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Sample records for anticoagulation point-of-care testing

  1. Evaluation of patient perceptions and outcomes related to anticoagulation point-of-care testing in ambulatory care clinics

    Directory of Open Access Journals (Sweden)

    Fermo JD

    2009-12-01

    Full Text Available Until recently, Prothrombin Time/International Normalized Ratio (PT/INR measurements have typically been used to monitor patients on warfarin through institutional laboratories via venous puncture. The Point-of-Care Testing (POCT device has revolutionized the patient care process by allowing for laboratory testing outside of the central laboratory. Objective: To analyze humanistic and clinical outcomes in patients currently treated with warfarin and monitored through a pharmacist-managed anticoagulation clinic using point-of-care testing (POCT device versus venipuncture within ambulatory care clinics at our institution. Methods: All patients currently treated with warfarin therapy who were managed by clinical pharmacists for anticoagulation monitoring at the Medical University of South Carolina (MUSC Family Medicine Center and University Diagnostic Center, were enrolled. Patients were asked to complete a satisfaction survey regarding their anticoagulation monitoring. In addition, data related to emergency department (ED visits, hospitalizations and percent of time in the INR therapeutic range for 6 months pre- and post-implementation of POCT device was collected. This information was obtained through an electronic patient information database, Oacis. Results: A total of 145 patients were included in the data collection from the two clinics. The majority (41% of these patients were taking warfarin for atrial fibrillation. Satisfaction surveys were completed by 86 (59 % of patients. The surveys revealed that POCT device was preferred over venipuncture in 95% of patients. Reasons for the preference included more face-to-face interaction, less wait time, less pain, less blood needed, and quicker results. Of the 145 patients who were included in the objective data analysis, no significant differences were found in the number of hospitalizations, ED visits, or percent of time in the INR therapeutic range pre- and post- implementation of POCT device

  2. 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...

  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

    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...... was notsignificant (4.2 percentage points (pp); 95% confidenceinterval (CI): –0.8-9.2). Short sampling intervals, e.g. 10-20days (–11 pp, 95% CI: –16-–6)) and lack of diagnostic coding(–11.8 pp; 95% CI: –19.9-–3.7) were correlated with a lowTTR. CONCLUSION: In our study most of the general practices usingINR POCT...... in the management of patients in warfarintreatment provided good quality of care. Sampling intervaland diagnostic coding were significantly correlated withtreatment quality. FUNDING: The study received financial support from theSarah Krabbe Foundation, the General Practitioners’ Educationand Development Foundation...

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

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    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.

  5. Point of care testing: diagnosis outside the virology laboratory.

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    Blyth, Christopher C; Booy, Robert; Dwyer, Dominic E

    2011-01-01

    Numerous point-of-care tests (POCTs) are available to diagnose viral infections in both hospital and community settings. The ideal POCT is rapid, sensitive, specific, and simple to perform. This chapter will describe the benefits of POCTs, factors that can influence the accuracy of POCTs and highlight some limitations of POCT strategies. The sensitivity, specificity, and turn-around time of available POCTs are included for common conditions including respiratory viral infections (e.g. influenza, RSV) and blood-borne viral infections (e.g. HIV).

  6. Point-of-care testing. Conception, regulations, and usage.

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    Cvitkovic, Michaela

    2011-01-01

    Point-of-care testing (POCT) has revolutionized clinical decision making in the intensive care unit. Much of the credit for successful systems today could not have happened without the vision of the Connectivity Industry Consortium (CIC). The intent of this working group, first convened in 1999, was to ensure that all POCT devices could connect with any data management system, by-passing frustrations and concerns about separate connections, proprietary software, computer modifications, and other barriers to implementation. The CIC believed that the adoption of a common connectivity standard would finally enable hospitals to pursue POCT initiatives without concerns about compatibility of various bedside laboratory devices and hospital data management systems. More than a decade later, some POCT devices are not compliant with the CIC standards, either due to a lack of technological updating or the manufacturer's unwillingness to embrace the fundamental requirements of the CIC standards. Glucose meters, originally connected in the early 1990s, are the most advanced POCT devices, and their relative sophistication is serving as the benchmark for other laboratory instrumentation at the point of care. Through a discussion of the preanalytical, analytical and postanalytical phases of glucose testing, the complexities of POCT will be illustrated, along with factors relating to safety, quality assurance, and patient outcomes.

  7. Risk Management for Point-of-Care Testing

    Science.gov (United States)

    2014-01-01

    Point-of-care testing (POCT) is growing in popularity, and with this growth comes an increased chance of errors. Risk management is a way to reduce errors. Originally developed for the manufacturing industry, risk management principles have application for improving the quality of test results in the clinical laboratory. The Clinical and Laboratory Standards Institute (CLSI), EP23-A Laboratory Quality Control based on Risk Management guideline, introduces risk management to the clinical laboratory and describes how to build and implement a quality control plan for a laboratory test. A simple, unit-use blood gas analyzer is utilized as an example for developing a laboratory quality control plan. The US Centers for Medicare and Medicaid Services (CMS) has revised the Clinical and Laboratory Improvement Amendments (CLIA) interpretive guidelines to provide a new quality control option, individualized quality control plans (IQCP), for decreasing the frequency of analyzing liquid controls from two levels each day of testing to manufacturer recommended frequencies in conjunction with a device’s built-in internal control processes and the risk of error when testing with that device. IQCPs have the advantage of allowing laboratories the flexibility to adopt alternative control processes in concert with traditional liquid controls to improve efficiency and cost effectiveness while providing optimal quality POCT results for patient care. PMID:27683462

  8. Point of care testing: The impact of nanotechnology.

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    Syedmoradi, Leila; Daneshpour, Maryam; Alvandipour, Mehrdad; Gomez, Frank A; Hajghassem, Hassan; Omidfar, Kobra

    2017-01-15

    Point-of-care (POC) diagnostic devices are integral in the health care system and particularly for the diagnosis and monitoring of diseases. POC testing has a variety of advantages including the ability to provide rapid and accurate results, ease of use, low cost, and little need for specialized equipment. One of the goals of POC testing is the development of a chip-based, miniaturized, portable, and self-containing system that allows for the assay of different analytes in complex samples. To achieve these goals, many researchers have focused on paper-based and printed electrode technologies as the material for fabricating POC diagnostic systems. These technologies are affordable, sensitive, user-friendly, rapid, and scalable for manufacturing. Moreover, the combination such devices with nanomaterials provide a path for the development of highly sensitive and selective biosensors for future generation POC tools. This review article discusses present technologies in on-site or at home POC diagnostic assays implemented in paper-based microfluidic and screen printing devices over the past decade as well as in the near future. In addition, recent advances in the application of nanomaterials such as gold nanoparticles, carbon nanotubes (CNTs), magnetic nanoparticles, and graphene in POC devices will be reviewed. The factors that limit POC testing to become real world products and future directions are also identified.

  9. [Point-of-care-testing--the intensive care laboratory].

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    Müller, M M; Hackl, W; Griesmacher, A

    1999-01-01

    After successful centralization of laboratory analyses since more than 30 years, advances in biosensors, microprocessors, measurement of undiluted whole blood and miniaturization of laboratory analyzers are leading nowadays more and more to a re-decentralization in the laboratory medicine. Point-of-care-testing (POCT), which is defined as any laboratory test performed outside central or decentralized laboratories, is becoming more and more popular. The theoretical advantages of POCT are faster turn-around-times (TAT), more rapid medical decisions, avoidance of sample identification and sample transport problems and the need of only small specimen volumes. These advantages are frequently mentioned, but are not associated with a clear clinical benefit. The disadvantages of POCT such as incorrect handling and/or maintenance of the analyzers by nontrained clinical staff, inadequate or even absent calibrations and/or quality controls, lack of cost-effectiveness because of an increased number of analyzers and more expensive reagents, insufficient documentation and difficult comparability of the obtained POCT-results with routine laboratory results, are strongly evident. According to the authors' opinion the decision for the establishing of POCT has only to be made in a close co-operation between physicians and laboratorians in order to vouch for necessity and high quality of the analyses. Taking the local situation into consideration (24-h-central laboratory, etc.) the spectrum of parameters measured by means of POCT should be rigorously restricted to the vital functions. Such analytes should be: hemoglobin or hematocrit, activated whole blood clotting time, blood gases, sodium, potassium, ionized calcium, glucose, creatinine, ammonia and lactate.

  10. 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. Beger (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 febr

  11. Point-of-care testing in UK primary care : a survey to establish clinical needs

    NARCIS (Netherlands)

    Turner, Philip J.; Van den Bruel, Ann; Jones, Caroline H. D.; Pluddemann, Annette; Heneghan, Carl; Thompson, Matthew J.; Price, Christopher P.; Howick, Jeremy

    2016-01-01

    Background. A number of point-of-care diagnostic tests are commercially available in the UK, however, not much is known regarding GPs’ desire for these tests or the clinical areas of interest. Objective. We sought to establish for which conditions point-of-care tests (POCTs) would be most helpful to

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

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    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.

  13. Challenges and Opportunities of Centrifugal Microfluidics for Extreme Point-of-Care Testing

    Directory of Open Access Journals (Sweden)

    Issac J. Michael

    2016-02-01

    Full Text Available The advantages offered by centrifugal microfluidic systems have encouraged its rapid adaptation in the fields of in vitro diagnostics, clinical chemistry, immunoassays, and nucleic acid tests. Centrifugal microfluidic devices are currently used in both clinical and point-of-care settings. Recent studies have shown that this new diagnostic platform could be potentially used in extreme point-of-care settings like remote villages in the Indian subcontinent and in Africa. Several technological inventions have decentralized diagnostics in developing countries; however, very few microfluidic technologies have been successful in meeting the demand. By identifying the finest difference between the point-of-care testing and extreme point-of-care infrastructure, this review captures the evolving diagnostic needs of developing countries paired with infrastructural challenges with technological hurdles to healthcare delivery in extreme point-of-care settings. In particular, the requirements for making centrifugal diagnostic devices viable in developing countries are discussed based on a detailed analysis of the demands in different clinical settings including the distinctive needs of extreme point-of-care settings.

  14. Pre-implementation guidelines for infectious disease point-of-care testing in medical institutions

    NARCIS (Netherlands)

    A.A. Eijck (Annemiek); A. Tintu (Andrei); J.P. Hays (John)

    2017-01-01

    textabstractInfectious disease point-of-care test (ID-POCT) devices are becoming widely available, and in this respect, international quality standards and guidelines are available for consultation once ID-POCT has been implemented into medical institutions. However, specific guidelines for consulta

  15. A laboratory-based evaluation of four rapid point-of-care tests for syphilis.

    Directory of Open Access Journals (Sweden)

    Louise M Causer

    Full Text Available 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 need to be

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

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    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.

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

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    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.

  18. Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public

    Directory of Open Access Journals (Sweden)

    Kaman WE

    2013-06-01

    Full Text Available Wendy E Kaman,1 Eleni-Rosalina Andrinopoulou,2 John P Hays11Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands; 2Department of Biostatistics, Erasmus Medical Center, Rotterdam, The NetherlandsBackground: The proper development and implementation of point-of-care (POC diagnostics requires knowledge of the perceived requirements and barriers to their implementation. To determine the current requirements and perceived barriers to the introduction of POC diagnostics in the field of medical microbiology (MM-POC a prospective online survey (TEMPOtest-QC was established.Methods and results: The TEMPOtest-QC survey was online between February 2011 and July 2012 and targeted the medical community, POC test diagnostic manufacturers, general practitioners, and the general public. In total, 293 individuals responded to the survey, including 91 (31% medical microbiologists, 39 (13% nonmedical microbiologists, 25 (9% employees of POC test manufacturers, and 138 (47% members of the general public. Responses were received from 18 different European countries, with the largest percentage of these living in The Netherlands (52%. The majority (>50% of medical specialists regarded the development of MM-POC for blood culture and hospital acquired infections as “absolutely necessary”, but were much less favorable towards their use in the home environment. Significant differences in perceptions between medical specialists and the general public included the: (1 Effect on quality of patient care; (2 Ability to better monitor patients; (3 Home testing and the doctor-patient relationship; and (4 MM-POC interpretation. Only 34.7% of the general public is willing to pay more than €10 ($13 for a single MM-POC test, with 85.5% preferring to purchase their MM-POC test from a pharmacy.Conclusion: The requirements for the proper implementation of MM-POC were found to be generally similar between medical

  19. What's the Point? How Point-of-Care STI Tests Can Impact Infected Patients.

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    Huppert, Jill; Hesse, Elizabeth; Gaydos, Charlotte A

    2010-03-01

    Point-of-care (POC) tests are an important strategy to address the epidemic of sexually transmitted infections (STIs) among both adolescents and young adults. While access to care and confidentiality are major barriers to STI care, POC tests allow the clinician to provide immediate and confidential test results and treatment. In addition, POC test results constitute a "teachable moment"; that is, an opportunity to provide immediate feedback to the patient that may impact his/her risk behaviors. This paper reviews published data and manufacturer's product literature describing current point-of-care STI tests, including studies of test performance as well as impact on treatment intervals and disease spread. It presents theoretical and proposed pitfalls and solutions of implementing POC tests in clinical settings, non-traditional settings, and home care venues. We reviewed the available STI tests according to the World Health Organization (WHO) criteria for judging POC tests: the "ASSURRED" criteria (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment-free, Delivered).

  20. Feasibility of HIV point-of-care tests for resource-limited settings: challenges and solutions.

    Science.gov (United States)

    Stevens, Wendy; Gous, Natasha; Ford, Nathan; Scott, Lesley E

    2014-09-08

    Improved access to anti-retroviral therapy increases the need for affordable monitoring using assays such as CD4 and/or viral load in resource-limited settings. Barriers to accessing treatment, high rates of loss to initiation and poor retention in care are prompting the need to find alternatives to conventional centralized laboratory testing in certain countries. Strong advocacy has led to a rapidly expanding repertoire of point-of-care tests for HIV. point-of-care testing is not without its challenges: poor regulatory control, lack of guidelines, absence of quality monitoring and lack of industry standards for connectivity, to name a few. The management of HIV increasingly requires a multidisciplinary testing approach involving hematology, chemistry, and tests associated with the management of non-communicable diseases, thus added expertise is needed. This is further complicated by additional human resource requirements and the need for continuous training, a sustainable supply chain, and reimbursement strategies. It is clear that to ensure appropriate national implementation either in a tiered laboratory model or a total decentralized model, clear country-specific assessments need to be conducted.

  1. Qualitative research on point-of-care testing strategies and programs for HIV.

    Science.gov (United States)

    Engel, Nora; Pant Pai, Nitika

    2015-01-01

    Point-of-care (POC) testing in communities, home settings and primary healthcare centers plays an important role in cutting delays in HIV diagnosis and in the uptake of voluntary testing and counseling. Qualitative research methods have important potential to overcome the current challenges in expanding HIV POC testing programs and strategies, by examining the diagnostic processes, complex inter-relationships and patterns involved in making POC diagnostics work in real-world settings. This article reviews existing qualitative studies on POC testing strategies and programs for HIV. Qualitative research on POC diagnostics around the uptake of POC tests, the actual diagnostic and testing processes involved, the influence of POC tests on clinical decision-making, communication of decisions and decisions exercised by patients are limited. Equally limited are studies that explore adaptation of POC programs to various socio-cultural contexts. More qualitative research is needed to inform test developers, funders and policymakers.

  2. A point-of-care PCR test for HIV-1 detection in resource-limited settings.

    Science.gov (United States)

    Jangam, Sujit R; Agarwal, Abhishek K; Sur, Kunal; Kelso, David M

    2013-04-15

    A low-cost, fully integrated sample-to-answer, quantitative PCR (qPCR) system that can be used for detection of HIV-1 proviral DNA in infants at the point-of-care in resource-limited settings has been developed and tested. The system is based on a novel DNA extraction method, which uses a glass fiber membrane, a disposable assay card that includes on-board reagent storage, provisions for thermal cycling and fluorescence detection, and a battery-operated portable analyzer. The system is capable of automated PCR mix assembly using a novel reagent delivery system and performing qPCR. HIV-1 and internal control targets are detected using two spectrally separated fluorophores, FAM and Quasar 670. In this report, a proof-of-concept of the platform is demonstrated. Initial results with whole blood demonstrate that the test is capable of detecting HIV-1 in blood samples containing greater than 5000 copies of HIV-1. In resource-limited settings, a point-of-care HIV-1 qPCR test would greatly increase the number of test results that reach the infants caregivers, allowing them to pursue anti-retroviral therapy.

  3. Perceptions of point-of-care infectious disease testing among European medical personnel, point-of-care test kit manufacturers, and the general public

    NARCIS (Netherlands)

    W.E. Kaman (Wendy); E-R. Andrinopoulou (Eleni-Rosalina); J.P. Hays (John)

    2013-01-01

    textabstractBackground: The proper development and implementation of point-of-care (POC) diagnostics requires knowledge of the perceived requirements and barriers to their implementation. To determine the current requirements and perceived barriers to the introduction of POC diagnostics in the field

  4. 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

    ... 510K cleared Point of Care (POC) tests and kits for the purpose of disease state recognition, detection..., pancreas, stomach, gallbladder, breast, lung, endometrium and cervix. Current methodologies of...

  5. Point-of-care testing for sexually transmitted infections: recent advances and implications for disease control

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    Tucker, Joseph D.; Bien, Cedric H.; Peeling, Rosanna W.

    2013-01-01

    Purpose of review Sexually transmitted infections (STIs) remain a major global public health issue, with more than 448 million incident bacterial infections each year. We review recent advances in STI point-of-care (POC) testing and implications for STI prevention and control. Recent findings Accurate immunochromatographic assays to detect HIV, hepatitis C virus (HCV) and syphilis antibodies have made home or supervised self-testing possible. Several studies have demonstrated feasibility and excellent test characteristics for HIV, HCV and syphilis POC tests. Rapid oral HIV tests are now available for purchase at retail sites across the United States. Combined HIV and syphilis tests using a single finger prick blood sample are under evaluation. Summary Oral POC STI tests with comparable performance to blood-based POC tests are available for self-testing. POC tests can expand screening, improve syndromic management and reduce loss to follow up. POC STI tests have the potential to facilitate prompt treatment and partner services. POC STI tests create opportunities for new social and financial models of community-based testing services. Increasing equity and access to testing will create challenges in linkage to care, quality assurance, partner services and surveillance. These important developments warrant research to understand appropriate contexts for implementation. PMID:23242343

  6. 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.

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

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    Herbst de Cortina, Sasha; Bristow, Claire C.; Joseph Davey, Dvora; Klausner, Jeffrey D.

    2016-01-01

    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. PMID:27313440

  8. Evaluation of novel second-generation RSV and influenza rapid tests at the point of care.

    Science.gov (United States)

    Tuttle, Ryan; Weick, Anja; Schwarz, Wiebke Sabrina; Chen, Xi; Obermeier, Patrick; Seeber, Lea; Tief, Franziska; Muehlhans, Susann; Karsch, Katharina; Peiser, Christian; Duwe, Susanne; Schweiger, Brunhilde; Rath, Barbara

    2015-03-01

    Acute respiratory infections represent common pediatric emergencies. Infection control warrants immediate and accurate diagnoses. In the past, first-generation respiratory syncytial virus (RSV) rapid tests (strip tests) have shown suboptimal sensitivities. In 2013, the Food and Drug Administration licensed a second-generation RSV rapid test providing user-independent readouts (SOFIA™-RSV) using automated fluorescence assay technology known to yield superior results with influenza rapid testing. We are reporting the first point-of-care evaluation of the SOFIA™-RSV rapid test. In the Charité Influenza-Like Disease Cohort, 686 nasopharyngeal samples were tested in parallel with SOFIA™-RSV and SOFIA™-Influenza A+B. Compared to real-time PCR, SOFIA™-RSV sensitivities/specificities were 78.6%/93.9%, respectively (SOFIA™-Influenza A: 80.6%/99.3%). Performance was greatest in patients below 2 years of age with a test sensitivity of 81.8%. RSV sensitivities were highest (85%) in the first 2 days of illness and with nasopharyngeal compared to nasal swabs (P=0.055, McNemar's test). Second-generation RSV and influenza rapid testing provides highly accurate results facilitating timely patient cohortation and management.

  9. 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.

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

    Science.gov (United States)

    Lehe, Jonathan D; Sitoe, Nádia E; Tobaiwa, Ocean; Loquiha, Osvaldo; Quevedo, Jorge I; Peter, Trevor F; Jani, Ilesh V

    2012-01-01

    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.

  11. Utility of immunochromatographic assay as a rapid point of care test for screening of antenatal syphilis

    Directory of Open Access Journals (Sweden)

    Bineeta Kashyap

    2015-01-01

    Full Text Available Background and Objectives: Syphilis is one of the most common preventable causes of adverse effects during pregnancy. Antenatal screening prevents the delay between diagnosis and treatment there by reducing the risk of congenital syphilis. The objective of this study was to evaluate the utility of an immunochromatographic assay as a point of care test for antenatal screening of syphilis. Materials and Methods: Sera of 200 antenatal mothers were evaluated for serodiagnosis of syphilis by the venereal disease research laboratory (VDRL, Treponema pallidum hemagglutination assay (TPHA and SD BIOLINE Syphilis 3.0 test. The performance of SD BIOLINE Syphilis 3.0 test was compared with VDRL as screening assay and TPHA as a confirmatory test. Results: The antenatal prevalence of syphilis was found to be 2% by both VDRL and TPHA. The sensitivity, specificity, positive predictive value, and the negative predictive value of SD BIOLINE Syphilis 3.0 test were 75%, 100%, 100%, and 99.45%, respectively. Conclusions: Antenatal screening and treatment of maternal syphilis are cost-effective health interventions even under the low prevalence of infection. SD BIOLINE Syphilis 3.0 test, although having less sensitivity than the existing testing strategy, can have a tremendous impact on the disease burden if used prudently for the screening of antenatal mothers in peripheral health settings.

  12. Cardiac troponin: a critical review of the case for point-of-care testing in the ED.

    Science.gov (United States)

    Bingisser, Roland; Cairns, Charles; Christ, Michael; Hausfater, Pierre; Lindahl, Bertil; Mair, Johannes; Panteghini, Mauro; Price, Christopher; Venge, Per

    2012-10-01

    The measurement of cardiac troponin concentrations in the blood is a key element in the evaluation of patients with suspected acute coronary syndromes, according to current guidelines, and contributes importantly to the ruling in or ruling out of acute myocardial infarction. The introduction of point-of-care testing for cardiac troponin has the potential to reduce turnaround time for assay results, compared with central laboratory testing, optimizing resource use. Although, in general, many point-of-care cardiac troponin tests are less sensitive than cardiac troponin tests developed for central laboratory-automated analyzers, point-of-care systems have been used successfully within accelerated protocols for the reliable ruling out of acute coronary syndromes, without increasing subsequent readmission rates for this condition. The impact of shortened assay turnaround times with point-of-care technology on length of stay in the emergency department has been limited to date, with most randomized evaluations of this technology having demonstrated little or no reduction in this outcome parameter. Accordingly, the point-of-care approach has not been shown to be cost-effective relative to central laboratory testing. Modeling studies suggest, however, that reengineering overall procedures within the emergency department setting, to take full advantage of reduced therapeutic turnaround time, has the potential to improve the flow of patients through the emergency department, to shorten discharge times, and to reduce cost. To properly evaluate the potential contribution of point-of-care technology in the emergency department, including its cost-effectiveness, future evaluations of point-of-care platforms will need to be embedded completely within a local decision-making structure designed for its use.

  13. 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.

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

    Directory of Open Access Journals (Sweden)

    Adrienne F.A. Meyers

    2016-10-01

    Full Text Available In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of peopleinfected with HIV to become aware of their status, access antiretroviral therapies and ultimatelybe 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 decentralisingtesting increases patient access to diagnostics, it presents many challenges with regard totraining and assuring the quality of tests and testing. To ensure synergies, the London Schoolof Hygiene & Tropical Medicine held a series of consultations with countries with an interestin quality assurance and their implementing partners, and agreed on an external qualityassessment (EQA programme to ensure reliable results so that the results lead to the bestpossible care for HIV patients. As a result of the consultations, EQA International wasestablished, bringing together EQA providers and implementers to develop a strategic planfor countries to establish national POC EQA programmes and to estimate the cost of setting upand maintaining the programme. With the dramatic increase in the number of proficiencytesting panels required for thousands of POC testing sites across Africa, it is important tofacilitate technology transfer from global EQA providers to a network of regional EQA centresin Africa for regional proficiency testing panel production. EQA International will continue toidentify robust and cost-effective EQA technologies for quality POC testing, integrating noveltechnologies to support sustainable country-owned EQA programmes in Africa.

  15. 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

  16. 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.

  17. Selection of Antigens and Development of Prototype Tests for Point-of-Care Leprosy Diagnosis▿ †

    Science.gov (United States)

    Duthie, Malcolm S.; Ireton, Greg C.; Kanaujia, Ganga V.; Goto, Wakako; Liang, Hong; Bhatia, Ajay; Busceti, Jean Marie; Macdonald, Murdo; Neupane, Kapil Dev; Ranjit, Chaman; Sapkota, Bishwa Raj; Balagon, Marivic; Esfandiari, Javan; Carter, Darrick; Reed, Steven G.

    2008-01-01

    Leprosy can be a devastating chronic infection that causes nerve function impairment and associated disfigurement. Despite the recent reduction in the number of registered worldwide leprosy cases as a result of the widespread use of multidrug therapy, the number of new cases detected each year remains relatively stable. The diagnosis of leprosy is currently based on the appearance of clinical signs and requires expert clinical, as well as labor-intensive and time-consuming laboratory or histological, evaluation. For the purpose of developing an effective, simple, rapid, and low-cost diagnostic alternative, we have analyzed the serologic antibody response to identify Mycobacterium leprae proteins that are recognized by leprosy patients. More than 100 recombinant antigens were analyzed in a protein array format to select those with discriminatory properties for leprosy diagnosis. As expected, multibacillary leprosy patients recognized more antigens with stronger antibody responses than paucibacillary leprosy patients. Our data indicate, however, that multibacillary patients can be distinguished from paucibacillary patients, and both of these groups can be segregated from endemic control groups. We went on to confirm the diagnostic properties of antigens ML0405 and ML2331 and the LID-1 fusion construct of these two proteins by enzyme-linked immunosorbent assay. We then demonstrated the performance of these antigens in rapid test formats with a goal of developing a point-of-care diagnostic test. A serological diagnostic test capable of identifying and allowing treatment of leprosy could reduce transmission, prevent functional disabilities and stigmatizing deformities, and facilitate leprosy eradication. PMID:18716007

  18. Electrochemical K-562 cells sensor based on origami paper device for point-of-care testing.

    Science.gov (United States)

    Ge, Shenguang; Zhang, Lina; Zhang, Yan; Liu, Haiyun; Huang, Jiadong; Yan, Mei; Yu, Jinghua

    2015-12-01

    A low-cost, simple, portable and sensitive paper-based electrochemical sensor was established for the detection of K-562 cell in point-of-care testing. The hybrid material of 3D Au nanoparticles/graphene (3D Au NPs/GN) with high specific surface area and ionic liquid (IL) with widened electrochemical windows improved the good biocompatibility and high conductivity was modified on paper working electrode (PWE) by the classic assembly method and then employed as the sensing surface. IL could not only enhance the electron transfer ability but also provide sensing recognition interface for the conjugation of Con A with cells, with the cell capture efficiency and the sensitivity of biosensor strengthened simultaneously. Concanavalin A (Con A) immobilization matrix was used to capture cells. As proof-of-concept, the paper-based electrochemical sensor for the detection of K-562 cells was developed. With such sandwich-type assay format, K-562 cells as model cells were captured on the surface of Con A/IL/3D AuNPs@GN/PWE. Con A-labeled dendritic PdAg NPs were captured on the surface of K-562 cells. Such dendritic PdAg NPs worked as catalysts promoting the oxidation of thionine (TH) by H2O2 which was released from K-562 cells via the stimulation of phorbol 12-myristate-13-acetate (PMA). Therefore, the current signal response was dependent on the amount of PdAg NPs and the concentration of H2O2, the latter of which corresponded with the releasing amount from cells. So, the detection method of K-562 cell was also developed. Under optimized experimental conditions, 1.5×10(-14) mol of H2O2 releasing from each cell was calculated. The linear range and the detection limit for K-562 cells were determined to be 1.0×10(3)-5.0×10(6) cells/mL and 200 cells/mL, respectively. Such as-prepared sensor showed excellent analytical performance with good fabrication reproducibility, acceptable precision and satisfied accuracy, providing a novel protocol in point-of-care testing of cells.

  19. Point-of-care monitoring of oral anticoagulation therapy in children. Comparison of the CoaguChek XS system with venous INR and venous INR using an International Reference Thromboplastin preparation (rTF/95).

    Science.gov (United States)

    Greenway, Anthea; Ignjatovic, Vera; Summerhayes, Robyn; Newall, Fiona; Burgess, Janet; DeRosa, Lydia; Monagle, Paul

    2009-07-01

    Point-of-care (POC) monitoring of oral anticoagulation has been widely adopted in both paediatric and adult patients. A new POC system, the CoaguChek XS has recently been developed to measure the international normalised ratio (INR) and may offer significant advantages. The CoaguChek XS utilises a new method of electrochemical clot detection based on thrombin generation. This system has not been previously evaluated in children with reference to the laboratory gold standard, the prothrombin time using reference thromboplastin. It was the objective to compare values obtained by the CoaguChek XS system with both the venous INR and the gold standard for anticoagulant monitoring, prothrombin time with reference thromboplastin (rTF/95). To evaluate the impact of testing using the CoaguChek XS on clinical anticoagulant dosing decisions. Fifty paired venous INR and capillary CoaguChek XS results were obtained from 31 children (aged up to 16 years). The laboratory gold standard, a manual prothrombin time with reference thromboplastin (rTF/95) was additionally performed on 26 samples. Correlation between the CoaguChek XS result and the venous INR was r = 0.810. Agreement between the CoaguChek XS result and the reference INR was shown to be higher (r=0.95), in the subset analysed by this method. Correlation between the venous INR and reference INR was r=0.90. Despite changes to the methodology of testing with the CoaguChek XS POC monitoring system, the accuracy of this method when compared with both the venous INR and gold standard reference INR was satisfactory. This resulted in infrequent changes to clinical decision making regarding anticoagulation.

  20. [Point-of-care diagnostics compared to standard coagulation tests in multiple trauma. Pros and cons].

    Science.gov (United States)

    Johanning, K

    2014-02-01

    The haemostasiological management of patients with multiple injuries requires rapid and adequate therapy decisions due to the highly dynamic surroundings. For this, diagnostic techniques which have the ability to detect and differentiate coagulation disorders that are commonly present in multiple trauma patients are necessary. Widely used routine coagulation tests (e.g., aPTT or PT) sensitively measure impairments of the intrinsic or extrinsic pathway, but without further identification or differentiation. Important influencing parameters like acidosis, hypothermia, fibrinolysis or polymerization dysfunction but especially the clot quality are not detectable. Moreover, the turn around times of these tests are about 30-60 min. However, thrombelastography measures clot strength and stability in whole blood under the present conditions of the injured patient. Impairments of clot quality can be differentiated. Because of the visualization of the clot formation, a patient's coagulation capacity can be assessed within minutes. Admittedly the use of these point-of-care devices in the operation theatre requires human and temporal resources.

  1. 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.

  2. Amorphous silicon based p-i-i-n photodetectors for point-of-care testing

    Energy Technology Data Exchange (ETDEWEB)

    Furin, Dominik; Proll, Guenther; Gauglitz, Guenther [Universitaet Tuebingen, Institut fuer Physikalische und Theoretische Chemie, Auf der Morgenstelle 8, 72076 Tuebingen (Germany); Thielmann, Johannes; Harendt, Christine [Institut fuer Mikroelektronik Stuttgart, Allmandring 30a, 70569 Stuttgart (Germany); Pfaefflin, Albrecht; Schleicher, Erwin [Universitaetsklinikum und Medizinische Fakultaet, Universitaetsklinikum Tuebingen, Geissweg 3, 72076 Tuebingen (Germany); Schubert, Markus B. [Institut fuer Physikalische Elektronik, Universitaet Stuttgart, Pfaffenwaldring 47, 70569 Stuttgart (Germany); Saemann, Marc

    2010-04-15

    Modern medical diagnostics demands point-of-care testing (POCT) systems for quick tests in clinical or out-patient environments. This investigation combines the Reflectometric Interference Spectroscopy (RIfS) with thin film technology for a highly sensitive, direct optical and label-free detection of proteins, e.g. inflammation or cardiovascular markers. Amorphous silicon (a-Si) based thin film photodetectors replace the so far needed spectrometer and permit downsizing of the POCT system. Photodetectors with p-i-i-n structure adjust their spectral sensitivity according to the applied read-out voltage. The use of amorphous silicon carbide in the p-type and the first intrinsic layer enhances the sensitivity through very low dark currents of the photodetectors and enables the adjustment of their absorption characteristics. Integrating the thin film photodetectors on the rear side of the RIfS substrate eliminates optical losses and distortions, as compared to the standard RIfS setup. An integrated Application Specific Integrated Circuit (ASIC) chip performs a current-frequency conversion to accurately detect the photocurrent of up to eight parallel photodetector channels. In addition to the optimization of the photo-detectors, this contribution presents first successful direct optical and label-free RIfS measurements of C-reactive protein (CRP) and D-dimer in buffer solution in physiological relevant concentrations. (copyright 2010 WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim) (orig.)

  3. The Accuracy of Point-of-Care Creatinine Testing in the Emergency Department

    Directory of Open Access Journals (Sweden)

    Moises Moreno

    2015-01-01

    Full Text Available Objective. To determine the accuracy of Point-Of-Care testing (PoCT creatinine values when compared to standard central laboratory testing (IDMS and to demonstrate if and how a discrepancy could lead to improper risk stratification for contrast induced nephropathy (CIN. Methods. We conducted a descriptive retrospective chart review of patients seen in the Emergency Department of a single suburban, community, and academic medical center. We included patients who presented to the department between March 2013 and September 2014 who had blood samples analyzed by both PoCT and IDMS. Results. Mean IDMS creatinine values were 0.23 mg/dL higher when compared with i-Stat values. 95% of the time, the IDMS creatinine value was variable and ranged from −0.45 mg/dL to +0.91 mg/dL when compared to the i-Stat creatinine. When using i-Stat creatinine values to calculate GFR, 47 out of 156 patients had risk category variations compared to using the IDMS value. This affected 30.1% of the total eligible sample population (22.9% to 37.3% with 95% CI. Conclusion. We found a significant discrepancy between PoCT and IDMS creatinine values and found that this discrepancy could lead to improper risk stratification for CIN.

  4. Reducing patient identification errors related to glucose point-of-care testing

    Directory of Open Access Journals (Sweden)

    Gaurav Alreja

    2011-01-01

    Full Text Available Background: Patient identification (ID errors in point-of-care testing (POCT can cause test results to be transferred to the wrong patient′s chart or prevent results from being transmitted and reported. Despite the implementation of patient barcoding and ongoing operator training at our institution, patient ID errors still occur with glucose POCT. The aim of this study was to develop a solution to reduce identification errors with POCT. Materials and Methods: Glucose POCT was performed by approximately 2,400 clinical operators throughout our health system. Patients are identified by scanning in wristband barcodes or by manual data entry using portable glucose meters. Meters are docked to upload data to a database server which then transmits data to any medical record matching the financial number of the test result. With a new model, meters connect to an interface manager where the patient ID (a nine-digit account number is checked against patient registration data from admission, discharge, and transfer (ADT feeds and only matched results are transferred to the patient′s electronic medical record. With the new process, the patient ID is checked prior to testing, and testing is prevented until ID errors are resolved. Results: When averaged over a period of a month, ID errors were reduced to 3 errors/month (0.015% in comparison with 61.5 errors/month (0.319% before implementing the new meters. Conclusion: Patient ID errors may occur with glucose POCT despite patient barcoding. The verification of patient identification should ideally take place at the bedside before testing occurs so that the errors can be addressed in real time. The introduction of an ADT feed directly to glucose meters reduced patient ID errors in POCT.

  5. 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.

  6. Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes

    Directory of Open Access Journals (Sweden)

    Marijana Vučić Lovrenčić

    2013-01-01

    Full Text Available Point-of-care (POC glucose technology is currently considered to be insufficiently accurate for the diagnosis of diabetes. The objective of this study was to investigate the diagnostic accuracy of an innovative, interference-resistant POC glucose meter (StatStrip glucose hospital meter, Nova Biomedical, USA in subjects with a previous history of dysglycaemia, undergoing a 75 g diagnostic oral glucose tolerance test (oGTT. Venous and capillary blood sampling for the reference laboratory procedure (RLP and POC-glucose measurement was carried out at fasting and 2 h oGTT, and categories of glucose tolerance were classified according to 2006 WHO diagnostic criteria for the respective sample type. We found an excellent between-method correlation at fasting (r=0.9681, P<0.0001 and 2 h oGTT (r=0.9768, P<0.0001 and an almost perfect diagnostic agreement (weighted Kappa = 0.858. Within a total of 237 study subjects, 137 were diagnosed with diabetes with RLP, and only 6 of them were reclassified as having glucose intolerance with POC. The diagnostic performance of POC-fasting glucose in discriminating between the normal and any category of disturbed glucose tolerance did not differ from the RLP (P=0.081. Results of this study indicate that StatStrip POC glucose meter could serve as a reliable tool for the diabetes diagnosis, particularly in primary healthcare facilities with dispersed blood sampling services.

  7. Portable simultaneous multiple analyte whole-blood analyzer for point-of-care testing.

    Science.gov (United States)

    Schembri, C T; Ostoich, V; Lingane, P J; Burd, T L; Buhl, S N

    1992-09-01

    We describe a portable clinical chemistry analyzer for point-of-care measurements of multiple analytes in less than 10 min from approximately 40 microL of whole blood (fingerstick or venous). Whole blood is applied directly to a 7.9-cm-diameter, single-use plastic rotor containing liquid diluent and greater than or equal to 4-12 tests in the form of 1- to 2-mm-diameter dry reagent beads. The reagent/rotor is immediately placed in a portable instrument along with a ticket/label results card. As the instrument spins the rotor, capillary and rotational forces process the blood into diluted plasma, distribute the patient's diluted sample to cuvettes containing the reagent beads, and mix the diluted sample with the reagents. The instrument monitors the chemical reactions optically at nine wavelengths; sample volume and temperature are also measured optically. The calibration data for each reagent are read from a bar code on the periphery of each rotor. The instrument processes all the measurements to calculate, store, print, and communicate the results. Each reagent/rotor contains an enzymatic control that must be within a defined range before the results from that analysis are reported.

  8. Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes

    Science.gov (United States)

    Božičević, Sandra; Pape-Medvidović, Edita; Ljubić, Spomenka

    2013-01-01

    Point-of-care (POC) glucose technology is currently considered to be insufficiently accurate for the diagnosis of diabetes. The objective of this study was to investigate the diagnostic accuracy of an innovative, interference-resistant POC glucose meter (StatStrip glucose hospital meter, Nova Biomedical, USA) in subjects with a previous history of dysglycaemia, undergoing a 75 g diagnostic oral glucose tolerance test (oGTT). Venous and capillary blood sampling for the reference laboratory procedure (RLP) and POC-glucose measurement was carried out at fasting and 2 h oGTT, and categories of glucose tolerance were classified according to 2006 WHO diagnostic criteria for the respective sample type. We found an excellent between-method correlation at fasting (r = 0.9681, P < 0.0001) and 2 h oGTT (r = 0.9768, P < 0.0001) and an almost perfect diagnostic agreement (weighted Kappa = 0.858). Within a total of 237 study subjects, 137 were diagnosed with diabetes with RLP, and only 6 of them were reclassified as having glucose intolerance with POC. The diagnostic performance of POC-fasting glucose in discriminating between the normal and any category of disturbed glucose tolerance did not differ from the RLP (P = 0.081). Results of this study indicate that StatStrip POC glucose meter could serve as a reliable tool for the diabetes diagnosis, particularly in primary healthcare facilities with dispersed blood sampling services. PMID:24382960

  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. Evaluation of point-of-care test calprotectin and lactoferrin for inflammatory bowel disease among children with chronic gastrointestinal symptoms

    NARCIS (Netherlands)

    Holtman, Gea A; Lisman-van Leeuwen, Yvonne; van Rheenen, Patrick F; Kollen, Boudewijn J; Escher, Johanna C; Kindermann, Angelika; de Rijke, Yolanda B; Berger, Marjolein Y

    2016-01-01

    BACKGROUND: Faecal calprotectin is considered to be a valid test for ruling out inflammatory bowel disease (IBD) in children with chronic gastrointestinal symptoms in specialist care. In contrast, faecal lactoferrin has higher specificity. The recent availability of both as point-of-care tests (POCT

  11. The use of upconverting phosphors in point-of-care (POC) testing

    Science.gov (United States)

    Tanke, Hans J.; Zuiderwijk, Michel; Wiesmeijer, Karien C.; Breedveld, Robert N.; Abrams, William R.; de Dood, Claudia J.; Tjon Kon Fat, Elisa M.; Corstjens, Paul L. A. M.

    2014-03-01

    Point-of-care (POC) testing is increasingly applied as a cost effective alternative to many diagnostic tests. Key in POC testing is to create sufficient assay sensitivity with relatively low cost reagents and equipment. For this purpose we have employed a unique reporter, upconverting phosphor (UCP) particles, in combination with lateral flow (LF) assays. UCPs, submicron ceramic particles doped with rare earth ions (lanthanides), convert infrared to visible light and do not suffer from autofluorescence which limits conventional fluorescence based assays. Low cost handheld readers and microfluidics were evaluated in various applications. Designed assays are well suited for applications outside diagnostic laboratories, in resource poor settings, and can even be used by patients at home. Using two distinctly different UCP-LF assay formats, we focussed on assays for infectious diseases based on the detection of pathogen-specific antibodies and/or antigens including nucleic acids to demonstrate active infection with HIV. Only minor adaptation of the standard UCP-LF assay format is needed to render the format suitable for applications involving low affinity capture antibodies (e.g. in the detection of neurotoxin, botulism), capture of small molecules (e.g. detection of melatonin, a key hormone in chronopharmacology) or the use of dry UCP reagents (e.g. detection of protein based fruit-ripening markers, of economic interest in agriculture). Finally, we anticipate on developments in healthcare (personalized medicine) by discussing the potential of one of the UCP-LF assay formats to measure serum trough levels of immunodrugs (e.g. infliximab or adalimumab) in patients treated for inflammatory bowel disease and rheumatoid arthritis.

  12. 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.

  13. Point-of-care testing for HCV infection: recent advances and implications for alternative screening.

    Science.gov (United States)

    Parisi, Maria Rita; Soldini, Laura; Vidoni, Gianmarino; Mabellini, Chiara; Belloni, Teresa; Brignolo, Livia; Negri, Silvia; Schlusnus, Karin; Dorigatti, Fernanda; Lazzarin, Adriano

    2014-10-01

    Over the last few years, hepatitis C virus (HCV) infection has emerged as one of the most significant causes of chronic liver disease worldwide, with an estimated prevalence ranging from 2.2 to 3.0%. In Italy, approximately 2% of subjects are infected with HCV. Considering that acute HCV infection is usually asymptomatic, early diagnosis is rare. Those people who develop chronic infection, even though undiagnosed, may suffer serious liver damage, making chronic HCV infection a major health problem. New initiatives are needed to identify a submerged portion of patients with chronic viral hepatitis and to propose controls and antiviral treatments to avoid the progression to liver cirrhosis or hepatocellular carcinoma (HCC). Since January 2011, the Infectious Diseases Department of San Raffaele Scientific Institute in Milan has been carrying out a prevention program called "EASY test project", using a new oral test, the OraQuick® HCV rapid antibody test (OraSure technologies, Inc.). The main objective of the project is to evaluate the acceptability of an alternative, free and anonymous HCV test offer, available in different settings (Points of Care, STDs Prevention clinics and General Practitioner clinics). From January 2011 to April 2014, 29,600 subjects were approached to inform them about HCV infection and other sexually transmitted diseases; 4,507 (15.2% of the contacted subjects) of them, total eligible volunteers, performed HCV tests on saliva and completed the interview in the alternative POCTs. Twenty-seven subjects (0.6% of the total) turned HCV oral test reactive (27/4.507) during the evaluation period; all of them were confirmed by conventional test. All 27 patients were asymptomatic and without a history of HCV-re- lated symptoms. The results from this analysis suggest that the promotion of alternative HCV test screening has not yet been fully developed as a strategy to increase levels of HCV testing among people at risk for HCV infection. Increasing

  14. A highly sensitive and simply operated protease sensor toward point-of-care testing.

    Science.gov (United States)

    Park, Seonhwa; Shin, Yu Mi; Seo, Jeongwook; Song, Ji-Joon; Yang, Haesik

    2016-04-21

    Protease sensors for point-of-care testing (POCT) require simple operation, a detection period of less than 20 minutes, and a detection limit of less than 1 ng mL(-1). However, it is difficult to meet these requirements with protease sensors that are based on proteolytic cleavage. This paper reports a highly reproducible protease sensor that allows the sensitive and simple electrochemical detection of the botulinum neurotoxin type E light chain (BoNT/E-LC), which is obtained using (i) low nonspecific adsorption, (ii) high signal-to-background ratio, and (iii) one-step solution treatment. The BoNT/E-LC detection is based on two-step proteolytic cleavage using BoNT/E-LC (endopeptidase) and l-leucine-aminopeptidase (LAP, exopeptidase). Indium-tin oxide (ITO) electrodes are modified partially with reduced graphene oxide (rGO) to increase their electrocatalytic activities. Avidin is then adsorbed on the electrodes to minimize the nonspecific adsorption of proteases. Low nonspecific adsorption allows a highly reproducible sensor response. Electrochemical-chemical (EC) redox cycling involving p-aminophenol (AP) and dithiothreitol (DTT) is performed to obtain a high signal-to-background ratio. After adding a C-terminally AP-labeled oligopeptide, DTT, and LAP simultaneously to a sample solution, no further treatment of the solution is necessary during detection. The detection limits of BoNT/E-LC in phosphate-buffered saline are 0.1 ng mL(-1) for an incubation period of 15 min and 5 fg mL(-1) for an incubation period of 4 h. The detection limit in commercial bottled water is 1 ng mL(-1) for an incubation period of 15 min. The developed sensor is selective to BoNT/E-LC among the four types of BoNTs tested. These results indicate that the protease sensor meets the requirements for POCT.

  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 BACKGROUND: 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. METHODOLOGY/PRINCIPAL FINDINGS: 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. CONCLUSIONS: 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 Smoke

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

    Directory of Open Access Journals (Sweden)

    Elke Wynberg

    2014-01-01

    Full Text Available Introduction: 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. Methods: 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. Results: 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. Discussion: 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.

  17. 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.

  18. Factors determining patients’ intentions to use point-of-care testing medical devices for self-monitoring: the case of international normalized ratio self-testing

    Science.gov (United States)

    Shah, Syed Ghulam Sarwar; Barnett, Julie; Kuljis, Jasna; Hone, Kate; Kaczmarski, Richard

    2013-01-01

    Purpose To identify factors that determine patients’ intentions to use point-of-care medical devices, ie, portable coagulometer devices for self-testing of the international normalized ratio (INR) required for ongoing monitoring of blood-coagulation intensity among patients on long-term oral anticoagulation therapy with vitamin K antagonists, eg, warfarin. Methods A cross-sectional study that applied the technology-acceptance model through a self-completed questionnaire, which was administered to a convenience sample of 125 outpatients attending outpatient anticoagulation services at a district general hospital in London, UK. Data were analyzed using descriptive statistics, factor analyses, and structural equation modeling. Results The participants were mainly male (64%) and aged ≥ 71 years (60%). All these patients were attending the hospital outpatient anticoagulation clinic for INR testing; only two patients were currently using INR self-testing, 84% of patients had no knowledge about INR self-testing using a portable coagulometer device, and 96% of patients were never offered the option of the INR self-testing. A significant structural equation model explaining 79% of the variance in patients’ intentions to use INR self-testing was observed. The significant predictors that directly affected patients’ intention to use INR self-testing were the perception of technology (β = 0.92, P < 0.001), trust in doctor (β = −0.24, P = 0.028), and affordability (β = 0.15, P = 0.016). In addition, the perception of technology was significantly affected by trust in doctor (β = 0.43, P = 0.002), age (β = −0.32, P < 0.001), and affordability (β = 0.23, P = 0.013); thereby, the intention to use INR self-testing was indirectly affected by trust in doctor (β = 0.40), age (β = −0.29), and affordability (β = 0.21) via the perception of technology. Conclusion Patients’ intentions to use portable coagulometers for INR self-testing are affected by patients

  19. 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 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 volume compared to the non

  20. 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.

  1. Point-of-Care Viral Load Testing for Sub-Saharan Africa: Informing a Target Product Profile

    Science.gov (United States)

    Phillips, Andrew N.; Cambiano, Valentina; Nakagawa, Fumiyo; Ford, Deborah; Apollo, Tsitsi; Murungu, Joseph; Rousseau, Christine; Garnett, Geoff; Ehrenkranz, Peter; Bansi-Matharu, Loveleen; Vojnov, Lara; Katz, Zachary; Peeling, Rosanna; Revill, Paul

    2016-01-01

    Point-of-care viral load tests are being developed to monitor patients on antiretroviral therapy (ART) in sub-Saharan Africa. Test design involves trade-offs between test attributes, including accuracy, complexity, robustness, and cost. We used a model of the human immunodeficiency virus epidemic and ART program in Zimbabwe and found that the attributes of a viral load testing approach that are most influential for cost effectiveness are avoidance of a high proportion of failed tests or results not received, use of an approach that best facilitates retention on ART, and the ability to facilitate greater use of differentiated care, including through expanding coverage of testing availability. PMID:27704016

  2. 即时检测常用技术及其临床应用%Common Technologies and Clinical Applications of Point of Care Testing

    Institute of Scientific and Technical Information of China (English)

    刘波

    2013-01-01

    本文综合论述了即时检测(Point of Care Testing, POCT)的基本概念、工作原理、常用技术及其临床应用。%This paper discussed the basic conception, working principle, common technologies and clinical applications of point of care testing.

  3. 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...

  4. Factors determining patients' intentions to use point-of-care testing medical devices for self-monitoring: the case of international normalized ratio self-testing

    Directory of Open Access Journals (Sweden)

    Shah SG

    2012-12-01

    Full Text Available Syed Ghulam Sarwar Shah,1 Julie Barnett,1 Jasna Kuljis,2 Kate Hone,2 Richard Kaczmarski31Multidisciplinary Assessment of Technology Centre for Healthcare, 2Department of Information Systems and Computing, Brunel University London, Uxbridge, Middlesex, UK; 3Department of Haematology, Hillingdon Hospital, Uxbridge, Middlesex, UKPurpose: To identify factors that determine patients' intentions to use point-of-care medical devices, ie, portable coagulometer devices for self-testing of the international normalized ratio (INR required for ongoing monitoring of blood-coagulation intensity among patients on long-term oral anticoagulation therapy with vitamin K antagonists, eg, warfarin.Methods: A cross-sectional study that applied the technology-acceptance model through a self-completed questionnaire, which was administered to a convenience sample of 125 outpatients attending outpatient anticoagulation services at a district general hospital in London, UK. Data were analyzed using descriptive statistics, factor analyses, and structural equation modeling.Results: The participants were mainly male (64% and aged ≥ 71 years (60%. All these patients were attending the hospital outpatient anticoagulation clinic for INR testing; only two patients were currently using INR self-testing, 84% of patients had no knowledge about INR self-testing using a portable coagulometer device, and 96% of patients were never offered the option of the INR self-testing. A significant structural equation model explaining 79% of the variance in patients’ intentions to use INR self-testing was observed. The significant predictors that directly affected patients' intention to use INR self-testing were the perception of technology (β = 0.92, P < 0.001, trust in doctor (β = −0.24, P = 0.028, and affordability (β = 0.15, P = 0.016. In addition, the perception of technology was significantly affected by trust in doctor (β = 0.43, P = 0.002, age (β = −0.32, P < 0.001, and

  5. 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.

  6. 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

  7. 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.

  8. Affinity and enzyme-based biosensors: recent advances and emerging applications in cell analysis and point-of-care testing.

    Science.gov (United States)

    Liu, Ying; Matharu, Zimple; Howland, Michael C; Revzin, Alexander; Simonian, Aleksandr L

    2012-09-01

    The applications of biosensors range from environmental testing and biowarfare agent detection to clinical testing and cell analysis. In recent years, biosensors have become increasingly prevalent in clinical testing and point-of-care testing. This is driven in part by the desire to decrease the cost of health care, to shift some of the analytical tests from centralized facilities to "frontline" physicians and nurses, and to obtain more precise information more quickly about the health status of a patient. This article gives an overview of recent advances in the field of biosensors, focusing on biosensors based on enzymes, aptamers, antibodies, and phages. In addition, this article attempts to describe efforts to apply these biosensors to clinical testing and cell analysis.

  9. 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.

  10. 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).

  11. Hematology point of care testing and laboratory errors: an example of multidisciplinary management at a children's hospital in northeast Italy

    Directory of Open Access Journals (Sweden)

    Parco S

    2014-01-01

    Full Text Available Sergio Parco, Patrizia Visconti, Fulvia Vascotto Institute for Maternal and Child Health, Trieste, Italy Abstract: Involvement of health personnel in a medical audit can reduce the number of errors in laboratory medicine. The checked control of point of care testing (POCT could be an answer to developing a better medical service in the emergency department and decreasing the time taken to report tests. The performance of sanitary personnel from different disciplines was studied over an 18-month period in a children's hospital. Clinical errors in the emergency and laboratory departments were monitored by: nursing instruction using specific courses, POCT, and external quality control; improvement of test results and procedural accuracy; and reduction of hemolyzed and nonprotocol-conforming samples sent to the laboratory department. In January 2012, point of care testing (POCT was instituted in three medical units (neonatology, resuscitation, delivery room at the Children's Hospital in Trieste, northeast Italy, for analysis of hematochemical samples. In the same period, during the months of January 2012 and June 2013, 1,600 samples sent to central laboratory and their related preanalytical errors were examined for accuracy. External quality control for POCT was also monitored in the emergency department; three meetings were held with physicians, nurses, and laboratory technicians to highlight problems, ie, preanalytical errors and analytical methodologies associated with POCT. During the study, there was an improvement in external quality control for POCT from -3 or -2 standard deviations or more to one standard deviation for all parameters. Of 800 samples examined in the laboratory in January 2012, we identified 64 preanalytical errors (8.0%; in June 2013, there were 17 preanalytical errors (2.1%, representing a significant decrease (P<0.05, χ2 test. Multidisciplinary management and clinical audit can be used as tools to detect errors caused by

  12. 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.

  13. The efficacy of computer reminders on external quality assessment for point-of-care testing in Danish general practice

    DEFF Research Database (Denmark)

    Waldorff, Frans B; Siersma, Volkert; Ertmann, Ruth;

    2011-01-01

    BACKGROUND: Point-of-care testing (POCT) is increasingly being used in general practice to assist general practitioners (GPs) in their management of patients with diseases. However, low adherence to quality guidelines in terms of split test procedures has been observed among GPs in parts...... of the Capital Region in Denmark. Computer reminders embedded in GPs electronic medical records (ComRem) may facilitate improved quality control behaviour, but more research is needed to identify what types of reminders work and when. The overall aim of this study is to evaluate the efficacy of ComRem to improve...... GPs adherence to quality guidelines. This article describes the rationale and methods of the study that constitute this research project. METHODS/DESIGN: The study is conducted as two randomised controlled trials (RCTs) among general practices in two districts of the Capital Region in Denmark...

  14. Comparison of point-of-care testing and laboratory testing of myocardial damage markers in the diagnosis and prognosis of acute coronary syndrome

    Institute of Scientific and Technical Information of China (English)

    杨军

    2013-01-01

    Objective To compare the point-of-care testing(POCT) and laboratory testing of myocardial damage markers in the diagnosis and prognosis of acute coronary syndrome (ACS). Methods A total of 3467 patients with ACS who were treated in the Emergency Department of Beijing

  15. Electrolytes assessed by point-of-care testing - Are the values comparable with results obtained from the central laboratory?

    Directory of Open Access Journals (Sweden)

    Binila Chacko

    2011-01-01

    Full Text Available Background and Aims: When dealing with very sick patients, the speed and accuracy of tests to detect metabolic derangements is very important. We evaluated if there was agreement between whole blood electrolytes measured by a point-of-care device and serum electrolytes measured using indirect ion-selective electrodes. Materials and Methods: In this prospective study, electrolytes were analyzed in 44 paired samples drawn from critically ill patients. Whole blood electrolytes were analyzed using a point-of-care blood gas analyzer and serum electrolytes were analyzed in the central laboratory on samples transported through a rapid transit pneumatic system. Agreement was summarized by the mean difference with 95% limits of agreement (LOA and Lin′s concordance correlation (p c. Results: There was a significant difference in the mean (±standard deviation sodium value between whole blood and serum samples (135.8 ± 5.7 mmol/L vs. 139.9 ± 5.4 mmol/L, P < 0.001, with the agreement being modest (p c = 0.71; mean difference -4.0; 95% LOA -8.78 to 0.65. Although the agreement between whole blood and serum potassium was good (p c = 0.96, and the average difference small (-0.3; 95% LOA -0.72 to 0.13, individual differences were clinically significant, particularly at lower potassium values. For potassium values <3.0 mmol/L, the concordance was low (p c = 0.53 and the LOA was wide (1.0 to -0.13. The concordance for potassium was good (p c = 0.96 for values ≥3.0 (mean difference -0.2; 95% LOA -0.48 to 0.06. Conclusions: Clinicians should be aware of the difference between whole blood and serum electrolytes, particularly when urgent samples are tested at point of care and routine follow-up electrolytes are sent to the central laboratory. A correction factor needs to be determined at each center.

  16. 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 occu

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

    DEFF Research Database (Denmark)

    Kristensen, Troels; Rose Olsen, Kim

    , 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......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...

