Full Text Available The objective of this study was to examine the analytical performance of 14 comprehensive metabolic panel analytes on the Abaxis Piccolo Xpress® Point of Care analyzer in serum, plasma, and whole blood. A method comparison was performed on all three specimen types intended for use on the Piccolo Xpress®: serum, heparinized plasma, and whole blood. This data is also presented in Murata et al. (2015 . This article includes the actual Bland-Altman bias plots of the difference in results obtained for analytes in the comprehensive metabolic panel from the Abaxis Piccolo Xpress and the comparison instrument, the Ortho Vitros. Keywords: Clinical chemistry, Point-of care testing
Kosack, Cara Simone; de Kieviet, Wim; Bayrak, Kubra; Milovic, Anastacija; Page, Anne Laure
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. PMID:25886375
Kosack, Cara Simone; de Kieviet, Wim; Bayrak, Kubra; Milovic, Anastacija; Page, Anne Laure
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.
Dietrich, Christoph F; Goudie, Adrian; Chiorean, Liliana
Over the last decade, the use of portable ultrasound scanners has enhanced the concept of point of care ultrasound (PoC-US), namely, "ultrasound performed at the bedside and interpreted directly by the treating clinician." PoC-US is not a replacement for comprehensive ultrasound, but rather allows...... and critical care medicine, cardiology, anesthesiology, rheumatology, obstetrics, neonatology, gynecology, gastroenterology and many other applications. In the future, PoC-US will be more diverse than ever and be included in medical student training....
McDonald, John S; Noback, Carl R; Cheng, Drew; Lee, T K; Nenov, Val
We are developing a dynamic prototype visual communication system for the operating room environs. This has classically been viewed as an isolated and impenetrable workplace. All medical experiences and all teaching remain in a one to one closed loop with no recall or subsequent sharing for the training and education of other colleagues. The "Anesthesia Point of Care" (APOC) concept embraces the sharing of, recording of, and presentation of various physiological and pharmacological events so that real time memory can be shared at a later time for the edification of other colleagues who were not present at the time of the primary learning event. In addition it also provides a remarkably rapid tool for fellow faculty to respond to obvious stress and crisis events that can be broadcast instantly at the time of happening. Finally, it also serves as an efficient and effective means of paging and general communication throughout the daily routines among various healthcare providers in anesthesiology who work as a team unit; these include the staff, residents, CRNAs, physician assistants, and technicians. This system offers a unique opportunity to eventually develop future advanced ideas that can include training exercises, presurgical evaluations, surgical scheduling and improvements in efficiency based upon earlier than expected case completion or conversely later than expected case completion and even as a unique window to development of improved billing itemization and coordination.
In support of a UAV contract the Piccolo SL and Piccolo II autopilots were installed and operated on various aircraft. Numerous problems with the autopilot setup and analysis processes were found along with numerous problems with documentation and autopilot system information. Major areas of concern are identified along with objectives to eliminate the major areas of concern. Piccolo simulator vehicle gain calculations and Piccolo generation 2 version 2.1.4 control laws are reverse engineered. A complete modeling guide is created. Methods are developed to perform and analyze doublet maneuvers. A series of flight procedures are outlined that include methods for tuning gains. A series of MATLAB graphical user interfaces were created to analyze flight data and pertinent control loop data for gain tuning.
Suupilliklubi Piccolo kontserdist 17. juunil Pärnu Lastepargis, mis on pühendatud Saksa pillimeistrile Christian Friedrich Ludwig Buschmannile. Pärnu neljandast rahvusvahelisest suupillifestivalist "Baltic-Nordic Harmonica"
Full Text Available of pregnant women, the Cellnostics portable blood analyser and paper-based diagnostic solutions. Umbiflow is a Doppler ultrasound device that can determine at the primary point of care, such as a clinic, whether a fetus that is small for gestational age...
Tänavuse Lappeenrantas toimunud rahvusvahelise suupillifestivali võistumängimisel osalesid suupilliklubi Piccolo orkester, kvartett ja noored solistid. Grand prix' ehk suure võidukarika pälvis Piccolo suupillikvartett koosseisus Ilmar Tõnisson, Andrus Haugas, Andres Kokk ja Elmar Trink. Noorte kategooria võitjaks tunnistati Martin Merevits, kolmandad kohad saavutasid Janek Sildvee bluusi- ja Eduard Einmann diatoonilise suupilli kategoorias
Brightwell, Ron [Louisiana State Univ., Baton Rouge, LA (United States); Sterling, Thomas [Louisiana State Univ., Baton Rouge, LA (United States); Koniges, Alice [Louisiana State Univ., Baton Rouge, LA (United States); Kaiser, Hartmut [Louisiana State Univ., Baton Rouge, LA (United States); Gabriel, Edgar [Louisiana State Univ., Baton Rouge, LA (United States); Porterfield, Allan [Louisiana State Univ., Baton Rouge, LA (United States); Malony, Allen [Louisiana State Univ., Baton Rouge, LA (United States)
The XPRESS Project is one of four major projects of the DOE Office of Science Advanced Scientific Computing Research X-stack Program initiated in September, 2012. The purpose of XPRESS is to devise an innovative system software stack to enable practical and useful exascale computing around the end of the decade with near-term contributions to efficient and scalable operation of trans-Petaflops performance systems in the next two to three years; both for DOE mission-critical applications. To this end, XPRESS directly addresses critical challenges in computing of efficiency, scalability, and programmability through introspective methods of dynamic adaptive resource management and task scheduling.
Ferreira, Carlos E S; Guerra, Joao C C; Slhessarenko, Natasha; Scartezini, Marileia; Franca, Carolina N; Colombini, Marjorie P; Berlitz, Fernando; Machado, Antonia M O; Campana, Gustavo A; Faulhaber, Adriana C L; Galoro, Cesar A; Dias, Claudia M; Shcolnik, Wilson; Martino, Marines D V; Cesar, Katia R; Sumita, Nairo M; Mendes, Maria E; Faulhaber, Marcelo H W; Pinho, Joao R R; Barbosa, Ismar V; Batista, Marcelo C; Khawali, Cristina; Pariz, Vitor M; Andriolo, Adagmar
Point-of-Care Testing (POCT) has been highlighted in the health care sector in recent decades. On the other hand, due to its low demand, POCT is at a disadvantage compared to conventional equipment, since its cost is inversely proportional to the volume of use. In addition, for the implementation of POCT to succeed, it is essential to rely on the work of a multidisciplinary team. The awareness of health professionals of the importance of each step is perhaps the critical success factor. The trend towards the continuous advancement of the use of POCT and the great potential of its contributions reinforce the need to implement quality management tools, including performance indicators, to ensure their results. This review presents some advantages and disadvantages concerning POCT and the real need to use it. A worldwide call for the availability of easy-to-use health technologies that are increasingly closer to the final user is one of the main reasons for this focus.
Lee, Eui Jung; Shin, Sang Do; Song, Kyoung Jun; Kim, Seong Chun; Cho, Jin Seong; Lee, Seung Chul; Park, Ju Ok; Cha, Won Chul
Our study compared clinical decision time between patients managed with a point-of-care chemistry test (POCT) and patients managed with the traditional central laboratory test (CLT). This was a randomized controlled multicenter trial in the emergency departments (EDs) of 5 academic teaching hospitals. We randomly assigned patients to POCT or CLT stratified by the Emergency Severity Index. A POCT chemistry analyzer (Piccolo; Abaxis, Inc, Union City, Calif), which is able to test liver panel, renal panel, pancreas enzymes, lipid panel, electrolytes, and blood gases, was set up in each ED. Primary and secondary end point was turnaround time and door-to-clinical-decision time. The total 2323 patients were randomly assigned to the POCT group (n = 1167) or to the CLT group (n = 1156). All of the basic characteristics were similar in the 2 groups. The turnaround time (median, interquartile range [IQR]) of the POCT group was shorter than that of the CLT group (14, 12-19 versus 55, 45-69 minutes; P CLT group (46, 33-61 versus 86, 68-107 minutes; P CLT group (P CLT. Copyright © 2011 Elsevier Inc. All rights reserved.
Objective. The HemoCue is a point-of-care analytical system for haemoglobin concentration (Hb) measurement. Point-of-care testing has been validated in hospitals and outpatient departments to assist with urgent patient management by providing rapid laboratory test results. Method. In this prospective study we compared ...
Porterfield, Allan Kennedy [Univ. of North Carolina, Chapel Hill, NC (United States); Fowler, Robert Joseph [Univ. of North Carolina, Chapel Hill, NC (United States)
This is the final report for UNC activities as its part in the XStack program XPRESS project. A project-wide final report will be submitted by the project as a whole through Sandia National Laboratory when the contracts to the other participating organizations have reached their conclusion(s).
Lifecycle1: Flute (piccolo), oboe, clarinet (bass clarinet), bassoon, horn, 2 percussionists, 2 violins and cello, Xhosa vocal ensemble and indigenous instruments. J Zaidel-Rudoulph. Abstract. No Abstract Journal for the Musical Arts in Africa Vol. 3 2007: pp. 80-81. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT
Chapman, Barbara [Univ. of Houston, TX (United States); Gabriel, Edgar [Univ. of Houston, TX (United States)
Exascale systems, with a thousand times the compute capacity of today’s leading edge petascale computers, are expected to emerge during the next decade. Their software systems will need to facilitate the exploitation of exceptional amounts of concurrency in applications, and ensure that jobs continue to run despite the occurrence of system failures and other kinds of hard and soft errors. Adapting computations at runtime to cope with changes in the execution environment, as well as to improve power and performance characteristics, is likely to become the norm. As a result, considerable innovation is required to develop system support to meet the needs of future computing platforms. The XPRESS project aims to develop and prototype a revolutionary software system for extreme-scale computing for both exascale and strongscaled problems. The XPRESS collaborative research project will advance the state-of-the-art in high performance computing and enable exascale computing for current and future DOE mission-critical applications and supporting systems. The goals of the XPRESS research project are to: A. enable exascale performance capability for DOE applications, both current and future, B. develop and deliver a practical computing system software X-stack, OpenX, for future practical DOE exascale computing systems, and C. provide programming methods and environments for effective means of expressing application and system software for portable exascale system execution.
Cummins, Brian M; Ligler, Frances S; Walker, Glenn M
Point-of-care or point-of-use diagnostics are analytical devices that provide clinically relevant information without the need for a core clinical laboratory. In this review we define point-of-care diagnostics as portable versions of assays performed in a traditional clinical chemistry laboratory. This review discusses five areas relevant to human and animal health where increased attention could produce significant impact: veterinary medicine, space travel, sports medicine, emergency medicine, and operating room efficiency. For each of these areas, clinical need, available commercial products, and ongoing research into new devices are highlighted. Copyright © 2016 Elsevier Inc. All rights reserved.
