-of-care (POC are currently lacking. Recent methodologies for fluorescence-based rapid testing have been developed to provide improved sensitivities with the initial diagnosis. The present study aims to explore the utility of second-generation rapid testing during longitudinal follow-up of influenza patients (Rapid Influenza Follow-up Testing = RIFT. Signal/control fluorescent readouts (Quantitative Influenza Follow-up Testing = QIFT are evaluated as a potential biomarker for the monitoring of disease activity at the POC. METHODS AND FINDINGS: RIFT (SOFIA and QIFT were performed at the POC and compared to blinded RT-PCR at the National Reference Centre for Influenza. From 10/2011-4/2013, a total of 2048 paediatric cases were studied prospectively; 273 cases were PCR-confirmed for influenza. During follow-up, RIFT results turned negative either prior to PCR (68%, or simultaneously (30%. The first negative RIFT occurred after a median of 8 days with a median virus load (VL of 5.6×10∧3 copies/ml and cycle threshold of 37, with no evidence of viral rebound. Binning analysis revealed that QIFT differentiated accurately between patients with low, medium and high viral titres. QIFT increase/decrease showed 88% agreement (sensitivity = 52%, specificity = 95% with VL increase/decrease, respectively. QIFT-based viral clearance estimates showed similar values compared to PCR-based estimates. Variations in viral clearance rates were lower in treated compared to untreated patients. The study was limited by use of non-invasive, semi-quantitative nasopharyngeal samples. VL measurements below the limit of detection could not be quantified reliably. CONCLUSIONS: During follow-up, RIFT provides a first surrogate measure for influenza disease activity. A "switch" from positive to negative values may

  5. Multidisciplinary Point-of-Care Testing in South African Primary Health Care Clinics Accelerates HIV ART Initiation but Does Not Alter Retention in Care.

    Science.gov (United States)

    Stevens, Wendy S; Gous, Natasha M; MacLeod, William B; Long, Lawrence C; Variava, Ebrahim; Martinson, Neil A; Sanne, Ian; Osih, Regina; Scott, Lesley E

    2017-09-01

    Lack of accessible laboratory infrastructure limits HIV antiretroviral therapy (ART) initiation, monitoring, and retention in many resource-limited settings. Point-of-care testing (POCT) is advocated as a mechanism to overcome these limitations. We executed a pragmatic, prospective, randomized, controlled trial comparing the impact of POCT vs. standard of care (SOC) on treatment initiation and retention in care. Selected POC technologies were embedded at 3 primary health clinics in South Africa. Confirmed HIV-positive participants were randomized to either SOC or POC: SOC participants were venesected and specimens referred to the laboratory with patient follow-up as per algorithm (∼3 visits); POC participants had phlebotomy and POCT immediately on-site using Pima CD4 to assess ART eligibility followed by hematology, chemistry, and tuberculosis screening with the goal of receiving same-day adherence counseling and treatment initiation. Participant outcomes measured at recruitment 6 and 12 months after initiation. Four hundred thirty-two of 717 treatment eligible participants enrolled between May 2012 and September 2013: 198 (56.7%) SOC; 234 (63.6%) POC. Mean age was 37.4 years; 60.5% were female. Significantly more participants were initiated using POC [adjusted prevalence ratio (aPR) 0.83; 95% confidence interval (CI): 0.74 to 0.93; P ART was similar for both arms at 6 months (47 vs. 50%) (aPR 0.96; 95% CI: 0.79 to 1.16) and 12 months (32 vs. 32%) (aPR 1.05; 95% CI: 0.80 to 1.38), with similar mortality rates. Loss to follow-up at 12 months was higher for POC (36% vs. 51%) (aPR 0.82; 95% CI: 0.65 to 1.04). Adoption of POCT accelerated ART initiation but once on treatment, there was unexpectedly higher loss to follow-up on POC and no improvement in outcomes at 12 months over SOC.

  6. Point of care testing provides an accurate measurement of creatinine, anion gap, and osmolal gap in ex-vivo whole blood samples with nitromethane.

    Science.gov (United States)

    Cao, D; Maynard, S; Mitchell, A M; Kerns, W P; Beuhler, M

    2014-07-01

    Nitromethane interferes with Jaffé measurements of creatinine, potentially mimicking acute kidney injury. We determined the proportional contribution of nitromethane in blood samples to creatinine measured by the Jaffé colorimetric and the point-of-care (POC) reactions and determined whether the difference can reliably estimate the concentration of nitromethane. Additionally, we determined whether the presence of nitromethane interferes with anion/osmolal gaps and ascertained the stability of nitromethane in serum after 7 days. Nitromethane was added to whole blood from four healthy volunteers to achieve concentrations of 0, 0.25, 0.5, 1, and 2 mmol/L. The following tests were performed: creatinine (Jaffé and POC), electrolytes (associated with Jaffé and POC), osmolality and nitromethane concentration (gas chromatography [GC]). Remaining samples were refrigerated and reanalyzed using GC at 7 days. Anion and osmolal gaps were calculated. Proportional recovery and degradation of nitromethane were measured using GC. Data were analyzed for agreement with single-factor ANOVA (p = 0.05). Mean creatinine for POC and Jaff methods were 0.93 vs. 0.76 mg/dL, respectively. Jaff creatinine concentrations increased linearly with increasing nitromethane concentrations (R(2) = 1, p = 0.01): measured creatinine (mg/dL) = 7.1*nitromethane (mmol/L) = 0.79. POC creatinine remained unchanged across the range of nitromethane concentrations (p = 0.99). Anion and osmolal gaps also remained unchanged. Nitromethane was reliably identified in all sample concentrations using GC on Day 0. Detection of 0.25 mmol/L nitromethane was not consistently recovered on Day 7. Nitromethane degradation was most pronounced at 2 mmol/L concentrations (81% recovery). Nitromethane alters apparent concentration of creatinine using the Jaffé reaction in a linear fashion but not when using the POC reaction. Measured difference between Jaffé and POC creatinine may identify the presence and estimate

  7. “I Do Feel Like a Scientist at Times”: A Qualitative Study of the Acceptability of Molecular Point-Of-Care Testing for Chlamydia and Gonorrhoea to Primary Care Professionals in a Remote High STI Burden Setting

    Science.gov (United States)

    Natoli, Lisa; Guy, Rebecca J.; Shephard, Mark; Causer, Louise; Badman, Steven G.; Hengel, Belinda; Tangey, Annie; Ward, James; Coburn, Tony; Anderson, David; Kaldor, John; Maher, Lisa

    2015-01-01

    Background Point-of-care tests for chlamydia (CT) and gonorrhoea (NG) could increase the uptake and timeliness of testing and treatment, contribute to improved disease control and reduce reproductive morbidity. The GeneXpert (Xpert CT/NG assay), suited to use at the point-of-care, is being used in the TTANGO randomised controlled trial (RCT) in 12 remote Australian health services with a high burden of sexually transmissible infections (STIs). This represents the first ever routine use of a molecular point-of-care diagnostic for STIs in primary care. The purpose of this study was to explore the acceptability of the GeneXpert to primary care staff in remote Australia. Methods In-depth qualitative interviews were conducted with 16 staff (registered or enrolled nurses and Aboriginal Health Workers/Practitioners) trained and experienced with GeneXpert testing. Interviews were digitally-recorded and transcribed verbatim prior to content analysis. Results Most participants displayed positive attitudes, indicating the test was both easy to use and useful in their clinical context. Participants indicated that point-of-care testing had improved management of STIs, resulting in more timely and targeted treatment, earlier commencement of partner notification, and reduced follow up efforts associated with client recall. Staff expressed confidence in point-of-care test results and treating patients on this basis, and reported greater job satisfaction. While point-of-care testing did not negatively impact on client flow, several found the manual documentation processes time consuming, suggesting that improved electronic connectivity and test result transfer between the GeneXpert and patient management systems could overcome this. Managing positive test results in a shorter time frame was challenging for some but most found it satisfying to complete episodes of care more quickly. Conclusions In the context of a RCT, health professionals working in remote primary care in Australia

  8. "I Do Feel Like a Scientist at Times": A Qualitative Study of the Acceptability of Molecular Point-Of-Care Testing for Chlamydia and Gonorrhoea to Primary Care Professionals in a Remote High STI Burden Setting.

    Directory of Open Access Journals (Sweden)

    Lisa Natoli

    Full Text Available Point-of-care tests for chlamydia (CT and gonorrhoea (NG could increase the uptake and timeliness of testing and treatment, contribute to improved disease control and reduce reproductive morbidity. The GeneXpert (Xpert CT/NG assay, suited to use at the point-of-care, is being used in the TTANGO randomised controlled trial (RCT in 12 remote Australian health services with a high burden of sexually transmissible infections (STIs. This represents the first ever routine use of a molecular point-of-care diagnostic for STIs in primary care. The purpose of this study was to explore the acceptability of the GeneXpert to primary care staff in remote Australia.In-depth qualitative interviews were conducted with 16 staff (registered or enrolled nurses and Aboriginal Health Workers/Practitioners trained and experienced with GeneXpert testing. Interviews were digitally-recorded and transcribed verbatim prior to content analysis.Most participants displayed positive attitudes, indicating the test was both easy to use and useful in their clinical context. Participants indicated that point-of-care testing had improved management of STIs, resulting in more timely and targeted treatment, earlier commencement of partner notification, and reduced follow up efforts associated with client recall. Staff expressed confidence in point-of-care test results and treating patients on this basis, and reported greater job satisfaction. While point-of-care testing did not negatively impact on client flow, several found the manual documentation processes time consuming, suggesting that improved electronic connectivity and test result transfer between the GeneXpert and patient management systems could overcome this. Managing positive test results in a shorter time frame was challenging for some but most found it satisfying to complete episodes of care more quickly.In the context of a RCT, health professionals working in remote primary care in Australia found the GeneXpert highly

  9. Effect of point-of-care CD4 cell count results on linkage to care and antiretroviral initiation during a home-based HIV testing campaign: a non-blinded, cluster-randomised trial.

    Science.gov (United States)

    Desai, Mitesh A; Okal, Dancun O; Rose, Charles E; Ndivo, Richard; Oyaro, Boaz; Otieno, Fredrick O; Williams, Tiffany; Chen, Robert T; Zeh, Clement; Samandari, Taraz

    2017-09-01

    HIV disease staging with referral laboratory-based CD4 cell count testing is a key barrier to the initiation of antiretroviral treatment (ART). Point-of-care CD4 cell counts can improve linkage to HIV care among people living with HIV, but its effect has not been assessed with a randomised controlled trial in the context of home-based HIV counselling and testing (HBCT). We did a two-arm, cluster-randomised, controlled efficacy trial in two districts of western Kenya with ongoing HBCT. Housing compounds were randomly assigned (1:1) to point-of-care CD4 cell counts (366 compounds with 417 participants) or standard-of-care (318 compounds with 353 participants) CD4 cell counts done at one of three referral laboratories serving the study catchment area. In each compound, we enrolled people with HIV not engaged in care in the previous 6 months. All participants received post-test counselling and referral for HIV care. Point-of-care test participants received additional counselling on the result, including ART eligibility if CD4 was less than 350 cells per μL, the cutoff in Kenyan guidelines. Participants were interviewed 6 months after enrolment to ascertain whether they sought HIV care, verified through chart reviews at 23 local clinics. The prevalence of loss to follow-up at 6 months (LTFU) was listed as the main outcome in the study protocol. We analysed linkage to care at 6 months (defined as 1-LTFU) as the primary outcome. All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT02515149. We enrolled 770 participants between July 1, 2013, and Feb 28, 2014. 692 (90%) had verified linkage to care status and 78 (10%) were lost to follow-up. Of 371 participants in the point-of-care group, 215 (58%) had linked to care within 6 months versus 108 (34%) of 321 in the standard-of-care group (Cox proportional multivariable hazard ratio [HR] 2·14, 95% CI 1·67-2·74; log rank pPoint-of-care CD4 cell counts in a resource-limited HBCT

  10. Implementation of Point-of-Care Diagnostics Leads to Variable Uptake of Syphilis, Anemia and CD4+ T-Cell Count Testing in Rural Maternal and Child Health Clinics.

    Science.gov (United States)

    De Schacht, Caroline; Lucas, Carlota; Sitoe, Nádia; Machekano, Rhoderick; Chongo, Patrina; Temmerman, Marleen; Tobaiwa, Ocean; Guay, Laura; Kassaye, Seble; Jani, Ilesh V

    2015-01-01

    Anemia, syphilis and HIV are high burden diseases among pregnant women in sub-Saharan Africa. A quasi-experimental study was conducted in four health facilities in Southern Mozambique to evaluate the effect of point-of-care technologies for hemoglobin quantification, syphilis testing and CD4+ T-cell enumeration performed within maternal and child health services on testing and treatment coverage, and assessing acceptability by health workers. Demographic and testing data on women attending first antenatal care services were extracted from existing records, before (2011; n = 865) and after (2012; n = 808) introduction of point-of-care testing. Study outcomes per health facility were compared using z-tests (categorical variables) and Wilcoxon rank-sum test (continuous variables), while inverse variance weights were used to adjust for possible cluster effects in the pooled analysis. A structured acceptability-assessment interview was conducted with health workers before (n = 22) and after (n = 19). After implementation of point-of-care testing, there was no significant change in uptake of overall hemoglobin screening (67.9% to 83.0%; p = 0.229), syphilis screening (80.8% to 87.0%; p = 0.282) and CD4+ T-cell testing (84.9% to 83.5%; p = 0.930). Initiation of antiretroviral therapy for treatment eligible women was similar in the weighted analysis before and after, with variability among the sites. Time from HIV diagnosis to treatment initiation decreased (median of 44 days to 17 days; ppoint-of-care testing was seen among health workers. Point-of-care CD4+ T-cell enumeration resulted in a decreased time to initiation of antiretroviral therapy among treatment eligible women, without significant increase in testing coverage. Overall hemoglobin and syphilis screening increased. Despite the perception that point-of-care technologies increase access to health services, the variability in results indicate the potential for detrimental effects in some settings. Local context

  11. DEPIVIH 2: Use of three HIV testing methods in French primary care settings - ELISA laboratory screening versus two rapid point-of-care HIV tests.

    Science.gov (United States)

    Papadima, D; Gauthier, R; Prévoteau du Clary, F; Bouée, S; Conort, G; Livrozet, J-M; Taulera, O; Wajsbrot, A; Majerholc, C; Peter, J-M; Aubert, J-P

    2018-03-01

    The primary endpoint was to evaluate the use of HIV testing methods by French primary care providers: Elisa laboratory screening, instant result HIV diagnostic test and rapid result HIV diagnostic test. The secondary endpoints were the population screening rate of unknown HIV status consulting during the study period, reasons for screening and for choosing the specific screening method, the investigators' satisfaction with the rapid diagnostic test (RDT) and problems encountered. National prospective interventional study with French family physicians (FP) from December 2013 to December 2014. FPs enrolled all consenting adults consulting for an HIV screening test during a 6-month period: the choice was an Elisa laboratory test or one of the two RDTs. During the study period, 43 FPs included 981 patients. HIV screening was performed for the first time for 31.6% of patients; 767 (78.2%) Elisa laboratory test prescriptions and 214 (21.8%) RDTs were performed, leading to a screening rate of 1.3%. For 120 (15.7%) of the Elisa laboratory tests, the result was not reported and six RDTs were not valid. Nine patients were diagnosed as HIV-infected (0.9%): five with Elisa laboratory test and four with RDT. Almost 90% of FPs were willing to keep on using RDTs in their daily practice. In general practice, RDTs may be an important additional tool to traditional HIV screening. They could account for one in five tests prescribed in this context. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  12. Point-of-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries.

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    Ian J Begeman

    2017-06-01

    Full Text Available Congenital toxoplasmosis is a serious but preventable and treatable disease. Gestational screening facilitates early detection and treatment of primary acquisition. Thus, fetal infection can be promptly diagnosed and treated and outcomes can be improved.We tested 180 sera with the Toxoplasma ICT IgG-IgM point-of-care (POC test. Sera were from 116 chronically infected persons (48 serotype II; 14 serotype I-III; 25 serotype I-IIIa; 28 serotype Atypical, haplogroup 12; 1 not typed. These represent strains of parasites infecting mothers of congenitally infected children in the U.S. 51 seronegative samples and 13 samples from recently infected persons known to be IgG/IgM positive within the prior 2.7 months also were tested. Interpretation was confirmed by two blinded observers. A comparison of costs for POC vs. commercial laboratory testing methods was performed.We found that this new Toxoplasma ICT IgG-IgM POC test was highly sensitive (100% and specific (100% for distinguishing IgG/IgM-positive from negative sera. Use of such reliable POC tests can be cost-saving and benefit patients.Our work demonstrates that the Toxoplasma ICT IgG-IgM test can function reliably as a point-of-care test to diagnose Toxoplasma gondii infection in the U.S. This provides an opportunity to improve maternal-fetal care by using approaches, diagnostic tools, and medicines already available. This infection has serious, lifelong consequences for infected persons and their families. From the present study, it appears a simple, low-cost POC test is now available to help prevent morbidity/disability, decrease cost, and make gestational screening feasible. It also offers new options for improved prenatal care in low- and middle-income countries.

  13. Point-of-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries.

    Science.gov (United States)

    Begeman, Ian J; Lykins, Joseph; Zhou, Ying; Lai, Bo Shiun; Levigne, Pauline; El Bissati, Kamal; Boyer, Kenneth; Withers, Shawn; Clouser, Fatima; Noble, A Gwendolyn; Rabiah, Peter; Swisher, Charles N; Heydemann, Peter T; Contopoulos-Ioannidis, Despina G; Montoya, Jose G; Maldonado, Yvonne; Ramirez, Raymund; Press, Cindy; Stillwaggon, Eileen; Peyron, François; McLeod, Rima

    2017-06-01

    Congenital toxoplasmosis is a serious but preventable and treatable disease. Gestational screening facilitates early detection and treatment of primary acquisition. Thus, fetal infection can be promptly diagnosed and treated and outcomes can be improved. We tested 180 sera with the Toxoplasma ICT IgG-IgM point-of-care (POC) test. Sera were from 116 chronically infected persons (48 serotype II; 14 serotype I-III; 25 serotype I-IIIa; 28 serotype Atypical, haplogroup 12; 1 not typed). These represent strains of parasites infecting mothers of congenitally infected children in the U.S. 51 seronegative samples and 13 samples from recently infected persons known to be IgG/IgM positive within the prior 2.7 months also were tested. Interpretation was confirmed by two blinded observers. A comparison of costs for POC vs. commercial laboratory testing methods was performed. We found that this new Toxoplasma ICT IgG-IgM POC test was highly sensitive (100%) and specific (100%) for distinguishing IgG/IgM-positive from negative sera. Use of such reliable POC tests can be cost-saving and benefit patients. Our work demonstrates that the Toxoplasma ICT IgG-IgM test can function reliably as a point-of-care test to diagnose Toxoplasma gondii infection in the U.S. This provides an opportunity to improve maternal-fetal care by using approaches, diagnostic tools, and medicines already available. This infection has serious, lifelong consequences for infected persons and their families. From the present study, it appears a simple, low-cost POC test is now available to help prevent morbidity/disability, decrease cost, and make gestational screening feasible. It also offers new options for improved prenatal care in low- and middle-income countries.

  14. Point-of-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries

    Science.gov (United States)

    Zhou, Ying; Lai, Bo Shiun; Levigne, Pauline; El Bissati, Kamal; Boyer, Kenneth; Withers, Shawn; Clouser, Fatima; Noble, A. Gwendolyn; Rabiah, Peter; Swisher, Charles N.; Heydemann, Peter T.; Contopoulos-Ioannidis, Despina G.; Montoya, Jose G.; Maldonado, Yvonne; Ramirez, Raymund; Press, Cindy; Stillwaggon, Eileen; Peyron, François

    2017-01-01

    Background Congenital toxoplasmosis is a serious but preventable and treatable disease. Gestational screening facilitates early detection and treatment of primary acquisition. Thus, fetal infection can be promptly diagnosed and treated and outcomes can be improved. Methods We tested 180 sera with the Toxoplasma ICT IgG-IgM point-of-care (POC) test. Sera were from 116 chronically infected persons (48 serotype II; 14 serotype I-III; 25 serotype I-IIIa; 28 serotype Atypical, haplogroup 12; 1 not typed). These represent strains of parasites infecting mothers of congenitally infected children in the U.S. 51 seronegative samples and 13 samples from recently infected persons known to be IgG/IgM positive within the prior 2.7 months also were tested. Interpretation was confirmed by two blinded observers. A comparison of costs for POC vs. commercial laboratory testing methods was performed. Results We found that this new Toxoplasma ICT IgG-IgM POC test was highly sensitive (100%) and specific (100%) for distinguishing IgG/IgM-positive from negative sera. Use of such reliable POC tests can be cost-saving and benefit patients. Conclusions Our work demonstrates that the Toxoplasma ICT IgG-IgM test can function reliably as a point-of-care test to diagnose Toxoplasma gondii infection in the U.S. This provides an opportunity to improve maternal-fetal care by using approaches, diagnostic tools, and medicines already available. This infection has serious, lifelong consequences for infected persons and their families. From the present study, it appears a simple, low-cost POC test is now available to help prevent morbidity/disability, decrease cost, and make gestational screening feasible. It also offers new options for improved prenatal care in low- and middle-income countries. PMID:28650970

  15. Canadian Public Health Laboratory Network laboratory Guidelines for the Use of Serological Tests (excluding point-of-care tests for the Diagnosis of Syphilis in Canada

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    Paul N Levett

    2015-01-01

    Full Text Available Syphilis, caused by the bacterium Treponema pallidum subsp. pallidum, is an infection recognized since antiquity. It was first reported at the end of the 15th century in Europe. Infections may be sexually transmitted as well as spread from an infected mother to her fetus or through blood transfusions. The laboratory diagnosis of syphilis infection is complex. Because this organism cannot be cultured, serology is used as the principal diagnostic method. Some of the issues related to serological diagnoses are that antibodies take time to appear after infection, and serology screening tests require several secondary confirmatory tests that can produce complex results needing interpretation by experts in the field. Traditionally, syphilis screening was performed using either rapid plasma reagin or Venereal Disease Research Laboratory tests, and confirmed by treponemal tests such as MHA-TP, TPPA or FTA-Abs. Currently, that trend is reversed, ie, most of the laboratories in Canada now screen for syphilis using treponemal enzyme immunoassays and confirm the status of infection using rapid plasma reagin or Venereal Disease Research Laboratory tests; this approach is often referred to as the reverse algorithm. This chapter reviews guidelines for specimen types and sample collection, treponemal and non-treponemal tests utilized in Canada, the current status of serological tests for syphilis in Canada, the complexity of serological diagnosis of syphilis infection and serological testing algorithms. Both traditional and reverse sequence algorithms are recommended and the algorithm used should be based on a combination of local disease epidemiology, test volumes, performance of the proposed assays and available resources.