  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 min

  19. 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.

  20. Development of a multi-analyte CMOS sensor for point-of-care testing

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    Holger Klapproth

    2015-09-01

    Full Text Available A typical microarray experiment requires both a biochip on which the biological reactions take place and a microarray scanner for analysis and visualization of the data. Here, we report on the generation of a chip, which consists of a CMOS photodiode array onto which receptors are immobilized and which are used for the detection and quantification of proteins in sera solution. Such an approach allows direct electronic read-out of the chip via a computer port so that the size of the whole analytical setup is very compact, opening the avenue to the generation of simple handheld devices. ELISA reactions directly performed on the surface of the photodiode arrays are used to measure a number of serum factors with a broad range in concentrations of samples with volumes of less than 10 μl. As in physiological sera analyte concentrations of the different parameters vary frequently by several orders of magnitude, parallel competitive reactions are used to adjust the dynamic range of several ELISA tests on the chip. We show as a demonstration case that this allows to quantify simultaneously C-reactive protein, Immunoglobulin E, Cystatin C, Myoglobin and Ferritin in a single assay.

  1. Point-Of-Care p24 Infant Testing for HIV May Increase Patient Identification despite Low Sensitivity

    Science.gov (United States)

    Bollinger, Timothy; Mabunda, Nédio; Vubil, Adolfo; Tobaiwa, Ocean; Quevedo, Jorge I.; Loquiha, Osvaldo; Vojnov, Lara; Peter, Trevor F.; Jani, Ilesh V.

    2017-01-01

    The long delay in returning test results during early infant diagnosis of HIV (EID) often causes loss-to-follow-up prior to antiretroviral treatment (ART) initiation in resource-limited settings. A point-of-care (POC) test may help overcome these challenges. We evaluated the performance of the LYNX p24 Antigen POC test in Mozambique. 879 HIV-exposed infants under 18 months of age were enrolled consecutively at three primary healthcare clinics (PHC). Lancet heel-drawn blood was tested on-site by nurses using a prototype POC test for HIV Gag p24 antigen detection. Results of POC testing were compared to laboratory-based nucleic acid testing on dried blood spots. A comparison of the effect of sensitivity and timely test results return on successful diagnosis by POC and laboratory-based platforms was also calculated. The sensitivity and specificity of the LYNX p24 Ag test were 71.9%; (95% confidence interval [CI]: 58.5–83.0%) and 99.6% (95% CI: 98.9–99.9%), respectively. The predictive value of positive and negative tests were 93.2% (95% CI: 81.3–98.6%) and 97.9% (95% CI: 96.8–98.8%), respectively. Overall agreement was high (Cohen Kappa = 0.80; 95% CI: 0.71–0.89). Despite its lower sensitivity, the POC test had the potential to provide test results to up to 81% more patients compared to the laboratory-based test. This prototype POC p24 assay was feasible for use in PHCs but demonstrated low sensitivity for HIV detection. POC EID technologies that perform below standard recommendations may still be valuable diagnostic tools in settings with inefficient EID networks. PMID:28060886

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

    DEFF Research Database (Denmark)

    Llor, Carl; 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...... of interventions were performed: the full intervention group received prescriber feedback with discussion of the results of the first registry, courses for GPs, guidelines, patient information leaflets, workshops, and access to point-of-care tests (rapid streptococcal antigen detection test and C-reactive protein...... test); and the partial intervention group underwent all of the above interventions except for the workshop and access to point-of-care tests. RESULTS: A total of 210 GPs were assigned to the full intervention group and 71 to the partial intervention group. A total of 25,479 subjects with respiratory...

  3. 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 OBJECTIVES: To determine the prevalence and correlates of syphilis among pregnant women in rural areas of South China. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

  4. Three-dimensional paper-based slip device for one-step point-of-care testing

    Science.gov (United States)

    Han, Kwi Nam; Choi, Jong-Soon; Kwon, Joseph

    2016-05-01

    In this study, we developed a new type of paper-based analytical device (PAD), the three-dimensional (3D) slip-PAD, to detect infectious human norovirus for global healthcare. The 3D configuration of the papers combined with a slip design provides unique features and versatility that overcome the limitations of fluidic manipulation and sensitivity in point-of-care (POC) tests. The assay can be carried out in a single step based on a moveable slip design, making it suitable for unskilled users. The 3D fluidic network developed by layered construction of wax-patterned papers provides different fluidic paths for the sequential delivery of multiple fluids without the need for peripheral equipment. The release and mixing of enhancement reagents on the device improved the sensitivity and detection limit. The assay results could be visualized by naked eye within 10 min, with subsequent amplification of the signal over time (human norovirus. These results demonstrate that the 3D slip-PAD is a sensitive diagnostic assay for detecting human norovirus infection that is particularly suitable for POC testing in regions where resources are scarce.

  5. A centrifugally actuated point-of-care testing system for the surface acoustic wave immunosensing of cardiac troponin I.

    Science.gov (United States)

    Lee, Woochang; Jung, Jaeyeon; Hahn, Young Ki; Kim, Sang Kyu; Lee, Yeolho; Lee, Joonhyung; Lee, Tae-Han; Park, Jin-Young; Seo, Hyejung; Lee, Jung Nam; Oh, Jin Ho; Choi, Youn-Suk; Lee, Soo Suk

    2013-05-07

    A fully automated point-of-care testing (POCT) system with a surface acoustic wave (SAW) immunosensor was developed for rapid and sensitive detection of cardiac troponin I (cTnI) in body fluid (plasma and whole blood). The assay, based on gold nanoparticle sandwich immunoassay and subsequent gold staining, was performed on the SAW immunosensor packaged inside a disposable microfluidic cartridge. The entire fluidic process, including plasma separation, reagent transport, metering, and mixing, was carried out by controlling the centrifugal force acting on the rotating cartridge and laser-irradiated ferrowax microvalves. On investigation of sensor response to various cTnI concentrations, the system exhibited a high performance with a detection limit of 6.7 pg mL(-1), and the coefficient of variation was less than 10% over the entire test range (10 pg mL(-1) to 25 ng mL(-1)). On comparing this POCT system with a clinically utilized system in a physical laboratory (Centaur® XP; Siemens), a correlation coefficient of 0.998 was found, validating the diagnostic capability of the SAW immunosensor.

  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. Results of a survey among GP practices on how they manage patient safety aspects related to point-of-care testing in every day practice.

    NARCIS (Netherlands)

    Vries, C. de; Doggen, C.J.M.; Hilbers, E.; Verheij, R.; IJzerman, M.; Geertsma, R.; Kusters, R.

    2015-01-01

    Background Point-of-care (POC) tests are devices or test strips that can be used near or at the site where care is delivered to patients, enabling a relatively fast diagnosis. Although many general practitioners (GPs) in the Netherlands are using POC tests in their practice, little i

  8. Results of a survey among GP practices on how they manage patient safety aspects related to point-of-care testing in every day practice

    NARCIS (Netherlands)

    Vries, de Claudette; Doggen, Carine; Hilbers, Ellen; Verheij, Robert; IJzerman, Maarten; Geertsma, Robert; Kusters, Ron

    2015-01-01

    Background Point-of-care (POC) tests are devices or test strips that can be used near or at the site where care is delivered to patients, enabling a relatively fast diagnosis. Although many general practitioners (GPs) in the Netherlands are using POC tests in their practice, little is known on how t

  9. Current and future use of point-of-care tests in primary care : an international survey in Australia, Belgium, The Netherlands, the UK and the USA

    NARCIS (Netherlands)

    Howick, Jeremy; Cals, Jochen W L; Jones, Caroline; Price, Christopher P; Plüddemann, Annette; Heneghan, Carl; Berger, Marjolein Y.; Buntinx, Frank; Hickner, John; Pace, Wilson; Badrick, Tony; Van den Bruel, Ann; Laurence, Caroline; van Weert, Henk C; van Severen, Evie; Parrella, Adriana; Thompson, Matthew

    2014-01-01

    OBJECTIVE: Despite the growing number of point-of-care (POC) tests available, little research has assessed primary care clinician need for such tests. We therefore aimed to determine which POC tests they actually use or would like to use (if not currently available in their practice). DESIGN: Cross-

  10. 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.

  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. Optimization of an optical inspection system based on the Taguchi method for quantitative analysis of point-of-care testing.

    Science.gov (United States)

    Yeh, Chia-Hsien; Zhao, Zi-Qi; Shen, Pi-Lan; Lin, Yu-Cheng

    2014-09-01

    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).

  13. Smartphone-based point-of-care testing of salivary α-amylase for personal psychological measurement.

    Science.gov (United States)

    Zhang, Lin; Yang, Wentao; Yang, Yuankui; Liu, Hong; Gu, Zhongze

    2015-11-07

    Here we report a smartphone-based potentiometric biosensor for point-of-care testing of salivary α-amylase (sAA), which is one of the most sensitive indices of autonomic nervous system activity, and therefore a promising non-invasive biomarker for mental health. The biosensing system includes a smartphone having a sAA-detection App, a potentiometric reader and a sensing chip with preloaded reagents. The saliva sample wicks into the reaction zone on the sensing chip so that the sAA reacts with the preloaded reagents, resulting in conversion of an electron mediator Fe(CN)6(3-) to Fe(CN)6(4-). The sensing chip is then pressed by fingers to push the reaction mixture into the detection zone for the potentiometric measurement. The potential measured by the smartphone-powered potentiometric reader is sent to the smartphone App via the USB port, and converted into sAA concentration based on a calibration curve. Using our method, sAA in real human sample is quantitatively analyzed within 5 min. The results are in good agreement with that obtained using a reference method, and correlated to psychological states of the subjects.

  14. The cost-effectiveness of point of care testing in a general practice setting: results from a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Briggs Nancy E

    2010-06-01

    Full Text Available Abstract Background While point of care testing (PoCT for general practitioners is becoming increasingly popular, few studies have investigated whether it represents value for money. This study aims to assess the relative cost-effectiveness of PoCT in general practice (GP compared to usual testing practice through a pathology laboratory. Methods A cost-effectiveness analysis based on a randomized controlled trial with 4,968 patients followed up for 18 months and fifty-three general practices in urban, rural and remote locations across three states in Australia. The incremental costs and health outcomes associated with a clinical strategy of PoCT for INR, HbA1c, lipids, and ACR were compared to those from pathology laboratory testing. Costs were expressed in year 2006 Australian dollars. Non-parametric bootstrapping was used to generate 95% confidence intervals. Results The point estimate of the total direct costs per patient to the health care sector for PoCT was less for ACR than for pathology laboratory testing, but greater for INR, HbA1c and Lipids, although none of these differences was statistically significant. PoCT led to significant cost savings to patients and their families. When uncertainty around the point estimates was taken into account, the incremental cost-effectiveness ratio (ICER for PoCT was found to be unfavourable for INR, but somewhat favourable for ACR, while substantial uncertainty still surrounds PoCT for HbA1c and Lipids. Conclusions The decision whether to fund PoCT will depend on the price society is willing to pay for achievement of the non-standard intermediate outcome indicator. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12605000272695

  15. A comparison of rapid point-of-care tests for the detection of avian influenza A(H7N9) virus, 2013

    NARCIS (Netherlands)

    C. Baas (Chantal); I.G. Barr (Ian); R.A.M. Fouchier (Ron); A. Kelso; A.C. Hurt (Aeron)

    2013-01-01

    textabstractSix antigen detection-based rapid influenza point-of-care tests were compared for their ability to detect avian influenza A(H7N9) virus. The sensitivity of at least four tests, standardised by viral infectivity (TCID50) or RNA copy number, was lower for the influenza A(H7N9) virus than f

  16. 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.

  17. 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.

  18. Comparison of three feline leukaemia virus (FeLV) point-of-care antigen test kits using blood and saliva.

    Science.gov (United States)

    Westman, Mark E; Malik, Richard; Hall, Evelyn; Sheehy, Paul A; Norris, Jacqueline M

    2017-02-01

    Feline leukaemia virus (FeLV) can be a challenging infection to diagnose due to a complex feline host-pathogen relationship and occasionally unreliable test results. This study compared the accuracy of three point-of-care (PoC) FeLV p27 antigen test kits commonly used in Australia and available commercially worldwide (SNAP FIV/FeLV Combo, Witness FeLV/FIV and Anigen Rapid FIV/FeLV), using detection of FeLV provirus by an in-house real-time polymerase chain reaction (qPCR) assay as the diagnostic gold standard. Blood (n=563) and saliva (n=419) specimens were collected from a population of cats determined to include 491 FeLV-uninfected and 72 FeLV-infected individuals (45 progressive infections [p27 and qPCR positive], 27 regressive infections [p27 negative, qPCR positive]). Sensitivity and specificity using whole blood was 63% and 94% for SNAP Combo, 57% and 98% for Witness, and 57% and 98% for Anigen Rapid, respectively. SNAP Combo had a significantly lower specificity using blood compared to the other two kits (P=0.004 compared to Witness, P=0.007 compared to Anigen Rapid). False-positive test results occurred with all three kits using blood, and although using any two kits in parallel increased specificity, no combination of kits completely eliminated the occurrence of false-positive results. We therefore recommend FeLV proviral PCR testing for any cat that tests positive with a PoC FeLV antigen kit, as well as for any cat that has been potentially exposed to FeLV but tests negative with a FeLV antigen kit, before final assignment of FeLV status can be made with confidence. For saliva testing, sensitivity and specificity was 54% and 100%, respectively, for all three test kits. The reduced sensitivity of saliva testing compared to blood testing, although not statistically significant, suggests saliva testing with the current generation of PoC FeLV antigen kits is unsuitable for screening large populations of cats, such as in shelters.

  19. 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.

  20. Improving the Quality of Diagnostic Studies Evaluating Point of Care Tests for Acute HIV Infections: Problems and Recommendations.

    Science.gov (United States)

    Smallwood, Megan; Pant Pai, Nitika

    2017-03-04

    The diagnosis of acute human immunodeficiency virus (HIV) infection (AHI) plays a unique role in preventing the spread of HIV and ending the epidemic. Acutely infected individuals are thought to contribute substantially to forward transmissions of HIV; however, diagnosing AHI in resource-limited settings has proven to be a challenge. While fourth generation antigen-antibody combination assays have been successful in high-resource settings, rapid point of care (POC) versions of these assays have yet to demonstrate high sensitivity to detect AHI. Newer RNA/DNA based POC technologies are being validated, but the challenge to understand the additional value of these devices depends on the quality of study evaluations, in particular choice of study designs and case mix of included populations. In this commentary, we aimed to review the quality of studies evaluating a new fourth generation rapid test for detecting AHI, to identify general methodological limitations and biases in diagnostic accuracy studies, and to recommend strategies for avoiding them in future evaluations. The new studies that were evaluated continued to report the same weaknesses and biases that were seen in previous evaluations of fourth generation rapid tests. We recommend that investigators design future studies carefully, keeping in mind how diagnostic performance may be influenced by prevalence, population, patient case mixes, and reference standards. Care must be taken to avoid biases specific to diagnostic accuracy studies (spectrum, verification, incorporation and reference standard biases). To improve on quality, reporting checklists and guidelines such as Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Standards for Reporting Diagnostic accuracy studies (STARD) should be reviewed prior to conducting studies.

  1. Screening for hepatitis C in average and high-risk populations of Qatar using rapid point-of-care testing

    Science.gov (United States)

    Al Kaabi, Saad; John, Anil K; Al Dweik, Nazeeh; Ullah Wani, Hameed; Babu Thandassary, Ragesh; Derbala, Moutaz F; Al Ejji, Khalid; Sultan, Khaleel; Pasic, Fuad; Al Mohannadi, Munnera; Yacoub, Rafae; Butt, Mohd Tariq; Singh, Rajvir

    2015-01-01

    Background Screening for hepatitis C has been found to be beneficial in high-risk individuals and ‘baby boomers’. Objective Our aim was to screen for hepatitis C in average and high-risk individuals and compare the disease characteristics and response to treatment among the screened group (SG) and non-screened group (NSG). Method Community-based screening for hepatitis C was done in the average and high-risk populations of Qatar. Screening was done using rapid point-of-care testing. All patients with stage 1 fibrosis on liver biopsy were treated with pegylated interferon and ribavirin. Results In total, 13,704 people were screened and 272 (2%, 95% CI (1.8–2.2%) had positive antibodies to hepatitis C. During the same period, 237 non-screened patients (NSG) with hepatitis C were referred for treatment. Alanine and aspartate aminotransferases (ALT, AST) and overall fibrosis were significantly lower in the SG as compared with the NSG (p = 0.04, 0.04 and 0.01, respectively). The response to treatment was similar in the SG as compared with the NSG (sustained viral response 61.7 % versus 69.1%, p = 0.55). Average-risk patients had significantly lower ALT levels (p = 0.04) but had similar response to treatment as the high-risk individuals (sustained viral response 63.2 % versus 61%, p = 0.87). Conclusion Screening detects hepatitis C with lesser fibrosis but does not result in better response to pegylated interferon and ribavirin as compared with non-screened patients. PMID:26279845

  2. Ensuring quality: a key consideration in scaling-up HIV-related point-of-care testing programs

    Science.gov (United States)

    Fonjungo, Peter N.; Osmanov, Saladin; Kuritsky, Joel; Ndihokubwayo, Jean Bosco; Bachanas, Pam; Peeling, Rosanna W.; Timperi, Ralph; Fine, Glenn; Stevens, Wendy; Habiyambere, Vincent; Nkengasong, John N.

    2016-01-01

    Objective: The objective of the WHO/US President's Emergency Plan for AIDS Relief consultation was to discuss innovative strategies, offer guidance, and develop a comprehensive policy framework for implementing quality-assured HIV-related point-of-care testing (POCT). Methods: The consultation was attended by representatives from international agencies (WHO, UNICEF, UNITAID, Clinton Health Access Initiative), United States Agency for International Development, Centers for Disease Control and Prevention/President's Emergency Plan for AIDS Relief Cooperative Agreement Partners, and experts from more than 25 countries, including policy makers, clinicians, laboratory experts, and program implementers. Main outcomes: There was strong consensus among all participants that ensuring access to quality of POCT represents one of the key challenges for the success of HIV prevention, treatment, and care programs. The following four strategies were recommended: implement a newly proposed concept of a sustainable quality assurance cycle that includes careful planning; definition of goals and targets; timely implementation; continuous monitoring; improvements and adjustments, where necessary; and a detailed evaluation; the importance of supporting a cadre of workers [e.g. volunteer quality corps (Q-Corps)] with the role to ensure that the quality assurance cycle is followed and sustained; implementation of the new strategy should be seen as a step-wise process, supported by development of appropriate policies and tools; and joint partnership under the leadership of the ministries of health to ensure sustainability of implementing novel approaches. Conclusion: The outcomes of this consultation have been well received by program implementers in the field. The recommendations also laid the groundwork for developing key policy and quality documents for the implementation of HIV-related POCT. PMID:26807969

  3. Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

    NARCIS (Netherlands)

    Schot, Marjolein J C; van Delft, Sanne; Kooijman-Buiting, Antoinette M J; de Wit, Niek J; Hopstaken, Rogier M

    2015-01-01

    OBJECTIVE: Various point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection i

  4. 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

  5. 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

  6. 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

  7. Clinic-Based Evaluation of a Rapid Point-of-Care Test for Detection of Chlamydia trachomatis in Specimens from Sex Workers in Escuintla, Guatemala▿

    OpenAIRE

    Sabidó, M; G. Hernández; González, V; Vallès, X; Montoliu, A.; Figuerola, J.; Isern, V.; Viñado, B; Figueroa,L.; Casabona, J.

    2008-01-01

    We evaluated a rapid point-of-care test for the detection of Chlamydia trachomatis in specimens from 278 sex workers attending sexually transmitted infection clinics in Guatemala. The sensitivity and the specificity of the test compared to the results of PCR were 62.96% and 99.60%, respectively. The test performed moderately well as a screening tool in a context in which clinical follow-up visits are infrequent.

  8. Same-Day CD4 Testing to Improve Uptake of HIV Care and Treatment in South Africa: Point-of-Care Is Not Enough

    Directory of Open Access Journals (Sweden)

    Bruce A. Larson

    2013-01-01

    Full Text Available Background. We evaluated whether a pilot program providing point-of-care (POC, but not rapid, CD4 testing (BD FACSCount immediately after testing HIV-positive improved retention in care. Methods. We conducted a retrospective record review at the Themba Lethu Clinic in Johannesburg, South Africa. We compared all walk-in patients testing HIV-positive during February, July 2010 (pilot POC period to patients testing positive during January 2008–February 2009 (baseline period. The outcome for those with a ≤250 cells/mm3 when testing HIV-positive was initiating ART <16 weeks after HIV testing. Results. 771 patients had CD4 results from the day of HIV testing (421 pilots, 350 baselines. ART initiation within 16 weeks was 49% in the pilot period and 46% in the baseline period. While all 421 patients during the pilot period should have been offered the POC test, patient records indicate that only 73% of them were actually offered it, and among these patients only 63% accepted the offer. Conclusions. Offering CD4 testing using a point-of-care, but not rapid, technology and without other health system changes had minor impacts on the uptake of HIV care and treatment. Point-of-care technologies alone may not be enough to improve linkage to care and treatment after HIV testing.

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

    OpenAIRE

    Debrah I. Boeras; 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 quali...

  10. 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

    2013-01-01

    Objectives 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. Methods 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. Results 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. Conclusions 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. PMID:24175121

  11. Accuracy of a point-of-care ELISA test kit for predicting the presence of protective canine parvovirus and canine distemper virus antibody concentrations in dogs.

    Science.gov (United States)

    Litster, A L; Pressler, B; Volpe, A; Dubovi, E

    2012-08-01

    Canine parvovirus (CPV) and canine distemper virus (CDV) are highly infectious and often fatal diseases with worldwide distributions, and are important population management considerations in animal shelters. A point-of-care ELISA test kit is available to detect serum antibodies to CPV and CDV, and presumptively to predict protective status. The aim of this study was to determine the diagnostic accuracy of the test compared to CPV hemagglutination inhibition titers and CDV serum neutralization titers determined by a reference laboratory, using sera collected from dogs housed at animal shelters. The ELISA test was used under both field and laboratory conditions and duplicate specimens were processed using an extra wash step. The test kit yielded accurate results (CPV: sensitivity 92.3%, specificity 93.5%; CDV: sensitivity 75.7%, specificity 91.8%) under field conditions. CDV sensitivity was improved by performing the test under laboratory conditions and using an optical density (OD) meter (laboratory performed 94.0%; OD 88.1%). Point-of-care ELISA testing for serum CPV and CDV antibody titers was demonstrated to be a useful tool for determining antibody status when making decisions regarding the need for CPV and/or CDV vaccination and also in animal shelters for population management.

  12. 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

    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...... 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...

  13. 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.

  14. 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.

  15. Hand-drawn&written pen-on-paper electrochemiluminescence immunodevice powered by rechargeable battery for low-cost point-of-care testing.

    Science.gov (United States)

    Yang, Hongmei; Kong, Qingkun; Wang, Shaowei; Xu, Jinmeng; Bian, Zhaoquan; Zheng, Xiaoxiao; Ma, Chao; Ge, Shenguang; Yu, Jinghua

    2014-11-15

    In this paper, a pen-on-paper electrochemiluminescence (PoP-ECL) device was entirely hand drawn and written in commercially available crayon and pencil in turn for the first time, and a constant potential-triggered sandwich-type immunosensor was introduced into the PoP-ECL device to form a low-cost ECL immunodevice proof. Each PoP-ECL device contained a hydrophilic paper channel and two PoP electrodes, and the PoP-ECL device was produced as follows: crayon was firstly used to draw hydrophobic regions on pure cellulose paper to create the hydrophilic paper channels followed with a baking treatment, and then a 6B-type black pencil with low resistivity was applied for precision writing, as the PoP electrodes, across the hydrophilic paper channel. For further point-of-care testing, a portable, low-cost rechargeable battery was employed as the power source to provide constant potential to the PoP electrodes to trigger the ECL. Using Carbohydrate antigen 199 as model analyte, this PoP-ECL immunodevice showed a good linear response range from 0.01-200 U mL(-1) with a detection limit of 0.0055 U mL(-1), a high sensitivity and stability. The proposed PoP-ECL immunodevice could be used in point-of-care testing of other tumor markers for remote regions and developing countries.

  16. The continuous development of new technologies of point of care testing%不断发展的 POCT 新技术

    Institute of Scientific and Technical Information of China (English)

    向代军; 王成彬

    2016-01-01

    The application of point-of-care testing ( POCT) has increased rapidly over years.There mainly are two types of POCT analytical equipments:handheld and desktop device that all can used for qualitative or quantitative measurements.New emerging equipments include those that can be used for molecular analysis such as PCR to provide infectious disease testing at the point of care. Quality control will improve quality of POCT clinical application.%近年来POCT的应用快速增长,主要分为手持式与台式POCT分析设备,可进行定性与定量分析。新出现的POCT分析设备包括可用于分子检测的仪器,如用于感染性疾病床旁诊断的PCR技术等。 POCT的质量管理有助于其在临床应用中的质量提高。

  17. 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 BACKGROUND: 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. METHODS AND FINDINGS: 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

  18. The effectiveness of computer reminders for improving quality assessment for point-of-care testing in general practice - a randomized controlled trial

    DEFF Research Database (Denmark)

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

    2013-01-01

    for improving adherence to a quality assessment scheme for point-of-care testing in general practice. METHOD: The study was conducted as a randomized controlled crossover trial among general practices in the Capital Region of Denmark. The intervention consisted of sending computer reminders (Com......BACKGROUND: Computer reminders are increasingly being applied in efforts to improve quality and patient safety. However, research is still needed to establish the effectiveness of different kinds of reminders in various settings. This study aimed to evaluate the effectiveness of computer reminders...... the other group only received the GIA. For the second follow-up period, the intervention was switched between the two groups. Outcomes were measured as split test procedure adherence. RESULTS: A total of 142 practices were randomly allocated to the early intervention group and 144 practices to the late...

  19. 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...... family practices that use the Elective Laboratory of the Capital Region, Denmark, and regularly conduct INR POCT were randomly allocated into two similarly sized groups. During the 4-month intervention, these practices were sent either computer reminders (ComRem) or computer generated postal reminders....... 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...

  20. Improving clinical outcomes through advances in point-of-care testing%在临床实践中更好地应用POCT

    Institute of Scientific and Technical Information of China (English)

    潘柏申

    2010-01-01

    POCT在临床实践中已经得到广泛应用.应该认真回顾总结,冷静思考有关检测速度与费用、检测质量等方面的问题,并尽快制定临床应用POCT的指南或规范性文件.这有助于POCT检测结果的准确可靠,有助于POCT在临床实践中的准确应用.%Point-of-care testing systems has been rapidly and widespreadly used in clinical practice.We ought to think about the speed, cost, quality and other aspects of the testing and formulate clinical guidelines for POCT as soon as possible.That will help to assure the reliable results of POCT and the correct application in the clinical management.

  1. What qualities are most important to making a point of care test desirable for clinicians and others offering sexually transmitted infection testing?

    Directory of Open Access Journals (Sweden)

    Yu-Hsiang Hsieh

    Full Text Available BACKGROUND: To investigate the possible effects of different levels of attributes of a point-of-care test (POCT on sexually transmitted infection (STI professionals' decisions regarding an ideal POCT for STI(s. METHODS: An online survey was designed based on a large-scale in-depth focus discussion study among STI experts and professionals. The last section of the survey "build your own POCT" was designed by employing the discrete choice experiment approach. Practicing clinicians from two venues, STI-related international conference attendees and U.S. STD clinic clinicians were invited to participate in the survey. Conditional logistical regression modeling was used for data analysis. RESULTS: Overall, 256 subjects took the online survey with 218 (85% completing it. Most of the participants were STD clinic clinicians who already used some POCTs in their practice. "The time frame required" was identified as a major barrier that currently made it difficult to use STI POCTs. Chlamydia trachomatis was the organism chosen as the top priority for a new POCT, followed by a test that would diagnose early seroconversion for HIV, and a syphilis POCT. Without regard to organism type selected, sensitivity of 90-99% was always the most important attribute to be considered, followed by a cost of $20. However, when the test platform was prioritized for early HIV seroconversion or syphilis, sensitivity was still ranked as most important, but specificity was rated second most important. CONCLUSIONS: STI professionals preferred C. trachomatis as the top priority for a new POCT with sensitivity over 90%, low cost, and a very short completion time.

  2. Clinically relevant analytical techniques, organizational concepts for application and future perspectives of point-of-care testing.

    Science.gov (United States)

    Luppa, Peter B; Bietenbeck, Andreas; Beaudoin, Christopher; Giannetti, Ambra

    2016-01-01

    Applications of near-patient testing have developed rapidly during the last years. It offers quick test results and minimal preanalytical interference, having the potential to improve patient outcomes, even when still under scrutiny by laboratory and healthcare professionals. Near-patient diagnostics are currently also used increasingly in developing countries, due to the burden of inadequate healthcare services in resource-constrained settings. This review describes the underlying emerging techniques that are based on advanced microfluidics and nanomaterials, device miniaturization, and multiplexing the detection mode. The organizational concepts for reasonable applications, contributing significantly to the future perspectives of this nascent diagnostic modality, are supplementary portrayed.

  3. 13[C]-urea breath test as a novel point-of-care biomarker for tuberculosis treatment and diagnosis.

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    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.

  4. Development and validation of a point-of-care test for detecting hantavirus antibodies in human and rodent samples.

    Science.gov (United States)

    Koishi, Andrea Cristine; Aoki, Mateus Nóbrega; Jorge, Taissa Ricciardi; Suzukawa, Andréia Akemi; Zanluca, Camila; Levis, Silvana; Duarte Dos Santos, Claudia Nunes

    2016-07-01

    Hantaviruses are etiologic agents of a zoonotic disease transmitted mainly from wild rodents to humans, causing Hemorrhagic Fever with Renal Syndrome in Eurasia and the Hantavirus Cardiopulmonary Syndrome in the Americas (HCPS), reaching a lethality rate of 40% in Brazil. Hantavirus diagnostic and seroprevalence are often based on the presence of IgM and IgG antibodies against the virus. Here we propose a rapid test assay able to identify hantavirus antibodies with sensibility and specificity similar to ELISA assays. We analyzed five groups of samples, including healthy human population and small mammals of endemic areas, suspected cases of HCPS, patients with non-related infections and a serum panel from a different geographical region. The test presented good rates of sensibility (87-100%) and specificity (97-100%) for all groups, being a promising tool suitable for both rodent and human hantavirus epidemiological surveys.

  5. 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.

  6. A Meta-analysis of Point-of-care Laboratory Tests in the Diagnosis of Novel 2009 Swine-lineage Pandemic Influenza A(H1N1)

    Science.gov (United States)

    Babin, Steven M.; Hsieh, Yu-Hsiang; Rothman, Richard E.; Gaydos, Charlotte A.

    2010-01-01

    This paper reviews fourteen published studies describing performance characteristics, including sensitivity and specificity, of commercially-available rapid, point-of-care (POC) influenza tests in patients affected by an outbreak of a novel swine-related influenza A (H1N1) that was declared a pandemic in 2009. Although these POC tests weren’t intended to be specific for this pandemic influenza strain, the non-specialized skills required and the timeliness of results make these POC tests potentially valuable for clinical and public health use. Pooled sensitivity and specificity for the POC tests studied were 68% and 81%, respectively, but published values were not homogeneous with sensitivities and specificities ranging from 10–88% and 51–100%, respectively. Pooled positive and negative likelihood ratios were 5.94 and 0.42, respectively. These results support current recommendations for use of rapid POC tests when H1N1 is suspected, recognizing that positive results are more reliable than negative results in determining infection, especially when disease prevalence is high. PMID:21396538

  7. Integration of an optical CMOS sensor with a microfluidic channel allows a sensitive readout for biological assays in point-of-care tests.

    Science.gov (United States)

    Van Dorst, Bieke; Brivio, Monica; Van Der Sar, Elfried; Blom, Marko; Reuvekamp, Simon; Tanzi, Simone; Groenhuis, Roelf; Adojutelegan, Adewole; Lous, Erik-Jan; Frederix, Filip; Stuyver, Lieven J

    2016-04-15

    In this manuscript, a microfluidic detection module, which allows a sensitive readout of biological assays in point-of-care (POC) tests, is presented. The proposed detection module consists of a microfluidic flow cell with an integrated Complementary Metal-Oxide-Semiconductor (CMOS)-based single photon counting optical sensor. Due to the integrated sensor-based readout, the detection module could be implemented as the core technology in stand-alone POC tests, for use in mobile or rural settings. The performance of the detection module was demonstrated in three assays: a peptide, a protein and an antibody detection assay. The antibody detection assay with readout in the detection module proved to be 7-fold more sensitive that the traditional colorimetric plate-based ELISA. The protein and peptide assay showed a lower limit of detection (LLOD) of 200 fM and 460 fM respectively. Results demonstrate that the sensitivity of the immunoassays is comparable with lab-based immunoassays and at least equal or better than current mainstream POC devices. This sensitive readout holds the potential to develop POC tests, which are able to detect low concentrations of biomarkers. This will broaden the diagnostic capabilities at the clinician's office and at patient's home, where currently only the less sensitive lateral flow and dipstick POC tests are implemented.

  8. 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.

  9. How do you get the Rose Bengal Test at the point-of-care to diagnose brucellosis in Africa? The importance of a systems approach.

    Science.gov (United States)

    Ducrotoy, Marie J; Bardosh, Kevin L

    2017-01-01

    Brucellosis is a major neglected zoonotic disease, whose burden both in animals and humans is severely under-reported. Diagnosis in humans identifies cases in order to treat the disease at the individual level. In animals diagnosis is implemented at the population level in the context of appropriate control or eradication strategies. Molecular and bacteriological diagnosis are rarely undertaken in sub-Saharan Africa, at least outside research projects, due to cost, skills and laboratory infrastructure issues. The brucellosis toolbox contains a wide range of serological tests, but the perfect test for use in animals and humans respectively does not exist. Drug and diagnostic discovery for the neglected zoonoses are notoriously poor, and there is limited investment interest in developing new tools for brucellosis diagnosis. But are current tools being used to their full capacity? The rose Bengal test (RBT) stands out as an efficient, practical and very cheap test adapted for use in the resource-poor context. In this paper, we argue that a social science or system's approach to explore the practicality of improving diagnostic capacity at the point-of care in high-risk brucellosis areas of rural Africa may be a step towards solving the issue of under-diagnosis, but this must go hand-in-hand with implementation of control measures at source in the animal reservoir and capacity to treat human cases.

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

    Energy Technology Data Exchange (ETDEWEB)

    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

  11. Investigation of a measles outbreak in Zimbabwe, 2010: potential of a point of care test to replace laboratory confirmation of suspected cases.

    Science.gov (United States)

    Shonhai, A; Warrener, L; Mangwanya, D; Slibinskas, R; Brown, K; Brown, D; Featherstone, D; Samuel, D

    2015-12-01

    Blood and oral fluid (OF) samples were collected from 103 suspected measles cases between February and November 2010 during a nationwide measles outbreak in Zimbabwe. Siemens measles IgM enzyme immunoassay (EIA) on serum, Microimmune measles IgM capture EIA on OF, real-time haemagglutinin (H) gene PCR and nested nucleocapsid (N) gene PCR on OF were performed, confirming 75 measles cases. These samples were then used to evaluate a newly developed point of care test (POCT) for measles and determine its potential for identifying measles cases in outbreaks. After performing POCTs on OF samples, nucleic acid was extracted from the used test strips and the measles H and N genes amplified by RT-PCR. The sensitivity, specificity, positive and negative predictive values of the POCT for IgM in OF was 75·0% [95% confidence interval (CI) 63·4-84·5], 96·2% (95% CI 80·4-99·9), 98·2% (95% CI 90·3-100) and 58·1% (95% CI 42·1-73·0), respectively. The N gene sequences showed high level of agreement between original OF and corresponding POCT strips. Measles genotype B3 was identified in all cases. We conclude that the measles POCT has the potential to be used, at the point of contact, in outbreak situations and provide molecular characterization of the virus at a later date.

  12. A scalable engineering approach to improve performance of a miniaturized optical detection system for in vitro point-of-care testing

    Science.gov (United States)

    Robbins, Hannah; Hu, Sijung; Liu, Changqing

    2015-03-01

    The demand for rapid screening technologies, to be used outside of a traditional healthcare setting, has been vastly expanding. This is requiring a new engineering platform for faster and cost effective techniques to be easily adopted through forward-thinking manufacturing procedures, i.e., advanced miniaturisation and heterogeneous integration of high performance microfluidics based point-of-care testing (POCT) systems. Although there has been a considerable amount of research into POCT systems, there exist tremendous challenges and bottlenecks in the design and manufacturing in order to reach a clinical acceptability of sensitivity and selectivity, as well as smart microsystems for healthcare. The project aims to research how to enable scalable production of such complex systems through 1) advanced miniaturisation of a physical layout and opto-electronic component allocation through an optimal design; and 2) heterogeneous integration of multiplexed fluorescence detection (MFD) for in vitro POCT. Verification is being arranged through experimental testing with a series of dilutions of commonly used fluorescence dye, i.e. Cy5. Iterative procedures will be engaged until satisfaction of the detection limit, of Cy5 dye, 1.209x10-10 M. The research creates a new avenue of rapid screening POCT manufacturing solutions with a particular view on high performance and multifunctional detection systems not only in POCT, but also life sciences and environmental applications.

  13. A Dual Point-of-Care Test Shows Good Performance in Simultaneously Detecting Nontreponemal and Treponemal Antibodies in Patients With Syphilis: A Multisite Evaluation Study in China

    Science.gov (United States)

    Yin, Yue-Ping; Chen, Xiang-Sheng; Wei, Wan-Hui; Gong, Kuang-Long; Cao, Wen-Ling; Yong, Gang; Feng, Liang; Huang, Shu-Jie; Wang, Dong-Mei; Han, Yan; Chen, Shao-Chun; Mabey, David; Peeling, Rosanna W.

    2013-01-01

    Background. Rapid point-of-care (POC) syphilis tests based on simultaneous detection of treponemal and nontreponemal antibodies (dual POC tests) offer the opportunity to increase coverage of syphilis screening and treatment. This study aimed to conduct a multisite performance evaluation of a dual POC syphilis test in China. Methods. Participants were recruited from patients at sexually transmitted infection clinics and high-risk groups in outreach settings in 6 sites in China. Three kinds of specimens (whole blood [WB], fingerprick blood [FB], and blood plasma [BP]) were used for evaluating sensitivity and specificity of the Dual Path Platform (DPP) Syphilis Screen and Confirm test using its treponemal and nontreponemal lines to compare Treponema pallidum particle agglutination (TPPA) assay and toluidine red unheated serum test (TRUST) as reference standards. Results. A total of 3134 specimens (WB 1323, FB 488, and BP 1323) from 1323 individuals were collected. The sensitivities as compared with TPPA were 96.7% for WB, 96.4% for FB, and 94.6% for BP, and the specificities were 99.3%, 99.1%, and 99.6%, respectively. The sensitivities as compared with TRUST were 87.2% for WB, 85.8% for FB, and 88.4% for BP, and the specificities were 94.4%, 96.1%, and 95.0%, respectively. For specimens with a TRUST titer of 1:4 or higher, the sensitivities were 100.0% for WB, 97.8% for FB, and 99.6% for BP. Conclusions. DPP test shows good sensitivity and specificity in detecting treponemal and nontreponemal antibodies in 3 kinds of specimens. It is hoped that this assay can be considered as an alternative in the diagnosis of syphilis, particularly in resource-limited areas. PMID:23132172

  14. Evaluation of a commercial in-clinic point-of-care polymerase chain reaction test for Ehrlichia canis DNA in artificially infected dogs.

    Science.gov (United States)

    Waner, Trevor; Nachum-Biala, Yaarit; Harrus, Shimon

    2014-12-01

    A novel in-clinic point-of-care (ICPOC) polymerase chain reaction (PCR) test was evaluated for its ability to detect Ehrlichia canis DNA in artificially infected dogs compared to a real-time PCR assay. Six Beagle dogs negative for E. canis antibodies and PCR negative were artificially infected with an Israeli E. canis strain (611). All dogs developed IgG antibodies 8 days post infection (PI), and clinical and hematological abnormalities on day 10 PI. Only the real-time PCR detected E. canis DNA in the blood of five dogs at days 3 and 5 PI. At day 12 PI during the acute phase of the disease, 1 day after the initiation of doxycycline treatment, the ICPOC PCR assay detected E. canis DNA in all infected dogs, which were also positive by the real-time PCR. Two days later the ICPOC PCR assay was able to detect only 3/6 infected dogs, which were all positive by the real-time PCR. At days 17 and 19 PI, the ICPOC PCR assay did not detect E. canis DNA in the dogs while the real-time PCR detected all dogs as positive on day 17 PI and two dogs on day 19 PI. In conclusion, the sensitivity of the ICPOC PCR assay was 75% for the acute phase of the disease and 30% for the whole study, suggesting that this ICPOC assay has a potential utility for the diagnosis of acute canine monocytic ehrlichiosis.

  15. 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.

  16. Progression in Point-of-Care Testing for Tuberculosis%肺结核即时诊断技术研究进展

    Institute of Scientific and Technical Information of China (English)

    胡杰; 王琳; 隗慧林; 王书崎; 徐峰

    2012-01-01

    肺结核给全球特别是发展中国家和地区的公共卫生健康带来严重危害.潜伏期、耐药性肺结核的检测,以及患者依从性差给全球肺结核的预防和控制提出了新的难题.WHO要求对结核病检测成本低廉、使用方便、快速可靠、无需设备,且普及性强.因此,本文总结了现有的基于免疫血清学和分子生物学开发的肺结核诊断产品,以及即时诊断(point-of-care testing,POCT)技术的最新研究进展,以期为将来开发新型高效的结核病POCT技术和产品提供思路.

  17. 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.

  18. Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname.

    Directory of Open Access Journals (Sweden)

    Jannie J van der Helm

    Full Text Available BACKGROUND: In general, point-of-care (POC tests for Chlamydia trachomatis (Ct show disappointing test performance, especially disappointing sensitivity results. However, one study sponsored by the manufacturer (Diagnostics for the Real World reported over 80% sensitivity with their Chlamydia Rapid Test (CRT. We evaluated the performance of this CRT in a non-manufacturer-sponsored trial. METHODS: Between July 2009 and February 2010, we included samples from 912 women in both high- and low-risk clinics for sexually transmitted infections (STIs in Paramaribo, Suriname. Sensitivity, specificity, positive- and negative predictive values (PPV and NPV for CRT compared to NAAT (Aptima, Gen-Probe were determined. Quantitative Ct load and human cell load were determined in all CRT and/or NAAT positive samples. RESULTS: CRT compared to NAAT showed a sensitivity and specificity of 41.2% (95% CI, 31.9%-50.9% and 96.4% (95% CI, 95.0%-97.5%, respectively. PPV and NPV were 59.2% (95% CI, 47.5%-70.1% and 92.9% (95% CI, 91.0%-94.5%, respectively. Quantitative Ct bacterial load was 73 times higher in NAAT-positive/CRT-positive samples compared to NAAT-positive/CRT-negative samples (p<0.001. Human cell load did not differ between true-positive and false-negative CRT results (p = 0.835. Sensitivity of CRT in samples with low Ct load was 12.5% (95% CI, 5.2%-24.2% and in samples with high Ct load 73.5% (95% CI, 59.9%-84.4%. CONCLUSIONS: The sensitivity of CRT for detecting urogenital Ct in this non-manufacturer-sponsored study did not meet the expectations as described previously. The CRT missed samples with a low Ct load. Improved POC are needed as meaningful diagnostic to reduce the disease burden of Ct.

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

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    Virginia De Azevedo

    2013-07-01

    Full Text Available Introduction: 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. Methods: 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. Results: 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, p<0.0001]. More patients in World Health Organization (WHO Stage 1 disease (85% vs. 69%, with CD4 counts≥350 cells/µL (58% vs. 35% and more males (13% vs. 7% were detected in Group B. The proportion of eligible patients who initiated ART was 50% and 44% (p=0.6 in Groups B and A, respectively; and 50% and 43% (p=0.5 when restricted to patients with baseline CD4 count≤250 cells/µL. Time between HIV-testing and ART initiation was reduced from 36 to 28 days (p=0.6. Discussion: POC CD4 testing significantly improved assessment for ART eligibility. The improvement in the proportion initiating ART and the

  20. 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

    Science.gov (United States)

    Ncube, Alexander Tshaka; Sweeney, Sedona; Fleischer, Colette; Mumba, Grace Tembo; Gill, Michelle M.; Strasser, Susan; Peeling, Rosanna W.; Terris-Prestholt, Fern

    2015-01-01

    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 antenatal care in

  1. 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

  2. Perceptions of an ideal point-of-care test for sexually transmitted infections--a qualitative study of focus group discussions with medical providers.

    Directory of Open Access Journals (Sweden)

    Yu-Hsiang Hsieh

    Full Text Available BACKGROUND: A point-of-care test (POCT for sexually transmitted infections (STIs, which offers immediate diagnosis resulting in patients receiving diagnosis and treatment in a single visit, has the ability to address some of the STI control needs. However, needs assessment from STI experts and end users about currently available STI POCTs and their future new development has not been evaluated since World Health Organization Sexually Transmitted Diseases Diagnostics Initiative was formed over 15 years ago. Therefore, our objective was to explore the perceptions of the ideal types of STI POCT for use in health care settings. METHODOLOGY/PRINCIPAL FINDINGS: A qualitative study, encompassing eight focus groups, was conducted from March 2008 through April 2009. Participants included 6 STD clinic directors, 63 clinicians, and 7 public health/laboratory/epidemiology professionals in the STI field. Discussion topics included currently available POCT, perceived barriers to using POCT in clinics, priority STI for the development of new POCT, and characteristics of the ideal POCT. All discussions were recorded and transcribed verbatim. Themes raised as barriers for current POCT included complexity, long time frames of the so-called "rapid" test, multiple time-driven steps, requiring laboratory technician, difficulty in reading result, interruption of workflow, unreliability, and invasiveness. Chlamydia trachomatis was identified as the priority organism for development of a new STI POCT. Themes indicated for the ideal POCT included rapid turnaround (up to 20 minutes, ease of use, non-invasive, accurate (preferred sensitivity and specificity in the range of high 90s, Clinical Laboratory Improvement Amendments (CLIA-waived, user-friendly (for both patients and staff, compact, durable, and sturdy. CONCLUSIONS/SIGNIFICANCE: Focus group discussions with STI experts and professionals highlighted chlamydia as the top priority pathogen for POCT development, and

  3. 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.

    Science.gov (United States)

    Shelley, Katharine D; Ansbro, Éimhín M; Ncube, Alexander Tshaka; Sweeney, Sedona; Fleischer, Colette; Tembo Mumba, Grace; Gill, Michelle M; Strasser, Susan; Peeling, Rosanna W; Terris-Prestholt, Fern

    2015-01-01

    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 antenatal care in

  4. 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

  5. Are Treponema pallidum specific rapid and point-of-care tests for syphilis accurate enough for screening in resource limited settings? Evidence from a meta-analysis.

    Directory of Open Access Journals (Sweden)

    Yalda Jafari

    Full Text Available BACKGROUND: Rapid and point-of-care (POC tests for syphilis are an invaluable screening tool, yet inadequate evaluation of their diagnostic accuracy against best reference standards limits their widespread global uptake. To fill this gap, a systematic review and meta-analysis was conducted to evaluate the sensitivity and specificity of rapid and POC tests in blood and serum samples against Treponema pallidum (TP specific reference standards. METHODS: Five electronic databases (1980-2012 were searched, data was extracted from 33 articles, and Bayesian hierarchical models were fit. RESULTS: In serum samples, against a TP specific reference standard point estimates with 95% credible intervals (CrI for the sensitivities of popular tests were: i Determine, 90.04% (80.45, 95.21, ii SD Bioline, 87.06% (75.67, 94.50, iii VisiTect, 85.13% (72.83, 92.57, and iv Syphicheck, 74.48% (56.85, 88.44, while specificities were: i Syphicheck, 99.14% (96.37, 100, ii Visitect, 96.45% (91.92, 99.29, iii SD Bioline, 95.85% (89.89, 99.53, and iv Determine, 94.15% (89.26, 97.66. In whole blood samples, sensitivities were: i Determine, 86.32% (77.26, 91.70, ii SD Bioline, 84.50% (78.81, 92.61, iii Syphicheck, 74.47% (63.94, 82.13, and iv VisiTect, 74.26% (53.62, 83.68, while specificities were: i Syphicheck, 99.58% (98.91, 99.96, ii VisiTect, 99.43% (98.22, 99.98, iii SD Bioline, 97.95%(92.54, 99.33, and iv Determine, 95.85% (92.42, 97.74. CONCLUSIONS: Rapid and POC treponemal tests reported sensitivity and specificity estimates comparable to laboratory-based treponemal tests. In resource limited settings, where access to screening is limited and where risk of patients lost to follow up is high, the introduction of these tests has already been shown to improve access to screening and treatment to prevent stillbirths and neonatal mortality due to congenital syphilis. Based on the evidence, it is concluded that rapid and POC tests are useful in resource limited settings

  6. Are Treponema pallidum Specific Rapid and Point-of-Care Tests for Syphilis Accurate Enough for Screening in Resource Limited Settings? Evidence from a Meta-Analysis

    Science.gov (United States)

    Jafari, Yalda; Peeling, Rosanna W.; Shivkumar, Sushmita; Claessens, Christiane; Joseph, Lawrence; Pai, Nitika Pant

    2013-01-01

    Background Rapid and point-of-care (POC) tests for syphilis are an invaluable screening tool, yet inadequate evaluation of their diagnostic accuracy against best reference standards limits their widespread global uptake. To fill this gap, a systematic review and meta-analysis was conducted to evaluate the sensitivity and specificity of rapid and POC tests in blood and serum samples against Treponema pallidum (TP) specific reference standards. Methods Five electronic databases (1980–2012) were searched, data was extracted from 33 articles, and Bayesian hierarchical models were fit. Results In serum samples, against a TP specific reference standard point estimates with 95% credible intervals (CrI) for the sensitivities of popular tests were: i) Determine, 90.04% (80.45, 95.21), ii) SD Bioline, 87.06% (75.67, 94.50), iii) VisiTect, 85.13% (72.83, 92.57), and iv) Syphicheck, 74.48% (56.85, 88.44), while specificities were: i) Syphicheck, 99.14% (96.37, 100), ii) Visitect, 96.45% (91.92, 99.29), iii) SD Bioline, 95.85% (89.89, 99.53), and iv) Determine, 94.15% (89.26, 97.66). In whole blood samples, sensitivities were: i) Determine, 86.32% (77.26, 91.70), ii) SD Bioline, 84.50% (78.81, 92.61), iii) Syphicheck, 74.47% (63.94, 82.13), and iv) VisiTect, 74.26% (53.62, 83.68), while specificities were: i) Syphicheck, 99.58% (98.91, 99.96), ii) VisiTect, 99.43% (98.22, 99.98), iii) SD Bioline, 97.95%(92.54, 99.33), and iv) Determine, 95.85% (92.42, 97.74). Conclusions Rapid and POC treponemal tests reported sensitivity and specificity estimates comparable to laboratory-based treponemal tests. In resource limited settings, where access to screening is limited and where risk of patients lost to follow up is high, the introduction of these tests has already been shown to improve access to screening and treatment to prevent stillbirths and neonatal mortality due to congenital syphilis. Based on the evidence, it is concluded that rapid and POC tests are useful in resource

  7. Estimating implementation and operational costs of an integrated tiered CD4 service including laboratory and point of care testing in a remote health district in South Africa.

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    Naseem Cassim

    Full Text Available An integrated tiered service delivery model (ITSDM has been proposed to provide 'full-coverage' of CD4 services throughout South Africa. Five tiers are described, defined by testing volumes and number of referring health-facilities. These include: (1 Tier-1/decentralized point-of-care service (POC in a single site; Tier-2/POC-hub servicing processing 600 samples/day and serving > 100 or > 200 health-clinics, respectively. The objective of this study was to establish costs of existing and ITSDM-tiers 1, 2 and 3 in a remote, under-serviced district in South Africa.Historical health-facility workload volumes from the Pixley-ka-Seme district, and the total volumes of CD4 tests performed by the adjacent district referral CD4 laboratories, linked to locations of all referring clinics and related laboratory-to-result turn-around time (LTR-TAT data, were extracted from the NHLS Corporate-Data-Warehouse for the period April-2012 to March-2013. Tiers were costed separately (as a cost-per-result including equipment, staffing, reagents and test consumable costs. A one-way sensitivity analyses provided for changes in reagent price, test volumes and personnel time.The lowest cost-per-result was noted for the existing laboratory-based Tiers- 4 and 5 ($6.24 and $5.37 respectively, but with related increased LTR-TAT of > 24-48 hours. Full service coverage with TAT < 6-hours could be achieved with placement of twenty-seven Tier-1/POC or eight Tier-2/POC-hubs, at a cost-per-result of $32.32 and $15.88 respectively. A single district Tier-3 laboratory also ensured 'full service coverage' and < 24 hour LTR-TAT for the district at $7.42 per-test.Implementing a single Tier-3/community laboratory to extend and improve delivery of services in Pixley-ka-Seme, with an estimated local ∼ 12-24-hour LTR-TAT, is ∼ $2 more than existing referred services per-test, but 2-4 fold cheaper than implementing eight Tier-2/POC-hubs or providing twenty-seven Tier-1/POCT CD4

  8. Anticoagulants

    Science.gov (United States)

    ... Receptor Blockers Angiotensin-Converting Enzyme (ACE) Inhibitors Antiarrhythmics Antiplatelet Therapy Aspirin Beta-Blockers Blood Thinners Calcium Channel Blockers Digitalis Medicines Diuretics Inotropic Agents Nitrates Statins, Cholesterol-Lowering Medicines Anticoagulants Related terms: ...

  9. 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 (95th percentiles from 5.5 to 17.2 U/g Hg). Ninety-seven subjects (10.7%) had <3.6 U/g Hg and were classified as G6PD deficient. Prevalence of deficiency was 15.0% (64/425) among men and 6.9% (33/478) among women. Genotype was analyzed in 66 G6PD-deficient subjects and 63 of these exhibited findings consistent with Viangchang genotype. The sensitivity and specificity of the CareStart™ 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. PMID:22164279

  10. 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.

  11. Proactive therapeutic drug monitoring of infliximab: a comparative study of a new point-of-care quantitative test with two established ELISA assays

    OpenAIRE

    Afonso, J.; S. Lopes; Gonçalves, R.; Caldeira, P; Lago, P; Tavares de Sousa, H; Ramos, J; Gonçalves, AR; Ministro, P; Rosa, I; Vieira, AI; Dias, CC; Magro, F

    2016-01-01

    BACKGROUND: Therapeutic drug monitoring is a powerful strategy known to improve the clinical outcomes and to optimise the healthcare resources in the treatment of autoimmune diseases. Currently, most of the methods commercially available for the quantification of infliximab (IFX) are ELISA-based, with a turnaround time of approximately 8 h, and delaying the target dosage adjustment to the following infusion. AIM: To validate the first point-of-care IFX quantification device available...

  12. 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

  13. "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

  14. ‘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’

    OpenAIRE

    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

    2016-01-01

    Background 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 ana...

  15. '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'.

    OpenAIRE

    Lau, M.S.; Mooney, P.; White, W.; Appleby, V.; Moreea, S.; Haythem, I.; Elias, J.; Bundhoo, K.; Corbett, G; Wong, L.; Tsai, H H; Cross, S; Hebden, J.; Hoque, S.; Sanders, D

    2016-01-01

    BACKGROUND: 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 an...

  16. Analysis of application and management status of point-of-care testing in China and America%浅析中国与美国 POCT 的应用与管理现状

    Institute of Scientific and Technical Information of China (English)

    陈霖; 卞成蓉; 李伯安

    2014-01-01

    Point-of-care testing ( POCT ) is a new area in the laboratory medicine.This article discusses the current situation in regulations , industry management , quality management , personnel management and training and other aspects of POCT in America and China.Then this article points out the challenges of POCT development in China , and further puts forward advanced measures and suggestions for improving POCT management system in China.%POCT(point-of-care testing)是检验医学的新领域,本文旨在深入探讨中美两国在POCT的法规、行业管理、质量管理、人员管理和培训等方面的现状,阐明我国POCT发展面临的挑战,并进一步提出了完善我国POCT管理体系的措施和建议。

  17. 床旁凝血分析的临床应用%Clinical using of point-of-care coagulation test

    Institute of Scientific and Technical Information of China (English)

    彭黎明; 颜存粮

    2004-01-01

    床旁分析(point-of-care testing,POCT)是指在患者身旁所进行的实时医学检验。POCT是一类极具潜力的检测技术,可提高效率、降低成本,具有缩短检验周期(TAT)、需样量少、操作简单、使用方便等优点。同时,其结果和传统或参考方法所得结果具有可比性,并在临床可接受范围内。随着血栓性疾病快速筛检及POCT技术在止凝血检验中的应用日渐成熟,加之抗凝治疗和使用促纤溶药物,抗血小板药物

  18. [New oral anticoagulants - influence on coagulation tests].

    Science.gov (United States)

    Simeon, L; Nagler, M; Wuillemin, W A

    2014-01-01

    The new oral anticoagulants (NOACs) represent alternative antithrombotic agents for prophylaxis and therapy of thromboembolic diseases. They act either by inhibition of the clotting factor Xa or IIa (thrombin). As a consequence, they influence several coagulation assays (for example prothrombin time, activated partial thromboplastin time). Because of the short half-life of these new agents, these changes show great variations in the course of 24 hours. Furthermore, there are significant differences of laboratory results depending on the used reagents. We explain the influence of apixaban, rivaroxaban (factor Xa inhibitors) and dabigatran (thrombin inhibitor) on the most commonly used coagulation assays. Besides we show that this influence depends on the way of action of the drug as well as on the principle of the coagulation assay. Being aware of this relationships helps to interpret the results of coagulation assays under influence of NOACs correctly.