ClinicalKey is a new point-of-care resource for health care professionals. Through controlled vocabulary, ClinicalKey offers a cross section of resources on diseases and procedures, from journals to e-books and practice guidelines to patient education. A sample search was conducted to demonstrate the features of the database, and a comparison with similar tools is presented.
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...
Kintzios, Spyridon E
This book describes the principles, design and applications of a new generation of analytical and diagnostic biomedical devices, characterized by their very small size, ease of use, multi-analytical capabilities and speed to provide handheld and mobile point-of-care (POC) diagnostics.
Staring, A.J.; Meertens, L. O.; Sikkel, N.
Point-Of-Care Testing (POCT) enables clinical tests at or near the patient, with test results that are available instantly or in a very short time frame, to assist caregivers with immediate diagnosis and/or clinical intervention. The goal of POCT is to provide accurate, reliable, fast, and
Annals of Biomedical Sciences ... The service providers (hospital management) and the testing personnel are faced with the task of trying to explain these problems. Objective of the study: To critically do a policy analysis of the problems of point of care testing with the aim of identifying the causes of these problems and ...
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.
You, Won Suk; Park, Jae Jun; Jin, Sung Moon; Ryew, Sung Moo; Choi, Hyouk Ryeol
Blood tests are some of the core clinical laboratory tests for diagnosing patients. In hospitals, an automated process called total laboratory automation, which relies on a set of sophisticated equipment, is normally adopted for blood tests. Noting that the total laboratory automation system typically requires a large footprint and significant amount of power, slim and easy-to-move blood test equipment is necessary for specific demands such as emergency departments or small-size local clinics. In this article, we present a point-of-care test system that can provide flexibility and portability with low cost. First, the system components, including a reagent tray, dispensing module, microfluidic disk rotor, and photometry scanner, and their functions are explained. Then, a scheduler algorithm to provide a point-of-care test platform with an efficient test schedule to reduce test time is introduced. Finally, the results of diagnostic tests are presented to evaluate the system. © 2014 Society for Laboratory Automation and Screening.
James, H. Nichols
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 labor...
Vardell, Emily; Paulaitis, Gediminas Geddy
Nursing Reference Center is a point-of-care resource designed for the practicing nurse, as well as nursing administrators, nursing faculty, and librarians. Users can search across multiple resources, including topical Quick Lessons, evidence-based care sheets, patient education materials, practice guidelines, and more. Additional features include continuing education modules, e-books, and a new iPhone application. A sample search and comparison with similar databases were conducted.
Full Text Available Irreducible umbilical swelling in infants is considered a surgical emergency because a delay in surgical intervention for an incarcerated umbilical hernia can lead to bowel ischemia and necrosis. We report two patients who presented to a pediatric emergency department with history and symptoms of irreducible umbilical mass suggestive of umbilical hernia. Point-of-care ultrasound was used at the bedside to demonstrate the presence of urachal cyst remnants and accurately guided the care of these children.
Rajan, Aruna; Glorikian, Harry
There is a significant demand for in vitro diagnostic (IVD) testing to move closer to the patient point-of-care diagnostics [POC]), whether in the hospital, physician's office, rapid clinic or the home, effectively cutting time to results and helping patients make better informed decisions about their health. To analyze the point-of-care market and its trends and growth drivers. In 2007, POC made up 30% of the IVD market and is expected to grow at 9% a year. Although the overall POC market is expected to grow steadily, infectious POC is now the most attractive segment. Availability of rapid random access molecular diagnostic system for critical care infectious diseases such as MRSA and sepsis in the near future is likely to be a significant driver of infectious POC post 2012. Owing to the extraordinary increase in the cost of care, healthcare delivery is moving to increasingly decentralized settings such as rapid clinics and the home, driven by point-of-care diagnostics that provide accurate and directional results. We are evolving from the analog testing world to the digital testing world, where diagnosis is exact and therapy can be administered and be predictably effective.
Adiguzel, Yekbun; Kulah, Haluk
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. PMID:23112587
Full Text Available Mar Piccolo of Taranto is an estuarine basin heavily exploited for commercial mussel (Mytilus galloprovincialis L. farming. The historical renown of the Taranto mussels has suffered over the last decade following policy decisions to expand the mussel farms and to relocate a portion of the urban sewage to an outfall outside of Mar Piccolo. The resulting decline in mussel quality and the quandary of how to restore stability to Taranto mussel production became the focal issue for our application of the systems approach framework (SAF. We simulated the ecological, economic, and social interactions that affect mussel production. Stakeholders and mussel farmers contributed by participating in meetings during the entire exercise. Our simulation analysis provided them with a means for understanding the effects of policy scenarios on the system. We present three aspects from our initial results that demonstrate the value of the SAF, as: (1 an operational model to monitor and better research the status of the ecosystem, (2 a management tool to evaluate sustainable mussel farming strategies, and (3 an opportunity for improved communication with and engagement of stakeholders, policy, and the public. The application has also raised important questions about how the food chain is controlled, what could be changed to stabilize the ecosystem to a higher level of productivity, and what role the public and policy could play in promoting sustainable development.
Cmiel, Vratislav; Svoboda, Ondrej; Koscova, Pavlina; Provaznik, Ivo
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.
Nassar, Alicia; Talbot, Richard; Grant, Ashley; Derr, Charlotte
It is important to rapidly diagnosis and treat rhabdomyolysis in order to decrease morbidity and mortality. To date there are no reports in the emergency medicine literature on the use of point-of-care ultrasound in the diagnosis of rhabdomyolysis. This unique case describes how ultrasound was used in the emergency department (ED) to quickly diagnose and treat rhabdomyolysis prior to confirmation with an elevated serum creatine kinase. When coupled with a high index of suspicion, ultrasound can be one of the most portable, readily available, low cost, and minimally invasive techniques for making a rapid diagnosis of rhabdomyolysis in the ED.
Full Text Available It is important to rapidly diagnosis and treat rhabdomyolysis in order to decrease morbidity and mortality. To date there are no reports in the emergency medicine literature on the use of point-of-care ultrasound in the diagnosis of rhabdomyolysis. This unique case describes how ultrasound was used in the emergency department (ED to quickly diagnose and treat rhabdomyolysis prior to confirmation with an elevated serum creatine kinase. When coupled with a high index of suspicion, ultrasound can be one of the most portable, readily available, low cost, and minimally invasive techniques for making a rapid diagnosis of rhabdomyolysis in the ED.
Liu, Ya; Cheng, Liang; Liu, Zhiqiang
Piccolo is a lightweight block cipher that adopts a generalized Feistel network structure with 4 branches, each of which is 16 bit long. The key length is 80 or 128 bit, denoted by Piccolo-80 and Piccolo-128, respectively. In this paper, we mounted meet-in-the-middle attacks on 14-round Piccolo-80...... and at the end, respectively. Based on this structure, we mounted an attack on 14-round Piccolo-80 from the 5th round to the 18th round. The data, time, and memory complexities were 252 chosen plaintexts, 267.44 encryptions, and 264.91 blocks, respectively. For Piccolo-128, we built a 7-round distinguisher...... to attack 18-round Piccolo-128 from the 4th round to the 21st round. The data, time, and memory complexities were 252 chosen plaintexts, 2126.63 encryptions, and 2125.29 blocks, respectively. If not considering results on biclique cryptanalysis, these are currently the best public results on this reduced...
Julie L.V. Shaw
Full Text Available Point of care testing (POCT refers to laboratory testing that occurs near to the patient, often at the patient bedside. POCT can be advantageous in situations requiring rapid turnaround time of test results for clinical decision making. There are many challenges associated with POCT, mainly related to quality assurance. POCT is performed by clinical staff rather than laboratory trained individuals which can lead to errors resulting from a lack of understanding of the importance of quality control and quality assurance practices. POCT is usually more expensive than testing performed in the central laboratory and requires a significant amount of support from the laboratory to ensure the quality testing and meet accreditation requirements.Here, specific challenges related to POCT compliance with accreditation standards are discussed along with strategies that can be used to overcome these challenges. These areas include: documentation of POCT orders, charting of POCT results as well as training and certification of individuals performing POCT. Factors to consider when implementing connectivity between POCT instruments and the electronic medical record are also discussed in detail and include: uni-directional versus bidirectional communication, linking patient demographic information with POCT software, the importance of positive patient identification and considering where to chart POCT results in the electronic medical record. Keywords: Point of care Testing, Laboratory accreditation, Medical directive, Results documentation, Electronic Medical Record, Transcription error, Connectivity, Positive patient identification
Chan, Ho Nam; Tan, Ming Jun Andrew; Wu, Hongkai
Point-of-care testing (POCT) devices fulfil a critical need in the modern healthcare ecosystem, enabling the decentralized delivery of imperative clinical strategies in both developed and developing worlds. To achieve diagnostic utility and clinical impact, POCT technologies are immensely dependent on effective translation from academic laboratories out to real-world deployment. However, the current research and development pipeline is highly bottlenecked owing to multiple restraints in material, cost, and complexity of conventionally available fabrication techniques. Recently, 3D printing technology has emerged as a revolutionary, industry-compatible method enabling cost-effective, facile, and rapid manufacturing of objects. This has allowed iterative design-build-test cycles of various things, from microfluidic chips to smartphone interfaces, that are geared towards point-of-care applications. In this review, we focus on highlighting recent works that exploit 3D printing in developing POCT devices, underscoring its utility in all analytical steps. Moreover, we also discuss key advantages of adopting 3D printing in the device development pipeline and identify promising opportunities in 3D printing technology that can benefit global health applications.
You-Ten, Kong Eric; Siddiqui, Naveed; Teoh, Wendy H
is to provide an overview of the indications for point-of-care ultrasound (POCUS) of the upper airway. The use of US to guide and assist clinical airway management has potential benefits for both provider and patient. Ultrasound can be utilized to determine airway size and predict the appropriate diameter...... of single-lumen endotracheal tubes (ETTs), double-lumen ETTs, and tracheostomy tubes. Ultrasonography can differentiate tracheal, esophageal, and endobronchial intubation. Ultrasonography of the neck can accurately localize the cricothyroid membrane for emergency airway access and similarly identify...... tracheal rings for US-guided tracheostomy. In addition, US can identify vocal cord dysfunction and pathology before induction of anesthesia. A rapidly growing body of evidence showing ultrasonography used in conjunction with hands-on management of the airway may benefit patient care. Increasing awareness...
Todsen, Tobias; Tolsgaard, Martin Grønnebæk; Olsen, Beth Härstedt
physicians' OSAUS scores with diagnostic accuracy. RESULTS: The generalizability coefficient was high (0.81) and a D-study demonstrated that 1 assessor and 5 cases would result in similar reliability. The construct validity of the OSAUS scale was supported by a significant difference in the mean scores......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...... conditions. However, the quality of performance is highly operator-dependent. Therefore, reliable and valid assessment of trainees' ultrasonography competence is needed to ensure patient safety. METHODS: Twenty-four physicians, representing novices, intermediates, and experts in POC US, scanned 4 different...