  16. Integrated thin film Si fluorescence sensor coupled with a GaN microLED for microfluidic point-of-care testing

    Science.gov (United States)

    Robbins, Hannah; Sumitomo, Keiko; Tsujimura, Noriyuki; Kamei, Toshihiro

    2018-02-01

    An integrated fluorescence sensor consisting of a SiO2/Ta2O5 multilayer optical interference filter and hydrogenated amorphous silicon (a-Si:H) pin photodiode was coupled with a GaN microLED to construct a compact fluorescence detection module for point-of-care microfluidic biochemical analysis. The combination of the small size of the GaN microLED and asymmetric microlens resulted in a focal spot diameter of the excitation light of approximately 200 µm. The limit of detection of the sensor was as high as 36 nM for fluorescein solution flowing in a 100 µm deep microfluidic channel because of the lack of directionality of the LED light. Nevertheless, we used the GaN microLED coupled with the a-Si:H fluorescence sensor to successfully detect fluorescence from a streptavidin R-phycoerythrin conjugate that bound to biotinylated antibody-coated microbeads trapped by the barrier in the microfluidic channel.

  17. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    Cals, Jochen W L; Hopstaken, Rogier M; Butler, Christopher C; Hood, Kerenza; Severens, Johan L; Dinant, Geert-Jan

    2007-03-29

    Most antibiotic prescriptions for acute cough due to lower respiratory tract infections (LRTI) in primary care are not warranted. Diagnostic uncertainty and patient expectations and worries are major drivers of unnecessary antibiotic prescribing. A C-reactive protein (CRP) point of care test may help GPs to better guide antibiotic treatment by ruling out pneumonia in cases of low test results. Alternatively, enhanced communication skills training to help clinicians address patients' expectations and worries could lead to a decrease in antibiotic prescribing, without compromising clinical recovery, while enhancing patient enablement. The aim of this paper is to describe the design and methods of a study to assess two interventions for improving LRTI management in general practice. This cluster randomised controlled, factorial trial will introduce two interventions in general practice; point of care CRP testing and enhanced communication skills training for LRTI. Twenty general practices with two participating GPs per practice will recruit 400 patients with LRTI during two winter periods. Patients will be followed up for at least 28 days. The primary outcome measure is the antibiotic prescribing rate. Secondary outcomes are clinical recovery, cost-effectiveness, use of other diagnostic tests and medical services (including reconsultation), and patient enablement. This trial is the first cluster randomised trial to evaluate the influence of point of care CRP testing in the hands of the general practitioner and enhanced communication skills, on the management of LRTI in primary care. The pragmatic nature of the study, which leaves treatment decisions up to the responsible clinicians, will enhance the applicability and generalisability of findings. The factorial design will allow conclusion to be made about the value of CRP testing on its own, communication skills training on its own, and the two combined. Evaluating a biomedical and communication based intervention

  18. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T: study protocol of a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Severens Johan L

    2007-03-01

    Full Text Available Abstract Background Most antibiotic prescriptions for acute cough due to lower respiratory tract infections (LRTI in primary care are not warranted. Diagnostic uncertainty and patient expectations and worries are major drivers of unnecessary antibiotic prescribing. A C-reactive protein (CRP point of care test may help GPs to better guide antibiotic treatment by ruling out pneumonia in cases of low test results. Alternatively, enhanced communication skills training to help clinicians address patients' expectations and worries could lead to a decrease in antibiotic prescribing, without compromising clinical recovery, while enhancing patient enablement. The aim of this paper is to describe the design and methods of a study to assess two interventions for improving LRTI management in general practice. Methods/Design This cluster randomised controlled, factorial trial will introduce two interventions in general practice; point of care CRP testing and enhanced communication skills training for LRTI. Twenty general practices with two participating GPs per practice will recruit 400 patients with LRTI during two winter periods. Patients will be followed up for at least 28 days. The primary outcome measure is the antibiotic prescribing rate. Secondary outcomes are clinical recovery, cost-effectiveness, use of other diagnostic tests and medical services (including reconsultation, and patient enablement. Discussion This trial is the first cluster randomised trial to evaluate the influence of point of care CRP testing in the hands of the general practitioner and enhanced communication skills, on the management of LRTI in primary care. The pragmatic nature of the study, which leaves treatment decisions up to the responsible clinicians, will enhance the applicability and generalisability of findings. The factorial design will allow conclusion to be made about the value of CRP testing on its own, communication skills training on its own, and the two combined

  19. Exploring potential anticoagulant drug formulations using thrombin generation test

    Directory of Open Access Journals (Sweden)

    Elena Zavyalova

    2016-03-01

    The thrombin generation test was used to assess the whole coagulation cascade in normal and factor-deficient human blood plasma. Potential therapeutic windows were estimated for coagulation factors, ranking them as targets for anticoagulant drugs. Thrombin and factor Xa have been revealed as the most promising targets, which fully agrees with the current drug development strategy. Inhibitors of factors Va and VIIa are expected to have narrow therapeutic windows. Inhibitors of factors VIIIa and IXa are expected to have a moderate anticoagulant effect. Factors XI and XII are poor targets for anticoagulant drugs. Compared with plasma that is deficient in factor II, the thrombin inhibitors bivalirudin and aptamer HD1 had increased activity. Both inhibitors were tested in deficient plasma providing a model of potential drug combination. The most promising combinations were anti-thrombin with anti-V/Va and also anti-thrombin with anti-IX/IXa. Each combination had an incremental dose-effect dependence that is promising from the standpoint of the therapeutic window.

  20. Point-of-care biosensor system.

    Science.gov (United States)

    Vasan, Arvind Sai Sarathi; Mahadeo, Dinesh Michael; Doraiswami, Ravi; Huang, Yunhan; Pecht, Michael

    2013-01-01

    Point-of-care biosensor systems can potentially improve patient care through real-time and remote health monitoring. Over the past few decades, research has been conducted in the field of biosensors to detect patterns of biomarkers and provide information on their concentration in biological samples for robust diagnosis. In future point-of-care applications, requirements such as rapid label-free detection, miniaturized sensor size, and portability will limit the types of biosensors that can be used. This paper reviews label-free detection techniques using Biological MicroElectroMechanical Systems as a potential candidate for point-of-care biosensing applications. Furthermore, detailed surveys have been carried out on wireless networking schemes applicable for a point-of-care environment and on prognostic techniques that will enable decision-support services. This paper concludes by providing a list of challenges that must be resolved before realizing biosensor systems for next-generation point-of-care applications.

  1. Point-of-Care Endocrine Diagnostics.

    Science.gov (United States)

    Ehrenkranz, Joel

    2017-09-01

    Endocrinology relies on hormone and metabolite measurement for public health screening, diagnostics, and disease management. Advances in microfluidics, immunoassay technology, electronics, and software are moving in vitro endocrine diagnostics from the laboratory to the point of care. Point-of-care endocrine diagnostics provide results clinically equivalent to those produced by expensive laboratory instrumentation for a fraction of the cost and with a substantially more rapid turnaround time. Similar to the transformation of mainframe computers into laptops, tablets, and smartphones, clinical laboratories are evolving into point-of-care technologies. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Usefulness in clinical practice of a point-of-care rapid test for simultaneous detection of nontreponemal and Treponema pallidum-specific antibodies in patients suffering from documented syphilis.

    Science.gov (United States)

    Guinard, Jérôme; Prazuck, Thierry; Péré, Hélène; Poirier, Claire; LeGoff, Jérôme; Boedec, Erwan; Guigon, Aurélie; Day, Nesrine; Bélec, Laurent

    2013-12-01

    The usefulness of a point-of-care immunochromatographic dual test for the simultaneous detection of both nontreponemal and Treponema pallidum-specific antibodies (Chembio Diagnostics Systems Inc., Medford, NY, USA) was assessed in various situations related to syphilis, by reference to conventional syphilis serology. Thawed sera were obtained from 100 adults including 36 primary syphilis, 6 secondary syphilis, 6 re-infection, 9 recently-treated syphilis, and 43 old syphilis. Doubtful reactivities for the treponemal line were considered positive; doubtful reactivities for the nontreponemal line were considered positive only when the treponemal line was present. The sensitivity, the specificity, and its concordance to gold standard serology of treponemal line were high, around 90%. The sensitivity of nontreponemal line was 96.3%, its specificity 76.7%, and its concordance 83.4%. In conclusion, the dual rapid test from Chembio Diagnostics Systems Inc. is useful for rapid point-of-care diagnosis in the various situations encountered with patients suffering from syphilis.

  3. Procalcitonin for selecting the antibiotic regimen in outpatients with low-risk community-acquired pneumonia using a rapid point-of-care testing: A single-arm clinical trial

    Science.gov (United States)

    Masiá, Mar; Padilla, Sergio; Ortiz de la Tabla, Victoria; González, Matilde; Bas, Cristina; Gutiérrez, Félix

    2017-01-01

    Objective We aimed to assess the role of procalcitonin (PCT) to guide the initial selection of the antibiotic regimen for low-risk community-acquired pneumonia (CAP). Methods A single-arm clinical trial was conducted including outpatients with CAP and Pneumonia Severity Index risk classes I-II. Antimicrobial selection was based on the results of PCT measured with a rapid point-of-care testing. According to serum PCT levels, patients were assigned to two treatment strategies: oral azithromycin if PCT was Atypical organisms were more common in patients given azithromycin (18.5% vs 8.1%, respectively). The majority (93%) of patients with atypical pneumonia had low PCT levels. Clinical cure rates were 95.8% in the azithromycin group, 94.6% in the levofloxacin group, and 94.4% in the historical control group. No 30-day mortality or recurrences were observed, and the 3-year rates of recurrence and mortality were very low in both groups. Adverse events occurrence was also infrequent. Conclusion A PCT-guided strategy with a rapid point-of-care testing safely allowed selecting empirical narrow-spectrum antibiotics in outpatients with CAP. Trial registration The study is registered with ClinicalTrials.gov, number NCT02600806 PMID:28426811

  4. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial.

    Science.gov (United States)

    Do, Nga T T; Ta, Ngan T D; Tran, Ninh T H; Than, Hung M; Vu, Bich T N; Hoang, Long B; van Doorn, H Rogier; Vu, Dung T V; Cals, Jochen W L; Chandna, Arjun; Lubell, Yoel; Nadjm, Behzad; Thwaites, Guy; Wolbers, Marcel; Nguyen, Kinh V; Wertheim, Heiman F L

    2016-09-01

    Inappropriate antibiotic use for acute respiratory tract infections is common in primary health care, but distinguishing serious from self-limiting infections is difficult, particularly in low-resource settings. We assessed whether C-reactive protein point-of-care testing can safely reduce antibiotic use in patients with non-severe acute respiratory tract infections in Vietnam. We did a multicentre open-label randomised controlled trial in ten primary health-care centres in northern Vietnam. Patients aged 1-65 years with at least one focal and one systemic symptom of acute respiratory tract infection were assigned 1:1 to receive either C-reactive protein point-of-care testing or routine care, following which antibiotic prescribing decisions were made. Patients with severe acute respiratory tract infection were excluded. Enrolled patients were reassessed on day 3, 4, or 5, and on day 14 a structured telephone interview was done blind to the intervention. Randomised assignments were concealed from prescribers and patients but not masked as the test result was used to assist treatment decisions. The primary outcome was antibiotic use within 14 days of follow-up. All analyses were prespecified in the protocol and the statistical analysis plan. All analyses were done on the intention-to-treat population and the analysis of the primary endpoint was repeated in the per-protocol population. This trial is registered under number NCT01918579. Between March 17, 2014, and July 3, 2015, 2037 patients (1028 children and 1009 adults) were enrolled and randomised. One adult patient withdrew immediately after randomisation. 1017 patients were assigned to receive C-reactive protein point-of-care testing, and 1019 patients were assigned to receive routine care. 115 patients in the C-reactive protein point-of-care group and 72 patients in the routine care group were excluded in the intention-to-treat analysis due to missing primary endpoint. The number of patients who used antibiotics

  5. Exploring risks and benefits of point-of-care tests for healthcare and self-tests for laypersons: an interview study assessing complementary expert perspectives on diagnostic lab-on-a-chip systems.

    Science.gov (United States)

    Kuecuekbalaban, Pinar; Schmidt, Silke; Kraft, Kathleen; Hoffmann, Wolfgang; Muehlan, Holger

    2014-01-01

    A commercial breakthrough of point-of-care testing (POCT) and self-tests for laypersons (direct-to-consumer applications, DTC) is anticipated based on the advancements in the development of lab-on-a-chip system (LOC) technology. The aim of this study was to investigate risks and benefits of LOC based diagnostic devices for healthcare and private self-testers. Interviews with 22 developers/researchers of LOC technology and 10 technology assessment experts were conducted about the (a) need for, (b) benefits, and (c) risks of LOCs for healthcare and as DTC applications. A qualitative content analysis was conducted. Need for LOCs were seen mainly for healthcare, but not as DTC applications for fatal diseases. While benefits were seen mainly for healthcare and partially for DTC applications (e.g. faster diagnostics, more favourable diagnostics, POCT), risks were emphasised especially for DTC applications and less frequently for healthcare (e.g. various technical challenges, misinterpretation of test results, quality/reliability requirements). Medical expertise is the key imperative for the application of LOC based portable diagnostic devices in healthcare and particularly for self-testing. LOCs have to be designed to be easily operated and interpreted by self-testers. For healthcare, LOCs are envisaged to be a promising emerging technology with various benefits.

  6. Results of an Innovative Education, Training and Quality Assurance Program for Point-of-Care HbA1c Testing using the Bayer DCA 2000 in Australian Aboriginal Community Controlled Health Services

    Science.gov (United States)

    Shephard, Mark D; Gill, Janice P

    2003-01-01

    This study describes the development, implementation and management of a multi-faceted quality assurance program called Quality Assurance for Aboriginal Medical Services (QAAMS) to support point-of-care HbA1c testing on the Bayer DCA 2000 in Aboriginal people with diabetes from 45 Australian Aboriginal Community Controlled Health Services. The quality assurance program comprised four elements: production of culturally appropriate education resources, formal training for Aboriginal Health Workers conducting HbA1c testing, an external quality assurance program and on-going quality management support services including a help hotline and an annual workshop. Aboriginal Health Workers were required to test two quality assurance (QAAMS) samples in a blind sense every month since July 1999. Samples were linearly related and comprised six paired levels of HbA1c. The short and long term performance of each service’s DCA 2000 was reviewed monthly and at the end of each six month testing cycle. The average participation rate over 7 six-monthly QAAMS testing cycles was 88%. 84% of 3100 quality assurance tests performed were within preset limits of acceptability. The median precision (CV%) for HbA1c testing has averaged 3.8% across the past 5 cycles (range 3.4 to 4.0%) and is continuing to improve. The introduction of a medical rebate for HbA1c testing has ensured the program’s sustainability. Through continuing education and training, Aboriginal Health Workers have achieved consistent analytical performance for HbA1c testing on the DCA 2000, equivalent to that of laboratory scientists using the same instrument. This unique quality assurance model can be readily adapted to other Indigenous health settings and other point-of-care tests and instruments. PMID:18568052

  7. Should malaria treatment be guided by a point of care rapid test? A threshold approach to malaria management in rural Burkina Faso.

    Directory of Open Access Journals (Sweden)

    Zeno Bisoffi

    Full Text Available BACKGROUND: In Burkina Faso, rapid diagnostic tests for malaria have been made recently available. Previously, malaria was managed clinically. This study aims at assessing which is the best management option of a febrile patient in a hyperendemic setting. Three alternatives are: treating presumptively, testing, or refraining from both test and treatment. The test threshold is the tradeoff between refraining and testing, the test-treatment threshold is the tradeoff between testing and treating. Only if the disease probability lies between the two should the test be used. METHODS AND FINDINGS: Data for this analysis was obtained from previous studies on malaria rapid tests, involving 5220 patients. The thresholds were calculated, based on disease risk, treatment risk and cost, test accuracy and cost. The thresholds were then matched against the disease probability. For a febrile child under 5 in the dry season, the pre-test probability of clinical malaria (3.2%, was just above the test/treatment threshold. In the rainy season, that probability was 63%, largely above the test/treatment threshold. For febrile children >5 years and adults in the dry season, the probability was 1.7%, below the test threshold, while in the rainy season it was higher (25.1%, and situated between the two thresholds (3% and 60.9%, only if costs were not considered. If they were, neither testing nor treating with artemisinin combination treatments (ACT would be recommended. CONCLUSIONS: A febrile child under 5 should be treated presumptively. In the dry season, the probability of clinical malaria in adults is so low, that neither testing nor treating with any regimen should be recommended. In the rainy season, if costs are considered, a febrile adult should not be tested, nor treated with ACT, but a possible alternative would be a presumptive treatment with amodiaquine plus sulfadoxine-pyrimethamine. If costs were not considered, testing would be recommended.

  8. A novel point-of-care testing strategy for sexually transmitted infections among pregnant women in high-burden settings: results of a feasibility study in Papua New Guinea.

    Science.gov (United States)

    Badman, Steven G; Vallely, Lisa M; Toliman, Pamela; Kariwiga, Grace; Lote, Bomesina; Pomat, William; Holmer, Caroline; Guy, Rebecca; Luchters, Stanley; Morgan, Chris; Garland, Suzanne M; Tabrizi, Sepehr; Whiley, David; Rogerson, Stephen J; Mola, Glen; Wand, Handan; Donovan, Basil; Causer, Louise; Kaldor, John; Vallely, Andrew

    2016-06-06

    Sexually transmitted and genital infections in pregnancy are associated with an increased risk of adverse maternal and neonatal health outcomes. High prevalences of sexually transmitted infections have been identified among antenatal attenders in Papua New Guinea. Papua New Guinea has amongst the highest neonatal mortality rates worldwide, with preterm birth and low birth weight major contributors to neonatal mortality. The overall aim of our study was to determine if a novel point-of-care testing and treatment strategy for the sexually transmitted and genital infections Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Bacterial vaginosis (BV) in pregnancy is feasible in the high-burden, low-income setting of Papua New Guinea. Women attending their first antenatal clinic visit were invited to participate. CT/NG and TV were tested using the GeneXpert platform (Cepheid, USA), and BV tested using BVBlue (Gryphus Diagnostics, USA). Participants received same-day test results and antibiotic treatment as indicated. Routine antenatal care including HIV and syphilis screening were provided. Point-of-care testing was provided to 125/222 (56 %) of women attending routine antenatal care during the three-month study period. Among the 125 women enrolled, the prevalence of CT was 20.0 %; NG, 11.2 %; TV, 37.6 %; and BV, 17.6 %. Over half (67/125, 53.6 %) of women had one or more of these infections. Most women were asymptomatic (71.6 %; 47/67). Women aged 24 years and under were more likely to have one or more STI compared with older women (odds ratio 2.38; 95 % CI: 1.09, 5.21). Most women with an STI received treatment on the same day (83.6 %; 56/67). HIV prevalence was 1.6 % and active syphilis 4.0 %. Point-of-care STI testing and treatment using a combination of novel, newly-available assays was feasible during routine antenatal care in this setting. This strategy has not previously been evaluated in any setting and offers the

  9. Acceptability and feasibility of point-of-care CD4 testing on HIV continuum of care in low and middle income countries: a systematic review.

    Science.gov (United States)

    Pham, Minh D; Agius, Paul A; Romero, Lorena; McGlynn, Peter; Anderson, David; Crowe, Suzanne M; Luchters, Stanley

    2016-08-02

    CD4 testing is, and will remain an important part of HIV treatment and care in low and middle income countries (LMICs). We report the findings of a systematic review assessing acceptability and feasibility of POC CD4 testing in field settings. Electronic databases were searched for studies published in English between 2005 and 2015 that describe POC CD4 platforms. Studies conducted in LMICs and under field conditions outside a laboratory environment were eligible. Qualitative and descriptive data analysis was used to present the findings. Twelve studies were included, 11 of which were conducted in sub-Saharan countries and used one POC CD4 test (The Alere Pima CD4). Patients reported positively regarding the implementation of POC CD4 testing at primary health care and community level with ≥90 % of patients accepting the test across various study settings. Health service providers expressed preference toward POC CD4 testing as it is easy-to-use, efficient and satisfied patients' needs to a greater extent as compared to conventional methods. However, operational challenges including preference toward venous blood rather than finger-prick sampling, frequent device failures and operator errors, quality of training for test operators and supervisors, and increased staff workload were also identified. POC CD4 testing seems acceptable and feasible in LIMCs under field conditions. Further studies using different POC CD4 tests available on the market are required to provide critical data to support countries in selection and implementation of appropriate POC CD4 technologies.

  10. How to estimate the cost of point-of-care CD4 testing in program settings: an example using the Alere Pima Analyzer in South Africa.

    Directory of Open Access Journals (Sweden)

    Bruce Larson

    Full Text Available Integrating POC CD4 testing technologies into HIV counseling and testing (HCT programs may improve post-HIV testing linkage to care and treatment. As evaluations of these technologies in program settings continue, estimates of the costs of POC CD4 tests to the service provider will be needed and estimates have begun to be reported. Without a consistent and transparent methodology, estimates of the cost per CD4 test using POC technologies are likely to be difficult to compare and may lead to erroneous conclusions about costs and cost-effectiveness. This paper provides a step-by-step approach for estimating the cost per CD4 test from a provider's perspective. As an example, the approach is applied to one specific POC technology, the Pima Analyzer. The costing approach is illustrated with data from a mobile HCT program in Gauteng Province of South Africa. For this program, the cost per test in 2010 was estimated at $23.76 (material costs  = $8.70; labor cost per test  = $7.33; and equipment, insurance, and daily quality control  = $7.72. Labor and equipment costs can vary widely depending on how the program operates and the number of CD4 tests completed over time. Additional costs not included in the above analysis, for on-going training, supervision, and quality control, are likely to increase further the cost per test. The main contribution of this paper is to outline a methodology for estimating the costs of incorporating POC CD4 testing technologies into an HCT program. The details of the program setting matter significantly for the cost estimate, so that such details should be clearly documented to improve the consistency, transparency, and comparability of cost estimates.