  19. Clinical significance of the mixing test in laboratory diagnoses of lupus anticoagulant: the fate of the mixing test in integrated lupus anticoagulant test systems.

    Science.gov (United States)

    Hong, Sung Kuk; Hwang, Sang Mee; Kim, Ji-Eun; Kim, Hyun Kyung

    2012-12-01

    The mixing test is used to determine the presence of inhibitors in laboratory diagnoses of lupus anticoagulant. Updated international guidelines state that an integrated lupus anticoagulant test system does not require the mixing test; an appraisal of the mixing tests in integrated lupus anticoagulant test systems is, therefore, required. We investigated the clinical relevance of mixing tests by using the best cutoff value of the mixing test through thrombotic risk analysis. A retrospective analysis was performed on 525 specimens with positive screening tests by using two integrated lupus anticoagulant tests: diluted Russell's Viper venom (dRVVT) and silica clotting time. The diagnostic performance of two interpretation formulas (percentage correction, Rosner index) was assessed, and the thrombotic risk of a subgroup based on the mixing results was investigated. Finally, the thrombotic risk of lupus anticoagulant positivity based on the integrated lupus anticoagulant test system procedures was assessed for the appraisal of mixing test exclusion in integrated lupus anticoagulant test systems. The best cutoff values of mixing test interpretation methods based on dRVVT were as follows: 60.1% for percentage correction and 15.7 for Rosner index. There was no substantial difference in the thrombotic risk between percentage correction and the Rosner index. The mixing-positive group showed a higher lupus anticoagulant titer and higher thrombotic risk than the mixing-negative group. However, even the mixing-negative group carried a significant risk of thrombosis. Finally, lupus anticoagulant positivity determined by the updated two-step procedure (screening and confirmation tests) showed higher thrombotic risk than that determined by the traditional three-step procedure (screening, mixing, and confirmation tests). Although a positive mixing result can predict a high risk of thrombosis, negative mixing results are also associated with a substantial thrombotic risk. The

  20. 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.

  1. Point of care testing in the management of coagulation dysfunction in cardiovascular surgery%即时检验在心血管手术出凝血管理中的应用

    Institute of Scientific and Technical Information of China (English)

    周珊

    2012-01-01

    即时检验是指现场采样即刻分析、快速得到检验结果的一类新方法,主要优势在于检测方法简单易行、耗时较短,能在手术室内操作完成.心血管手术患者术后失血量大,血小板功能异常是重要原因之一.本文综述了目前常用的几种血小板功能即时检验方法在心脏手术中的应用.%Point of care testing is a new developing technology, which can reduce the turn-around time of results and provide quick information for clinicians. Platelet dysfunction is one of the major reasons of postoperative bleeding after cardiovascular surgery. In this review , we focused on the use of point of care testing in the management of coagulation dysfunction in cardiovascular surgey.

  2. Promotion from qualitative to quantitative test is one of challenges of point-of-care testing development%从定性到定量的转变是 POCT 发展历程中的重要挑战

    Institute of Scientific and Technical Information of China (English)

    周蕾; 杨瑞馥

    2014-01-01

    With non-professional based on-site detection mode and miniature , portable and intelligent techniques as the basis , the potential of point-of-care testing ( POCT ) to feedback the result timely and help to make right decisions to handle emergencies has drawn the attention from extensive fields , including clinical investigation , disease control and prevention , quality control , environmental protection , forensic investigation, import and export inspection and so on.In this review, the definition, history and challenge of POCT promotion from qualitative detection to quantitative one were discussed .%POCT以“现场非专门训练人员”的操作模式与“微型、便携、智能”的检测技术为基础,以“事发现场快速获得检验结果进而指导科学处置”为目标,日益受到临床、疾控、质检、环保、法医、海关等广义检验领域的关注。在此,对POCT的定义、简史以及从定性到定量转变过程中面临的挑战进行阐述。

  3. 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.

  4. 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 Somuncu; Pressler, Tania;

    2014-01-01

    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.MethodPatients followed at the Copenhagen CF Center were comprehensively screened for pulmonary NTM infection between May 2012...... and December 2013. Urine samples were tested for LAM using the 2013 DetermineTM TB LAM Ag strip test.ResultsThree-hundred and six patients had a total of 3,322 respiratory samples cultured for NTM and 198 had urine collected (65%). A total of 23/198 (12%) had active pulmonary NTM infection. None had active TB...

  5. 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

  6. 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.

    Directory of Open Access Journals (Sweden)

    Éimhín M Ansbro

    Full Text Available 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

  7. Point-of-care continuous 13C-methacetin breath test improves decision making in acute liver disease: Results of a pilot clinical trial

    Institute of Scientific and Technical Information of China (English)

    Gadi Lalazar; Tomer Adar; Yaron Ilan

    2009-01-01

    AIM: To assess the role of the 13C-methacetin breath test (MBT) in patients with acute liver disease. METHODS: Fifteen patients with severe acute liver disease from diverse etiologies were followed-up with 13C-MBT during the acute phase of their illnesses (range 3-116 d after treatment). Patients fasted for 8 h and ingested 75 mg of methacetin prior to the MBT. We compared results from standard clinical assessment, serum liver enzymes, synthetic function, and breath test scores. RESULTS: Thirteen patients recovered and two patients died. In patients that recovered, MBT parameters improved in parallel with improvements in lab results. Evidence of consistent improvement began on day 3 for MBT parameters and between days 7 and 9 for blood tests. Later convergence to normality occurred at an average of 9 d for MBT parameters and from 13 to 28 d for blood tests. In both patients that died, MBT parameters remained low despite fluctuating laboratory values. CONCLUSION: The 13C-MBT provides a rapid, noninvasive assessment of liver function in acute severe liver disease of diverse etiologies. The results of this pilot clinical trial suggest that the MBT may offer greater sensitivity than standard clinical tests for managing patients with severe acute liver disease.

  8. Lupus-anticoagulant testing at NOAC trough levels.

    Science.gov (United States)

    Ratzinger, Franz; Lang, Mona; Belik, Sabine; Jilma-Stohlawetz, Petra; Schmetterer, Klaus G; Haslacher, Helmuth; Perkmann, Thomas; Quehenberger, Peter

    2016-08-01

    Non-vitamin K antagonist oral anticoagulants (NOAC), including rivaroxaban, apixaban or dabigatran, regularly show relevant effects on coagulation tests, making the interpretation of results difficult. The aim of this study was to evaluate possible interferences of NOACs in trough level concentrations in lupus anticoagulant (LA) testing. Citrate plasma specimens of 30 healthy volunteers were spiked with rivaroxaban, apixaban or dabigatran in four plasma concentration levels at or below trough NOAC levels. The NOAC concentration was measured using dedicated surrogate concentration tests and a stepwise diagnostic procedure for LA-testing was applied using screening, mixing and confirmatory testing. Results were compared to NOAC-free specimens. Starting with a plasma concentration of 12.5 ng/ml, dabigatran-spiked specimens showed significant prolongations in the lupus anticoagulant-sensitive activated partial thromboplastin time (aPTT-LA) as well as in the Dilute Russell viper venom time (dRVVT), leading to 43.3 % false positives in confirmatory testing in the dRVVT. In contrast, rivaroxaban, beginning with 7.5 ng/ml, exclusively affected dRVVT-based tests. In confirmatory tests, 30.0 % of rivaroxaban-spiked specimens showed false positive results. Starting with 18.75 ng/ml apixaban, a significant prolongation of the dRVVT and up to 20.7 % false positives in confirmatory tests were found. In contrast to other NOACs tested, apixaban did not present with a dose-dependent increase of the dRVVT ratio. In conclusion, the rate of false positive results in LA-testing is unacceptably high at expected trough levels of NOACs. Even at plasma concentrations below the LLOQ of commercially available surrogate tests, LA testing is best avoided in patients with NOAC therapy.

  9. 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

  10. An HIV1/2 point of care test on sputum for screening TB/HIV co-infection in central India - Will it work?

    Institute of Scientific and Technical Information of China (English)

    Prabha Desikan; Sajal De; Nitika Pant Pai; Pradyumna K Mishra; Kaushal Kumar; Nikita Panwalkar; Mayanka Verma; Zia Ul Hasan; Kewal K Maudar

    2013-01-01

    Objective:To determine whether theOraQuick®HIV-1/2Assay(OraSureTechnologies, Inc.,Bethlehem,PA,USA) in sputum is a valid tool forHIV surveillance amongTB patients. Methods:A cross sectional study was carried out on sputa of patients diagnosed with tuberculosis.Sputa were tested for antibodies toHIV usingOraQuick®HIV-1/2Assay(OraSure Technologies,Inc.,Bethlehem,PA,USA).The results were compared with results of serum ELISA.Results:Compared to serumELISA, theOraQuick®HIV-1/2Assay in sputum specimens reported90% sensitivity(9/10) and100% specificity(307/307), with a positive predictive value of 100%(95%CI:66.37%-100.00%) and a negative predictive value of99.68%(95%CI:98.20%-99.99%). Conclusions:This testing method may provide a useful strategy for conductingHIV surveillance in possible co-infectedTB patients at peripheral centres.Since there is no investment on infrastructure, it may be possible for paramedical health professionals to carry out the test, particularly in areas with lowHIV endemicity.

  11. APPLICATIONS OF PHARMACOGENETIC TESTING FOR PERSONALIZATION OF THERAPY WITH ORAL ANTICOAGULANTS IN RUSSIA

    Directory of Open Access Journals (Sweden)

    D. A. Sychev

    2013-01-01

    Full Text Available The clinical significance of the patient genetic characteristics in the individual pharmacological response to oral anticoagulants is considered. Possible tactics of warfarin dosing and new oral anticoagulants choice on the basis of pharmacogenetic testing as well as indications for this approach in clinical practice are discussed. It should increase efficacy and safety of anticoagulant therapy.

  12. 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.

  13. CMOS cell sensors for point-of-care diagnostics.

    Science.gov (United States)

    Adiguzel, Yekbun; Kulah, Haluk

    2012-01-01

    The burden of health-care related services in a global era with continuously increasing population and inefficient dissipation of the resources requires effective solutions. From this perspective, point-of-care diagnostics is a demanded field in clinics. It is also necessary both for prompt diagnosis and for providing health services evenly throughout the population, including the rural districts. The requirements can only be fulfilled by technologies whose productivity has already been proven, such as complementary metal-oxide-semiconductors (CMOS). CMOS-based products can enable clinical tests in a fast, simple, safe, and reliable manner, with improved sensitivities. Portability due to diminished sensor dimensions and compactness of the test set-ups, along with low sample and power consumption, is another vital feature. CMOS-based sensors for cell studies have the potential to become essential counterparts of point-of-care diagnostics technologies. Hence, this review attempts to inform on the sensors fabricated with CMOS technology for point-of-care diagnostic studies, with a focus on CMOS image sensors and capacitance sensors for cell studies.

  14. CMOS Cell Sensors for Point-of-Care Diagnostics

    Directory of Open Access Journals (Sweden)

    Haluk Kulah

    2012-07-01

    Full Text Available The burden of health-care related services in a global era with continuously increasing population and inefficient dissipation of the resources requires effective solutions. From this perspective, point-of-care diagnostics is a demanded field in clinics. It is also necessary both for prompt diagnosis and for providing health services evenly throughout the population, including the rural districts. The requirements can only be fulfilled by technologies whose productivity has already been proven, such as complementary metal-oxide-semiconductors (CMOS. CMOS-based products can enable clinical tests in a fast, simple, safe, and reliable manner, with improved sensitivities. Portability due to diminished sensor dimensions and compactness of the test set-ups, along with low sample and power consumption, is another vital feature. CMOS-based sensors for cell studies have the potential to become essential counterparts of point-of-care diagnostics technologies. Hence, this review attempts to inform on the sensors fabricated with CMOS technology for point-of-care diagnostic studies, with a focus on CMOS image sensors and capacitance sensors for cell studies.

  15. An early evaluation of clinical and economic costs and benefits of implementing point of care NAAT tests for Chlamydia trachomatis and Neisseria gonorrhoea in genitourinary medicine clinics in England

    Science.gov (United States)

    Turner, Katherine M E; Round, Jeff; Horner, Patrick; Macleod, John; Goldenberg, Simon; Deol, Arminder; Adams, Elisabeth J

    2013-01-01

    Objectives To estimate the costs and benefits of clinical pathways incorporating a point of care (POC) nucleic acid amplification test (NAAT) for chlamydia and gonorrhoea in genitourinary medicine (GUM) clinics compared with standard off-site laboratory testing. Method We simulated 1.2 million GUM clinic attendees in England. A simulation in Microsoft Excel was developed to compare existing standard pathways of management for chlamydia and gonorrhoea with a POC NAAT. We conducted scenario analyses to evaluate the robustness of the model findings. The primary outcome was the incremental cost-effectiveness ratio. Secondary outcomes included the number of inappropriate treatments, complications and transmissions averted. Results The baseline cost of using the point of POC NAAT was £103.9 million compared with £115.6 million for standard care. The POC NAAT was also associated with a small increase of 46 quality adjusted life years, making the new test both more effective and cheaper. Over 95 000 inappropriate treatments might be avoided by using a POC NAAT. Patients receive diagnosis and treatment on the same day as testing, which may also prevent 189 cases of pelvic inflammatory disease and 17 561 onward transmissions annually. Discussion Replacing standard laboratory tests for chlamydia and gonorrhoea with a POC test could be cost saving and patients would benefit from more accurate diagnosis and less unnecessary treatment. Overtreatment currently accounts for about a tenth of the reported treatments for chlamydia and gonorrhoea and POC NAATs would effectively eliminate the need for presumptive treatment. PMID:24273127

  16. Comparison of two point-of-care testing (POCT) methods for glycated haemoglobin(HbA1c) testing%糖化血红蛋白两种床旁检测方法性能的比较

    Institute of Scientific and Technical Information of China (English)

    王薇; 杨雪; 胡丽涛; 王治国

    2012-01-01

    目的 比较两种H bA1c床旁检测方法的性能.方法 通过对已发表的两种HbA1c床旁检测方法(POC A,POC B)与两种中心实验室仪器(Central X,Central Y)验证试验的数据分析得到两种HbA1c床旁检测仪器与中心实验室仪器相比的不精密度(CV%)、偏倚(Bias%),并将其与质量要求进行比较.结果 POC A测定HbA1c在6.0%和10.4%浓度水平时的变异系数(CV)分别为3.8%、3.7%,与中心实验室仪器(Central X)比对测得的偏倚分别为10.33%、13.58%,与中心实验室仪器(Central Y)比对得到的偏倚分别为7.83%、10.44%;POCB测定HbA1 c在5.5%和11.9%浓度水平时的CV分别为3.4%、7.3%,与CentralX比对测得的偏倚分别为0.45%、11.08%,与CentralY比对得到的偏倚分别为3.73%、9.57%.结论 两种HbA1c床旁检测方法的性能不能满足目前对HbA1 c检测的质量要求.%Objective To evaluate the performance of two point-of-care testing (POCT) methods for HbA1c testing. Methods Using published data from a study, the two POCT HbA1c devices with two central laboratory instruments for HbA1c measurement were compared. The imprecision bias for the two methods of POC A and POC B was determined by verification tests with two central laboratory instruments of Central X and Central Y, from the published data, and then was compared with the requirement of quality. Results At HbA, c level 6. 0% and 10. 4%, the total CV of POC A was 3. 8% and 3. 7% respectively and when comparing with Central X, the bias of POC A was 10. 33% and 13. 58%. Comparing with Central Y, the bias was 7. 83% and 10. 44%. At A,C level 5. 5% and 11. 9% the total CV of POC B was 3. 4%, 7. 3% respectively, and when comparing with Central X, the bias was 0. 45% and 11. 08%. Comparing with Central Y, the bias was 3. 73% and 9. 57%respectively. Conclusions The performance of the two methods for HbA1c testing cannot meet the current quality requirements for the HbA1c testing .

  17. 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.

  18. Evaluation of a Rapid Point of Care Test for Detecting Acute and Established HIV Infection, and Examining the Role of Study Quality on Diagnostic Accuracy: A Bayesian Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Megan Smallwood

    Full Text Available Fourth generation (Ag/Ab combination point of care HIV tests like the FDA-approved Determine HIV1/2 Ag/Ab Combo test offer the promise of timely detection of acute HIV infection, relevant in the context of HIV control. However, a synthesis of their performance has not yet been done. In this meta-analysis we not only assessed device performance but also evaluated the role of study quality on diagnostic accuracy.Two independent reviewers searched seven databases, including conferences and bibliographies, and independently extracted data from 17 studies. Study quality was assessed with QUADAS-2. Data on sensitivity and specificity (overall, antigen, and antibody were pooled using a Bayesian hierarchical random effects meta-analysis model. Subgroups were analyzed by blood samples (serum/plasma vs. whole blood and study designs (case-control vs. cross-sectional.The overall specificity of the Determine Combo test was 99.1%, 95% credible interval (CrI [97.3-99.8]. The overall pooled sensitivity for the device was at 88.5%, 95% [80.1-93.4]. When the components of the test were analyzed separately, the pooled specificities were 99.7%, 95% CrI [96.8-100] and 99.6%, 95% CrI [99.0-99.8], for the antigen and antibody components, respectively. Pooled sensitivity of the antibody component was 97.3%, 95% CrI [60.7-99.9], and pooled sensitivity for the antigen component was found to be 12.3%, 95% (CrI [1.1-44.2]. No significant differences were found between subgroups by blood sample or study design. However, it was noted that many studies restricted their study sample to p24 antigen or RNA positive specimens, which may have led to underestimation of overall test performance. Detection bias, selection (spectrum bias, incorporation bias, and verification bias impaired study quality.Although the specificity of all test components was high, antigenic sensitivity will merit from an improvement. Besides the accuracy of the device itself, study quality, also impacts

  19. Head to Head Comparison of Two Point-of-care Platelet Function Tests Used for Assessment of On-clopidogrel Platelet Reactivity in Chinese Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention

    Institute of Scientific and Technical Information of China (English)

    Yi Yao; Jia-Hui Zhang; Xiao-Fang Tang; Chen He; Yuan-Liang Ma; Jing-Jing Xu; Ying Song

    2016-01-01

    Background:Platelet function tests are widely used in clinical practice to guide personalized antiplatelet therapy.In China,the thromboelastography (TEG) test has been well accepted in clinics,whereas VerifyNow,mainly used for scientific research,has not been used in routine clinical practice.The aim of the current study was to compare these two point-of-care platelet function tests and to analyze the consistency between the two tests for evaluating on-clopidogrel platelet reactivity in Chinese acute myocardial infarction patients undergoing percutaneous coronary intervention (PCI).Methods:A total of 184 patients admitted to Fuwai Hospital between August 2014 and May 2015 were enrolled in the study.On-clopidogrel platelet reactivity was assessed 3 days after PCI by TEG and VerifyNow using adenosine diphosphate as an agonist.Based on the previous reports,an inhibition of platelet aggregation (IPA) <30% for TEG or a P2Y12 reaction unit (PRU) >230 for VerifyNow was defined as high on-clopidogrel platelet reactivity (HPR).An IPA >70% or a PRU <178 was defined as low on-clopidogrel platelet reactivity (LPR).Correlation and agreement between the two methods were analyzed using the Spearman correlation coefficient (r) and kappa value (κ),respectively.Results:Our results showed that VerifyNow and TEG had a moderate but significant correlation in evaluating platelet reactivity (r =-0.511).A significant although poor agreement (κ =0.225) in identifying HPR and a significantly moderate agreement in identifying LPR (κ =0.412) were observed between TEG and VerifyNow.By using TEG as the reference for comparison,the cutoffvalues of VerifyNow for the Chinese patients in this study were identified as PRU >205 for HPR and PRU <169 for LPR.Conclusions:By comparing VerifyNow to TEG which has been widely used in clinics,VerifyNow could be an attractive alternative to TEG for monitoring on-clopidogrel platelet reactivity in Chinese patients.

  20. 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 BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

  1. Study on the accuracy and application values of point-of-care testing of capillary blood glucose andglycosy lated haemoglobin%床旁检测血糖和HbAlc的准确性及其应用价值

    Institute of Scientific and Technical Information of China (English)

    余文辉; 周小梅; 李伟雄; 张书楠

    2008-01-01

    Objective To assess the accuracy and application values of point-of-care testing (POCT) of capillary blood glucose and glyeosylated haemoglobin(Hbalc) levels.Methods 152 residents (aged 21~75 years)were recruited.who had POCT glucose measurements in October 2006.Eighty-eight cases with POCT glucose level≥5.0 mmol/L,or self-reported diabetes mellitus(DM).Thereafter,88 cases had POCT HbAlc and laboratory glucose and HbAlc measurements,respectively.The POCT and laboratory measurements of glucose and HbAlc were compared,and the correlation coefficient r,mean difference and limits of agreement (LOA) between capillary POCT and venous blood laboratory measurements of glucose and HbAlc were evaluated for cross-sectional study.Results Mean and median POCT capillary glucose levels were 7.99 mmol/L and 6.25 mmol/L,respectively,while mean and median laboratory venous plasma glucose concentrations were 7.63 mmol/L and 5.35 mmol/L.Mean and median of POCT capillary HbAlc and laboratory HbAlc were 6.98% and 5.96%,and those of laboratory HbAlc were 7.06%and 6.O%,respectively.The correlation coefficient r for POCT and laboratory results was 0.98 for glucose and 0.95 for HbAlc.The mean difference in results was 0.36 mmol/L for glucose(95% CI:0.13~0.62;LOA:-2.07~2.79 mmol/L,P=0.007) and 0.02% for HbAlc(95%CI:-0.07%~0.09%;LOA:-O.66%~0.68%;P=0.95),respectively. Conclusion POCT capillary HoAle testing offers an accurate,practical and convenient way of monitoring the therapy effects of diabetes in community.While POCT capillary glucose results should be calibrated regularly by a laboratory test of venous plasma,it couldh't be directly used to diagnos DM.%目的 评价床旁检测(POCT)血糖和糖化血红蛋白(HbAlc)的准确性及其应用价值.方法 对88例疑似糖尿病者行POCT方法测定HbAlc和实验室方法测定血浆血糖及HbAlc.将POCT方法测定毛细血管血糖及HbAlc的结果与相应静脉血的实验室测定结果作比较,评估POCT与实验室

  2. CD-Based Microfluidics for Primary Care in Extreme Point-of-Care Settings

    Directory of Open Access Journals (Sweden)

    Suzanne Smith

    2016-01-01

    Full Text Available We review the utility of centrifugal microfluidic technologies applied to point-of-care diagnosis in extremely under-resourced environments. The various challenges faced in these settings are showcased, using areas in India and Africa as examples. Measures for the ability of integrated devices to effectively address point-of-care challenges are highlighted, and centrifugal, often termed CD-based microfluidic technologies, technologies are presented as a promising platform to address these challenges. We describe the advantages of centrifugal liquid handling, as well as the ability of a standard CD player to perform a number of common laboratory tests, fulfilling the role of an integrated lab-on-a-CD. Innovative centrifugal approaches for point-of-care in extremely resource-poor settings are highlighted, including sensing and detection strategies, smart power sources and biomimetic inspiration for environmental control. The evolution of centrifugal microfluidics, along with examples of commercial and advanced prototype centrifugal microfluidic systems, is presented, illustrating the success of deployment at the point-of-care. A close fit of emerging centrifugal systems to address a critical panel of tests for under-resourced clinic settings, formulated by medical experts, is demonstrated. This emphasizes the potential of centrifugal microfluidic technologies to be applied effectively to extremely challenging point-of-care scenarios and in playing a role in improving primary care in resource-limited settings across the developing world.

  3. Rapid detection of Avian Influenza Virus - Towards point of care diagnosis

    DEFF Research Database (Denmark)

    Dhumpa, Raghuram

    be to have a point-of-care (POC) diagnostic test at or near the site of sample collection to provide results in very short time and can improve medical decision-making. The available commercial POC tests that are used for screening of influenza A virus are rapid (5-30 minutes) but have low sensitivity...

  4. 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.

    2011-01-01

    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 f

  5. 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...

  6. Anticoagulant response to Agkistrodon contortrix venom (ACV test): a new global test to screen for defects in the anticoagulant protein C pathway.

    Science.gov (United States)

    Robert, A; Eschwège, V; Hameg, H; Drouet, L; Aillaud, M F

    1996-04-01

    As specific assays used to identify defects in the protein C (PC) anticoagulant pathway are laborious and expensive, we describe here a global test to screen for these defects. This assay is expressed as the ratio of two activated partial thromboplastin times, one in the absence and one in the presence of 0,125 U/ml of the PC activator of Agkistrodon contortrix venom (ACV). Eight of the 168 healthy volunteers of the control group exhibited an ACV ratio below the lower normal limit of 3.37 [6 subjects with the mutation Arg 506 to Gln in their factor V gene (FV R506Q) and one with PS deficiency]. 128 patients who have had at least one episode of deep-vein thrombosis were retrospectively studied. All patients carrying FV Q506R (n = 48), PC deficiency (n = 14) or combined defects, i.e. FV Q506R and PC deficiency (n = 4) or FV Q506R and PS deficiency (n = 3), had ACV ratios ACV ratios which overlapped normal range. ACV ratios of one out of seven patients with antithrombin deficiency, and 10% of patients without identified defect in the PC anticoagulant pathway (n = 30) were ACV ratio raised to 3.70 could lead to a test identifying all patients with a defect in the PC anticoagulant pathway.

  7. 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 c...

  8. 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

  9. Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting.

    Science.gov (United States)

    Ottiger, Cornelia; Gygli, Nicole; Huber, Andreas R; Fernandez-Tresguerres, Beatriz; Pardo, Scott; Petruschke, Thorsten

    2016-07-01

    This study assesses and demonstrates that CONTOUR® XT-BGMS (CXT-BGMS) complies with the requirements of the German (RiliBÄK) and Swiss (QUALAB) quality control guidelines for point-of-care testing (POCT) and fulfills the ISO15197:2013 accuracy limits criteria under the routine conditions of a hospital point-of care setting. This single-center study was conducted in Switzerland using 105 venous blood samples from hospitalized patients. Each sample was tested in comparison to the hexokinase reference method. Compliance with POCT guidelines was assessed by daily BGMS measurements using control solutions. Accuracy of CXT-BGMS according to ISO limits was 98.41%. All control measurements were within the limits defined by RiliBÄK (within ± 11% of target values and root mean square error [RMSE] within RMSE limits), and QUALAB (within ± 10% of target values).

  10. Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

    Science.gov (United States)

    Ottiger, Cornelia; Gygli, Nicole; Huber, Andreas R.; Fernandez-Tresguerres, Beatriz; Pardo, Scott; Petruschke, Thorsten

    2016-01-01

    This study assesses and demonstrates that CONTOUR® XT-BGMS (CXT-BGMS) complies with the requirements of the German (RiliBÄK) and Swiss (QUALAB) quality control guidelines for point-of-care testing (POCT) and fulfills the ISO15197:2013 accuracy limits criteria under the routine conditions of a hospital point-of care setting. This single-center study was conducted in Switzerland using 105 venous blood samples from hospitalized patients. Each sample was tested in comparison to the hexokinase reference method. Compliance with POCT guidelines was assessed by daily BGMS measurements using control solutions. Accuracy of CXT-BGMS according to ISO limits was 98.41%. All control measurements were within the limits defined by RiliBÄK (within ± 11% of target values and root mean square error [RMSE] within RMSE limits), and QUALAB (within ± 10% of target values). PMID:26989068

  11. A framework for key considerations regarding point-of-care screening of newborns.

    Science.gov (United States)

    Kemper, Alex R; Kus, Christopher A; Ostrander, Robert J; Comeau, Anne Marie; Boyle, Coleen A; Dougherty, Denise; Mann, Marie Y; Botkin, Jeffrey R; Green, Nancy S

    2012-12-01

    Newborn screening is performed under public health authority, with analysis carried out primarily by public health laboratories or other centralized laboratories. Increasingly, opportunities to improve infant health will arise from including screening tests that are completed at the birth centers instead of in centralized laboratories, constituting a significant shift for newborn screening. This report summarizes a framework developed by the US Secretary of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children based on a series of meetings held during 2011 and 2012. These meetings were for the purpose of evaluating whether conditions identifiable through point-of-care screening should be added to the recommended universal screening panel, and to identify key considerations for birth hospitals, public health agencies, and clinicians when point-of-care newborn screening is implemented.

  12. Comparison of point-of-care-compatible lysis methods for bacteria and viruses.

    Science.gov (United States)

    Heiniger, Erin K; Buser, Joshua R; Mireles, Lillian; Zhang, Xiaohong; Ladd, Paula D; Lutz, Barry R; Yager, Paul

    2016-09-01

    Nucleic acid sample preparation has been an especially challenging barrier to point-of-care nucleic acid amplification tests in low-resource settings. Here we provide a head-to-head comparison of methods for lysis of, and nucleic acid release from, several pathogenic bacteria and viruses-methods that are adaptable to point-of-care usage in low-resource settings. Digestion with achromopeptidase, a mixture of proteases and peptidoglycan-specific hydrolases, followed by thermal deactivation in a boiling water bath, effectively released amplifiable nucleic acid from Staphylococcus aureus, Bordetella pertussis, respiratory syncytial virus, and influenza virus. Achromopeptidase was functional after dehydration and reconstitution, even after eleven months of dry storage without refrigeration. Mechanical lysis methods proved to be effective against a hard-to-lyse Mycobacterium species, and a miniature bead-mill, the AudioLyse, is shown to be capable of releasing amplifiable DNA and RNA from this species. We conclude that point-of-care-compatible sample preparation methods for nucleic acid tests need not introduce amplification inhibitors, and can provide amplification-ready lysates from a wide range of bacterial and viral pathogens.

  13. 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.

  14. Low-molecular-weight heparin as a multipurpose anticoagulant for laboratory testing.

    Science.gov (United States)

    Kawamoto, T; Hiino, M; Takubo, T; Tatsumi, N

    2000-06-01

    The availability of low-molecular-weight heparin (LMWH) for use as an anti-coagulant for laboratory testing was studied. Hematology and chemistry tests were performed with an automated hematology analyzer and an automated chemistry analyzer, respectively. The results of hematology tests of LMWH-treated blood were similar to those obtained for blood treated with ethylenediaminetetraacetic acid (EDTA)-2K, except for platelet count. The platelet count of LMWH-treated blood was lower than that of EDTA-treated blood, and the decrease in platelet count in the former was due to platelet aggregation. Prothrombin time tests could be performed with plasma prepared from LMWH-treated blood, although with such blood the prothrombin time was prolonged. Chemistry tests could be performed for all 18 parameters. These results suggest that LMWH is a candidate for use for hematology testing (with the exception of platelet count), coagulation testing, and chemistry tests.

  15. Comparison of blood glucose test results between point-of-care testing glucose meter and biochemical analyzer%POCT血糖仪与生化分析仪血糖检测结果的比对试验及分析

    Institute of Scientific and Technical Information of China (English)

    刘加红

    2014-01-01

    Objective To explore precision and accuracy of point-of-care testing(POCT) blood glucose meter through comparing blood glucose results between POCT glucose meter and biochemical analyzer. Methods Selected 4 sets of POCT glucose meter to detect the same sample and compared blood glucose results between Beckman CX-9 biochemical analyzer and POCT blood glucose meter. Results Measured results of Beckman CX-9 biochemical analyzer and POCT glucose meter were highly correlated(P>0.05), differences were not statistically significant. Conclusion POCT blood glucose meter is a consistent and convenient detection method for measuring blood glucose results as biochemical analyzer, so it is worthy of clinical promotion and application.%目的对比床旁检测(POCT)血糖仪与生化分析仪对血糖测定的结果,对POCT血糖仪的精密度与准确度进行探讨。方法选用4台POCT血糖仪对同一标本进行测定,并比较贝克曼CX-9生化分析仪与POCT血糖仪的测定结果。结果贝克曼CX-9生化分析仪与POCT血糖仪的测定结果高度相关(P>0.05),差异不具有统计学意义。结论 POCT血糖仪与生化分析仪对血糖的测定结果具有一致性,且方便快捷,可作为急诊的检测方法,值得在临床过程中推广、应用。

  16. Handheld, point-of-care laser speckle imaging

    Science.gov (United States)

    Farraro, Ryan; Fathi, Omid; Choi, Bernard

    2016-09-01

    Laser speckle imaging (LSI) enables measurement of relative changes in blood flow in biological tissues. We postulate that a point-of-care form factor will lower barriers to routine clinical use of LSI. Here, we describe a first-generation handheld LSI device based on a tablet computer. The coefficient of variation of speckle contrast was 0.05) between the measured speckle contrast values using either a handheld or mounted configuration. In vivo data collected during occlusion experiments demonstrate that a handheld LSI is capable of both quantitative and qualitative assessment of changes in blood flow. Finally, as a practical application of handheld LSI, we collected data from a 53-day-old neonate with confirmed compromised blood flow in the hand. We readily identified with LSI a region of diminished blood flow in the thumb of the affected hand. Our data collectively suggest that handheld LSI is a promising technique to enable clinicians to obtain point-of-care measurements of blood flow.

  17. 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.

  18. 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

    This paper describes how sixteen partners from eight different countries across Europe are working together in two EU projects focused on the development of a point of care system. This system uses disposable Lab on a Chips (LOCs) that carry out the complete assay from sample preparation to result...... 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...... interface (a smartphone), creating a new instrument namely "The SmartBioPhone (TM)". All standard smartphone capabilities will be at the disposal of the point of care instrument by a simple click. In order to guarantee the future mass production of these LOCs, the project will develop a large dry film...

  19. 78 FR 44624 - Proposed Information Collection (Conduct the Point-of-Care Research Questionnaire); Activities...

    Science.gov (United States)

    2013-07-24

    ... AFFAIRS [OMB Control No. 2900-NEW (Conduct the Point-of-Care Research Questionnaire)] Proposed Information Collection (Conduct the Point-of-Care Research Questionnaire); Activities Under OMB Review AGENCY: Veterans...) 395-7316. Please refer to ``OMB Control No. 2900-NEW (Conduct the Point of Care Research...

  20. 78 FR 9108 - Proposed Information Collection (Conduct the Point-of-Care Research Questionnaire) Activity...

    Science.gov (United States)

    2013-02-07

    ... AFFAIRS Proposed Information Collection (Conduct the Point-of-Care Research Questionnaire) Activity... refer to ``OMB Control No. 2900-NEW (Conduct the Point-of-Care Research Questionnaire)'' in any... Questionnaire, VA Form 10-0557. OMB Control Number: 2900-NEW (Conduct the Point-of-Care Research...

  1. Direct oral anticoagulants and antiplatelet agents. Clinical relevance and options for laboratory testing.

    Science.gov (United States)

    Sibbing, D; Spannagl, M

    2014-01-01

    Oral anticoagulants and platelet receptor blockers are widely used in clinical practice with the aim of reducing the risk of thrombotic complications in patients with cardiovascular diseases. Their regular intake and adequate antithrombotic action is vital and this is way numerous assays have been developed for laboratory testing and monitoring of these agents. Available assays can be stratified into pharmacokinetic and pharmacodynamic assays. Such assays are increasingly used in clinical routine and their daily use is triggered by the advent of the novel direct oral anticoagulants (DOACs) as an alternative for vitamin K antagonist (VKA) treatment, which are dabigatran, rivaroxaban and apixaban, and by the advent of prasugrel or ticagrelor as an alternative for clopidogrel with regard to platelet P2Y12 receptor inhibition. In this review the most important and most commonly used laboratory assays are summarized as well as their clinical implications with the focus on DOACs as an alternative for VKAs and the different P2Y12 receptor blockers for antiplatelet treatment.

  2. 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.

  3. Point of Care Testing——检验医学的新挑战

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ POCT的发展历程 近几年来,在检验医学和临床领域.Point of Care Testing(POCT)成为一个比较热门的词汇,它最早出现在美国,要表达的意思是,在发病或者发生事件的地点进行诊断、监控和治疗,能快速地获得检验结果并及时作出正确的处理.

  4. Comparison of point-of-care testing and laboratory testing of myocardial damage markers in the diagnosis and prognosis of acute coronary syndrome%床旁快速检测对急性冠脉综合征的诊断和预后的影响

    Institute of Scientific and Technical Information of China (English)

    杨军; 李春盛

    2012-01-01

    目的 对比床旁快速检测与传统实验室方法检测心肌损伤标志物对急性冠脉综合征(ACS)的诊断及预后的影响.方法 回顾性分析2006年1月1日至2010年6月30日首都医科大学附属北京朝阳医院急诊科收治已确诊的3467例急性冠脉综合征的患者,记录患者的年龄、性别、既往病史和吸烟史等基本人口资料,以及心肌损伤标志物(CTNI CKMB MYO)、D二聚体、NTproBNP、心脏彩超EF等实验室指标,采用统计学方法比较应用床旁快速检测与实验室检测心肌损伤标志物的患者,在急诊滞留时间(急诊就诊到接受介入或保守治疗之间用时)、入院到住院期间的心血管事件(心衰、室颤、脑血管病)的发生率和28 d病死率的不同.结果 床旁快速检测组的急诊滞留时间、心血管事件发生率和28 d病死率均低于常规实验室检测组(p=0.000),且急诊滞留时间越长,早期肌红蛋白和D二聚体测定值越高,EF测定值越低,28 d死亡风险越高.结论 床旁快速检测比常规实验室检测能缩短ACS患者的急诊滞留时间,降低心血管事件发生率并能明显改善预后.%Objective To compare the point-of-care testing (POCT) and laboratory testing of myocardial damage markers in the diagnosis and prognosis of acute coronary syndrome (ACS).Methods A total of 3467 patients with ACS who were treated in the Emergency Department Beijing Chaoyang Hospital Affiliated to Capital Medical University between January 1,2006 and June 30,2010 were retrospectively reviewed.The patient demographics (age,sex,past medical history and smoking history) and laboratory testing results (myocardial damage markers,D-dimer,NTproBNP,and ejection fraction [EF]) were analyzed.The patients who received POCT or laboratory testing of myocardial damage markers were compared with regard to emergency department stay (i.e.,the time from the emergency visit to interventional or conservative treatment),cardiovascular events

  5. Phospholipase A2 as a point of care alternative to serum amylase and pancreatic lipase

    Science.gov (United States)

    Liu, Nathan J.; Chapman, Robert; Lin, Yiyang; Bentham, Andrew; Tyreman, Matthew; Philips, Natalie; Khan, Shahid A.; Stevens, Molly M.

    2016-06-01

    Acute pancreatitis is a relatively common and potentially fatal condition, but the presenting symptoms are non-specific and diagnosis relies largely on the measurement of amylase activity by the hospital clinical laboratory. In this work we develop a point of care test for pancreatitis measuring concentration of secretory phospholipase A2 group IB (sPLA2-IB). Novel antibodies for sPLA2-IB were raised and used to design an ELISA and a lateral flow device (LFD) for the point of care measurement of sPLA2-IB concentration, which was compared to pancreatic amylase activity, lipase activity, and sPLA2-IB activity in 153 serum samples. 98 of these samples were obtained from the pathology unit of a major hospital and classified retrospectively according to presence or absence of pancreatitis, and the remaining 55 were obtained from commercial sources to serve as high lipase (n = 20), CA19-9 positive (n = 15), and healthy (n = 20) controls. sPLA2-IB concentration correlated well with the serum activity of both amylase and lipase, and performed at least as well as either markers in the differentiation of pancreatitis from controls.Acute pancreatitis is a relatively common and potentially fatal condition, but the presenting symptoms are non-specific and diagnosis relies largely on the measurement of amylase activity by the hospital clinical laboratory. In this work we develop a point of care test for pancreatitis measuring concentration of secretory phospholipase A2 group IB (sPLA2-IB). Novel antibodies for sPLA2-IB were raised and used to design an ELISA and a lateral flow device (LFD) for the point of care measurement of sPLA2-IB concentration, which was compared to pancreatic amylase activity, lipase activity, and sPLA2-IB activity in 153 serum samples. 98 of these samples were obtained from the pathology unit of a major hospital and classified retrospectively according to presence or absence of pancreatitis, and the remaining 55 were obtained from commercial sources to

  6. Connecting knowledge resources to the veterinary electronic health record: opportunities for learning at point of care.

    Science.gov (United States)

    Alpi, Kristine M; Burnett, Heidi A; Bryant, Sheila J; Anderson, Katherine M

    2011-01-01

    Electronic health records (EHRs) provide clinical learning opportunities through quick and contextual linkage of patient signalment, symptom, and diagnosis data with knowledge resources covering tests, drugs, conditions, procedures, and client instructions. This paper introduces the EHR standards for linkage and the partners-practitioners, content publishers, and software developers-necessary to leverage this possibility in veterinary medicine. The efforts of the American Animal Hospital Association (AAHA) Electronic Health Records Task Force to partner with veterinary practice management systems to improve the use of controlled vocabulary is a first step in the development of standards for sharing knowledge at the point of care. The Veterinary Medical Libraries Section (VMLS) of the Medical Library Association's Task Force on Connecting the Veterinary Health Record to Information Resources compiled a list of resources of potential use at point of care. Resource details were drawn from product Web sites and organized by a metric used to evaluate medical point-of-care resources. Additional information was gathered from questions sent by e-mail and follow-up interviews with two practitioners, a hospital network, two software developers, and three publishers. Veterinarians with electronic records use a variety of information resources that are not linked to their software. Systems lack the infrastructure to use the Infobutton standard that has been gaining popularity in human EHRs. While some veterinary knowledge resources are digital, publisher sites and responses do not indicate a Web-based linkage of veterinary resources with EHRs. In order to facilitate lifelong learning and evidence-based practice, veterinarians and educators of future practitioners must demonstrate to veterinary practice software developers and publishers a clinically-based need to connect knowledge resources to veterinary EHRs.

  7. Point-of-Care Diagnostics for Improving Maternal Health in South Africa.

    Science.gov (United States)

    Mashamba-Thompson, Tivani P; Sartorius, Benn; Drain, Paul K

    2016-08-31

    Improving maternal health is a global priority, particularly in high HIV-endemic, resource-limited settings. Failure to use health care facilities due to poor access is one of the main causes of maternal deaths in South Africa. "Point-of-care" (POC) diagnostics are an innovative healthcare approach to improve healthcare access and health outcomes in remote and resource-limited settings. In this review, POC testing is defined as a diagnostic test that is carried out near patients and leads to rapid clinical decisions. We review the current and emerging POC diagnostics for maternal health, with a specific focus on the World Health Organization (WHO) quality-ASSURED (Affordability, Sensitivity, Specificity, User friendly, Rapid and robust, Equipment free and Delivered) criteria for an ideal point-of-care test in resource-limited settings. The performance of POC diagnostics, barriers and challenges related to implementing POC diagnostics for maternal health in rural and resource-limited settings are reviewed. Innovative strategies for overcoming these barriers are recommended to achieve substantial progress on improving maternal health outcomes in these settings.

  8. Advances in paper-based point-of-care diagnostics.

    Science.gov (United States)

    Hu, Jie; Wang, ShuQi; Wang, Lin; Li, Fei; Pingguan-Murphy, Belinda; Lu, Tian Jian; Xu, Feng

    2014-04-15

    Advanced diagnostic technologies, such as polymerase chain reaction (PCR) and enzyme-linked immunosorbent assay (ELISA), have been widely used in well-equipped laboratories. However, they are not affordable or accessible in resource-limited settings due to the lack of basic infrastructure and/or trained operators. Paper-based diagnostic technologies are affordable, user-friendly, rapid, robust, and scalable for manufacturing, thus holding great potential to deliver point-of-care (POC) diagnostics to resource-limited settings. In this review, we present the working principles and reaction mechanism of paper-based diagnostics, including dipstick assays, lateral flow assays (LFAs), and microfluidic paper-based analytical devices (μPADs), as well as the selection of substrates and fabrication methods. Further, we report the advances in improving detection sensitivity, quantification readout, procedure simplification and multi-functionalization of paper-based diagnostics, and discuss the disadvantages of paper-based diagnostics. We envision that miniaturized and integrated paper-based diagnostic devices with the sample-in-answer-out capability will meet the diverse requirements for diagnosis and treatment monitoring at the POC.

  9. 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.

  10. 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.

  11. 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

  12. Portable point-of-care blood analysis system for global health (Conference Presentation)

    Science.gov (United States)

    Dou, James J.; Aitchison, James Stewart; Chen, Lu; Nayyar, Rakesh

    2016-03-01

    In this paper we present a portable blood analysis system based on a disposable cartridge and hand-held reader. The platform can perform all the sample preparation, detection and waste collection required to complete a clinical test. In order to demonstrate the utility of this approach a CD4 T cell enumeration was carried out. A handheld, point-of-care CD4 T cell system was developed based on this system. In particular we will describe a pneumatic, active pumping method to control the on-chip fluidic actuation. Reagents for the CD4 T cell counting assay were dried on a reagent plug to eliminate the need for cold chain storage when used in the field. A micromixer based on the active fluidic actuation was designed to complete sample staining with fluorescent dyes that was dried on the reagent plugs. A novel image detection and analysis algorithm was developed to detect and track the flight of target particles and cells during each analysis. The handheld, point-of-care CD4 testing system was benchmarked against clinical cytometer. The experimental results demonstrated experimental results were closely matched with the flow cytometry. The same platform can be further expanded into a bead-array detection system where other types of biomolecules such as proteins can be detected using the same detection system.

  13. 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.

  14. Infectious Disease Management through Point-of-Care Personalized Medicine Molecular Diagnostic Technologies.

    Science.gov (United States)

    Bissonnette, Luc; Bergeron, Michel G

    2012-05-02

    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.

  15. International Federation for Emergency Medicine point of care ultrasound curriculum.

    Science.gov (United States)

    Atkinson, Paul; Bowra, Justin; Lambert, Mike; Lamprecht, Hein; Noble, Vicki; Jarman, Bob

    2015-03-01

    To meet a critical and growing need for a standardized approach to emergency point of care ultrasound (PoCUS) worldwide, emergency physicians must be trained to deliver and teach this skill in an accepted and reliable format. Currently, there is no globally recognized, standard PoCUS curriculum that defines the accepted applications, as well as standards for training and practice of PoCUS by specialists and trainees in emergency medicine. To address this deficit, the International Federation for Emergency Medicine (IFEM) convened a sub-committee of international experts in PoCUS to outline a curriculum for training of specialists in emergency PoCUS. This curriculum document represents the consensus of recommendations by this sub-committee. The curriculum is designed to provide a framework for PoCUS education in emergency medicine. The focus is on the processes required to select core and enhanced applications, as well as the key elements required for the delivery of PoCUS training from introduction through to continuing professional development and skill maintenance. It is designed not to be prescriptive but to assist educators and emergency medicine leadership to advance PoCUS education in emergency medicine no matter the training venue. The content of this curriculum is relevant not just for communities with mature emergency medicine systems but in particular for developing nations or for nations seeking to develop PoCUS training programs within the current educational structure. We anticipate that there will be wide variability in how this curriculum is implemented and taught, reflecting the existing educational environment, resources and goals of educational programs.

  16. A Proposed Framework for the Implementation of Early Infant Diagnosis Point-of-Care

    Science.gov (United States)

    Modi, Surbhi; Hurlston, Mackenzie; Beard, R. Suzanne; Nkengasong, John N.

    2017-01-01

    Abstract Early diagnosis of HIV infection in infants and children remains a challenge in resource-limited settings, with approximately half of all HIV-exposed infants receiving virological testing for HIV by the recommended age of 2 months in 2015. To reduce morbidity and mortality among HIV-infected children and close the treatment gap for HIV-infected children, there is an urgent need to evaluate existing programmatic and laboratory practices for early infant diagnosis and introduce strategies to improve identification of HIV-exposed infants and ensure access to systematic, early HIV testing, with early linkage to treatment for HIV-infected infants. This article describes progress made in follow-up of HIV-exposed infants since 2006, including remaining unmet laboratory and programmatic needs, and recommends strategies for improvement, especially those related to the implementation of point-of-care technology for early infant diagnosis. PMID:27758117

  17. Evidence-Based Point-of-Care Diagnostics: Current Status and Emerging Technologies

    Science.gov (United States)

    Chan, Cangel Pui Yee; Mak, Wing Cheung; Cheung, Kwan Yee; Sin, King Keung; Yu, Cheuk Man; Rainer, Timothy H.; Renneberg, Reinhard

    2013-06-01

    Point-of-care (POC) diagnostics brings tests nearer to the site of patient care. The turnaround time is short, and minimal manual interference enables quick clinical management decisions. Growth in POC diagnostics is being continuously fueled by the global burden of cardiovascular and infectious diseases. Early diagnosis and rapid initiation of treatment are crucial in the management of such patients. This review provides the rationale for the use of POC tests in acute coronary syndrome, heart failure, human immunodeficiency virus, and tuberculosis. We also consider emerging technologies that are based on advanced nanomaterials and microfluidics, improved assay sensitivity, miniaturization in device design, reduced costs, and high-throughput multiplex detection, all of which may shape the future development of POC diagnostics.

  18. 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 retrospective observational study we included persons referred for thrombophilia testing during 2011-2014. Persons with autoimmune disease, thrombophilia or presence of specific anti-phospholipid antibodies were excluded. Multivariate logistic regression analyses adjusted for age and sex was performed and odds...

  19. Sample to answer visualization pipeline for low-cost point-of-care blood cell counting

    Science.gov (United States)

    Smith, Suzanne; Naidoo, Thegaran; Davies, Emlyn; Fourie, Louis; Nxumalo, Zandile; Swart, Hein; Marais, Philip; Land, Kevin; Roux, Pieter

    2015-03-01

    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 solutions [1], and can be particularly beneficial for blood cell count tests, which are often the starting point in the process of diagnosing a patient [2]. The initial focus of this work is on total white and red blood cell counts, using a microfluidic cartridge [3] for sample processing. Analysis of the processed samples has been implemented by means of two main optical visualization systems developed in-house: 1) a fluidic operation analysis system using high speed video data to determine volumes, mixing efficiency and flow rates, and 2) a microscopy analysis system to investigate homogeneity and concentration of blood cells. Fluidic parameters were derived from the optical flow [4] as well as color-based segmentation of the different fluids using a hue-saturation-value (HSV) color space. Cell count estimates were obtained using automated microscopy analysis and were compared to a widely accepted manual method for cell counting using a hemocytometer [5]. The results using the first iteration microfluidic device [3] showed that the most simple - and thus low-cost - approach for microfluidic component implementation was not adequate as compared to techniques based on manual cell counting principles. An improved microfluidic design has been developed to incorporate enhanced mixing and metering components, which together with this work provides the foundation on which to successfully implement automated, rapid and low-cost blood cell counting tests.

  20. Assessment of a pharmacist-driven point-of-care spirometry clinic within a primary care physicians office

    OpenAIRE

    Cawley MJ; Pacitti R; Warning W

    2011-01-01

    Objective: To assess value-added service of a pharmacist-driven point-of-care spirometry clinic to quantify respiratory disease abnormalities within a primary care physicians officeMethods: This retrospective, cohort study was an analysis of physician referred patients who attended our spirometry clinic during 2008-2010 due to pulmonary symptoms or disease. After spirometry testing, data was collected retrospectively to include patient demographics, spirometry results, and pulmonary pharmaceu...

  1. Flexible low-cost cardiovascular risk marker biosensor for point-of-care applications

    KAUST Repository

    Sivashankar, S.

    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.

  2. Evolvable Smartphone-Based Platforms for Point-Of-Care In-Vitro Diagnostics Applications

    DEFF Research Database (Denmark)

    Patou, François; Al Atraktchi, Fatima Al-Zahraa; Kjærgaard, Claus

    2016-01-01

    The association of smart mobile devices and lab-on-chip technologies offers unprecedented opportunities for the emergence of direct-to-consumer in vitro medical diagnostics applications. Despite their clear transformative potential, obstacles remain to the large-scale disruption and long......-based biosensors. Our findings suggest that several change-enabling mechanisms implemented in the higher abstraction software layers of the system can promote evolvability, together with the design of change-absorbing hardware/software interfaces. Our platform architecture is based on a mobile software application......-lasting success of these systems in the consumer market. For instance, the increasing level of complexity of instrumented lab-on-chip devices, coupled to the sporadic nature of point-of-care testing, threatens the viability of a business model mainly relying on disposable/consumable lab-on-chips. We argued...

  3. Interdisciplinary care team adoption of electronic point-of-care documentation systems: an unrealized opportunity.

    Science.gov (United States)

    Sockolow, Paulina S; Bowles, Kathryn H; Rogers, Michelle; Adelsberger, Marguerite C; Chittams, Jesse L; Liao, Cindy

    2013-01-01

    We conducted three health care evaluation studies in community and hospital settings to examine adoption of point-of-care documentation systems among interdisciplinary care team clinicians. Both community studies used a mixed methods design to assess actual system usage and clinician satisfaction. In the hospitals, scenario testing was used. Results indicated clinician adoption of the systems was universal, although not always timely with: (1) a mismatch between system functionality and workflow which was a barrier to clinician system access during patient care and reduced clinician efficiency; (2) no increase in interdisciplinary team communication; and (3) no impact on patient outcomes identified by clinicians. To facilitate adoption, clinicians should see the value of using the system as intended by receiving patient care and patient safety feedback that uses system data.

  4. Opportunities in interdisciplinary care team adoption of electronic point-of-care documentation systems.

    Science.gov (United States)

    Sockolow, Paulina S; Bowles, Kathryn H; Rogers, Michelle; Adelsberger, Marguerite C; Chittams, Jesse L; Liao, Cindy

    2014-01-01

    We conducted three evaluation studies in community and hospital settings to examine point-of-care documentation system adoption among interdisciplinary care team clinicians. In the community settings, quantitative methods included documentation time-to-completion and a clinician satisfaction survey. Qualitative methods included observations and follow-up interviews. Qualitative data and quantitative data were merged comparing findings along themes. In the hospitals, qualitative scenario testing results indicated clinician system adoption was universal, though not always timely. At all sites, mismatch between system functionality and workflow was a barrier to clinician system access during patient care and reduced clinician efficiency. Clinicians at all settings were satisfied with their ability to access other clinicians' notes, without increased interdisciplinary team communication. Clinicians did not identify any systems impact on patient outcomes. To facilitate adoption, clinicians should see the value of using the system as intended by receiving system data feedback that shows improvement of patient care and patient safety.

  5. Molecular isothermal techniques for combating infectious diseases: towards low-cost point-of-care diagnostics.

    Science.gov (United States)

    de Paz, Hector David; Brotons, Pedro; Muñoz-Almagro, Carmen

    2014-09-01

    Nucleic acid amplification techniques such as PCR have facilitated rapid and accurate diagnosis in central laboratories over the past years. PCR-based amplifications require high-precision instruments to perform thermal cycling reactions. Such equipment is bulky, expensive and complex to operate. Progressive advances in isothermal amplification chemistries, microfluidics and detectors miniaturisation are paving the way for the introduction and use of compact 'sample in-results out' diagnostic devices. However, this paradigm shift towards decentralised testing poses diverse technological, economic and organizational challenges both in industrialized and developing countries. This review describes the landscape of molecular isothermal diagnostic techniques for infectious diseases, their characteristics, current state of development, and available products, with a focus on new directions towards point-of-care applications.

  6. 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...

  7. 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.

  8. A study to assess the influence of interprofessional point of care simulation training on safety culture in the operating theatre environment of a university teaching hospital.

    Science.gov (United States)

    Hinde, Theresa; Gale, Thomas; Anderson, Ian; Roberts, Martin; Sice, Paul

    2016-01-01

    Interprofessional point of care or in situ simulation is used as a training tool in our operating theatre directorate with the aim of improving crisis behaviours. This study aimed to assess the impact of interprofessional point of care simulation on the safety culture of operating theatres. A validated Safety Attitude Questionnaire was administered to staff members before each simulation scenario and then re-administered to the same staff members after 6-12 months. Pre- and post-training Safety Attitude Questionnaire-Operating Room (SAQ-OR) scores were compared using paired sample t-tests. Analysis revealed a statistically significant perceived improvement in both safety (p culture) 6-12 months after interprofessional simulation training. A growing body of literature suggests that a positive safety culture is associated with improved patient outcomes. Our study supports the implementation of point of care simulation as a useful intervention to improve safety culture in theatres.

  9. 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.

  10. 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.

  11. Optimal duration of anticoagulation. Provoked versus unprovoked VTE and role of adjunctive thrombophilia and imaging tests.

    Science.gov (United States)

    Prandoni, Paolo; Barbar, Sofia; Milan, Marta; Campello, Elena; Spiezia, Luca; Piovella, Chiara; Pesavento, Raffaele

    2015-06-01

    Once anticoagulation is stopped, the risk of recurrent venous thromboembolism (VTE) over years after a first episode is consistently around 30%. This risk is higher in patients with unprovoked than in those with (transient) provoked VTE, and among the latter in patients with medical than in those with surgical risk factors. Baseline parameters that have been found to be related to the risk of recurrent VTE are the proximal location of deep-vein thrombosis, obesity, old age, male sex and non-0 blood group, whereas the role of inherited thrombophilia is controversial. The persistence of residual vein thrombosis at ultrasound assessment has consistently been shown to increase the risk, as do persistently high values of D-dimer and the early development of the post-thrombotic syndrome. Although the latest international guidelines suggest indefinite anticoagulation for most patients with the first episode of unprovoked VTE, strategies that incorporate the assessment of residual vein thrombosis and D-dimer have the potential to identify subjects in whom anticoagulation can be safely discontinued. Moreover, new opportunities are offered by a few emerging anti-Xa and anti-IIa oral compounds, which are likely to induce fewer haemorrhagic complications than vitamin K antagonists while preserving the same effectiveness; and by low-dose aspirin, which has the potential to prevent the occurrence of both venous and arterial thrombotic events.