St John, Andrew; Price, Christopher P
Health economics has been an established feature of the research, policymaking, practice and management in the delivery of healthcare. However its role is increasing as the cost of healthcare begins to drive changes in most healthcare systems. Thus the output from cost effectiveness studies is now being taken into account when making reimbursement decisions, e.g. in Australia and the United Kingdom. Against this background it is also recognised that the health economic tools employed in healthcare, and particularly the output from the use of these tools however, are not always employed in the routine delivery of services. One of the notable consequences of this situation is the poor record of innovation in healthcare with respect to the adoption of new technologies, and the realisation of their benefits. The evidence base for the effectiveness of diagnostic services is well known to be limited, and one consequence of this has been a very limited literature on cost effectiveness. One reason for this situation is undoubtedly the reimbursement strategies employed in laboratory medicine for many years, simplistically based on the complexity of the test procedure, and the delivery as a cost-per-test service. This has proved a disincentive to generate the required evidence, and little effort to generate an integrated investment and disinvestment business case, associated with care pathway changes. Point-of-care testing creates a particularly challenging scenario because, on the one hand, the unit cost-per-test is larger through the loss of the economy of scale offered by automation, whilst it offers the potential of substantial savings through enabling rapid delivery of results, and reduction of facility costs. This is important when many health systems are planning for complete system redesign. We review the literature on economic assessment of point-of-care testing in the context of these developments. PMID:24151342
Advances in miniaturization, nanotechnology, and microfluidics, along with developments in cloud-connected point-of-care (POC) diagnostics technologies are pushing the frontiers of POC devices toward low-cost, user-friendly, and enhanced sensitivity molecular-level diagnostics. The combination of various bio-sensing platforms within smartphone-integrated electronic readers provides accurate on-site and on-time diagnostics based on various types of chemical and biological targets. Further, 3D printing technology shows a huge potential toward fabrication and improving the performance of POC devices. Integration of skin-like flexible sensors with wireless communication technology creates a unique opportunity for continuous, real-time monitoring of patients for both preventative healthcare and during disease outbreaks. Here, we review recent developments and advances in POC technologies and describe how these advances enhance the performance of POC platforms. Also, this review describes challenges, directions, and future trends on application of emerging technologies in POC diagnostics. Copyright © 2017 Elsevier B.V. All rights reserved.
Buerger, Anita M; Clark, Kevin R
To discuss the current and growing use of point-of-care (POC) ultrasound in the management and care of patients. Several electronic research databases were searched to find articles that emphasized the use of POC ultrasound by health care providers who manage and treat critically ill or injured patients. Thirty-five relevant peer-reviewed journal articles were selected for this literature review. Common themes identified in the literature included the use of POC ultrasound in emergency medicine, military medicine, and remote care; comparison of POC ultrasound to other medical imaging modalities; investigation of the education and training required for nonimaging health care professionals who perform POC ultrasound in their practices; and discussion of the financial implications and limitations of POC ultrasound. POC ultrasound provides clinicians with real-time information to better manage and treat critically ill or injured patients in emergency medicine, military medicine, and remote care. In addition to providing immediate bedside diagnostic information, use of POC ultrasound has increased because of concerns regarding radiation protection. Finally, the expansion of POC ultrasound to other specialty areas requires nonimaging health care professionals to perform bedside ultrasound examinations and interpret the resulting images. Because POC ultrasound is user-dependent, adequate training is essential for all who perform and interpret the examinations. Research involving POC ultrasound will continue as innovations and confidence in ultrasound applications advance. Future research should continue to examine the broad use of POC ultrasound in patient care and management. ©2017 American Society of Radiologic Technologists.
The sparse cells that are shed from tumors into peripheral circulation are an increasingly promising resource for noninvasive monitoring of cancer progression, early diagnosis of disease, and serve as a tool for improving our understanding of cancer metastasis. However, the extremely sparse concentration of circulating tumor cells (CTCs) in blood (~1-100 CTC in 7.5 mL of blood) as well as their heterogeneous biomarker expression has limited their detection using conventional laboratory techniques. To overcome these challenges, we have developed a microfluidic chip-based micro-Hall detector (μHD), which can directly measure single, immunomagnetically tagged cells in whole blood. The μHD can detect individual cells even in the presence of vast numbers of blood cells and unbound reactants, and does not require any washing or purification steps. Furthermore, this cost-effective, single-cell analytical technique is well suited for miniaturization into a mobile platform for low-cost point-of-care use. In this chapter, we describe the methodology used to design, fabricate, and apply these chips to cancer diagnostics.
Shaw, Julie L V
Point of care testing (POCT) refers to laboratory testing that occurs near to the patient, often at the patient bedside. POCT can be advantageous in situations requiring rapid turnaround time of test results for clinical decision making. There are many challenges associated with POCT, mainly related to quality assurance. POCT is performed by clinical staff rather than laboratory trained individuals which can lead to errors resulting from a lack of understanding of the importance of quality control and quality assurance practices. POCT is usually more expensive than testing performed in the central laboratory and requires a significant amount of support from the laboratory to ensure the quality testing and meet accreditation requirements. Here, specific challenges related to POCT compliance with accreditation standards are discussed along with strategies that can be used to overcome these challenges. These areas include: documentation of POCT orders, charting of POCT results as well as training and certification of individuals performing POCT. Factors to consider when implementing connectivity between POCT instruments and the electronic medical record are also discussed in detail and include: uni-directional versus bidirectional communication, linking patient demographic information with POCT software, the importance of positive patient identification and considering where to chart POCT results in the electronic medical record.
CREDO is a framework for understanding human expertise and for designing and deploying systems that support cognitive tasks like situation and risk assessment, decision-making, therapy planning and workflow management. The framework has evolved through an extensive program of research on human decision-making and clinical practice. It draws on concepts from cognitive science, and has contributed new results to cognitive theory and understanding of human expertise and knowledge-based AI. These results are exploited in a suite of technologies for designing, implementing and deploying clinical services, early versions of which were reported by Das et al. (1997)  and Fox and Das (2000) . A practical outcome of the CREDO program is a technology stack, a key element of which is an agent specification language (PROforma: Sutton and Fox (2003) ) which has proved to be a versatile tool for designing point of care applications in many clinical specialties and settings. Since software became available for implementing and deploying PROforma applications many kinds of services have been successfully built and trialed, some of which are in large-scale routine use. This retrospective describes the foundations of the CREDO model, summarizes the main theoretical, technical and clinical contributions, and discusses benefits of the cognitive approach. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.
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
Aldekhyl, Sara; Cavalcanti, Rodrigo B; Naismith, Laura M
The ability to maintain good performance with low cognitive load is an important marker of expertise. Incorporating cognitive load measurements in the context of simulation training may help to inform judgements of competence. This exploratory study investigated relationships between demographic markers of expertise, cognitive load measures, and simulator performance in the context of point-of-care ultrasonography. Twenty-nine medical trainees and clinicians at the University of Toronto with a range of clinical ultrasound experience were recruited. Participants answered a demographic questionnaire then used an ultrasound simulator to perform targeted scanning tasks based on clinical vignettes. Participants were scored on their ability to both acquire and interpret ultrasound images. Cognitive load measures included participant self-report, eye-based physiological indices, and behavioural measures. Data were analyzed using a multilevel linear modelling approach, wherein observations were clustered by participants. Experienced participants outperformed novice participants on ultrasound image acquisition. Ultrasound image interpretation was comparable between the two groups. Ultrasound image acquisition performance was predicted by level of training, prior ultrasound training, and cognitive load. There was significant convergence between cognitive load measurement techniques. A marginal model of ultrasound image acquisition performance including prior ultrasound training and cognitive load as fixed effects provided the best overall fit for the observed data. In this proof-of-principle study, the combination of demographic and cognitive load measures provided more sensitive metrics to predict ultrasound simulator performance. Performance assessments which include cognitive load can help differentiate between levels of expertise in simulation environments, and may serve as better predictors of skill transfer to clinical practice.
Maleki, Teimour; Fricke, Todd; Quesenberry, J. T.; Todd, Paul W.; Leary, James F.
Recent advances in MEMS technology have provided an opportunity to develop microfluidic devices with enormous potential for portable, point-of-care, low-cost medical diagnostic tools. Hand-held flow cytometers will soon be used in disease diagnosis and monitoring. Despite much interest in miniaturizing commercially available cytometers, they remain costly, bulky, and require expert operation. In this article, we report progress on the development of a battery-powered handheld blood analyzer that will quickly and automatically process a drop of whole human blood by real-time, on-chip magnetic separation of white blood cells (WBCs), fluorescence analysis of labeled WBC subsets, and counting a reproducible fraction of the red blood cells (RBCs) by light scattering. The whole blood (WB) analyzer is composed of a micro-mixer, a special branching/separation system, an optical detection system, and electronic readout circuitry. A droplet of un-processed blood is mixed with the reagents, i.e. magnetic beads and fluorescent stain in the micro-mixer. Valve-less sorting is achieved by magnetic deflection of magnetic microparticle-labeled WBC. LED excitation in combination with an avalanche photodiode (APD) detection system is used for counting fluorescent WBC subsets using several colors of immune-Qdots, while counting a reproducible fraction of red blood cells (RBC) is performed using a laser light scatting measurement with a photodiode. Optimized branching/channel width is achieved using Comsol Multi-Physics™ simulation. To accommodate full portability, all required power supplies (40v, +/-10V, and +3V) are provided via step-up voltage converters from one battery. A simple onboard lock-in amplifier is used to increase the sensitivity/resolution of the pulse counting circuitry.
Naunheim, Rosanne; Jang, Timothy J; Banet, Gerald; Richmond, Alec; McGill, Janet
Diabetic ketoacidosis (DKA) is a common, life-threatening complication of diabetes. The diagnosis of DKA relies on signs and symptoms, plus laboratory findings of blood glucose (BG) of > 250 mg/dL, an anion gap (AG) of > or = 15 mmol/L, and carbon dioxide (CO2) of 250 mg/dL underwent testing for beta-OHB with the Precision Xtra meter (Abbott Laboratories, North Chicago, IL) at triage in a large urban hospital emergency department. The diagnosis of DKA was made by clinicians by using standard clinical criteria without knowledge of the beta-OHB test. A diagnosis of DKA was made in 57 of 160 subjects. The beta-OHB values correlated strongly with AG (r = 0.66, p < 0.001) and with CO2 (r = -0.69, p < 0.001), as well as with glucose (r = 0.31, p < 0.001). Cross-classification of DKA vs. beta-OHB yielded sensitivity of 98% (95% CI = 91% to 100%), specificity of 85% (95% CI = 78% to 91%), with a positive likelihood ratio of 6.7 (95% CI = 4.22 to 10.78), and negative likelihood ratio of 0.021 (95% CI = 0.003 to 0.144) at the manufacturer-suggested beta-OHB level of 1.5. The point-of-care test for beta-OHB was as sensitive as more established indicators of DKA. It is more useful than glucose alone for the diagnosis of DKA and offers immediate diagnosis of patients at triage.