  11. Evaluation of the LDBIO point of care test for the combined detection of toxoplasmic IgG and IgM.

    Science.gov (United States)

    Chapey, Emmanuelle; Wallon, Martine; Peyron, François

    2017-01-01

    The toxoplasma ICT IgG-IgM rapid diagnostic test for the simultaneous detection of specific toxoplasmic immunoglobulin (Ig) G and IgM was compared with the Architect fully automated chemiluminescence test. Four hundred sera were included, among which 248 scored negative in Architect. The cassettes were easily read with the naked eye. Diagnostic sensitivity and specificity were 97% and 96%, respectively. The test scored 8 false-positive IgG and yielded negative results in 3 sera displaying unspecific IgM in Architect. The LDBIO appears to be a reliable first line test, although the false-positive results for IgG deserve further investigation. Such an easily performed test could be used advantageously for screening for toxoplasmosis in pregnant women. Copyright © 2016 Elsevier B.V. All rights reserved.

  12. Urine lipoarabinomannan point-of-care testing in patients affected by pulmonary nontuberculous mycobacteria - experiences from the Danish Cystic Fibrosis cohort study

    DEFF Research Database (Denmark)

    Qvist, Tavs; Johansen, Isik S.; Pressler, Tania

    2014-01-01

    . We set forth to investigate if the test detects LAM in urine from a Danish cystic fibrosis (CF) population characterized by a high NTM prevalence and negligible TB exposure. Method: Patients followed at the Copenhagen CF Center were comprehensively screened for pulmonary NTM infection between May.......1%) at the grade 1 cut -point. Test specificity for NTM diagnosis was 98.3% and 93.1 for grade 2 and 1 cut-point respectively. Conclusions: This is the first study to assess urine LAM detection in patients with confirmed NTM infection. The study demonstrated low cross-reactivity due to NTM infection when using...... the recommended grade 2 cut-point as positivity threshold. This is reassuring in regards to interpretation of the LAM test for TB diagnosis in a TB prevalent setting. The test was not found suitable for NTM detection among patients with CF....

  13. Molecular point-of-care testing for respiratory viruses versus routine clinical care in adults with acute respiratory illness presenting to secondary care: a pragmatic randomised controlled trial protocol (ResPOC).

    Science.gov (United States)

    Brendish, Nathan J; Malachira, Ahalya K; Clark, Tristan W

    2017-02-06

    Respiratory viruses are associated with a huge socio-economic burden and are responsible for a large proportion of acute respiratory illness in hospitalised adults. Laboratory PCR is accurate but takes at least 24 h to generate a result to clinicians and antigen-based point-of-care tests (POCT) lack sensitivity. Rapid molecular platforms, such as the FilmArray Respiratory Panel, have equivalent diagnostic accuracy to laboratory PCR and can generate a result in 1 h making them deployable as POCT. Molecular point-of-care testing for respiratory viruses in hospital has the potential to improve the detection rate of respiratory viruses, improve the use of influenza antivirals and reduce unnecessary antibiotic use, but high quality randomised trials with clinically relevant endpoints are needed. The ResPOC study is a pragmatic randomised controlled trial of molecular point-of-care testing for respiratory viruses in adults with acute respiratory illness presenting to a large teaching hospital in the United Kingdom. Eligible participants are adults presenting with acute respiratory illness to the emergency department or the acute medicine unit. Participants are allocated 1:1 by internet-based randomisation service to either the intervention of a nose and throat swab analysed immediately on the FilmArray Respiratory Panel as a POCT or receive routine clinical care. The primary outcome is the proportion of patients treated with antibiotics. Secondary outcomes include turnaround time, virus detection, neuraminidase inhibitor use, length of hospital stay and side room use. Analysis of the primary outcome will be by intention-to-treat and all enrolled participants will be included in safety analysis. Multiple novel molecular POCT platforms for infections including respiratory viruses have been developed and licensed in the last few years and many more are in development but the evidence base for clinical benefit above standard practice is minimal. This randomised controlled

  14. Exploiting LBL-assembled Au nanoparticles to enhance Raman signals for point-of-care testing of osteoporosis with excreta sample

    Science.gov (United States)

    Sun, Jian F.; Liu, Xuan; Guo, Zhi R.; Dong, Jian; Huang, Yawen; Zhang, Jie; Jin, Hui; Gu, Ning

    2017-02-01

    Due to the intrinsic lack of specific biomarkers, there is an increasing demand for degenerative diseases to develop a testing method independent upon the targeting biomolecules. In this paper, we proposed a novel idea for this issue which was to analyze the characteristic information of metabolites with Raman spectrum. First, we achieved the fabrication of stable, uniform and reproducible substrate to enhance the Raman signals, which is crucial to the following analysis of information. This idea was confirmed with the osteoporosis-modeled mice. Furthermore, the testing results with clinical samples also preliminarily exhibited the feasibility of this strategy. The substrate to enhance Raman signal was fabricated by the layer-by-layer assembly of Au nanoparticles. The osteoporosis modeling was made by bilateral ovariectomy. Ten female mice were randomly divided into two groups. The urine and dejecta samples of mice were collected every week. Clinic urine samples were collected from patients with osteoporosis while the controlled samples were from the young students in our university. The LBL-assembled substrate of Au nanoparticles was uniform, stable and reproducible to significantly enhance the Raman signals from tiny amount of samples. With a simple data processing technique, the Raman signal-based method can effectively reflect the development of osteoporosis by comparison with micro-CT characterization. Moreover, the Raman signal from samples of clinic patients also showed the obvious difference with that of the control. Raman spectrum may be a good tool to convey the pathological information of metabolites in molecular level. Our results manifested that the information-based testing is possibly feasible and promising. Our strategy utilizes the characteristic information rather than the biological recognition to test the diseases which are difficult to find specific biomarkers. This will be greatly beneficial to the prevention and diagnosis of degenerative

  15. Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers’ Perspectives on Testing, Training and Quality Assurance

    Science.gov (United States)

    Ansbro, Éimhín M.; Gill, Michelle M.; Reynolds, Joanna; Shelley, Katharine D.; Strasser, Susan; Sripipatana, Tabitha; Ncube, Alexander Tshaka; Tembo Mumba, Grace; Terris-Prestholt, Fern; Peeling, Rosanna W.; Mabey, David

    2015-01-01

    Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new

  16. Automated microfluidic cartridges for point-of-care cell counting

    CSIR Research Space (South Africa)

    Smith, S

    2016-10-01

    Full Text Available This work presents microfluidic cartridges for automated blood cell counting towards a point-of-care (POC) full blood count (FBC). Total white blood cell count (WBC) and red blood cell count (RBC) tests were implemented using low-cost, disposable...

  17. A systematic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and syphilis.

    Science.gov (United States)

    Gliddon, Harriet D; Peeling, Rosanna W; Kamb, Mary L; Toskin, Igor; Wi, Teodora E; Taylor, Melanie M

    2017-12-01

    Mother-to-child transmission (MTCT) of syphilis and HIV continue to be important yet preventable causes of perinatal and infant morbidity and mortality. To systematically review, critically appraise and perform a meta-analysis to evaluate the operational characteristics of dual rapid diagnostic tests (RDTs) for HIV/syphilis and evaluate whether they are cost effective, acceptable and easy to use. Systematic review and meta-analysis. We searched seven electronic bibliographic databases from 2012 to December 2016 with no language restrictions. Search keywords included HIV, syphilis and diagnosis. We included studies that evaluated the operational characteristics of dual HIV/syphilis RDTs. Outcomes included diagnostic test accuracy, cost effectiveness, ease of use and interpretation and acceptability. All studies were assessed against quality criteria and assessed for risk of bias. Of 1914 identified papers, 18 were included for the meta-analysis of diagnostic accuracy for HIV and syphilis. All diagnostic accuracy evaluation studies showed a very high sensitivity and specificity for HIV and a lower, yet adequate, sensitivity and specificity for syphilis, with some variation among types of test. Dual screening for HIV and syphilis was more cost effective than single rapid tests for HIV and syphilis and prevented more adverse pregnancy outcomes. Qualitative data suggested dual RDTs were highly acceptable to clients, who cited time to result, cost and the requirement of a single finger prick as important characteristics of dual RDTs. The results of this systematic review and meta-analysis can be used by policy-makers and national programme managers who are considering implementing dual RDTs for HIV and syphilis. PROSPERO 2016:CRD42016049168. © World Health Organization 2017. Licensee BMJ Publishing Group Limited. This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (https://creativecommons.org/licenses/by/3.0/igo

  18. Procalcitonin for selecting the antibiotic regimen in outpatients with low-risk community-acquired pneumonia using a rapid point-of-care testing: A single-arm clinical trial.

    Directory of Open Access Journals (Sweden)

    Mar Masiá

    Full Text Available We aimed to assess the role of procalcitonin (PCT to guide the initial selection of the antibiotic regimen for low-risk community-acquired pneumonia (CAP.A single-arm clinical trial was conducted including outpatients with CAP and Pneumonia Severity Index risk classes I-II. Antimicrobial selection was based on the results of PCT measured with a rapid point-of-care testing. According to serum PCT levels, patients were assigned to two treatment strategies: oral azithromycin if PCT was <0.5 ng/ml, or levofloxacin if levels were ≥0.5 ng/ml. Primary outcome was clinical cure rate. Short-term and long-term outcomes were assessed. Results were compared with those of a historical standard-of-care control-group treated in our centre.Of 253 subjects included, 216 (85.4% were assigned to azithromycin. Pneumococcal infection was diagnosed in 26 (12% and 21 (56.8% patients allocated to azithromycin and levofloxacin groups, respectively. No patients in the azithromycin group developed bacteraemia. Atypical organisms were more common in patients given azithromycin (18.5% vs 8.1%, respectively. The majority (93% of patients with atypical pneumonia had low PCT levels. Clinical cure rates were 95.8% in the azithromycin group, 94.6% in the levofloxacin group, and 94.4% in the historical control group. No 30-day mortality or recurrences were observed, and the 3-year rates of recurrence and mortality were very low in both groups. Adverse events occurrence was also infrequent.A PCT-guided strategy with a rapid point-of-care testing safely allowed selecting empirical narrow-spectrum antibiotics in outpatients with CAP.The study is registered with ClinicalTrials.gov, number NCT02600806.

  19. Multiplex PCR point of care testing versus routine, laboratory-based testing in the treatment of adults with respiratory tract infections: a quasi-randomised study assessing impact on length of stay and antimicrobial use.

    Science.gov (United States)

    Andrews, Denise; Chetty, Yumela; Cooper, Ben S; Virk, Manjinder; Glass, Stephen K; Letters, Andrew; Kelly, Philip A; Sudhanva, Malur; Jeyaratnam, Dakshika

    2017-10-10

    Laboratory-based respiratory pathogen (RP) results are often available too late to influence clinical decisions such as hospitalisation or antibiotic treatment due to time delay in transport of specimens and testing schedules. Ward-based i.e. point of care (POC) testing providing rapid results may alter the clinical management pathway. FilmArray® RP polymerase chain reaction (PCR) systems were placed in three in-patient and out-patient medical areas. Patients presenting with influenza-like illness /upper respiratory tract infection +/- lower RTI were recruited between January-July 2015. FilmArray® POC testing occurred on even days of the month (intervention) or routine, laboratory-based RP PCR testing +/- atypical serology on odd days (control). The primary outcome was length of hospital stay. The secondary outcomes were impact on the use of antimicrobials, readmissions, all-cause mortality, length of ward stay and turn-around time (TAT) (time to result from admission). Of 606 eligible patients, 545 (89.9%) were included; 211 in the control arm and 334 in the intervention arm. 20% of control arm patients and 24% of intervention arm patients had an RP detected. POC testing was not associated with the primary outcome measure, length of stay, but reduced the TAT from 39.5 h to 19.0 h, p testing and length of stay or most of the secondary outcomes except the antimicrobial prescribing decision. This was probably due to a delay in initiating FilmArray® testing. Despite this, POC testing allowed time-critical antivirals to be given significantly faster, appropriate mycoplasma treatment and results were available considerably faster than routine, laboratory-based testing. Ward-staff of all grades performed POC testing without difficulty suggesting potential use across many divergent healthcare settings. Further studies evaluating the implementation of rapid respiratory PCR POC testing and the effect on length of stay and antimicrobial use are required. ISRCTN10470967

  20. The effect of introducing point-of-care or dried blood spot analysis on the uptake of hepatitis C virus testing in high-risk populations: A systematic review of the literature.

    Science.gov (United States)

    Coats, Josh T; Dillon, John F

    2015-11-01

    Testing for hepatitis C virus (HCV) infection typically relies upon blood samples taken by traditional phlebotomy for laboratory processing. Novel testing methods, including using dried blood spots (DBS) and point-of-care (PoC) testing enable easier access to high risk populations who have less frequent contact with healthcare professionals. Many of these individuals have been exposed to HCV but have not previously been tested. We aimed to establish whether the availability of these novel testing methods increased either uptake of testing or the number of new diagnoses of HCV. The PubMed, Cochrane and SCOPUS databases were searched for terms relating to the study. References and associated bibliographies were also examined for further relevant articles. Studies were included if they contained quantitative data on frequency of testing and/or new diagnoses following the introduction of PoC and/or DBS testing of high-risk populations. Studies were then examined for findings and limitations and graded upon the quality of evidence provided. No studies were found which introduced PoC testing and determined its effect on frequency of testing or new diagnoses. Six studies were identified in which DBS testing was introduced and its effect evaluated. Two of the studies were randomised controlled trials, two were prospective cohort studies, one was an ecological study and one was a clinical audit. Populations studied included those attending substance misuse clinics, prisons and needle exchanges. Injection drug use was the commonest risk factor for HCV. Five of the six studies provided evidence that the introduction of DBS testing increased the number of tests, new diagnoses or both. Current evidence indicates that DBS testing availability may increase the uptake of testing for HCV in high-risk populations. There is currently no evidence regarding the efficacy of PoC testing in these populations. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. The Success of Self-Testing for Anticoagulation Therapy

    Directory of Open Access Journals (Sweden)

    Cetin Songur

    2013-10-01

    Full Text Available Aim: The optimal therapeutic range for INR of the patient who were on warfarin therapy is narrow. There are various methods of INR monitoring to adjust the appropriate dosage of warfarin therapy. This study aims to test the reliability of POC (Point of care devices used for INR(International normalized ratio monitoring. Material and Method: Forty six  patients who were on warfarin therapy for any reasons were enrolled for this study. Their INR  were divided into 3 groups according to their laboratory INR results. Grup 1 had INR results lower than 2, group 2 had INR levels of 2 to 3.5, group 3 had INR levels of higher than 3.5 INR of the patients were remeasured with the POC device.  Results: The ages of the patients were between 24 to 84. Twenty six patients were male and 20 were female. The mean INR level of laboratory measurements was 1.26 in group 1 whereas it was 1.45 for POC device measurements. There were not statistically significant difference between two devices for group 1 (p=0.15. In group 2 the mean INR levels were measured by laboratory instrument and POC device were 2.74 and 3.51 respectively (p=0,01. In group 3 mean INR levels were measured by laboratory instrument and POC device were 4.27 and 5.25 respectively (p=0.01. Discussion: We suppose it is rational to adjust warfarin dosage by specialists using laboratory results in order to prevent hemorrhagic and thromboembolic complications.

  2. Impact of point-of-care pre-procedure creatinine and eGFR testing in patients with ST segment elevation myocardial infarction undergoing primary PCI: The pilot STATCREAT study.

    Science.gov (United States)

    Karamasis, Grigoris V; Hampton-Till, James; Al-Janabi, Firas; Mohdnazri, Shah; Parker, Michael; Ioannou, Adam; Jagathesan, Rohan; Kabir, Alagmir; Sayer, Jeremy W; Robinson, Nicholas M; Aggarwal, Rajesh K; Clesham, Gerald J; Gamma, Reto A; Kelly, Paul A; Tang, Kare H; Davies, John R; Keeble, Thomas

    2017-08-01

    Contrast-induced acute kidney injury (CI-AKI) is a recognised complication during primary PCI that affects short and long term prognosis. The aim of this study was to assess the impact of point-of-care (POC) pre-PPCI creatinine and eGFR testing in STEMI patients. 160 STEMI patients (STATCREAT group) with pre-procedure POC testing of Cr and eGFR were compared with 294 consecutive retrospective STEMI patients (control group). Patients were further divided into subjects with or without pre-existing CKD. The incidence of CI-AKI in the whole population was 14.5% and not different between the two overall groups. For patients with pre-procedure CKD, contrast dose was significantly reduced in the STATCREAT group (124.6ml vs. 152.3ml, p=0.015). The incidence of CI-AKI was 5.9% (n=2) in the STATCREAT group compared with 17.9% (n=10) in the control group (p=0.12). There was no difference in the number of lesions treated (1.118 vs. 1.196, p=0.643) or stents used (1.176 vs. 1.250, p=0.78). For non-CKD patients, there was no significant difference in contrast dose (172.4ml vs. 158.4ml, p=0.067), CI-AKI incidence (16.7% vs. 13.4%, p=0.4), treated lesions (1.167 vs. 1.164, p=1.0) or stents used (1.214 vs. 1.168, p=0.611) between the two groups. Pre-PPCI point-of-care renal function testing did not reduce the incidence of CI-AKI in the overall group of STEMI patients. In patients with CKD, contrast dose was significantly reduced, but a numerical reduction in CI-AKI was not found to be statistically significant. No significant differences were found in the non-CKD group. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  3. Point-of-Care Diagnostics on a Chip

    CERN Document Server

    Westervelt, Robert

    2013-01-01

    The topic of this book is the development of automated and inexpensive tools that transfer medical tests from a specialized clinical laboratory directly to the point of care, using biochip technology. Immediate access to medically relevant biochemical information for doctors and nurses promises to revolutionize patient care and dramatically lower costs. The miniaturization and automation of medical tests are made possible by biochip technology, that integrates advances in integrated circuits, microelectromechanical systems (MEMS), microfluidics, and electronics. The target audience for this book includes engineering and biomedical researchers who would like to develop or apply biochip technology. They can use this book as a review of the field and as a guide for the development of novel biochip technology for point of care medicine. This book can also be used as a teaching tool for engineering and biomedical students, as as well as a reference for physicians and health professionals.

  4. Point-of-care lactate and creatinine analysis for sick obstetric ...

    African Journals Online (AJOL)

    2016-03-15

    Mar 15, 2016 ... and while point-of-care devices are often used for research studies, they are scarcely available for routine ... Point-of-care clinical chemistry testing was feasible, practical, and well received by staff, and was considered to have a useful role to play in the clinical care of sick obstetric patients at this referral ...

  5. Sample to answer visualization pipeline for low-cost point-of-care blood cell counting

    CSIR Research Space (South Africa)

    Smith, S

    2015-02-01

    Full Text Available We present a visualization pipeline from sample to answer for point-of-care blood cell counting applications. Effective and low-cost point-of-care medical diagnostic tests provide developing countries and rural communities with accessible healthcare...

  6. Biochemical testing in a laboratory tent and semi-intensive care of Ebola patients on-site in a remote part of Guinea: a paradigm shift based on a bleach-sensitive point-of-care device.

    Science.gov (United States)

    Irenge, Leonid M; Dindart, Jean-Michel; Gala, Jean-Luc

    2017-10-26

    During the West Africa Ebola virus disease (EVD) outbreak, a Belgian laboratory was deployed for supporting the Ebola treatment unit (ETU) of N'Zerekore, Guinea. Besides diagnosis of EVD and malaria, biochemical parameters were tested and used to guide supportive treatment of EVD. To preserve analytes stability, lithium-heparin blood samples were analyzed using the i-STAT® point-of-care testing (POCT) handheld device without the viral inactivation step. To mitigate the risk of Ebola virus transmission, assays were performed inside a portable glovebox with strict biosafety procedures. Providing the medical staff with real-time biochemical data modified their therapeutic attitude, shifting from empiric to a semi-intensive laboratory-guided treatment of hydro-electrolytic disturbances, metabolic acidosis and/or impaired kidney function. As illustrated with representative EVD cases (n=8), optimized supportive treatment with intravenous fluid therapy and electrolyte replacement often helped correct these abnormalities. However, the harsh operating conditions, especially the use of bleach decontamination inside the glovebox, caused several technical failures and the final breakdown of the POCT device. POCT availability resulted in a paradigm shift in laboratory practice and care delivery at the N'Zerekore ETU. We conclude that there is urgent need for novel well-designed and validated POCT devices usable by non-expert operators in high ambient temperature and limited space. These devices should withstand regular and thorough decontamination by the personnel working on-site with life-threatening pathogens and be compatible with high biosafety level procedures. Such specific users' requirements need a European validation and standardization process of proposed solutions led by the EU Standardization Committee (CEN).

  7. The impact of a point-of-care testing device on CVD risk assessment completion in New Zealand primary-care practice: A cluster randomised controlled trial and qualitative investigation.