  12. Evaluation of the PIMA point-of-care CD4 analyzer in VCT clinics in Zimbabwe.

    Science.gov (United States)

    Mtapuri-Zinyowera, Sekesai; Chideme, Memory; Mangwanya, Douglas; Mugurungi, Owen; Gudukeya, Stephano; Hatzold, Karin; Mangwiro, Alexio; Bhattacharya, Gaurav; Lehe, Jonathan; Peter, Trevor

    2010-09-01

    Point-of-care (POC) CD4 testing was implemented at a stand-alone HIV voluntary testing and counseling centre in Harare, Zimbabwe. To validate the use of this new technology, paired blood samples were collected from 165 patients either by a nurse or a laboratory technician and tested using POC and conventional laboratory CD4 machines. Finger prick (capillary) blood was collected directly into the PIMA POC CD4 Analyzer cartridges and tested immediately, whereas venous blood collected into evacuated tubes was used for CD4 enumeration on a Becton Dickinson FACSCalibur. There was no significant difference in mean absolute CD4 counts between the POC PIMA and Becton Dickinson FACSCalibur platforms (+7.6 cells/microL; P = 0.72). Additionally, there was no significant difference in CD4 counts between the platforms when run by either a nurse (+18.0 cells/microL; P = 0.49), or a laboratory technicians (-3.1 cells/microL; P = 0.93). This study demonstrates that POC CD4 testing can be conducted in a voluntary testing and counseling setting for staging HIV-positive clients. Both nurses and laboratory technicians performed the test accurately, thereby increasing the human resources available for POC CD4 testing. By producing same-day results, POC CD4 facilitates immediate decision-making, patient management and referral and may help improve patient care and retention. POC CD4 may also alleviate testing burdens at traditional central CD4 laboratories, hence improving test access in both rural and urban environments.

  13. Diagnosing dengue at the point-of-care: utility of a rapid combined diagnostic kit in Singapore.

    Science.gov (United States)

    Gan, Victor C; Tan, Li-Kiang; Lye, David C; Pok, Kwoon-Yong; Mok, Shi-Qi; Chua, Rachel Choon-Rong; Leo, Yee-Sin; Ng, Lee-Ching

    2014-01-01

    WHO recommendations for dengue diagnosis require laboratory facilities. Antibody-based rapid diagnostic tests (RDTs) have performed poorly, and clinical diagnosis remains the mainstay in dengue-endemic countries. We evaluated a combination antigen-antibody RDT for point-of-care testing in a high-prevalence setting. In this prospective cohort study, adults were enrolled from a tertiary infectious disease centre for evaluation of undifferentiated febrile illness from October 2011 to May 2012. SD Bioline Dengue Duo was evaluated at point-of-care against a WHO-based reference standard of viral isolation, RT-PCR, NS1-, IgM-, and IgG-ELISA. 246 adults were enrolled (median age 34 years, range 18-69), of which 197 could be confirmed definitively as either dengue or non-dengue. DENV-2 was the predominant serotype (79.5%) and the ratio of primary to secondary cases was 1∶1.1. There were no test failures and minimal interobserver variation with a Fleiss' kappa of 0.983 (95% CI 0.827-1.00). Overall sensitivity and specificity were 93.9% (95% CI 88.8-96.8%) and 92.0% (95% CI 81.2-96.9%) respectively. Using WHO clinical criteria alone for diagnosis had similar sensitivities (95.9%, 95% CI 91.4-98.1%) and lower specificities (20.0%, 95% CI 11.2-33.0%). No significant difference in performance was found when testing early versus late presenters, primary versus secondary cases, or DENV-1 versus DENV-2 infections. The use of a combination RDT fulfills WHO ASSURED criteria for point-of-care testing and can enhance dengue diagnosis in an endemic setting. This has the potential to markedly improve clinical management of dengue in the field.

  14. Diagnosing dengue at the point-of-care: utility of a rapid combined diagnostic kit in Singapore.

    Directory of Open Access Journals (Sweden)

    Victor C Gan

    Full Text Available WHO recommendations for dengue diagnosis require laboratory facilities. Antibody-based rapid diagnostic tests (RDTs have performed poorly, and clinical diagnosis remains the mainstay in dengue-endemic countries. We evaluated a combination antigen-antibody RDT for point-of-care testing in a high-prevalence setting. In this prospective cohort study, adults were enrolled from a tertiary infectious disease centre for evaluation of undifferentiated febrile illness from October 2011 to May 2012. SD Bioline Dengue Duo was evaluated at point-of-care against a WHO-based reference standard of viral isolation, RT-PCR, NS1-, IgM-, and IgG-ELISA. 246 adults were enrolled (median age 34 years, range 18-69, of which 197 could be confirmed definitively as either dengue or non-dengue. DENV-2 was the predominant serotype (79.5% and the ratio of primary to secondary cases was 1∶1.1. There were no test failures and minimal interobserver variation with a Fleiss' kappa of 0.983 (95% CI 0.827-1.00. Overall sensitivity and specificity were 93.9% (95% CI 88.8-96.8% and 92.0% (95% CI 81.2-96.9% respectively. Using WHO clinical criteria alone for diagnosis had similar sensitivities (95.9%, 95% CI 91.4-98.1% and lower specificities (20.0%, 95% CI 11.2-33.0%. No significant difference in performance was found when testing early versus late presenters, primary versus secondary cases, or DENV-1 versus DENV-2 infections. The use of a combination RDT fulfills WHO ASSURED criteria for point-of-care testing and can enhance dengue diagnosis in an endemic setting. This has the potential to markedly improve clinical management of dengue in the field.

  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. Single-use paper-based hydrogen fuel cells for point-of-care diagnostic applications

    Science.gov (United States)

    Esquivel, J. P.; Buser, J. R.; Lim, C. W.; Domínguez, C.; Rojas, S.; Yager, P.; Sabaté, N.

    2017-02-01

    This work demonstrates a stand-alone power source that integrates a paper-based hydrogen fuel cell with a customized chemical heater that produces hydrogen in-situ upon the addition of a liquid. The presented approach operates by capillary action and takes advantage of the hydrogen released as a by-product of an exothermic reaction used in point-of-care diagnostics. The paper-based fuel cell produces a maximum power of 25.8 mW (103.2 mW cm-2), which is suitable for powering a diversity of electrical devices such as commercially available digital pregnancy tests and glucometers. While device shape and dimensions can be customized, here it is shown that the fuel cell can be designed in a compact form factor and footprint comparable to a lateral flow test while providing a remarkable power output. This approach holds great promise for powering portable diagnostics, as the generated electric power could enable device functionalities required for advanced assays, such as device timing, actuation, and signal quantification. Part of the same liquid sample that is to be analyzed (urine, saliva, water, etc) could be used to trigger the hydrogen generation and start the fuel cell operation.

  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. Plastic-Chip-Based Magnetophoretic Immunoassay for Point-of-Care Diagnosis of Tuberculosis.

    Science.gov (United States)

    Kim, Jeonghyo; Jang, Minji; Lee, Kyoung G; Lee, Kil-Soo; Lee, Seok Jae; Ro, Kyung-Won; Kang, In Sung; Jeong, Byung Do; Park, Tae Jung; Kim, Hwa-Jung; Lee, Jaebeom

    2016-09-14

    Tuberculosis (TB) remains a relevant infectious disease in the 21st century, and its extermination is still far from being attained. Due to the extreme infectivity of incipient TB patients, a rapid sensing system for proficient point-of-care (POC) diagnostics is required. In our study, a plastic-chip-based magnetophoretic immunoassay (pcMPI) is introduced using magnetic and gold nanoparticles (NPs) modified with Mycobacterium tuberculosis (MTB) antibodies. This pcMPI offers an ultrasensitive limit of detection (LOD) of 1.8 pg·ml(-1) for the detection of CFP-10, an MTB-secreted antigen, as a potential TB biomarker with high specificity. In addition, by combining the plastic chip with an automated spectrophotometer setup, advantages include ease of operation, rapid time to results (1 h), and cost-effectiveness. Furthermore, the pcMPI results using clinical sputum culture filtrate samples are competitively compared with and integrated with clinical data collected from conventional tools such as the acid-fast bacilli (AFB) test, mycobacteria growth indicator tube (MGIT), polymerase chain reaction (PCR), and physiological results. CFP-10 concentrations were consistently higher in patients diagnosed with MTB infection than those seen in patients infected with nontuberculosis mycobacteria (NTM) (P < 0.05), and this novel test can distinguish MTB and NTM while MGIT cannot. All these results indicate that this pcMPI has the potential to become a new commercial TB diagnostic POC platform in view of its sensitivity, portability, and affordability.

  19. What Are Anticoagulants and Antiplatelet Agents?

    Science.gov (United States)

    ... by heart Treatments + Tests What Are Anticoagulants and Antiplatelet Agents? Anticoagulants and antiplatelet agents are medicines that reduce blood clotting in an artery, a vein or the heart. Blood clots can block the ...

  20. Point of care investigations in pediatric care to improve health care in rural areas.

    Science.gov (United States)

    Walia, Kamini

    2013-07-01

    The good quality laboratory services in developing countries are often limited to major urban centers. As a result, many commercially available high-quality diagnostic tests for infectious diseases are neither accessible nor affordable to patients in the rural areas. Health facilities in rural areas are compromised and this limits the usability and performance of the best medical diagnostic technologies in rural areas as they are designed for air-conditioned laboratories, refrigerated storage of chemicals, a constant supply of calibrators and reagents, stable electrical power, highly trained personnel and rapid transportation of samples. The advent of new technologies have allowed miniaturization and integration of complex functions, which has made it possible for sophisticated diagnostic tools to move out of the developed-world laboratory in the form of a "point of care"(POC) tests. Many diagnostic tests are being developed using these platforms. However, the challenge is to develop diagnostics which are inexpensive, rugged and well suited to the medical and social contexts of the developing world and do not compromise on accuracy and reliability. The already available POC tests which are reliable and affordable, like for HIV infection, malaria, syphilis, and some neglected tropical diseases, and POC tests being developed for other diseases if correctly used and effectively regulated after rigorous evaluation, have the potential to make a difference in clinical management and improve surveillance. In order to use these tests effectively they would need to be supported by technically competent manpower, availability of good-quality reagents, and healthcare providers who value and are able to interpret laboratory results to guide treatment; and a system for timely communication between the laboratory and the healthcare provider. Strengthening the laboratories at the rural level can enable utilization of these diagnostics for improving the diagnosis and management of

  1. Point-of-care diagnostics: an advancing sector with nontechnical issues.

    Science.gov (United States)

    Huckle, David

    2008-11-01

    The particular reasons for the relative lack in development of point-of-care (PoC) diagnostics in a business context were discussed in our sister journal, Expert Review of Medical Devices, over 2 years ago. At that time, it could be seen that the concept of PoC testing was being revisited for at least the fifth time in the last 20 years. There had been important advances in technology but, with changes in global healthcare structures and funding, the overall in vitro diagnostics sector has had sluggish growth. Only molecular diagnostics and PoC testing are growing strongly. PoC testing is now a quarter of the total global in vitro diagnostics market, but largely due to use in diabetes monitoring. An increased focus on areas other than glucose self-testing has created a disturbance in the market. An implementation issue from this disturbance is that of control between central laboratories and the proposed sites for PoC testing. Evidence is presented to show that the first step is likely to be increased use in clinics and outpatient facilities closely linked with the laboratory. The aim will be to control the quality of the test, maintenance of equipment and provide support for the clinician in interpretation. The major problem for effective PoC implementation will be the significant changes to patient pathways that are required. The changes will benefit the patient and clinical outcomes but will require healthcare professionals to change their work patterns. This will be an uphill task!

  2. Accuracy of Handheld Point-of-Care Fingertip Lactate Measurement in the Emergency Department

    Directory of Open Access Journals (Sweden)

    Gaieski, David G

    2013-02-01

    Full Text Available Introduction: Early recognition of elevated lactate levels in sepsis may hasten the detection of those patients eligible for aggressive resuscitation. Point-of-care (POC testing is now increasingly available for use in the emergency department (ED. We examined the accuracy and time-saving effect of a handheld POC device for the measurement of fingertip and whole blood lactate as compared with reference laboratory testing in critically ill ED patients.Methods: A convenience sample of adult ED patients receiving serum lactate testing was prospectively enrolled at an urban, tertiary care US hospital. Consenting patients underwent fingertip POC lactate measurement with a portable device and simultaneous whole blood sampling for analysis by both the POC device and standard laboratory analyzer (‘‘reference method’’. Lactate measurements were compared by intraclass correlation (ICC and Bland and Altman plots. Differences in time to test result were compared by paired t test.Results: Twenty-four patients, 19 (79% with sepsis and 21 (88% with lactate levels below 4 mmol/L, were included from April 2005 to May 2005. Fingertip POC and whole blood POC lactate measurements each correlated tightly with the reference method (ICC ¼ 0.90 and ICC ¼ 0.92, respectively. Mean time between obtaining fingertip lactate samples and whole blood reference lactate samples was 8 6 13 minutes. Mean time between obtaining POC and reference laboratory lactate results was 65 minutes (95% confidence interval, 30–103.Conclusion: Fingertip POC lactate measurement is an accurate method to determine lactate levels in infected ED patients with normal or modestly elevated lactate values and significantly decreases time to test results. These findings should be verified in a larger, more critically ill, ED population. [West J Emerg Med. 2013;14(1:58-62.

  3. Determining the feline immunodeficiency virus (FIV) status of FIV-vaccinated cats using point-of-care antibody kits.

    Science.gov (United States)

    Westman, Mark E; Malik, Richard; Hall, Evelyn; Sheehy, Paul A; Norris, Jacqueline M

    2015-10-01

    This study challenges the commonly held view that the feline immunodeficiency virus (FIV) infection status of FIV-vaccinated cats cannot be determined using point-of-care antibody test kits due to indistinguishable antibody production in FIV-vaccinated and naturally FIV-infected cats. The performance of three commercially available point-of-care antibody test kits was compared in a mixed population of FIV-vaccinated (n=119) and FIV-unvaccinated (n=239) cats in Australia. FIV infection status was assigned by considering the results of all antibody kits in concert with results from a commercially available PCR assay (FIV RealPCR™). Two lateral flow immunochromatography test kits (Witness FeLV/FIV; Anigen Rapid FIV/FeLV) had excellent overall sensitivity (100%; 100%) and specificity (98%; 100%) and could discern the true FIV infection status of cats, irrespective of FIV vaccination history. The lateral flow ELISA test kit (SNAP FIV/FeLV Combo) could not determine if antibodies detected were due to previous FIV vaccination, natural FIV infection, or both. The sensitivity and specificity of FIV RealPCR™ for detection of viral and proviral nucleic acid was 92% and 99%, respectively. These results will potentially change the way veterinary practitioners screen for FIV in jurisdictions where FIV vaccination is practiced, especially in shelter scenarios where the feasibility of mass screening is impacted by the cost of testing.

  4. Agarose-based microfluidic device for point-of-care concentration and detection of pathogen.

    Science.gov (United States)

    Li, Yiwei; Yan, Xinghua; Feng, Xiaojun; Wang, Jie; Du, Wei; Wang, Yachao; Chen, Peng; Xiong, Liang; Liu, Bi-Feng

    2014-11-04

    Preconcentration of pathogens from patient samples represents a great challenge in point-of-care (POC) diagnostics. Here, a low-cost, rapid, and portable agarose-based microfluidic device was developed to concentrate biological fluid from micro- to picoliter volume. The microfluidic concentrator consisted of a glass slide simply covered by an agarose layer with a binary tree-shaped microchannel, in which pathogens could be concentrated at the end of the microchannel due to the capillary effect and the strong water permeability of the agarose gel. The fluorescent Escherichia coli strain OP50 was used to demonstrate the capacity of the agarose-based device. Results showed that 90% recovery efficiency could be achieved with a million-fold volume reduction from 400 μL to 400 pL. For concentration of 1 × 10(3) cells mL(-1) bacteria, approximately ten million-fold enrichment in cell density was realized with volume reduction from 100 μL to 1.6 pL. Urine and blood plasma samples were further tested to validate the developed method. In conjugation with fluorescence immunoassay, we successfully applied the method to the concentration and detection of infectious Staphylococcus aureus in clinics. The agarose-based microfluidic concentrator provided an efficient approach for POC detection of pathogens.

  5. Surface enhanced Raman spectroscopy as a point-of-care diagnostic for infection in wound effluent

    Science.gov (United States)

    Ghebremedhin, Meron; Yesupriya, Shubha; Crane, Nicole J.

    2016-03-01

    In military medicine, one of the challenges in dealing with large combat-related injuries is the prevalence of bacterial infection, including multidrug resistant organisms. This can prolong the wound healing process and lead to wound dehiscence. Current methods of identifying bacterial infection rely on culturing microbes from patient material and performing biochemical tests, which together can take 2-3 days to complete. Surface Enhanced Raman Spectroscopy (SERS) is a powerful vibrational spectroscopy technique that allows for highly sensitive structural detection of analytes adsorbed onto specially prepared metal surfaces. In the past, we have been able to discriminate between bacterial isolates grown on solid culture media using standard Raman spectroscopic methods. Here, SERS is utilized to assess the presence of bacteria in wound effluent samples taken directly from patients. To our knowledge, this is the first attempt for the application of SERS directly to wound effluent. The utilization of SERS as a point-of-care diagnostic tool would enable physicians to determine course of treatment and drug administration in a matter of hours.

  6. Identifying and Overcoming Obstacles to Point-of-Care Data Collection for Eye Care Professionals

    Science.gov (United States)

    Lobach, David F.; Silvey, Garry M.; Macri, Jennifer M.; Hunt, Megan; Kacmaz, Roje O.; Lee, Paul P.

    2005-01-01

    Supporting data entry by clinicians is considered one of the greatest challenges in implementing electronic health records. In this paper we describe a formative evaluation study using three different methodologies through which we identified obstacles to point-of-care data entry for eye care and then used the formative process to develop and test solutions to overcome these obstacles. The greatest obstacles were supporting free text annotation of clinical observations and accommodating the creation of detailed diagrams in multiple colors. To support free text entry, we arrived at an approach that captures an image of a free text note and associates this image with related data elements in an encounter note. The detailed diagrams included a color pallet that allowed changing pen color with a single stroke and also captured the diagrams as an image associated with related data elements. During observed sessions with simulated patients, these approaches satisfied the clinicians’ documentation needs by capturing the full range of clinical complexity that arises in practice. PMID:16779083

  7. Detection of autoantibodies in a point-of-care rheumatology setting.

    Science.gov (United States)

    Konstantinov, Konstantin N; Tzamaloukas, Antonios; Rubin, Robert L

    2013-08-01

    Autoimmune rheumatic diseases are common and confront society with serious medical, social, and financial burdens imposed by their debilitating nature. Many autoimmune diseases are associated with a particular set of autoantibodies, which have emerged as highly useful to define and classify disease, predict flares, or monitor efficacy of therapy. However, current practice for monitoring autoantibodies is protracted, labor-intensive, and expensive. This review provides an overview on the value of point-of-care (POC) biosensor technology in the diagnosis and management of patients with autoimmune rheumatic diseases. Real-time measurement of autoantibodies will clearly benefit the rheumatology practice in emergency and urgent care settings, where definitive diagnosis is essential for initiation of correct critical care therapy. Immediate serological information in clinic will provide considerable value for long-term patient care and an opportunity for an instant, result-deduced therapeutic action, avoiding delays and improving compliance, especially in field-based and remote areas. We describe the particular autoantibodies that are useful disease and activity markers and would, therefore, be attractive to POC applications. Already existing biosensors and platforms that show promise for autoantibody testing are summarized and comparatively evaluated. As POC assessment is gaining momentum in several areas of patient care, we propose that rheumatology is poised to benefit from this innovative and affordable technology.

  8. Self-powered integrated microfluidic point-of-care low-cost enabling (SIMPLE) chip

    Science.gov (United States)

    Yeh, Erh-Chia; Fu, Chi-Cheng; Hu, Lucy; Thakur, Rohan; Feng, Jeffrey; Lee, Luke P.

    2017-01-01

    Portable, low-cost, and quantitative nucleic acid detection is desirable for point-of-care diagnostics; however, current polymerase chain reaction testing often requires time-consuming multiple steps and costly equipment. We report an integrated microfluidic diagnostic device capable of on-site quantitative nucleic acid detection directly from the blood without separate sample preparation steps. First, we prepatterned the amplification initiator [magnesium acetate (MgOAc)] on the chip to enable digital nucleic acid amplification. Second, a simplified sample preparation step is demonstrated, where the plasma is separated autonomously into 224 microwells (100 nl per well) without any hemolysis. Furthermore, self-powered microfluidic pumping without any external pumps, controllers, or power sources is accomplished by an integrated vacuum battery on the chip. This simple chip allows rapid quantitative digital nucleic acid detection directly from human blood samples (10 to 105 copies of methicillin-resistant Staphylococcus aureus DNA per microliter, ~30 min, via isothermal recombinase polymerase amplification). These autonomous, portable, lab-on-chip technologies provide promising foundations for future low-cost molecular diagnostic assays. PMID:28345028

  9. Paper-based sample-to-answer molecular diagnostic platform for point-of-care diagnostics.

    Science.gov (United States)

    Choi, Jane Ru; Tang, Ruihua; Wang, ShuQi; Wan Abas, Wan Abu Bakar; Pingguan-Murphy, Belinda; Xu, Feng

    2015-12-15

    Nucleic acid testing (NAT), as a molecular diagnostic technique, including nucleic acid extraction, amplification and detection, plays a fundamental role in medical diagnosis for timely medical treatment. However, current NAT technologies require relatively high-end instrumentation, skilled personnel, and are time-consuming. These drawbacks mean conventional NAT becomes impractical in many resource-limited disease-endemic settings, leading to an urgent need to develop a fast and portable NAT diagnostic tool. Paper-based devices are typically robust, cost-effective and user-friendly, holding a great potential for NAT at the point of care. In view of the escalating demand for the low cost diagnostic devices, we highlight the beneficial use of paper as a platform for NAT, the current state of its development, and the existing challenges preventing its widespread use. We suggest a strategy involving integrating all three steps of NAT into one single paper-based sample-to-answer diagnostic device for rapid medical diagnostics in the near future.

  10. 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.

  11. The SmartBioPhone, a point of care vision under development through two European projects: OPTOLABCARD and LABONFOIL.

    Science.gov (United States)

    Ruano-López, Jesus M; Agirregabiria, Maria; Olabarria, Garbiñe; Verdoy, Dolores; Bang, Dang D; Bu, Minqiang; Wolff, Anders; Voigt, Anja; Dziuban, Jan A; Walczak, Rafał; Berganzo, Javier

    2009-06-07

    This paper describes how sixteen partners from eight different countries across Europe are working together in two EU projects focused on the development of a point of care system. This system uses disposable Lab on a Chips (LOCs) that carry out the complete assay from sample preparation to result interpretation of raw samples. The LOC is either embedded in a flexible motherboard with the form of a smartcard (Labcard) or in a Skinpatch. The first project, OPTOLABCARD, extended and tested the use of a thick photoresit (SU-8) as a structural material to manufacture LOCs by lamination. This project produced several examples where SU-8 microfluidic circuitry revealed itself as a viable material for several applications, such as the integration on chip of a Polymerase Chain Reaction (PCR) that includes sample concentration, PCR amplification and optical detection of Salmonella spp. using clinical samples. The ongoing project, LABONFOIL, is using two results of OPTOLABCARD: the sample concentration method and the capability to fabricate flexible and ultra thin LOCs based on sheets instead of wafers. This rupture from the limited and expensive wafer surface heritage allows the development of a platform where 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 interface (a smartphone), creating a new instrument namely "The SmartBioPhone". All standard smartphone capabilities will be at the disposal of the point of care instrument by a simple click. In order to guarantee the future mass production of these LOCs, the project will develop a large dry film equipment where LOCs will be fabricated at a low cost.

  12. 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.

  13. Diagnosis of a Strangulated Laparoscopic Incisional Hernia with Point-of-Care Ultrasonography

    Directory of Open Access Journals (Sweden)

    Argintaru, Niran

    2015-05-01

    Full Text Available The use of point-of-care ultrasound for the diagnosis of bowel obstructions and hernias is becoming increasingly common in the emergency department (ED. Using a relatively rare case of an incisional port hernia, we demonstrate the ultrasound findings of a strangulated hernia causing a partial small bowel obstruction. A 46-year-old female presented four days following a laparoscopic surgery complaining of abdominal pain, nausea and lack of bowel movements. There was a palpable mass in the left lower quadrant under the 12mm trocar port incision. ED point-of-care ultrasound revealed herniated akinetic loops of bowel through her laparoscopy incision. This is the first case report to describe the use of point-of-care ultrasound for the diagnosis of a strangulated incisional port hernia at the bedside. [West J Emerg Med. 2015;16(3:450–452.

  14. The future point-of-care detection of disease and its data capture and handling.

    Science.gov (United States)

    Lopez-Barbosa, Natalia; Gamarra, Jorge D; Osma, Johann F

    2016-04-01

    Point-of-care detection is a widely studied area that attracts effort and interest from a large number of fields and companies. However, there is also increased interest from the general public in this type of device, which has driven enormous changes in the design and conception of these developments and the way data is handled. Therefore, future point-of-care detection has to include communication with front-end technology, such as smartphones and networks, automation of manufacture, and the incorporation of concepts like the Internet of Things (IoT) and cloud computing. Three key examples, based on different sensing technology, are analyzed in detail on the basis of these items to highlight a route for the future design and development of point-of-care detection devices and their data capture and handling.

  15. Operationalizing Semantic Medline for meeting the information needs at point of care.

    Science.gov (United States)

    Rastegar-Mojarad, Majid; Li, Dingcheng; Liu, Hongfang

    2015-01-01

    Scientific literature is one of the popular resources for providing decision support at point of care. It is highly desirable to bring the most relevant literature to support the evidence-based clinical decision making process. Motivated by the recent advance in semantically enhanced information retrieval, we have developed a system, which aims to bring semantically enriched literature, Semantic Medline, to meet the information needs at point of care. This study reports our work towards operationalizing the system for real time use. We demonstrate that the migration of a relational database implementation to a NoSQL (Not only SQL) implementation significantly improves the performance and makes the use of Semantic Medline at point of care decision support possible.

  16. Overview of point-of-care abdominal ultrasound in emergency and critical care.

    Science.gov (United States)

    Kameda, Toru; Taniguchi, Nobuyuki

    2016-01-01

    Point-of-care abdominal ultrasound (US), which is performed by clinicians at bedside, is increasingly being used to evaluate clinical manifestations, to facilitate accurate diagnoses, and to assist procedures in emergency and critical care. Methods for the assessment of acute abdominal pain with point-of-care US must be developed according to accumulated evidence in each abdominal region. To detect hemoperitoneum, the methodology of a focused assessment with sonography for a trauma examination may also be an option in non-trauma patients. For the assessment of systemic hypoperfusion and renal dysfunction, point-of-care renal Doppler US may be an option. Utilization of point-of-care US is also considered in order to detect abdominal and pelvic lesions. It is particularly useful for the detection of gallstones and the diagnosis of acute cholecystitis. Point-of-case US is justified as the initial imaging modality for the diagnosis of ureterolithiasis and the assessment of pyelonephritis. It can be used with great accuracy to detect the presence of abdominal aortic aneurysm in symptomatic patients. It may also be useful for the diagnoses of digestive tract diseases such as appendicitis, small bowel obstruction, and gastrointestinal perforation. Additionally, point-of-care US can be a modality for assisting procedures. Paracentesis under US guidance has been shown to improve patient care. US appears to be a potential modality to verify the placement of the gastric tube. The estimation of the amount of urine with bladder US can lead to an increased success rate in small children. US-guided catheterization with transrectal pressure appears to be useful in some male patients in whom standard urethral catheterization is difficult. Although a greater accumulation of evidences is needed in some fields, point-of-care abdominal US is a promising modality to improve patient care in emergency and critical care settings.

  17. A Multiplexed Diagnostic Platform for Point-of-Care Pathogen Detection

    Energy Technology Data Exchange (ETDEWEB)

    Regan, J F; Letant, S E; Adams, K L; Mahnke, R C; Nguyen, N T; Dzenitis, J M; Hindson, B J; Hadley, D R; Makarewicz, T J; Henderer, B D; Breneman, J W; Tammero, L F; Ortiz, J I; Derlet, R W; Cohen, S; Colston, W W; McBride, M T; Birch, J M

    2008-02-04

    We developed an automated point-of-care diagnostic instrument that is capable of analyzing nasal swab samples for the presence of respiratory diseases. This robust instrument, called FluIDx, performs autonomous multiplexed RT-PCR reactions that are analyzed by microsphere xMAP technology. We evaluated the performance of FluIDx, in comparison rapid tests specific for influenza and respiratory syncytial virus, in a clinical study performed at the UC Davis Medical Center. The clinical study included samples positive for RSV (n = 71), influenza A (n = 16), influenza B (n = 4), adenovirus (n = 5), parainfluenza virus (n = 2), and 44 negative samples, according to a composite reference method. FluIDx and the rapid tests detected 85.9% and 62.0% of the RSV positive samples, respectively. Similar sensitivities were recorded for the influenza B samples; whereas the influenza A samples were poorly detected, likely due to the utilization of an influenza A signature that did not accurately match currently circulating influenza A strains. Data for all pathogens were compiled and indicate that FluIDx is more sensitive than the rapid tests, detecting 74.2% (95% C.I. of 64.7-81.9%) of the positive samples in comparison to 53.6% (95% C.I. of 43.7-63.2%) for the rapid tests. The higher sensitivity of FluIDx was partially offset by a lower specificity, 77.3% versus 100.0%. Overall, these data suggest automated flow-through PCR-based instruments that perform multiplexed assays can successfully screen clinical samples for infectious diseases.

  18. Overcoming Obstacles to Collecting Narrative Data from Eye Care Professionals at the Point-of-Care

    Science.gov (United States)

    Silvey, Garry M.; Lobach, David F.; Macri, Jennifer M.; Hunt, Megan; Kacmaz, Roje O.; Lee, Paul P.

    2005-01-01

    Capturing the nuances of clinical observations in an electronic format has been a major challenge in implementing electronic health records. In a formative evaluation study using three different methodologies, we identified that the greatest obstacle to point-of-care data entry for eye care was supporting free text annotation of clinical observations. To overcome this obstacle, we developed an approach that captures an image of a free text entry and associates this image with related data elements in an encounter note. Through simulated patient studies, we observed that this approach successfully supported complex documentation at the point of care by clinicians. PMID:16779403

  19. Miniaturized Protein Microarray with Internal Calibration as Point-of-Care Device for Diagnosis of Neonatal Sepsis

    Directory of Open Access Journals (Sweden)

    Hedvig Toth-Székély

    2012-02-01

    Full Text Available Neonatal sepsis is still a leading cause of death among newborns. Therefore a protein-microarray for point-of-care testing that simultaneously quantifies the sepsis associated serum proteins IL-6, IL-8, IL-10, TNF alpha, S-100, PCT, E-Selectin, CRP and Neopterin has been developed. The chip works with only a 4 µL patient serum sample and hence minimizes excessive blood withdrawal from newborns. The 4 µL patient samples are diluted with 36 µL assay buffer and distributed to four slides for repetitive measurements. Streptavidin coated magnetic particles that act as distinct stirring detection components are added, not only to stir the sample, but also to detect antibody antigen binding events. We demonstrate that the test is complete within 2.5 h using a single step assay. S-100 conjugated to BSA is spotted in increasing concentrations to create an internal calibration. The presented low volume protein-chip fulfills the requirements of point-of-care testing for accurate and repeatable (CV < 14% quantification of serum proteins for the diagnosis of neonatal sepsis.

  20. Evaluation of PIMA Point-of-care CD4 Analyzer in Yunnan, China

    Directory of Open Access Journals (Sweden)

    Jun Liang

    2015-01-01

    Full Text Available Background: CD4 count is used to determine antiretroviral therapy (ART eligibility. In China, flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas. In an attempt to address this issue, we conducted a study to validate the performance of Alere PIMA point-of-care CD4 analyzer. Methods: Venous and finger-prick blood specimens were collected from HIV-positive participants from two voluntary counseling and testing sites in Yunnan Province. Both venous and finger-prick blood specimens were tested with the PIMA analyzer. Venous blood specimens tested with the Becton Dickinson FACSCalibur were used as a reference. Results: Venous specimens from 396 and finger-prick specimens from 387 persons were available for analysis. CD4 counts by PIMA correlated well with those from FACSCalibur with an R2 of 0.91 for venous blood and 0.81 for finger-prick blood. Compared to FACSCalibur, the PIMA analyzer yielded lower counts with a mean bias of − 47.0 cells/μl (limit of agreement, [LOA]: −204-110 cells/μl for venous blood and −71.0 cells/μl (LOA: −295-153 cells/μl for finger-prick blood. For a CD4 threshold of 350 cells/μl, the positive predictive value (PPV of PIMA was 84.2% and 75.7% and the negative predictive value (NPV was 97.6% and 95.8% for venous and finger-prick blood, respectively. For an ART threshold of 500 cells/μl, the corresponding PPV was 90.3% and 84.0% and NPV was 94.3% and 93.4%, respectively. Conclusions: CD4 counting using venous blood with PIMA analyzers is a feasible alternative to a large flow cytometer to determine ART eligibility.

  1. Web-based teaching in point-of-care ultrasound: an alternative to the classroom?

    Directory of Open Access Journals (Sweden)

    Kang TL

    2015-03-01

    Full Text Available Tarina Lee Kang,1 Kristin Berona,1 Marsha A Elkhunovich,2 Roberto Medero-Colon,1 Dina Seif,1 Mikael L Chilstrom,1 Tom Mailhot1 1Department of Emergency Medicine, Los Angeles County and the University of Southern California (LAC + USC Medical Center, 2Department of Emergency Medicine, Children’s Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA Objectives: To evaluate two educational methods for point-of-care ultrasound (POC US in order to: 1 determine participant test performance and attitudes in using POC US and 2 compare cost and preparation time to run the courses.Methods: This was a pilot study conducted at a county teaching hospital. Subjects were assigned to participate in either a large group course with live classroom lectures (Group A or a group asked to watch 4.5 hours of online prerecorded lectures (Group B. Both groups participated in small-group hands-on training after watching the lectures. Both groups took a pre- and post-course exam, and completed course surveys. Cost and time spent running the courses were also compared.Results: Forty-seven physicians participated in the study. The pre-test and post-test scores between the two groups did not differ significantly. Of those with prior ultrasound experience, the majority of both groups preferred to continue classroom-based teaching for future courses. Interestingly, in the groups who had no ultrasound experience prior to their course participation, there was a higher percentage who preferred web-based teaching. Lastly, Group B was shown to have the potential to take less preparatory time when compared to Group A.Conclusion: A web-based curriculum in POC US appears to be a promising and potentially time saving alternative to live classroom lectures and seems to offer similar educational benefits for the postgraduate learner. Keywords: attending education, classroom-based teaching, hands-on training

  2. Nano-enabled paper humidity sensor for mobile based point-of-care lung function monitoring.

    Science.gov (United States)

    Bhattacharjee, Mitradip; Nemade, Harshal B; Bandyopadhyay, Dipankar

    2017-03-22

    The frequency of breathing and peak flow rate of exhaled air are necessary parameters to detect chronic obstructive pulmonary diseases (COPDs) such as asthma, bronchitis, or pneumonia. We developed a lung function monitoring point-of-care-testing device (LFM-POCT) consisting of mouthpiece, paper-based humidity sensor, micro-heater, and real-time monitoring unit. Fabrication of a mouthpiece of optimal length ensured that the exhaled air was focused on the humidity-sensor. The resistive relative humidity sensor was developed using a filter paper coated with nanoparticles, which could easily follow the frequency and peak flow rate of the human breathing. Adsorption followed by condensation of the water molecules of the humid air on the paper-sensor during the forced exhalation reduced the electrical resistance of the sensor, which was converted to an electrical signal for sensing. A micro-heater composed of a copper-coil embedded in a polymer matrix helped in maintaining an optimal temperature on the sensor surface. Thus, water condensed on the sensor surface only during forcible breathing and the sensor recovered rapidly after the exhalation was complete by rapid desorption of water molecules from the sensor surface. Two types of real-time monitoring units were integrated into the device based on light emitting diodes (LEDs) and smart phones. The LED based unit displayed the diseased, critical, and fit conditions of the lungs by flashing LEDs of different colors. In comparison, for the mobile based monitoring unit, an application was developed employing an open source software, which established a wireless connectivity with the LFM-POCT device to perform the tests.

  3. Towards detection and diagnosis of Ebola virus disease at point-of-care.

    Science.gov (United States)

    Kaushik, Ajeet; Tiwari, Sneham; Dev Jayant, Rahul; Marty, Aileen; Nair, Madhavan

    2016-01-15

    Ebola outbreak-2014 (mainly Zaire strain related Ebola virus) has been declared most widely spread deadly persistent epidemic due to unavailability of rapid diagnostic, detection, and therapeutics. Ebola virus disease (EVD), a severe viral hemorrhagic fever syndrome caused by Ebola virus (EBOV) is transmitted by direct contact with the body fluids of infected person and objects contaminated with virus or infected animals. World Health Organization (WHO) has declared EVD epidemic as public health emergency of international concern with severe global economic burden. At fatal EBOV infection stage, patients usually die before the antibody response. Currently, rapid blood tests to diagnose EBOV infection include the antigen or antibodies capture using ELISA and RNA detection using RT/Q-PCR within 3-10 days after the onset of symptoms. Moreover, few nanotechnology-based colorimetric and paper-based immunoassay methods have been recently reported to detect Ebola virus. Unfortunately, these methods are limited to laboratory only. As state-of-the art (SoA) diagnostics time to confirm Ebola infection, varies from 6h to about 3 days, it causes delay in therapeutic approaches. Thus developing a cost-effective, rapid, sensitive, and selective sensor to detect EVD at point-of-care (POC) is certainly worth exploring to establish rapid diagnostics to decide therapeutics. This review highlights SoA of Ebola diagnostics and also a call to develop rapid, selective and sensitive POC detection of EBOV for global health care. We propose that adopting miniaturized electrochemical EBOV immunosensing can detect virus level at pM concentration within ∼40min compared to 3 days of ELISA test at nM levels.

  4. Optimal Spectral Regions For Laser Excited Fluorescence Diagnostics For Point Of Care Application

    Science.gov (United States)

    Vaitkuviene, A.; Gėgžna, V.; Varanius, D.; Vaitkus, J.

    2011-09-01

    The tissue fluorescence gives the response of light emitting molecule signature, and characterizes the cell composition and peculiarities of metabolism. Both are useful for the biomedical diagnostics, as reported in previous our and others works. The present work demonstrates the results of application of laser excited autofluorescence for diagnostics of pathology in genital tissues, and the feasibility for the bedside at "point of care—off lab" application. A portable device using the USB spectrophotometer, micro laser (355 nm Nd:YAG, 0,5 ns pulse, repetition rate 10 kHz, output power 15 mW), three channel optical fiber and computer with diagnostic program was designed and ready for clinical trial to be used for cytology and biopsy specimen on site diagnostics, and for the endoscopy/puncture procedures. The biopsy and cytology samples, as well as intervertebral disc specimen were evaluated by pathology experts and the fluorescence spectra were investigated in the fresh and preserved specimens. The spectra were recorded in the spectral range 350-900 nm. At the initial stage the Gaussian components of spectra were found and the Mann-Whitney test was used for the groups' differentiation and the spectral regions for optimal diagnostics purpose were found. Then a formal dividing of spectra in the components or the definite width bands, where the main difference of the different group spectra was observed, was used to compare these groups. The ROC analysis based diagnostic algorithms were created for medical prognosis. The positive prognostic values and negative prediction values were determined for cervical Liquid PAP smear supernatant sediment diagnosis of being Cervicitis and Norma versus CIN2+. In a case of intervertebral disc the analysis allows to get the additional information about the disc degeneration status. All these results demonstrated an efficiency of the proposed procedure and the designed device could be tested at the point-of-care site or for

  5. Hematological clozapine monitoring with a point-of-care device: A randomized cross-over trial

    DEFF Research Database (Denmark)

    Nielsen, Jimmi; Thode, Dorrit; Stenager, Elsebeth

    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...

  6. Hematological clozapine monitoring with a point-of-care device: A randomized cross-over trial

    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...

  7. Integrated Systems for Rapid Point of Care (PoC) Blood Cell Analysis

    NARCIS (Netherlands)

    Van Berkel, C.; Gwyer, J.D.; Deane, S.; Hollis, V.; Holloway, J.; Green, N.; Morgan, H.M.

    2011-01-01

    Counting the different subpopulations of cells in a fingerprick of human blood is important for a number of clinical Point of Care applications. It is a challenge to demonstrate the integration of sample preparation and detection techniques in a single platform. In this article we review the applica

  8. [The added value of information summaries supporting clinical decisions at the point-of-care.

    Science.gov (United States)

    Banzi, Rita; González-Lorenzo, Marien; Kwag, Koren Hyogene; Bonovas, Stefanos; Moja, Lorenzo

    2016-11-01

    Evidence-based healthcare requires the integration of the best research evidence with clinical expertise and patients' values. International publishers are developing evidence-based information services and resources designed to overcome the difficulties in retrieving, assessing and updating medical information as well as to facilitate a rapid access to valid clinical knowledge. Point-of-care information summaries are defined as web-based medical compendia that are specifically designed to deliver pre-digested, rapidly accessible, comprehensive, and periodically updated information to health care providers. Their validity must be assessed against marketing claims that they are evidence-based. We periodically evaluate the content development processes of several international point-of-care information summaries. The number of these products has increased along with their quality. The last analysis done in 2014 identified 26 products and found that three of them (Best Practice, Dynamed e Uptodate) scored the highest across all evaluated dimensions (volume, quality of the editorial process and evidence-based methodology). Point-of-care information summaries as stand-alone products or integrated with other systems, are gaining ground to support clinical decisions. The choice of one product over another depends both on the properties of the service and the preference of users. However, even the most innovative information system must rely on transparent and valid contents. Individuals and institutions should regularly assess the value of point-of-care summaries as their quality changes rapidly over time.

  9. Staying afloat in a sea of information: Point-of-care resources.

    Science.gov (United States)

    Andrews, Rebecca; Mehta, Neil; Maypole, Jack; Martin, Stephen A

    2017-03-01

    Physicians can use a variety of electronic resources at the point of care to help them make decisions about patient management. The authors address the need for these resources, characterize the elements of good resources, and compare several popular ones, ie, Clinical Evidence, Dynamed, Evidence Essentials, First Consult, Medscape, and UpToDate.

  10. Novel methods for point-of-care diagnosis of nerve agent exposure (Abstract)

    NARCIS (Netherlands)

    Noort, D.; Schans, M.J. van der; Fidder, A.; Verstappen, D.R.W.; Hulst, A.G.; Mars-Groenendijk, R.

    2012-01-01

    Methods to unequivocally and rapidly assess exposure to nerve agents are highly valuable from a military and security perspective. Within this framework we currently follow two different approaches towards rapid point-of-care diagnosis. Regarding the first approach we hypothesized that proteins in t

  11. 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.

  12. Does Radar Technology Support the Diagnosis of Pneumothorax? PneumoScan—A Diagnostic Point-of-Care Tool

    Directory of Open Access Journals (Sweden)

    T. Lindner

    2013-01-01

    Full Text Available Background. A nonrecognized pneumothorax (PTX may become a life-threatening tension PTX. A reliable point-of-care diagnostic tool could help in reduce this risk. For this purpose, we investigated the feasibility of the use of the PneumoScan, an innovative device based on micropower impulse radar (MIR. Patients and Methods. addition to a standard diagnostic protocol including clinical examination, chest X-ray (CXR, and computed tomography (CT, 24 consecutive patients with chest trauma underwent PneumoScan testing in the shock trauma room to exclude a PTX. Results. The application of the PneumoScan was simple, quick, and reliable without functional disorder. Clinical examination and CXR each revealed one and PneumoScan three out of altogether four PTXs (sensitivity 75%, specificity 100%, positive predictive value 100%, and negative predictive value 95%. The undetected PTX did not require intervention. Conclusion. The PneumoScan as a point-of-care device offers additional diagnostic value in patient management following chest trauma. Further studies with more patients have to be performed to evaluate the diagnostic accuracy of the device.

  13. Evolvable Smartphone-Based Platforms for Point-of-Care In-Vitro Diagnostics Applications.

    Science.gov (United States)

    Patou, François; AlZahra'a Alatraktchi, Fatima; Kjægaard, Claus; Dimaki, Maria; Madsen, Jan; Svendsen, Winnie E

    2016-09-03

    The association of smart mobile devices and lab-on-chip technologies offers unprecedented opportunities for the emergence of direct-to-consumer in vitro medical diagnostics applications. Despite their clear transformative potential, obstacles remain to the large-scale disruption and long-lasting success of these systems in the consumer market. For instance, the increasing level of complexity of instrumented lab-on-chip devices, coupled to the sporadic nature of point-of-care testing, threatens the viability of a business model mainly relying on disposable/consumable lab-on-chips. We argued recently that system evolvability, defined as the design characteristic that facilitates more manageable transitions between system generations via the modification of an inherited design, can help remedy these limitations. In this paper, we discuss how platform-based design can constitute a formal entry point to the design and implementation of evolvable smart device/lab-on-chip systems. We present both a hardware/software design framework and the implementation details of a platform prototype enabling at this stage the interfacing of several lab-on-chip variants relying on current- or impedance-based biosensors. Our findings suggest that several change-enabling mechanisms implemented in the higher abstraction software layers of the system can promote evolvability, together with the design of change-absorbing hardware/software interfaces. Our platform architecture is based on a mobile software application programming interface coupled to a modular hardware accessory. It allows the specification of lab-on-chip operation and post-analytic functions at the mobile software layer. We demonstrate its potential by operating a simple lab-on-chip to carry out the detection of dopamine using various electroanalytical methods.

  14. Evolvable Smartphone-Based Platforms for Point-of-Care In-Vitro Diagnostics Applications

    Directory of Open Access Journals (Sweden)

    François Patou

    2016-09-01

    Full Text Available The association of smart mobile devices and lab-on-chip technologies offers unprecedented opportunities for the emergence of direct-to-consumer in vitro medical diagnostics applications. Despite their clear transformative potential, obstacles remain to the large-scale disruption and long-lasting success of these systems in the consumer market. For instance, the increasing level of complexity of instrumented lab-on-chip devices, coupled to the sporadic nature of point-of-care testing, threatens the viability of a business model mainly relying on disposable/consumable lab-on-chips. We argued recently that system evolvability, defined as the design characteristic that facilitates more manageable transitions between system generations via the modification of an inherited design, can help remedy these limitations. In this paper, we discuss how platform-based design can constitute a formal entry point to the design and implementation of evolvable smart device/lab-on-chip systems. We present both a hardware/software design framework and the implementation details of a platform prototype enabling at this stage the interfacing of several lab-on-chip variants relying on current- or impedance-based biosensors. Our findings suggest that several change-enabling mechanisms implemented in the higher abstraction software layers of the system can promote evolvability, together with the design of change-absorbing hardware/software interfaces. Our platform architecture is based on a mobile software application programming interface coupled to a modular hardware accessory. It allows the specification of lab-on-chip operation and post-analytic functions at the mobile software layer. We demonstrate its potential by operating a simple lab-on-chip to carry out the detection of dopamine using various electroanalytical methods.

  15. Application of fluorescent tracer agent technology to point-of-care gastrointestinal permeability measurement

    Science.gov (United States)

    Dorshow, Richard B.; Shieh, Jeng-Jong; Rogers, Thomas E.; Hall-Moore, Carla; Shaikh, Nurmohammad; Talcott, Michael; Tarr, Phillip I.

    2016-03-01

    Gut dysfunction, often accompanied by increased mucosal permeability to gut contents, frequently accompanies a variety of human intestinal inflammatory conditions. These disorders include inflammatory bowel diseases (e.g., Crohn's Disease) and environmental enteropathy and enteric dysfunction, a condition strongly associated with childhood malnutrition and stunting in resource poor areas of the world. The most widely used diagnostic assay for gastrointestinal permeability is the lactulose to mannitol ratio (L:M) measurement. These sugars are administered orally, differentially absorbed by the gut, and then cleared from the body by glomerular filtration in the kidney. The amount of each sugar excreted in the urine is measured. The larger sugar, lactulose, is minimally absorbed through a healthy gut. The smaller sugar, mannitol, in contrast, is readily absorbed through both a healthy and injured gut. Thus a higher ratio of lactulose to mannitol reflects increased intestinal permeability. However, several issues prevent widespread use of the L:M ratio in clinical practice. Urine needs to be collected over time intervals of several hours, the specimen then needs to be transported to an analytical laboratory, and sophisticated equipment is required to measure the concentration of each sugar in the urine. In this presentation we show that fluorescent tracer agents with molecular weights similar to those of the sugars, selected from our portfolio of biocompatible renally cleared fluorophores, mimic the L:M ratio test for gut permeability. This fluorescent tracer agent detection technology can be used to overcome the limitations of the L:M assay, and is amenable to point-of-care clinical use.

  16. Evolvable Smartphone-Based Platforms for Point-of-Care In-Vitro Diagnostics Applications

    Science.gov (United States)

    Patou, François; AlZahra’a Alatraktchi, Fatima; Kjægaard, Claus; Dimaki, Maria; Madsen, Jan; Svendsen, Winnie E.

    2016-01-01

    The association of smart mobile devices and lab-on-chip technologies offers unprecedented opportunities for the emergence of direct-to-consumer in vitro medical diagnostics applications. Despite their clear transformative potential, obstacles remain to the large-scale disruption and long-lasting success of these systems in the consumer market. For instance, the increasing level of complexity of instrumented lab-on-chip devices, coupled to the sporadic nature of point-of-care testing, threatens the viability of a business model mainly relying on disposable/consumable lab-on-chips. We argued recently that system evolvability, defined as the design characteristic that facilitates more manageable transitions between system generations via the modification of an inherited design, can help remedy these limitations. In this paper, we discuss how platform-based design can constitute a formal entry point to the design and implementation of evolvable smart device/lab-on-chip systems. We present both a hardware/software design framework and the implementation details of a platform prototype enabling at this stage the interfacing of several lab-on-chip variants relying on current- or impedance-based biosensors. Our findings suggest that several change-enabling mechanisms implemented in the higher abstraction software layers of the system can promote evolvability, together with the design of change-absorbing hardware/software interfaces. Our platform architecture is based on a mobile software application programming interface coupled to a modular hardware accessory. It allows the specification of lab-on-chip operation and post-analytic functions at the mobile software layer. We demonstrate its potential by operating a simple lab-on-chip to carry out the detection of dopamine using various electroanalytical methods. PMID:27598208

  17. Electrochemical magnetic microbeads-based biosensor for point-of-care serodiagnosis of infectious diseases.

    Science.gov (United States)

    Cortina, María E; Melli, Luciano J; Roberti, Mariano; Mass, Mijal; Longinotti, Gloria; Tropea, Salvador; Lloret, Paulina; Serantes, Diego A Rey; Salomón, Francisco; Lloret, Matías; Caillava, Ana J; Restuccia, Sabrina; Altcheh, Jaime; Buscaglia, Carlos A; Malatto, Laura; Ugalde, Juan E; Fraigi, Liliana; Moina, Carlos; Ybarra, Gabriel; Ciocchini, Andrés E; Comerci, Diego J

    2016-06-15

    Access to appropriate diagnostic tools is an essential component in the evaluation and improvement of global health. Additionally, timely detection of infectious agents is critical in early diagnosis and treatment of infectious diseases. Conventional pathogen detection methods such as culturing, enzyme linked immunosorbent assay (ELISA) or polymerase chain reaction (PCR) require long assay times, and complex and expensive instruments making them not adaptable to point-of-care (PoC) needs at resource-constrained places and primary care settings. Therefore, there is an unmet need to develop portable, simple, rapid, and accurate methods for PoC detection of infections. Here, we present the development and validation of a portable, robust and inexpensive electrochemical magnetic microbeads-based biosensor (EMBIA) platform for PoC serodiagnosis of infectious diseases caused by different types of microorganisms (parasitic protozoa, bacteria and viruses). We demonstrate the potential use of the EMBIA platform for in situ diagnosis of human (Chagas disease and human brucellosis) and animal (bovine brucellosis and foot-and-mouth disease) infections clearly differentiating infected from non-infected individuals or animals. For Chagas disease, a more extensive validation of the test was performed showing that the EMBIA platform displayed an excellent diagnostic performance almost indistinguishable, in terms of specificity and sensitivity, from a fluorescent immunomagnetic assay and the conventional ELISA using the same combination of antigens. This platform technology could potentially be applicable to diagnose other infectious and non-infectious diseases as well as detection and/or quantification of biomarkers at the POC and primary care settings.

  18. Evaluation of portable point-of-care CD4 counter with high sensitivity for detecting patients eligible for antiretroviral therapy.

    Directory of Open Access Journals (Sweden)

    Yukari C Manabe

    Full Text Available BACKGROUND: Accurate, inexpensive point-of-care CD4+ T cell testing technologies are needed that can deliver CD4+ T cell results at lower level health centers or community outreach voluntary counseling and testing. We sought to evaluate a point-of-care CD4+ T cell counter, the Pima CD4 Test System, a portable, battery-operated bench-top instrument that is designed to use finger stick blood samples suitable for field use in conjunction with rapid HIV testing. METHODS: Duplicate measurements were performed on both capillary and venous samples using Pima CD4 analyzers, compared to the BD FACSCalibur (reference method. The mean bias was estimated by paired Student's t-test. Bland Altman plots were used to assess agreement. RESULTS: 206 participants were enrolled with a median CD4 count of 396 (range; 18-1500. The finger stick PIMA had a mean bias of -66.3 cells/µL (95%CI -83.4-49.2, P500 cells/µL with a mean bias of -120.6 (95%CI -162.8, -78.4, P<0.001. The sensitivity (95%CI of the Pima CD4 analyzer was 96.3% (79.1-99.8% for a <250 cells/ul cut-off with a negative predictive value of 99.2% (95.1-99.9%. CONCLUSIONS: The Pima CD4 finger stick test is an easy-to-use, portable, relatively fast device to test CD4+ T cell counts in the field. Issues of negatively-biased CD4 cell counts especially at higher absolute numbers will limit its utility for longitudinal immunologic response to ART. The high sensitivity and negative predictive value of the test makes it an attractive option for field use to identify patients eligible for ART, thus potentially reducing delays in linkage to care and ART initiation.

  19. 百草枯尿液检测试剂盒行床旁尿液检测在百草枯中毒中的应用%The clinical application of paraquat urine test kit for point-of-care testing urine for patient with paraquat intoxication

    Institute of Scientific and Technical Information of China (English)

    程辉; 周宇明; 钟振洲; 肖世辉; 廖祥明

    2015-01-01

    Objective Using paraquat urine test kit measure the paraquet’s levels in urine of patients,in order to determine degree and prognosis of patients after paraquart intoxication. Methods To retrospective analysis the relationship between the uri-nary concentrations of paraquat and the patient’s illness severity by using Paraquat urine test kit testing urine repeatedly. Results The survival status of 38 cases who was paraquat intoxication was significantl postively correlated with paraquat semi-determi-nalion results in urine (P<0.01). Conclusion By using Paraquat urine test kit,we can detect urinary concentrations of paraquat rapidly,and it is useful to determine the degree and prognosis of patients who was paraquat intoxication.%目的:应用百草枯尿液检测试剂盒检测百草枯中毒患者的尿液,以判断其中毒程度和预后。方法使用百草枯尿液检测试剂盒对百草枯中毒患者进行多次尿液检测,回顾性分析患者尿百草枯浓度与患者病情危重度以及预后的相关性。结果38例百草枯中毒患者存活状况与尿百草枯半定量检测结果显著相关(P<0.01)。结论应用百草枯尿液检测试剂盒可迅速检测患者尿百草枯浓度,有助于判断患者中毒程度和预后。

  20. Laboratory Evaluation of a Point-of-Care Downward-Flow Assay for Simultaneous Detection of Antibodies to Treponema pallidum and Human Immunodeficiency Virus

    OpenAIRE

    Herbst de Cortina, S.; Bristow, C. C.; Vargas, S. K.; Perez, D. G.; Konda, K. A.; Caceres, C. F.; Klausner, J. D.

    2016-01-01

    Combining the detection of syphilis and HIV antibodies into one point-of-care test integrates syphilis screening into already existing HIV screening programs, which may be particularly beneficial in settings such as antenatal care. Using the INSTI Multiplex downward-flow immunoassay, we tested 200 stored serum samples from high-risk patients enrolled in a longitudinal study on HIV infection and syphilis in Peruvian men who have sex with men and transgender women. This rapid assay detected HIV...

  1. Evaluation of PIMA Point-of-care CD4 Analyzer in Yunnan, China

    Institute of Scientific and Technical Information of China (English)

    Jun Liang; Song Duan; Yan-Ling Ma; Ji-Bao Wang; Ying-Zhen Su; Hui Zhang; Chin-Yih Qu

    2015-01-01

    Background:CD4 count is used to determine antiretroviral therapy (ART) eligibility.In China,flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas.In an attempt to address this issue,we conducted a study to validate the performance ofAlere PIMA point-of-care CD4 analyzer.Methods:Venous and finger-prick blood specimens were collected from HIV-positive participants from two voluntary counseling and testing sites in Yunnan Province.Both venous and finger-prick blood specimens were tested with the PIMA analyzer.Venous blood specimens tested with the Becton Dickinson FACSCalibur were used as a reference.Results:Venous specimens from 396 and finger-prick specimens from 387 persons were available for analysis.CD4 counts by PIMA correlated well with those from FACSCalibur with an R2 of 0.91 for venous blood and 0.81 for finger-prick blood.Compared to FACSCalibur,the PIMA analyzer yielded lower counts with a mean bias of-47.0 cells/μl (limit of agreement,[LOA]:-204-110 cells/μl) for venous blood and-71.0 cells/μl (LOA:-295-153 cells/μ1) for finger-prick blood.For a CD4 threshold of 350 cells/μl,the positive predictive value (PPV) of PIMA was 84.2% and 75.7% and the negative predictive value (NPV) was 97.6% and 95.8% for venous and finger-prick blood,respectively.For an ART threshold of 500 cells/μl,the corresponding PPV was 90.3% and 84.0% and NPV was 94.3% and 93.4%,respectively.Conclusions:CD4 counting using venous blood with PIMA analyzers is a feasible alternative to a large flow cytometer to determine ART eligibility.