Background Probabilistic assignment of ambiguously mapped fragments produced by high-throughput sequencing experiments has been demonstrated to greatly improve accuracy in the analysis of RNA-Seq and ChIP-Seq, and is an essential step in many other sequence census experiments. A maximum likelihood method using the expectation-maximization (EM) algorithm for optimization is commonly used to solve this problem. However, batch EM-based approaches do not scale well with the size of sequencing datasets, which have been increasing dramatically over the past few years. Thus, current approaches to fragment assignment rely on heuristics or approximations for tractability. Results We present an implementation of a distributed EM solution to the fragment assignment problem using Spark, a data analytics framework that can scale by leveraging compute clusters within datacenters–“the cloud”. We demonstrate that our implementation easily scales to billions of sequenced fragments, while providing the exact maximum likelihood assignment of ambiguous fragments. The accuracy of the method is shown to be an improvement over the most widely used tools available and can be run in a constant amount of time when cluster resources are scaled linearly with the amount of input data. Conclusions The cloud offers one solution for the difficulties faced in the analysis of massive high-thoughput sequencing data, which continue to grow rapidly. Researchers in bioinformatics must follow developments in distributed systems–such as new frameworks like Spark–for ways to port existing methods to the cloud and help them scale to the datasets of the future. Our software, eXpress-D, is freely available at: http://github.com/adarob/express-d. PMID:24314033
Kemper, D.W.; Semjonow, V.; de Theije, F.; Keizer, D.; van Lippen, L.; Mair, J.; Wille, B.; Christ, M.; Geijer, F.; Hausfater, P.; Pariente, D.; Scharnhorst, V.; Curvers, J.; Nieuwenhuis, J.
OBJECTIVES: Point-of-care cardiac troponin testing with adequate analytical performances has the potential to improve chest pain patients flow in the emergency department. We present the analytical evaluation of the newly developed Philips Minicare cTnI point-of-care immunoassay. DESIGN & METHODS:
Bruckner, Joseph J.; Gratz, Scott J.; Slind, Jessica K.; Geske, Richard R.; Cummings, Alexander M.; Galindo, Samantha E.; Donohue, Laura K.; O'Connor-Giles, Kate M.
Neuronal communication depends on the precisely orchestrated release of neurotransmitter at specialized sites called active zones (AZs). A small number of scaffolding and cytoskeletal proteins comprising the cytomatrix of the active zone (CAZ) are thought to organize the architecture and functional properties of AZs. The majority of CAZ proteins are evolutionarily conserved, underscoring the fundamental similarities in neurotransmission at all synapses. However, core CAZ proteins Piccolo and Bassoon have long been believed exclusive to vertebrates, raising intriguing questions about the conservation of the molecular mechanisms that regulate presynaptic properties. Here, we present the identification of a piccolo-rim-related gene in invertebrates, together with molecular phylogenetic analyses that indicate the encoded proteins may represent Piccolo orthologs. In accordance, we find that the Drosophila homolog, Fife, is neuronal and localizes to presynaptic AZs. To investigate the in vivo function of Fife, we generated a deletion of the fife locus. We find that evoked neurotransmitter release is substantially decreased in fife mutants and loss of fife results in motor deficits. Through morphological analysis of fife synapses, we identify underlying AZ abnormalities including pervasive presynaptic membrane detachments and reduced synaptic vesicle clustering. Our data demonstrate the conservation of a Piccolo-related protein in invertebrates and identify critical roles for Fife in regulating AZ structure and function. These findings suggest the CAZ is more conserved than previously thought, and open the door to a more complete understanding of how CAZ proteins regulate presynaptic structure and function through genetic studies in simpler model systems. PMID:23197698
W.E. Kaman (Wendy); E-R. Andrinopoulou (Eleni-Rosalina); J.P. Hays (John)
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
Point-of-care estimation of haemoglobin concentration in all age groups in clinical ... and the results were compared using standard scatter and difference plots. ... Hb measurements with a smaller sample volume, improved turnaround time, ...
Evaluation of point-of-care tests for detecting microalbuminuria in diabetic patients. ... creatinine (modified Jaffe) and albumin-to-creatinine ratio (ACR). Results: Linear regression analysis demonstrated a good correlation for the HemoCue® ...
Cheng, Chao-Min; Chen, Chien-Fu
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...
Huslig, Mary Ann; Vardell, Emily
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.
Lau, Han Yih; Botella, Jose R.
Diagnostic technologies for the detection of plant pathogens with point-of-care capability and high multiplexing ability are an essential tool in the fight to reduce the large agricultural production losses caused by plant diseases. The main desirable characteristics for such diagnostic assays are high specificity, sensitivity, reproducibility, quickness, cost efficiency and high-throughput multiplex detection capability. This article describes and discusses various DNA-based point-of care di...
Issac J. Michael
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.
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.
Rastegar-Mojarad, Majid; Li, Dingcheng; Liu, Hongfang
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. PMID:26306259
Heffler, Enrico; Terranova, Giovanni; Chessari, Carlo; Frazzetto, Valentina; Crimi, Claudia; Fichera, Silvia; Picardi, Giuseppe; Nicolosi, Giuliana; Porto, Morena; Intravaia, Rossella; Crimi, Nunzio
One of the main severe asthma phenotypes is severe eosinophilic or eosinophilic refractory asthma for which novel biologic agents are emerging as therapeutic options. In this context, blood eosinophil counts are one of the most reliable biomarkers. To evaluate the performance of a point-of-care peripheral blood counter in a patients with severe asthma. The blood eosinophil counts of 76 patients with severe asthma were evaluated by point-of-care and standard analyzers. A significant correlation between blood eosinophils assessed by the 2 devices was found (R 2 = 0.854, P asthma and the ELEN index, a composite score useful to predict sputum eosinophilia. The results of our study contribute to the validation of a point-of-care device to assess blood eosinophils and open the possibility of using this device for the management of severe asthma management. Copyright © 2017 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Rastegar-Mojarad, Majid; Li, Dingcheng; Liu, Hongfang
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.
Liu, Nathan J.; Chapman, Robert; Lin, Yiyang; Mmesi, Jonas; Bentham, Andrew; Tyreman, Matthew; Abraham, Sonya; Stevens, Molly M.
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
Pastoor, Rob; Hatta, Mochammad; Abdoel, Theresia H.; Smits, Henk L.
We developed a point-of-care test for the serodiagnosis of typhoid fever in the format of an immunochromatographic lateral flow assay. The flow assay for typhoid fever is based on the detection of Salmonella enterica serotype Typhi lipopolysaccharide-specific immunoglobulin M (IgM) antibodies. The
Ávila Muñoz, Mónica; Floris, J.; Staal, S.S.; Ríos, Ángel; Eijkel, Jan C.T.; van den Berg, Albert
A point-of-care device for the determination of elevated creatinine levels in blood is reported. This device potentially offers a new and simple clinical regime for the determination of creatinine that will give huge time savings and removal of several steps of determination. The test employs a
Sabid?, Meritxell; Benzaken, Adele S.; de Andrade Rodrigues, ?nio Jos?; Mayaud, Philippe
: We assessed the acceptability and operational suitability of a rapid point-of-care syphilis test and identified barriers to testing among high-risk groups and healthcare professionals in a sexually transmitted infections clinic in Manaus, Brazil. Use of this test could considerably alleviate the impact of syphilis in hard-to-reach populations in the Amazon region of Brazil.
Mar 15, 2016 ... may take up to three days via the main hospital laboratory. The aim of this ... for handling point-of-care clinical chemistry devices and the most suitable .... Creatinine test strips and quality control solutions were stored in the ...
The wide variation in biological effect, narrow therapeutic range and pharmacokinetic and pharmacodynamic characteristics of warfarin require monitoring of the international normalised ratio (INR). Point-of-care results that are readily accessible for interpretation, allows the pharmacist to make dose adjustments ...
Full Text Available Microfluidic systems enable precise control over tiny volumes of fluid in a compact and low-cost form, thus providing the ideal platform on which to develop point-of-care diagnostic solutions. Centrifugal microfluidic systems, also referred...
Full Text Available Disposable, low-cost microfluidic cartridges for automated blood cell counting applications are presented in this article. The need for point-of-care medical diagnostic tools is evident, particularly in low-resource and rural settings, and a full...
Full Text Available -of-care diagnostic systems, particularly in under-resourced settings to enable instant diagnosis and improve healthcare. Although numerous and varied advances in the field of microfluidics have enabled point-of-care systems to be realized, there is often a trade...
Ďurč, P.; Foret, František; Kubáň, Petr
Roč. 183, JUN (2018), s. 55-60 ISSN 0039-9140 Institutional support: RVO:68081715 Keywords : blood plasma separation * capillary electrophoresis * point of care analysis * methanol * metabolites Subject RIV: CB - Analytical Chemistry, Separation OBOR OECD: Analytical chemistry Impact factor: 4.162, year: 2016
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...
Cohen, Stephanie G; Beck, Sierra C
A 4-year-old girl presented to the emergency department for evaluation of finger swelling after a dog bite. Point-of-care ultrasound was used to diagnose pyogenic flexor tenosynovitis of the digit after visualizing a fluid collection within the flexor tendon sheath. The patient underwent emergent incision and drainage of the digit with good outcome.
Scholtes-Timmerman, M.J.; Bijlsma, S.; Fokkert, M.J.; Slingerland, R.; Veen, S.J.F. van
Self-monitoring of glucose is important for managing diabetes. Noninvasive glucose monitors are not yet available, but patients would benefit highly from such a device. We present results that may lead to a novel, point-of-care noninvasive system to measure blood glucose based on Raman spectroscopy.
estimated that the annual cost of treating DKA in the USA exceeds. 1 billion ... If urinary ketones are positive, patients are referred for further management – often ... To evaluate a hand-held electrochemical (point-of-care testing; POCT) ketone monitor and compare it with the gold-standard ..... renal failure may be present.