    Science.gov (United States)

    Wells, Sue; Rafter, Natasha; Kenealy, Timothy; Herd, Geoff; Eggleton, Kyle; Lightfoot, Rose; Arcus, Kim; Wadham, Angela; Jiang, Yannan; Bullen, Chris

    2017-01-01

    To assess the effect of a point of care (POC) device for testing lipids and HbA1c in addition to testing by community laboratory facilities (usual practice) on the completion of cardiovascular disease (CVD) risk assessments in general practice. We conducted a pragmatic, cluster randomised controlled trial in 20 New Zealand general practices stratified by size and rurality and randomised to POC device plus usual practice or usual practice alone (controls). Patients aged 35-79 years were eligible if they met national guideline criteria for CVD risk assessment. Data on CVD risk assessments were aggregated using a web-based decision support programme common to each practice. Data entered into the on-line CVD risk assessment form could be saved pending blood test results. The primary outcome was the proportion of completed CVD risk assessments. Qualitative data on practice processes for CVD risk assessment and feasibility of POC testing were collected at the end of the study by interviews and questionnaire. The POC testing was supported by a comprehensive quality assurance programme. A CVD risk assessment entry was recorded for 7421 patients in 10 POC practices and 6217 patients in 10 control practices; 99.5% of CVD risk assessments had complete data in both groups (adjusted odds ratio 1.02 [95%CI 0.61-1.69]). There were major external influences that affected the trial: including a national performance target for CVD risk assessment and changes to CVD guidelines. All practices had invested in systems and dedicated staff time to identify and follow up patients to completion. However, the POC device was viewed by most as an additional tool rather than as an opportunity to review practice work flow and leverage the immediate test results for patient education and CVD risk management discussions. Shortly after commencement, the trial was halted due to a change in the HbA1c test assay performance. The trial restarted after the manufacturing issue was rectified but this

  8. Procalcitonin as a biomarker for severe Plasmodium falciparum disease: a critical appraisal of a semi-quantitative point-of-care test in a cohort of travellers with imported malaria

    Directory of Open Access Journals (Sweden)

    Petit Pieter

    2009-09-01

    Full Text Available Abstract Background Imported malaria occurs as a relatively rare event in developed countries. As a consequence, most clinicians have little experience in making clinical assessments of disease severity and decisions regarding the need for parenteral therapy or high-level monitoring. In this study, the diagnostic accuracy of procalcitonin (PCT for severe Plasmodium falciparum disease was assessed in a cohort of 100 consecutive travellers with various species of imported malaria. Methods and results In all patients, PCT was measured on admission with a semi-quantitative 'point-of-care' test. Patients with severe P. falciparum malaria had significantly higher median PCT levels on admission as compared with patients with uncomplicated P. falciparum disease. In addition, PCT levels in patients with non-falciparum malaria were also higher compared with patients with non-severe falciparum malaria but lower compared with severe P. falciparum malaria. At a cut-off point of 10 ng/mL, PCT had a sensitivity of 0,67 and a specificity of 0,94 for severe falciparum disease. However, at lower cut-off points the specificity and positive predictive value were rather poor although the sensitivity and negative predictive value remained high. Discussion Potential drawbacks in the interpretation of elevated PCT levels on admission may be caused by infections with non-falciparum species and by concomitant bacterial infections. Conclusion Semi-quantitative determination of PCT on admission is of limited use in the initial clinical assessment of disease severity in travellers with imported malaria, especially in settings with limited experience with the treatment of malaria.

  9. Establishing an external quality assessment scheme for point-of-care international normalized ratio in Thailand.

    Science.gov (United States)

    Tientadakul, P; Chuntarut, A

    2015-08-01

    Effective warfarin therapy management has gained national interest, resulting in the increased use of point-of-care testing (POCT) for international normalized ratio (INR). External quality assessment (EQA) is recommended to ensure quality of the testing. CoaguChek XS and CoaguChek XS Plus are the only commonly available POCT INR monitors in Thailand. Therefore, Thailand NEQAS for Blood Coagulation initiated the scheme for POCT INR in 2013, including only hospitals using these devices. Questionnaires were sent to the hospitals, enquiring about their interest in EQA participation. Two surveys were distributed; each included five certified European Concerted Action on Anticoagulation (ECAA) INR plasma sets. Unsatisfactory performance was indicated by a 15% deviation from the certified mean INR value. There were 156 hospitals using the devices. Thirty-five hospitals responded to the questionnaires. Medical personnel undertaking POCT INR were limited to laboratory staff in 29 (83%) of these centers, and 31 hospitals actually participated. The medians of results from participants were the same or nearly the same as the certified mean INRs. External quality assessment for POCT INR in Thailand is feasible using the ECAA plasmas as control materials. The results therefore appear encouraging to other developing countries to establish their own EQA schemes. © 2014 John Wiley & Sons Ltd.

  10. Comparison of rapid MMP-8 and interleukin-6 point-of-care tests to identify intra-amniotic inflammation/infection and impending preterm delivery in patients with preterm labor and intact membranes.

    Science.gov (United States)

    Chaemsaithong, Piya; Romero, Roberto; Docheva, Nikolina; Chaiyasit, Noppadol; Bhatti, Gaurav; Pacora, Percy; Hassan, Sonia S; Yeo, Lami; Erez, Offer

    2018-01-01

    Among patients presenting with preterm labor and intact membranes, those with intra-amniotic inflammation have adverse obstetrical and neonatal outcomes. The diagnosis of intra-amniotic inflammation can easily be made by detecting an elevated concentration of the cytokine interleukin (IL)-6 or the enzyme neutrophil collagenase, also known as matrix metalloproteinase (MMP)-8. The diagnostic performances of MMP-8 and IL-6 enzyme-linked immunosorbent assay tests are similar. Recently, a rapid test has become available for point-of-care determination of either MMP-8 or IL-6. The objectives of this study were to compare the diagnostic indices and predictive values between the rapid MMP-8 and IL-6 tests for the identification of intra-amniotic inflammation in patients with preterm labor and intact membranes. We performed a retrospective cohort study including 124 women with singleton pregnancies who presented with symptoms of preterm labor and underwent transabdominal amniocentesis for the evaluation of microbial invasion of the amniotic cavity (MIAC). MIAC was defined according to amniotic fluid culture results (aerobic and anaerobic bacteria as well as genital Mycoplasmas). Amniotic fluid white blood cell (WBC) counts were determined using a hemocytometer chamber. An elevated amniotic fluid MMP-8 concentration was assessed using Yoon's MMP-8 Check ® (cutoff: 10 ng/mL). An elevated amniotic fluid IL-6 concentration was scored when there was a positive result for the lateral flow-based immunoassay (cutoff: ≥745 pg/mL and ≥1000 pg/mL). In order to objectively compare rapid MMP-8 and rapid IL-6 tests to identify intra-amniotic inflammation, an amniotic fluid WBC count of ≥50 cells/mm 3 was used to define intra-amniotic inflammation. (1) The rapid tests had the same sensitivity for the detection of intra-amniotic inflammation [85.7% (18/21) for all]; (2) the specificity of the rapid MMP-8 test was higher than that of the rapid IL-6 test (cutoff: 745

  11. 'Pre-endoscopy point of care test (Simtomax- IgA/IgG-Deamidated Gliadin Peptide) for coeliac disease in iron deficiency anaemia: diagnostic accuracy and a cost saving economic model'.

    Science.gov (United States)

    Lau, Michelle Shui Yee; Mooney, Peter; White, William; Appleby, Victoria; Moreea, Sulleman; Haythem, Ismail; Elias, Joshua; Bundhoo, Kiran; Corbett, Gareth; Wong, Liam; Tsai, Her Hsin; Cross, Simon; Hebden, John; Hoque, Sami; Sanders, David

    2016-09-15

    International guidelines recommend coeliac serology in iron deficiency anaemia, and duodenal biopsy for those tested positive to detect coeliac disease. However, pre-endoscopy serology is often unavailable, thus committing endoscopists to take routine duodenal biopsies. Some endoscopists consider duodenal biopsy mandatory in anaemia to exclude other pathologies. We hypothesise that using a point of care test at endoscopy could fill this gap, by providing rapid results to target anaemic patients who require biopsies, and save costs by biopsy avoidance. We therefore assessed three key aspects to this hypothesis: 1) the availability of pre-endoscopy serology in anaemia; 2) the sensitivities and cost effectiveness of pre-endoscopy coeliac screening with Simtomax in anaemia; 3) whether other anaemia-related pathologies could be missed by this targeted-biopsy approach. Group 1: pre-endoscopy serology availability was retrospectively analysed in a multicentre cohort of 934 anaemic patients at 4 UK hospitals. Group 2: the sensitivities of Simtomax, endomysial and tissue-transglutaminase antibodies were compared in 133 prospectively recruited patients with iron deficiency anaemia attending for a gastroscopy. The sensitivities were measured against duodenal histology as the reference standard in all patients. The cost effectiveness of Simtomax was calculated based on the number of biopsies that could have been avoided compared to an all-biopsy approach. Group 3: the duodenal histology of 153 patients presenting to a separate iron deficiency anaemia clinic were retrospectively reviewed. In group 1, serology was available in 361 (33.8 %) patients. In group 2, the sensitivity and negative predictive value (NPV) were 100 % and 100 % for Simtomax, 96.2 % and 98.9 % for IgA-TTG, and 84.6 % and 96.4 % for EMA respectively. In group 3, the duodenal histology found no causes for anaemia other than coeliac disease. Simtomax had excellent diagnostic accuracy in iron deficiency

  12. Challenges of diagnosing acute HIV-1 subtype C infection in African women: performance of a clinical algorithm and the need for point-of-care nucleic-acid based testing.

    Directory of Open Access Journals (Sweden)

    Koleka Mlisana

    Full Text Available Prompt diagnosis of acute HIV infection (AHI benefits the individual and provides opportunities for public health intervention. The aim of this study was to describe most common signs and symptoms of AHI, correlate these with early disease progression and develop a clinical algorithm to identify acute HIV cases in resource limited setting.245 South African women at high-risk of HIV-1 were assessed for AHI and received monthly HIV-1 antibody and RNA testing. Signs and symptoms at first HIV-positive visit were compared to HIV-negative visits. Logistic regression identified clinical predictors of AHI. A model-based score was assigned to each predictor to create a risk score for every woman.Twenty-eight women seroconverted after a total of 390 person-years of follow-up with an HIV incidence of 7.2/100 person-years (95%CI 4.5-9.8. Fifty-seven percent reported ≥1 sign or symptom at the AHI visit. Factors predictive of AHI included age <25 years (OR = 3.2; 1.4-7.1, rash (OR = 6.1; 2.4-15.4, sore throat (OR = 2.7; 1.0-7.6, weight loss (OR = 4.4; 1.5-13.4, genital ulcers (OR = 8.0; 1.6-39.5 and vaginal discharge (OR = 5.4; 1.6-18.4. A risk score of 2 correctly predicted AHI in 50.0% of cases. The number of signs and symptoms correlated with higher HIV-1 RNA at diagnosis (r = 0.63; p<0.001.Accurate recognition of signs and symptoms of AHI is critical for early diagnosis of HIV infection. Our algorithm may assist in risk-stratifying individuals for AHI, especially in resource-limited settings where there is no routine testing for AHI. Independent validation of the algorithm on another cohort is needed to assess its utility further. Point-of-care antigen or viral load technology is required, however, to detect asymptomatic, antibody negative cases enabling early interventions and prevention of transmission.

  13. Comparing patient and healthcare worker experiences during a dengue outbreak in Singapore: understanding the patient journey and the introduction of a point-of-care test (POCT) toward better care delivery.

    Science.gov (United States)

    Tan, Qinghui; Hildon, Zoe J-L; Singh, Shweta; Jing, Jin; Thein, Tun Linn; Coker, Richard; Vrijhoef, Hubertus J M; Leo, Yee Sin

    2017-07-19

    In the aftermath of an upsurge in the number of dengue cases in 2013 and 2014, the SD BIOLINE Dengue Duo rapid diagnostic Point-of-Care Test (POCT) kit was introduced in Tan Tock Seng Hospital, Singapore in June 2013. It is known that the success of POCT usage is contingent on its implementation within the health system. We evaluated health services delivery and the Dengue Duo rapid diagnostic test kit application in Singapore from healthcare workers' perspectives and patient experiences of dengue at surge times. Focus group discussions were conducted with dengue patients, from before and after the POCT implementation period. In-depth interviews with semi-structured components with healthcare workers were carried out. A patient centred process mapping technique was used for evaluation, which mapped the patient's journey and was mirrored from the healthcare worker's perspective. Patients and healthcare workers confirmed a wide range of symptoms in adults, making it challenging to determine diagnosis. There were multiple routes to help seeking, and no 'typical patient journey', with patients either presenting directly to the hospital emergency department, or being referred there by a primary care provider. Patients groups diagnosed before and after POCT implementation expressed some differences between speed of diagnoses and attitudes of doctors, yet shared negative feelings about waiting times and a lack of communication and poor information delivery. However, the POCT did not in its current implementation do much to help waiting times. Healthcare workers expressed that public perceptions of dengue in recent years was a major factor in changing patient management, and that the POCT kit was helpful in improving the speed and accuracy of diagnoses. Health service delivery for dengue patients in Singapore was overall perceived to be of an acceptable clinical standard, which was enhanced by the introduction of the POCT. However, improvements can be focused on Adapting

  14. Point-of-care ultrasonography in patients admitted with respiratory symptoms

    DEFF Research Database (Denmark)

    Laursen, Christian B; Sloth, Erik; Lassen, Annmarie Touborg

    2014-01-01

    BACKGROUND: When used with standard diagnostic testing, point-of-care ultrasonography might improve the proportion of patients admitted with respiratory symptoms who are correctly diagnosed 4 h after admission to the emergency department. We therefore assessed point-of-care ultrasonography......, oxygen saturation of less than 95%, oxygen therapy, dyspnoea, cough, or chest pain were randomly assigned in a 1:1 ratio with a computer-generated list to a standard diagnostic strategy (control group) or to standard diagnostic tests supplemented with point-of-care ultrasonography of the heart, lungs......% CI 15·0-33·1) and 1·38 (1·01-1·31), respectively. No adverse events were reported. INTERPRETATION: Point-of-care ultrasonography is a feasible, radiation free, diagnostic test, which alongside standard diagnostic tests is superior to standard diagnostic tests alone for establishing a correct...

  15. Outpatient management of oral anticoagulation treatment (OAT in general practice: the “Medicina di Gruppo di Masate” experience

    Directory of Open Access Journals (Sweden)

    Fiorenzo Massimo Corti

    2017-04-01

    Full Text Available Outpatient management of oral anticoagulation treatment (OAT in general practice: the “Medicina di Gruppo di Masate” experienceOral anticoagulants are used for prophylaxis in thromboembolic conditions. Vitamin K antagonists (VKAs such as warfarin, are commonly employed. The anticoagulation activity induced by VKAs is monitored by the prothrombin time test to determine the International Normalized Ratio (INR. Point-of-care testing (POCT devices can be used to monitor anticoagulant therapy improving the quality of oral anticoagulation. This paper aims at describing the relevant experience of the “Medicina di Gruppo di Masate” in general practice. We also put this experience into the general context of the international evidence on the impact of POCT. Both our experience and the international evidence may support anticoagulant therapy management by GPs (General Practitioners.

  16. Diagnostic Accuracy of History, Physical Examination, Laboratory Tests, and Point-of-care Ultrasound for Pediatric Acute Appendicitis in the Emergency Department: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Benabbas, Roshanak; Hanna, Mark; Shah, Jay; Sinert, Richard

    2017-05-01

    Acute appendicitis (AA) is the most common surgical emergency in children. Accurate and timely diagnosis is crucial but challenging due to atypical presentations and the inherent difficulty of obtaining a reliable history and physical examination in younger children. The aim of this study was to determine the utility of history, physical examination, laboratory tests, Pediatric Appendicitis Score (PAS) and Emergency Department Point-of-Care Ultrasound (ED-POCUS) in the diagnosis of AA in ED pediatric patients. We performed a systematic review and meta-analysis and used a test-treatment threshold model to identify diagnostic findings that could rule in/out AA and obviate the need for further imaging studies, specifically computed tomography (CT) scan, magnetic resonance imaging (MRI), and radiology department ultrasound (RUS). We searched PubMed, EMBASE, and SCOPUS up to October 2016 for studies on ED pediatric patients with abdominal pain. Quality Assessment Tool for Diagnostic Accuracy Studies (QUADAS-2) was used to evaluate the quality and applicability of included studies. Positive and negative likelihood ratios (LR+ and LR-) for diagnostic modalities were calculated and when appropriate data was pooled using Meta-DiSc. Based on the available literature on the test characteristics of different imaging modalities and applying the Pauker-Kassirer method we developed a test-treatment threshold model. Twenty-one studies were included encompassing 8,605 patients with weighted AA prevalence of 39.2%. Studies had variable quality using the QUADAS-2 tool with most studies at high risk of partial verification bias. We divided studies based on their inclusion criteria into two groups of "undifferentiated abdominal pain" and abdominal pain "suspected of AA." In patients with undifferentiated abdominal pain, history of "pain migration to right lower quadrant (RLQ)" (LR+ = 4.81, 95% confidence interval [CI] = 3.59-6.44) and presence of "cough/hop pain" in the physical

  17. Lupus anticoagulant : performance of the tests as recommended by the latest ISTH guidelines

    NARCIS (Netherlands)

    Swadzba, J.; Iwaniec, T.; Pulka, M.; De Laat, B.; De Groot, P. G.; Musial, J.

    Objectives: Lupus anticoagulant (LA) is clinically the most relevant among all antiphospholipid antibody tests. Recently, new guidelines for LA detection were published. The objective of this retrospective cohort study was to compare tests recommended under these guidelines with other methods used

  18. Anticoagulant Resistance

    DEFF Research Database (Denmark)

    Heiberg, Ann-Charlotte

    Although sewer rat control is carried out in more than 80 % of all Danish municipalities, with usage of large amounts of anticoagulant rodenticides, knowledge on anticoagulant resistance among rats living in the sewers is limited. As rat problems in urban areas are believed to be related to sewer...... problems (70-90 % in UK and DK) unawareness of resistance amongst these populations of Brown rats may constitute a future control problem and knowledge on this issue has become crucial. Rats were captured in sewers from seven different locations in the suburban area of Copenhagen. Locations was chosen...... to represent different sewer rat management strategies i) no anticoagulants for approx. 20 years ii) no anticoagulants for the last 5 years and iii) continuous control for many years. Animals were tested for resistance to bromadiolone by Blood-Clotting Response test, as bromadiolone is the most frequently used...

  19. Point-of-care coagulation monitoring: first clinical experience using a paper-based lateral flow diagnostic device.

    Science.gov (United States)

    Hegener, Michael A; Li, Hua; Han, Daewoo; Steckl, Andrew J; Pauletti, Giovanni M

    2017-09-01

    Vitamin K antagonists such as warfarin are the most widely used class of oral anticoagulants. Due to a narrow therapeutic window, patients on warfarin require regular monitoring. Self-testing using point-of-care (POC) diagnostic devices is available, but cost makes this monitoring method beyond reach for many. The main objective of this research was to assess the clinical utility of a low-cost, paper-based lateral flow POC diagnostic device developed for anticoagulation monitoring without the need for a separate electronic reader. Custom-fabricated lateral flow assay (LFA) test strips comprised of a glass fiber sample pad, a nitrocellulose analytical membrane, a cellulose wicking pad, and a plastic backing card were assembled in a plastic cassette. Healthy volunteers and patients on warfarin therapy were recruited for this prospective study. For each participant, a whole blood sample was collected via fingerstick to determine: (1) international normalized ratio (INR) using the CoaguChek® XS coagulometer, (2) hematocrit by centrifugation, and (3) red blood cell (RBC) travel distance on the experimental LFA device after 240 s using digital image analysis. RBC travel distance measured on the LFA device using blood samples obtained from warfarin patients positively correlated with increasing INR value and the LFA device had the capability to statistically distinguish between healthy volunteer INR values and those for patients groups with INR ≥ 2.6. From these data, it is predicted that this low-cost, paper-based LFA device can have clinical utility for identifying anticoagulated patients taking vitamin K antagonists who are outside of the desired therapeutic efficacy window.