  2. 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...... 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...

  3. Evolvable Smartphone-Based Point-of-Care Systems For In-Vitro Diagnostics

    DEFF Research Database (Denmark)

    Patou, François

    -to-consumer applications remain scarce. This thesis addresses this limitation. After identifying system evolvability as a key enabler to the adoption and long-lasting success of next-generation point-of-care systems by favoring the integration of new technologies, streamlining the reengineering efforts for system upgrades...... architecture at initial design-time. Important considerations arise as to where in Lab-on-Chip/smart-device platforms can these mechanisms be integrated, and how to implement them. Our investigation revolves around the silicon-nanowire biological field effect transistor, a promising biosensing technology...... enablers for the decentralization of many in-vitro medical diagnostics applications to the point-of-care, supporting the advent of a preventive and personalized medicine. Although the technical feasibility and the potential of Lab-on-Chip/smart-device systems is repeatedly demonstrated, direct...

  4. Challenges of managing medications for older people at transition points of care.

    Science.gov (United States)

    Manias, Elizabeth; Hughes, Carmel

    2015-01-01

    In clinical practice, pharmacists play a very important role in identifying and correcting medication discrepancies as older patients move across transition points of care. With increasing complexity of health care needs of older people, these discrepancies are likely to increase. The major concern with identifying and correcting medication discrepancies is that medication reconciliation is considered a retrospective problem--that is, dealing with medication discrepancies after they have occurred. It is argued here that a more proactive stance should be taken where doctors, nurses and pharmacists collectively work together to prevent medication discrepancies from happening in the first place. Improved involvement of patients and family members will help to facilitate better management of medications across transition points of care. Efficient use of information technology aids, such as electronic medication reconciliation tools, should also assist with organizational systems problems associated with the working culture, heavy workloads, and staff and skill mix of health professionals.

  5. Precision nutrition - review of methods for point-of-care assessment of nutritional status.

    Science.gov (United States)

    Srinivasan, Balaji; Lee, Seoho; Erickson, David; Mehta, Saurabh

    2017-04-01

    Precision nutrition encompasses prevention and treatment strategies for optimizing health that consider individual variability in diet, lifestyle, environment and genes by accurately determining an individual's nutritional status. This is particularly important as malnutrition now affects a third of the global population, with most of those affected or their care providers having limited means of determining their nutritional status. Similarly, program implementers often have no way of determining the impact or success of their interventions, thus hindering their scale-up. Exciting new developments in the area of point-of-care diagnostics promise to provide improved access to nutritional status assessment, as a first step towards enabling precision nutrition and tailored interventions at both the individual and community levels. In this review, we focus on the current advances in developing portable diagnostics for assessment of nutritional status at point-of-care, along with the numerous design challenges in this process and potential solutions.

  6. Weber B Distal Fibular Fracture Diagnosed by Point of Care Ultrasound in the Emergency Department

    OpenAIRE

    Makinen, James

    2016-01-01

    We report the case of a 45 year-old woman who presented to the Emergency Department (ED) after an acute ankle inversion injury. After history and physical exam suggested a potential fracture, point of care (POC) ultrasound demonstrated a cortical defect of the distal fibula, consistent with fracture. Plain radiography failed to demonstrate a fracture. Later, the fracture was identified as a Weber B distal fibular fracture by stress-view radiography. This case reviews the evaluation of acute a...

  7. Point-of-care (POC) devices by means of advanced MEMS.

    Science.gov (United States)

    Karsten, Stanislav L; Tarhan, Mehmet C; Kudo, Lili C; Collard, Dominique; Fujita, Hiroyuki

    2015-12-01

    Microelectromechanical systems (MEMS) have become an invaluable technology to advance the development of point-of-care (POC) devices for diagnostics and sample analyses. MEMS can transform sophisticated methods into compact and cost-effective microdevices that offer numerous advantages at many levels. Such devices include microchannels, microsensors, etc., that have been applied to various miniaturized POC products. Here we discuss some of the recent advances made in the use of MEMS devices for POC applications.

  8. Engineering of a Clinical Decision Support Framework for the Point of Care Use

    OpenAIRE

    Wilk, Szymon; Michalowski, Wojtek; O’Sullivan, Dympna; Farion, Ken; Matwin, Stan

    2008-01-01

    Computerized decision support for use at the point of care has to be comprehensive. It means that clinical information stored in electronic health records needs to be integrated with various forms of clinical knowledge (elicited from experts, discovered from data or summarized in systematic reviews of clinical trials). In order to provide such comprehensive support we created the MET-A3Support framework for constructing clinical applications aimed at various medical conditions. We employed th...

  9. Design of a Wireless EEG System for Point-of-Care Applications.

    Science.gov (United States)

    Jia, Wenyan; Bai, Yicheng; Sun, Mingui; Sclabassi, Robert J

    2013-04-01

    This study aims to develop a wireless EEG system to provide critical point-of-care information about brain electrical activity. A novel dry electrode, which can be installed rapidly, is used to acquire EEG from the scalp. A wireless data link between the electrode and a data port (i.e., a smartphone) is established based on the Bluetooth technology. A prototype of this system has been implemented and its performance in acquiring EEG has been evaluated.

  10. Osmotic actuation for microfluidic components in point-of-care applications

    KAUST Repository

    Chen, Yu-Chih

    2013-01-01

    We present a novel design of micropumps and valves driven by osmotic force for point-of-care applications. Although there have been significant progresses in microfluidic components and control devices such as fluidic diodes, switches, resonators and digital-to-analog converters, the ultimate power source still depends on bulky off-chip components, which are expensive and cannot be easily miniaturized. For point-of-care applications, it is critical to integrate all the components in a compact size at low cost. In this work, we report two key active components actuated by osmotic mechanism for total integrated microfluidic system. For the proof of concept, we have demonstrated valve actuation, which can maintain stable ON/OFF switching operations under 125 kPa back pressure. We have also implemented an osmotic pump, which can pump a high flow rate over 30 μL/min for longer than 30 minutes. The experimental data demonstrates the possibility and potential of applying osmotic actuation in point-of-care disposable microfluidics. © 2013 IEEE.

  11. Asteroid Hyalosis: A Mimic of Vitreous Hemorrhage on Point of Care Ultrasound.

    Science.gov (United States)

    Stringer, Charles E A; Ahn, Justin S; Kim, Daniel J

    2016-08-30

    Point of care ultrasound in the emergency department (ED) is increasingly being used to diagnose time-sensitive, vision-threatening conditions. We present a case of a 64-year-old female who presented to the ED with a three-day history of worsening left eye floaters. Point of care ocular ultrasound demonstrated a posterior chamber containing many echogenic opacities of varying size without acoustic shadowing. Movement of the eye resulted in significant after-movement of these opacities, giving the classic "washing machine" appearance seen with vitreous hemorrhage (VH). Based on these ultrasound findings, the patient was diagnosed with a VH and was referred to ophthalmology. The consulting ophthalmologist ultimately diagnosed the patient with asteroid hyalosis without VH. Asteroid hyalosis is a benign condition of the vitreous resulting in calcium phosphate and lipid deposits that can mimic more serious VH on point of care ultrasound. Knowledge of this mimic is helpful for communication with specialists and for awareness of the potential for misdiagnosis with ocular ultrasound.

  12. User Interface Considerations for Collecting Data at the Point of Care in the Tablet PC Computing Environment

    Science.gov (United States)

    Silvey, Garry M.; Lobach, David F.; Macri, Jennifer M.; Hunt, Megan; Kacmaz, Roje O.; Lee, Paul P.

    2006-01-01

    Collecting clinical data directly from clinicians is a challenge. Many standard development environments designed to expedite the creation of user interfaces for electronic healthcare applications do not provide acceptable components for satisfying the requirements for collecting and displaying clinical data at the point of care on the tablet computer. Through an iterative design and testing approach using think-aloud sessions in the eye care setting, we were able to identify and resolve several user interface issues. Issues that we discovered and subsequently resolved included checkboxes that were too small to be selectable with a stylus, radio buttons that could not be unselected, and font sizes that were too small to be read at arm’s length. PMID:17238715

  13. Desenvolvimento de competências para o uso da ultrassonografia point-of-care em Nefrologia

    Directory of Open Access Journals (Sweden)

    Aida Aguilar Nunes

    2016-06-01

    Full Text Available Resumo Introdução: O uso do ultrassonografia (US por não radiologista tem aumentado e decorre da necessidade de o médico integrar "novas" informações clínicas ao processo diagnóstico. Na Nefrologia, ainda não foi estabelecido um currículo de treinamento em US definido e que tenha sido validado. O objetivo do estudo é apresentar os resultados do desenvolvimento de competências para o uso do ultrassom point-of-care (POCUS em Nefrologia. Métodos: Nove residentes, quatro de Nefrologia e cinco de clínica médica, frequentaram um curso de ultrassom teórico-prático de 16 horas. Foram abordados temas de ultrassom relacionados ao trato urinário, pulmão, coração, vasos sanguíneos, biópsia renal e inserção de cateter venoso central. A avaliação constou de testes cognitivos (TC de múltipla escolha e associação de imagens antes e após o curso e de avaliação prática de competências na geração de imagens ultrassonográficas e realização de procedimentos pelo Exame Estruturado de Habilidades Clínicas (OSCE. Resultados: Todos os residentes concluíram o curso. Observou-se melhora significativa dos conhecimentos quando se compararam as notas obtidas pelos residentes antes e após o TC de múltipla escolha (p < 0,004 e de associação de imagens (p < 0,02. A avaliação de competência dos residentes pelo OSCE, com exceção da estação sobre pulmão, foi considerada muito boa. Conclusão: Um curso de POCUS em Nefrologia de apenas 16 horas, não limitado aos temas do trato urinário, possibilita o desenvolvimento de competências na obtenção de imagens e a realização de procedimentos nefrológicos. O currículo desenvolvido pode servir de modelo para o aprendizado do POCUS em Nefrologia.

  14. Linearity analysis and comparison study on the epoc(®) point-of-care blood analysis system in cardiopulmonary bypass patients.

    Science.gov (United States)

    Chen, Jianing; Gorman, Monique; O'Reilly, Bill; Chen, Yu

    2016-03-01

    The epoc(®) blood analysis system (Epocal Inc., Ottawa, Ontario, Canada) is a newly developed in vitro diagnostic hand-held analyzer for testing whole blood samples at point-of-care, which provides blood gas, electrolytes, ionized calcium, glucose, lactate, and hematocrit/calculated hemoglobin rapidly. The analytical performance of the epoc(®) system was evaluated in a tertiary hospital, see related research article "Analytical evaluation of the epoc(®) point-of-care blood analysis system in cardiopulmonary bypass patients" [1]. Data presented are the linearity analysis for 9 parameters and the comparison study in 40 cardiopulmonary bypass patients on 3 epoc(®) meters, Instrumentation Laboratory GEM4000, Abbott iSTAT, Nova CCX, and Roche Accu-Chek Inform II and Performa glucose meters.

  15. Linearity analysis and comparison study on the epoc® point-of-care blood analysis system in cardiopulmonary bypass patients

    Directory of Open Access Journals (Sweden)

    Jianing Chen

    2016-03-01

    Full Text Available The epoc® blood analysis system (Epocal Inc., Ottawa, Ontario, Canada is a newly developed in vitro diagnostic hand-held analyzer for testing whole blood samples at point-of-care, which provides blood gas, electrolytes, ionized calcium, glucose, lactate, and hematocrit/calculated hemoglobin rapidly. The analytical performance of the epoc® system was evaluated in a tertiary hospital, see related research article “Analytical evaluation of the epoc® point-of-care blood analysis system in cardiopulmonary bypass patients” [1]. Data presented are the linearity analysis for 9 parameters and the comparison study in 40 cardiopulmonary bypass patients on 3 epoc® meters, Instrumentation Laboratory GEM4000, Abbott iSTAT, Nova CCX, and Roche Accu-Chek Inform II and Performa glucose meters.

  16. Linearity analysis and comparison study on the epoc® point-of-care blood analysis system in cardiopulmonary bypass patients

    Science.gov (United States)

    Chen, Jianing; Gorman, Monique; O’Reilly, Bill; Chen, Yu

    2016-01-01

    The epoc® blood analysis system (Epocal Inc., Ottawa, Ontario, Canada) is a newly developed in vitro diagnostic hand-held analyzer for testing whole blood samples at point-of-care, which provides blood gas, electrolytes, ionized calcium, glucose, lactate, and hematocrit/calculated hemoglobin rapidly. The analytical performance of the epoc® system was evaluated in a tertiary hospital, see related research article “Analytical evaluation of the epoc® point-of-care blood analysis system in cardiopulmonary bypass patients” [1]. Data presented are the linearity analysis for 9 parameters and the comparison study in 40 cardiopulmonary bypass patients on 3 epoc® meters, Instrumentation Laboratory GEM4000, Abbott iSTAT, Nova CCX, and Roche Accu-Chek Inform II and Performa glucose meters. PMID:26937460

  17. Evaluation of the Nova StatSensor® Xpress(TM) Creatinine point-of-care handheld analyzer.

    Science.gov (United States)

    Kosack, Cara Simone; de Kieviet, Wim; Bayrak, Kubra; Milovic, Anastacija; Page, Anne Laure

    2015-01-01

    Creatinine is a parameter that is required to monitor renal function and is important to follow in patients under treatment with potentially toxic renal drugs, such as the anti-HIV drug Tenofovir. A point of care instrument to measure creatinine would be useful for patients monitoring in resource-limited settings, where more instruments that are sophisticated are not available. The StatSensor Xpress Creatinine (Nova Biomedical Cooperation, Waltham, MA, USA) point of care analyzer was evaluated for its diagnostic performance in indicating drug therapy change. Creatinine was measured in parallel using the Nova StatSensor Xpress Creatinine analyzer and the Vitros 5,1FS (Ortho Clinical Diagnostics, Inc, Rochester, USA), which served as reference standard. The precision (i.e., repeatability and reproducibility) and accuracy of the StatSensor Xpress Creatinine analyzer were calculated using a panel of specimens with normal, low pathological and high pathological values. Two different Nova StatSensor Xpress Creatinine analyzers were used for the assessment of accuracy using repeated measurements. The coefficient of variation of the StatSensor Xpress Creatinine analyzers ranged from 2.3 to 5.9% for repeatability and from 4.2 to 9.0% for between-run reproducibility. The concordance correlation agreement was good except for high values (>600 µmol/L). The Bland-Altman analysis in high pathological specimens suggests that the Nova StatSensor Xpress Creatinine test tends to underestimate high creatinine values (i.e., >600 µmol/L). The Nova StatSensor Xpress Creatinine analyzers showed acceptable to good results in terms of repeatability, inter-device reproducibility and between-run reproducibility over time using quality control reagents. The analyzer was found sufficiently accurate for detecting pathological values in patients (age >10 year) and can be used with a moderate risk of misclassification.

  18. Does point of care prothrombin time measurement reduce the transfusion of fresh frozen plasma in patients undergoing major surgery? The POC-OP randomized-controlled trial

    Directory of Open Access Journals (Sweden)

    Alberio Lorenzo

    2009-11-01

    Full Text Available Abstract Background Bleeding is a frequent complication during surgery. The intraoperative administration of blood products, including packed red blood cells, platelets and fresh frozen plasma (FFP, is often live saving. Complications of blood transfusions contribute considerably to perioperative costs and blood product resources are limited. Consequently, strategies to optimize the decision to transfuse are needed. Bleeding during surgery is a dynamic process and may result in major blood loss and coagulopathy due to dilution and consumption. The indication for transfusion should be based on reliable coagulation studies. While hemoglobin levels and platelet counts are available within 15 minutes, standard coagulation studies require one hour. Therefore, the decision to administer FFP has to be made in the absence of any data. Point of care testing of prothrombin time ensures that one major parameter of coagulation is available in the operation theatre within minutes. It is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP. Methods/Design The objective of the POC-OP trial is to determine the effectiveness of point of care prothrombin time testing to reduce the administration of FFP. It is a patient and assessor blind, single center randomized controlled parallel group trial in 220 patients aged between 18 and 90 years undergoing major surgery (any type, except cardiac surgery and liver transplantation with an estimated blood loss during surgery exceeding 20% of the calculated total blood volume or a requirement of FFP according to the judgment of the physicians in charge. Patients are randomized to usual care plus point of care prothrombin time testing or usual care alone without point of care testing. The primary outcome is the relative risk to receive any FFP perioperatively. The inclusion of 110 patients per group will yield more than 80% power to detect a clinically relevant relative risk

  19. Health information needs of professional nurses required at the point of care

    Directory of Open Access Journals (Sweden)

    Esmeralda Ricks

    2015-02-01

    Full Text Available Background: Professional nurses work in dynamic environments and need to keep up to date with relevant information for practice in nursing to render quality patient care. Keeping up to date with current information is often challenging because of heavy workload, diverse information needs and the accessibility of the required information at the point of care. Objectives: The aim of the study was to explore and describe the information needs of professional nurses at the point of care in order to make recommendations to stakeholders to develop a mobile library accessible by means of smart phones when needed. Method: The researcher utilised a quantitative, descriptive survey design to conduct this study. The target population comprised 757 professional nurses employed at a state hospital. Simple random sampling was used to select a sample of the wards, units and departments for inclusion in the study. A convenience sample of 250 participants was selected. Two hundred and fifty structured self-administered questionnaires were distributed amongst the participants. Descriptive statistics were used to analyse the data. Results: A total of 136 completed questionnaires were returned. The findings highlighted the types and accessible sources of information. Information needs of professional nurses were identified such as: extremely drug-resistant tuberculosis, multi-drug-resistant tuberculosis, HIV, antiretrovirals and all chronic lifestyle diseases. Conclusion: This study has enabled the researcher to identify the information needs required by professional nurses at the point of care to enhance the delivery of patient care. The research results were used to develop a mobile library that could be accessed by professional nurses.

  20. Vein visualization using a smart phone with multispectral Wiener estimation for point-of-care applications.

    Science.gov (United States)

    Song, Jae Hee; Kim, Choye; Yoo, Yangmo

    2015-03-01

    Effective vein visualization is clinically important for various point-of-care applications, such as needle insertion. It can be achieved by utilizing ultrasound imaging or by applying infrared laser excitation and monitoring its absorption. However, while these approaches can be used for vein visualization, they are not suitable for point-of-care applications because of their cost, time, and accessibility. In this paper, a new vein visualization method based on multispectral Wiener estimation is proposed and its real-time implementation on a smart phone is presented. In the proposed method, a conventional RGB camera on a commercial smart phone (i.e., Galaxy Note 2, Samsung Electronics Inc., Suwon, Korea) is used to acquire reflectance information from veins. Wiener estimation is then applied to extract the multispectral information from the veins. To evaluate the performance of the proposed method, an experiment was conducted using a color calibration chart (ColorChecker Classic, X-rite, Grand Rapids, MI, USA) and an average root-mean-square error of 12.0% was obtained. In addition, an in vivo subcutaneous vein imaging experiment was performed to explore the clinical performance of the smart phone-based Wiener estimation. From the in vivo experiment, the veins at various sites were successfully localized using the reconstructed multispectral images and these results were confirmed by ultrasound B-mode and color Doppler images. These results indicate that the presented multispectral Wiener estimation method can be used for visualizing veins using a commercial smart phone for point-of-care applications (e.g., vein puncture guidance).

  1. Point-of-care technologies for molecular diagnostics using a drop of blood.

    Science.gov (United States)

    Song, Yujun; Huang, Yu-Yen; Liu, Xuewu; Zhang, Xiaojing; Ferrari, Mauro; Qin, Lidong

    2014-03-01

    Molecular diagnostics is crucial for prevention, identification, and treatment of disease. Traditional technologies for molecular diagnostics using blood are limited to laboratory use because they rely on sample purification and sophisticated instruments, are labor and time intensive, expensive, and require highly trained operators. This review discusses the frontiers of point-of-care (POC) diagnostic technologies using a drop of blood obtained from a finger prick. These technologies, including emerging biotechnologies, nanotechnologies, and microfluidics, hold the potential for rapid, accurate, and inexpensive disease diagnostics.

  2. Flexible Substrate-Based Devices for Point-of-Care Diagnostics.

    Science.gov (United States)

    Wang, ShuQi; Chinnasamy, Thiruppathiraja; Lifson, Mark A; Inci, Fatih; Demirci, Utkan

    2016-11-01

    Point-of-care (POC) diagnostics play an important role in delivering healthcare, particularly for clinical management and disease surveillance in both developed and developing countries. Currently, the majority of POC diagnostics utilize paper substrates owing to affordability, disposability, and mass production capability. Recently, flexible polymer substrates have been investigated due to their enhanced physicochemical properties, potential to be integrated into wearable devices with wireless communications for personalized health monitoring, and ability to be customized for POC diagnostics. Here, we focus on the latest advances in developing flexible substrate-based diagnostic devices, including paper and polymers, and their clinical applications.

  3. Does point-of-care ultrasonography cause discomfort in patients admitted with respiratory symptoms?

    DEFF Research Database (Denmark)

    Laursen, Christian B; Sloth, Erik; Lassen, Annmarie Touborg;

    2015-01-01

    BACKGROUND: This study aimed to assess the patient-rated level of discomfort during point-of-care ultrasonography (POCUS) of the heart, lungs and deep veins in a population of patients admitted to an ED with respiratory symptoms and to what extent the patients would accept being assessed by the use...... of POCUS if they had to be examined for possible disease. METHODS: A questionnaire-based observational study was conducted in an ED. Inclusion criteria were one or more of the following: respiratory rate > 20/min, oxygen saturation 

  4. 3D printed microfluidic mixer for point-of-care diagnosis of anemia.

    Science.gov (United States)

    Plevniak, Kimberly; Campbell, Matthew; Mei He

    2016-08-01

    3D printing has been an emerging fabrication tool in prototyping and manufacturing. We demonstrated a 3D microfluidic simulation guided computer design and 3D printer prototyping for quick turnaround development of microfluidic 3D mixers, which allows fast self-mixing of reagents with blood through capillary force. Combined with smartphone, the point-of-care diagnosis of anemia from finger-prick blood has been successfully implemented and showed consistent results with clinical measurements. Capable of 3D fabrication flexibility and smartphone compatibility, this work presents a novel diagnostic strategy for advancing personalized medicine and mobile healthcare.

  5. Point-of-care sonographic detection of intestinal ascaris lumbricoides in the pediatric emergency department.

    Science.gov (United States)

    Kessler, David O; Gurwitz, Avrahom; Tsung, James W

    2010-08-01

    Point-of-care ultrasound use is rapidly growing in acute-care settings such as pediatric emergency departments, and new applications are continually being explored. This is especially true in the developing world where the World Health Organization estimates that 75% of people have no access to any imaging or availability of more costly imaging technology may be limited (Essential Health Technologies Strategy 2004-2007). We report a case of intestinal roundworm infection in a 3-year-old boy and describe the ultrasound findings of Ascaris lumbricoides.

  6. Development of a magnetic lab-on-a-chip for point-of-care sepsis diagnosis

    Energy Technology Data Exchange (ETDEWEB)

    Schotter, Joerg [Austrian Research Centers GmbH-ARC, Nano-System-Technologies, Donau-City-Strasse 1, Tech Gate Vienna 2. OG, 1220 Vienna (Austria)], E-mail: Joerg.Schotter@arcs.ac.at; Shoshi, Astrit; Brueckl, Hubert [Austrian Research Centers GmbH-ARC, Nano-System-Technologies, Donau-City-Strasse 1, Tech Gate Vienna 2. OG, 1220 Vienna (Austria)

    2009-05-15

    We present design criteria, operation principles and experimental examples of magnetic marker manipulation for our magnetic lab-on-a-chip prototype. It incorporates both magnetic sample preparation and detection by embedded GMR-type magnetoresistive sensors and is optimized for the automated point-of-care detection of four different sepsis-indicative cytokines directly from about 5 {mu}l of whole blood. The sample volume, magnetic particle size and cytokine concentration determine the microfluidic volume, sensor size and dimensioning of the magnetic gradient field generators. By optimizing these parameters to the specific diagnostic task, best performance is expected with respect to sensitivity, analysis time and reproducibility.

  7. Development of a magnetic lab-on-a-chip for point-of-care sepsis diagnosis

    Science.gov (United States)

    Schotter, Joerg; Shoshi, Astrit; Brueckl, Hubert

    2009-05-01

    We present design criteria, operation principles and experimental examples of magnetic marker manipulation for our magnetic lab-on-a-chip prototype. It incorporates both magnetic sample preparation and detection by embedded GMR-type magnetoresistive sensors and is optimized for the automated point-of-care detection of four different sepsis-indicative cytokines directly from about 5 μl of whole blood. The sample volume, magnetic particle size and cytokine concentration determine the microfluidic volume, sensor size and dimensioning of the magnetic gradient field generators. By optimizing these parameters to the specific diagnostic task, best performance is expected with respect to sensitivity, analysis time and reproducibility.

  8. Desenvolvimento de competências para o uso da ultrassonografia point-of-care em Nefrologia

    OpenAIRE

    Aida Aguilar Nunes; José Muniz Pazeli Júnior; Anderson Tavares Rodrigues; Ana Luisa Silveira Vieira Tollendal; Oscarina da Silva Ezequiel; Fernando Antonio Basile Colugnati; Marcus Gomes Bastos

    2016-01-01

    Resumo Introdução: O uso do ultrassonografia (US) por não radiologista tem aumentado e decorre da necessidade de o médico integrar "novas" informações clínicas ao processo diagnóstico. Na Nefrologia, ainda não foi estabelecido um currículo de treinamento em US definido e que tenha sido validado. O objetivo do estudo é apresentar os resultados do desenvolvimento de competências para o uso do ultrassom point-of-care (POCUS) em Nefrologia. Métodos: Nove residentes, quatro de Nefrologia e cinco...

  9. Multiplexed lateral flow biosensors: Technological advances for radically improving point-of-care diagnoses.

    Science.gov (United States)

    Li, Jia; Macdonald, Joanne

    2016-09-15

    Lateral flow biosensors are a leading technology in point-of-care diagnostics due to their simplicity, rapidness and low cost. Their primacy in this arena continues through technological breakthroughs such as multiplexing: the detection of more than one biomarker in a single assay. Multiplexing capacity is critical for improving diagnostic efficiency, enhancing the diagnostic precision for specific diseases and reducing diagnostic cost. Here we review, for the first time, the various types and strategies employed for creating multiplexed lateral flow biosensors. These are classified into four main categories in terms of specific application or multiplexing level, namely linear, parameter, spatial and conceptual. We describe the practical applications and implications for each approach and compare their advantages and disadvantages. Importantly, multiplexing is still subject to limitations of the traditional lateral flow biosensor, such as sensitivity and specificity. However, by pushing the limitations of the traditional medium into the multiplex arena, several technological breakthroughs are emerging with novel solutions that further expand the utility of lateral flow biosensing for point-of-care applications.

  10. A 'green button' for using aggregate patient data at the point of care.

    Science.gov (United States)

    Longhurst, Christopher A; Harrington, Robert A; Shah, Nigam H

    2014-07-01

    Randomized controlled trials have traditionally been the gold standard against which all other sources of clinical evidence are measured. However, the cost of conducting these trials can be prohibitive. In addition, evidence from the trials frequently rests on narrow patient-inclusion criteria and thus may not generalize well to real clinical situations. Given the increasing availability of comprehensive clinical data in electronic health records (EHRs), some health system leaders are now advocating for a shift away from traditional trials and toward large-scale retrospective studies, which can use practice-based evidence that is generated as a by-product of clinical processes. Other thought leaders in clinical research suggest that EHRs should be used to lower the cost of trials by integrating point-of-care randomization and data capture into clinical processes. We believe that a successful learning health care system will require both approaches, and we suggest a model that resolves this escalating tension: a "green button" function within EHRs to help clinicians leverage aggregate patient data for decision making at the point of care. Giving clinicians such a tool would support patient care decisions in the absence of gold-standard evidence and would help prioritize clinical questions for which EHR-enabled randomization should be carried out. The privacy rule in the Health Insurance Portability and Accountability Act (HIPAA) of 1996 may require revision to support this novel use of patient data.

  11. Point-of-care ultrasound in aerospace medicine: known and potential applications.

    Science.gov (United States)

    Wagner, Michael S; Garcia, Kathleen; Martin, David S

    2014-07-01

    Since its initial introduction into the bedside assessment of the trauma patient via the Focused Assessment with Sonography for Trauma (FAST) exam, the use of point-of-care ultrasound has expanded rapidly. A growing body of literature demonstrates ultrasound can be used by nonradiologists as an extension of the physical exam to accurately diagnose or exclude a variety of conditions. These conditions include, but are not limited to, hemoperitoneum, pneumothorax, pulmonary edema, long-bone fracture, deep vein thrombosis, and elevated intracranial pressure. As ultrasound machines have become more compact and portable, their use has extended outside of hospitals to places where the physical exam and diagnostic capabilities may be limited, including the aviation environment. A number of studies using focused sonography have been performed to meet the diagnostic challenges of space medicine. The following article reviews the available literature on portable ultrasound use in aerospace medicine and highlights both known and potential applications of point-of-care ultrasound for the aeromedical clinician.

  12. Nanoparticle Detection of Urinary Markers for Point-of-Care Diagnosis of Kidney Injury.

    Directory of Open Access Journals (Sweden)

    Hyun Jung Chung

    Full Text Available The high incidence of acute and chronic kidney injury due to various environmental factors such as heavy metals or chemicals has been a major problem in developing countries. However, the diagnosis of kidney injury in these areas can be more challenging due to the lack of highly sensitive and specific techniques that can be applied in point-of-care settings. To address this, we have developed a technique called 'micro-urine nanoparticle detection (μUNPD', that allows the detection of trace amounts of molecular markers in urine. Specifically, this technique utilizes an automated on-chip assay followed by detection with a hand-held device for the read-out. Using the μUNPD technology, the kidney injury markers KIM-1 and Cystatin C were detected down to concentrations of 0.1 ng/ml and 20 ng/ml respectively, which meets the cut-off range required to identify patients with acute or chronic kidney injury. Thus, we show that the μUNPD technology enables point of care and non-invasive detection of kidney injury, and has potential for applications in diagnosing kidney injury with high sensitivity in resource-limited settings.

  13. A paper based graphene-nanocauliflower hybrid composite for point of care biosensing.

    Science.gov (United States)

    Burrs, S L; Bhargava, M; Sidhu, R; Kiernan-Lewis, J; Gomes, C; Claussen, J C; McLamore, E S

    2016-11-15

    We demonstrate the first report of graphene paper functionalized with fractal platinum nanocauliflower for use in electrochemical biosensing of small molecules (glucose) or detection of pathogenic bacteria (Escherichia coli O157:H7). Raman spectroscopy, scanning electron microscopy and energy dispersive spectroscopy show that graphene oxide-coated nanocellulose was partially reduced by both thermal treatment, and further reduced by chemical treatment (ascorbic acid). Fractal nanoplatinum with cauliflower-like morphology was formed on the reduced graphene oxide paper using pulsed sonoelectrodeposition, producing a conductive paper with an extremely high electroactive surface area (0.29±0.13cm(2)), confirmed by cyclic voltammetry and electrochemical impedance spectroscopy. The platinum surface was functionalized with either glucose oxidase (via chitosan encapsulation) or a RNA aptamer (via covalent linking) for demonstration as a point of care biosensor. The detection limit for both glucose (0.08±0.02μM) and E. coli O157:H7 (≈4 CFUmL(-1)) were competitive with, or superior to, previously reported devices in the biosensing literature. The response time (6s for glucose and 12min for E. coli) were also similar to silicon biochip and commercial electrode sensors. The results demonstrate that the nanocellulose-graphene-nanoplatinum material is an excellent paper-based platform for development of electrochemical biosensors targeting small molecules or whole cells for use in point of care biosensing.

  14. Enabling Precision Medicine With Digital Case Classification at the Point-of-Care

    Directory of Open Access Journals (Sweden)

    Patrick Obermeier

    2016-02-01

    Full Text Available Infectious and inflammatory diseases of the central nervous system are difficult to identify early. Case definitions for aseptic meningitis, encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM are available, but rarely put to use. The VACC-Tool (Vienna Vaccine Safety Initiative Automated Case Classification-Tool is a mobile application enabling immediate case ascertainment based on consensus criteria at the point-of-care. The VACC-Tool was validated in a quality management program in collaboration with the Robert-Koch-Institute. Results were compared to ICD-10 coding and retrospective analysis of electronic health records using the same case criteria. Of 68,921 patients attending the emergency room in 10/2010–06/2013, 11,575 were hospitalized, with 521 eligible patients (mean age: 7.6 years entering the quality management program. Using the VACC-Tool at the point-of-care, 180/521 cases were classified successfully and 194/521 ruled out with certainty. Of the 180 confirmed cases, 116 had been missed by ICD-10 coding, 38 misclassified. By retrospective application of the same case criteria, 33 cases were missed. Encephalitis and ADEM cases were most likely missed or misclassified. The VACC-Tool enables physicians to ask the right questions at the right time, thereby classifying cases consistently and accurately, facilitating translational research. Future applications will alert physicians when additional diagnostic procedures are required.

  15. Conflict of interest in online point-of-care clinical support websites.

    Science.gov (United States)

    Amber, Kyle T; Dhiman, Gaurav; Goodman, Kenneth W

    2014-08-01

    Point-of-care evidence-based medicine websites allow physicians to answer clinical queries using recent evidence at the bedside. Despite significant research into the function, usability and effectiveness of these programmes, little attention has been paid to their ethical issues. As many of these sites summarise the literature and provide recommendations, we sought to assess the role of conflicts of interest in two widely used websites: UpToDate and Dynamed. We recorded all conflicts of interest for six articles detailing treatment for the following conditions: erectile dysfunction, fibromyalgia, hypogonadism, psoriasis, rheumatoid arthritis and Crohn's disease. These diseases were chosen as their medical management is either controversial, or they are treated using biological drugs which are mostly available by brand name only. Thus, we hypothesised that the role of conflict of interest would be more significant in these conditions than in an illness treated with generic medications or by strict guidelines. All articles from the UpToDate articles demonstrated a conflict of interest. At times, the editor and author would have a financial relationship with a company whose drug was mentioned within the article. This is in contrast with articles on the Dynamed website, in which no author or editor had a documented conflict. We offer recommendations regarding the role of conflict of interest disclosure in these point-of-care evidence-based medicine websites.

  16. An Instantaneous Low-Cost Point-of-Care Anemia Detection Device

    Directory of Open Access Journals (Sweden)

    Jaime Punter-Villagrasa

    2015-02-01

    Full Text Available We present a small, compact and portable device for point-of-care instantaneous early detection of anemia. The method used is based on direct hematocrit measurement from whole blood samples by means of impedance analysis. This device consists of a custom electronic instrumentation and a plug-and-play disposable sensor. The designed electronics rely on straightforward standards for low power consumption, resulting in a robust and low consumption device making it completely mobile with a long battery life. Another approach could be powering the system based on other solutions like indoor solar cells, or applying energy-harvesting solutions in order to remove the batteries. The sensing system is based on a disposable low-cost label-free three gold electrode commercial sensor for 50 µL blood samples. The device capability for anemia detection has been validated through 24 blood samples, obtained from four hospitalized patients at Hospital Clínic. As a result, the response, effectiveness and robustness of the portable point-of-care device to detect anemia has been proved with an accuracy error of 2.83% and a mean coefficient of variation of 2.57% without any particular case above 5%.

  17. NIH-IEEE 2015 Strategic Conference on Healthcare Innovations and Point-of-Care Technologies for Prec

    Science.gov (United States)

    NIH and the Institute for Electrical and Electronics Engineering, Engineering in Medicine and Biology Society (IEEE/EMBS) hosted the third iteration of the Healthcare Innovations and Point-of-Care Technologies Conference last week.

  18. Point-of-Care Sexually Transmitted Infection Diagnostics: Proceedings of the STAR Sexually Transmitted Infection-Clinical Trial Group Programmatic Meeting.

    Science.gov (United States)

    Cristillo, Anthony D; Bristow, Claire C; Peeling, Rosanna; Van Der Pol, Barbara; de Cortina, Sasha Herbst; Dimov, Ivan K; Pai, Nitika Pant; Jin Shin, Dong; Chiu, Ricky Y T; Klapperich, Catherine; Madhivanan, Purnima; Morris, Sheldon R; Klausner, Jeffrey D

    2017-04-01

    The goal of the point-of-care (POC) sexually transmitted infection (STI) Diagnostics meeting was to review the state-of-the-art research and develop recommendations for the use of POC STI diagnostics. Experts from academia, government, nonprofit, and industry discussed POC diagnostics for STIs such as Chlamydia trachomatis, human papillomavirus, Neisseria gonorrhoeae, Trichomonas vaginalis, and Treponema pallidum. Key objectives included a review of current and emerging technologies, clinical and public health benefits, POC STI diagnostics in developing countries, regulatory considerations, and future areas of development. Key points of the meeting are as follows: (i) although some rapid point-of-care tests are affordable, sensitive, specific, easy to perform, and deliverable to those who need them for select sexually transmitted infections, implementation barriers exist at the device, patient, provider, and health system levels; (ii) further investment in research and development of point-of-care tests for sexually transmitted infections is needed, and new technologies can be used to improve diagnostic testing, test uptake, and treatment; (iii) efficient deployment of self-testing in supervised (ie, pharmacies, clinics, and so on) and/or unsupervised (ie, home, offices, and so on) settings could facilitate more screening and diagnosis that will reduce the burden of sexually transmitted infections; (iv) development of novel diagnostic technologies has outpaced the generation of guidance tools and documents issued by regulatory agencies; and (v) questions regarding quality management are emerging including the mechanism by which poor-performing diagnostics are removed from the market and quality assurance of self-testing is ensured.

  19. Integrated quality control: implementation and validation of instrument function checks and procedural controls for a cartridge-based point-of-care system for critical care analysis.

    Science.gov (United States)

    D'Orazio, Paul; Mansouri, Sohrab

    2013-03-01

    In this article, the process used to develop and validate an integrated quality-control system for a cartridge-based, point-of-care system for critical care analysis is outlined. Application of risk management principles has resulted in a quality control system using a combination of statistical quality control with onboard reference solutions and failure pattern recognition used to flag common failure modes during the analytical phase of the testing process. A combination of traditional external quality control, integrated quality control to monitor ongoing instrument functionality, operator training, and other laboratory-implemented monitors is most effective in controlling known failure modes during the testing process.

  20. Optoelectronic capillary sensors in microfluidic and point-of-care instrumentation.

    Science.gov (United States)

    Borecki, Michał; Korwin-Pawlowski, Michael L; Beblowska, Maria; Szmidt, Jan; Jakubowski, Andrzej

    2010-01-01

    This paper presents a review, based on the published literature and on the authors' own research, of the current state of the art of fiber-optic capillary sensors and related instrumentation as well as their applications, with special emphasis on point-of-care chemical and biochemical sensors, systematizing the various types of sensors from the point of view of the principles of their construction and operation. Unlike classical fiber-optic sensors which rely on changes in light propagation inside the fiber as affected by outside conditions, optical capillary sensors rely on changes of light transmission in capillaries filled with the analyzed liquid, which opens the possibility of interesting new applications, while raising specific issues relating to the construction, materials and instrumentation of those sensors.

  1. Microfluidic Surface Plasmon Resonance Sensors: From Principles to Point-of-Care Applications.

    Science.gov (United States)

    Wang, Da-Shin; Fan, Shih-Kang

    2016-07-27

    Surface plasmon resonance (SPR) is a label-free, highly-sensitive, and real-time sensing technique. Conventional SPR sensors, which involve a planar thin gold film, have been widely exploited in biosensing; various miniaturized formats have been devised for portability purposes. Another type of SPR sensor which utilizes localized SPR (LSPR), is based on metal nanostructures with surface plasmon modes at the structural interface. The resonance condition is sensitive to the refractive index change of the local medium. The principles of these two types of SPR sensors are reviewed and their integration with microfluidic platforms is described. Further applications of microfluidic SPR sensors to point-of-care (POC) diagnostics are discussed.

  2. Optoelectronic Capillary Sensors in Microfluidic and Point-of-Care Instrumentation

    Directory of Open Access Journals (Sweden)

    Michał Borecki

    2010-04-01

    Full Text Available This paper presents a review, based on the published literature and on the authors’ own research, of the current state of the art of fiber-optic capillary sensors and related instrumentation as well as their applications, with special emphasis on point-of-care chemical and biochemical sensors, systematizing the various types of sensors from the point of view of the principles of their construction and operation. Unlike classical fiber-optic sensors which rely on changes in light propagation inside the fiber as affected by outside conditions, optical capillary sensors rely on changes of light transmission in capillaries filled with the analyzed liquid, which opens the possibility of interesting new applications, while raising specific issues relating to the construction, materials and instrumentation of those sensors.

  3. Appendicitis Diagnosed by Emergency Physician Performed Point-of-care Transvaginal Ultrasound: Case Series

    Directory of Open Access Journals (Sweden)

    Robert Bramante

    2013-09-01

    Full Text Available Lower abdominal pain in females of reproductive age continues to be a diagnostic dilemma for the emergency physician (EP. Point-of-care ultrasound (US allows for rapid, accurate, and safe evaluation of abdominal and pelvic pain in both the pregnant and non-pregnant patient. We present 3 cases of females presenting with right lower quadrant and adnexal tenderness where transvaginal ultrasonography revealed acute appendicitis. The discussion focuses on the use of EP-performed transvaginal US in gynecologic and intra-abdominal pathology and discusses the use of a staged approach to evaluation using US and computed tomography, as indicated. [West J Emerg Med. 2013;14(5:415-418.

  4. A low-cost miniaturized potentiostat for point-of-care diagnosis.

    Science.gov (United States)

    Cruz, Andres Felipe Diaz; Norena, Nicolas; Kaushik, Ajeet; Bhansali, Shekhar

    2014-12-15

    This paper presents a novel approach of using a miniaturized potentiostat (M-P) chip (LMP91000) to perform full range cyclic voltammetry (CV) measurements for the detection of biomarkers. The LMP91000 evaluation board was reconfigured to perform three-electrode CV measurements in order to achieve electrochemical cortisol immunosensing. The microelectrodes for cortisol estimation were fabricated by immobilizing monoclonal anti-cortisol antibody (Anti-M-Cab) onto self-assembled monolayer (SAM) modified Au microelectrodes. The results obtained using the M-P were compared to those obtained using a conventional potentiostat. The M-P was successful in measuring cortisol levels in the range of pM. The outcomes of the studies suggest that M-P can effectively perform biochemical measurements on three electrode systems, enabling the development of miniature systems for point-of-care (POC) diagnosis.

  5. Optical biosensor technologies for molecular diagnostics at the point-of-care

    Science.gov (United States)

    Schotter, Joerg; Schrittwieser, Stefan; Muellner, Paul; Melnik, Eva; Hainberger, Rainer; Koppitsch, Guenther; Schrank, Franz; Soulantika, Katerina; Lentijo-Mozo, Sergio; Pelaz, Beatriz; Parak, Wolfgang; Ludwig, Frank; Dieckhoff, Jan

    2015-05-01

    Label-free optical schemes for molecular biosensing hold a strong promise for point-of-care applications in medical research and diagnostics. Apart from diagnostic requirements in terms of sensitivity, specificity, and multiplexing capability, also other aspects such as ease of use and manufacturability have to be considered in order to pave the way to a practical implementation. We present integrated optical waveguide as well as magnetic nanoparticle based molecular biosensor concepts that address these aspects. The integrated optical waveguide devices are based on low-loss photonic wires made of silicon nitride deposited by a CMOS compatible plasma-enhanced chemical vapor deposition (PECVD) process that allows for backend integration of waveguides on optoelectronic CMOS chips. The molecular detection principle relies on evanescent wave sensing in the 0.85 μm wavelength regime by means of Mach-Zehnder interferometers, which enables on-chip integration of silicon photodiodes and, thus, the realization of system-on-chip solutions. Our nanoparticle-based approach is based on optical observation of the dynamic response of functionalized magneticcore/ noble-metal-shell nanorods (`nanoprobes') to an externally applied time-varying magnetic field. As target molecules specifically bind to the surface of the nanoprobes, the observed dynamics of the nanoprobes changes, and the concentration of target molecules in the sample solution can be quantified. This approach is suitable for dynamic real-time measurements and only requires minimal sample preparation, thus presenting a highly promising point-of-care diagnostic system. In this paper, we present a prototype of a diagnostic device suitable for highly automated sample analysis by our nanoparticle-based approach.

  6. A paper based graphene-nanocauliflower hybrid composite for point of care biosensing

    Science.gov (United States)

    Burrs, S. L.; Sidhu, R.; Bhargava, M.; Kiernan-Lewis, J.; Schwalb, N.; Rong, Y.; Gomes, C.; Claussen, J.; Vanegas, D. C.; McLamore, E. S.

    2016-05-01

    Graphene paper has diverse applications in printed circuit board electronics, bioassays, 3D cell culture, and biosensing. Although development of nanometal-graphene hybrid composites is commonplace in the sensing literature, to date there are only a few examples of nanometal-decorated graphene paper for use in biosensing. In this manuscript, we demonstrate the synthesis and application of Pt nano cauliflower-functionalized graphene paper for use in electrochemical biosensing of small molecules (glucose, acetone, methanol) or detection of pathogenic bacteria (Escherichia coli O157:H7). Raman spectroscopy, scanning electron microscopy and energy dispersive spectroscopy were used to show that graphene oxide deposited on nanocellulose crystals was partially reduced by both thermal and chemical treatment. Fractal platinum nanostructures were formed on the reduced graphene oxide paper, producing a conductive paper with an extremely high electroactive surface area, confirmed by cyclic voltammetry and electrochemical impedance spectroscopy. To show the broad applicability of the material, the platinum surface was functionalized with three different biomaterials: 1) glucose oxidase (via chitosan encapsulation); 2) a DNA aptamer (via covalent linking), or 3) a chemosensory protein (via his linking). We demonstrate the application of this device for point of care biosensing. The detection limit for both glucose (0.08 +/- 0.02 μM) and E. coli O157:H7 (1.3 +/- 0.1 CFU mL-1) were competitive with, or superior to, previously reported devices in the biosensing literature. The response time (6 sec for glucose and 10 min for E. coli) were also similar to silicon biochip and commercial electrode sensors. The results demonstrate that the nanocellulose-graphene-nanoplatinum material is an excellent paper-based platform for development of electrochemical biosensors targeting small molecules or whole cells for use in point of care biosensing.

  7. Point-of-care ultrasound education: the increasing role of simulation and multimedia resources.

    Science.gov (United States)

    Lewiss, Resa E; Hoffmann, Beatrice; Beaulieu, Yanick; Phelan, Mary Beth

    2014-01-01

    This article reviews the current technology, literature, teaching models, and methods associated with simulation-based point-of-care ultrasound training. Patient simulation appears particularly well suited for learning point-of-care ultrasound, which is a required core competency for emergency medicine and other specialties. Work hour limitations have reduced the opportunities for clinical practice, and simulation enables practicing a skill multiple times before it may be used on patients. Ultrasound simulators can be categorized into 2 groups: low and high fidelity. Low-fidelity simulators are usually static simulators, meaning that they have nonchanging anatomic examples for sonographic practice. Advantages are that the model may be reused over time, and some simulators can be homemade. High-fidelity simulators are usually high-tech and frequently consist of many computer-generated cases of virtual sonographic anatomy that can be scanned with a mock probe. This type of equipment is produced commercially and is more expensive. High-fidelity simulators provide students with an active and safe learning environment and make a reproducible standardized assessment of many different ultrasound cases possible. The advantages and disadvantages of using low- versus high-fidelity simulators are reviewed. An additional concept used in simulation-based ultrasound training is blended learning. Blended learning may include face-to-face or online learning often in combination with a learning management system. Increasingly, with simulation and Web-based learning technologies, tools are now available to medical educators for the standardization of both ultrasound skills training and competency assessment.

  8. Point of care nucleic acid detection of viable pathogenic bacteria with isothermal RNA amplification based paper biosensor

    Science.gov (United States)

    Liu, Hongxing; Xing, Da; Zhou, Xiaoming

    2014-09-01

    Food-borne pathogens such as Listeria monocytogenes have been recognized as a major cause of human infections worldwide, leading to substantial health problems. Food-borne pathogen identification needs to be simpler, cheaper and more reliable than the current traditional methods. Here, we have constructed a low-cost paper biosensor for the detection of viable pathogenic bacteria with the naked eye. In this study, an effective isothermal amplification method was used to amplify the hlyA mRNA gene, a specific RNA marker in Listeria monocytogenes. The amplification products were applied to the paper biosensor to perform a visual test, in which endpoint detection was performed using sandwich hybridization assays. When the RNA products migrated along the paper biosensor by capillary action, the gold nanoparticles accumulated at the designated Test line and Control line. Under optimized experimental conditions, as little as 0.5 pg/μL genomic RNA from Listeria monocytogenes could be detected. The whole assay process, including RNA extraction, amplification, and visualization, can be completed within several hours. The developed method is suitable for point-of-care applications to detect food-borne pathogens, as it can effectively overcome the false-positive results caused by amplifying nonviable Listeria monocytogenes.

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

    Science.gov (United States)

    2015-10-01

    Leishmania and is generally transmitted by the bite of sand flies of the genus Lutzomyia or Phlebotomus, The disease has significant global impact...because it is highly sensitive, fast, inexpensive and able to work at most ambient temperatures . Furthermore, RPA does not require refrigeration of...genus Lutzomyia or Phlebotomus, The disease has significant global impact, producing 10-20 million cases of leishmaniasis worldwide. Cutaneous

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

    Science.gov (United States)

    2015-10-01

    14. ABSTRACT Leishmaniasis is caused by the protozoan Leishmania and is generally transmitted by the bite of sand flies of the genus Lutzomyia or...diseases that can be used at the POC because it is highly sensitive, fast, inexpensive and able to work at most ambient temperatures . 15. SUBJECT...INTRODUCTION: Leishmaniasis is caused by the protozoan Leishmania and is generally transmitted by the bite of sand flies of the genus Lutzomyia

  11. Venous Thromboembolism Anticoagulation Therapy

    Institute of Scientific and Technical Information of China (English)

    刘泽霖

    2009-01-01

    @@ VTE of the main treatment for anticoagulant thera-py, anticoagulant therapy drug of choice for low molecu-lar weight heparin (LMWH) for the overwhelming major-ity of clinicians agree that long-term oral anticoagulant therapy is still Vit. K antagonist (mainly warfarin).

  12. Lab-on-DVD: standard DVD drives as a novel laser scanning microscope for image based point of care diagnostics.

    Science.gov (United States)

    Ramachandraiah, Harisha; Amasia, Mary; Cole, Jackie; Sheard, Paul; Pickhaver, Simon; Walker, Chris; Wirta, Valtteri; Lexow, Preben; Lione, Richard; Russom, Aman

    2013-04-21

    We present a novel "Lab-on-DVD" system and demonstrate its capability for rapid and low-cost HIV diagnostics by counting CD4+ cells isolated from whole blood. We show that a commercial DVD drive can, with certain modifications, be turned into an improved DVD-based laser scanning microscope (DVD-LSM). The system consists of a multi-layered disposable polymer disc and a modified commercial DVD reader with rotational control for sample handling, temperature control for optimized bioassay, a photodiode array for detection, and software for signal processing and user interface - all the necessary components required for a truly integrated lab-on-a-chip system, with the capability to deliver high-resolution images down to 1 μm in size. Using discs modified with antibodies, we specifically captured CD4+ cells from whole blood, demonstrating single cell resolution imaging. The novel integrated DVD platform with sub-micron image resolution brings, for the first time, affordable cellular diagnostic testing to the point-of-care and should be readily applicable at resource-limited settings.

  13. A multiplexed microfluidic PCR assay for sensitive and specific point-of-care detection of Chlamydia trachomatis.

    Directory of Open Access Journals (Sweden)

    Deborah Dean

    Full Text Available BACKGROUND: Chlamydia trachomatis (Ct is the most common cause of bacterial sexually transmitted diseases (STD worldwide. While commercial nucleic acid amplification tests (NAAT are available for Ct, none are rapid or inexpensive enough to be used at the point-of-care (POC. Towards the first Ct POC NAAT, we developed a microfluidic assay that simultaneously interrogates nine Ct loci in 20 minutes. METHODOLOGY AND PRINCIPAL FINDINGS: Endocervical samples were selected from 263 women at high risk for Ct STDs (∼35% prevalence. A head-to-head comparison was performed with the Roche-Amplicor NAAT. 129 (49.0% and 88 (33.5% samples were positive by multiplex and Amplicor assays, respectively. Sequencing resolved 71 discrepant samples, confirming 53 of 53 positive multiplex samples and 12 of 18 positive Amplicor samples. The sensitivity and specificity were 91.5% and 100%, and 62.4% and 95.9%, respectively, for multiplex and Amplicor assays. Positive and negative predictive values were 100% and 91%, and 94.1% and 68.6%, respectively. CONCLUSIONS: This is the first rapid multiplex approach to Ct detection, and the assay was also found to be superior to a commercial NAAT. In effect, nine simultaneous reactions significantly increased sensitivity and specificity. Our assay can potentially increase Ct detection in globally diverse clinical settings at the POC.

  14. Evaluation of a pan-serotype point-of-care rapid diagnostic assay for accurate detection of acute dengue infection.

    Science.gov (United States)

    Vivek, Rosario; Ahamed, Syed Fazil; Kotabagi, Shalini; Chandele, Anmol; Khanna, Ira; Khanna, Navin; Nayak, Kaustuv; Dias, Mary; Kaja, Murali-Krishna; Shet, Anita

    2017-03-01

    The catastrophic rise in dengue infections in India and globally has created a need for an accurate, validated low-cost rapid diagnostic test (RDT) for dengue. We prospectively evaluated the diagnostic performance of NS1/IgM RDT (dengue day 1) using 211 samples from a pediatric dengue cohort representing all 4 serotypes in southern India. The dengue-positive panel consisted of 179 dengue real-time polymerase chain reaction (RT-PCR) positive samples from symptomatic children. The dengue-negative panel consisted of 32 samples from dengue-negative febrile children and asymptomatic individuals that were negative for dengue RT-PCR/NS1 enzyme-linked immunosorbent assay/IgM/IgG. NS1/IgM RDT sensitivity was 89.4% and specificity was 93.8%. The NS1/IgM RDT showed high sensitivity throughout the acute phase of illness, in primary and secondary infections, in different severity groups, and detected all 4 dengue serotypes, including coinfections. This NS1/IgM RDT is a useful point-of-care assay for rapid and reliable diagnosis of acute dengue and an excellent surveillance tool in our battle against dengue.

  15. Blister pouches for effective reagent storage and release for low cost point-of-care diagnostic applications

    Science.gov (United States)

    Smith, Suzanne; Sewart, Rene; Land, Kevin; Roux, Pieter; Gärtner, Claudia; Becker, Holger

    2016-03-01

    Lab-on-a-chip devices are often applied to point-of-care diagnostic solutions as they are low-cost, compact, disposable, and require only small sample volumes. For such devices, various reagents are required for sample preparation and analysis and, for an integrated solution to be realized, on-chip reagent storage and automated introduction are required. This work describes the implementation and characterization of effective liquid reagent storage and release mechanisms utilizing blister pouches applied to various point-of-care diagnostic device applications. The manufacturing aspects as well as performance parameters are evaluated.

  16. Microfluidic-integrated biosensors: prospects for point-of-care diagnostics.

    Science.gov (United States)

    Kumar, Suveen; Kumar, Saurabh; Ali, Md Azahar; Anand, Pinki; Agrawal, Ved Varun; John, Renu; Maji, Sagar; Malhotra, Bansi D

    2013-11-01

    There is a growing demand to integrate biosensors with microfluidics to provide miniaturized platforms with many favorable properties, such as reduced sample volume, decreased processing time, low cost analysis and low reagent consumption. These microfluidics-integrated biosensors would also have numerous advantages such as laminar flow, minimal handling of hazardous materials, multiple sample detection in parallel, portability and versatility in design. Microfluidics involves the science and technology of manipulation of fluids at the micro- to nano-liter level. It is predicted that combining biosensors with microfluidic chips will yield enhanced analytical capability, and widen the possibilities for applications in clinical diagnostics. The recent developments in microfluidics have helped researchers working in industries and educational institutes to adopt some of these platforms for point-of-care (POC) diagnostics. This review focuses on the latest advancements in the fields of microfluidic biosensing technologies, and on the challenges and possible solutions for translation of this technology for POC diagnostic applications. We also discuss the fabrication techniques required for developing microfluidic-integrated biosensors, recently reported biomarkers, and the prospects of POC diagnostics in the medical industry.

  17. Multiplexed, rapid point of care platform to quantify allergen-specific IgE.

    Science.gov (United States)

    Monroe, M R; Reddington, A P; Cretich, M; Chiari, M; Little, F; Ünlü, M S

    2011-01-01

    Variation of probe immobilization on microarrays hinders the ability to make high quality, assertive and statistically relevant conclusions needed in the healthcare setting. To address this problem, we have developed a calibrated, compact, inexpensive, multiplexed, dual modality point-of-care detection platform that calibrates and correlates surface probe density measured label-free to captured labeled secondary antibody, is independent of chip-to-chip variability, and improves upon existing diagnostic technology. We have identified four major technological advantages of our proposed platform: the capability to perform single spot analysis based on the fluorophore used for detection, a 10-fold gain in fluorescence signal due to optimized substrate, a calibrated, quantitative method that uses the combined fluorescent and label-free modalities to accurately measure the density of probe and bound target for a variety of systems, and a compact measurement platform offering reliable and rapid results at the doctor's office. Already, we have formulated over a 90% linear correlation between the amount of probe bound to surface and the resulting fluorescence of captured target for IgG, β-lactoglobulin, Ara h 1 peanut allergen, and Phl 5a Timothy grass allergen.