Johansen, Benjamin D; Blue, Rebecca S; Castleberry, Tarah L; Antonsen, Erik L; Vanderploeg, James M
With the development of the commercial space industry, growing numbers of spaceflight participants will engage in activities with a risk for pulmonary injuries, including pneumothorax, ebullism, and decompression sickness, as well as other concomitant trauma. Medical triage capabilities for mishaps involving pulmonary conditions have not been systematically reviewed. Recent studies have advocated the use of point-of-care ultrasound to screen for lung injury or illness. The operational utility of portable ultrasound systems in disaster relief and other austere settings may be relevant to commercial spaceflight. A systematic review of published literature was conducted concerning the use of point-of-care pulmonary ultrasound techniques in austere environments, including suggested examination protocols for triage and diagnosis. Recent studies support the utility of pulmonary ultrasound examinations when performed by skilled operators, and comparability of the results to computed tomography and chest radiography for certain conditions, with important implications for trauma management in austere environments. Pulmonary injury and illness are among the potential health risks facing spaceflight participants. Implementation of point-of-care ultrasound protocols could aid in the rapid diagnosis, triage, and treatment of such conditions. Though operator-dependent, ultrasound, with proper training, experience, and equipment, could be a valuable tool in the hands of a first responder supporting remote spaceflight operations.Johansen BD, Blue RS, Castleberry TL, Antonsen EL, Vanderploeg JM. Point-of-care ultrasound for pulmonary concerns in remote spaceflight triage environments. Aerosp Med Hum Perform. 2018; 89(2):122-129.
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.
Laksanasopin, Tassaneewan; Chin, Curtis D.; Moore, Hannah; Wang, Jennifer; Cheung, Yuk Kee; Sia, Samuel K.
Point-of-care (POC) diagnostics have tremendous potential to improve human health in remote and resource-poor settings. However, the design criteria for diagnostic tests appropriate in settings with limited infrastructure are unique and challenging. Here we present a custom optical reader which quantifies silver absorbance from heterogeneous immunoassays. The reader is simple and low-cost and suited for POC diagnostics.
Steinfelder-Visscher, J.; Teerenstra, S.; Klein Gunnewiek, J.M.T.; Weerwind, P.W.
Point-of-care analyzers may benefit therapeutic decision making by reducing turn-around-time for samples. This is especially true when biochemical parameters exceed the clinical reference range, in which acute and effective treatment is essential. We therefore evaluated the analytical performance of
Vrouwe, E.X.; Luttge, R.; Vermes, I.; Berg, van den A.
Background: Microchip capillary electrophoresis (CE) is a promising method for chemical analysis of complex samples such as whole blood. We evaluated the method for point-of-care testing of lithium. Methods: Chemical separation was performed on standard glass microchip CE devices with a conductivity
Kiilerich-Pedersen, Katrine; Dapra, Johannes; Cherré, Solène
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...
Neue, G.; Hejtmánek, M.; Marčišovský, M.; Voleš, P.
This work concerns the design and construction of a flexible FPGA based data acquisition system aimed for particle detectors. The interface card as presented was designed for large area detectors with millions of individual readout channels. Flexibility was achieved by partitioning the design into multiple PCBs, creating a set of modular blocks, allowing the creation of a wide variety of configurations by simply stacking functional PCBs together. This way the user can easily toggle the polarity of the high voltage bias supply or switch the downstream interface from CoaXPress to PCIe or stream directly HDMI. We addressed the issues of data throughput, data buffering, bias voltage generation, trigger timing and fine tuning of the whole readout chain enabling a smooth data transmission. On the current prototype, we have wire-bonded a MediPix2 MXR quad and connected it to a XILINX FPGA. For the downstream interface, we implemented the CoaXPress communication protocol, which enables us to stream data at 3.125 Gbps to a standard PC
Causer, Louise M.; Kaldor, John M.; Fairley, Christopher K.; Donovan, Basil; Karapanagiotidis, Theo; Leslie, David E.; Robertson, Peter W.; McNulty, Anna M.; Anderson, David; Wand, Handan; Conway, Damian P.; Denham, Ian; Ryan, Claire; Guy, Rebecca J.
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
Kraft, Clara; Lasure, Benjamin; Sharon, Melinda; Patel, Paulina; Minardi, Joseph
The diagnosis of lung abscess can be difficult to make and often requires imaging beyond plain chest x-ray. The decision to further image with computed tomography should be weighed against the risks of radiation exposure, especially in pediatric patients. In addition, the cost and potential impact on length of stay from obtaining computed tomography scans should be considered. In this report, we describe a case of lung abscess made immediately using point-of-care ultrasound in the emergency department. To our knowledge, there are no previous cases describing lung abscess diagnosed by point-of-care ultrasound. This case report aims to describe a case of pediatric lung abscess, review the ultrasound findings, and discuss relevant literature on the topic.
Wang, Li-Ju; Chang, Yu-Chung; Sun, Rongrong; Li, Lei
Smartphone optosensors with integrated optical components make mobile point-of-care (MPoC) diagnostics be done near patients' side. It'll especially have a significant impact on healthcare delivery in rural or remote areas. Current FDA-approved PoC devices achieving clinical level are still at high cost and not affordable in rural hospitals. We present a series of ultra low-cost smartphone optical sensing devices for mobile point-of-care diagnosis. Aiming different targeting analytes and sensing mechanisms, we developed custom required optical components for each smartphone optosensros. These optical devices include spectrum readers, colorimetric readers for microplate, lateral flow device readers, and chemiluminescence readers. By integrating our unique designed optical components into smartphone optosening platform, the anlaytes can be precisely detected. Clinical testing results show the clinical usability of our smartphone optosensors. Ultra low-cost portable smartphone optosensors are affordable for rural/remote doctors.
Luan, Bo; Sun, Mingui; Jia, Wenyan
The Electroencephalography (EEG) is a common diagnostic tool for neurological diseases and dysfunctions, such as epilepsy and insomnia. However, the current EEG technology cannot be utilized quickly and conveniently at the point of care due to the complex skin preparation procedures required and the inconvenient EEG data acquisition systems. This work presents a portable amplifier design that integrates a set of skin screw electrodes and a wireless data link. The battery-operated amplifier contains an instrumentation amplifier, two noninverting amplifiers, two high-pass filters, and a low-pass filter. It is able to magnify the EEG signals over 10,000 times and has a high impedance, low noise, small size and low weight. Our electrode and amplifier are ideal for point-of-care applications, especially during transportation of patients suffering from traumatic brain injury or stroke.
Nakku-Joloba, Edith; Kiragga, Agnes; Mbazira, Joshua Kimeze; Kambugu, Fred; Jett-Goheen, Mary; Ratanshi, Rosalind Parkes; Gaydos, Charlotte; Manabe, Yukari C
A diagnostic performance study comparing the only Food and Drug Administration-approved, point-of-care (POC) treponemal test (Syphilis Health Check) and the World Health Organization pre-qualified SD Bioline POC treponemal test against a treponemal hemagglutination test (TPHA) and a sequential algorithm of nontreponemal rapid plasma reagin and TPHA found both POC tests had >85% sensitivity compared with the TPHA and >85% sensitivity and >95% specificity compared with the rapid plasma reagin and TPHA standards.
Full Text Available While the use of ultrasound to diagnose a fetal intracranial hemorrhage in utero is not a new concept, the emphasis of point-of-care ultrasound (POCUS at the initial trauma presentation of the mother to evaluate for fetal injury is novel. A review of the literature failed to reveal a single case report wherein POCUS in the workup of a pregnant trauma patient led to the diagnosis of fetal intracranial hemorrhage. This is such a case.
Cook, David A; Sorensen, Kristi J; Wilkinson, John M; Berger, Richard A
Answering clinical questions affects patient-care decisions and is important to continuous professional development. The process of point-of-care learning is incompletely understood. To understand what barriers and enabling factors influence physician point-of-care learning and what decisions physicians face during this process. Focus groups with grounded theory analysis. Focus group discussions were transcribed and then analyzed using a constant comparative approach to identify barriers, enabling factors, and key decisions related to physician information-seeking activities. Academic medical center and outlying community sites. Purposive sample of 50 primary care and subspecialist internal medicine and family medicine physicians, interviewed in 11 focus groups. Insufficient time was the main barrier to point-of-care learning. Other barriers included the patient comorbidities and contexts, the volume of available information, not knowing which resource to search, doubt that the search would yield an answer, difficulty remembering questions for later study, and inconvenient access to computers. Key decisions were whether to search (reasons to search included infrequently seen conditions, practice updates, complex questions, and patient education), when to search (before, during, or after the clinical encounter), where to search (with the patient present or in a separate room), what type of resource to use (colleague or computer), what specific resource to use (influenced first by efficiency and second by credibility), and when to stop. Participants noted that key features of efficiency (completeness, brevity, and searchability) are often in conflict. Physicians perceive that insufficient time is the greatest barrier to point-of-care learning, and efficiency is the most important determinant in selecting an information source. Designing knowledge resources and systems to target key decisions may improve learning and patient care.
Full Text Available Background: Laboratory test in transport is a critical component of patient care, and capillary blood is a preferred sample type particularly in children. This study evaluated the performance of capillary blood testing on the epoc Point of Care Blood Analysis System (Alere Inc. Methods: Ten fresh venous blood samples was tested on the epoc system under the capillary mode. Correlation with GEM 4000 (Instrumentation Laboratory was examined for Na+, K+, Cl-, Ca2+, glucose, lactate, hematocrit, hemoglobin, pO2, pCO2, and pH, and correlation with serum tested on Vitros 5600 (Ortho Clinical Diagnostics was examined for creatinine. Eight paired capillary and venous blood was tested on epoc and ABL800 (Radiometer for the correlation of Na+, K+, Cl-, Ca2+, glucose, lactate, hematocrit, hemoglobin, pCO2, and pH. Capillary blood from 23 apparently healthy volunteers was tested on the epoc system to assess the concordance to reference ranges used locally. Results: Deming regression correlation coefficients for all the comparisons were above 0.65 except for ionized Ca2+. Accordance of greater than 85% to the local reference ranges were found in all assays with the exception of pO2 and Cl-. Conclusion: Data from this study indicates that capillary blood tests on the epoc system provide comparable results to reference method for these assays, Na+, K+, glucose, lactate, hematocrit, hemoglobin, pCO2, and pH. Further validation in critically ill patients is needed to implement the epoc system in patient transport. Impact of the study: This study demonstrated that capillary blood tests on the epoc Point of Care Blood Analysis System give comparable results to other chemistry analyzers for major blood gas and critical tests. The results are informative to institutions where pre-hospital and inter-hospital laboratory testing on capillary blood is a critical component of patient point of care testing. Keywords: Epoc, Capillary, Transport, Blood gas, Point of care
Full Text Available sensors, Paper-based sensors, Radio frequency identification, Point-of-care diagnostics INTRODUCTION Data connectivity is an imperative consideration in the development of new POC diagnostic devices, particularly in the developing world [1... healthcare information standards. A low-cost color detector was implemented for use with existing lateral flow devices (LFDs) utilizing an RFID sensing chip (SL900A-DK-STQFN16, ams, Aus- tria), green light-emitting diode (LED), and photodetector (SFH...