  20. A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT: A randomized, controlled non-inferiority trial.

    Directory of Open Access Journals (Sweden)

    Kristina Keitel

    2017-10-01

    Full Text Available The management of childhood infections remains inadequate in resource-limited countries, resulting in high mortality and irrational use of antimicrobials. Current disease management tools, such as the Integrated Management of Childhood Illness (IMCI algorithm, rely solely on clinical signs and have not made use of available point-of-care tests (POCTs that can help to identify children with severe infections and children in need of antibiotic treatment. e-POCT is a novel electronic algorithm based on current evidence; it guides clinicians through the entire consultation and recommends treatment based on a few clinical signs and POCT results, some performed in all patients (malaria rapid diagnostic test, hemoglobin, oximeter and others in selected subgroups only (C-reactive protein, procalcitonin, glucometer. The objective of this trial was to determine whether the clinical outcome of febrile children managed by the e-POCT tool was non-inferior to that of febrile children managed by a validated electronic algorithm derived from IMCI (ALMANACH, while reducing the proportion with antibiotic prescription.We performed a randomized (at patient level, blocks of 4, controlled non-inferiority study among children aged 2-59 months presenting with acute febrile illness to 9 outpatient clinics in Dar es Salaam, Tanzania. In parallel, routine care was documented in 2 health centers. The primary outcome was the proportion of clinical failures (development of severe symptoms, clinical pneumonia on/after day 3, or persistent symptoms at day 7 by day 7 of follow-up. Non-inferiority would be declared if the proportion of clinical failures with e-POCT was no worse than the proportion of clinical failures with ALMANACH, within statistical variability, by a margin of 3%. The secondary outcomes included the proportion with antibiotics prescribed on day 0, primary referrals, and severe adverse events by day 30 (secondary hospitalizations and deaths. We enrolled 3

  1. A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT): A randomized, controlled non-inferiority trial.

    Science.gov (United States)

    Keitel, Kristina; Kagoro, Frank; Samaka, Josephine; Masimba, John; Said, Zamzam; Temba, Hosiana; Mlaganile, Tarsis; Sangu, Willy; Rambaud-Althaus, Clotilde; Gervaix, Alain; Genton, Blaise; D'Acremont, Valérie

    2017-10-01

    The management of childhood infections remains inadequate in resource-limited countries, resulting in high mortality and irrational use of antimicrobials. Current disease management tools, such as the Integrated Management of Childhood Illness (IMCI) algorithm, rely solely on clinical signs and have not made use of available point-of-care tests (POCTs) that can help to identify children with severe infections and children in need of antibiotic treatment. e-POCT is a novel electronic algorithm based on current evidence; it guides clinicians through the entire consultation and recommends treatment based on a few clinical signs and POCT results, some performed in all patients (malaria rapid diagnostic test, hemoglobin, oximeter) and others in selected subgroups only (C-reactive protein, procalcitonin, glucometer). The objective of this trial was to determine whether the clinical outcome of febrile children managed by the e-POCT tool was non-inferior to that of febrile children managed by a validated electronic algorithm derived from IMCI (ALMANACH), while reducing the proportion with antibiotic prescription. We performed a randomized (at patient level, blocks of 4), controlled non-inferiority study among children aged 2-59 months presenting with acute febrile illness to 9 outpatient clinics in Dar es Salaam, Tanzania. In parallel, routine care was documented in 2 health centers. The primary outcome was the proportion of clinical failures (development of severe symptoms, clinical pneumonia on/after day 3, or persistent symptoms at day 7) by day 7 of follow-up. Non-inferiority would be declared if the proportion of clinical failures with e-POCT was no worse than the proportion of clinical failures with ALMANACH, within statistical variability, by a margin of 3%. The secondary outcomes included the proportion with antibiotics prescribed on day 0, primary referrals, and severe adverse events by day 30 (secondary hospitalizations and deaths). We enrolled 3,192 patients

  2. Towards point of care testing for C. difficile infection by volatile profiling, using the combination of a short multi-capillary gas chromatography column with metal oxide sensor detection

    International Nuclear Information System (INIS)

    McGuire, N D; Ewen, R J; De Lacy Costello, B; Garner, C E; Vaughan, K; Ratcliffe, N M; Probert, C S J

    2014-01-01

    Rapid volatile profiling of stool sample headspace was achieved using a combination of short multi-capillary chromatography column (SMCC), highly sensitive heated metal oxide semiconductor sensor and artificial neural network software. For direct analysis of biological samples this prototype offers alternatives to conventional gas chromatography (GC) detectors and electronic nose technology. The performance was compared to an identical instrument incorporating a long single capillary column (LSCC). The ability of the prototypes to separate complex mixtures was assessed using gas standards and homogenized in house ‘standard’ stool samples, with both capable of detecting more than 24 peaks per sample. The elution time was considerably faster with the SMCC resulting in a run time of 10 min compared to 30 min for the LSCC. The diagnostic potential of the prototypes was assessed using 50 C. difficile positive and 50 negative samples. The prototypes demonstrated similar capability of discriminating between positive and negative samples with sensitivity and specificity of 85% and 80% respectively. C. difficile is an important cause of hospital acquired diarrhoea, with significant morbidity and mortality around the world. A device capable of rapidly diagnosing the disease at the point of care would reduce cases, deaths and financial burden. (paper)

  3. Interference of the new oral anticoagulant dabigatran with frequently used coagulation tests.

    Science.gov (United States)

    Halbmayer, Walter-Michael; Weigel, Guenter; Quehenberger, Peter; Tomasits, Josef; Haushofer, Alexander C; Aspoeck, Gerold; Loacker, Lorin; Schnapka-Koepf, Mirjam; Goebel, Georg; Griesmacher, Andrea

    2012-01-01

    Dabigatran etexilate is a new oral anticoagulant for the therapy and prophylaxis of venous thromboembolism and stroke prevention in patients with atrial fibrillation. To investigate the extent of interactions of this new anticoagulant with frequently used coagulation assays, we completed a multicenter in vitro trial with Conformité Européenne(CE)-labeled dabigatran-spiked plasma samples. Lyophilized plasma samples with dabigatran concentrations ranging from 0.00 to 0.48 μg/mL were sent to the coagulation laboratories of six major Austrian hospitals for evaluation. Coagulation assays were performed under routine conditions using standard reagents and analyzer. Dabigatran led to a dose-dependent prolongation of the clotting times in coagulometric tests and influenced the majority of the parameters measured. Statistically significant interference could be observed with the prothrombin time (PT), activated partial thromboplastin time (aPTT) and PT/aPTT-based assays (extrinsic/intrinsic factors, APC-resistance test) as well as lupus anticoagulant testing. Even non-clotting tests, such as the colorimetric factor XIII activity assay and to a minor extent the amidolytic antithrombin activity assay (via factor IIa) were affected. This multicenter trial confirms and also adds to existing data, demonstrating that laboratories should expect to observe strong interferences of coagulation tests with increasing concentrations of dabigatran. This finding might become particularly important in the elderly and in patients with renal impairment as well as patients whose blood is drawn at peak levels of dabigatran.

  4. Point-of-care ultrasound detection of acute scaphoid fracture.

    Science.gov (United States)

    Tessaro, Mark O; McGovern, Terrance R; Dickman, Eitan; Haines, Lawrence E

    2015-03-01

    In cases of traumatic wrist pain, emergency physicians must maintain a high index of suspicion for scaphoid fractures due to their potential for serious complications. A growing body of literature supports the use of point-of-care ultrasonography by emergency physicians in the evaluation of potential fractures. We report a case of a pediatric scaphoid fracture that was initially not visualized on x-ray and was subsequently detected using point-of-care ultrasound in the ED.

  5. Single test isolated lupus anticoagulant positivity is associated with increased plasma levels of inflammatory markers and dyslipidemia

    DEFF Research Database (Denmark)

    Just, S A; Nybo, M; Laustrup, H

    2016-01-01

    OBJECTIVE: To investigate whether a single positive test for lupus anticoagulant (LA) is associated with levels of inflammatory markers and traditional cardiovascular risk factors, independent of autoimmune disease, thrombophilia and occurrence of other antiphospholipid antibodies. METHODS: In a ...

  6. Point-of-Care Coagulation Monitoring in Trauma Patients.

    Science.gov (United States)

    Stein, Philipp; Kaserer, Alexander; Spahn, Gabriela H; Spahn, Donat R

    2017-06-01

    Trauma remains one of the major causes of death and disability all over the world. Uncontrolled blood loss and trauma-induced coagulopathy represent preventable causes of trauma-related morbidity and mortality. Treatment may consist of allogeneic blood product transfusion at a fixed ratio or in an individualized goal-directed way based on point-of-care (POC) and routine laboratory measurements. Viscoelastic POC measurement of the developing clot in whole blood and POC platelet function testing allow rapid and tailored coagulation and transfusion treatment based on goal-directed, factor concentrate-based algorithms. The first studies have been published showing that this concept reduces the need for allogeneic blood transfusion and improves outcome. This review highlights the concept of goal-directed POC coagulation management in trauma patients, introduces a selection of POC devices, and presents algorithms which allow a reduction in allogeneic blood product transfusion and an improvement of trauma patient outcome. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  7. Augmenting Epidemiological Models with Point-Of-Care Diagnostics Data.

    Directory of Open Access Journals (Sweden)

    Özgür Özmen

    Full Text Available Although adoption of newer Point-of-Care (POC diagnostics is increasing, there is a significant challenge using POC diagnostics data to improve epidemiological models. In this work, we propose a method to process zip-code level POC datasets and apply these processed data to calibrate an epidemiological model. We specifically develop a calibration algorithm using simulated annealing and calibrate a parsimonious equation-based model of modified Susceptible-Infected-Recovered (SIR dynamics. The results show that parsimonious models are remarkably effective in predicting the dynamics observed in the number of infected patients and our calibration algorithm is sufficiently capable of predicting peak loads observed in POC diagnostics data while staying within reasonable and empirical parameter ranges reported in the literature. Additionally, we explore the future use of the calibrated values by testing the correlation between peak load and population density from Census data. Our results show that linearity assumptions for the relationships among various factors can be misleading, therefore further data sources and analysis are needed to identify relationships between additional parameters and existing calibrated ones. Calibration approaches such as ours can determine the values of newly added parameters along with existing ones and enable policy-makers to make better multi-scale decisions.

  8. Point of care creatinine measurement for diagnosis of renal disease using a disposable microchip

    NARCIS (Netherlands)

    Ávila Muñoz, Mónica; Floris, J.; Staal, S.S.; Ríos, Ángel; Eijkel, Jan C.T.; van den Berg, Albert

    2013-01-01

    A point-of-care device for the determination of elevated creatinine levels in blood is reported. This device potentially offers a new and simple clinical regime for the determination of creatinine that will give huge time savings and removal of several steps of determination. The test employs a

  9. Microchip capillary electrophoresis for point-of-care analysis of lithium

    NARCIS (Netherlands)

    Vrouwe, E.X.; Lüttge, Regina; Vermes, I.; van den Berg, Albert

    Background: Microchip capillary electrophoresis (CE) is a promising method for chemical analysis of complex samples such as whole blood. We evaluated the method for point-of-care testing of lithium. Methods: Chemical separation was performed on standard glass microchip CE devices with a conductivity

  10. Smartphone chloridometer for point-of-care applications

    Science.gov (United States)

    Zhang, Chenji; Kim, Jimin P.; Creer, Michael; Yang, Jian; Liu, Zhiwen

    2017-08-01

    Chloride level in sweat is a major diagnostic criterion for cystic fibrosis (CF) and many other health conditions. In an effort to develop a low cost, point-of-care sweat diagnostics system for chloride concentration measurement, we demonstrated a smartphone-based chloridometer to measure sweat chloride by using our recently developed fluorescence chloride sensor. We characterized the performance of our device to validate its clinical potential. The study indicates that our smartphone-based chloridometer may potentially advance the point-of-care diagnostic system by reducing cost and improving diagnostic accuracy.

  11. Hematological clozapine monitoring with a point-of-care device

    DEFF Research Database (Denmark)

    Nielsen, Jimmi; Thode, Dorrit; Stenager, Elsebeth

    2012-01-01

    for several reasons, perhaps most importantly because of the mandatory hematological monitoring. The Chempaq Express Blood Counter (Chempaq XBC) is a point-of-care device providing counts of white blood cells (WBC) and granulocytes based on a capillary blood sampling. A randomized cross-over trial design...

  12. Reliable and Valid Assessment of Point-of-care Ultrasonography

    DEFF Research Database (Denmark)

    Todsen, Tobias; Tolsgaard, Martin Grønnebæk; Olsen, Beth Härstedt

    2015-01-01

    OBJECTIVE: To explore the reliability and validity of the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale for point-of-care ultrasonography (POC US) performance. BACKGROUND: POC US is increasingly used by clinicians and is an essential part of the management of acute surgical...

  13. Portable biosensors and point-of-care systems

    CERN Document Server

    Kintzios, Spyridon E

    2017-01-01

    This book describes the principles, design and applications of a new generation of analytical and diagnostic biomedical devices, characterized by their very small size, ease of use, multi-analytical capabilities and speed to provide handheld and mobile point-of-care (POC) diagnostics.

  14. Point-of-care estimation of haemoglobin concentration in neonates ...

    African Journals Online (AJOL)

    Point-of-care estimation of haemoglobin concentration in neonates and infants. Elise Schapkaitz, MB BCh, FCPath (Haem), MMed (Haem). Johnny Ndoni Mahlangu, BSc, MB BCh, FCPath (Haem), MMed (Haem), Cert Clin Haem. Department of Haematology and Molecular Medicine, University of the Witwatersrand and ...

  15. A handheld point-of-care genomic diagnostic system.

    Directory of Open Access Journals (Sweden)

    Frank B Myers

    Full Text Available The rapid detection and identification of infectious disease pathogens is a critical need for healthcare in both developed and developing countries. As we gain more insight into the genomic basis of pathogen infectivity and drug resistance, point-of-care nucleic acid testing will likely become an important tool for global health. In this paper, we present an inexpensive, handheld, battery-powered instrument designed to enable pathogen genotyping in the developing world. Our Microfluidic Biomolecular Amplification Reader (µBAR represents the convergence of molecular biology, microfluidics, optics, and electronics technology. The µBAR is capable of carrying out isothermal nucleic acid amplification assays with real-time fluorescence readout at a fraction of the cost of conventional benchtop thermocyclers. Additionally, the µBAR features cell phone data connectivity and GPS sample geotagging which can enable epidemiological surveying and remote healthcare delivery. The µBAR controls assay temperature through an integrated resistive heater and monitors real-time fluorescence signals from 60 individual reaction chambers using LEDs and phototransistors. Assays are carried out on PDMS disposable microfluidic cartridges which require no external power for sample loading. We characterize the fluorescence detection limits, heater uniformity, and battery life of the instrument. As a proof-of-principle, we demonstrate the detection of the HIV-1 integrase gene with the µBAR using the Loop-Mediated Isothermal Amplification (LAMP assay. Although we focus on the detection of purified DNA here, LAMP has previously been demonstrated with a range of clinical samples, and our eventual goal is to develop a microfluidic device which includes on-chip sample preparation from raw samples. The µBAR is based entirely around open source hardware and software, and in the accompanying online supplement we present a full set of schematics, bill of materials, PCB layouts

  16. Coagulation Monitoring Devices: Past, Present, and Future at the Point of Care

    OpenAIRE

    Harris, Leanne F; Castro-Lopez, Vanessa; Killard, Tony J

    2013-01-01

    Automated technologies have revolutionised the monitoring of coagulation disorders in the central hospital laboratory setting, allowing for high throughput testing, improved accuracy and precision, accompanied by a marked reduction in human error. However, they still require trained operators and sample transportation. With the advent of point of care (POC) testing, the working principle of traditional coagulometers was used as the foundation for the development of miniaturised devices. A num...

  17. Blood lipid profiles and factors associated with dyslipidemia assessed by a point-of-care testing device in an outpatient setting: A large-scale cross-sectional study in Southern China.

    Science.gov (United States)

    Zhang, Pei-dong; He, Lin-yun; Guo, Yang; Liu, Peng; Li, Gong-xin; Wang, Li-zi; Liu, Ying-feng

    2015-06-01

    To promote the concept of POCT and to investigate dyslipidemia in Guangzhou, China, we performed a study examining blood lipids assessed by POCT and reported factors associated with dyslipidemia. This multicenter, cross-sectional study enrolled outpatients from 9 Guangzhou hospitals from May through September 2013. After informed consent was obtained, the following information was collected: age; gender; the presence of diabetes mellitus, obesity, and hypertension as well as current use of cigarettes or alcohol. Patients were asked to fast for 8h before the blood examination performed on a POCT device, the CardioChek PA. Of 4012 patients enrolled (1544 males, 2468 females; mean age 60.35±9.41 years), 1993 (49.7%) patients had dyslipidemia, but only 101 (5.1%) took statins. The multivariate tests of associations between demographic variables, comorbidities, and the risk of having dyslipidemia found that the significant predictors of dyslipidemia were male gender, age ≥60 years, being a current smoker or alcohol drinker, and hypertension. Most dyslipidemia patients in Guangzhou remain untreated. POCT in China is feasible, and its widespread use might improve dyslipidemia awareness, treatment and control. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  18. Intraoperative point-of-care testing | Von Rahden | Southern African ...

    African Journals Online (AJOL)

    Southern African Journal of Anaesthesia and Analgesia. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 20, No 1 (2014) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · Download this PDF file. The PDF ...

  19. Patients' perspectives on self-testing of oral anticoagulation therapy: content analysis of patients' internet blogs.

    Science.gov (United States)

    Shah, Syed Ghulam Sarwar; Robinson, Ian

    2011-02-03

    Patients on oral anticoagulant therapy (OAT) require regular testing of the prothrombin time (PT) and the international normalised ratio (INR) to monitor their blood coagulation level to avoid complications of either over or under coagulation. PT/INR can be tested by a healthcare professional or by the patient. The latter mode of the testing is known as patient self-testing or home testing. The objective of this study was to elicit patients' perspectives and experiences regarding PT/INR self-testing using portable coagulometer devices. Internet blog text mining was used to collect 246 blog postings by 108 patients, mainly from the USA and the UK. The content of these qualitative data were analysed using XSight and NVivo software packages. The key themes in relation to self-testing of OAT identified were as follows: Patient benefits reported were time saved, personal control, choice, travel reduction, cheaper testing, and peace of mind. Equipment issues included high costs, reliability, quality, and learning how to use the device. PT/INR issues focused on the frequency of testing, INR fluctuations and individual target (therapeutic) INR level. Other themes noted were INR testing at laboratories, the interactions with healthcare professionals in managing and testing OAT and insurance companies' involvement in acquiring the self-testing equipment. Social issues included the pain and stress of taking and testing for OAT. Patients' blogs on PT/INR testing provide insightful information that can help in understanding the nature of the experiences and perspectives of patients on self-testing of OAT. The themes identified in this paper highlight the substantial complexities involved in self-testing programmes in the healthcare system. Thus, the issues elicited in this study are very valuable for all stakeholders involved in developing effective self-testing strategies in healthcare that are gaining considerable current momentum particularly for patients with chronic

  20. Patients' perspectives on self-testing of oral anticoagulation therapy: Content analysis of patients' internet blogs

    Directory of Open Access Journals (Sweden)

    Robinson Ian

    2011-02-01

    Full Text Available Abstract Background Patients on oral anticoagulant therapy (OAT require regular testing of the prothrombin time (PT and the international normalised ratio (INR to monitor their blood coagulation level to avoid complications of either over or under coagulation. PT/INR can be tested by a healthcare professional or by the patient. The latter mode of the testing is known as patient self-testing or home testing. The objective of this study was to elicit patients' perspectives and experiences regarding PT/INR self-testing using portable coagulometer devices. Methods Internet blog text mining was used to collect 246 blog postings by 108 patients, mainly from the USA and the UK. The content of these qualitative data were analysed using XSight and NVivo software packages. Results The key themes in relation to self-testing of OAT identified were as follows: Patient benefits reported were time saved, personal control, choice, travel reduction, cheaper testing, and peace of mind. Equipment issues included high costs, reliability, quality, and learning how to use the device. PT/INR issues focused on the frequency of testing, INR fluctuations and individual target (therapeutic INR level. Other themes noted were INR testing at laboratories, the interactions with healthcare professionals in managing and testing OAT and insurance companies' involvement in acquiring the self-testing equipment. Social issues included the pain and stress of taking and testing for OAT. Conclusions Patients' blogs on PT/INR testing provide insightful information that can help in understanding the nature of the experiences and perspectives of patients on self-testing of OAT. The themes identified in this paper highlight the substantial complexities involved in self-testing programmes in the healthcare system. Thus, the issues elicited in this study are very valuable for all stakeholders involved in developing effective self-testing strategies in healthcare that are gaining

  1. ROM Plus®: accurate point-of-care detection of ruptured fetal membranes

    Directory of Open Access Journals (Sweden)

    McQuivey RW

    2016-05-01

    Full Text Available Ross W McQuivey,1 Jon E Block2 1Clinical Affairs, Clinical Innovations, Salt Lake City, UT, 2Independent Clinical Consultant, San Francisco, CA, USAAbstract: Accurate and timely diagnosis of rupture of fetal membranes is imperative to inform and guide gestational age-specific interventions to optimize perinatal outcomes and reduce the risk of serious complications, including preterm delivery and infections. The ROM Plus is a rapid, point-of-care, qualitative immunochromatographic diagnostic test that uses a unique monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations: alpha-fetoprotein and insulin-like growth factor binding protein-1. Clinical study results have uniformly demonstrated high diagnostic accuracy and performance characteristics with this point-of-care test that exceeds conventional clinical testing with external laboratory evaluation. The description, indications for use, procedural steps, and laboratory and clinical characterization of this assay are presented in this article.Keywords: ROM Plus®, premature rupture of membranes, point-of-care immunoassay, insulin-like growth factor binding protein-1, IGFBP-1, placental protein 12, PP12, alpha-fetoprotein, AFP

  2. Budget Impact of Increasing Market Share of Patient Self-Testing and Patient Self-Management in Anticoagulation

    NARCIS (Netherlands)

    Stevanović, Jelena; Postma, Maarten J.; Le, Hoa H.

    Background: Patient self-testing (PST) and/or patient self-management (PSM) might provide better coagulation care than monitoring at specialized anticoagulation centers. Yet, it remains an underused strategy in the Netherlands. Methods: Budget-impact analyses of current and new market-share

  3. Smartphone-Powered Electrochemical Dongle for Point-of-Care Monitoring of Blood β-Ketone.

    Science.gov (United States)

    Guo, Jinhong

    2017-09-05

    A smartphone-powered medical dongle as a miniaturized electrochemical analyzer associated with an enzymatic β-hydroxybutyrate test strip for accurate characterization of blood ketone in peripheral whole blood at the point-of-care, which is capable of providing critical guidance for the evaluation and treatment of diabetic ketoacidosis (DK) and diabetic ketosis acid (DKA), is reported. The measured results of blood ketone by the medical dongle were compared with the clinical results from a bulky biochemical analyzer, and the analysis showed good agreement. The proposed medical smartphone-powered dongle was demonstrated to be a very promising platform as a miniaturized electrochemical analyzer for point-of-care monitoring of the critical biochemical parameters such as blood ketone and a good solution for mobile health management.

  4. Smartphone based point-of-care detector of urine albumin

    Science.gov (United States)

    Cmiel, Vratislav; Svoboda, Ondrej; Koscova, Pavlina; Provaznik, Ivo

    2016-03-01

    Albumin plays an important role in human body. Its changed level in urine may indicate serious kidney disorders. We present a new point-of-care solution for sensitive detection of urine albumin - the miniature optical adapter for iPhone with in-built optical filters and a sample slot. The adapter exploits smart-phone flash to generate excitation light and camera to measure the level of emitted light. Albumin Blue 580 is used as albumin reagent. The proposed light-weight adapter can be produced at low cost using a 3D printer. Thus, the miniaturized detector is easy to use out of lab.

  5. Rapid Diagnosis of Rhabdomyolysis with Point-of-Care Ultrasound.

    Science.gov (United States)

    Nassar, Alicia; Talbot, Richard; Grant, Ashley; Derr, Charlotte

    2016-11-01

    It is important to rapidly diagnosis and treat rhabdomyolysis in order to decrease morbidity and mortality. To date there are no reports in the emergency medicine literature on the use of point-of-care ultrasound in the diagnosis of rhabdomyolysis. This unique case describes how ultrasound was used in the emergency department (ED) to quickly diagnose and treat rhabdomyolysis prior to confirmation with an elevated serum creatine kinase. When coupled with a high index of suspicion, ultrasound can be one of the most portable, readily available, low cost, and minimally invasive techniques for making a rapid diagnosis of rhabdomyolysis in the ED.