  18. An embedded point-of-care malaria screening device for low-resource regions (Conference Presentation)

    Science.gov (United States)

    Das, Sayantan; Mandal, Subhamoy; Das, Debnath; Malviya, Richa; Garud, Hrushikesh T.; Ray, Ajoy K.

    2016-03-01

    In this article we propose a point-of-care screening device for the detection and identification of malaria parasite, plasmodium vivax, plasmodium malaria, plasmodium oval and plasmodium falciparum with a time frame of 15-20 minute. In our device we can provide 97-98% sensitivity for each species as we are using traditional staining methods for detecting the parasites. In addition, as we are also quantifying the parasites, it is possible to provide an accurate estimate about the malarial stage of the patient. The image processing approach increases the total numbers of samples screened by reducing interventions of trained pathologists. This helps in reducing the delays in screening process arising from increased number of potential cases based on seasonal and local variations. The same reduces mortality rate by faster diagnosis and reduced false negative detections (i.e. increased sensitivity). The system can also be integrated with telemedicine platform to obtain inputs from medical practitioners at tertiary healthcare units for diagnostic decision making. Through this paper, we present the functional prototype of this device containing all the integrated parts. The prototype incorporates image acquisition, image processing, storage, multimedia transmission and reporting environment for a low cost PDA device. It is a portable device capable of scanning slides. The acquired image will be preprocessed and processed to get desired output. The device is capable of transmitting and storing pathological information to database placed in a distant pathological center for further consultation.

  19. Point-of-care seeding of nitinol stents with blood-derived endothelial cells.

    Science.gov (United States)

    Jantzen, Alexandra E; Noviani, Maria; Mills, James S; Baker, Katherine M; Lin, Fu-Hsiung; Truskey, George A; Achneck, Hardean E

    2016-11-01

    Nitinol-based vascular devices, for example, peripheral and intracranial stents, are limited by thrombosis and restenosis. To ameliorate these complications, we developed a technology to promote vessel healing by rapidly seeding (QuickSeeding) autologous blood-derived endothelial cells (ECs) onto modified self-expanding nitinol stent delivery systems immediately before implantation. Several thousand micropores were laser-drilled into a delivery system sheath surrounding a commercial nitinol stent to allow for exit of an infused cell suspension. As suspension medium flowed outward through the micropores, ECs flowed through the delivery system attaching to the stent surface. The QuickSeeded ECs adhered to and spread on the stent surface following 24-h in vitro culture under static or flow conditions. Further, QuickSeeded ECs on stents that were deployed into porcine carotid arteries spread to endothelialize stent struts within 48 h (n = 4). The QuickSeeded stent struts produced significantly more nitric oxide in ex vivo flow circuits after 24 h, as compared to static conditions (n = 5). In conclusion, ECs QuickSeeded onto commercial nitinol stents within minutes of implantation spread to form a functional layer in vitro and in vivo, providing proof of concept that the novel QuickSeeding method with modified delivery systems can be used to seed functional autologous endothelium at the point of care. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1658-1665, 2016.

  20. Advanced yellow fever virus genome detection in point-of-care facilities and reference laboratories.

    Science.gov (United States)

    Domingo, Cristina; Patel, Pranav; Yillah, Jasmin; Weidmann, Manfred; Méndez, Jairo A; Nakouné, Emmanuel Rivalyn; Niedrig, Matthias

    2012-12-01

    Reported methods for the detection of the yellow fever viral genome are beset by limitations in sensitivity, specificity, strain detection spectra, and suitability to laboratories with simple infrastructure in areas of endemicity. We describe the development of two different approaches affording sensitive and specific detection of the yellow fever genome: a real-time reverse transcription-quantitative PCR (RT-qPCR) and an isothermal protocol employing the same primer-probe set but based on helicase-dependent amplification technology (RT-tHDA). Both assays were evaluated using yellow fever cell culture supernatants as well as spiked and clinical samples. We demonstrate reliable detection by both assays of different strains of yellow fever virus with improved sensitivity and specificity. The RT-qPCR assay is a powerful tool for reference or diagnostic laboratories with real-time PCR capability, while the isothermal RT-tHDA assay represents a useful alternative to earlier amplification techniques for the molecular diagnosis of yellow fever by field or point-of-care laboratories.

  1. Salivary Diagnostics—Point-of-Care diagnostics of MMP-8 in dentistry and medicine

    Directory of Open Access Journals (Sweden)

    Nilminie Rathnayake

    2017-01-01

    Full Text Available Human saliva is an easily accessible biological fluid and contains a variety of disease-related biomarkers, which makes it a potential diagnostic medium. The clinical use of salivary/oral fluid biomarkers to identify oral and systemic conditions requires the development of non-invasive screening and diagnostic technologies, and is among the main goals of oral fluid researchers. The analysis of the disease-specific oral and systemic biomarkers in saliva and oral fluids (i.e., mouth-rinse, gingival crevicular fluid (GCF and peri-implantitis sulcular fluid (PISF is demanding. Several factors influence their expression and release; these factors include the intracellular location, the molecular size and the flow characteristics of the biological fluid. The type of saliva/oral fluid utilized for the diagnostics affects the analysis. High sensitivity together with sophisticated methods and techniques are essential to get a useful outcome. We describe here a recently developed mouth-rinse that is practical, convenient and inexpensive, as well as PISF chair-side/point of care (PoC lateral-flow active matrix metalloproteinase (aMMP-8 immunoassays to detect, predict and monitor the course and treatment of periodontitis and peri-implantitis.

  2. Walsh-Hadamard Based 3D Steganography for Protecting Sensitive Information in Point-of-Care.

    Science.gov (United States)

    Abuadbba, Alsharif; Khalil, Ibrahim

    2016-11-29

    Remote points-of-care has recently had a lot of attention for their advantages such as saving lives and cost reduction. The transmitted streams usually contain (1) normal biomedical signals (e.g. ECG) and (2) highly private information (e.g. patient identity). Despite the obvious advantages, the primary concerns are privacy and authenticity of the transferred data. Therefore, this paper introduces a novel steganographic mechanism that ensures (1) strong privacy preservation of private information by random concealing inside the transferred signals employing a key, and (2) evidence of originality for the biomedical signals. To maximize hiding, Fast Walsh-Hadamard Transform is utilized to transform the signals into a group of coefficients. To ensure the lowest distortion, only less-significant values of coefficients are employed. To strengthen security, the key is utilized in a 3-Dimensional random coefficients' reform to produce a 3D order employed in the concealing process. The resultant distortion has been thoroughly measured in all stages. After extensive experiments on three types of signals, it has been proven that the algorithm has little impact on the genuine signals (< 1 %). The security evaluation also confirms that unlawful retrieval of the hidden information within rational time is mightily improbable.

  3. Wavelet-Based ECG Steganography for Protecting Patient Confidential Information in Point-of-Care Systems.

    Science.gov (United States)

    Ibaida, Ayman; Khalil, Ibrahim

    2013-12-01

    With the growing number of aging population and a significant portion of that suffering from cardiac diseases, it is conceivable that remote ECG patient monitoring systems are expected to be widely used as point-of-care (PoC) applications in hospitals around the world. Therefore, huge amount of ECG signal collected by body sensor networks from remote patients at homes will be transmitted along with other physiological readings such as blood pressure, temperature, glucose level, etc., and diagnosed by those remote patient monitoring systems. It is utterly important that patient confidentiality is protected while data are being transmitted over the public network as well as when they are stored in hospital servers used by remote monitoring systems. In this paper, a wavelet-based steganography technique has been introduced which combines encryption and scrambling technique to protect patient confidential data. The proposed method allows ECG signal to hide its corresponding patient confidential data and other physiological information thus guaranteeing the integration between ECG and the rest. To evaluate the effectiveness of the proposed technique on the ECG signal, two distortion measurement metrics have been used: the percentage residual difference and the wavelet weighted PRD. It is found that the proposed technique provides high-security protection for patients data with low (less than 1%) distortion and ECG data remain diagnosable after watermarking (i.e., hiding patient confidential data) and as well as after watermarks (i.e., hidden data) are removed from the watermarked data.

  4. Automatic indexing and retrieval of encounter-specific evidence for point-of-care support.

    Science.gov (United States)

    O'Sullivan, Dympna M; Wilk, Szymon A; Michalowski, Wojtek J; Farion, Ken J

    2010-08-01

    Evidence-based medicine relies on repositories of empirical research evidence that can be used to support clinical decision making for improved patient care. However, retrieving evidence from such repositories at local sites presents many challenges. This paper describes a methodological framework for automatically indexing and retrieving empirical research evidence in the form of the systematic reviews and associated studies from The Cochrane Library, where retrieved documents are specific to a patient-physician encounter and thus can be used to support evidence-based decision making at the point of care. Such an encounter is defined by three pertinent groups of concepts - diagnosis, treatment, and patient, and the framework relies on these three groups to steer indexing and retrieval of reviews and associated studies. An evaluation of the indexing and retrieval components of the proposed framework was performed using documents relevant for the pediatric asthma domain. Precision and recall values for automatic indexing of systematic reviews and associated studies were 0.93 and 0.87, and 0.81 and 0.56, respectively. Moreover, precision and recall for the retrieval of relevant systematic reviews and associated studies were 0.89 and 0.81, and 0.92 and 0.89, respectively. With minor modifications, the proposed methodological framework can be customized for other evidence repositories.

  5. The Value of Clinical Needs Assessments for Point-of-Care Diagnostics.

    Science.gov (United States)

    Weigl, Bernhard H; Gaydos, Charlotte A; Kost, Gerald; Beyette, Fred R; Sabourin, Stephanie; Rompalo, Anne; de Los Santos, Tala; McMullan, Jason T; Haller, John

    2012-06-01

    Most entrepreneurial ventures fail long before the core technology can be brought to the marketplace because of disconnects in performance and usability measures such as accuracy, cost, complexity, assay stability, and time requirements between technology developers' specifications and needs of the end-users. By going through a clinical needs assessment (CNA) process, developers will gain vital information and a clear focus that will help minimize the risks associated with the development of new technologies available for use within the health care system. This article summarizes best practices of the principal investigators of the National Institute of Biomedical Imaging and Bioengineering point-of-care (POC) centers within the National Institute of Biomedical Imaging and Bioengineering POC Technologies Research Network. Clinical needs assessments are particularly important for product development areas that do not sufficiently benefit from traditional market research, such as grant-funded research and development, new product lines using cutting-edge technologies developed in start-up companies, and products developed through product development partnerships for low-resource settings. The objectives of this article were to (1) highlight the importance of CNAs for development of POC devices, (2) discuss methods applied by POC Technologies Research Network for assessing clinical needs, and (3) provide a road map for future CNAs.

  6. Smartphone-Based Accurate Analysis of Retinal Vasculature towards Point-of-Care Diagnostics

    Science.gov (United States)

    Xu, Xiayu; Ding, Wenxiang; Wang, Xuemin; Cao, Ruofan; Zhang, Maiye; Lv, Peilin; Xu, Feng

    2016-01-01

    Retinal vasculature analysis is important for the early diagnostics of various eye and systemic diseases, making it a potentially useful biomarker, especially for resource-limited regions and countries. Here we developed a smartphone-based retinal image analysis system for point-of-care diagnostics that is able to load a fundus image, segment retinal vessels, analyze individual vessel width, and store or uplink results. The proposed system was not only evaluated on widely used public databases and compared with the state-of-the-art methods, but also validated on clinical images directly acquired with a smartphone. An Android app is also developed to facilitate on-site application of the proposed methods. Both visual assessment and quantitative assessment showed that the proposed methods achieved comparable results to the state-of-the-art methods that require high-standard workstations. The proposed system holds great potential for the early diagnostics of various diseases, such as diabetic retinopathy, for resource-limited regions and countries. PMID:27698369

  7. Point-of-care cardiac ultrasound techniques in the physical examination: better at the bedside.

    Science.gov (United States)

    Kimura, Bruce J

    2017-03-04

    The development of hand-carried, battery-powered ultrasound devices has created a new practice in ultrasound diagnostic imaging, called 'point-of-care' ultrasound (POCUS). Capitalising on device portability, POCUS is marked by brief and limited ultrasound imaging performed by the physician at the bedside to increase diagnostic accuracy and expediency. The natural evolution of POCUS techniques in general medicine, particularly with pocket-sized devices, may be in the development of a basic ultrasound examination similar to the use of the binaural stethoscope. This paper will specifically review how POCUS improves the limited sensitivity of the current practice of traditional cardiac physical examination by both cardiologists and non-cardiologists. Signs of left ventricular systolic dysfunction, left atrial enlargement, lung congestion and elevated central venous pressures are often missed by physical techniques but can be easily detected by POCUS and have prognostic and treatment implications. Creating a general set of repetitive imaging skills for these entities for application on all patients during routine examination will standardise and reduce heterogeneity in cardiac bedside ultrasound applications, simplify teaching curricula, enhance learning and recollection, and unify competency thresholds and practice. The addition of POCUS to standard physical examination techniques in cardiovascular medicine will result in an ultrasound-augmented cardiac physical examination that reaffirms the value of bedside diagnosis.

  8. Paper-based α-amylase detector for point-of-care diagnostics.

    Science.gov (United States)

    Dutta, Satarupa; Mandal, Nilanjan; Bandyopadhyay, Dipankar

    2016-04-15

    We report the fabrication of a paper-sensor for quantitative detection of α-amylase activity in human blood serum. Pieces of filter papers were coated with starch-iodine solution leading to an intense blue coloration on the surface. Dispensing α-amylase solution on the starch-iodine coated paper reduced the intensity of the color because of starch-hydrolysis catalyzed by amylase. The variation in the intensity of the color with the concentration of amylase was estimated in three stages: (i) initially, the paper-surface was illuminated with a light emitting diode, (ii) then, the transmitted (reflected) rays emitted through (from) the paper were collected on a photoresistor, and (iii) the variations in the electrical resistance of the photoresistor were correlated with the amylase concentration in analyte. The resistance of photoresistor decreased monotonically with an increase in amylase concentration because the intensity of the reflected (transmitted) rays collected from (through) the paper increased with reduction in the color intensity on the paper surface. Since a specific bio-reaction was employed to detect the activity of amylase, the sensor was found to be equally efficient in detecting unknown quantities of amylase in human blood serum. The reported sensor has shown the potential to graduate into a point-of-care detection tool for α-amylase.

  9. A single FPGA-based portable ultrasound imaging system for point-of-care applications.

    Science.gov (United States)

    Kim, Gi-Duck; Yoon, Changhan; Kye, Sang-Bum; Lee, Youngbae; Kang, Jeeun; Yoo, Yangmo; Song, Tai-kyong

    2012-07-01

    We present a cost-effective portable ultrasound system based on a single field-programmable gate array (FPGA) for point-of-care applications. In the portable ultrasound system developed, all the ultrasound signal and image processing modules, including an effective 32-channel receive beamformer with pseudo-dynamic focusing, are embedded in an FPGA chip. For overall system control, a mobile processor running Linux at 667 MHz is used. The scan-converted ultrasound image data from the FPGA are directly transferred to the system controller via external direct memory access without a video processing unit. The potable ultrasound system developed can provide real-time B-mode imaging with a maximum frame rate of 30, and it has a battery life of approximately 1.5 h. These results indicate that the single FPGA-based portable ultrasound system developed is able to meet the processing requirements in medical ultrasound imaging while providing improved flexibility for adapting to emerging POC applications.

  10. Paper-based capacitive sensors for identification and quantification of chemicals at the point of care.

    Science.gov (United States)

    Hu, Jie; Yew, Chee-Hong Takahiro; Chen, Xiaoshuang; Feng, Shangsheng; Yang, Qu; Wang, Shuqi; Wee, Wei-Hong; Pingguan-Murphy, Belinda; Lu, Tian Jian; Xu, Feng

    2017-04-01

    The identification and quantification of chemicals play a vital role in evaluation and surveillance of environmental health and safety. However, current techniques usually depend on costly equipment, professional staff, and/or essential infrastructure, limiting their accessibility. In this work, we develop paper-based capacitive sensors (PCSs) that allow simple, rapid identification and quantification of various chemicals from microliter size samples with the aid of a handheld multimeter. PCSs are low-cost parallel-plate capacitors (~$0.01 per sensor) assembled from layers of aluminum foil and filter paper via double-sided tape. The developed PCSs can identify different kinds of fluids (e.g., organic chemicals) and quantify diverse concentrations of substances (e.g., heavy metal ions) based on differences in dielectric properties, including capacitance, frequency spectrum, and dielectric loss tangent. The PCS-based method enables chemical identification and quantification to take place much cheaply, simply, and quickly at the point-of-care (POC), holding great promise for environmental monitoring in resource-limited settings.

  11. Surgeon-performed point-of-care ultrasound in severe eye trauma: Report of two cases

    Science.gov (United States)

    Abu-Zidan, Fikri M; Balac, Korana; Bhatia, Chetana Anand

    2016-01-01

    The indications of point-of-care ultrasound (POCUS) in the management of multiple trauma patients have been expanding. Although computed tomography (CT) scan of the orbit remains the gold standard for imaging orbital trauma, ultrasound is a quick, safe, and portable tool that can be performed bedside. Here we report two patients who had severe eye injuries with major visual impairment where surgeon-performed POCUS was very useful. One had a foreign body injury while the other had blunt trauma. POCUS was done using a linear probe under sterile conditions with minimum pressure on the eyes. Ultrasound showed a foreign body at the back of the left eye globe touching the eye globe in the first patient, and was normal in the second patient. Workup using CT scan, fundsocopy, optical coherence tomography, and magnetic resonance imaging of the orbits confirmed these findings. The first patient had vitreous and sub retinal haemorrhage and a full thickness macular hole of the left eye, while the second had traumatic optic neuropathy. POCUS gave accurate information concerning severe eye injuries. Trauma surgeons and emergency physicians should be trained in performing ocular ultrasound for eye injuries.

  12. Application of a point of care creatinine device for trend monitoring in kidney transplant patients: Fit for purpose?

    NARCIS (Netherlands)

    Lint, C.L. van; Boog, P.J.M. van der; Romijn, F.P.H.T.M.; Schenk, P.W.; Dijk, S. van; Rövekamp, T.J.M.; Kessler, A.; Siekmann, L.; Rabelink, T.J.; Cobbaert, C.M.

    2015-01-01

    Background: The StatSensor® Xpress-i™, a point-of-care system for blood creatinine measurement, offers patients the possibility of self-monitoring creatinine. In this study, the analytical performance of the StatSensor® for both detecting current renal function and monitoring renal (dys)function in

  13. 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...

  14. Planning for the integration of the digital library, clinical decision support, and evidence at the point of care.

    Science.gov (United States)

    Schwartz, Linda Matula; Iobst, Barbara

    2008-01-01

    Integrating knowledge-based resources at the point of care is an important opportunity for hospital library involvement. In the progression of an IAIMS planning grant, the digital library is recognized as pivotal to the success of information domain integration throughout the institution. The planning process, data collection, and evolution of the planning project are discussed.

  15. Personal Digital Assistants as Point-of-Care Tools in Long-Term Care Facilities: A Pilot Study

    Science.gov (United States)

    Qadri, Syeda S.; Wang, Jia; Ruiz, Jorge G.; Roos, Bernard A.

    2009-01-01

    This study used both survey and interview questionnaires. It was designed to assess the feasibility, usability, and utility of two point-of-care tools especially prepared with information relevant for dementia care by staff nurses in a small, a medium-sized, and a large nursing home in Florida. Twenty-five LPN or RN nurses were recruited for the…

  16. Point-of-care diagnosis and prognostication of cryptococcal meningitis with the cryptococcal antigen lateral flow assay on cerebrospinal fluid.

    Science.gov (United States)

    Kabanda, Taseera; Siedner, Mark J; Klausner, Jeffrey D; Muzoora, Conrad; Boulware, David R

    2014-01-01

    The cryptococcal antigen (CRAG) lateral flow assay (LFA) had 100% sensitivity and specificity on cerebrospinal fluid samples. Pretreatment LFA titers correlated with quantitative cultures (R(2) = 0.7) and predicted 2- and 10-week mortality. The CRAG LFA is an accurate diagnostic assay for CSF and should be considered for point-of-care diagnosis of cryptococcal meningitis.

  17. Sampling and detection of airborne influenza virus towards point-of-care applications

    Science.gov (United States)

    Ladhani, Laila; Meeuws, Hanne; van Wesenbeeck, Liesbeth; Schmidt, Kristiane; Stuyver, Lieven; van der Wijngaart, Wouter

    2017-01-01

    Airborne transmission of the influenza virus contributes significantly to the spread of this infectious pathogen, particularly over large distances when carried by aerosol droplets with long survival times. Efficient sampling of virus-loaded aerosol in combination with a low limit of detection of the collected virus could enable rapid and early detection of airborne influenza virus at the point-of-care setting. Here, we demonstrate a successful sampling and detection of airborne influenza virus using a system specifically developed for such applications. Our system consists of a custom-made electrostatic precipitation (ESP)-based bioaerosol sampler that is coupled with downstream quantitative polymerase chain reaction (qPCR) analysis. Aerosolized viruses are sampled directly into a miniaturized collector with liquid volume of 150 μL, which constitutes a simple and direct interface with subsequent biological assays. This approach reduces sample dilution by at least one order of magnitude when compared to other liquid-based aerosol bio-samplers. Performance of our ESP-based sampler was evaluated using influenza virus-loaded sub-micron aerosols generated from both cultured and clinical samples. Despite the miniaturized collection volume, we demonstrate a collection efficiency of at least 10% and sensitive detection of a minimum of 3721 RNA copies. Furthermore, we show that an improved extraction protocol can allow viral recovery of down to 303 RNA copies and a maximum sampler collection efficiency of 47%. A device with such a performance would reduce sampling times dramatically, from a few hours with current sampling methods down to a couple of minutes with our ESP-based bioaerosol sampler. PMID:28350811

  18. Pilot Point-of-Care Ultrasound Curriculum at Harvard Medical School: Early Experience

    Science.gov (United States)

    Rempell, Joshua S.; Saldana, Fidencio; DiSalvo, Donald; Kumar, Navin; Stone, Michael B.; Chan, Wilma; Luz, Jennifer; Noble, Vicki E.; Liteplo, Andrew; Kimberly, Heidi; Kohler, Minna J.

    2016-01-01

    Introduction Point-of-care ultrasound (POCUS) is expanding across all medical specialties. As the benefits of US technology are becoming apparent, efforts to integrate US into pre-clinical medical education are growing. Our objective was to describe our process of integrating POCUS as an educational tool into the medical school curriculum and how such efforts are perceived by students. Methods This was a pilot study to introduce ultrasonography into the Harvard Medical School curriculum to first- and second-year medical students. Didactic and hands-on sessions were introduced to first-year students during gross anatomy and to second-year students in the physical exam course. Student-perceived attitudes, understanding, and knowledge of US, and its applications to learning the physical exam, were measured by a post-assessment survey. Results All first-year anatomy students (n=176) participated in small group hands-on US sessions. In the second-year physical diagnosis course, 38 students participated in four sessions. All students (91%) agreed or strongly agreed that additional US teaching should be incorporated throughout the four-year medical school curriculum. Conclusion POCUS can effectively be integrated into the existing medical school curriculum by using didactic and small group hands-on sessions. Medical students perceived US training as valuable in understanding human anatomy and in learning physical exam skills. This innovative program demonstrates US as an additional learning modality. Future goals include expanding on this work to incorporate US education into all four years of medical school. PMID:27833681

  19. Nano-engineered flexible pH sensor for point-of-care urease detection

    Science.gov (United States)

    Sardarinejad, A.; Maurya, D. K.; Tay, C. Y.; Marshall, B. J.; Alameh, K.

    2015-12-01

    Accurate pH monitoring is crucial for many applications, such as, water quality monitoring, blood monitoring, chemical and biological analyses, environmental monitoring and clinical diagnostic. The most common technique for pH measurement is based on the use of conventional glass pH electrodes. Glass electrodes have several limitations, such as mechanical fragility, large size, limited shapes and high cost, making them impractical for implementation as Lab-onchips and pH sensor capsules. Various metal oxides, such as RuO2, IrO2, TiO2, SnO2, Ta2O5 and PdO have recently been proposed for the realization of pH sensing electrodes. Specifically, ruthenium oxide exhibits unique properties including thermal stability, excellent corrosion resistance, low hysteresis high sensitivity, and low resistivity. In this paper, we demonstrate the concept of a miniaturized ion selective electrode (ISE) based pH sensor for point-of-care urease monitoring. The sensor comprises a thin film RuO2 on platinum sensing electrode, deposited using E-beam and R.F. magnetron sputtering, in conjunction with an integrated Ag/AgCl reference electrode. The performance and characterization of the developed pH/urea sensors in terms of sensitivity, resolution, reversibility and hysteresis are investigated. Experimental results show a linear potential-versus-urea-concentration response for urea concentrations in the range 0 - 180 mg/ml. Experimental results demonstrate super-Nernstian slopes in the range of 64.33 mV/pH - 73.83 mV/pH for RF sputtered RuO2 on platinum sensing electrode using a 80%:20% Ar:O2 gas ratio. The RuO2 sensor exhibits stable operation and fast dynamic response, making it attractive for in vivo use, wearable and flexible biomedical sensing applications.

  20. Accuracy of point-of-care blood glucose measurements in critically ill patients in shock.

    Science.gov (United States)

    Garingarao, Carlo Jan Pati-An; Buenaluz-Sedurante, Myrna; Jimeno, Cecilia Alegado

    2014-09-01

    A widely used method in monitoring glycemic status of ICU patients is point-of-care (POC) monitoring devices. A possible limitation to this method is altered peripheral blood flow in patients in shock, which may result in over/underestimations of their true glycemic status. This study aims to determine the accuracy of blood glucose measurements with a POC meter compared to laboratory methods in critically ill patients in shock. POC blood glucose was measured with a glucose-1-dehydrogenase-based reflectometric meter. The reference method was venous plasma glucose measured by a clinical chemistry analyzer (glucose oxidase-based). Outcomes assessed were concordance to ISO 15197:2003 minimum accuracy criteria for glucose meters, bias in glucose measurements obtained by the 2 methods using Bland-Altman analysis, and clinical accuracy through modified error grid analysis. A total of 186 paired glucose measurements were obtained. ISO 2003 accuracy criteria were met in 95.7% and 79.8% of POC glucose values in the normotensive and hypotensive group, respectively. Mean bias for the normotensive group was -12.4 mg/dL, while mean bias in the hypotensive group was -34.9 mg/dL. POC glucose measurements within the target zone for clinical accuracy were 90.2% and 79.8% for the normotensive and hypotensive group, respectively. POC blood glucose measurements were significantly less accurate in the hypotensive subgroup of ICU patients compared to the normotensive group. We recommend a lower threshold in confirming POC blood glucose with a central laboratory method if clinically incompatible. In light of recently updated accuracy standards, we also recommend alternative methods of glucose monitoring for the ICU population as a whole regardless of blood pressure status.

  1. Anticoagulation for Prosthetic Valves

    Directory of Open Access Journals (Sweden)

    Tsuyoshi Kaneko

    2013-01-01

    Full Text Available Implantation of prosthetic valve requires consideration for anticoagulation. The current guideline recommends warfarin on all mechanical valves. Dabigatran is the new generation anticoagulation medication which is taken orally and does not require frequent monitoring. This drug is approved for treatment for atrial fibrillation and venous thromboembolism, but the latest large trial showed that this drug increases adverse events when used for mechanical valve anticoagulation. On-X valve is the new generation mechanical valve which is considered to require less anticoagulation due to its flow dynamics. The latest study showed that lower anticoagulation level lowers the incidence of bleeding, while the risk of thromboembolism and thrombosis remained the same. Anticoagulation poses dilemma in cases such as pregnancy and major bleeding event. During pregnancy, warfarin can be continued throughout pregnancy and switched to heparin derivative during 6–12 weeks and >36 weeks of gestation. Warfarin can be safely started after 1-2 weeks of discontinuation following major bleeding episode.

  2. Anticoagulation in the Elderly

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    Helia Robert-Ebadi

    2010-12-01

    Full Text Available Management of anticoagulation in elderly patients represents a particularly challenging issue. Indeed, this patient population is at high thromboembolic risk, but also at high hemorrhagic risk. Assessment of the benefit-risk balance of anticoagulation is the key point when decisions are made about introducing and/or continuing such treatments in the individual elderly patient. In order to maximise the safety of anticoagulation in the elderly, some specific considerations need to be taken into account, including renal insufficiency, modified pharmacodynamics of anticoagulants, especially vitamin K antagonists, and the presence of multiple comorbidities and concomitant medications. New anticoagulants could greatly simplify and possibly increase the safety of anticoagulation in the elderly in the near future.

  3. An integrated rotary microfluidic system with DNA extraction, loop-mediated isothermal amplification, and lateral flow strip based detection for point-of-care pathogen diagnostics.

    Science.gov (United States)

    Park, Byung Hyun; Oh, Seung Jun; Jung, Jae Hwan; Choi, Goro; Seo, Ji Hyun; Kim, Do Hyun; Lee, Eun Yeol; Seo, Tae Seok

    2017-05-15

    Point-of-care (POC) molecular diagnostics plays a pivotal role for the prevention and treatment of infectious diseases. In spite of recent advancement in microfluidic based POC devices, there are still rooms for development to realize rapid, automatic and cost-effective sample-to-result genetic analysis. In this study, we propose an integrated rotary microfluidic system that is capable of performing glass microbead based DNA extraction, loop mediated isothermal amplification (LAMP), and colorimetric lateral flow strip based detection in a sequential manner with an optimized microfluidic design and a rotational speed control. Rotation direction-dependent coriolis force and siphon valving structures enable us to perform the fluidic control and metering, and the use of the lateral flow strip as a detection method renders all the analytical processes for nucleic acid test simplified and integrated without the need of expensive instruments or human intervention. As a proof of concept for point-of-care DNA diagnostics, we identified the food-borne bacterial pathogen which was contaminated in water or milk. Not only monoplex Salmonella Typhimurium but also multiplex Salmonella Typhimurium and Vibrio parahaemolyticus were analysed on the integrated rotary genetic analysis microsystem with a limit of detection of 50 CFU in 80min. In addition, three multiple samples were simultaneously analysed on a single device. The sample-to-result capability of the proposed microdevice provides great usefulness in the fields of clinical diagnostics, food safety and environment monitoring.

  4. Detection of ESKAPE Bacterial Pathogens at the Point of Care Using Isothermal DNA-Based Assays in a Portable Degas-Actuated Microfluidic Diagnostic Assay Platform.

    Science.gov (United States)

    Renner, Lars D; Zan, Jindong; Hu, Linda I; Martinez, Manuel; Resto, Pedro J; Siegel, Adam C; Torres, Clint; Hall, Sara B; Slezak, Tom R; Nguyen, Tuan H; Weibel, Douglas B

    2017-02-15

    An estimated 1.5 billion microbial infections occur globally each year and result in ∼4.6 million deaths. A technology gap associated with commercially available diagnostic tests in remote and underdeveloped regions prevents timely pathogen identification for effective antibiotic chemotherapies for infected patients. The result is a trial-and-error approach that is limited in effectiveness, increases risk for patients while contributing to antimicrobial drug resistance, and reduces the lifetime of antibiotics. This paper addresses this important diagnostic technology gap by describing a low-cost, portable, rapid, and easy-to-use microfluidic cartridge-based system for detecting the ESKAPE (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.) bacterial pathogens that are most commonly associated with antibiotic resistance. The point-of-care molecular diagnostic system consists of a vacuum-degassed microfluidic cartridge preloaded with lyophilized recombinase polymerase amplification (RPA) assays and a small portable battery-powered electronic incubator/reader. The isothermal RPA assays detect the targeted ESKAPE pathogens with high sensitivity (e.g., a limit of detection of ∼10 nucleic acid molecules) that is comparable to that of current PCR-based assays, and they offer advantages in power consumption, engineering, and robustness, which are three critical elements required for the point-of-care setting.

  5. Low-cost computing and network communication for a point-of-care device to perform a 3-part leukocyte differential

    Science.gov (United States)

    Powless, Amy J.; Feekin, Lauren E.; Hutcheson, Joshua A.; Alapat, Daisy V.; Muldoon, Timothy J.

    2016-03-01

    Point-of-care approaches for 3-part leukocyte differentials (granulocyte, monocyte, and lymphocyte), traditionally performed using a hematology analyzer within a panel of tests called a complete blood count (CBC), are essential not only to reduce cost but to provide faster results in low resource areas. Recent developments in lab-on-a-chip devices have shown promise in reducing the size and reagents used, relating to a decrease in overall cost. Furthermore, smartphone diagnostic approaches have shown much promise in the area of point-of-care diagnostics, but the relatively high per-unit cost may limit their utility in some settings. We present here a method to reduce computing cost of a simple epi-fluorescence imaging system using a Raspberry Pi (single-board computer, count and differential from a low volume (blood obtained via fingerstick. Additionally, the system utilizes a "cloud-based" approach to send image data from the Raspberry Pi to a main server and return results back to the user, exporting the bulk of the computational requirements. Six images were acquired per minute with up to 200 cells per field of view. Preliminary results showed that the differential count varied significantly in monocytes with a 1 minute time difference indicating the importance of time-gating to produce an accurate/consist differential.

  6. The Urine Circulating Cathodic Antigen (CCA) Dipstick: A Valid Substitute for Microscopy for Mapping and Point-Of-Care Diagnosis of Intestinal Schistosomiasis

    Science.gov (United States)

    Sousa-Figueiredo, José Carlos; Betson, Martha; Kabatereine, Narcis B.; Stothard, J. Russell

    2013-01-01

    Background The World Health Organization now recommends the provision of praziquantel treatment to preschool-aged children infected with schistosomiasis. For intestinal schistosomiasis the current operational field diagnostic standard is examination of a thick Kato-Katz smear by microscopy prepared from a single stool specimen, and although pragmatic, this methodology has well-known shortcomings. Here, as a potential alternative, the performance of the urine circulating cathodic antigen (CCA) dipstick test was assessed in terms of disease-mapping and point-of-care diagnosis for intestinal schistosomiasis in preschool-aged children. Our manuscript reports on findings at baseline and at the end of a one-year longitudinal treatment study. Methodology/Principal Findings A total of 925 children (mean age 2.8 years) were initially recruited from six lakeshore villages representative of high, moderate and low levels of disease transmission. At baseline, all children were tested for intestinal schistosomiasis by microscopic examination of duplicate Kato-Katz smears prepared from a single stool faecal, by antigen detection with the urine CCA dipstick test and by serology with a commercially available ELISA test (as ‘gold-standard’) that measures host antibody titres to soluble egg antigens. As a point-of-care diagnosis, the urine CCA dipstick test achieved sensitivity and specificity values ranging from 52.5–63.2% and 57.7–75.6%, respectively, with faecal microscopy achieving very high specificities (>87%) but sensitivities as low as 16.7% in the low transmission setting. Conclusion/Significance The urine CCA test was shown to be more effective than faecal microscopy especially in lower transmission settings. The diagnostic performance of this test was not significantly impacted by treatment history or co-infections with other intestinal helminths. PMID:23359826

  7. The urine circulating cathodic antigen (CCA dipstick: a valid substitute for microscopy for mapping and point-of-care diagnosis of intestinal schistosomiasis.

    Directory of Open Access Journals (Sweden)

    José Carlos Sousa-Figueiredo

    Full Text Available BACKGROUND: The World Health Organization now recommends the provision of praziquantel treatment to preschool-aged children infected with schistosomiasis. For intestinal schistosomiasis the current operational field diagnostic standard is examination of a thick Kato-Katz smear by microscopy prepared from a single stool specimen, and although pragmatic, this methodology has well-known shortcomings. Here, as a potential alternative, the performance of the urine circulating cathodic antigen (CCA dipstick test was assessed in terms of disease-mapping and point-of-care diagnosis for intestinal schistosomiasis in preschool-aged children. Our manuscript reports on findings at baseline and at the end of a one-year longitudinal treatment study. METHODOLOGY/PRINCIPAL FINDINGS: A total of 925 children (mean age 2.8 years were initially recruited from six lakeshore villages representative of high, moderate and low levels of disease transmission. At baseline, all children were tested for intestinal schistosomiasis by microscopic examination of duplicate Kato-Katz smears prepared from a single stool faecal, by antigen detection with the urine CCA dipstick test and by serology with a commercially available ELISA test (as 'gold-standard' that measures host antibody titres to soluble egg antigens. As a point-of-care diagnosis, the urine CCA dipstick test achieved sensitivity and specificity values ranging from 52.5-63.2% and 57.7-75.6%, respectively, with faecal microscopy achieving very high specificities (>87% but sensitivities as low as 16.7% in the low transmission setting. CONCLUSION/SIGNIFICANCE: The urine CCA test was shown to be more effective than faecal microscopy especially in lower transmission settings. The diagnostic performance of this test was not significantly impacted by treatment history or co-infections with other intestinal helminths.

  8. A Quality Management Approach to Implementing Point-of-Care Technologies for HIV Diagnosis and Monitoring in Sub-Saharan Africa

    Directory of Open Access Journals (Sweden)

    Joseph P. Shott

    2012-01-01

    Full Text Available Technology advances in rapid diagnosis and clinical monitoring of human immunodeficiency virus (HIV infection have been made in recent years, greatly benefiting those at risk of HIV infection, those needing care and treatment, and those on antiretroviral (ART therapy in sub-Saharan Africa. However, resource-limited, geographically remote, and harsh climate regions lack uniform access to these technologies. HIV rapid diagnostic tests (RDTs and monitoring tools, such as those for CD4 counts, as well as tests for coinfections, are being developed and have great promise in these settings to aid in patient care. Here we explore the advances in point-of-care (POC technology in the era where portable devices are bringing the laboratory to the patient. Quality management approaches will be imperative for the successful implementation of POC testing in endemic settings to improve patient care.

  9. Synthesis and applications of magnetic nanoparticles for biorecognition and point of care medical diagnostics.

    Science.gov (United States)

    Sandhu, Adarsh; Handa, Hiroshi; Abe, Masanori

    2010-11-05

    ' by nanometer sized 'target beads', enabling the detection of small concentrations of beads as small as 8 nm in 'pumpless' microcapillary systems. Finally, we describe a 'label-less homogeneous' procedure referred to as 'magneto-optical transmission (MT) sensing', where the optical transmission of a solution containing rotating linear chains of magnetic nanobeads was used to detect biomolecules with pM-level sensitivity with a dynamic range of more than four orders of magnitude. Our research on the synthesis and applications of nanoparticles is particularly suitable for point of care diagnostics.

  10. TOPICAL REVIEW: Synthesis and applications of magnetic nanoparticles for biorecognition and point of care medical diagnostics

    Science.gov (United States)

    Sandhu, Adarsh; Handa, Hiroshi; Abe, Masanori

    2010-11-01

    beads' by nanometer sized 'target beads', enabling the detection of small concentrations of beads as small as 8 nm in 'pumpless' microcapillary systems. Finally, we describe a 'label-less homogeneous' procedure referred to as 'magneto-optical transmission (MT) sensing', where the optical transmission of a solution containing rotating linear chains of magnetic nanobeads was used to detect biomolecules with pM-level sensitivity with a dynamic range of more than four orders of magnitude. Our research on the synthesis and applications of nanoparticles is particularly suitable for point of care diagnostics.

  11. Synthesis and applications of magnetic nanoparticles for biorecognition and point of care medical diagnostics

    Energy Technology Data Exchange (ETDEWEB)

    Sandhu, Adarsh [Electronics-Inspired Interdisciplinary Research Institute (EIIRIS), Toyohashi University of Technology, 1-1 Hibarigaoka, Tempaku, Toyohashi 441-8580 (Japan); Handa, Hiroshi [Integrated Research Institute, Tokyo Institute of Technology, Yokohama 226-8503 (Japan); Abe, Masanori [Department of Electrical and Electronic Engineering, Tokyo Institute of Technology, 2-12-1 O-okayama, Meguro-ku, Tokyo 152-8552 (Japan)

    2010-11-05

    sized 'probe beads' by nanometer sized 'target beads', enabling the detection of small concentrations of beads as small as 8 nm in 'pumpless' microcapillary systems. Finally, we describe a 'label-less homogeneous' procedure referred to as 'magneto-optical transmission (MT) sensing', where the optical transmission of a solution containing rotating linear chains of magnetic nanobeads was used to detect biomolecules with pM-level sensitivity with a dynamic range of more than four orders of magnitude. Our research on the synthesis and applications of nanoparticles is particularly suitable for point of care diagnostics. (topical review)

  12. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies.

    Directory of Open Access Journals (Sweden)

    Etienne Gayat

    Full Text Available BACKGROUND: Measurement of blood hemoglobin (Hb concentration is a routine procedure. Using a non-invasive point-of-care device reduces pain and discomfort for the patient and allows time saving in patient care. The aims of the present study were to assess the concordance of Hb levels obtained non-invasively with the Pronto-7 monitor (version 2.1.9, Masimo Corporation, Irvine, USA or with the NBM-200MP monitor (Orsense, Nes Ziona, Israel and the values obtained from the usual colorimetric method using blood samples and to determine the source of discordance. METHODS AND FINDINGS: We conducted two consecutive prospective open trials enrolling patients presenting in the emergency department of a university hospital. The first was designed to assess Pronto-7™ and the second NBM-200MP™. In each study, the main outcome measure was the agreement between both methods. Independent factors associated with the bias were determined using multiple linear regression. Three hundred patients were prospectively enrolled in each study. For Pronto-7™, the absolute mean difference was 0.56 g.L(-1 (95% confidence interval [CI] 0.41 to 0.69 with an upper agreement limit at 2.94 g.L(-1 (95% CI [2.70;3.19], a lower agreement limit at -1.84 g.L(-1 (95% CI [-2.08;-1.58] and an intra-class correlation coefficient at 0.80 (95% CI [0.74;0.84]. The corresponding values for the NBM-200MP™ were 0.21 [0.02;0.39], 3.42 [3.10;3.74], -3.01 [-3.32;-2.69] and 0.69 [0.62;0.75]. Multivariate analysis showed that age and laboratory values of hemoglobin were independently associated with the bias when using Pronto-7™, while perfusion index and laboratory value of hemoglobin were independently associated with the bias when using NBM-200MP™. CONCLUSION: Despite a relatively limited bias in both cases, the large limits of agreement found in both cases render the clinical usefulness of such devices debatable. For both devices, the bias is independently and inversely associated

  13. Highly-integrated lab-on-chip system for point-of-care multiparameter analysis.

    Science.gov (United States)

    Schumacher, Soeren; Nestler, Jörg; Otto, Thomas; Wegener, Michael; Ehrentreich-Förster, Eva; Michel, Dirk; Wunderlich, Kai; Palzer, Silke; Sohn, Kai; Weber, Achim; Burgard, Matthias; Grzesiak, Andrzej; Teichert, Andreas; Brandenburg, Albrecht; Koger, Birgit; Albers, Jörg; Nebling, Eric; Bier, Frank F

    2012-02-07

    A novel innovative approach towards a marketable lab-on-chip system for point-of-care in vitro diagnostics is reported. In a consortium of seven Fraunhofer Institutes a lab-on-chip system called "Fraunhofer ivD-platform" has been established which opens up the possibility for an on-site analysis at low costs. The system features a high degree of modularity and integration. Modularity allows the adaption of common and established assay types of various formats. Integration lets the system move from the laboratory to the point-of-need. By making use of the microarray format the lab-on-chip system also addresses new trends in biomedicine. Research topics such as personalized medicine or companion diagnostics show that multiparameter analyses are an added value for diagnostics, therapy as well as therapy control. These goals are addressed with a low-cost and self-contained cartridge, since reagents, microfluidic actuators and various sensors are integrated within the cartridge. In combination with a fully automated instrumentation (read-out and processing unit) a diagnostic assay can be performed in about 15 min. Via a user-friendly interface the read-out unit itself performs the assay protocol, data acquisition and data analysis. So far, example assays for nucleic acids (detection of different pathogens) and protein markers (such as CRP and PSA) have been established using an electrochemical read-out based on redoxcycling or an optical read-out based on total internal reflectance fluorescence (TIRF). It could be shown that the assay performance within the cartridge is similar to that found for the same assay in a microtiter plate. Furthermore, recent developments are the integration of sample preparation and polymerase chain reaction (PCR) on-chip. Hence, the instrument is capable of providing heating-and-cooling cycles necessary for DNA-amplification. In addition to scientific aspects also the production of such a lab-on-chip system was part of the development since

  14. A Review of Lawsuits Related to Point-of-Care Emergency Ultrasound Applications

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    Stolz, Lori

    2014-12-01

    Full Text Available Introduction: New medical technology brings the potential of lawsuits related to the usage of that new technology. In recent years the use of point-of-care (POC ultrasound has increased rapidly in the emergency department (ED. POC ultrasound creates potential legal risk to an emergency physician (EP either using or not using this tool. The aim of this study was to quantify and characterize reported decisions in lawsuits related to EPs performing POC ultrasound. Methods: We conducted a retrospective review of all United States reported state and federal cases in the Westlaw database. We assessed the full text of reported cases between January 2008 and December 2012. EPs with emergency ultrasound fellowship training reviewed the full text of each case. Cases were included if an EP was named, the patient encounter was in the emergency department, the interpretation or failure to perform an ultrasound was a central issue and the application was within the American College of Emergency Physician (ACEP ultrasound core applications. In order to assess deferred risk, cases that involved ultrasound examinations that could have been performed by an EP but were deferred to radiology were included. Results: We identified five cases. All reported decisions alleged a failure to perform an ultrasound study or a failure to perform it in a timely manner. All studies were within the scope of emergency medicine and were ACEP emergency ultrasound core applications. A majority of cases (n=4 resulted in a patient death. There were no reported cases of failure to interpret or misdiagnoses. Conclusion: In a five-year period from January 2008 through December 2012, five malpractice cases involving EPs and ultrasound examinations that are ACEP core emergency ultrasound applications were documented in the Westlaw database. All cases were related to failure to perform an ultrasound study or failure to perform a study in a timely manner and none involved failure to

  15. Assessment of Point-of-Care Diagnostics for G6PD Deficiency in Malaria Endemic Rural Eastern Indonesia.

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    Ari W Satyagraha

    2016-02-01

    Full Text Available Patients infected by Plasmodium vivax or Plasmodium ovale suffer repeated clinical attacks without primaquine therapy against latent stages in liver. Primaquine causes seriously threatening acute hemolytic anemia in patients having inherited glucose-6-phosphate dehydrogenase (G6PD deficiency. Access to safe primaquine therapy hinges upon the ability to confirm G6PD normal status. CareStart G6PD, a qualitative G6PD rapid diagnostic test (G6PD RDT intended for use at point-of-care in impoverished rural settings where most malaria patients live, was evaluated.This device and the standard qualitative fluorescent spot test (FST were each compared against the quantitative spectrophotometric assay for G6PD activity as the diagnostic gold standard. The assessment occurred at meso-endemic Panenggo Ede in western Sumba Island in eastern Indonesia, where 610 residents provided venous blood. The G6PD RDT and FST qualitative assessments were performed in the field, whereas the quantitative assay was performed in a research laboratory at Jakarta. The median G6PD activity ≥ 5 U/gHb was 9.7 U/gHb and was considered 100% of normal activity. The prevalence of G6PD deficiency by quantitative assessment (<5 U/gHb was 7.2%. Applying 30% of normal G6PD activity as the cut-off for qualitative testing, the sensitivity, specificity, positive predictive value, and negative predictive value for G6PD RDT versus FST among males were as follows: 100%, 98.7%, 89%, and 100% versus 91.7%, 92%, 55%, and 99%; P = 0.49, 0.001, 0.004, and 0.24, respectively. These values among females were: 83%, 92.7%, 17%, and 99.7% versus 100%, 92%, 18%, and 100%; P = 1.0, 0.89, 1.0 and 1.0, respectively.The overall performance of G6PD RDT, especially 100% negative predictive value, demonstrates suitable safety for G6PD screening prior to administering hemolytic drugs like primaquine and many others. Relatively poor diagnostic performance among females due to mosaic G6PD phenotype is an

  16. Point of care strategy for rapid diagnosis of novel A/H1N1 influenza virus.

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    Antoine Nougairede

    Full Text Available Within months of the emergence of the novel A/H1N1 pandemic influenza virus (nA/H1N1v, systematic screening for the surveillance of the pandemic was abandoned in France and in some other countries. At the end of June 2009, we implemented, for the public hospitals of Marseille, a Point Of Care (POC strategy for rapid diagnosis of the novel A/H1N1 influenza virus, in order to maintain local surveillance and to evaluate locally the kinetics of the pandemic.Two POC laboratories, located in strategic places, were organized to receive and test samples 24 h/24. POC strategy consisted of receiving and processing naso-pharyngeal specimens in preparation for the rapid influenza diagnostic test (RIDT and real-time RT-PCR assay (rtRT-PCR. This strategy had the theoretical capacity of processing up to 36 samples per 24 h. When the flow of samples was too high, the rtRT-PCR test was abandoned in the POC laboratories and transferred to the core virology laboratory. Confirmatory diagnosis was performed in the core virology laboratory twice a day using two distinct rtRT-PCR techniques that detect either influenza A virus or nA/N1N1v. Over a period of three months, 1974 samples were received in the POC laboratories, of which 111 were positive for nA/H1N1v. Specificity and sensitivity of RIDT were 100%, and 57.7% respectively. Positive results obtained using RIDT were transmitted to clinical practitioners in less than 2 hours. POC processed rtRT-PCR results were available within 7 hours, and rtRT-PCR confirmation within 24 hours.The POC strategy is of benefit, in all cases (with or without rtRT-PCR assay, because it provides continuous reception/processing of samples and reduction of the time to provide consolidated results to the clinical practitioners. We believe that implementation of the POC strategy for the largest number of suspect cases may improve the quality of patient care and our knowledge of the epidemiology of the pandemic.

  17. Influence of the sample anticoagulant on the measurements of impedance aggregometry in cardiac surgery

    Directory of Open Access Journals (Sweden)

    Cristina Solomon

    2008-10-01

    Full Text Available Cristina Solomon1, Michael Winterhalter1, Isabel Gilde1, Ludwig Hoy2, Andreas Calatzis3, Niels Rahe-Meyer11Department of Anesthesiology, Hannover Medical School, Hannover, Germany; 2Institute for Biometry, Hannover Medical School, Hannover, Germany; 3Department Hemostasis Transfusion Medicine, University Hospital Munich, Munich, GermanyBackground: The standard method of assessment of platelet function is represented by light transmission aggregometry (LTA, performed in citrated platelet-rich plasma (PRP. With LTA, decrease and subsequent post-cardiopulmonary bypass (CPB recovery of platelet function have been reported during cardiac surgery. Multiple electrode aggregometry (MEA may be used as point-of-care method to monitor perioperative changes in platelet function. Since MEA assesses macroaggregation which is influenced by the plasmatic levels of unbound calcium, citrate may be inadequate as anticoagulant for MEA. We used citrate and heparin for MEA samples, to see with which anticoagulant the intraoperative decrease and postoperative recovery in platelet function previously described with other aggregometric methods in cardiac surgery may be observed with MEA.Methods: Blood was obtained from 60 patients undergoing routine cardiac surgery and the samples were collected in standard tubes containing unfractionated heparin (50 U/mL or trisodium citrate (3.2%. The samples were obtained before CPB, at 30 minutes on CPB, end of CPB and on the first postoperative day. MEA was performed using the Multiplate® analyzer. Collagen (COLtest, 100 μg/mL and TRAP-6 (thrombin receptor activating peptide, TRAPtest, 1mM/mL were used as aggregation agonists.Results: Platelet aggregometric response decreased significantly during CPB. Platelet aggregation assessed using TRAP-6 as agonist on heparinized blood significantly correlated with the duration of CPB (r = −0.41, p = 0.001, 2-tailed Pearson test. The aggregometric analysis performed on the first

  18. Point of care information services: a platform for self-directed continuing medical education for front line decision makers.

    Science.gov (United States)

    Moja, Lorenzo; Kwag, Koren Hyogene

    2015-02-01

    The structure and aim of continuing medical education (CME) is shifting from the passive transmission of knowledge to a competency-based model focused on professional development. Self-directed learning is emerging as the foremost educational method for advancing competency-based CME. In a field marked by the constant expansion of knowledge, self-directed learning allows physicians to tailor their learning strategy to meet the information needs of practice. Point of care information services are innovative tools that provide health professionals with digested evidence at the front line to guide decision making. By mobilising self-directing learning to meet the information needs of clinicians at the bedside, point of care information services represent a promising platform for competency-based CME. Several points, however, must be considered to enhance the accessibility and development of these tools to improve competency-based CME and the quality of care.

  19. Development of printed-circuit-board based industry-compatible point-of-care biosensing and bioprocessing technology with applications

    OpenAIRE

    Tseng, Hsiu-Yang

    2015-01-01

    This thesis presents the development of a technology employing printed circuit board (PCB) technology to facilitate the performance and translation of point-of-care (POC) biosensing and bioprocessing devices toward practical products. Key features of the proposed technology are a universal, standardized platform and a set of techniques, featuring integrated functional units, three-dimensional (3D) configurations, convenient device-instrumentation interconnections, and industry-compatible prec...

  20. Experiences of registered nurses with regard to accessing health information at the point-of-care via mobile computing devices

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    Esmeralda Ricks

    2015-07-01

    Full Text Available Background: The volume of health information necessary to provide competent health care today has become overwhelming. Mobile computing devices are fast becoming an essential clinical tool for accessing health information at the point-of-care of patients.Objectives: This study explored and described how registered nurses experienced accessing information at the point-of-care via mobile computing devices (MCDs.Method: A qualitative, exploratory, descriptive and contextual design was used. Ten in–depth interviews were conducted with purposively sampled registered nurses employed by a state hospital in the Nelson Mandela Bay Municipality (NMBM. Interviews were recorded, transcribed verbatim and analysed using Tesch’s data analysis technique. Ethical principles were adhered to throughout the study. Guba’s model of trustworthiness was used to confirm integrity of the study.Results: Four themes emerged which revealed that the registered nurses benefited from the training they received by enabling them to develop, and improve, their computer literacy levels. Emphasis was placed on the benefits that the accessed information had for educational purposes for patients and the public, for colleagues and students. Furthermore the ability to access information at the point-of-care was considered by registered nurses as valuable to improve patient care because of the wide range of accurate and readily accessible information available via the mobile computing device.Conclusion: The registered nurses in this study felt that being able to access information at the point-of-care increased their confidence and facilitated the provision of quality care because it assisted them in being accurate and sure of what they were doing.

  1. PHP47 - Early assessment of highly innovative medical technology: clinical and economical gains of point-of-care applications for measuring potassium concentrations

    NARCIS (Netherlands)

    Wetering, G.; Hummel, J.M.; Montfoort, A.; IJzerman, M.J.

    2009-01-01

    OBJECTIVES: Innovative point-of-care diagnostics are likely to be having a strong impact on health care. The aim of this study is to conduct an early assessment of point-of-care chips. These chips can detect many particles and, consequently, many product-market combinations can be developed. This st

  2. Utility of the point of care CD4 analyzer, PIMA, to enumerate CD4 counts in the field settings in India

    Directory of Open Access Journals (Sweden)

    Thakar Madhuri

    2012-09-01

    Full Text Available Abstract Background In resource limited settings non-availability of CD4 count facility at the site could adversely affect the ART roll out programme. Point of care CD4 enumerating equipments can make the CD4 count available at the site of care and improve the patients’ management considerably. This study is aimed at determining the utility of a Point of Care PIMA CD4 analyzer (Alere, Germany in the field settings in India. Method The blood samples were collected from 1790 participants at 21 ART centers from different parts of the country and tested using PIMA and the reference methods (FACSCalibur, FACSCount and CyFlow SL3. The paired finger prick and venous blood samples from 175 participants were tested by the PIMA CD4 Analyzer and then by FACSCalibur. Result The CD4 counts obtained by PIMA CD4 analyzer showed excellent correlation with the counts obtained by the reference methods; for venous blood the Pearson’s r was 0.921, p 500 cells/mm3, the differences in the median CD4 counts obtained by the reference method and the PIMA analyzer were not significant (P > 0.05 and the relative bias were low (−7 to 5.1%. The Intermachine comparison showed variation within the acceptable limit of%CV of 10%. Conclusion In the field settings, the POC PIMA CD4 analyzer gave CD4 counts comparable to the reference methods for all CD4 ranges. The POC equipment could identify the patients eligible for ART in 91% cases. Adequate training is necessary for finger prick sample collection for optimum results. Decentralization of CD4 testing by making the CD4 counts available at primary health centers, especially in remote areas with minimum or no infrastructure would reduce the missed visits and improve adherence of the patients.

  3. Dental management of the anticoagulated patient.

    Science.gov (United States)

    Purcell, C A

    1997-09-01

    Most anticoagulated patients can be safely managed for routine dental treatment in the outpatient setting by following appropriate guidelines. Management should be based on the present level of anticoagulation as assessed by tests, in particular the international normalised ratio (INR), which should be carried out as close to the intervention as possible. A philosophy of minimal, if any, alteration to the level of anticoagulation should be adopted. This is particularly true for procedures producing minimal bleeding such as scaling and cleaning which, in the past, have resulted in patients having their INR lowered, with its attendant risks. The patient's anticoagulation is potentially life-saving and, where at all possible, should be maintained at therapeutic levels when therapy for non-threatening conditions is planned.

  4. Development of a microwave-accelerated metal-enhanced fluorescence 40 second, cfu/ml point of care assay for the detection of Chlamydia trachomatis.

    Science.gov (United States)

    Zhang, Yongxia; Agreda, Patricia; Kelley, Shannon; Gaydos, Charlotte; Geddes, Chris D

    2011-03-01

    An inexpensive technology to both lyse Chlamydia trachomatis (CT) and detect DNA released from CT within 40 s is demonstrated. In a microwave cavity, energy is highly focused using 100-nm gold films with "bow-tie" structures to lyse CT within 10 s. The ultrafast detection of the released DNA from less than 100 cfu/mL CT is accomplished in an additional 30 s by employing the microwave-accelerated metal-enhanced fluorescence technique. This new "release and detect" platform technology is a highly attractive alternative method for the lysing of bacteria, DNA extraction, and the fast quantification of bacteria and potentially other pathogenic species and cells as well. Our approach is a significant step forward for the development of a point of care test for CT.