Full Text Available Microfluidic systems enable precise control over tiny volumes of fluid in a compact and low-cost form, thus providing the ideal platform on which to develop point-of-care diagnostic solutions. Centrifugal microfluidic systems, also referred to as lab-on-a-disc or lab-on-a-CD systems, provide a particularly attractive solution for the implementation of microfluidic point-of-care diagnostic solutions as a result of their simple and compact instrumentation, as well as their functional diversity. Here we detail the implementation of a centrifugal microfluidic platform the first of its kind in South Africa as a foundation for the development of point-of-care diagnostic applications for which both the need and impact is great. The centrifugal microfluidic platform consists of three main components: a microfluidic disc device similar in size and shape to a CD, a system for controlling fluid flow on the device, and a system for recording the results obtained. These components have been successfully implemented and tested. Preliminary test results show that microfluidic functions such as pumping and valving of fluids can be successfully achieved, as well as the generation of monodisperse microfluidic droplets, providing a complete centrifugal microfluidic platform and the building blocks on which to develop a variety of applications, including point-of-care diagnostics. The lab-on-a-disc platform has the potential to provide new diagnostic solutions at the point-of-need in health- and industry-related areas. This paves the way for providing resource limited areas with services such as improved, decentralised health-care access or water-quality monitoring, and reduced diagnosis times at a low cost.
Steinfelder-Visscher, Jacoline; Teerenstra, Steven; Gunnewiek, Jacqueline M T Klein; Weerwind, Patrick W
Point-of-care analyzers may benefit therapeutic decision making by reducing turn-around-time for samples. This is especially true when biochemical parameters exceed the clinical reference range, in which acute and effective treatment is essential. We therefore evaluated the analytical performance of the i-STAT point-of-care analyzer in two critically ill adult patient populations. During a 3-month period, 48 blood samples from patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and 42 blood samples from non-cardiac patients who needed intensive care treatment were analyzed on both the i-STAT analyzer (CPB and non-CPB mode, respectively) and our laboratory analyzers (RapidLab 865/Sysmex XE-2100 instrument). The agreement analysis for quantitative data was used to compare i-STAT to RapidLab for blood gas/electrolytes and for hematocrit with the Sysmex instrument. Point-of-care electrolytes and blood gases had constant deviation, except for pH, pO2, and hematocrit. A clear linear trend in deviation of i-STAT from RapidLab was noticed for pH during CPB (r = 0.32, p = .03) and for pO2 > 10 kPa during CPB (r = -0.59, p pO2 pO2 pO2 range (10.6 pO2 range below 25% (n = 11) using the i-STAT. The i-STAT analyzer is suitable for point-of-care testing of electrolytes and blood gases in critically ill patients, except for high pO2. However, the discrepancy in hematocrit bias shows that accuracy established in one patient population cannot be automatically extrapolated to other patient populations, thus stressing the need for separate evaluation.
Haggerty, Lauren; Tran, Deanna
To summarize the literature on cholesterol point-of-care tests (POCTs). This article would serve as a resource to assist community pharmacists in developing cholesterol point-of-care (POC) pharmacy services. A literature search was performed in MEDLINE Ovid, PubMed, EMBASE, and Cochrane database using the following medical subject headings (MeSH) terms: point-of-care test, cholesterol, blood chemical analysis, rapid testing, collaborative practice, community pharmacy, and ambulatory care. Additional resources including device manufacturer web sites were summarized to supplement the current literature. All human research articles, review articles, meta-analyses, and abstracts published in English through September 1, 2014, were considered. A total of 36 articles were applicable for review. Information was divided into the following categories to be summarized: devices, pharmacists' impact, and operational cost for the pharmacy. The current literature suggests that POCTs in community pharmacies assist with patient outcomes by providing screenings and referring patients with dyslipidemia for further evaluation. The majority of studies on cholesterol POC devices focused on accuracy, revealing the need for further studies to develop best practices and practice models with successful reimbursement. Accuracy, device specifications, required supplies, and patient preference should be considered when selecting a POC device for purchase.
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.
Full Text Available Recent advancements in point-of-care technologies show great transformative promises for personalized preventative and predictive medicine. However, fields like therapeutic drug monitoring, that first allowed for personalized treatment of patient’ disease, still lag behind in the widespread application of point-of-care devices for monitoring of patients. Surprisingly, very few applications in commonly monitored drugs, such as anti-epileptics, are paving the way for a point of care (PoC approach to patient’ therapy monitoring, compared to other fields –like intensive care cardiac markers monitoring, glycemic controls in diabetes, or bench-top hematological parameters analysis at the local drug store. Such delay in the development of portable fast clinically effective drug monitoring devices is in our opinion due more to an inertial drag on the pervasiveness of these new devices into the clinical field than a lack of technical capability. At the same time, some very promising technologies failed in the clinical practice for inadequate understanding of the outcome parameters necessary for a relevant technological breakthrough that has superior clinical performance. We hope, by overviewing both therapeutic drug monitoring practice and its yet unmet needs and latest advancement in micro and nanotechnology applications to PoC clinical devices, to help bridging the two communities, the one exploiting analytical technologies and the one mastering the most advanced techniques, into translating existing and forthcoming technologies in effective devices.
Full Text Available The adoption of PDAs and mobile communication is expected to provide a solution to the use of computer technology by healthcare workers at the point-of-care. The Australian National Health Information Strategy, Health Online, is providing national leadership for approaches to address the quality and availability of information to assist in the planning and delivery of care. One area for potential growth is the availability and capture of information at the point of care by healthcare providers. A key factor in the lack of adoption of systems, is that traditionally health care information systems have been designed for desktop computing whereas many healthcare workers are highly mobile. This paper discusses phase one of a larger, four-phase project which aims to develop information access applications at point-of-care for Ambulatory Care Services. The initial phase of the research (phase one involves workflow analysis, requirements specification and the development and testing of a system prototype to assess the feasibility of achieving increased efficiencies in workflow at the Ambulatory Care Service.
Na, Joo-Young; Park, Ji Hye; Choi, Byung Ha; Kim, Hyung-Seok; Park, Jong-Tae
An autopsy involves examination of a body using invasive methods such as dissection, and includes various tests using samples procured during dissection. During medicolegal autopsies, the blood carboxyhemoglobin concentration is commonly measured using the AVOXimeter® 4000 as a point-of-care test. When evaluating the body following hypovolemic shock, characteristics such as reduced livor mortis or an anemic appearance of the viscera can be identified, but these observations arequite subjective. Thus, a more objective test is required for the postmortem diagnosis of anemia. In the present study, the AVOXimeter® 4000 was used to investigate the utility of point-of-care hemoglobin testing. Hemoglobin tests were performed in 93 autopsy cases. The AVOXimeter® 4000 and the BC-2800 Auto Hematology Analyzer were used to test identical samples in 29 of these cases. The results of hemoglobin tests performed with these two devices were statistically similar (r = 0.969). The results of hemoglobin tests using postmortem blood were compared with antemortem test results from medical records from 31 cases, and these results were similar. In 13 of 17 cases of death from internal hemorrhage, hemoglobin levels were lower in the cardiac blood than in blood from the affected body cavity, likely due to compensatory changes induced by antemortem hemorrhage. It is concluded that blood hemoglobin testing may be useful as a point-of-care test for diagnosing postmortem anemia.
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
Luci Maria Sant'Ana Dusse
Full Text Available Na última década, foram desenvolvidos os testes point-of-care visando à geração rápida de resultados de exames. Na área da hemostasia, a razão normatizada internacional, o RNI point-of-care test (RNI-POCT, constitui o principal exame dessa nova proposta. Esse teste tem grande potencial de benefício em situações em que o resultado rápido da RNI influencia a tomada de decisão clínica, como no acidente vascular cerebral isquêmico agudo, antes de procedimentos cirúrgicos e durante cirurgias cardíacas, além de permitir que o próprio paciente faça a monitoração da anticoagulação oral. Entretanto, a precisão e a acurácia da RNI-POCT ainda precisam ser aprimoradas para aumentar a eficácia e a eficiência do teste. A RDC/ANVISA Nº 302 deixa claro que os testes POCT devem ser supervisionados pelo responsável técnico do Laboratório Clínico nas fases pré-analítica, analítica e pós-analítica. Na prática, o laboratório não participa da execução desses testes e liberação dos resultados, não sendo, portanto, o mais indicado para garantir a qualidade dos mesmos. Os clínicos, especialmente aqueles envolvidos com a anticoagulação oral de pacientes, têm grande expectativa na incorporação da RNI-POCT na prática diária, apesar das limitações desse método. Esses profissionais mostram-se dispostos a treinar o paciente para realizar o teste, mas legalmente não são os responsáveis pela qualidade do mesmo e não estão preparados para a manutenção dos equipamentos. A definição do responsável pelo RNI-POCT precisa ser reavaliada pelos órgãos competentes, de forma a garantir que seja cumprida, e constitui etapa essencial para assegurar a qualidade do teste e, consequentemente, sua maior utilização.In the last decade, point-of-care tests were developed to provide rapid generation of test results. These tests have increasingly broad applications. In the area of hemostasis, the international normalized ratio
Ricks, Esmeralda; ten Ham, Wilma
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. 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. 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. 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. 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.
Baier, K A; Markham, L E; Flaigle, S P; Nelson, P W; Shield, C F; Muruve, N A; Aeder, M I; Murillo, D; Bryan, C F
Our organ procurement organization (OPO) evaluated the clinical and financial efficacy of point-of-care testing (POCT) in management of our deceased organ donors. Before we implemented point-of care testing with the i-STAT into routine clinical donor management, we compared the i-STAT result with the result from the respective donor hospital lab (DHL) for certain analytes on 15 consecutive donors in our OPO from 26 March to 14 May 2001. The financial impact was studied by reviewing 77 donors from July 2001 to March 2002. There was a strong correlation for each analyte between the POC and DHL test results with r-values as follows: pH 0.86; PCO2 = 0.96; PO2 = 0.98; sodium = 0.98; potassium = 0.95; chloride = 0.94; BUN = 0.98; glucose = 0.92; haematocrit = 0.87 and creatinine = 0.95. Since our OPO coordinators began using i-STAT in their routine clinical management of organ donors, they can now more quickly maximize oxygenation and fluid management of the donor and make extra-renal placement calls sooner. Finally, since we are no longer being billed for the testing performed on the i-STAT, average financial savings to our OPO are US dollars 733 per case. Point-of-care testing in management of our OPO donors provides a result that is equivalent to that of the donor hospital lab, has quicker turn-around time than the donor hospital laboratory, allowing more immediate clinical management decisions to be made so that extra-renal offers may begin sooner.