  6. Rapid Diagnosis of Rhabdomyolysis with Point-of-Care Ultrasound

    Directory of Open Access Journals (Sweden)

    Alicia Nassar

    2016-11-01

    Full Text Available It is important to rapidly diagnosis and treat rhabdomyolysis in order to decrease morbidity and mortality. To date there are no reports in the emergency medicine literature on the use of point-of-care ultrasound in the diagnosis of rhabdomyolysis. This unique case describes how ultrasound was used in the emergency department (ED to quickly diagnose and treat rhabdomyolysis prior to confirmation with an elevated serum creatine kinase. When coupled with a high index of suspicion, ultrasound can be one of the most portable, readily available, low cost, and minimally invasive techniques for making a rapid diagnosis of rhabdomyolysis in the ED.

  7. A centrifugal microfluidic platform for point-of-care diagnostic applications

    Directory of Open Access Journals (Sweden)

    Suzanne Hugo

    2014-02-01

    Full Text Available Microfluidic systems enable precise control over tiny volumes of fluid in a compact and low-cost form, thus providing the ideal platform on which to develop point-of-care diagnostic solutions. Centrifugal microfluidic systems, also referred to as lab-on-a-disc or lab-on-a-CD systems, provide a particularly attractive solution for the implementation of microfluidic point-of-care diagnostic solutions as a result of their simple and compact instrumentation, as well as their functional diversity. Here we detail the implementation of a centrifugal microfluidic platform the first of its kind in South Africa as a foundation for the development of point-of-care diagnostic applications for which both the need and impact is great. The centrifugal microfluidic platform consists of three main components: a microfluidic disc device similar in size and shape to a CD, a system for controlling fluid flow on the device, and a system for recording the results obtained. These components have been successfully implemented and tested. Preliminary test results show that microfluidic functions such as pumping and valving of fluids can be successfully achieved, as well as the generation of monodisperse microfluidic droplets, providing a complete centrifugal microfluidic platform and the building blocks on which to develop a variety of applications, including point-of-care diagnostics. The lab-on-a-disc platform has the potential to provide new diagnostic solutions at the point-of-need in health- and industry-related areas. This paves the way for providing resource limited areas with services such as improved, decentralised health-care access or water-quality monitoring, and reduced diagnosis times at a low cost.

  8. Point-of-Care Pathology with Miniature Microscopes

    Science.gov (United States)

    Liu, Jonathan T. C.; Loewke, Nathan O.; Mandella, Michael J.; Levenson, Richard M.; Crawford, James M.; Contag, Christopher H.

    2011-01-01

    Advances in optical designs are enabling the development of miniature microscopes that can examine tissue in situ for early anatomic and molecular indicators of disease, in real time, and at cellular resolution. These new devices will lead to major changes in how diseases are detected and managed, driving a shift from today's diagnostic paradigm of biopsy followed by histopathology and recommended therapy, to non-invasive point-of-care diagnosis with possible same-session definitive treatment. This shift may have major implications for the training requirements of future physicians to enable them to interpret real-time in vivo microscopic data, and will also shape the emerging fields of telepathology and telemedicine. Implementation of new technologies into clinical practice is a complex process that requires bridging gaps between clinicians, engineers and scientists. This article provides a forward-looking discussion of these issues, with a focus on malignant and pre-malignant lesions, by first highlighting some of the clinical areas where point-of-care in vivo microscopy could address unmet needs, and then by reviewing the technological challenges that are being addressed, or need to be addressed, for in vivo microscopy to become a standard clinical tool. PMID:21673433

  9. Point-of-Care Pathology with Miniature Microscopes

    Directory of Open Access Journals (Sweden)

    Jonathan T. C. Liu

    2011-01-01

    Full Text Available Advances in optical designs are enabling the development of miniature microscopes that can examine tissue in situ for early anatomic and molecular indicators of disease, in real time, and at cellular resolution. These new devices will lead to major changes in how diseases are detected and managed, driving a shift from today's diagnostic paradigm of biopsy followed by histopathology and recommended therapy, to non-invasive point-of-care diagnosis with possible same-session definitive treatment. This shift may have major implications for the training requirements of future physicians to enable them to interpret real-time in vivo microscopic data, and will also shape the emerging fields of telepathology and telemedicine. Implementation of new technologies into clinical practice is a complex process that requires bridging gaps between clinicians, engineers and scientists. This article provides a forward-looking discussion of these issues, with a focus on malignant and pre-malignant lesions, by first highlighting some of the clinical areas where point-of-care in vivo microscopy could address unmet needs, and then by reviewing the technological challenges that are being addressed, or need to be addressed, for in vivo microscopy to become a standard clinical tool.

  10. Evaluation of the i-STAT point-of-care analyzer in critically ill adult patients.

    Science.gov (United States)

    Steinfelder-Visscher, Jacoline; Teerenstra, Steven; Gunnewiek, Jacqueline M T Klein; Weerwind, Patrick W

    2008-03-01

    Point-of-care analyzers may benefit therapeutic decision making by reducing turn-around-time for samples. This is especially true when biochemical parameters exceed the clinical reference range, in which acute and effective treatment is essential. We therefore evaluated the analytical performance of the i-STAT point-of-care analyzer in two critically ill adult patient populations. During a 3-month period, 48 blood samples from patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and 42 blood samples from non-cardiac patients who needed intensive care treatment were analyzed on both the i-STAT analyzer (CPB and non-CPB mode, respectively) and our laboratory analyzers (RapidLab 865/Sysmex XE-2100 instrument). The agreement analysis for quantitative data was used to compare i-STAT to RapidLab for blood gas/electrolytes and for hematocrit with the Sysmex instrument. Point-of-care electrolytes and blood gases had constant deviation, except for pH, pO2, and hematocrit. A clear linear trend in deviation of i-STAT from RapidLab was noticed for pH during CPB (r = 0.32, p = .03) and for pO2 > 10 kPa during CPB (r = -0.59, p pO2 pO2 pO2 range (10.6 pO2 range below 25% (n = 11) using the i-STAT. The i-STAT analyzer is suitable for point-of-care testing of electrolytes and blood gases in critically ill patients, except for high pO2. However, the discrepancy in hematocrit bias shows that accuracy established in one patient population cannot be automatically extrapolated to other patient populations, thus stressing the need for separate evaluation.

  11. Anticoagulant carryover may influence clot formation in direct tube coagulase tests from blood cultures.

    Science.gov (United States)

    Varettas, Kerry; Mukerjee, Chinmoy; Taylor, Peter C

    2005-09-01

    The tube coagulase test (TCT) performed directly from positive blood culture bottles has been used to reduce the turnaround time for identifying Staphylococcus aureus. Most reports have shown the test to be specific but often lacking sufficient sensitivity to be useful. In a prospective study of blood culture bottles (BCB) signaling positive, with a Gram-stained smear showing gram-positive cocci resembling staphylococci, the sensitivity of the direct TCT was improved by diluting the BCB broth 1:10 in saline before inoculating 0.1 ml into 1.0 ml of 10% pooled human plasma. It was hypothesized that the improved sensitivity might be explained by reduced carryover of the anticoagulant sodium polyanetholesulfonate (SPS) used in blood culture media. By titrating the inoculum size and the concentration of SPS in an in vitro checkerboard assay, it was shown that concentrations of SPS >0.0008% prevented plasma coagulation. The 1:10 dilution of blood culture broth reduced the amount of residual SPS carried over to the TCT to a level (0.0005%) that did not impair plasma coagulation. The direct TCT inoculated with a 1:10 saline dilution of blood culture broth achieved 100% specificity and sensitivity within 4 h of inoculation without reducing the quality or quantity of coagulum.

  12. Faculty development in point of care ultrasound for internists

    Directory of Open Access Journals (Sweden)

    Anna Maw

    2016-12-01

    Full Text Available Lack of general medicine faculty expertise is a likely contributor to the slow adoption of point of care ultrasound (POCUS by internal medicine (IM residency training programs. We developed a 10-week faculty development program, during which 15 faculty members participated in 2 hours and 10 hours of online didactic and hands-on training, respectively. Pre–post comparisons showed that there were statistically significant improvements in faculty participants' ability to interpret images (p<0.001, perceived understanding of the capabilities and limitations of POCUS (p=0.003, comfort using POCUS to make clinical decisions (p=0.003, and perceptions regarding the extent to which POCUS can improve patient care (p=0.026. The next challenge for IM programs is to improve access to ultrasound machines and provide follow-up workshops to facilitate further development of skills and integration of POCUS into daily practice by general medicine faculty.

  13. The prevalence of lupus anticoagulant in normal pregnancy and in women with recurrent fetal loss--recommendations for laboratory testing for lupus anticoagulant.

    Science.gov (United States)

    Al-Mishari, Abdul Aziz A; Gader, Abdel Galil M Abdel; Al-Jabbari, Abdul Wahab; Al-Momen, Abdul Karim M; El Rab, Mohamed O Gad; Babay, Zainab H; Mahmoud, Nasim

    2004-01-01

    There is wide disagreement in the literature on the rate of detection of lupus anticoagulant (LA) in women with recurrent fetal loss (RFL). The aim of this study was to determine the prevalence of LA using four phospholipid-dependant coagulation tests in a large population of Saudi women. We determined the prevalence of LA in women with RFL (n=925), normal pregnancy (n=663), and in healthy blood donors (n=204), at the King Khalid University Hospital, Riyadh. The following coagulation tests were employed: the activated partial thromboplastin time (APTT), platelet neutralization procedure (PNP), kaolin clotting time (KCT) and the dilute Russel's viper venom test (dRVVT). In RFL patients, positive APTT was 10.2%, APTT+PNP 3.6%, KCT 10.5%, and dRVVT 10.9%. In normal pregnancy, the corresponding figures were 12.8%, 3.1%, 10.8%, and 5.6%. Three positive tests occurred in 2.3% of RFL patients, including APTT+KCT 3.5%, APTT+dRVVT 3.9%, and KCT+dRWT 4.1%. The corresponding figures for normal pregnancy were 1.6% for three positive tests, and 3.0%, 1.8%, 2.4%, respectively. The dRVVT was the only test that showed a rate of positive results almost double that seen in normal pregnancy. If only one or even two screening tests were performed, a significant number of LA positive cases would have been missed. This could make a difference to treating physicians as to the possible etiology and management of RFL. It is therefore advisable to routinely use the three tests (APTT, KCT and dRRVT) when screening for LA.

  14. Point-of-Care Ultrasonography for the Diagnosis of Pediatric Soft Tissue Infection.

    Science.gov (United States)

    Adams, Cynthia M; Neuman, Mark I; Levy, Jason A

    2016-02-01

    To determine the test characteristics of point-of-care ultrasonography for the identification of a drainable abscess and to compare the test characteristics of ultrasonography with physical examination. In addition, we sought to measure the extent to which ultrasonography impacts clinical management of children with skin and soft tissue infections (SSTIs). We performed a prospective study of children with SSTIs evaluated in a pediatric emergency department. Treating physicians recorded their initial impression of whether a drainable abscess was present based on physical examination. Another physician, blinded to the treating physician's assessment, performed an ultrasound study and conveyed their interpretation and recommendations to the treating physician. Any management change was recorded. An abscess was defined as a lesion from which purulent fluid was expressed during a drainage procedure in the emergency department or during the 2- to 5-day follow-up period. We defined a change in management as correct when the ultrasound diagnosis was discordant from physical examination and matched the ultimate lesion classification. Of 151 SSTIs evaluated among 148 patients, the sensitivity and specificity of point-of-care ultrasonography for the presence of abscess were 96% (95% CI 90%-99%) and 87% (74%-95%), respectively. The sensitivity and specificity of physical examination for the presence of abscess were 84% (75%-90%) and 60% (44%-73%), respectively. For every 4 ultrasound examinations performed, there was 1 correct change in management. Point-of-care ultrasonography demonstrates excellent test characteristics for the identification of skin abscess and has superior test characteristics compared with physical examination alone. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Change in Intraocular Pressure During Point-of-Care Ultrasound

    Directory of Open Access Journals (Sweden)

    Berg, Cameron

    2015-03-01

    Full Text Available Introduction: Point-of-care ocular ultrasound (US is a valuable tool for the evaluation of traumatic ocular injuries. Conventionally, any maneuver that may increase intraocular pressure (IOP is relatively contraindicated in the setting of globe rupture. Some authors have cautioned against the use of US in these scenarios because of a theoretical concern that an US examination may cause or exacerbate the extrusion of intraocular contents. This study set out to investigate whether ocular US affects IOP. The secondary objective was to validate the intraocular pressure measurements obtained with the Diaton® as compared with standard applanation techniques (the Tono-Pen®.   Methods: We enrolled a convenience sample of healthy adult volunteers. We obtained the baseline IOP for each patient by using a transpalpebral tonometer. Ocular US was then performed on each subject using a high-frequency linear array transducer, and a second IOP was obtained during the US examination. A third IOP measurement was obtained following the completion of the US examination. To validate transpalpebral measurement, a subset of subjects also underwent traditional transcorneal applanation tonometry prior to the US examination as a baseline measurement. In a subset of 10 patients, we obtained baseline pre-ultrasound IOP measurements with the Diaton® and Tono-Pen®, and then compared them.   Results: The study included 40 subjects. IOP values during ocular US examination were slightly greater than baseline (average +1.8mmHg, p=0.01. Post-US examination IOP values were not significantly different than baseline (average -0.15mmHg, p=0.42. In a subset of 10 subjects, IOP values were not significantly different between transpalpebral and transcorneal tonometry (average +0.03mmHg, p=0.07.   Conclusion: In healthy volunteer subjects, point-of-care ocular US causes a small and transient increase in IOP. We also showed no difference between the Diaton® and Tono-Pen® methods

  16. Accuracy of three hemoglobin A1c point-of-care systems for glucose monitoring in patients with diabetes mellitus.

    Science.gov (United States)

    Torregrosa, María-Eugenia; Molina, Juan; Argente, Carlos R; Ena, Javier

    2015-12-01

    Use of hemoglobin A1c point-of-care devices in physician offices provides immediate results and reduces inconveniences for the patients. We compared the analytical performances of 3 point-of-care HbA1c analyzers to high pressure liquid chromatography (HPLC). We preselected a pool of 40 EDTA-preserved whole blood samples from our laboratory with HbA1c results obtained by HPLC (mean 6.6% [49 mmol/mol] and range: 4.6-9.9% [27-87 mmol/mol]). Aliquots of theses samples were tested by Afinion AS100, DCA Vantage and In2it point-of-care systems. According the Clinical Laboratory Standards Institute EP-09 protocol we determined linearity (linear regression and correlation coefficient between point-of-care and reference methods), bias (Bland-Altman analysis) and coefficient of variation (%). We used the acceptability criteria endorsed by the National Glycohemoglobin Standardization Program. The calculated correlation coefficients (r) were 0.98, 0.98 and 0.83 for Afinion AS100, DCA Vantage and In2it systems, respectively. The 95% confidence interval of the error between point-of-care systems and the reference method was -0.41% and +0.34% (p =.22) for Afinion AS100, -0.62% and +0.05% (p =.57) for DCA Vantage, and -1.15% and +1.26% (p<.001) for the In2it. The coefficients of variation for Afinion AS100, DCA Vantage and In2it systems were 1.80, 3.74 and 7.14%, respectively. Only the Afinion AS100 point-of-care system met all NGSP performance criteria. Copyright © 2015 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

  17. Cognitive systems at the point of care: The CREDO program.

    Science.gov (United States)

    Fox, John

    2017-04-01

    CREDO is a framework for understanding human expertise and for designing and deploying systems that support cognitive tasks like situation and risk assessment, decision-making, therapy planning and workflow management. The framework has evolved through an extensive program of research on human decision-making and clinical practice. It draws on concepts from cognitive science, and has contributed new results to cognitive theory and understanding of human expertise and knowledge-based AI. These results are exploited in a suite of technologies for designing, implementing and deploying clinical services, early versions of which were reported by Das et al. (1997) [9] and Fox and Das (2000) [26]. A practical outcome of the CREDO program is a technology stack, a key element of which is an agent specification language (PROforma: Sutton and Fox (2003) [55]) which has proved to be a versatile tool for designing point of care applications in many clinical specialties and settings. Since software became available for implementing and deploying PROforma applications many kinds of services have been successfully built and trialed, some of which are in large-scale routine use. This retrospective describes the foundations of the CREDO model, summarizes the main theoretical, technical and clinical contributions, and discusses benefits of the cognitive approach. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  18. Fluorescence Technology for Point of Care Wound Management.

    Science.gov (United States)

    Anghel, Ersilia L; Falola, Reuben A; Kim, Paul J

    2016-04-01

    As the prevalence of chronic wounds continues to rise, the need for point of care wound assessment has also increased. While a variety of technologies have been developed to improve diagnostic abilities and monitoring of wounds, none have proven completely effective in all settings. Further, many of the stalwart wound management techniques remain costly, time consuming, and technically challenging. The two key pivotal events of ischemia and infection can lead to limb loss. A relatively new crop of fluorescence-based technologies, including devices that measure pathogenic auto-fluorescence, fluorescence angiography, or map cutaneous oxygenation, are increasingly being utilized for adjunct wound assessment-both clinical and operative settings can address these events. These technologies offer rapid, efficient, visual, and quantitative data that can aid the wound provider in evaluating the viability of tissues, ensuring adequate perfusion, and optimizing wound bed preparation. In the following review, pathogenic auto-fluorescence is compared to gross evaluation of wound infection and culture based diagnostics, indocyanine green fluorescence angiography is compared to various methods of visual and physical assessments of tissue perfusion by the practitioner, and cutaneous oxygenation is compared to clinical signs of ischemia. We focus on the current applications of fluorescence technologies in wound management, with emphasis placed on the evidence for clinical and operative implementation, a safety analyses, procedural limitations, and the future direction of this growing field of wound assessment.

  19. Characterizing physicians' information needs at the point of care.

    Science.gov (United States)

    Maggio, Lauren A; Cate, Olle Ten; Moorhead, Laura L; van Stiphout, Feikje; Kramer, Bianca M R; Ter Braak, Edith; Posley, Keith; Irby, David; O'Brien, Bridget C

    2014-11-01

    Physicians have many information needs that arise at the point of care yet go unmet for a variety of reasons, including uncertainty about which information resources to select. In this study, we aimed to identify the various types of physician information needs and how these needs relate to physicians' use of the database PubMed and the evidence summary tool UpToDate. We conducted semi-structured interviews with physicians (Stanford University, United States; n = 13; and University Medical Center Utrecht, the Netherlands; n = 9), eliciting participants' descriptions of their information needs and related use of PubMed and/or UpToDate. Using thematic analysis, we identified six information needs: refreshing, confirming, logistics, teaching, idea generating and personal learning. Participants from both institutions similarly described their information needs and selection of resources. The identification of these six information needs and their relation to PubMed and UpToDate expands upon previously identified physician information needs and may be useful to medical educators designing evidence-based practice training for physicians.

  20. Advances in point-of-care technologies for molecular diagnostics.

    Science.gov (United States)

    Zarei, Mohammad

    2017-12-15

    Advances in miniaturization, nanotechnology, and microfluidics, along with developments in cloud-connected point-of-care (POC) diagnostics technologies are pushing the frontiers of POC devices toward low-cost, user-friendly, and enhanced sensitivity molecular-level diagnostics. The combination of various bio-sensing platforms within smartphone-integrated electronic readers provides accurate on-site and on-time diagnostics based on various types of chemical and biological targets. Further, 3D printing technology shows a huge potential toward fabrication and improving the performance of POC devices. Integration of skin-like flexible sensors with wireless communication technology creates a unique opportunity for continuous, real-time monitoring of patients for both preventative healthcare and during disease outbreaks. Here, we review recent developments and advances in POC technologies and describe how these advances enhance the performance of POC platforms. Also, this review describes challenges, directions, and future trends on application of emerging technologies in POC diagnostics. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Evaluation of point-of-care analyzers' ability to reduce bias in conductivity-based hematocrit measurement during cardiopulmonary bypass

    NARCIS (Netherlands)

    Teerenstra, S.; Steinfelder-Visscher, J.; Gunnewiek, J.K.; Weerwind, P.W.

    2014-01-01

    Most point-of-care testing analyzers use the conductivity method to measure hematocrit (hct). During open-heart surgery, blood-conductivity is influenced by shifts in electrolyte and colloid concentrations caused by infusion media used, and this may lead to considerable bias in the hct measurement.

  2. The SmartBioPhone (TM), a point of care vision under development through two European projects: OPTOLABCARD and LABONFOIL

    DEFF Research Database (Denmark)

    Ruano-Lopez, J.M.; Agirregabiria, M.; Olabarria, G.

    2009-01-01

    LOCs are big enough to include all the sample preparation subcomponents at a low price. These LOCs will be used in four point of care applications: environment, food, cancer and drug monitoring. The user will obtain the results of the tests by connecting the Labcard/Skinpatch reader to a very popular...

  3. Cognitive load predicts point-of-care ultrasound simulator performance.

    Science.gov (United States)

    Aldekhyl, Sara; Cavalcanti, Rodrigo B; Naismith, Laura M

    2018-02-01

    The ability to maintain good performance with low cognitive load is an important marker of expertise. Incorporating cognitive load measurements in the context of simulation training may help to inform judgements of competence. This exploratory study investigated relationships between demographic markers of expertise, cognitive load measures, and simulator performance in the context of point-of-care ultrasonography. Twenty-nine medical trainees and clinicians at the University of Toronto with a range of clinical ultrasound experience were recruited. Participants answered a demographic questionnaire then used an ultrasound simulator to perform targeted scanning tasks based on clinical vignettes. Participants were scored on their ability to both acquire and interpret ultrasound images. Cognitive load measures included participant self-report, eye-based physiological indices, and behavioural measures. Data were analyzed using a multilevel linear modelling approach, wherein observations were clustered by participants. Experienced participants outperformed novice participants on ultrasound image acquisition. Ultrasound image interpretation was comparable between the two groups. Ultrasound image acquisition performance was predicted by level of training, prior ultrasound training, and cognitive load. There was significant convergence between cognitive load measurement techniques. A marginal model of ultrasound image acquisition performance including prior ultrasound training and cognitive load as fixed effects provided the best overall fit for the observed data. In this proof-of-principle study, the combination of demographic and cognitive load measures provided more sensitive metrics to predict ultrasound simulator performance. Performance assessments which include cognitive load can help differentiate between levels of expertise in simulation environments, and may serve as better predictors of skill transfer to clinical practice.