  5. Point-of-care platelet function assays demonstrate reduced responsiveness to clopidogrel, but not aspirin, in patients with Drug-Eluting Stent Thrombosis whilst on dual antiplatelet therapy

    Directory of Open Access Journals (Sweden)

    Dawkins Keith D

    2008-02-01

    Full Text Available Abstract Background To test the hypothesis that point-of-care assays of platelet reactivity would demonstrate reduced response to antiplatelet therapy in patients who experienced Drug Eluting Stent (DES ST whilst on dual antiplatelet therapy compared to matched DES controls. Whilst the aetiology of stent thrombosis (ST is multifactorial there is increasing evidence from laboratory-based assays that hyporesponsiveness to antiplatelet therapy is a factor in some cases. Methods From 3004 PCI patients, seven survivors of DES ST whilst on dual antiplatelet therapy were identified and each matched with two patients without ST. Analysis was performed using (a short Thrombelastogram PlateletMapping™ (TEG and (b VerifyNow Aspirin and P2Y12 assays. TEG analysis was performed using the Area Under the Curve at 15 minutes (AUC15 as previously described. Results There were no differences in responses to aspirin. There was significantly greater platelet reactivity on clopidogrel in the ST group using the Accumetrics P2Y12 assay (183 ± 51 vs. 108 ± 31, p = 0.02 and a trend towards greater reactivity using TEG AUC15 (910 ± 328 vs. 618 ± 129, p = 0.07. 57% of the ST group by TEG and 43% of the ST cases by Accumetrics PRU had results > two standard deviations above the expected mean in the control group. Conclusion This study demonstrates reduced platelet response to clopidogrel in some patients with DES ST compared to matched controls. The availability of point-of-care assays that can detect these responses raises the possibility of prospectively identifying DES patients at risk of ST and manipulating their subsequent risk.

  6. Repurposed automated handheld counter as a point-of-care tool to identify individuals 'at risk' of serious post-ivermectin encephalopathy.

    Directory of Open Access Journals (Sweden)

    Sasisekhar Bennuru

    2014-09-01

    Full Text Available Administration of ivermectin (IVM as part of mass drug administration (MDA campaigns for onchocerciasis and/or lymphatic filariasis (LF has been suspended in areas co-endemic for Loa loa due to severe post-treatment adverse events (SAEs associated with high-burden of infection (>30,000 mf/ml. One simple approach for preventing SAEs is to identify and exclude individuals at risk from MDA. Here, we describe a repurposed hand-held automated cell counter (Scepter 2.0; HHAC as a rapid, point-of-care method for quantifying microfilariae (mf in the blood of infected individuals.The quantification of microfilarial levels in blood of naturally infected humans, experimentally infected baboons, or mf-spiked human blood was tested using a microfluidic-based automated counter and compared to traditional calibrated thick-smears. We demonstrate that mf can be quantified in 20 µl of whole blood following lysis with 10% saponin within a minute of obtaining blood. There was a highly significant concordance between the counts obtained by the HHAC and those by microscopy for mf densities of >5,000 (p30,000 per ml (p<0.0001, r(c = 0.90. Preliminary proof of concept field studies in Cameroon with 20 µl of blood from L. loa infected humans (n = 22 and baboons (n = 4 also demonstrated a significantly high concordance (p<0.0001, r(c = 0.89 with calibrated thick blood smears counts.A repurposed HHAC is a portable, sensitive, rapid, point-of-care and quantitative tool to identify individuals with high levels of L. loa mf that put them at risk for SAEs following MDA. In addition, it provides ease of data storage and accessibility.

  7. Accuracy of point-of-care lung ultrasonography for the diagnosis of cardiogenic pulmonary edema in dogs and cats with acute dyspnea.

    Science.gov (United States)

    Ward, Jessica L; Lisciandro, Gregory R; Keene, Bruce W; Tou, Sandra P; DeFrancesco, Teresa C

    2017-03-15

    OBJECTIVE To determine the accuracy of a point-of-care lung ultrasonography (LUS) protocol designed to diagnose cardiogenic pulmonary edema (CPE) in dyspneic dogs and cats. DESIGN Diagnostic test evaluation. ANIMALS 76 dogs and 24 cats evaluated for dyspnea. PROCEDURES Dogs and cats were evaluated by LUS; B lines were counted at 4 anatomic sites on each hemithorax. A site was scored as positive when > 3 B lines were identified. Animals with ≥ 2 positive sites identified on each hemithorax were considered positive for CPE. Medical records were evaluated to obtain a final diagnosis (reference standard) for calculation of the sensitivity and specificity of LUS and thoracic radiography for the diagnosis of CPE. RESULTS Dogs and cats with a final diagnosis of CPE had a higher number of positive LUS sites than did those with noncardiac causes of dyspnea. Overall sensitivity and specificity of LUS for the diagnosis of CPE were 84% and 74%, respectively, and these values were similar to those of thoracic radiography (85% and 87%, respectively). Use of LUS generally led to the misdiagnosis of CPE (ie, a false-positive result) in animals with diffuse interstitial or alveolar disease. Interobserver agreement on LUS results was high (κ > 0.85). CONCLUSIONS AND CLINICAL RELEVANCE LUS was useful for predicting CPE as the cause of dyspnea in dogs and cats, although this technique could not be used to differentiate CPE from other causes of diffuse interstitial or alveolar disease. Point-of-care LUS has promise as a diagnostic tool for dyspneic dogs and cats.

  8. Providing Doctors With High-Quality Information: An Updated Evaluation of Web-Based Point-of-Care Information Summaries

    Science.gov (United States)

    Kwag, Koren Hyogene; González-Lorenzo, Marien; Banzi, Rita; Bonovas, Stefanos

    2016-01-01

    Background The complexity of modern practice requires health professionals to be active information-seekers. Objective Our aim was to review the quality and progress of point-of-care information summaries—Web-based medical compendia that are specifically designed to deliver pre-digested, rapidly accessible, comprehensive, and periodically updated information to health care providers. We aimed to evaluate product claims of being evidence-based. Methods We updated our previous evaluations by searching Medline, Google, librarian association websites, and conference proceedings from August 2012 to December 2014. We included Web-based, regularly updated point-of-care information summaries with claims of being evidence-based. We extracted data on the general characteristics and content presentation of products, and we quantitatively assessed their breadth of disease coverage, editorial quality, and evidence-based methodology. We assessed potential relationships between these dimensions and compared them with our 2008 assessment. Results We screened 58 products; 26 met our inclusion criteria. Nearly a quarter (6/26, 23%) were newly identified in 2014. We accessed and analyzed 23 products for content presentation and quantitative dimensions. Most summaries were developed by major publishers in the United States and the United Kingdom; no products derived from low- and middle-income countries. The main target audience remained physicians, although nurses and physiotherapists were increasingly represented. Best Practice, Dynamed, and UptoDate scored the highest across all dimensions. The majority of products did not excel across all dimensions: we found only a moderate positive correlation between editorial quality and evidence-based methodology (r=.41, P=.0496). However, all dimensions improved from 2008: editorial quality (P=.01), evidence-based methodology (P=.015), and volume of diseases and medical conditions (P<.001). Conclusions Medical and scientific publishers are

  9. Profilometry and subsurface imaging in point of care diagnosis in ocular disease and lymphedema after breast cancer treatment

    Science.gov (United States)

    Sayegh, Samir I.; Taghian, Alphonse

    2013-02-01

    Breast cancer-related lymphedema (BCRL) can be irreversible with profound negative impact on patients' quality of life. Programs that provide screening and active surveillance for BCRL are essential to determine whether early detection and intervention influences the course of lymphedema development. Established methods of quantitatively assessing lymphedema at early stages include "volume" methods such as perometry and bioimpedance spectroscopy. Here we demonstrate 1) Use of topographical techniques analogous to those used in corneal topography 2) Development of point-of-care lymphedema detection and characterization based on off-the-shelf hardward 3) The role of subsurface imaging 4) Multimodal diagnostics and integration yielding higher sensitivity/ specificity.

  10. Fiber free plug and play on-chip scattering cytometer module – for implementation in microfluidic point of care devices

    DEFF Research Database (Denmark)

    Jensen, Thomas Glasdam; Kutter, Jörg Peter

    2010-01-01

    In this paper, we report on recent progress toward the development of a plug and play on-chip cytometer based on light scattering. By developing a device that does not depend on the critical alignment and cumbersome handling of fragile optical fibers, we approach a device that is suitable for non......-expert users and Point-Of-Care (POC) applications. It has been demonstrated that this device is capable of detecting and counting particles down to 1 μm at 100 particles per second. This device only depends on a single microfluidic channel. Hence, the device is easy to implement, or to use on its own....

  11. Free Access to Point of Care Resource Results in Increased Use and Satisfaction by Rural Healthcare Providers

    OpenAIRE

    Lindsay Alcock

    2016-01-01

    A Review of: Eldredge, J. D., Hall, L. J., McElfresh, K. R., Warner, T. D., Stromberg, T. L., Trost, J. T., & Jelinek, D. A. (2016). Rural providers’ access to online resources: A randomized controlled trial. Journal of the Medical Library Association, 104(1), 33-41. http://dx.doi.org/10.3163/1536-5050.104.1.005 Objective – To determine whether free access to the point of care (PoC) resource Dynamed or the electronic book collection AccessMedicine was more useful to rural health care p...

  12. A Five-Country Evaluation of a Point-of-Care Circulating Cathodic Antigen Urine Assay for the Prevalence of Schistosoma mansoni

    Science.gov (United States)

    Colley, Daniel G.; Binder, Sue; Campbell, Carl; King, Charles H.; Tchuem Tchuenté, Louis-Albert; N'Goran, Eliézer K.; Erko, Berhanu; Karanja, Diana M. S.; Kabatereine, Narcis B.; van Lieshout, Lisette; Rathbun, Stephen

    2013-01-01

    We evaluated a commercial point-of-care circulating cathodic antigen (POC-CCA) test for assessing Schistosoma mansoni infection prevalence in areas at risk. Overall, 4,405 school-age children in Cameroon, Côte d'Ivoire, Ethiopia, Kenya, and Uganda provided urine for POC-CCA testing and stool for Kato-Katz assays. By latent class analysis, one POC-CCA test was more sensitive (86% versus 62%) but less specific (72% versus ∼100%) than multiple Kato-Katz smears from one stool. However, only 1% of POC-CCA tests in a non-endemic area were false positives, suggesting the latent class analysis underestimated the POC-CCA specificity. Multivariable modeling estimated POC-CCA as significantly more sensitive than Kato-Katz at low infection intensities (< 100 eggs/gram stool). By linear regression, 72% prevalence among 9–12 year olds by POC-CCA corresponded to 50% prevalence by Kato-Katz, whereas 46% POC-CCA prevalence corresponded to 10% Kato-Katz prevalence. We conclude that one urine POC-CCA test can replace Kato-Katz testing for community-level S. mansoni prevalence mapping. PMID:23339198

  13. Value Assessment at the Point of Care: Incorporating Patient Values throughout Care Delivery and a Draft Taxonomy of Patient Values.

    Science.gov (United States)

    Armstrong, Melissa J; Mullins, C Daniel

    2017-02-01

    Incorporation of patient values is a key element of patient-centered care, but consistent incorporation of patient values at the point of care is lacking. Shared decision making encourages incorporation of patient values in decision making, but associated tools often lack guidance on value assessment. In addition, focusing on patient values relating only to specific decisions misses an opportunity for a more holistic approach to value assessment that could impact other aspects of clinical encounters, including health care planning, communication, and stakeholder involvement. In this commentary, we propose a taxonomy of values underlying patient decision making and provide examples of how these impact provision of health care. The taxonomy describes four categories of patient values: global, decisional, situational, and external. Global values are personal values impacting decision making at a universal level and can include value traits and life priorities. Decisional values are the values traditionally conceptualized in decision making, including considerations such as efficacy, toxicity, quality of life, convenience, and cost. Situational values are values tied to a specific moment in time that modify patients' existing global and decisional values. Finally, discussion of external values acknowledges that many patients consider values other than their own when making decisions. Recognizing the breadth of values impacting patient decision making has implications for both overall health care delivery and shared decision making because value assessments focusing only on decisional values may miss important patient considerations. This draft taxonomy highlights different values impacting decision making and facilitates a more complete value assessment at the point of care.

  14. Direct Comparison of a Tablet Computer and a Personal Digital Assistant for Point-of-Care Documentation in Eye Care

    Science.gov (United States)

    Silvey, Garry M.; Macri, Jennifer M.; Lee, Paul P.; Lobach, David F.

    2005-01-01

    New mobile computing devices including personal digital assistants (PDAs) and tablet computers have emerged to facilitate data collection at the point of care. Unfortunately, little research has been reported regarding which device is optimal for a given care setting. In this study we created and compared functionally identical applications on a Palm operating system-based PDA and a Windows-based tablet computer for point-of-care documentation of clinical observations by eye care professionals when caring for patients with diabetes. Eye-care professionals compared the devices through focus group sessions and through validated usability surveys. We found that the application on the tablet computer was preferred over the PDA for documenting the complex data related to eye care. Our findings suggest that the selection of a mobile computing platform depends on the amount and complexity of the data to be entered; the tablet computer functions better for high volume, complex data entry, and the PDA, for low volume, simple data entry. PMID:16779128

  15. Longitudinal lactate levels from routine point-of-care monitoring in adult Malawian antiretroviral therapy patients: associations with stavudine toxicities

    Science.gov (United States)

    Chagoma, Newton; Mallewa, Jane; Kaunda, Symon; Njalale, Yasin; Kampira, Elizabeth; Mukaka, Mavuto; Heyderman, Robert S; van Oosterhout, Joep J

    2013-01-01

    Introduction Stavudine is still widely used in under-resourced settings such as Malawi due to its low price. It frequently causes peripheral neuropathy and lipodystrophy and increases the risk of lactic acidosis and other high lactate syndromes. Methods We studied the association of longitudinal lactate levels, obtained by routine, 3-monthly point-of-care monitoring, with peripheral neuropathy, lipodystrophy and high lactate syndromes in adult Malawians who were in the second year of stavudine containing antiretroviral therapy (ART). Results Point-of-care lactate measurements were feasible in a busy urban ART clinic. Of 1170 lactate levels collected from 253 patients over the course of one year, 487 (41.8%) were elevated (>2.2mg/dl), 58 (5.0%) were highly elevated (>3.5mg/dl). At least one elevated lactate level occurred in 210 (83.0%) of patients and sustained hyperlactatemia in 65 (26.4%). In random effects analyses lipodystrophy and peripheral neuropathy were associated with higher lactate levels. Only five patients developed high lactate syndromes (one lactic acidosis) of whom no preceding lactate measurements were available because events had started before enrolment. Lactate levels significantly decreased over time and no high lactate syndromes were observed after the 15th month on ART. Conclusion Lipodystrophy and peripheral neuropathy were associated with higher lactate levels. Lactate levels decreased over time, coinciding with absence of new high lactate syndromes after the 15th month on ART. PMID:23926161

  16. Patient values and preferences when choosing anticoagulants

    Directory of Open Access Journals (Sweden)

    Palacio AM

    2015-01-01

    Full Text Available Ana M Palacio,1–3 Irene Kirolos,2,3 Leonardo Tamariz1–3 1The Department of Medicine, Miller School of Medicine, University of Miami, 2The Veterans Affairs Medical Center, Miami, FL, USA; 3Division of Public Health Sciences, University of Miami, Miami, Florida, USA Background: New oral anticoagulants have similar efficacy and lower bleeding rates compared with warfarin. However, in case of bleeding there is no specific antidote to reverse their effects. We evaluated the preferences and values of anticoagulants of patients at risk of atrial fibrillation and those who have already made a decision regarding anticoagulation.Methods: We conducted a cross-sectional study of Veterans in the primary care clinics and the international normalized ratio (INR laboratory. We developed an instrument with patient and physician input to measure patient values and preferences. The survey contained a hypothetical scenario of the risk of atrial fibrillation and the attributes of each anticoagulant. After the scenario, we asked participants to choose the option that best fits their preferences. The options were: 1 has better efficacy at reducing risk of stroke; 2 has been in the market for a long period of time; 3 has an antidote to reverse the rare case of bleeding; 4 has better quality of life profile with no required frequent laboratory tests; or 5 I want to follow physician recommendations. We stratified our results by those patients who are currently exposed to anticoagulants and those who are not exposed but are at risk of atrial fibrillation.Results: We approached 173 Veterans and completed 137 surveys (79% response rate. Ninety subjects were not exposed to anticoagulants, 46 reported being on warfarin, and one reported being on dabigatran at the time of the survey. Ninety-eight percent of subjects stated they would like to participate in the decision-making process of selecting an anticoagulant. Thirty-six percent of those exposed and 37% of those

  17. Programmable Bio-nanochip Platform: A Point-of-Care Biosensor System with the Capacity To Learn.

    Science.gov (United States)

    McRae, Michael P; Simmons, Glennon; Wong, Jorge; McDevitt, John T

    2016-07-19

    The combination of point-of-care (POC) medical microdevices and machine learning has the potential transform the practice of medicine. In this area, scalable lab-on-a-chip (LOC) devices have many advantages over standard laboratory methods, including faster analysis, reduced cost, lower power consumption, and higher levels of integration and automation. Despite significant advances in LOC technologies over the years, several remaining obstacles are preventing clinical implementation and market penetration of these novel medical microdevices. Similarly, while machine learning has seen explosive growth in recent years and promises to shift the practice of medicine toward data-intensive and evidence-based decision making, its uptake has been hindered due to the lack of integration between clinical measurements and disease determinations. In this Account, we describe recent developments in the programmable bio-nanochip (p-BNC) system, a biosensor platform with the capacity for learning. The p-BNC is a "platform to digitize biology" in which small quantities of patient sample generate immunofluorescent signal on agarose bead sensors that is optically extracted and converted to antigen concentrations. The platform comprises disposable microfluidic cartridges, a portable analyzer, automated data analysis software, and intuitive mobile health interfaces. The single-use cartridges are fully integrated, self-contained microfluidic devices containing aqueous buffers conveniently embedded for POC use. A novel fluid delivery method was developed to provide accurate and repeatable flow rates via actuation of the cartridge's blister packs. A portable analyzer instrument was designed to integrate fluid delivery, optical detection, image analysis, and user interface, representing a universal system for acquiring, processing, and managing clinical data while overcoming many of the challenges facing the widespread clinical adoption of LOC technologies. We demonstrate the p

  18. The development of aptamer-based technology for point-of-care malaria diagnosis

    OpenAIRE

    Dirkzwager, Roderick Marshall

    2016-01-01

    Malaria is an infectious disease caused by Plasmodium parasites which infects 200 million people a year and claims the lives of 600 000 despite a range of treatments being available. Effective diagnosis is key to malaria elimination but currently only 2/3 of patients receive a diagnostic test prior to administration of antimalarials. The overprescription of antimalarials carries the danger of exacerbating resistance. Antibody-based rapid diagnostic tests (RDTs) have greatly helped diagnosis i...

  19. Lupus anticoagulants and antiphospholipid antibodies

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/article/000547.htm Lupus anticoagulants and antiphospholipid antibodies To use the sharing features on this page, please enable JavaScript. Lupus anticoagulants are antibodies against substances in the lining ...

  20. A flexible mobile-device biosensing instrumentation platform for point-of-care medical diagnostics applications

    DEFF Research Database (Denmark)

    Patou, François; Pfreundt, Andrea; Zulfiqar, Azeem

    2014-01-01

    programmable electrical readout from LoCs potentially comprehending varied transducers addressing different targeted biological markers. A smart-phone/tablet docking-station embeds the hardware interface necessary for the implementation of a smart-phone digital lock-in amplifier. The platform is tested...

  1. Towards a Modular, Robust, and Portable Sensing Platform for Biological and Point of Care Diagnostics

    Science.gov (United States)

    2013-07-01

    Moore et al., “ Screening of Peptide Libraries against Protective Antigen of Bacillus anthracis in a Disposable Microfluidic Cartridge,” PLoS ONE, 6(11...gadgets have the potential to lower the cost of diagnosis and save immense amounts of time by removing the need to collect, preserve, and ship samples ...flow assays, such as pregnancy tests, disease and drug abuse screens , and blood protein markers, exhibit widespread use. Recent parallel advances

  2. Feasibility Analysis of the Heparin Anticoagulant Blood Plasma Used for Emergency Biochemical Test%肝素抗凝血浆用于急诊生化检验的可行性分析

    Institute of Scientific and Technical Information of China (English)

    邓春凤

    2015-01-01

    目的:分析肝素抗凝血浆用于急诊生化检验的可行性。方法以医院130例受检者为研究对象,常规采集静脉血6 ml,均分分别注入普通干燥管(血清组)和肝素钠抗凝管(血浆组)中,观察两组患者生化检验结果。结果两组患者Na+、K+、GLU、GGT检验结果比较差异具有统计学意义(P<0.05);剩余生化检验指标结果比较差异无统计学意义(P>0.05)。结论肝素抗凝血浆具有分离血浆速度快、抗凝能力强的优点,在急诊生化检验中具有高的应用价值。%Objective To analyze heparin anticoagulant blood plasma used for biochemical test the feasibility of the emergency.Methods 130 cases of patients as the research objects,routine venous blood was colected 6 ml,half-and-half respectively devided into ordinary drying tube(serum) and heparin anticoagulant tube(plasma),biochemical test results were observed of two groups of patients.ResultsInspection results of Na+, K+,GLU,GGT in two groups of patients,the differences had statisticaly significant(P0.05).Conclusion The heparin anticoagulant blood plasma has fast separation of plasma,the advantages of the anticoagulant ability, in the emergency biochemical test has higher application value.

  3. All-polymer biosensor for label-free point of care diagnostics

    DEFF Research Database (Denmark)

    Dapra, Johannes

    2013-01-01

    of this PhD project was to develop a modular platform based on electrochemical impedimetric sensing. This device can easily be modified by changing the biological receptors and therefore offers a broad range of possible applications. To keep the costs and the environmental footprint low the entire biosensor...... target molecules than antibodies. The biosensor platform was successfully adapted to different tasks and tested against three very different analytes: DNA, antibiotics and virus particles. Throughout the experiments the sensors showed high sensitivity and were able to detect very low analyte...

  4. Enhancing user acceptance of mandated mobile health information systems: the ePOC (electronic point-of-care project) experience.

    Science.gov (United States)

    Burgess, Lois; Sargent, Jason

    2007-01-01

    From a clinical perspective, the use of mobile technologies, such as Personal Digital Assistants (PDAs) within hospital environments is not new. A paradigm shift however is underway towards the acceptance and utility of these systems within mobile-based healthcare environments. Introducing new technologies and associated work practices has intrinsic risks which must be addressed. This paper contends that intervening to address user concerns as they arise throughout the system development lifecycle will lead to greater levels of user acceptance, while ultimately enhancing the deliverability of a system that provides a best fit with end user needs. It is envisaged this research will lead to the development of a formalised user acceptance framework based on an agile approach to user acceptance measurement. The results of an ongoing study of user perceptions towards a mandated electronic point-of-care information system in the Northern Illawarra Ambulatory Care Team (TACT) are presented.

  5. CMOS image sensor for detection of interferon gamma protein interaction as a point-of-care approach.

    Science.gov (United States)

    Marimuthu, Mohana; Kandasamy, Karthikeyan; Ahn, Chang Geun; Sung, Gun Yong; Kim, Min-Gon; Kim, Sanghyo

    2011-09-01

    Complementary metal oxide semiconductor (CMOS)-based image sensors have received increased attention owing to the possibility of incorporating them into portable diagnostic devices. The present research examined the efficiency and sensitivity of a CMOS image sensor for the detection of antigen-antibody interactions involving interferon gamma protein without the aid of expensive instruments. The highest detection sensitivity of about 1 fg/ml primary antibody was achieved simply by a transmission mechanism. When photons are prevented from hitting the sensor surface, a reduction in digital output occurs in which the number of photons hitting the sensor surface is approximately proportional to the digital number. Nanoscale variation in substrate thickness after protein binding can be detected with high sensitivity by the CMOS image sensor. Therefore, this technique can be easily applied to smartphones or any clinical diagnostic devices for the detection of several biological entities, with high impact on the development of point-of-care applications.

  6. Automated integration of wireless biosignal collection devices for patient-centred decision-making in point-of-care systems.

    Science.gov (United States)

    Menychtas, Andreas; Tsanakas, Panayiotis; Maglogiannis, Ilias

    2016-03-01

    The proper acquisition of biosignals data from various biosensor devices and their remote accessibility are still issues that prevent the wide adoption of point-of-care systems in the routine of monitoring chronic patients. This Letter presents an advanced framework for enabling patient monitoring that utilises a cloud computing infrastructure for data management and analysis. The framework introduces also a local mechanism for uniform biosignals collection from wearables and biosignal sensors, and decision support modules, in order to enable prompt and essential decisions. A prototype smartphone application and the related cloud modules have been implemented for demonstrating the value of the proposed framework. Initial results regarding the performance of the system and the effectiveness in data management and decision-making have been quite encouraging.

  7. Challenges in the Use of Compact Disc-Based Centrifugal Microfluidics for Healthcare Diagnostics at the Extreme Point of Care

    Directory of Open Access Journals (Sweden)

    Jordon Gilmore

    2016-03-01

    Full Text Available Since its inception, Compact Disc (CD-based centrifugal microfluidic technology has drawn a great deal of interest within research communities due to its potential use in biomedical applications. The technology has been referred to by different names, including compact-disc microfluidics, lab-on-a-disk, lab-on-a-CD and bio-disk. This paper critically reviews the state-of-the-art in CD-based centrifugal microfluidics devices and attempts to identify the challenges that, if solved, would enable their use in the extreme point of care. Sample actuation, manufacturing, reagent storage and implementation, target multiplexing, bio-particle detection, required hardware and system disposal, and sustainability are the topics of focus.

  8. Free Access to Point of Care Resource Results in Increased Use and Satisfaction by Rural Healthcare Providers

    Directory of Open Access Journals (Sweden)

    Lindsay Alcock

    2016-12-01

    Full Text Available A Review of: Eldredge, J. D., Hall, L. J., McElfresh, K. R., Warner, T. D., Stromberg, T. L., Trost, J. T., & Jelinek, D. A. (2016. Rural providers’ access to online resources: A randomized controlled trial. Journal of the Medical Library Association, 104(1, 33-41. http://dx.doi.org/10.3163/1536-5050.104.1.005 Objective – To determine whether free access to the point of care (PoC resource Dynamed or the electronic book collection AccessMedicine was more useful to rural health care providers in answering clinical questions in terms of usage and satisfaction. Design – Randomized controlled trial. Setting – Rural New Mexico. Subjects – Twenty-eight health care providers (physicians, nurses, physician assistants, and pharmacists with no reported access to PoC resources, (specifically Dynamed and AccessMedicine or electronic textbook collections prior to enrollment.

  9. The new oral anticoagulants.

    NARCIS (Netherlands)

    Verheugt, F.W.A.

    2010-01-01

    In patients with nonvalvular atrial fibrillation oral anticoagulation with the vitamin K antagonists acenocoumarol, phenprocoumon and warfarin reduces the risk of stroke by more than 60%, whereas single or double antiplatelet therapy is much less effective and sometimes associated with a similar ble

  10. Cataract surgery and anticoagulants

    NARCIS (Netherlands)

    Koopmans, SA; VanRij, G

    1996-01-01

    A questionnaire was sent to 240 members of the Netherlands Intraocular implant Club (NIOIC) to register their policy followed in 1993 with regard to anticoagulant therapy (ACT) and the use of aspirin in patients having cataract surgery. Ninety-one (32%) forms were suitable for analysis. Most eye sur

  11. Towards Improving Point-of-Care Diagnosis of Non-malaria Febrile Illness: A Metabolomics Approach.

    Directory of Open Access Journals (Sweden)

    Saskia Decuypere

    2016-03-01

    Full Text Available Non-malaria febrile illnesses such as bacterial bloodstream infections (BSI are a leading cause of disease and mortality in the tropics. However, there are no reliable, simple diagnostic tests for identifying BSI or other severe non-malaria febrile illnesses. We hypothesized that different infectious agents responsible for severe febrile illness would impact on the host metabolome in different ways, and investigated the potential of plasma metabolites for diagnosis of non-malaria febrile illness.We conducted a comprehensive mass-spectrometry based metabolomics analysis of the plasma of 61 children with severe febrile illness from a malaria-endemic rural African setting. Metabolite features characteristic for non-malaria febrile illness, BSI, severe anemia and poor clinical outcome were identified by receiver operating curve analysis.The plasma metabolome profile of malaria and non-malaria patients revealed fundamental differences in host response, including a differential activation of the hypothalamic-pituitary-adrenal axis. A simple corticosteroid signature was a good classifier of severe malaria and non-malaria febrile patients (AUC 0.82, 95% CI: 0.70-0.93. Patients with BSI were characterized by upregulated plasma bile metabolites; a signature of two bile metabolites was estimated to have a sensitivity of 98.1% (95% CI: 80.2-100 and a specificity of 82.9% (95% CI: 54.7-99.9 to detect BSI in children younger than 5 years. This BSI signature demonstrates that host metabolites can have a superior diagnostic sensitivity compared to pathogen-detecting tests to identify infections characterized by low pathogen load such as BSI.This study demonstrates the potential use of plasma metabolites to identify causality in children with severe febrile illness in malaria-endemic settings.

  12. Perioperative anticoagulation management in antiphospholipid syndrome.

    Science.gov (United States)

    Ishida, Keiichi; Masuda, Masahisa; Kohno, Hiroki; Tamura, Yusaku; Matsumiya, Goro

    2015-09-01

    Patients with antiphospholipid syndrome are at increased risk of developing thrombotic and hemorrhagic complications after cardiac surgery, and may have abnormal coagulation tests and develop thrombocytopenia after invasive procedures, which can complicate the perioperative management of anticoagulant therapy. We describe a patient with chronic thromboembolic pulmonary hypertension and antiphospholipid syndrome, who presented with prolonged activated partial thromboplastin and activated clotting times, and developed thrombocytopenia after the catheterization workup. We performed pulmonary endarterectomy and successfully managed anticoagulation by restricting heparin use at the time of surgery and monitoring the heparin effect by measuring heparin concentrations during cardiopulmonary bypass.

  13. Information at the Point of Care: An Informational Application for Cancer Resources.

    Science.gov (United States)

    Walker, Deborah Kirk; Hardeman, Amber; Owen, Larry; Frank, Jennifer Sandson

    2015-09-01

    The purpose of this project was to design, develop, and modify a cancer resource application (app) that providers, patients, and caregivers could use to locate local and national cancer resources. The project design used a modified version of the Questionnaire for User Interaction Survey 7.0 to gather information from a convenience sample of nurses and community participants regarding their perception of the app. These data helped to identify gaps in resources and modifications needed to make the app more user-friendly. The current cancer care system is complex, and patients often complain of uncoordinated care, lack of information, and insufficient psychosocial support. Cancer centers are working to meet the American College of Surgeons 2015 recommendation of psychosocial assessment and referrals; the Cancer Resource APP described here provides the resources to meet this need. Prototypes of the app were tested in practice and community settings, then solicited feedback guided needed technology modifications. The resulting Cancer Resource APP provides the healthcare community with information to make timely and consistent referrals for patients and caregivers.

  14. A Novel Point-of-Care Biomarker Recognition Method: Validation by Detecting Marker for Diabetic Nephropathy

    Directory of Open Access Journals (Sweden)

    Sahana Pentyala

    2015-04-01

    Full Text Available Biological fluid collection to identify and analyze different disease markers is a routine and normal procedure in health care settings. Body fluids are as varied as urine, blood, mucus, cerebrospinal fluid (CSF, tears, semen, etc. The volumes of the collected fluids range from micro liters (e.g., tears, CSF to tens and hundreds of milliliters (blood, urine, etc.. In some manifestations, a disease marker (particularly protein markers can occur in trace amounts, yet the fluids collected are in large volumes. To identify these trace markers, cumbersome methods, expensive instruments, and trained personnel are required. We developed an easy method to rapidly capture, concentrate, and identify protein markers in large volumes of test fluids. This method involves the utilization of two antibodies recognizing two different epitopes of the protein biomarker. Antibody-1 helps to capture and concentrate the biomarker and Antibody-2 adsorbed or conjugated to nanogold beads will detect the biomarker. This method was validated in capturing and detecting lipocalin type prostaglandin-D2 synthase, a marker in urine that implicates diabetic nephropathy. A one-step collection, concentration, and detection device was designed based on this method. This device can replace many of the normal body fluid collection devices such as tubes and containers. A one-step fluid collection and biomarker capture and concentration device for rapid diagnosis of diseases has tremendous advantage in terms of cost and providing timely results.

  15. Accuracy of the CoaguChek XS for point-of-care international normalized ratio (INR) measurement in children requiring warfarin.

    Science.gov (United States)

    Bauman, Mary E; Black, Karina L; Massicotte, Mary P; Bauman, Michelle L; Kuhle, Stefan; Howlett-Clyne, Susan; Cembrowski, George S; Bajzar, Laszlo

    2008-06-01

    Point-of-care INR (POC INR) meters can provide a safe and effective method for monitoring oral vitamin K antagonists (VKAs) in children. Stollery Children's Hospital has a large POC INR meter loan program for children requiring oral VKAs. Our protocol requires that POC INR results be compared to the standard laboratory INR for each child on several consecutive tests to ensure accuracy of CoaguChek XS (Roche Diagnostics, Basel Switzerland) meter. It was the objective of the study to determine the accuracy of the CoaguChek XS by comparing whole blood INR results from the CoaguChek XS to plasma INR results from the standard laboratory in children. POC INR meter validations were performed on plasma samples from two time points from 62 children receiving warfarin by drawing a venous blood sample for laboratory prothrombin (PT)-INR measurements and simultaneous INR determinations using the POC-INR meter. Agreement between CoaguChek XS INR and laboratory INR was assessed using Bland-Altman plots. Bland-Altman's 95% limits of agreement were 0.11 (-0.20; 0.42) and 0.13 (-0.22; 0.48) at the two time points, respectively. In conclusion, the CoaguChek XS meter appraisal generates an accurate and precise INR measure in children when compared to laboratory INR test results.

  16. A 10-minute point-of-care assay for detection of blood protein adducts resulting from low level exposure to organophosphate nerve agents.

    Science.gov (United States)

    VanDine, Robert; Babu, Uma Mahesh; Condon, Peter; Mendez, Arlene; Sambursky, Robert

    2013-03-25

    The OrganoTox test is a rapid, point-of-care assay capable of detecting clinically relevant organophosphate (OP) poisoning after low-level exposure to sarin, soman, tabun, or VX chemical nerve agents. The test utilizes either a finger stick peripheral blood sample or plasma specimen. While high-level nerve agent exposure can quickly lead to death, low-level exposure produces vague, nondescript signs and symptoms that are not easily clinically differentiated from other conditions. In initial testing, the OrganoTox test was used to detect the presence of blood protein-nerve agent adducts in exposed blood samples. In order to mimic the in vivo exposure as closely as possible, nerve agents stored in organic solvents were spiked in minute quantities into whole blood samples. For performance testing, 40 plasma samples were spiked with sarin, soman, tabun, or VX and 10 normal plasma samples were used as the negative control. The 40 nerve agent-spiked plasma samples included 10 replicates of each agent. At the clinically relevant low-level exposure of 10 ng/ml, the OrganoTox test demonstrated 100% sensitivity for soman, tabun, and VX and 80% sensitivity for sarin. The OrganoTox test demonstrated greater than 97% specificity with 150 blood samples obtained from healthy adults. No cross-reactivity or interference from pesticide precursor compounds was found. A rapid test for nerve agent exposure will help identify affected patients earlier in the clinical course and trigger more appropriate medical management in a more timely manner.

  17. An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481--The Home INR Study (THINRS).

    Science.gov (United States)

    Dolor, Rowena J; Ruybalid, R Lynne; Uyeda, Lauren; Edson, Robert G; Phibbs, Ciaran; Vertrees, Julia E; Shih, Mei-Chiung; Jacobson, Alan K; Matchar, David B

    2010-10-01

    Prior studies suggest patient self-testing (PST) of prothrombin time (PT) can improve the quality of anticoagulation (AC) and reduce complications (e.g., bleeding and thromboembolic events). "The Home INR Study" (THINRS) compared AC management with frequent PST using a home monitoring device to high-quality AC management (HQACM) with clinic-based monitoring on major health outcomes. A key clinical and policy question is whether and which patients can successfully use such devices. We report the results of Part 1 of THINRS in which patients and caregivers were evaluated for their ability to perform PST. Study-eligible patients (n = 3643) were trained to use the home monitoring device and evaluated after 2-4 weeks for PST competency. Information about demographics, medical history, warfarin use, medications, plus measures of numeracy, literacy, cognition, dexterity, and satisfaction with AC were collected. Approximately 80% (2931 of 3643) of patients trained on PST demonstrated competency; of these, 8% (238) required caregiver assistance. Testers who were not competent to perform PST had higher numbers of practice attempts, higher cuvette wastage, and were less able to perform a fingerstick or obtain blood for the cuvette in a timely fashion. Factors associated with failure to pass PST training included increased age, previous stroke history, poor cognition, and poor manual dexterity. A majority of patients were able to perform PST. Successful home monitoring of PT with a PST device required adequate levels of cognition and manual dexterity. Training a caregiver modestly increased the proportion of patients who can perform PST.

  18. Point-of-Care Troponin T Testing in the Management of Patients with Chest Pain in the Swedish Primary Care

    Directory of Open Access Journals (Sweden)

    Staffan Nilsson

    2013-01-01

    . Seven patients (5.5% from PHC centres with POCT-TnT and six (8.8% from PHC centres without POCT-TnT were diagnosed as AMI or UA (P=0.369. Two patients with AMI or UA from PHC centres with POCT-TnT were judged as missed cases in primary health care. Conclusion. The use of POCT-TnT may reduce emergency referrals but probably at the cost of an increased risk to miss patients with AMI or UA.

  19. Development of functional lab-on-a-chip on polymer for point-of-care testing of metabolic parameters.

    Science.gov (United States)

    Do, Jaephil; Lee, Sehwan; Han, Jungyup; Kai, Junhai; Hong, Chien-Chong; Gao, Chuan; Nevin, Joseph H; Beaucage, Gregory; Ahn, Chong H

    2008-12-01

    This paper presents the development of an easy-to-handle and disposable clinical diagnostic lab-on-a-chip using fully integrated plastic microfluidic components, which has the sampling/identifying capability to make fast and reliable measurements of metabolic parameters from human whole blood. A smart and functional lab-on-a-chip cartridge, which incorporates a full on-chip auto-calibration function for in the field applications, has been developed, and then fully characterized using a portable analyzer (3 (1/4)''x 5''x 1'') with multi-analyte detection capability. In addition, several new approaches in realizing smart and functional lab-on-a-chips on polymer have been adopted, which include the pinch valve for automatic fluidic sealing, a by-pass channel as the sampling indicator, and a robust connector design for long analyzer lifetimes. Metabolic parameters such as glucose, lactate, and partial oxygen from human whole blood have been successfully measured using the functional polymer lab-on-a-chips and the portable analyzer developed in this work.

  20. Effects of acidosis, alkalosis, hyperthermia and hypothermia on haemostasis : results of point of care testing with the thromboelastography analyser

    NARCIS (Netherlands)

    Ramaker, Albert J. D. W. R.; Meyer, Peter; van der Meer, Jan; Struys, Michel M. R. F.; Lisman, Ton; van Oeveren, Wim; Hendriks, Herman G. D.

    2009-01-01

    In this study we assessed the effects of changes in pH, temperature, and their combination in whole blood on thromboelastographic variables. Blood was collected from six healthy volunteers. Thromboelastograph (TEG series 5000; Haemoscope Corporation, Illinois, USA) channels were set at temperatures

  1. POCT血糖仪的性能分析%Analytic evaluation of point of care testing blood glucometers

    Institute of Scientific and Technical Information of China (English)

    唐立萍; 居漪; 欧元祝; 王美娟; 张瑞镐

    2010-01-01

    目的 比对5个品牌9款床边检测(POCT)血糖仪的主要分析性能.方法 用高、中、低3个浓度的质控品在9款POCT血糖仪上进行检测,连续测试30 d,计算变异系数(CV).取高、中、低3种不同葡萄糖浓度的患者样本,同一样本取2份.一份为新鲜全血[乙二胺四乙酸(EDTA)抗凝],在9款POCT血糖仪上进行检测,计算同一样本在9款POCT血糖仪上检测所得结果的均值() 、标准差(s)、CV;另一份为新鲜血清样本,用日立7060全自动生化分析仪进行检测,评价日立7060全自动生化仪与POCT血糖仪测定结果的相关性.结果 质控品在9款POCT血糖仪上所测结果的CV在2.62%~5.86%之间,符合国家对血糖检测系统的测量重复性要求(CV不超过7.5%).高浓度血糖用POCT血糖仪所测结果的CV在10%左右,中、低浓度血糖用POCT血糖仪所测结果的CV均>10%,与美国临床实验室标准化委员会(NCCLS)对葡萄糖POCT的管理要求(总误差≤10%)不符.Johnson Ultra和ArkRay GT-1810 2款POCT血糖仪与日立7060全自动生化仪所测结果的相关系数(r)<0.95,相关性略差;其他几款POCT血糖仪与日立7060全自动生化仪所测结果的r均≥0.95,相关性较好.KB CT-X10、Roche Integra、Advantage和Johnson Ultra POCT血糖仪的斜率(b)超出1.0±0.05.结论 POCT血糖仪仅可用于患者空腹血糖的监测或血糖过筛试验,不能代替实验室血糖的检测结果作为确诊试验.同时在选择POCT血糖仪时,不能仅一味追求其检测的快速,应该对血糖仪的分析性能进行综合评价.

  2. Determination of the International Sensitivity Index of a new near-patient testing device to monitor oral anticoagulant therapy--overview of the assessment of conformity to the calibration model.

    Science.gov (United States)

    Tripodi, A; Chantarangkul, V; Clerici, M; Negri, B; Mannucci, P M

    1997-08-01

    A key issue for the reliable use of new devices for the laboratory control of oral anticoagulant therapy with the INR is their conformity to the calibration model. In the past, their adequacy has mostly been assessed empirically without reference to the calibration model and the use of International Reference Preparations (IRP) for thromboplastin. In this study we reviewed the requirements to be fulfilled and applied them to the calibration of a new near-patient testing device (TAS, Cardiovascular Diagnostics) which uses thromboplastin-containing test cards for determination of the INR. On each of 10 working days citrated whole blood and plasma samples were obtained from 2 healthy subjects and 6 patients on oral anticoagulants. PT testing on whole blood and plasma was done with the TAS and parallel testing for plasma by the manual technique with the IRP CRM 149S. Conformity to the calibration model was judged satisfactory if the following requirements were met: (i) there was a linear relationship between paired log-PTs (TAS vs CRM 149S); (ii) the regression line drawn through patients data points, passed through those of normals; (iii) the precision of the calibration expressed as the CV of the slope was <3%. A good linear relationship was observed for calibration plots for plasma and whole blood (r = 0.98). Regression lines drawn through patients data points, passed through those of normals. The CVs of the slope were in both cases 2.2% and the ISIs were 0.965 and 1.000 for whole blood and plasma. In conclusion, our study shows that near-patient testing devices can be considered reliable tools to measure INR in patients on oral anticoagulants and provides guidelines for their evaluation.

  3. Comparability of Point-of-Care versus Central Laboratory Hemoglobin Determination in Emergency Patients at a Supra-Maximal Care Hospital

    Science.gov (United States)

    Dolscheid-Pommerich, Ramona C.; Dolscheid, Sarah; Grigutsch, Daniel; Stoffel-Wagner, Birgit; Graeff, Ingo

    2016-01-01

    Fulfilling the requirements of point-of-care testing (POCT) training regarding proper execution of measurements and compliance with internal and external quality control specifications is a great challenge. Our aim was to compare the values of the highly critical parameter hemoglobin (Hb) determined with POCT devices and central laboratory analyzer in the highly vulnerable setting of an emergency department in a supra maximal care hospital to assess the quality of POCT performance. In 2548 patients, Hb measurements using POCT devices (POCT-Hb) were compared with Hb measurements performed at the central laboratory (Hb-ZL). Additionally, sub collectives (WHO anemia classification, patients with Hb 85y.) were analyzed. Overall, the correlation between POCT-Hb and Hb-ZL was highly significant (r = 0.96, p2.5g/dl occurred. McNemar´s test revealed significant differences regarding anemia diagnosis according to WHO definition for male, female and total patients (♂ p<0.001; ♀ p<0.001, total p<0.001). Hb-ZL resulted significantly more often in anemia diagnosis. In samples with Hb<8g/dl, McNemar´s test yielded no significant difference (p = 0.169). In suprageriatric patients, McNemar´s test revealed significant differences regarding anemia diagnosis according to WHO definition in male, female and total patients (♂ p<0.01; ♀ p = 0.002, total p<0.001). The difference between Hb-ZL and POCT-Hb with Hb<8g/dl was not statistically significant (<8g/dl, p = 1.000). Overall, we found a highly significant correlation between the analyzed hemoglobin concentration measurement methods, i.e. POCT devices and at the central laboratory. The results confirm the successful implementation of the presented POCT concept. Nevertheless some limitations could be identified in anemic patients stressing the importance of carefully examining clinically implausible results. PMID:27880783

  4. Accuracy of CoaguChek XS for point-of-care antithrombotic monitoring in children with heart disease.

    Science.gov (United States)

    Moon, Ju Ryoung; Jeong, Soo In; Huh, June; Lee, Heung Jae; Park, Pyo Won; Kang, I-Seok

    2010-01-01

    The CoaguChek XS international normalized ratio (INR) assay was compared to INR assay by a standard laboratory method in children with heart disease on anticoagulant therapy. The data comprised 120 pairs of INR values for 42 patients (age XS and the standard method were performed within 1 hr by a single qualified technician and the paired results were evaluated by linear regression and Bland-Altman analysis. The mean difference in the INR values was -0.08 +/- 0.04 units (p = 0.63); the difference between the two results was consistently XS device are as accurate as the standard method, but faster and more convenient.

  5. Hyperthermostable binding molecules on phage: Assay components for point-of-care diagnostics for active tuberculosis infection.

    Science.gov (United States)

    Zhao, Ning; Spencer, John; Schmitt, Margaret A; Fisk, John D

    2017-03-15

    Tuberculosis is the leading cause of death from infectious disease worldwide. The low sensitivity, extended processing time, and high expense of current diagnostics are major challenges to the detection and treatment of tuberculosis. Mycobacterium tuberculosis ornithine transcarbamylase (Mtb OTC, Rv1656) has been identified in the urine of patients with active TB infection and is a promising target for point-of-care diagnostics. Specific binding proteins with low nanomolar affinities for Mtb OTC were selected from a phage display library built upon a hyperthermostable Sso7d scaffold. Phage particles displaying Sso7d variants were utilized to generate a sandwich ELISA-based assay for Mtb OTC. The assay response is linear between 2 ng/mL and 125 ng/mL recombinant Mtb OTC and has a limit of detection of 400 pg/mL recombinant Mtb OTC. The assay employing a phage-based detection reagent is comparable to commercially-available antibody-based biosensors. Importantly, the assay maintains functionality at both neutral and basic pH in presence of salt and urea over the range of concentrations typical for human urine. Phage-based diagnostic systems may feature improved physical stability and cost of production relative to traditional antibody-based reagents, without sacrificing specificity and sensitivity.

  6. An ontology-based, mobile-optimized system for pharmacogenomic decision support at the point-of-care.

    Directory of Open Access Journals (Sweden)

    Jose Antonio Miñarro-Giménez

    Full Text Available BACKGROUND: The development of genotyping and genetic sequencing techniques and their evolution towards low costs and quick turnaround have encouraged a wide range of applications. One of the most promising applications is pharmacogenomics, where genetic profiles are used to predict the most suitable drugs and drug dosages for the individual patient. This approach aims to ensure appropriate medical treatment and avoid, or properly manage, undesired side effects. RESULTS: We developed the Medicine Safety Code (MSC service, a novel pharmacogenomics decision support system, to provide physicians and patients with the ability to represent pharmacogenomic data in computable form and to provide pharmacogenomic guidance at the point-of-care. Pharmacogenomic data of individual patients are encoded as Quick Response (QR codes and can be decoded and interpreted with common mobile devices without requiring a centralized repository for storing genetic patient data. In this paper, we present the first fully functional release of this system and describe its architecture, which utilizes Web Ontology Language 2 (OWL 2 ontologies to formalize pharmacogenomic knowledge and to provide clinical decision support functionalities. CONCLUSIONS: The MSC system provides a novel approach for enabling the implementation of personalized medicine in clinical routine.

  7. Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders

    Science.gov (United States)

    Mashamba-Thompson, Tivani P.; Jama, Ngcwalisa A.; Sartorius, Benn; Drain, Paul K.; Thompson, Rowan M.

    2017-01-01

    Introduction: Key stakeholders’ involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. Method: We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. Results: 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients’ needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Conclusions: Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics. PMID:28075337

  8. Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders

    Directory of Open Access Journals (Sweden)

    Tivani P. Mashamba-Thompson

    2017-01-01

    Full Text Available Introduction: Key stakeholders’ involvement is crucial to the sustainability of quality point-of-care (POC diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC clinics in South Africa. Method: We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it criteria for POC diagnostic services in resource-limited settings. Results: 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients’ needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Conclusions: Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics.

  9. An Efficient Power Harvesting Mobile Phone-Based Electrochemical Biosensor for Point-of-Care Health Monitoring.

    Science.gov (United States)

    Sun, Alexander C; Yao, Chengyang; Venkatesh, A G; Hall, Drew A

    2016-11-01

    Cellular phone penetration has grown continually over the past two decades with the number of connected devices rapidly approaching the total world population. Leveraging the worldwide ubiquity and connectivity of these devices, we developed a mobile phone-based electrochemical biosensor platform for point-of-care (POC) diagnostics and wellness tracking. The platform consists of an inexpensive electronic module (power potentiostat that interfaces with and efficiently harvests power from a wide variety of phones through the audio jack. Active impedance matching improves the harvesting efficiency to 79%. Excluding loses from supply rectification and regulation, the module consumes 6.9 mW peak power and can measure power budget set by mobile devices and produce data that matches well with that of an expensive laboratory grade instrument. We demonstrate that the platform can be used to track the concentration of secretory leukocyte protease inhibitor (SLPI), a biomarker for monitoring lung infections in cystic fibrosis patients, in its physiological range via an electrochemical sandwich assay on disposable screen-printed electrodes with a 1 nM limit of detection.

  10. An ultra compact laser diode source for integration in a handheld point-of-care photoacoustic scanner

    Science.gov (United States)

    Kohl, A.; Canal, C.; Laugustin, A.; Rabot, O.

    2016-03-01

    Photoacoustics is a novel medical imaging technique with high potential for early detection of different diseases such as skin cancer or rheumatology. It is a hybrid modality with pulsed laser light for excitation of the tissue, and ultrasound as response. One of the hurdles for its introduction into the clinic, or even in clinical pilot studies and larger trials, is the bulkiness and price of existing photoacoustic systems. This presentation describes how recent developments in diode laser technology lead to a compact ultrasound scanner with built-in photoacoustic functionality. This is a key for the introduction of photoacoustic technology in the clinic and future point of care systems. We have developed a diode laser system and driver that deliver pulse energies which up to now were only achievable with Nd:YAG lasers. The efficiency and compactness allows integration in a handheld probe. The paper will highlights the laser technology and its radical integration with a medical ultrasound scanner, leading to a first prototype for clinical pilot studies.

  11. Point of Care Ultrasound Accurately Distinguishes Inflammatory from Noninflammatory Disease in Patients Presenting with Abdominal Pain and Diarrhea

    Directory of Open Access Journals (Sweden)

    Kerri L. Novak

    2016-01-01

    Full Text Available Background. Approaches to distinguish inflammatory bowel disease (IBD from noninflammatory disease that are noninvasive, accurate, and readily available are desirable. Such approaches may decrease time to diagnosis and better utilize limited endoscopic resources. The aim of this study was to evaluate the diagnostic accuracy for gastroenterologist performed point of care ultrasound (POCUS in the detection of luminal inflammation relative to gold standard ileocolonoscopy. Methods. A prospective, single-center study was conducted on convenience sample of patients presenting with symptoms of diarrhea and/or abdominal pain. Patients were offered POCUS prior to having ileocolonoscopy. Sensitivity, specificity, positive predictive value (PPV, and negative predictive value (NPV with 95% confidence intervals (CI, as well as likelihood ratios, were calculated. Results. Fifty-eight patients were included in this study. The overall sensitivity, specificity, PPV, and NPV were 80%, 97.8%, 88.9%, and 95.7%, respectively, with positive and negative likelihood ratios (LR of 36.8 and 0.20. Conclusion. POCUS can accurately be performed at the bedside to detect transmural inflammation of the intestine. This noninvasive approach may serve to expedite diagnosis, improve allocation of endoscopic resources, and facilitate initiation of appropriate medical therapy.

  12. An integrated CMOS quantitative-polymerase-chain-reaction lab-on-chip for point-of-care diagnostics.

    Science.gov (United States)

    Norian, Haig; Field, Ryan M; Kymissis, Ioannis; Shepard, Kenneth L

    2014-10-21

    Considerable effort has recently been directed toward the miniaturization of quantitative-polymerase-chain-reaction (qPCR) instrumentation in an effort to reduce both cost and form factor for point-of-care applications. Considerable gains have been made in shrinking the required volumes of PCR reagents, but resultant prototypes retain their bench-top form factor either due to heavy heating plates or cumbersome optical sensing instrumentation. In this paper, we describe the use of complementary-metal-oxide semiconductor (CMOS) integrated circuit (IC) technology to produce a fully integrated qPCR lab-on-chip. Exploiting a 0.35 μm high-voltage CMOS process, the IC contains all of the key components for performing qPCR. Integrated resistive heaters and temperature sensors regulate the surface temperature of the chip to an accuracy of 0.45 °C. Electrowetting-on-dielectric microfluidics are actively driven from the chip surface, allowing for droplet generation and transport down to volumes less than 1.2 nanoliter. Integrated single-photon avalanche diodes (SPADs) are used for fluorescent monitoring of the reaction, allowing for the quantification of target DNA with more than four-orders-of-magnitude of dynamic range and sensitivities down to a single copy per droplet. Using this device, reliable and sensitive real-time proof-of-concept detection of Staphylococcus aureus (S. aureus) is demonstrated.

  13. A volumetric meter chip for point-of-care quantitative detection of bovine catalase for food safety control.

    Science.gov (United States)

    Cui, Xingye; Hu, Jie; Choi, Jane Ru; Huang, Yalin; Wang, Xuemin; Lu, Tian Jian; Xu, Feng

    2016-09-07

    A volumetric meter chip was developed for quantitative point-of-care (POC) analysis of bovine catalase, a bioindicator of bovine mastitis, in milk samples. The meter chip displays multiplexed quantitative results by presenting the distance of ink bar advancement that is detectable by the naked eye. The meter chip comprises a poly(methyl methacrylate) (PMMA) layer, a double-sided adhesive (DSA) layer and a glass slide layer fabricated by the laser-etching method, which is typically simple, rapid (∼3 min per chip), and cost effective (∼$0.2 per chip). Specially designed "U shape" reaction cells are covered by an adhesive tape that serves as an on-off switch, enabling the simple operation of the assay. As a proof of concept, we employed the developed meter chip for the quantification of bovine catalase in raw milk samples to detect catalase concentrations as low as 20 μg/mL. The meter chip has great potential to detect various target analytes for a wide range of POC applications.

  14. Response to anticoagulant drug withdrawal.

    Science.gov (United States)

    Mulligan, R

    1987-09-01

    This study evaluated 44 separate medication withdrawal periods in 17 subjects who were attending a hospital anticoagulation clinic for management of anticoagulation medication. The data suggest that when anticoagulant withdrawal is needed for particular dental procedures, a 2-day hold is an effective period of medication withdrawal. No thromboembolic events were observed after any of the withdrawal periods. Further, no posttreatment hemorrhagic episodes were observed when the anticoagulant medication was reinstituted after dental treatment. Prothrombin time blood levels should be determined in the immediate pretreatment period, however, because the prothrombin time can fluctuate even in the best maintained patients.

  15. Anticoagulant activities of persicarin and isorhamnetin.

    Science.gov (United States)

    Ku, Sae-Kwang; Kim, Tae Hoon; Bae, Jong-Sup

    2013-04-01

    Persicarin and isorhamnetin were isolated from Oenanthe javanica and their anticoagulant activities were examined by monitoring activated partial thromboplastin time (aPTT), prothrombin time (PT), and the activities of cell-based thrombin and activated factor X (FXa). In addition, the effects of persicarin and isorhamnetin on the expressions of plasminogen activator inhibitor type 1 (PAI-1) and tissue-type plasminogen activator (t-PA) were tested in tumor necrosis factor-α (TNF-α) activated human umbilical vein endothelial cells (HUVECs). The data obtained showed that persicarin and isorhamnetin both prolonged aPTT and PT significantly and inhibited the activities of thrombin and FXa. In addition, they both inhibited the generations of thrombin and FXa in HUVECs. In accordance with these anticoagulant activities, persicarin and isorhamnetin prolonged in vivo bleeding time and inhibited TNF-α induced PAI-1 production. Furthermore, PAI-1/t-PA ratio was significantly decreased by persicarin. Interestingly, the anticoagulant and profibrinolytic effects of persicarin were greater than those of isorhamnetin, which suggest that the sulfonate group of persicarin positively regulates its anticoagulatory function. Accordingly, our results suggest that persicarin and isorhamnetin possess antithrombotic activities and that they could provide bases for the development of new anticoagulant agents.

  16. Anticoagulation manager: development of a clinical decision support mobile application for management of anticoagulants.