Cao, Jing; Edwards, Rachel; Chairez, Janette; Devaraj, Sridevi
Laboratory test in transport is a critical component of patient care, and capillary blood is a preferred sample type particularly in children. This study evaluated the performance of capillary blood testing on the epoc Point of Care Blood Analysis System (Alere Inc). Ten fresh venous blood samples was tested on the epoc system under the capillary mode. Correlation with GEM 4000 (Instrumentation Laboratory) was examined for Na+, K+, Cl-, Ca2+, glucose, lactate, hematocrit, hemoglobin, pO2, pCO2, and pH, and correlation with serum tested on Vitros 5600 (Ortho Clinical Diagnostics) was examined for creatinine. Eight paired capillary and venous blood was tested on epoc and ABL800 (Radiometer) for the correlation of Na+, K+, Cl-, Ca2+, glucose, lactate, hematocrit, hemoglobin, pCO2, and pH. Capillary blood from 23 apparently healthy volunteers was tested on the epoc system to assess the concordance to reference ranges used locally. Deming regression correlation coefficients for all the comparisons were above 0.65 except for ionized Ca2+. Accordance of greater than 85% to the local reference ranges were found in all assays with the exception of pO2 and Cl-. Data from this study indicates that capillary blood tests on the epoc system provide comparable results to reference method for these assays, Na+, K+, glucose, lactate, hematocrit, hemoglobin, pCO2, and pH. Further validation in critically ill patients is needed to implement the epoc system in patient transport. This study demonstrated that capillary blood tests on the epoc Point of Care Blood Analysis System give comparable results to other chemistry analyzers for major blood gas and critical tests. The results are informative to institutions where pre-hospital and inter-hospital laboratory testing on capillary blood is a critical component of patient point of care testing.
Full Text Available BACKGROUND: Previous studies have reported volatile organic compounds (VOCs in breath as biomarkers of breast cancer and abnormal mammograms, apparently resulting from increased oxidative stress and cytochrome p450 induction. We evaluated a six-minute point-of-care breath test for VOC biomarkers in women screened for breast cancer at centers in the USA and the Netherlands. METHODS: 244 women had a screening mammogram (93/37 normal/abnormal or a breast biopsy (cancer/no cancer 35/79. A mobile point-of-care system collected and concentrated breath and air VOCs for analysis with gas chromatography and surface acoustic wave detection. Chromatograms were segmented into a time series of alveolar gradients (breath minus room air. Segmental alveolar gradients were ranked as candidate biomarkers by C-statistic value (area under curve [AUC] of receiver operating characteristic [ROC] curve. Multivariate predictive algorithms were constructed employing significant biomarkers identified with multiple Monte Carlo simulations and cross validated with a leave-one-out (LOO procedure. RESULTS: Performance of breath biomarker algorithms was determined in three groups: breast cancer on biopsy versus normal screening mammograms (81.8% sensitivity, 70.0% specificity, accuracy 79% (73% on LOO [C-statistic value], negative predictive value 99.9%; normal versus abnormal screening mammograms (86.5% sensitivity, 66.7% specificity, accuracy 83%, 62% on LOO; and cancer versus no cancer on breast biopsy (75.8% sensitivity, 74.0% specificity, accuracy 78%, 67% on LOO. CONCLUSIONS: A pilot study of a six-minute point-of-care breath test for volatile biomarkers accurately identified women with breast cancer and with abnormal mammograms. Breath testing could potentially reduce the number of needless mammograms without loss of diagnostic sensitivity.
Full Text Available Richard Amini, Lori A Stolz, Parisa P Javedani, Kevin Gaskin, Nicola Baker, Vivienne Ng, Srikar Adhikari Department of Emergency Medicine, University of Arizona Medical Center, Tucson, AZ, USA Background: Emergency medicine milestones released by the Accreditation Council for Graduate Medical Education require residents to demonstrate competency in bedside ultrasound (US. The acquisition of these skills necessitates a combination of exposure to clinical pathology, hands-on US training, and feedback. Objectives: We describe a novel simulation-based educational and assessment tool designed to evaluate emergency medicine residents’ competency in point-of-care echocardiography for evaluation of a hypotensive patient with chest pain using bedside US. Methods: This was a cross-sectional study conducted at an academic medical center. A simulation-based module was developed to teach and assess the use of point-of-care echocardiography in the evaluation of the hypotensive patient. The focus of this module was sonographic imaging of cardiac pathology, and this focus was incorporated in all components of the session: asynchronous learning, didactic lecture, case-based learning, and hands-on stations. Results: A total of 52 residents with varying US experience participated in this study. Questions focused on knowledge assessment demonstrated improvement across the postgraduate year (PGY of training. Objective standardized clinical examination evaluation demonstrated improvement between PGY I and PGY III; however, it was noted that there was a small dip in hands-on scanning skills during the PGY II. Clinical diagnosis and management skills also demonstrated incremental improvement across the PGY of training. Conclusion: The 1-day, simulation-based US workshop was an effective educational and assessment tool at our institution. Keywords: point-of care ultrasound, simulation education
Schnell, Oliver; Crocker, J. Benjamin; Weng, Jianping
Diabetes is a highly prevalent disease also implicated in the development of several other serious complications like cardiovascular or renal disease. HbA1c testing is a vital step for effective diabetes management, however, given the low compliance to testing frequency and, commonly, a subsequent delay in the corresponding treatment modification, HbA1c at the point of care (POC) offers an opportunity for improvement of diabetes care. In this review, based on data from 1999 to 2016, we summarize the evidence supporting a further implementation of HbA1c testing at POC, discuss its limitations and propose recommendations for further development. PMID:27898388
Patou, François; Pfreundt, Andrea; Zulfiqar, Azeem
helping to address this challenge. Specifically, Lab-on-Chip (LoC) devices have a key role to play in the advent of Point-of-Care (PoC) medical applications, driving a shift of the medical diagnostics paradigm and the transition from a centralized, technical, high-throughput biological sample analysis...... 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...
Lanza, Nicole L; Valenzuela, Felipe; Perez, Victor L; Galor, Anat
Dry eye is a common, multifactorial disease currently diagnosed by a combination of symptoms and signs. However, the subjective symptoms of dry eye poorly correlate to the current gold standard for diagnostic tests, reflecting the need to develop better objective tests for the diagnosis of dry eye. This review considers the role of ocular surface matrix metalloproteinase 9 (MMP-9) in dry eye and the implications of a novel point-of-care test that measures MMP-9 levels, InflammaDry (RPS, Sarasota, FL) on choosing appropriate therapeutic treatments. Published by Elsevier Inc.
Full Text Available Steven D Reid, Sarah J Fidler, Graham S Cooke Department of Infectious Diseases, St Mary's Hospital, Imperial College London, London, UK Abstract: It is now around 30 years since the discovery of HIV, the virus that causes AIDS. More than 70 million people have been infected in that time and around 35 million have died. The majority of those currently living with HIV/AIDS are in low- and middle-income countries, with sub-Saharan Africa bearing a disproportionate burden of the global disease. In high-income countries, the introduction of antiretroviral therapy (ART has drastically reduced the morbidity and mortality associated with HIV. Patients on ART are now predicted to have near-normal life expectancy and the role of treatment is increasingly recognized in preventing new infections. In low- and middle-income countries, treatment is now more widely available and around half of those who need ART are currently receiving it. Early diagnosis of HIV is essential if ART is to be optimally implemented. Lab-based diagnostics for screening, diagnosis, treatment initiation, and the monitoring of treatment efficacy are critical in managing the disease and reducing the number of new infections each year. The introduction of point-of-care HIV rapid tests has transformed the epidemic, particularly in low- and middle-income countries. For the first time, these point-of-care tests allow for the rapid identification of infected individuals outside the laboratory who can undergo counseling and treatment and, in the case of pregnant women, allow the timely initiation of ART to reduce the risk of vertical transmission. Although survival is markedly improved with ART even in the absence of laboratory monitoring, long-term management of people living with HIV on ART, and their partners, is essential to ensure successful viral suppression. The burden of disease in many resource-poor settings with high HIV prevalence has challenged the ability of local laboratories
Song, Yujun; Huang, Yu-Yen; Liu, Xuewu; Zhang, Xiaojing; Ferrari, Mauro; Qin, Lidong
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. Copyright © 2014 Elsevier Ltd. All rights reserved.
Plevniak, Kimberly; Campbell, Matthew; Mei He
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.
Sehgal, A; McNamara, P J
Although the last two decades have seen major advances in the care of sick, extremely premature newborns, the approach to cardiovascular assessment and monitoring remains suboptimal owing to an overreliance on poorly predictive clinical markers such as heart rate or capillary refill time. Point-of-care functional echocardiography (PCFecho) enables real-time evaluation of cardiac performance and systemic hemodynamics to characterize acute physiology, identify the exact nature of cardiovascular compromise and guide therapeutic decisions. In this article, we will review four clinical scenarios where bedside functional cardiac imaging enabled delineation of the real clinical problem and refinement of the therapeutic care plan with direct patient benefits.
Tantra, Ratna; van Heeren, Henne
One of the most exciting applications of microfluidics-based diagnostics is its potential use in next generation point-of-care (POC) devices. Many prototypes are already in existence, but, as of yet, few have achieved commercialisation. In this article, we consider the issue surrounding product qualification as a potential barrier to market success. The study discusses, in the context of POC microfluidics-based diagnostics, what the generic issues are and potential solutions. Our findings underline the need for a community-based effort that is necessary to speed up the product qualification process.
Schotter, Joerg; Shoshi, Astrit; Brueckl, Hubert
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.