  4. Infectious Disease Management through Point-of-Care Personalized Medicine Molecular Diagnostic Technologies

    Directory of Open Access Journals (Sweden)

    Luc Bissonnette

    2012-05-01

    Full Text Available Infectious disease management essentially consists in identifying the microbial cause(s of an infection, initiating if necessary antimicrobial therapy against microbes, and controlling host reactions to infection. In clinical microbiology, the turnaround time of the diagnostic cycle (>24 hours often leads to unnecessary suffering and deaths; approaches to relieve this burden include rapid diagnostic procedures and more efficient transmission or interpretation of molecular microbiology results. Although rapid nucleic acid-based diagnostic testing has demonstrated that it can impact on the transmission of hospital-acquired infections, we believe that such life-saving procedures should be performed closer to the patient, in dedicated 24/7 laboratories of healthcare institutions, or ideally at point of care. While personalized medicine generally aims at interrogating the genomic information of a patient, drug metabolism polymorphisms, for example, to guide drug choice and dosage, personalized medicine concepts are applicable in infectious diseases for the (rapid identification of a disease-causing microbe and determination of its antimicrobial resistance profile, to guide an appropriate antimicrobial treatment for the proper management of the patient. The implementation of point-of-care testing for infectious diseases will require acceptance by medical authorities, new technological and communication platforms, as well as reimbursement practices such that time- and life-saving procedures become available to the largest number of patients.

  5. Fully 3D printed integrated reactor array for point-of-care molecular diagnostics.

    Science.gov (United States)

    Kadimisetty, Karteek; Song, Jinzhao; Doto, Aoife M; Hwang, Young; Peng, Jing; Mauk, Michael G; Bushman, Frederic D; Gross, Robert; Jarvis, Joseph N; Liu, Changchun

    2018-06-30

    Molecular diagnostics that involve nucleic acid amplification tests (NAATs) are crucial for prevention and treatment of infectious diseases. In this study, we developed a simple, inexpensive, disposable, fully 3D printed microfluidic reactor array that is capable of carrying out extraction, concentration and isothermal amplification of nucleic acids in variety of body fluids. The method allows rapid molecular diagnostic tests for infectious diseases at point of care. A simple leak-proof polymerization strategy was developed to integrate flow-through nucleic acid isolation membranes into microfluidic devices, yielding a multifunctional diagnostic platform. Static coating technology was adopted to improve the biocompatibility of our 3D printed device. We demonstrated the suitability of our device for both end-point colorimetric qualitative detection and real-time fluorescence quantitative detection. We applied our diagnostic device to detection of Plasmodium falciparum in plasma samples and Neisseria meningitides in cerebrospinal fluid (CSF) samples by loop-mediated, isothermal amplification (LAMP) within 50 min. The detection limits were 100 fg for P. falciparum and 50 colony-forming unit (CFU) for N. meningitidis per reaction, which are comparable to that of benchtop instruments. This rapid and inexpensive 3D printed device has great potential for point-of-care molecular diagnosis of infectious disease in resource-limited settings. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. Technology: Is There Sufficient Evidence to Change Practice in Point-of-Care Management of Coagulopathy?

    Science.gov (United States)

    Fabbro, Michael; Winkler, Anne M; Levy, Jerrold H

    2017-10-01

    Currently, hemostasis is one of the most widely researched topics in perioperative medicine. As investigators learn more about the complexity of coagulation, developing tests with the ability to rapidly monitor coagulation and guide targeted therapy is the key to optimizing hemostasis management. There is mounting evidence that algorithmic transfusion using point-of-care (POC) testing can reduce red cell and platelet transfusions and major bleeding after cardiac surgery. Integrating these tests during cardiac surgery and trauma management is especially important because these groups use the most blood products within a health system and the risks of transfusion are well documented. Currently, numerous POC tests are available for evaluating hemostasis. The purpose of this review is to provide a comprehensive evaluation of the current evidence surrounding the most common POC testing devices in practice for managing coagulation. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. High sensitivity point-of-care device for direct virus diagnostics

    DEFF Research Database (Denmark)

    Kiilerich-Pedersen, Katrine; Dapra, Johannes; Cherré, Solène

    2013-01-01

    Influenza infections are associated with high morbidity and mortality, carry the risk of pandemics, and pose a considerable economic burden worldwide. To improve the management of the illness, it is essential with accurate and fast point-of-care diagnostic tools for use in the field or at the pat......Influenza infections are associated with high morbidity and mortality, carry the risk of pandemics, and pose a considerable economic burden worldwide. To improve the management of the illness, it is essential with accurate and fast point-of-care diagnostic tools for use in the field...... or at the patient's bedside. Conventional diagnostic methods are time consuming, expensive and require specialized laboratory facilities. We present a highly sensitive, highly specific, and low cost platform to test for acute virus infections in less than 15. min, employing influenza A virus (H1N1) as an example...... of its usability. An all polymer microfluidic system with a functionalized conductive polymer (PEDOT-OH:TsO) microelectrode array was developed and exploited for label free and real time electrochemical detection of intact influenza A virus (H1N1) particles. DNA aptamers with affinity for influenza...

  8. Point-of-care laboratory halves door-to-therapy-decision time in acute stroke.

    Science.gov (United States)

    Walter, Silke; Kostopoulos, Panagiotis; Haass, Anton; Lesmeister, Martin; Grasu, Mihaela; Grunwald, Iris; Keller, Isabel; Helwig, Stephan; Becker, Carmen; Geisel, Juergen; Bertsch, Thomas; Kaffiné, Sarah; Leingärtner, Annika; Papanagiotou, Panagiotis; Roth, Christian; Liu, Yang; Reith, Wolfgang; Fassbender, Klaus

    2011-03-01

    Currently, stroke laboratory examinations are usually performed in the centralized hospital laboratory, but often planned thrombolysis is given before all results are available, to minimize delay. In this study, we examined the feasibility of gaining valuable time by transferring the complete stroke laboratory workup required by stroke guidelines to a point-of-care laboratory system, that is, placed at a stroke treatment room contiguous to the computed tomography, where the patients are admitted and where they obtain neurological, laboratory, and imaging examinations and treatment by the same dedicated team. Our results showed that reconfiguration of the entire stroke laboratory analysis to a point-of-care system was feasible for 200 consecutively admitted patients. This strategy reduced the door-to-therapy-decision times from 84 ± 26 to 40 ± 24 min (p laboratory tests (except activated partial thromboplastin time and international normalized ratio) revealed close agreement with results from a standard centralized hospital laboratory. These findings may offer a new solution for the integration of laboratory workup into routine hyperacute stroke management. Copyright © 2011 American Neurological Association.

  9. Comparison of the Liaison® Calprotectin kit with a well established point of care test (Quantum Blue - Bühlmann-Alere®) in terms of analytical performances and ability to detect relapses amongst a Crohn population in follow-up.

    Science.gov (United States)

    Delefortrie, Quentin; Schatt, Patricia; Grimmelprez, Alexandre; Gohy, Patrick; Deltour, Didier; Collard, Geneviève; Vankerkhoven, Patrick

    2016-02-01

    Although colonoscopy associated with histopathological sampling remains the gold standard in the diagnostic and follow-up of inflammatory bowel disease (IBD), calprotectin is becoming an essential biomarker in gastroenterology. The aim of this work is to compare a newly developed kit (Liaison® Calprotectin - Diasorin®) and its two distinct extraction protocols (weighing and extraction device protocol) with a well established point of care test (Quantum Blue® - Bühlmann-Alere®) in terms of analytical performances and ability to detect relapses amongst a Crohn's population in follow-up. Stool specimens were collected over a six month period and were composed of control and Crohn's patients. Amongst the Crohn's population disease activity (active vs quiescent) was evaluated by gastroenterologists. A significant difference was found between all three procedures in terms of calprotectin measurements (weighing protocol=30.3μg/g (median); stool extraction device protocol=36.9μg/g (median); Quantum Blue® (median)=63; Friedman test, P value=0.05). However, a good correlation was found between both extraction methods coupled with the Liaison® analyzer and between the Quantum Blue® (weighing protocol/extraction device protocol Rs=0.844, P=0.01; Quantum Blue®/extraction device protocol Rs=0.708, P=0.01; Quantum Blue®/weighing protocol, Rs=0.808, P=0.01). Finally, optimal cut-offs (and associated negative predictive values - NPV) for detecting relapses were in accordance with above results (Quantum Blue® 183.5μg/g and NPV of 100%>extraction device protocol+Liaison® analyzer 124.5μg/g and NPV of 93.5%>weighing protocol+Liaison® analyzer 106.5μg/g and NPV of 95%). Although all three methods correlated well and had relatively good NPV in terms of detecting relapses amongst a Crohn's population in follow-up, the lack of any international standard is the origin of different optimal cut-offs between the three procedures. Copyright © 2015 The Canadian Society of

  10. Reliability of point-of-care coagulometer measurements in patients with acute ischaemic stroke receiving intravenous fibrinolysis.

    Science.gov (United States)

    Guisado-Alonso, D; Fayos-Vidal, F; Martí-Fàbregas, J; Prats-Sánchez, L; Marín-Bueno, R; Martínez-Domeño, A; Delgado-Mederos, R; Camps-Renom, P

    2017-09-25

    Speed of administration conditions the effectiveness of intravenous fibrinolysis in treating acute ischaemic stroke. To reduce the risk of haemorrhagic complications, the intervention is contraindicated in certain cases, such as where the International Normalised Ratio (INR) is ≥ 1.7. This study aimed to determine the reliability of point-of-care INR readings (POC-INR) taken using the CoaguChek ® XS portable coagulometer compared to laboratory results (L-INR). We conducted a retrospective observational study of consecutive patients admitted to our centre with acute ischaemic stroke and who were treated with intravenous fibrinolysis, over a period of 4 years. Patients' INR was measured with a portable coagulometer and in the laboratory. Results were compared using the paired-sample t test; using L-INR results as a reference value, ROC analysis was performed to determine POC-INR with greater predictive value. The study included 210 patients with a mean age of 74.3±11.5 years old; 18 (8.6%) were taking vitamin K antagonist oral anticoagulants (OAC). There were no significant differences between the 2 INR measurements in the population as a whole (POC-INR-L-INR difference: 0.001±0.085; P=.82). In subgroup analysis, the results coincided for patients taking OACs (0.001±0.081; P=.42) and those with L-INR ≤ 1.2 (0.008±0.081; P=.16). For L-INR>1.2, however, the portable coagulometer underestimated INR (0.058±0.095; P=.01). Through ROC analysis, POC-INR < 1.6 was found to be the cut-off point with greatest sensitivity (100%) and specificity (98.97%) for identifying patients eligible for intravenous fibrinolysis (L-INR < 1.7). POC-INR shows a good correlation with L-INR. Our results suggest that the best threshold to predict an L-INR < 1.7 is POC-INR < 1.6. Internal validation studies for POC-INR should be considered in all treatment centres. Copyright © 2017 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Clinical accuracy of point-of-care urine culture in general practice

    DEFF Research Database (Denmark)

    Holm, Anne; Cordoba, Gloria; Sørensen, Tina Møller

    2017-01-01

    OBJECTIVE: To assess the clinical accuracy (sensitivity (SEN), specificity (SPE), positive predictive value and negative predictive value) of two point-of-care (POC) urine culture tests for the identification of urinary tract infection (UTI) in general practice. DESIGN: Prospective diagnostic...... accuracy study comparing two index tests (Flexicult™ SSI-Urinary Kit or ID Flexicult™) with a reference standard (urine culture performed in the microbiological department). SETTING: General practice in the Copenhagen area patients. Adult female patients consulting their general practitioner with suspected...... uncomplicated, symptomatic UTI. MAIN OUTCOME MEASURES: (1) Overall accuracy of POC urine culture in general practice. (2) Individual accuracy of each of the two POC tests in this study. (3) Accuracy of POC urine culture in general practice with enterococci excluded, since enterococci are known to multiply...

  12. A research protocol for developing a Point-Of-Care Key Evidence Tool 'POCKET': a checklist for multidimensional evidence reporting on point-of-care in vitro diagnostics.

    Science.gov (United States)

    Huddy, Jeremy R; Ni, Melody; Mavroveli, Stella; Barlow, James; Williams, Doris-Ann; Hanna, George B

    2015-07-10

    Point-of-care in vitro diagnostics (POC-IVD) are increasingly becoming widespread as an acceptable means of providing rapid diagnostic results to facilitate decision-making in many clinical pathways. Evidence in utility, usability and cost-effectiveness is currently provided in a fragmented and detached manner that is fraught with methodological challenges given the disruptive nature these tests have on the clinical pathway. The Point-of-care Key Evidence Tool (POCKET) checklist aims to provide an integrated evidence-based framework that incorporates all required evidence to guide the evaluation of POC-IVD to meet the needs of policy and decisionmakers in the National Health Service (NHS). A multimethod approach will be applied in order to develop the POCKET. A thorough literature review has formed the basis of a robust Delphi process and validation study. Semistructured interviews are being undertaken with POC-IVD stakeholders, including industry, regulators, commissioners, clinicians and patients to understand what evidence is required to facilitate decision-making. Emergent themes will be translated into a series of statements to form a survey questionnaire that aims to reach a consensus in each stakeholder group to what needs to be included in the tool. Results will be presented to a workshop to discuss the statements brought forward and the optimal format for the tool. Once assembled, the tool will be field-tested through case studies to ensure validity and usability and inform refinement, if required. The final version will be published online with a call for comments. Limitations include unpredictable sample representation, development of compromise position rather than consensus, and absence of blinding in validation exercise. The Imperial College Joint Research Compliance Office and the Imperial College Hospitals NHS Trust R&D department have approved the protocol. The checklist tool will be disseminated through a PhD thesis, a website, peer

  13. Advances in Candida detection platforms for clinical and point-of-care applications

    Science.gov (United States)

    Safavieh, Mohammadali; Coarsey, Chad; Esiobu, Nwadiuto; Memic, Adnan; Vyas, Jatin Mahesh; Shafiee, Hadi; Asghar, Waseem

    2016-01-01

    Invasive candidiasis remains one of the most serious community and healthcare-acquired infections worldwide. Conventional Candida detection methods based on blood and plate culture are time-consuming and require at least 2–4 days to identify various Candida species. Despite considerable advances for candidiasis detection, the development of simple, compact and portable point-of-care diagnostics for rapid and precise testing that automatically performs cell lysis, nucleic acid extraction, purification and detection still remains a challenge. Here, we systematically review most prominent conventional and nonconventional techniques for the detection of various Candida species, including Candida staining, blood culture, serological testing and nucleic acid-based analysis. We also discuss the most advanced lab on a chip devices for candida detection. PMID:27093473

  14. Emerging technologies in point-of-care molecular diagnostics for resource-limited settings.

    Science.gov (United States)

    Peeling, Rosanna W; McNerney, Ruth

    2014-06-01

    Emerging molecular technologies to diagnose infectious diseases at the point at which care is delivered have the potential to save many lives in developing countries where access to laboratories is poor. Molecular tests are needed to improve the specificity of syndromic management, monitor progress towards disease elimination and screen for asymptomatic infections with the goal of interrupting disease transmission and preventing long-term sequelae. In simplifying laboratory-based molecular assays for use at point-of-care, there are inevitable compromises between cost, ease of use and test performance. Despite significant technological advances, many challenges remain for the development of molecular diagnostics for resource-limited settings. There needs to be more advocacy for these technologies to be applied to infectious diseases, increased efforts to lower the barriers to market entry through streamlined and harmonized regulatory approaches, faster policy development for adoption of new technologies and novel financing mechanisms to enable countries to scale up implementation.

  15. Point-of-care diagnostic tools : Selection, evaluation and implementation in resource-constrained settings

    NARCIS (Netherlands)

    Kosack, C.S.

    2017-01-01

    In recent year’s point-of-care diagnostic tools especially for the three main killer diseases HIV/AIDS, tuberculosis and malaria have been emerging on the market. This thesis examines the selection, evaluation and implementation of point-of-care diagnostic tools for use in resource-constrained

  16. Critique on the use of the standardized avian acute oral toxicity test for first generation anticoagulant rodenticides

    Science.gov (United States)

    Vyas, Nimish B.; Rattner, Barnett A.

    2012-01-01

    Avian risk assessments for rodenticides are often driven by the results of standardized acute oral toxicity tests without regards to a toxicant's mode of action and time course of adverse effects. First generation anticoagulant rodenticides (FGARs) generally require multiple feedings over several days to achieve a threshold concentration in tissue and cause adverse effects. This exposure regimen is much different than that used in the standardized acute oral toxicity test methodology. Median lethal dose values derived from standardized acute oral toxicity tests underestimate the environmental hazard and risk of FGARs. Caution is warranted when FGAR toxicity, physiological effects, and pharmacokinetics derived from standardized acute oral toxicity testing are used for forensic confirmation of the cause of death in avian mortality incidents and when characterizing FGARs' risks to free-ranging birds.

  17. Flexible low-cost cardiovascular risk marker biosensor for point-of-care applications

    KAUST Repository

    Sivashankar, Shilpa

    2015-10-22

    The detection and quantification of protein on a laser written flexible substrate for point-of-care applications are described. A unique way of etching gold on polyethylene terephthalate (PET) substrate is demonstrated by reducing the damage that may be caused on PET sheets otherwise. On the basis of the quantity of the C-reactive protein (CRP) present in the sample, the risk of cardiac disease can be assessed. This hsCRP test is incorporated to detect the presence of CRP on a PET laser patterned biosensor. Concentrations of 1, 2, and 10 mg/l were chosen to assess the risk of cardiac diseases as per the limits set by the American Heart Association.

  18. Thrombolysis in stroke patients: Comparability of point-of-care versus central laboratory international normalized ratio.

    Science.gov (United States)

    Dolscheid-Pommerich, Ramona C; Dolscheid, Sarah; Eichhorn, Lars; Stoffel-Wagner, Birgit; Graeff, Ingo

    2018-01-01

    In acute stroke patients, thrombolysis is one gold standard therapy option within the first four hours after the ischemic event. A contraindication for thrombolysis is an International Normalized Ratio (INR) value >1.7. Since time is brain, rapid and reliable INR results are fundamental. Aim was to compare INR values determined by central laboratory (CL) analyzer and Point-of-Care Testing(POCT)-device and to evaluate the quality of POCT performance in cases of potential therapeutic thrombolysis at a certified stroke unit. In 153 patients INR measurements using POCT-devices (HEMOCHRON Signature Elite®) were compared to INR measurements (BCS®XP) performed at the central laboratory. Outlier evaluation was performed regarding the critical thrombolysis cut-off. Overall, we demonstrated a significant correlation (r = 0.809, p75 years. POCT-INR measurements based on our POCT concept are suitable to determine INR values in critical stroke patients. Nevertheless, outlier evaluation is mandatory.

  19. The 'carry-over' effects of patient self-testing: positive effects on usual care management by an anticoagulation management service.

    LENUS (Irish Health Repository)

    Ryan, Fiona

    2010-11-01

    Patient self-testing (PST) of the international normalised ratio (INR) has a positive effect on anticoagulation control. This study investigated whether the benefits of PST (other than increased frequency of testing, e.g. patient education, empowerment, compliance etc.) could be \\'carried-over\\' into usual care management after a period of home-testing has ceased.

  20. Integration of Stable Droplet Formation on a CD Microfluidic Device for Extreme Point of Care Applications

    Science.gov (United States)

    Ganesh, Shruthi Vatsyayani

    With the advent of microfluidic technologies for molecular diagnostics, a lot of emphasis has been placed on developing diagnostic tools for resource poor regions in the form of Extreme Point of Care devices. To ensure commercial viability of such a device there is a need to develop an accurate sample to answer system, which is robust, portable, isolated yet highly sensitive and cost effective. This need has been a driving force for research involving integration of different microsystems like droplet microfluidics, Compact-disc (CD)microfluidics along with sample preparation and detection modules on a single platform. This work attempts to develop a proof of concept prototype of one such device using existing CD microfluidics tools to generate stable droplets used in point of care diagnostics (POC diagnostics). Apart from using a fairly newer technique for droplet generation and stabilization, the work aims to develop this method focused towards diagnostics for rural healthcare. The motivation for this work is first described with an emphasis on the current need for diagnostic testing in rural health-care and the general guidelines prescribed by WHO for such a sample to answer system. Furthermore, a background on CD and droplet microfluidics is presented to understand the merits and de-merits of each system and the need for integrating the two. This phase of the thesis also includes different methods employed/demonstrated to generate droplets on a spinning platform. An overview on the detection platforms is also presented to understand the challenges involved in building an extreme point of care device. In the third phase of the thesis, general manufacturing techniques and materials used to accomplish this work is presented. Lastly, design trials for droplet generation is presented. The shortcomings of these trials are solved by investigating mechanisms pertaining to design modification and use of agarose based droplet generation to ensure a more robust sample

  1. Data from the analytical performance of the Abaxis Piccolo Xpress point of care analyzer in whole blood, serum, and plasma

    Directory of Open Access Journals (Sweden)

    Kazunori Murata

    2018-02-01

    Full Text Available The objective of this study was to examine the analytical performance of 14 comprehensive metabolic panel analytes on the Abaxis Piccolo Xpress® Point of Care analyzer in serum, plasma, and whole blood. A method comparison was performed on all three specimen types intended for use on the Piccolo Xpress®: serum, heparinized plasma, and whole blood. This data is also presented in Murata et al. (2015 [1]. This article includes the actual Bland-Altman bias plots of the difference in results obtained for analytes in the comprehensive metabolic panel from the Abaxis Piccolo Xpress and the comparison instrument, the Ortho Vitros. Keywords: Clinical chemistry, Point-of care testing

  2. Transfer from point-of-care Ultrasonography training to diagnostic performance on patients--a randomized controlled trial

    DEFF Research Database (Denmark)

    Todsen, Tobias; Jensen, Morten Lind; Tolsgaard, Martin Grønnebæk

    2016-01-01

    BACKGROUND: Clinicians are increasingly using point-of-care ultrasonography for bedside examinations of patients. However, proper training is needed in this technique, and it is unknown whether the skills learned from focused Ultrasonography courses are being transferred to diagnostic performance...... test and binary logistic regression, respectively. RESULTS: There was a significant difference in the performance score between the intervention group (27.4%) and the control group (18.0%, P = .004) and the diagnostic accuracy between the intervention group (65%) and the control group (39%, P = .014......). CONCLUSIONS: Clinicians could successfully transfer learning from an Ultrasonography course to improve diagnostic performance on patients. However, our results also indicate a need for more training when new technologies such as point-of-care ultrasonography are introduced....