    Science.gov (United States)

    Chih-Wen Cheng; Hang Wu; Thompson, Pamela J; Taylor, Julie R; Zehnbauer, Barbara A; Wilson, Karlyn K; Wang, May D

    2016-08-01

    Patients with certain clotting disorders or conditions have a greater risk of developing arterial or venous clots and downstream embolisms, strokes, and arterial insufficiency. These patients need prescription anticoagulant drugs to reduce the possibility of clot formation. However, historically, the clinical decision making workflow in determining the correct type and dosage of anticoagulant(s) is part science and part art. To address this problem, we developed Anticoagulation Manager, an intelligent clinical decision workflow management system on iOS-based mobile devices to help clinicians effectively choose the most appropriate and helpful follow-up clotting tests for patients with a common clotting profile. The app can provide physicians guidance to prescribe the most appropriate medication for patients in need of anticoagulant drugs. This intelligent app was jointly designed and developed by medical professionals in CDC and engineers at Georgia Tech, and will be evaluated by physicians for ease-of-use, robustness, flexibility, and scalability. Eventually, it will be deployed and shared in both physician community and developer community.

  17. Point-of-Care Multi-Organ Ultrasound Improves Diagnostic Accuracy in Adults Presenting to the Emergency Department with Acute Dyspnea

    Directory of Open Access Journals (Sweden)

    Daniel Mantuani, MD

    2016-01-01

    Full Text Available Introduction: Determining the etiology of acute dyspnea in emregency department (ED patients is often difficult. Point-of-care ultrasound (POCUS holds promise for improving immediate diagnostic accuracy (after history and physical, thus improving use of focused therapies. We evaluate the impact of a three-part POCUS exam, or “triple scan” (TS – composed of abbreviated echocardiography, lung ultrasound and inferior vena cava (IVC collapsibility assessment – on the treating physician’s immediate diagnostic impression. Methods: A convenience sample of adults presenting to our urban academic ED with acute dyspnea (Emergency Severity Index 1, 2 were prospectively enrolled when investigator sonographers were available. The method for performing components of the TS has been previously described in detail. Treating physicians rated the most likely diagnosis after history and physical but before other studies (except electrocardiogram returned. An investigator then performed TS and disclosed the results, after which most likely diagnosis was reassessed. Final diagnosis (criterion standard was based on medical record review by expert emergency medicine faculty blinded to TS result. We compared accuracy of pre-TS and post-TS impression (primary outcome with McNemar’s test. Test characteristics for treating physician impression were also calculated by dichotomizing acute decompensated heart failure (ADHF, chronic obstructive pulmonary disease (COPD and pneumonia as present or absent. Results: 57 patients were enrolled with the leading final diagnoses being ADHF (26%, COPD/ asthma (30%, and pneumonia (28%. Overall accuracy of the treating physician’s impression increased from 53% before TS to 77% after TS (p=0.003. The post-TS impression was 100% sensitive and 84% specific for ADHF. Conclusion: In this small study, POCUS evaluation of the heart, lungs and IVC improved the treating physician’s immediate overall diagnostic accuracy for ADHF

  18. A lab-on-a-chip system integrating tissue sample preparation and multiplex RT-qPCR for gene expression analysis in point-of-care hepatotoxicity assessment.

    Science.gov (United States)

    Lim, Geok Soon; Chang, Joseph S; Lei, Zhang; Wu, Ruige; Wang, Zhiping; Cui, Kemi; Wong, Stephen

    2015-10-21

    A truly practical lab-on-a-chip (LOC) system for point-of-care testing (POCT) hepatotoxicity assessment necessitates the embodiment of full-automation, ease-of-use and "sample-in-answer-out" diagnostic capabilities. To date, the reported microfluidic devices for POCT hepatotoxicity assessment remain rudimentary as they largely embody only semi-quantitative or single sample/gene detection capabilities. In this paper, we describe, for the first time, an integrated LOC system that is somewhat close to a practical POCT hepatotoxicity assessment device - it embodies both tissue sample preparation and multiplex real-time RT-PCR. It features semi-automation, is relatively easy to use, and has "sample-in-answer-out" capabilities for multiplex gene expression analysis. Our tissue sample preparation module incorporating both a microhomogenizer and surface-treated paramagnetic microbeads yielded high purity mRNA extracts, considerably better than manual means of extraction. A primer preloading surface treatment procedure and the single-loading inlet on our multiplex real-time RT-PCR module simplify off-chip handling procedures for ease-of-use. To demonstrate the efficacy of our LOC system for POCT hepatotoxicity assessment, we perform a preclinical animal study with the administration of cyclophosphamide, followed by gene expression analysis of two critical protein biomarkers for liver function tests, aspartate transaminase (AST) and alanine transaminase (ALT). Our experimental results depict normalized fold changes of 1.62 and 1.31 for AST and ALT, respectively, illustrating up-regulations in their expression levels and hence validating their selection as critical genes of interest. In short, we illustrate the feasibility of multiplex gene expression analysis in an integrated LOC system as a viable POCT means for hepatotoxicity assessment.

  19. Nanoporous Glass Integrated in Volumetric Bar-Chart Chip for Point-of-Care Diagnostics of Non-Small Cell Lung Cancer.

    Science.gov (United States)

    Li, Ying; Xuan, Jie; Song, Yujun; Qi, Wenjin; He, Bangshun; Wang, Ping; Qin, Lidong

    2016-01-26

    Point-of-care (POC) testing has the potential to enable rapid, low-cost, and large-scale screening. POC detection of a multiplexed biomarker panel can facilitate the early diagnosis of non-small cell lung cancer (NSCLC) and, thus, may allow for more timely surgical intervention for life-saving treatment. Herein, we report the nanoporous glass (NPG) integrated volumetric bar-chart chip (V-Chip) for POC detection of the three NSCLC biomarkers CEA, CYFRA 21-1, and SCCA, by the naked eye. The 3D nanostructures in the NPG membrane efficiently increase the number of binding sites for antibodies and decrease the diffusion distance between antibody and antigen, enabling the low detection limit and rapid analysis time of the NPG-V-Chip. We utilized the NPG-V-Chip to test the NSCLC biomarker panel and found that the limit of detection can reach 50 pg/mL (10-fold improvement over the original V-Chip), and the total assay time can be decreased from 4 to 0.5 h. We then detected CEA in 21 serum samples from patients with common cancers, and the on-chip results showed good correlation with the clinical results. We further assayed 10 lung cancer samples using the device and confirmed the results obtained using conventional ELISA methods. In summary, the NPG-V-Chip platform has the ability of multiplex, low detection limit, low cost, lack of need for accessory equipment, and rapid analysis time, which may render the V-Chip a useful platform for quantitative POC detection in resource-limited settings and personalized diagnostics.

  20. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records : evaluations of two exemplar trials

    NARCIS (Netherlands)

    van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

    2014-01-01

    BACKGROUND: Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES: To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify th

  1. DNA-Aptamer optical biosensors based on a LPG-SPR optical fiber platform for point-of-care diagnostic

    Science.gov (United States)

    Coelho, L.; Queirós, R. B.; Santos, J. L.; Martins, M. Cristina L.; Viegas, D.; Jorge, P. A. S.

    2014-03-01

    Surface Plasmon Resonance (SPR) is the base for some of the most sensitive label free optical fiber biosensors. However, most solutions presented to date require the use of fragile fiber optic structure such as adiabatic tapers or side polished fibers. On the other hand, long-period fiber gratings (LPG) present themselves as an interesting solution to attain an evanescent wave refractive index sensor platform while preserving the optical fiber integrity. The combination of these two approaches constitute a powerful platform that can potentially reach the highest sensitivities as it was recently demonstrated by detailed theoretical study [1, 2]. In this work, a LPG-SPR platform is explored in different configurations (metal coating between two LPG - symmetric and asymmetric) operating in the telecom band (around 1550 nm). For this purpose LPGs with period of 396 μm are combined with tailor made metallic thin films. In particular, the sensing regions were coated with 2 nm of chromium to improve the adhesion to the fiber and 16 nm of gold followed by a 100 nm thick layer of TiO2 dielectric material strategically chosen to attain plasmon resonance in the desired wavelength range. The obtained refractometric platforms were then validated as a biosensor. For this purpose the detection of thrombin using an aptamer based probe was used as a model system for protein detection. The surface of the sensing fibers were cleaned with isopropanol and dried with N2 and then the aminated thrombin aptamer (5'-[NH2]- GGTTGGTGTGGTTGG-3') was immobilized by physisorption using Poly-L-Lysine (PLL) as cationic polymer. Preliminary results indicate the viability of the LPFG-SPR-APTAMER as a flexible platforms point of care diagnostic biosensors.

  2. Programmable bio-nano-chip system: a flexible point-of-care platform for bioscience and clinical measurements.

    Science.gov (United States)

    McRae, Michael P; Simmons, Glennon W; Wong, Jorge; Shadfan, Basil; Gopalkrishnan, Sanjiv; Christodoulides, Nicolaos; McDevitt, John T

    2015-10-21

    The development of integrated instrumentation for universal bioassay systems serves as a key goal for the lab-on-a-chip community. The programmable bio-nano-chip (p-BNC) system is a versatile multiplexed and multiclass chemical- and bio-sensing system for bioscience and clinical measurements. The system is comprised of two main components, a disposable cartridge and a portable analyzer. The customizable single-use plastic cartridges, which now can be manufactured in high volumes using injection molding, are designed for analytical performance, ease of use, reproducibility, and low cost. These labcard devices implement high surface area nano-structured biomarker capture elements that enable high performance signaling and are index-matched to real-world biological specimens. This detection modality, along with the convenience of on-chip fluid storage in blisters and self-contained waste, represents a standard process to digitize biological signatures at the point-of-care. A companion portable analyzer prototype has been developed to integrate fluid motivation, optical detection, and automated data analysis, and it serves as the human interface for complete assay automation. In this report, we provide a systems-level perspective of the p-BNC universal biosensing platform with an emphasis on flow control, device integration, and automation. To demonstrate the flexibility of the p-BNC, we distinguish diseased and non-case patients across three significant disease applications: prostate cancer, ovarian cancer, and acute myocardial infarction. Progress towards developing a rapid 7 minute myoglobin assay is presented using the fully automated p-BNC system.

  3. Characterization of the Cellular Output of a Point-of-Care Device and the Implications for Addressing Critical Limb Ischemia.

    Science.gov (United States)

    Woodell-May, Jennifer E; Tan, Matthew L; King, William J; Swift, Matthew J; Welch, Zachary R; Murphy, Michael P; McKale, James M

    2015-01-01

    Critical limb ischemia (CLI) is a terminal disease with high morbidity and healthcare costs due to limb loss. There are no effective medical therapies for patients with CLI to prevent amputation. Cell-based therapies are currently being investigated to address this unmet clinical need and have shown promising preliminary results. The purpose of this study was to characterize the output of a point-of-care cell separator (MarrowStim P.A.D. Kit), currently under investigation for the treatment of CLI, and compare its output with Ficoll-based separation. The outputs of the MarrowStim P.A.D. Kit and Ficoll separation were characterized using an automated hematology analyzer, colony-forming unit (CFU) assays, and tubulogenesis assays. Hematology analysis indicated that the MarrowStim P.A.D. Kit concentrated the total nucleated cells, mononuclear cells, and granulocytes compared with baseline bone marrow aspirate. Cells collected were positive for VEGFR-2, CD3, CD14, CD34, CD45, CD56, CD105, CD117, CD133, and Stro-1 antigen. CFU assays demonstrated that the MarrowStim P.A.D. Kit output a significantly greater number of mesenchymal stem cells and hematopoietic stem cells compared with cells output by Ficoll separation. There was no significant difference in the number of endothelial progenitor cells output by the two separation techniques. Isolated cells from both techniques formed interconnected nodes and microtubules in a three-dimensional cell culture assay. This information, along with data currently being collected in large-scale clinical trials, will help instruct how different cellular fractions may affect the outcomes for CLI patients.

  4. Awareness, Interest, and Preferences of Primary Care Providers in Using Point-of-Care Cancer Screening Technology.

    Directory of Open Access Journals (Sweden)

    Chloe S Kim

    Full Text Available Well-developed point-of-care (POC cancer screening tools have the potential to provide better cancer care to patients in both developed and developing countries. However, new medical technology will not be adopted by medical providers unless it addresses a population's existing needs and end-users' preferences. The goals of our study were to assess primary care providers' level of awareness, interest, and preferences in using POC cancer screening technology in their practice and to provide guidelines to biomedical engineers for future POC technology development. A total of 350 primary care providers completed a one-time self-administered online survey, which took approximately 10 minutes to complete. A $50 Amazon gift card was given as an honorarium for the first 100 respondents to encourage participation. The description of POC cancer screening technology was provided in the beginning of the survey to ensure all participants had a basic understanding of what constitutes POC technology. More than half of the participants (57% stated that they heard of the term "POC technology" for the first time when they took the survey. However, almost all of the participants (97% stated they were either "very interested" (68% or "somewhat interested" (29% in using POC cancer screening technology in their practice. Demographic characteristics such as the length of being in the practice of medicine, the percentage of patients on Medicaid, and the average number of patients per day were not shown to be associated with the level of interest in using POC. These data show that there is a great interest in POC cancer screening technology utilization among this population of primary care providers and vast room for future investigations to further understand the interest and preferences in using POC cancer technology in practice. Ensuring that the benefits of new technology outweigh the costs will maximize the likelihood it will be used by medical providers and

  5. Awareness, Interest, and Preferences of Primary Care Providers in Using Point-of-Care Cancer Screening Technology.

    Science.gov (United States)

    Kim, Chloe S; Vanture, Sarah; Cho, Margaret; Klapperich, Catherine M; Wang, Catharine; Huang, Franklin W

    2016-01-01

    Well-developed point-of-care (POC) cancer screening tools have the potential to provide better cancer care to patients in both developed and developing countries. However, new medical technology will not be adopted by medical providers unless it addresses a population's existing needs and end-users' preferences. The goals of our study were to assess primary care providers' level of awareness, interest, and preferences in using POC cancer screening technology in their practice and to provide guidelines to biomedical engineers for future POC technology development. A total of 350 primary care providers completed a one-time self-administered online survey, which took approximately 10 minutes to complete. A $50 Amazon gift card was given as an honorarium for the first 100 respondents to encourage participation. The description of POC cancer screening technology was provided in the beginning of the survey to ensure all participants had a basic understanding of what constitutes POC technology. More than half of the participants (57%) stated that they heard of the term "POC technology" for the first time when they took the survey. However, almost all of the participants (97%) stated they were either "very interested" (68%) or "somewhat interested" (29%) in using POC cancer screening technology in their practice. Demographic characteristics such as the length of being in the practice of medicine, the percentage of patients on Medicaid, and the average number of patients per day were not shown to be associated with the level of interest in using POC. These data show that there is a great interest in POC cancer screening technology utilization among this population of primary care providers and vast room for future investigations to further understand the interest and preferences in using POC cancer technology in practice. Ensuring that the benefits of new technology outweigh the costs will maximize the likelihood it will be used by medical providers and patients.

  6. Measuring the level of agreement between a veterinary and a human point-of-care glucometer and a laboratory blood analyzer in Hispaniolan Amazon parrots (Amazona ventralis).

    Science.gov (United States)

    Acierno, Mark J; Schnellbacher, Rodney; Tully, Thomas N

    2012-12-01

    Although abnormalities in blood glucose concentrations in avian species are not as common as they are in mammals, the inability to provide point-of-care glucose measurement likely results in underreporting and missed treatment opportunities. A veterinary glucometer that uses different optimization codes for specific groups of animals has been produced. To obtain data for a psittacine bird-specific optimization code, as well as to calculate agreement between the veterinary glucometer, a standard human glucometer, and a laboratory analyzer, blood samples were obtained from 25 Hispaniolan Amazon parrots (Amazona ventralis) in a 2-phase study. In the initial phase, blood samples were obtained from 20 parrots twice at a 2-week interval. For each sample, the packed cell volume was determined, and the blood glucose concentration was measured by the veterinary glucometer. The rest of each sample was placed into a lithium heparin microtainer tube and centrifuged, and plasma was removed and frozen at -30 degrees C. Within 5 days, tubes were thawed, and blood glucose concentrations were measured with a laboratory analyzer. The data from both procedures were used to develop a psittacine bird-specific code. For the second phase of the study, the same procedure was repeated twice at a 2-week interval in 25 birds to determine agreement between the veterinary glucometer, a standard human glucometer, and a laboratory analyzer. Neither glucometer was in good agreement with the laboratory analyzer (veterinary glucometer bias, 9.0; level of agreement, -38.1 to 56.2; standard glucometer bias, 69.4; level of agreement -17.8 to 156.7). Based on these results, the use of handheld glucometers in the diagnostic testing of Hispaniolan Amazon parrots and other psittacine birds cannot be recommended.

  7. Optical enhanced luminescent measurements and sequential reagent mixing on a centrifugal microfluidic device for multi-analyte point-of-care applications

    Science.gov (United States)

    Bartholomeusz, Daniel A.; Davies, Rupert H.; Andrade, Joseph D.

    2006-02-01

    A centrifugal-based microfluidic device1 was built with lyophilized bioluminescent reagents for measuring multiple metabolites from a sample of less than 15 μL. Microfluidic channels, reaction wells, and valves were cut in adhesive vinyl film using a knife plotter with features down to 30 μm and transferred to metalized polycarbonate compact disks (CDs). The fabrication method was simple enough to test over 100 prototypes within a few months. It also allowed enzymes to be packaged in microchannels without exposure to heat or chemicals. The valves were rendered hydrophobic using liquid phase deposition. Microchannels were patterned using soft lithography to make them hydrophilic. Reagents and calibration standards were deposited and lyophilized in different wells before being covered with another adhesive film. Sample delivery was controlled by a modified CD ROM. The CD was capable of distributing 200 nL sample aliquots to 36 channels, each with a different set of reagents that mixed with the sample before initiating the luminescent reactions. Reflection of light from the metalized layer and lens configuration allowed for 20% of the available light to be collected from each channel. ATP was detected down to 0.1 μM. Creatinine, glucose, and galactose were also measured in micro and milliMolar ranges. Other optical-based analytical assays can easily be incorporated into the device design. The minimal sample size needed and expandability of the device make it easier to simultaneously measure a variety of clinically relevant analytes in point-of-care settings.

  8. Universal HIV screening at postnatal points of care: which public health approach for early infant diagnosis in Cote d'Ivoire?

    Directory of Open Access Journals (Sweden)

    Camille Ndondoki

    Full Text Available BACKGROUND: Universal HIV pediatric screening offered at postnatal points of care (PPOC is an entry point for early infant diagnosis (EID. We assessed the parents' acceptability of this approach in Abidjan, Côte d'Ivoire. METHODS: In this cross-sectional study, trained counselors offered systematic HIV screening to all children aged 6-26 weeks attending PPOC in three community health centers with existing access to HAART during 2008, as well as their parents/caregivers. HIV-testing acceptability was measured for parents and children; rapid HIV tests were used for parents. Both parents' consent was required according to the Ivorian Ethical Committee to perform a HIV test on HIV-exposed children. Free HIV care was offered to those who were diagnosed HIV-infected. FINDINGS: We provided 3,013 HIV tests for infants and their 2,986 mothers. While 1,731 mothers (58% accepted the principle of EID, only 447 infants had formal parental consent 15%; 95% confidence interval (CI: [14%-16%]. Overall, 1,817 mothers (61% accepted to test for HIV, of whom 81 were HIV-infected (4.5%; 95% CI: [3.5%-5.4%]. Among the 81 HIV-exposed children, 42 (52% had provided parental consent and were tested: five were HIV-infected (11.9%; 95% CI: [2.1%-21.7%]. Only 46 fathers (2% came to diagnose their child. Parental acceptance of EID was strongly correlated with prenatal self-reported HIV status: HIV-infected mothers were six times more likely to provide EID parental acceptance than mothers reporting unknown or negative prenatal HIV status (aOR: 5.9; 95% CI: [3.3-10.6], p = 0.0001. CONCLUSIONS: Although the principle of EID was moderately accepted by mothers, fathers' acceptance rate remained very low. Routine HIV screening of all infants was inefficient for EID at a community level in Abidjan in 2008. Our results suggest the need of focusing on increasing the PMTCT coverage, involving fathers and tracing children issued from PMTCT programs in low HIV prevalence countries.

  9. A critical insight into the development pipeline of microfluidic immunoassay devices for the sensitive quantitation of protein biomarkers at the point of care.

    Science.gov (United States)

    Barbosa, Ana I; Reis, Nuno M

    2017-03-13

    The latest clinical procedures for the timely and cost-effective diagnosis of chronic and acute clinical conditions, such as cardiovascular diseases, cancer, chronic respiratory diseases, diabetes or sepsis (i.e. the biggest causes of death worldwide), involve the quantitation of specific protein biomarkers released into the blood stream or other physiological fluids (e.g. urine or saliva). The clinical thresholds are usually in the femtomolar to picolomar range, and consequently the measurement of these protein biomarkers heavily relies on highly sophisticated, bulky and automated equipment in centralised pathology laboratories. The first microfluidic devices capable of measuring protein biomarkers in miniaturised immunoassays were presented nearly two decades ago and promised to revolutionise point-of-care (POC) testing by offering unmatched sensitivity and automation in a compact POC format; however, the development and adoption of microfluidic protein biomarker tests has fallen behind expectations. This review presents a detailed critical overview into the pipeline of microfluidic devices developed in the period 2005-2016 capable of measuring protein biomarkers from the pM to fM range in formats compatible with POC testing, with a particular focus on the use of affordable microfluidic materials and compact low-cost signal interrogation. The integration of these two important features (essential unique selling points for the successful microfluidic diagnostic products) has been missed in previous review articles and explain the poor adoption of microfluidic technologies in this field. Most current miniaturised devices compromise either on the affordability, compactness and/or performance of the test, making current tests unsuitable for the POC measurement of protein biomarkers. Seven core technical areas, including (i) the selected strategy for antibody immobilisation, (ii) the surface area and surface-area-to-volume ratio, (iii) surface passivation, (iv) the

  10. Value Analysis of Heparin Anticoagulant Plasma in the Emergency Biochemical Test%肝素抗凝血浆用于急诊生化检验的价值分析

    Institute of Scientific and Technical Information of China (English)

    柳宝忠

    2015-01-01

    Objective To explore the feasibility of heparin anticoagulant plasma in the emergency biochemical test. Methods We select 40 cases of patients in our hospital from January to July in 2014 who need emergency biochemical test and collect from them 40 copies of blood specimens,each of which is divided evenly into routine plasma group and heparin anticoagulant plasma group.The two groups of specimens are tested under routine examination and theresults are compared. Results According to the results,it is of significant difference in testing K+、Na+、Clu but not in Cl-、Ca2+、Mg2+、Bun、ALT、Cr、AST between the two groups. Conclusion Heparin anticoagulant plasma is of more efficency in the emergency biochemical test and can be a substitute for routine plasma.%目的:探究肝素抗凝血浆用于急诊生化检验的可行性。方法选择我院于2014年1月~2014年7月期间收治的40例需急诊生化检验的患者,采集血液标本40份,每份标本分成两份,分别为常规血清组和肝素抗凝剂血浆组。按常规检测方法检测,并比较检验结果。结果检测结果显示,在K+、Na+、Clu等方面,组间差异显著;在Cl-、Ca2+、Mg2+、Bun、ALT、Cr、AST等方面,组间差异不显著。结论肝素抗凝血浆检测速度快,可代替常规血清进行生化检验项目检测。

  11. Using a Personal Glucose Meter and Alkaline Phosphatase for Point-of-Care Quantification of Galactose-1-Phosphate Uridyltransferase in Clinical Galactosemia Diagnosis.

    Science.gov (United States)

    Zhang, Jingjing; Xiang, Yu; Novak, Donna E; Hoganson, George E; Zhu, Junjie; Lu, Yi

    2015-10-01

    The personal glucose meter (PGM) was recently shown to be a general meter to detect many targets. Most studies, however, focus on transforming either target binding or enzymatic activity that cleaves an artificial substrate into the production of glucose. More importantly, almost all reports exhibit their methods by using artificial samples, such as buffers or serum samples spiked with the targets. To expand the technology to even broader targets and to validate its potential in authentic, more complex clinical samples, we herein report expansion of the PGM method by using alkaline phosphatase (ALP) that links the enzymatic activity of galactose-1-phosphate uridyltransferase to the production of glucose, which allows point-of-care galactosemia diagnosis in authentic human clinical samples. Given the presence of ALP in numerous enzymatic assays for clinical diagnostics, the methods demonstrated herein advance the field closer to point-of-care detection of a wide range of targets in real clinical samples.

  12. Point-of-care pleural and lung ultrasound in a newborn suffering from cardiac arrest due to tension pneumothorax after cardiac surgery.

    Science.gov (United States)

    Polito, Angelo; Biasucci, Daniele G; Cogo, Paola

    2016-02-01

    We report the case of a 12-day-old newborn affected by coarctation of the aorta and intraventricular defect who underwent coarctectomy and pulmonary artery banding. On post-operative day 7, the patient suffered from pulseless electric activity due to tension pneumothorax. Point-of-care ultrasound was performed during cardiopulmonary resuscitation in an attempt to diagnose pneumothorax. The diagnosis was made without delaying or interrupting chest compressions, and the pneumothorax was promptly treated.

  13. In-vitro anticoagulant activity of fucoidan derivatives from brown seaweed Laminaria japonica

    Institute of Scientific and Technical Information of China (English)

    WANG Jing; ZHANG Quanbin; ZHANG Zhongshan; HOU Yun; ZHANG Hong

    2011-01-01

    Fucoidan, a group of sulfated heteropolysaccharides, was extracted from Laminariajaponica,an important economic alga species in China. The anticoagulant activity of fucoidan and its derivatives (including sulfated, phosphorylated, and aminated fucoidan) was examined using in-vitro anticoagulant systems. The correlation between chemical variations within the fucoidan group and anticoagulant activity was determined. The in-vitro anticoagulant properties of fucoidan and its derivatives were determined by measuring activated partial thromboplastin time (APTT), prothrombin time (PT), and thrombin time (TT).The results indicate anticoagulant activity in all samples using APTT and TT assays; however, only the fucoidan derivatives affected the PT assay. Thus, the fucoidan derivatives were able to inhibit both intrinsic and extrinsic blood coagulants. Fucoidan (FPS) and its derivatives presented better anticoagulant activity than low molecular weight fucoidan (DFPS) and its derivatives, suggesting that molecular weight and proper conformation are contributing factors for anticoagulant activity of polysaccharides. Amino groups have a positive charge and can thus change the charge density of fucoidan. Accordingly, among the tested samples, aminated fucoidan (NF) was the most active reflecting the importance of charge density for anticoagulant activity. Available data obtained using in-vitro models suggest that the sulfate content,sulfate/total-sugar ratio, molecular weight, and the substituted group of fucoidan are important factors for anticoagulant activity but that the influence of sulfate, phosphate and amino groups on anticoagulant activity was different.

  14. In-vitro anticoagulant activity of fucoidan derivatives from brown seaweed Laminaria japonica

    Science.gov (United States)

    Wang, Jing; Zhang, Quanbin; Zhang, Zhongshan; Hou, Yun; Zhang, Hong

    2011-05-01

    Fucoidan, a group of sulfated heteropolysaccharides, was extracted from Laminaria japonica, an important economic alga species in China. The anticoagulant activity of fucoidan and its derivatives (including sulfated, phosphorylated, and aminated fucoidan) was examined using in-vitro anticoagulant systems. The correlation between chemical variations within the fucoidan group and anticoagulant activity was determined. The in-vitro anticoagulant properties of fucoidan and its derivatives were determined by measuring activated partial thromboplastin time (APTT), prothrombin time (PT), and thrombin time (TT). The results indicate anticoagulant activity in all samples using APTT and TT assays; however, only the fucoidan derivatives affected the PT assay. Thus, the fucoidan derivatives were able to inhibit both intrinsic and extrinsic blood coagulants. Fucoidan (FPS) and its derivatives presented better anticoagulant activity than low molecular weight fucoidan (DFPS) and its derivatives, suggesting that molecular weight and proper conformation are contributing factors for anticoagulant activity of polysaccharides. Amino groups have a positive charge and can thus change the charge density of fucoidan. Accordingly, among the tested samples, aminated fucoidan (NF) was the most active reflecting the importance of charge density for anticoagulant activity. Available data obtained using in-vitro models suggest that the sulfate content, sulfate/total-sugar ratio, molecular weight, and the substituted group of fucoidan are important factors for anticoagulant activity but that the influence of sulfate, phosphate and amino groups on anticoagulant activity was different.

  15. Point of Care Tools im Vergleich des Universitätsklinikums Hamburg-Eppendorf (UKE: UpToDate, ClinicalResource@Ovid/Clin-eguide und Dynamed / Point of Care Tools in comparison at the University Medical Center Hamburg-Eppendorf: UpToDate, ClinicalResource@Ovid and Dynamed

    Directory of Open Access Journals (Sweden)

    Menn, Elke

    2006-09-01

    Full Text Available Point of Care Tools are used for clinical decision making – UpToDate is also used in continuing medical education. These databases compile only evidence-based knowledge which is updated regularly. Using Point of Care Tools promises to improve clinical outcomes. UpToDate has been used at the University Hospital Hamburg-Eppendorf for the last four years. In a recent trial the use of ClinicalResource@Ovid/Clin-eguide and Dynamed has been evaluated in comparison with UpToDate.

  16. Thrombotic and hemorrhagic complications in children with the lupus anticoagulant.

    Science.gov (United States)

    Bernstein, M L; Salusinsky-Sternbach, M; Bellefleur, M; Esseltine, D W

    1984-12-01

    Endogenous circulating anticoagulants are unusual in children without a congenital factor deficiency. In particular, the lupus anticoagulant has only rarely been reported in children. Despite its functioning in vitro to prolong the partial thromboplastin time, patients more frequently have problems with thrombosis than bleeding, unless there is a coexistent prothrombin deficiency or thrombocytopenia. We report the cases of three children with the lupus anticoagulant. Two children had associated thromboses. One had a thrombosis of the iliofemoral system and the other had a partial Budd-Chiari syndrome, a thrombosis of the deep calf veins and ureteric obstruction. The third child had a concomitant prothrombin deficiency and bleeding after tooth extraction. Associated findings in these patients included a positive antinuclear antibody test in two, a positive anti-DNA antibody test in two, a false-positive VDRL test in two, and an antiphospholipid antibody test in two.

  17. Optimizing Blue Persistent Luminescence in (Sr1-δBaδ)2MgSi2O7:Eu(2+),Dy(3+) via Solid Solution for Use in Point-of-Care Diagnostics.

    Science.gov (United States)

    Finley, Erin; Cobb, Angelica; Duke, Anna; Paterson, Andrew; Brgoch, Jakoah

    2016-10-12

    Inorganic persistent luminescent phosphors are an excellent class of optical reporters for enabling sensitive point-of-care diagnostics, particularly with smartphone-based biosensing devices in testing formats such as the lateral flow assay (LFA). Here, the development of persistent phosphors for this application is focused on the solid solution (Sr1-δBaδ)2MgSi2O7:Eu(2+),Dy(3+) (δ = 0, 0.125, 0.25, 0.375), which is prepared using a high-temperature solid-state reaction as confirmed by synchrotron X-ray powder diffraction. The substitution of barium for strontium enables control over the Eu(2+) 5d-orbital crystal field splitting (CFS) as a tool for tuning the emission wavelength while maintaining luminescence lifetimes >9 min across the composition range. Thermoluminescence measurements of the solid solution provide evidence that trap states contribute to the persistent lifetimes with the trap depths also remaining constant as a function of composition. Time-gated luminescence images of these compounds are captured on a smartphone arranged in a layout to mimic a point-of-care test and demonstrate the viability of using these materials as optical reporters. Moreover, comparing the blue-emitting (Sr0.625Ba0.375)2MgSi2O7:Eu(2+),Dy(3+) and the green-emitting SrAl2O4:Eu(2+),Dy(3+) in a single LFA-type format shows these two compounds can be detected and resolved simultaneously, thereby permitting the development of a multiplexed LFA.

  18. Use of INR to assess degree of anticoagulation in patients who have dental procedures.

    Science.gov (United States)

    Steinberg, M J; Moores, J F

    1995-08-01

    Dental professionals frequently treat patients who are receiving anticoagulation therapy. Proper treatment may require adjustment of the anticoagulant dose usually on the basis of the patient's current prothrombin time. This test has been shown to be less accurate than previously thought. The international normalized ratio is another method that attempts to standardize the degree of anticoagulation and to improve reproducibility of results. This system is slowly being implemented in laboratories in the United States. Practitioners who treat patients taking anticoagulants need to be aware of this system in order to make appropriate management decisions.

  19. Does plasmin have anticoagulant activity?

    Directory of Open Access Journals (Sweden)

    Jane Hoover-Plow

    2010-03-01

    Full Text Available Jane Hoover-PlowJoseph J Jacobs Center for Thrombosis and Vascular Biology, Departments of Cardiovascular Medicine and Molecular Cardiology, Lerner Research Institute Cleveland Clinic, Ohio, USAAbstract: The coagulation and fibrinolytic pathways regulate hemostasis and thrombosis, and an imbalance in these pathways may result in pathologic hemophilia or thrombosis. The plasminogen system is the primary proteolytic pathway for fibrinolysis, but also has important proteolytic functions in cell migration, extracellular matrix degradation, metalloproteinase activation, and hormone processing. Several studies have demonstrated plasmin cleavage and inactivation of several coagulation factors, suggesting plasmin may be not only be the primary fibrinolytic enzyme, but may have anticoagulant properties as well. The objective of this review is to examine both in vitro and in vivo evidence for plasmin inactivation of coagulation, and to consider whether plasmin may act as a physiological regulator of coagulation. While several studies have demonstrated strong evidence for plasmin cleavage and inactivation of coagulation factors FV, FVIII, FIX, and FX in vitro, in vivo evidence is lacking for a physiologic role for plasmin as an anticoagulant. However, inactivation of coagulation factors by plasmin may be useful as a localized anticoagulant therapy or as a combined thrombolytic and anticoagulant therapy.Keywords: thrombosis, anticoagulant, cardiovascular disease, plasminogen’s protease, blood

  20. Colonoscopic polypectomy in anticoagulated patients

    Institute of Scientific and Technical Information of China (English)

    Shai Friedland; Daniel Sedehi; Roy Soetikno

    2009-01-01

    AIM: To review our experience performing polypectomy in anticoagulated patients without interruption of anticoagulation.METHODS: Retrospective chart review at the Veterans Affairs Palo Alto Health Care System. Two hundred and twenty five polypectomies were performed in 123 patients. Patients followed a standardized protocol that included stopping warfarin for 36 h to avoid supratherapeutic anticoagulation from the bowel preparation. Patients with lesions larger than 1 cm were generally rescheduled for polypectomy off warfarin. Endoscopic clips were routinely applied prophylactically.RESULTS: One patient (0.8%, 95% CI: 0.1%-4.5%)developed major post-polypectomy bleeding that required transfusion. Two others (1.6%, 95% CI:0.5%-5.7%) had self-limited hematochezia at home and did not seek medical attention. The average polyp size was 5.1 ± 2.2 mm.

  1. Dietary vitamin K guidance: an effective strategy for stable control of oral anticoagulation?

    Science.gov (United States)

    Numerous factors have been identified as risk factors for instability of oral anticoagulation, including variability in vitamin K intake. However few studies have directly tested the feasibility of manipulating dietary vitamin K to achieve stable oral anticoagulation. Recent findings from a rando...

  2. Preoperative management of anticoagulation and antiplatelet agents.

    Science.gov (United States)

    Gleason, Lauren Jan; Friedman, Susan M

    2014-05-01

    This article describes current literature and treatment plans for managing anticoagulation and antiplatelet agents in patients presenting with hip fractures. Indications for anticoagulation and antiplatelet agents are discussed, and management techniques for when patients present with hip fractures are reviewed.

  3. Detection of integrase in retroviral particles by a specific DNA sensor with a potential for adaptation to point-of-care diagnosis

    DEFF Research Database (Denmark)

    Wang, Jing

    important to develop a sensitive and specific assay for the early detection, which can be adapted to point-of-care diagnosis. In the current study we describe a new specific DNA sensor system that allows the specific and sensitive detection of retrovirus IN activity. The system relies on one-end integration......The acquired immunodeficiency syndrome (AIDS) caused by HIV is one of the greatest threats to human health. Currently, HIV-infected individuals are treated by FDA approved highly active antiretroviral therapy that targets three steps of the HIV life cycle. HAART includes a protease inhibitor...

  4. New parenteral anticoagulants in development.

    Science.gov (United States)

    Gómez-Outes, Antonio; Suárez-Gea, Maria Luisa; Lecumberri, Ramón; Rocha, Eduardo; Pozo-Hernández, Carmen; Vargas-Castrillón, Emilio

    2011-02-01

    The therapeutic armamentarium of parenteral anticoagulants available to clinicians is mainly composed by unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), fondaparinux, recombinant hirudins (i.e. bivalirudin, desirudin, lepirudin) and argatroban. These drugs are effective and safe for prevention and/or treatment of thromboembolic diseases but they have some drawbacks. Among other inconveniences, UFH requires regular anticoagulant monitoring as a result of variability in the anticoagulant response and there is a risk of serious heparin-induced thrombocytopaenia (HIT). LMWH, fondaparinux and recombinant hirudins are mainly cleared through the kidneys and their use in patients with severe renal insufficiency may be problematic. LMWH is only partially neutralized by protamine while fondaparinux and recombinant hirudins have no specific antidote. Novel anticoagulants in development for parenteral administration include new indirect activated factor Xa (FXa) inhibitors (idrabiotaparinux, ultra-low-molecular-weight heparins [semuloparin, RO-14], new LMWH [M118]), direct FXa inhibitors (otamixaban), direct FIIa inhibitors (flovagatran sodium, pegmusirudin, NU172, HD1-22), direct FXIa inhibitors (BMS-262084, antisense oligonucleotides targeting FXIa, clavatadine), direct FIXa inhibitors (RB-006), FVIIIa inhibitors (TB-402), FVIIa/tissue factor inhibitors (tifacogin, NAPc2, PCI-27483, BMS-593214), FVa inhibitors (drotrecogin alpha activated, ART-123) and dual thrombin/FXa inhibitors (EP217609, tanogitran). These new compounds have the potential to complement established parenteral anticoagulants. In the present review, we discuss the pharmacology of new parenteral anticoagulants, the results of clinical studies, the newly planned or ongoing clinical trials with these compounds, and their potential advantages and drawbacks over existing therapies.

  5. [Anticoagulation in atrial fibrillation - an update].

    Science.gov (United States)

    Antz, Matthias; Hullmann, Bettina; Neufert, Christian; Vocke, Wolfgang

    2008-12-01

    The correct anticoagulation regimen for prevention of thromboembolic events is essential in patients with atrial fibrillation. However, only a minority of patients receives anticoagulation according to the guidelines. The current guidelines are intended to make the indication for anticoagulation more simple and are summarized in the present article. This includes recommendations for chronic anticoagulation, prevention of thromboembolic events after cardioversion and in ablation of atrial fibrillation.

  6. Current Controversies in Lupus Anticoagulant Detection

    Directory of Open Access Journals (Sweden)

    Gary W. Moore

    2016-12-01

    Full Text Available Antiphospholipid syndrome is an autoimmune, acquired thrombophilia diagnosed when vascular thrombosis or pregnancy morbidity are accompanied by persistent antiphospholipid antibodies. Lupus anticoagulants (LA are one of the criteria antibodies but calibration plasmas are unavailable and they are detected by inference based on antibody behaviour in a medley of coagulation-based assays. Elevated screening tests suggest the presence of a LA, which is confirmed with mixing tests to evidence inhibition and confirmatory tests to demonstrate phospholipid-dependence. At least two screening tests of different principle must be used to account for antibody heterogeneity and controversy exists on whether assays, in addition to dilute Russell’s viper venom time and activated partial thromboplastin time, should be employed. A variety of approaches to raw data manipulation and interpretation attract debate, as does inclusion or exclusion of mixing studies in circumstances where the presence of a LA is already evident from other results. Therapeutic anticoagulation compromises coagulation-based assays but careful data interpretation and use of alternative reagents can detect or exclude LA in specific circumstances, and this aspect of LA detection continues to evolve. This review focuses on the main areas of debate in LA detection.

  7. Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System

    Directory of Open Access Journals (Sweden)

    Venkatesh Ponemone

    2017-01-01

    Full Text Available Critical limb ischemia (CLI is the end stage of lower extremity peripheral vascular disease (PVD in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17 no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI, Transcutaneous Oxygen Pressure (TcPO2, mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS rate and amputation-free rates (AFR at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.

  8. Analysis of data captured by barcode medication administration system using a PDA; aiming at reducing medication errors at point of care in Japanese Red Cross Kochi Hospital.

    Science.gov (United States)

    Akiyama, Masanori; Koshio, Atsushi; Kaihotsu, Nobuyuki

    2010-01-01

    Preventing medication errors by using a barcode administration system has become prevalent in patient safety. Analyses of data captured by bar code systems provide opportunities to understand the actual situation at the point of care. Our study aims at understanding issues of medication safety as well as investigating measures taken to prevent medication accidents, by analyzing data captured by a bar code system and a personal digital assistant (PDA). The barcode administration system named Point-of-Act-System implemented in Japanese Red Cross Kochi Hospital was designed to capture every activity at the bedside. Complete activity data captured by the system, which included injections, treatment and other nursing activity, as well as injection warning data, were used for our analyses. We describe the data and analyze them statistically to find potentially times of risk and to ascertain the relation between busyness and error. The injection warning rate as a whole was 6.1% on average. The results showed there was a negative correlation between the number of injections given and the injection warning rate (-0.48, pmedication safety. A bar code administration system is quite an effective way not only to prevent medication error at point of care, but also to improve patient safety through analyses of data captured by such a system.

  9. Potential of a simplified measurement scheme and device structure for a low cost label-free point-of-care capacitive biosensor.

    Science.gov (United States)

    de Vasconcelos, Elder A; Peres, Newton G; Pereira, Cintya O; da Silva, Valdinete L; da Silva, Eronides F; Dutra, Rosa F

    2009-12-15

    A simplified measurement scheme and device structure aiming at developing a low cost, label-free, point-of-care capacitive biosensor were investigated. The detection principle is the increase of low frequency capacitance between two planar Al electrodes observed after antibody-antigen interaction. The electrodes, deposited on oxidized Si wafers, were covered with an antibody layer, with and without using self-assembled thiol monolayer. Immunoglobulin G (IgG) and cardiac troponin T (TnT) were used as analytes to asses this proposal. The device was able to detect successfully TnT levels in the range 0.07 to 6.83ng/mL in human serum from patients with cardiac diseases and in the range 0.01ng/mL to 5ng/mL for TnT in phosphate buffer saline. An equivalent circuit model able to reproduce the general behavior of experimental capacitance versus frequency curves was presented. The investigated features that have potential to reduce costs and simplify measurements were: use of single, low frequency (1kHz) measurement signal, within the range of low cost portable capacitance meters; employment of a lower cost electrode material, aluminum, instead of gold electrodes; and use of simple and miniaturized planar two-electrodes arrangement, thus making a portable system for point-of-care applications.

  10. Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.

    Science.gov (United States)

    Ponemone, Venkatesh; Gupta, Saniya; Sethi, Dalip; Suthar, Manish; Sharma, Monika; Powell, Richard J; Harris, Kenneth Lee; Jungla, Nungshi; Arambam, Priyadarshini; Kaul, Upendra; Seth, Ashok; Bukhari, Suhail

    2017-01-01

    Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO2), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.

  11. What is the point of the point-of-care? A case study of user resistance to an e-health system.

    Science.gov (United States)

    Whittaker, Louise; Van Zyl, Jaco; Soicher, Antony S

    2011-01-01

    The purpose of this article is to explore the response of nurses to a point-of-care e-health system that was implemented in a large private hospital in South Africa, to determine why the nursing staff rejected the implementation of the system. The study examines user responses with reference to a model designed to account for the use and adoption of mobile handheld devices, having adapted the model for an e-health context. In addition to the input features of technological characteristics and individual differences identified in the model, the added features of nursing culture and group differences were found to be influential factors in fuelling the nurses' resistance to the point-of-care system. Nurses perceived a lack of cultural fit between the system and their work. Their commitment to their nursing culture meant that they were not prepared to adapt their processes to integrate the system into their work. The study shows that the model is useful for understanding adoption in an organizational context and also that the additional elements of nursing culture and group differences are important in an e-health context.

  12. Multinational development of a questionnaire assessing patient satisfaction with anticoagulant treatment: the 'Perception of Anticoagulant Treatment Questionnaire' (PACT-Q©

    Directory of Open Access Journals (Sweden)

    Bousser Marie-Germaine

    2009-02-01

    Full Text Available Abstract Background The side effects and burden of anticoagulant treatments may contribute to poor compliance and consequently to treatment failure. A specific questionnaire is necessary to assess patients' needs and their perceptions of anticoagulant treatment. Methods A conceptual model of expectation and satisfaction with anticoagulant treatment was designed by an advisory board and used to guide patient (n = 31 and clinician (n = 17 interviews in French, US English and Dutch. Patients had either atrial fibrillation (AF, deep venous thrombosis (DVT, or pulmonary embolism (PE. Following interviews, three PACT-Q language versions were developed simultaneously and further pilot-tested by 19 patients. Linguistic validations were performed for additional language versions. Results Initial concepts were developed to cover three areas of interest: 'Treatment', 'Disease and Complications' and 'Information about disease and anticoagulant treatment'. After clinician and patient interviews, concepts were further refined into four domains and 17 concepts; test versions of the PACT-Q were then created simultaneously in three languages, each containing 27 items grouped into four domains: "Treatment Expectations" (7 items, "Convenience" (11 items, "Burden of Disease and Treatment" (2 items and "Anticoagulant Treatment Satisfaction" (7 items. No item was deleted or added after pilot testing as patients found the PACT-Q easy to understand and appropriate in length in all languages. The PACT-Q was divided into two parts: the first part to measure the expectations and the second to measure the convenience, burden and treatment satisfaction, for evaluation prior to and after anticoagulant treatment, respectively. Eleven additional language versions were linguistically validated. Conclusion The PACT-Q has been rigorously developed and linguistically validated. It is available in 14 languages for use with thromboembolic patients, including AF, PE and DVT patients

  13. Anticoagulation Quality and Complications of using Vitamin K Antagonists in the Cardiac Surgery Outpatient Clinic

    Directory of Open Access Journals (Sweden)

    Mário Augusto Cray da Costa

    Full Text Available ABSTRACT Introduction: In patients with mechanical prosthetic heart valves or atrial fibrillation requiring anticoagulation to prevent thromboembolic events, several factors influence adherence and anticoagulation complications. Objective: To evaluate the factors that interfere with the quality and complications of anticoagulation with vitamin K antagonists. Methods: A retrospective cohort study of 100 patients, in the period from 2011 to 2014, was performed. Anticoagulation conditions in the last year, regarding the presence of complications (embolisms/bleeding and inadequate treatment were assessed: achievement of less than 8 annual prothrombin times and International Normalized Ratio outside therapeutic target in more than 40% of prothrombin times. Results: There were 31 complications (22 minor bleeding without hospitalization and 9 major complications: 7 bleeding with hospitalization and two emboli; 70 were with International Normalized Ratio outside the target in more than 40% of the tests and 36 with insufficient number of prothrombin times. Socioeconomic factors, anticoagulant type and anticoagulation reason had no relationship with complications or with inadequate treatment. There were more complications in patients with longer duration of anticoagulation (P=0.001. Women had more International Normalized Ratio outside the target range (OR 2.61, CI:1.0-6.5; P=0.04. Patients with lower number of annual prothrombin times had longer times of anticoagulation (P=0.03, less annual consultations (P=0.02 and less dose adjustments (P=0.003. Patients with longer duration of anticoagulation have more complications (P=0.001. Conclusion: There was a high rate of major complications and International Normalized Ratio was outside the goal. Less annual prothrombin times was related to longer duration of anticoagulation, less annual consultations and less dose adjustments. More major complications occurred in patients with longer duration of

  14. Personalized antiplatelet and anticoagulation therapy: applications and significance of pharmacogenomics

    Directory of Open Access Journals (Sweden)

    Beitelshees AL

    2015-02-01

    Full Text Available Amber L Beitelshees,1,* Deepak Voora,2,* Joshua P Lewis,1,* 1Program for Personalized and Genomic Medicine and Division of Endocrinology, Diabetes, and Nutrition, University of Maryland School of Medicine, Baltimore, MD, USA; 2Center for Applied Genomics & Precision Medicine, Department of Medicine, Duke School of Medicine, Durham, NC, USA*All authors contributed equally to this work Abstract: In recent years, substantial effort has been made to better understand the influence of genetic factors on the efficacy and safety of numerous medications. These investigations suggest that the use of pharmacogenetic data to inform physician decision-making has great potential to enhance patient care by reducing on-treatment clinical events, adverse drug reactions, and health care-related costs. In fact, integration of such information into the clinical setting may be particularly applicable for antiplatelet and anticoagulation therapeutics, given the increasing body of evidence implicating genetic variation in variable drug response. In this review, we summarize currently available pharmacogenetic information for the most commonly used antiplatelet (ie, clopidogrel and aspirin and anticoagulation (ie, warfarin medications. Furthermore, we highlight the currently known role of genetic variability in response to next-generation antiplatelet (prasugrel and ticagrelor and anticoagulant (dabigatran agents. While compelling evidence suggests that genetic variants are important determinants of antiplatelet and anticoagulation therapy response, significant barriers to clinical implementation of pharmacogenetic testing exist and are described herein. In addition, we briefly discuss development of new diagnostic targets and therapeutic strategies as well as implications for enhanced patient care. In conclusion, pharmacogenetic testing can provide important information to assist clinicians with prescribing the most personalized and effective antiplatelet and

  15. Development and examination of a rubric for evaluating point-of-care medical applications for mobile devices.

    Science.gov (United States)

    Butcher, Robyn; MacKinnon, Martin; Gadd, Kathleen; LeBlanc-Duchin, Denise

    2015-01-01

    The rapid development and updates of mobile medical resource applications (apps) highlight the need for an evaluation tool to assess the content of these resources. The purpose of the study was to develop and test a new evaluation rubric for medical resource apps. The evaluation rubric was designed using existing literature and through a collaborative effort between a hospital and an academic librarian. Testing found scores ranging from 23% to 88% for the apps. The evaluation rubric proved able to distinguish levels of quality within each content component of the apps, demonstrating potential for standardization of medical resource app evaluations.

  16. Vitamin K and stability of oral anticoagulant therapy

    NARCIS (Netherlands)

    Rombouts, Eva Karolien

    2011-01-01

    One of the causes of unstable anticoagulation is a variable vitamin K intake. The main objective of this thesis was to test the hypothesis that the INR is particularly sensitive to changes in vitamin K intake when vitamin K status is low, and that patients with a low vitamin K intake would therefore

  17. A Portable, Pressure Driven, Room Temperature Nucleic Acid Extraction and Storage System for Point of Care Molecular Diagnostics

    OpenAIRE

    Byrnes, Samantha; Fan, Andy; Trueb, Jacob; Jareczek, Francis; Mazzochette, Mark; Sharon, Andre; Sauer-Budge, Alexis F.; Klapperich, Catherine M.

    2013-01-01

    Many new and exciting portable HIV viral load testing technologies are emerging for use in global medicine. While the potential to provide fast, isothermal, and quantitative molecular diagnostic information to clinicians in the field will soon be a reality, many of these technologies lack a robust front end for sample clean up and nucleic acid preparation. Such a technology would enable many different downstream molecular assays. Here, we present a portable system for centrifuge-free room tem...

  18. Anticoagulant medication errors in nursing homes: characteristics, causes, outcomes, and association with patient harm.

    Science.gov (United States)

    Desai, Rishi J; Williams, Charlotte E; Greene, Sandra B; Pierson, Stephanie; Hansen, Richard A

    2013-01-01

    Appropriate and safe use of medications is an important aspect of quality of care in nursing home patients. Because of their complex medication use process, anticoagulants are prone to medication errors in the frail elderly. Therefore, we designed this study to characterize anticoagulant medication errors and to evaluate their association with patient harm using individual medication error incidents reported by all North Carolina nursing homes to the Medication Error Quality Initiative (MEQI) during fiscal years 2010-2011. Characteristics, causes, and specific outcomes of harmful anticoagulant medication errors were reported as frequencies and proportions and compared between anticoagulant errors and other medication errors using chi-square tests. A multivariate logistic regression model explored the relationship between anticoagulant medication errors and patient harm, controlling for patient- and error-related factors.

  19. [Antiplatelet agents and anticoagulants: management of the anticoagulated surgical patient].

    Science.gov (United States)

    Llau, Juan V; Ferrandis, Raquel; López Forte, Cristina

    2009-06-01

    Among the drugs most widely consumed by patients are both antiplatelet agents (aspirin, clopidogrel, ticlopidine) and anticoagulants (acenocoumarol, warfarin, low molecular weight heparin, fondaparinux). The use of these drugs in the perioperative period is an essential concern in patient care due to the need to balance the risk of bleeding against thrombotic risk (arterial or venous), which is increased in surgical patients. The present review highlights three main aspects. Firstly, withdrawal of antiplatelet agents is recommended between 1 week and 10 days before surgery to minimize perioperative bleeding. However, this practice has been questioned because patients without the required antiplatelet coverage may be at greater risk of developing cardiac, cerebral or peripheral vascular complications. Therefore, the recommendation of systematic antiplatelet withdrawal for a specific period should be rejected. Currently, risks should be evaluated on an individual basis to minimize the time during which the patient remains without adequate antiplatelet protection. Secondly, thromboprophylaxis is required in most surgical patients due to the high prevalence of venous thromboembolic disease. This implies the use of anticoagulants and the practice of regional anesthesia has been questioned in these patients. However, with the safety recommendations established by the various scientific societies, this practice has been demonstrated to be safe. Finally, "bridge therapy" in patients anticoagulated with acenocoumarol should be performed on an individual basis rather than systematically without taking into account the thrombotic risks of each patient. The perioperative period involves high arterial and venous thrombotic risk and the optimal use of antiplatelet agents and anticoagulants should be a priority to minimize this risk without increasing hemorrhagic risk. Multidisciplinary consensus is essential on this matter.

  20. Point of care technology or standard laboratory service in an emergency department: is there a difference in time to action? A randomised trial

    DEFF Research Database (Denmark)

    Backer Mogensen, Christian; Borch, Anders; Brandslund, Ivan

    2011-01-01

    Emergency Departments (ED) have a high flow of patients and time is often crucial. New technologies for laboratory analysis have been developed, including Point of Care Technologies (POCT), which can reduce the transport time and time of analysis significantly compared with central laboratory...... services. However, the question is if the time to clinical action is also reduced if a decisive laboratory answer is available during the first contact between the patient and doctor. The present study addresses this question: Does a laboratory answer, provided by POCT to the doctor who first attends...... the patient on admission, change the time to clinical decision in commonly occurring diseases in an ED compared with the traditional service from a central laboratory?...

  1. Evaluation of Optical Detection Platforms for Multiplexed Detection of Proteins and the Need for Point-of-Care Biosensors for Clinical Use

    Directory of Open Access Journals (Sweden)

    Samantha Spindel

    2014-11-01

    Full Text Available This review investigates optical sensor platforms for protein multiplexing, the ability to analyze multiple analytes simultaneously. Multiplexing is becoming increasingly important for clinical needs because disease and therapeutic response often involve the interplay between a variety of complex biological networks encompassing multiple, rather than single, proteins. Multiplexing is generally achieved through one of two routes, either through spatial separation on a surface (different wells or spots or with the use of unique identifiers/labels (such as spectral separation—different colored dyes, or unique beads—size or color. The strengths and weaknesses of conventional platforms such as immunoassays and new platforms involving protein arrays and lab-on-a-chip technology, including commercially-available devices, are discussed. Three major public health concerns are identified whereby detecting medically-relevant markers using Point-of-Care (POC multiplex assays could potentially allow for a more efficient diagnosis and treatment of diseases.

  2. Clinically integrated multi-organ point-of-care ultrasound for undifferentiated respiratory difficulty, chest pain, or shock: a critical analytic review.

    Science.gov (United States)

    Ha, Young-Rock; Toh, Hong-Chuen

    2016-01-01

    Rapid and accurate diagnosis and treatment are paramount in the management of the critically ill. Critical care ultrasound has been widely used as an adjunct to standard clinical examination, an invaluable extension of physical examination to guide clinical decision-making at bedside. Recently, there is growing interest in the use of multi-organ point-of-care ultrasound (MOPOCUS) for the management of the critically ill, especially in the early phase of resuscitation. This article will review the role and utility of symptom-based and sign-oriented MOPOCUS in patients with undifferentiated respiratory difficulty, chest pain, or shock and how it can be performed in a timely, effective, and efficient manner.

  3. Transitions of care in anticoagulated patients

    Directory of Open Access Journals (Sweden)

    Michota F

    2013-06-01

    Full Text Available Franklin Michota Department of Hospital Medicine, Cleveland Clinic, Cleveland, OH, USA Abstract: Anticoagulation is an effective therapeutic means of reducing thrombotic risk in patients with various conditions, including atrial fibrillation, mechanical heart valves, and major surgery. By its nature, anticoagulation increases the risk of bleeding; this risk is particularly high during transitions of care. Established anticoagulants are not ideal, due to requirements for parenteral administration, narrow therapeutic indices, and/or a need for frequent therapeutic monitoring. The development of effective oral anticoagulants that are administered as a fixed dose, have low potential for drug-drug and drug-food interactions, do not require regular anticoagulation monitoring, and are suitable for both inpatient and outpatient use is to be welcomed. Three new oral anticoagulants, the direct thrombin inhibitor, dabigatran etexilate, and the factor Xa inhibitors, rivaroxaban and apixaban, have been approved in the US for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; rivaroxaban is also approved for prophylaxis and treatment of deep vein thrombosis, which may le