  3. Demonstration of anticoagulation patient self-testing feasibility at an Indian Health Service facility: A case series analysis

    Directory of Open Access Journals (Sweden)

    Schupbach RR

    2013-03-01

    Full Text Available Background: Anticoagulation patient self-testing (PST represents an alternative approach to warfarin monitoring by enabling patients to use coagulometers to test their international normalized ratio (INR values. PST offers several advantages that potentially improve warfarin management. Objective: To describe implementation and associated performance of a PST demonstration program at an Indian Health Service (IHS facility. Methods: A non-consecutive case series analysis of patients from a pharmacy-managed PST demonstration program was performed at an IHS facility in Oklahoma between July 2008 and February 2009.Results: Mean time in therapeutic range (TTR for the seven patients showed a small, absolute increase during the twelve weeks of PST compared to the twelve weeks prior to PST. Four of the seven patients had an increase in TTR during the twelve week course of PST compared to their baseline TTR. Three of four patients with increased TTR in the final eight week period of PST achieved a TTR of 100%. Of the three patients who experienced a decrease in TTR after initiating self-testing, two initially presented with a TTR of 100% prior to PST and one patient had a TTR of 100% for the final eight weeks of PST. The two patients not achieving a TTR of 100% during the twelve week PST period demonstrated an increase in TTR following the first four weeks of PST. Conclusion: Although anticoagulation guidelines now emphasize patient self-management (PSM only, optimal PST remains an integral process in PSM delivery. In the patients studied, the results of this analysis suggest that PST at the IHS facility provided a convenient, alternative method for management of chronic warfarin therapy for qualified patients. More than half of the patients demonstrated improvement in TTR. Although there is a learning curve immediately following PST initiation, the mean TTR for the entire PST period increased modestly when compared to the time period prior to PST.

  4. Improved LFIAs for highly sensitive detection of BNP at point-of-care.

    Science.gov (United States)

    Gong, Yan; Hu, Jie; Choi, Jane Ru; You, Minli; Zheng, Yamin; Xu, Bo; Wen, Ting; Xu, Feng

    2017-01-01

    Heart failure (HF) has become a major cause of morbidity and mortality with a significant global economic burden. Although well-established clinical tests could provide early diagnosis, access to these tests is limited in developing countries, where a relatively higher incidence of HF is present. This has prompted an urgent need for developing a cost-effective, rapid and robust diagnostic tool for point-of-care (POC) detection of HF. Lateral flow immunoassay (LFIA) has found widespread applications in POC diagnostics. However, the low sensitivity of LFIA limits its ability to detect important HF biomarkers (e.g., brain natriuretic peptide [BNP]) that are normally present in low concentration in blood. To address this issue, we developed an improved LFIA by optimizing the gold nanoparticle (GNP)-antibody conjugate conditions (e.g., the conjugate pH and the amount of added antibody), the diameter of GNP and the concentration of antibody embedded on the test line and modifying the structure of test strip. Through these improvements, the proposed test strip enabled the detection of BNP down to 0.1 ng/mL within 10-15 min, presenting ~15-fold sensitivity enhancement over conventional lateral flow assay. We also successfully applied our LFIA in the analysis of BNP in human serum samples, highlighting its potential use for clinical assessment of HF. The developed LFIA for BNP could rapidly rule out HF with the naked eye, offering tremendous potential for POC test and personalized medicine.

  5. Use of a centrifugation-based, point-of-care device for production of canine autologous bone marrow and platelet concentrates.

    Science.gov (United States)

    Thoesen, Michael S; Berg-Foels, Wendy S Vanden; Stokol, Tracy; Rassnick, Kenneth M; Jacobson, May S; Kevy, Sherwin V; Todhunter, Rory J

    2006-10-01

    To analyze a centrifugation-based, point-of-care device that concentrates canine platelets and bone marrow-derived cells. 19 adult sexually intact dogs. Anticoagulated peripheral blood (60 mL) and 60 mL of anticoagulated bone marrow aspirate (BMA) were concentrated by centrifugation with the centrifugation-based, point-of-care device to form a platelet and a bone marrow concentrate (BMC) from 11 dogs. Blood samples were analyzed on the basis of hemograms, platelet count, and PCV. The BMA and BMC were analyzed to determine PCV, total nucleated cell count, RBC count, and differential cell counts. The BMC stromal cells were cultured in an osteoinductive medium. Eight additional dogs were used to compare the BMC yield with that in which heparin was infused into the bone marrow before aspiration. The centrifugation-based, point-of-care device concentrated platelets by 6-fold over baseline (median recovery, 63.1%) with a median of 1,336 x 10(3) platelets/microL in the 7-mL concentrate. The nucleated cells in BMCs increased 7-fold (median recovery, 42.9%) with a median of 720 x 10(3) cells/microL in the 4-mL concentrate. The myeloid nucleated cells and mononuclear cells increased significantly in BMCs with a significant decrease in PCV, compared with that of BMAs. Stromal cell cultures expressed an osteoblastic phenotype in culture. Infusion of heparin into the bone marrow eliminated clot formation and created less variation in the yield (median recovery, 61.9%). Bone marrow-derived cell and platelet-rich concentrates may form bone if delivered in an engineered graft, thus decreasing the need for cancellous bone grafts.

  6. Recombinant human G6PD for quality control and quality assurance of novel point-of-care diagnostics for G6PD deficiency

    OpenAIRE

    Kahn, Maria; LaRue, Nicole; Zhu, Changcheng; Pal, Sampa; Mo, Jack S.; Barrett, Lynn K.; Hewitt, Steve N.; Dumais, Mitchell; Hemmington, Sandra; Walker, Adrian; Joynson, Jeff; Leader, Brandon T.; Van Voorhis, Wesley C.; Domingo, Gonzalo J.

    2017-01-01

    Background A large gap for the support of point-of-care testing is the availability of reagents to support quality control (QC) of diagnostic assays along the supply chain from the manufacturer to the end user. While reagents and systems exist to support QC of laboratory screening tests for glucose-6-phosphate dehydrogenase (G6PD) deficiency, they are not configured appropriately to support point-of-care testing. The feasibility of using lyophilized recombinant human G6PD as a QC reagent in n...

  7. An automated smartphone-based diagnostic assay for point-of-care semen analysis

    Science.gov (United States)

    Kanakasabapathy, Manoj Kumar; Sadasivam, Magesh; Singh, Anupriya; Preston, Collin; Thirumalaraju, Prudhvi; Venkataraman, Maanasa; Bormann, Charles L.; Draz, Mohamed Shehata; Petrozza, John C.; Shafiee, Hadi

    2017-01-01

    Male infertility affects up to 12% of the world’s male population and is linked to various environmental and medical conditions. Manual microscope-based testing and computer-assisted semen analysis (CASA) are the current standard methods to diagnose male infertility; however, these methods are labor-intensive, expensive, and laboratory-based. Cultural and socially dominated stigma against male infertility testing hinders a large number of men from getting tested for infertility, especially in resource-limited African countries. We describe the development and clinical testing of an automated smartphone-based semen analyzer designed for quantitative measurement of sperm concentration and motility for point-of-care male infertility screening. Using a total of 350 clinical semen specimens at a fertility clinic, we have shown that our assay can analyze an unwashed, unprocessed liquefied semen sample with smartphone capabilities, can make remote semen quality testing accessible to people in both developed and developing countries who have access to smartphones. PMID:28330865

  8. In-vitro diagnostic devices introduction to current point-of-care diagnostic devices

    CERN Document Server

    Cheng, Chao-Min; Chen, Chien-Fu

    2016-01-01

    Addressing the origin, current status, and future development of point-of-care diagnostics, and serving to integrate knowledge and tools from Analytical Chemistry, Bioengineering, Biomaterials, and Nanotechnology, this book focusses on addressing the collective and combined needs of industry and academia (including medical schools) to effectively conduct interdisciplinary research. In addition to summarizing and detailing developed diagnostic devices, this book will attempt to point out the possible future trends of development for point-of-care diagnostics using both scientifically based research and practical engineering needs with the aim to help novices comprehensively understand the development of point-of-care diagnostics. This includes demonstrating several common but critical principles and mechanisms used in point-of-care diagnostics that address practical needs (e.g., disease or healthcare monitoring) using two well-developed examples so far: 1) blood glucose meters (via electrochemistry); and, 2) p...

  9. ClinicalKey 2.0: Upgrades in a Point-of-Care Search Engine.

    Science.gov (United States)

    Huslig, Mary Ann; Vardell, Emily

    2015-01-01

    ClinicalKey 2.0, launched September 23, 2014, offers a mobile-friendly design with a search history feature for targeting point-of-care resources for health care professionals. Browsing is improved with searchable, filterable listings of sources highlighting new resources. ClinicalKey 2.0 improvements include more than 1,400 new Topic Pages for quick access to point-of-care content. A sample search details some of the upgrades and content options.

  10. Point-of-care diagnosis of periodontitis using saliva: technically feasible but still a challenge.

    Science.gov (United States)

    Ji, Suk; Choi, Youngnim

    2015-01-01

    Periodontitis is a chronic inflammation of the periodontium caused by persistent bacterial infection that leads to the breakdown of connective tissue and bone. Because the ability to reconstruct the periodontium is limited after alveolar bone loss, early diagnosis and intervention should be the primary goals of periodontal treatment. However, periodontitis often progresses without noticeable symptoms, and many patients do not seek professional dental care until the periodontal destruction progresses to the point of no return. Furthermore, the current diagnosis of periodontitis depends on time-consuming clinical measurements. Therefore, there is an unmet need for near-patient testing to diagnose periodontitis. Saliva is an optimal biological fluid to serve as a near-patient diagnostic tool for periodontitis. Recent developments in point-of-care (POC) testing indicate that a diagnostic test for periodontitis using saliva is now technically feasible. A number of promising salivary biomarkers associated with periodontitis have been reported. A panel of optimal biomarkers must be carefully selected based on the pathogenesis of periodontitis. The biggest hurdle for the POC diagnosis of periodontitis using saliva may be the process of validation in a large, diverse patient population. Therefore, we propose the organization of an International Consortium for Biomarkers of Periodontitis, which will gather efforts to identify, select, and validate salivary biomarkers for the diagnosis of periodontitis.

  11. Point-of-care diagnosis of periodontitis using saliva: technically feasible but still a challenge

    Directory of Open Access Journals (Sweden)

    Suk eJi

    2015-09-01

    Full Text Available Periodontitis is a chronic inflammation of the periodontium caused by persistent bacterial infection that leads to the breakdown of connective tissue and bone. Because the ability to reconstruct the periodontium is limited after alveolar bone loss, early diagnosis and intervention should be the primary goals of periodontal treatment. However, periodontitis often progresses without noticeable symptoms, and many patients do not seek professional dental care until the periodontal destruction progresses to the point of no return. Furthermore, the current diagnosis of periodontitis depends on time-consuming clinical measurements. Therefore, there is an unmet need for near-patient testing to diagnose periodontitis. Saliva is an optimal biological fluid to serve as a near-patient diagnostic tool for periodontitis. Recent developments in point-of-care (POC testing indicate that a diagnostic test for periodontitis using saliva is now technically feasible. A number of promising salivary biomarkers associated with periodontitis have been reported. A panel of optimal biomarkers must be carefully selected based on the pathogenesis of periodontitis. The biggest hurdle for the POC diagnosis of periodontitis using saliva may be the process of validation in a large, diverse patient population. Therefore, we propose the organization of an International Consortium for Biomarkers of Periodontitis, which will gather efforts to identify, select, and validate salivary biomarkers for the diagnosis of periodontitis.

  12. Toward unstained cytology and complete blood counts at the point of care (Conference Presentation)

    Science.gov (United States)

    Zuluaga, Andres F.; Pierce, Mark C.; MacAulay, Calum E.

    2017-02-01

    Cytology tests, whether performed on body fluids, aspirates, or scrapings are commonly used to detect, diagnose, and monitor a wide variety of health conditions. Complete blood counts (CBCs) quantify the number of red and white blood cells in a blood volume, as well as the different types of white blood cells. There is a critical unmet need for an instrument that can perform CBCs at the point of care (POC), and there is currently no product in the US that can perform this test at the bedside. We have developed a system that is capable of tomographic images with sub-cellular resolution with consumer-grade broadband (LED) sources and CMOS detectors suitable for POC implementation of CBC tests. The systems consists of cascaded static Michelson and Sagnac interferometers that map phase (encoding depth) and a transverse spatial dimension onto a two-dimensional output plane. Our approach requires a 5 microliter sample, can be performed in 5 minutes or less, and does not require staining or other processing as it relies on intrinsic contrast. We will show results directly imaging and differentiating unstained blood cells using supercontinuum fiber lasers and LEDs as sources and CMOS cameras as sensors. We will also lay out the follow up steps needed, including image segmentation, analysis and classification, to verify performance and advance toward CBCs that can be performed bedside and do not require CLIA-certified laboratories.

  13. Point-of-care diagnostics: extending the laboratory network to reach the last mile.

    Science.gov (United States)

    Drain, Paul K; Rousseau, Christine

    2017-03-01

    More point-of-care (POC) diagnostic tests are becoming available for HIV diagnosis and treatment in resource-limited settings. These novel technologies have the potential to foster decentralized HIV care and treatment for the benefit of clinical laboratories, HIV clinics, and HIV-infected patients. There continue to be many business, technological, and operational challenges that limit product development and regulatory approval, which limits products available for the required operational and cost-effectiveness studies and delays policy adoption and implementation. Although the rapid HIV diagnostic test has been widely successful, the pathways for POC CD4 cell count and HIV viral load assay analyzers have been more challenging. We describe significant hurdles for product development, approval, and implementation, which include the business case, technical development, clinical impact, and integrating laboratory and clinical networks. The objective of this review is to highlight the obstacles for developing and implementing appropriate strategies for POC HIV testing assays to improve the clinical services for HIV-infected patients in resource-limited settings.

  14. Potential impact of co-payment at point of care to influence emergency department utilization.

    Science.gov (United States)

    Baum, Zachary; Simmons, Michael R; Guardiola, Jose H; Smith, Cynthia; Carrasco, Lynn; Ha, Joann; Richman, Peter

    2016-01-01

    Background. Many proponents for healthcare reform suggest increased cost-sharing by patients as a method to reduce overall expenditures. Prior studies on the effects of co-payments for ED visits have generally not been directed toward understanding patient attitudes/behavior at point of care. Objectives. We conducted a survey at point of care to test our hypothesis that a significant number of patients with urgent chief complaints might have avoided the ED if asked to provide a co-payment. Methods. Cross-sectional study design. Stable, oriented, consenting patients at an inner-city, academic ED were consecutively enrolled at hours in which trained research associates were available to assist with data collection. Enrolled patients completed a written survey providing demographic/chief complaint information, and then were asked whether 13 interval amounts of co-payment ranging from 0 to >500 would have impacted their decision to visit the ED. Categorical data are presented as frequency of occurrence and analyzed by chi-square; continuous data presented as means ± standard deviation, analyzed by t-tests. ORs and 95% confidence intervals provided. Primary outcome parameter was the % of patients who would have avoided the ED if asked to pay any co-payment for several urgent chief complaints: chest pain, SOB, and abdominal pain. Results. A total of 581 patients were enrolled; 63.1% female, mean age 42.4 ± 15.1 years, 65% Hispanic, 71.2% income less than 20,000, 28.6% less than high school graduate, 81.3% had primary care physician, 57.6% had 2 or more ED visits/past year. Overall, 30.2% of patients chose 0 as the maximum they would have been willing to pay if it was required to be seen in the ED. 16/58 (28%; 95% CI [18-40%]) of chest pain patients, 9/43 (20.9%; 95% CI [11-35%]) of SOB patients, and 24/127 (26.8%; 95% CI [13-27%]) of abdominal pain patients would have been unwilling to pay a co-pay. Patients with income >20,000 were more willing to pay a co-payment (OR

  15. Potential impact of co-payment at point of care to influence emergency department utilization

    Directory of Open Access Journals (Sweden)

    Zachary Baum

    2016-01-01

    Full Text Available Background. Many proponents for healthcare reform suggest increased cost-sharing by patients as a method to reduce overall expenditures. Prior studies on the effects of co-payments for ED visits have generally not been directed toward understanding patient attitudes/behavior at point of care.Objectives. We conducted a survey at point of care to test our hypothesis that a significant number of patients with urgent chief complaints might have avoided the ED if asked to provide a co-payment.Methods. Cross-sectional study design. Stable, oriented, consenting patients at an inner-city, academic ED were consecutively enrolled at hours in which trained research associates were available to assist with data collection. Enrolled patients completed a written survey providing demographic/chief complaint information, and then were asked whether 13 interval amounts of co-payment ranging from 0 to >500 would have impacted their decision to visit the ED. Categorical data are presented as frequency of occurrence and analyzed by chi-square; continuous data presented as means ± standard deviation, analyzed by t-tests. ORs and 95% confidence intervals provided. Primary outcome parameter was the % of patients who would have avoided the ED if asked to pay any co-payment for several urgent chief complaints: chest pain, SOB, and abdominal pain.Results. A total of 581 patients were enrolled; 63.1% female, mean age 42.4 ± 15.1 years, 65% Hispanic, 71.2% income less than 20,000, 28.6% less than high school graduate, 81.3% had primary care physician, 57.6% had 2 or more ED visits/past year. Overall, 30.2% of patients chose 0 as the maximum they would have been willing to pay if it was required to be seen in the ED. 16/58 (28%; 95% CI [18–40%] of chest pain patients, 9/43 (20.9%; 95% CI [11–35%] of SOB patients, and 24/127 (26.8%; 95% CI [13–27%] of abdominal pain patients would have been unwilling to pay a co-pay. Patients with income >20,000 were more willing to

  16. Scenario-Based Assessment of User Needs for Point-of-Care Robots.

    Science.gov (United States)

    Lee, Hyeong Suk; Kim, Jeongeun

    2018-01-01

    This study aimed to derive specific user requirements and barriers in a real medical environment to define the essential elements and functions of two types of point-of-care (POC) robot: a telepresence robot as a tool for teleconsultation, and a bedside robot to provide emotional care for patients. An analysis of user requirements was conducted; user needs were gathered and identified, and detailed, realistic scenarios were created. The prototype robots were demonstrated in physical environments for envisioning and evaluation. In all, three nurses and three clinicians participated as evaluators to observe the demonstrations and evaluate the robot systems. The evaluators were given a brief explanation of each scene and the robots' functionality. Four major functions of the teleconsultation robot were defined and tested in the demonstration. In addition, four major functions of the bedside robot were evaluated. Among the desired functions for a teleconsultation robot, medical information delivery and communication had high priority. For a bedside robot, patient support, patient monitoring, and healthcare provider support were the desired functions. The evaluators reported that the teleconsultation robot can increase support from and access to specialists and resources. They mentioned that the bedside robot can improve the quality of hospital life. Problems identified in the demonstration were those of space conflict, communication errors, and safety issues. Incorporating this technology into healthcare services will enhance communication and teamwork skills across distances and thereby facilitate teamwork. However, repeated tests will be needed to evaluate and ensure improved performance.

  17. Electricity-free amplification and detection for molecular point-of-care diagnosis of HIV-1.

    Science.gov (United States)

    Singleton, Jered; Osborn, Jennifer L; Lillis, Lorraine; Hawkins, Kenneth; Guelig, Dylan; Price, Will; Johns, Rachel; Ebels, Kelly; Boyle, David; Weigl, Bernhard; LaBarre, Paul

    2014-01-01

    In resource-limited settings, the lack of decentralized molecular diagnostic testing and sparse access to centralized medical facilities can present a critical barrier to timely diagnosis, treatment, and subsequent control and elimination of infectious diseases. Isothermal nucleic acid amplification methods, including reverse transcription loop-mediated isothermal amplification (RT-LAMP), are well-suited for decentralized point-of-care molecular testing in minimal infrastructure laboratories since they significantly reduce the complexity of equipment and power requirements. Despite reduced complexity, however, there is still a need for a constant heat source to enable isothermal nucleic acid amplification. This requirement poses significant challenges for laboratories in developing countries where electricity is often unreliable or unavailable. To address this need, we previously developed a low-cost, electricity-free heater using an exothermic reaction thermally coupled with a phase change material. This heater achieved acceptable performance, but exhibited considerable variability. Furthermore, as an enabling technology, the heater was an incomplete diagnostic solution. Here we describe a more precise, affordable, and robust heater design with thermal standard deviation electricity-free heater and NALF-detection platform, we demonstrate sensitive and repeatable detection of HIV-1 with a ß-actin positive internal amplification control from processed sample to result in less than 80 minutes. Together, these elements are building blocks for an electricity-free platform capable of isothermal amplification and detection of a variety of pathogens.

  18. Development of skills to utilize point-of-care ultrasonography in nephrology practice.

    Science.gov (United States)

    Nunes, Aida Aguilar; Pazeli Júnior, José Muniz; Rodrigues, Anderson Tavares; Tollendal, Ana Luisa Silveira Vieira; Ezequiel, Oscarina da Silva; Colugnati, Fernando Antonio Basile; Bastos, Marcus Gomes

    2016-06-01

    The use of ultrasonography (US) by non-radiologists has increased due to the need of physicians to integrate "new" clinical information into the diagnostic process. A defined and validated ultrasound training program has not been established in Nephrology. This study aimed to present the results of assessment of the development of skills to utilize point-of-care ultrasonography (POCUS) in Nephrology practice. Nine residents, four from Nephrology and five from internal medicine program, attended a 16-hour course that covered