Myers, Gerard J; Browne, Joe
The use of point-of-care blood gas analyzers in cardiac surgery has been on the increase over the past decade. The availability of these analyzers in the operating room and post-operative intensive care units eliminates the time delays to transport samples to the main laboratory and reduces the amount of blood sampled to measure such parameters as electrolytes, blood gases, lactates, glucose and hemoglobin/hematocrit. Point-of-care analyzers also lead to faster and more reliable clinical decisions while the patient is still on the heart lung machine. Point-of-care devices were designed to provide safe, appropriate and consistent care of those patients in need of rapid acid/base balance and electrolyte management in the clinical setting. As a result, clinicians rely on their values to make decisions regarding ventilation, acid/base management, transfusion and glucose management. Therefore, accuracy and reliability are an absolute must for these bedside analyzers in both the cardiac operating room and the post-op intensive care units. Clinicians have a choice of two types of technology to measure hemoglobin/hematocrit during bypass, which subsequently determines their patient's level of hemodilution, as well as their transfusion threshold. All modern point-of-care blood gas analyzers measure hematocrit using a technology called conductivity, while other similar devices measure hemoglobin using a technology called co-oximetry. The two methods are analyzed and compared in this review. The literature indicates that using conductivity to measure hematocrit during and after cardiac surgery could produce inaccurate results when hematocrits are less than 30%, and, therefore, result in unnecessary homologous red cell transfusions in some patients. These inaccuracies are influenced by several factors that are common and unique to cardiopulmonary bypass, and will also be reviewed here. It appears that the only accurate, consistent and reliable method to determine hemodilution
AFRL-AFOSR-JP-TR-2017-0061 Broadband integrated mid-infrared light sources as enabling technology for point-of-care mid- infrared spectroscopy Alex...mid-infrared light sources as enabling technology for point-of-care mid-infrared spectroscopy 5a. CONTRACT NUMBER 5b. GRANT NUMBER FA2386-16-1-4037...Broadband integrated mid-infrared light sources as enabling technology for point-of-care mid- infrared spectroscopy ” Date: 16th August 2017 Name
Kadimisetty, Karteek; Song, Jinzhao; Doto, Aoife M; Hwang, Young; Peng, Jing; Mauk, Michael G; Bushman, Frederic D; Gross, Robert; Jarvis, Joseph N; Liu, Changchun
Molecular diagnostics that involve nucleic acid amplification tests (NAATs) are crucial for prevention and treatment of infectious diseases. In this study, we developed a simple, inexpensive, disposable, fully 3D printed microfluidic reactor array that is capable of carrying out extraction, concentration and isothermal amplification of nucleic acids in variety of body fluids. The method allows rapid molecular diagnostic tests for infectious diseases at point of care. A simple leak-proof polymerization strategy was developed to integrate flow-through nucleic acid isolation membranes into microfluidic devices, yielding a multifunctional diagnostic platform. Static coating technology was adopted to improve the biocompatibility of our 3D printed device. We demonstrated the suitability of our device for both end-point colorimetric qualitative detection and real-time fluorescence quantitative detection. We applied our diagnostic device to detection of Plasmodium falciparum in plasma samples and Neisseria meningitides in cerebrospinal fluid (CSF) samples by loop-mediated, isothermal amplification (LAMP) within 50 min. The detection limits were 100 fg for P. falciparum and 50 colony-forming unit (CFU) for N. meningitidis per reaction, which are comparable to that of benchtop instruments. This rapid and inexpensive 3D printed device has great potential for point-of-care molecular diagnosis of infectious disease in resource-limited settings. Copyright © 2018 Elsevier B.V. All rights reserved.
Tiwari, Aseem Kumar; Setya, Divya; Aggarwal, Geet; Arora, Dinesh; Dara, Ravi C; Ratan, Ankita; Bhardwaj, Gunjan; Acharya, Devi Prasad
Erycard 2.0 is a "point-of-care" device that is primarily being used for patient blood grouping before transfusion. Erycard 2.0 was compared with conventional slide technology for accuracy and time taken for ABO and Rh forward grouping result with column agglutination technology (CAT) being the gold standard. Erycard 2.0 as a device was also evaluated for its stability under different storage conditions and stability of result till 48 h. In addition, grouping of hemolyzed samples was also tested with Erycard 2.0. Ease of use of Erycard 2.0 was evaluated with a survey among paramedical staff. Erycard 2.0 demonstrated 100% concordance with CAT as compared with slide technique (98.9%). Mean time taken per test by Erycard 2.0 and slide technique was 5.13 min and 1.7 min, respectively. After pretesting storage under different temperature and humidity conditions, Erycard 2.0 did not show any deviation from the result. The result did not change even after 48 h of testing and storage under room temperature. 100% concordance was recorded between pre- and post-hemolyzed blood grouping. Ease of use survey revealed that Erycard 2.0 was more acceptable to paramedical staff for its simplicity, objectivity, and performance than conventional slide technique. Erycard 2.0 can be used as "point-of-care" device for blood donor screening for ABO and Rh blood group and can possibly replace conventional slide technique.
Li, Jia; Macdonald, Joanne
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. Copyright © 2016 Elsevier B.V. All rights reserved.
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.
Sarkar, Probir Kumar; Pal, Sanchari; Polley, Nabarun; Aich, Rajarshi; Adhikari, Aniruddha; Halder, Animesh; Chakrabarti, Subhananda; Chakrabarti, Prantar; Pal, Samir Kumar
Anemia severely and adversely affects human health and socioeconomic development. Measuring hemoglobin with the minimal involvement of human and financial resources has always been challenging. We describe a translational spectroscopic technique for noncontact hemoglobin measurement at low-resource point-of-care settings in human subjects, independent of their skin color, age, and sex, by measuring the optical spectrum of the blood flowing in the vascular bed of the bulbar conjunctiva. We developed software on the LabVIEW platform for automatic data acquisition and interpretation by nonexperts. The device is calibrated by comparing the differential absorbance of light of wavelength 576 and 600 nm with the clinical hemoglobin level of the subject. Our proposed method is consistent with the results obtained using the current gold standard, the automated hematology analyzer. The proposed noncontact optical device for hemoglobin estimation is highly efficient, inexpensive, feasible, and extremely useful in low-resource point-of-care settings. The device output correlates with the different degrees of anemia with absolute and trending accuracy similar to those of widely used invasive methods. Moreover, the device can instantaneously transmit the generated report to a medical expert through e-mail, text messaging, or mobile apps.
Newman, Ashleigh W; Behling-Kelly, Erica
With advancements in the standard of care in veterinary medicine and instrument technology, performing in-house laboratory work on a variety of point-of-care instruments, ranging from glucometers to benchtop chemistry analyzers, has become increasingly commonplace. However, the ability of an instrument to perform a test does not guarantee that those results are accurate. Ensuring that your in-clinic laboratory is providing reliable data requires a comprehensive plan that encompasses both common sense practices aimed at preventing errors at each stage of the testing process, as well as standard operating procedures to validate and monitor analyzer performance. These 2 arms of the plan are known as quality assurance and quality control. Although these concepts are typically out of the comfort zone for veterinarians, just as the thought of business management may deter some veterinarians from practice ownership, it is not beyond the capabilities of veterinarians to learn, understand, and incorporate them into their practice. The objectives of this article are to convey the importance of quality assurance and quality control, walk you through the American Society for Veterinary Clinical Pathology guidelines on this topic, and provide direction to additional resources for further education on this topic, all with the focus on point-of-care testing in the in-clinic laboratory. Copyright © 2016 Elsevier Inc. All rights reserved.
Gerrald, Katherine R; Dixon, Dave L; Barnette, Debra J; Williams, Virginia G
Hyperlipidemia is a significant, modifiable risk factor for developing coronary heart disease. Low-density lipoprotein cholesterol (LDL-C) goal achievement has improved overall, but many high-risk patients remain above the desired LDL-C goals. Published data have demonstrated the ability of pharmacist-managed lipid clinics to improve lipid management in a variety of clinical settings. This observational analysis aimed to report the impact of a newly developed hospital-based, outpatient lipid clinic by the use of point-of-care testing on LDL-C goal attainment. A retrospective, observational analysis was conducted from February 2007 to December 2008. The primary outcome measure was the change in the proportion of patients who achieved their LDL-C goal at the end of the observation period compared with baseline. A total of 81 patients met study inclusion criteria. Mean duration of follow-up was 9.0 ± 4.9 (SD) months. At the end of the observation period, 82.9% of patients achieved their LDL-C goal compared with 55.3% at baseline (P used point-of-care testing to obtain lipid results for making therapy adjustments during the face-to-face visit. Copyright © 2010 National Lipid Association. Published by Elsevier Inc. All rights reserved.
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%.
Wong, Karen; Huang, Shao Hui; O'Sullivan, Brian; Lockwood, Gina; Dale, Darlene; Michaelson, Terry; Waldron, John; Bayley, Andrew; Cummings, Bernard; Dawson, Laura A.; Kim, John; Liu, Geoffrey; Ringash, Jolie
Background and purpose: To assess the completeness and accuracy of stage and outcome data in the Anthology of Outcomes (AOs), a prospective point-of-care physician-collected electronic data system for patients at Princess Margaret Hospital. Material and methods: A random sample of 10% of the AO cases registered between July 2003 and December 2005 was drawn. An audit was conducted of the AO data compared with chart review and cancer registry. Results: The AO system was applied first to a head and neck (HN) cancer patient cohort. From 1152 HN cases, 120 were audited. TNM stage was recorded in all cases. Discrepancy was found between the AO and primary data sources in 3-13% of cases. Physician review showed a 3% error rate in overall stage recorded in the AO. Sixty-two outcomes in 43 patients were found on chart review. No outcomes were incorrectly recorded in the AO. Nineteen (31%) outcomes in 17 patients were missed in the AO. Conclusions: Our experience has demonstrated the feasibility of real-time outcome recording at point-of-care. New processes needed to improve the completeness of capture of patient outcomes in the AO have more recently been introduced. This successful system has been expanded to other disease sites.
Han Yih Lau
Full Text Available Diagnostic technologies for the detection of plant pathogens with point-of-care capability and high multiplexing ability are an essential tool in the fight to reduce the large agricultural production losses caused by plant diseases. The main desirable characteristics for such diagnostic assays are high specificity, sensitivity, reproducibility, quickness, cost efficiency and high-throughput multiplex detection capability. This article describes and discusses various DNA-based point-of care diagnostic methods for applications in plant disease detection. Polymerase chain reaction (PCR is the most common DNA amplification technology used for detecting various plant and animal pathogens. However, subsequent to PCR based assays, several types of nucleic acid amplification technologies have been developed to achieve higher sensitivity, rapid detection as well as suitable for field applications such as loop-mediated isothermal amplification, helicase-dependent amplification, rolling circle amplification, recombinase polymerase amplification, and molecular inversion probe. The principle behind these technologies has been thoroughly discussed in several review papers; herein we emphasize the application of these technologies to detect plant pathogens by outlining the advantages and disadvantages of each technology in detail.
Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W
Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).
Wagner, Michael S; Garcia, Kathleen; Martin, David S
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.
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.
Amini, Richard; Stolz, Lori A; Javedani, Parisa P; Gaskin, Kevin; Baker, Nicola; Ng, Vivienne; Adhikari, Srikar
Emergency medicine milestones released by the Accreditation Council for Graduate Medical Education require residents to demonstrate competency in bedside ultrasound (US). The acquisition of these skills necessitates a combination of exposure to clinical pathology, hands-on US training, and feedback. We describe a novel simulation-based educational and assessment tool designed to evaluate emergency medicine residents' competency in point-of-care echocardiography for evaluation of a hypotensive patient with chest pain using bedside US. This was a cross-sectional study conducted at an academic medical center. A simulation-based module was developed to teach and assess the use of point-of-care echocardiography in the evaluation of the hypotensive patient. The focus of this module was sonographic imaging of cardiac pathology, and this focus was incorporated in all components of the session: asynchronous learning, didactic lecture, case-based learning, and hands-on stations. A total of 52 residents with varying US experience participated in this study. Questions focused on knowledge assessment demonstrated improvement across the postgraduate year (PGY) of training. Objective standardized clinical examination evaluation demonstrated improvement between PGY I and PGY III; however, it was noted that there was a small dip in hands-on scanning skills during the PGY II. Clinical diagnosis and management skills also demonstrated incremental improvement across the PGY of training. The 1-day, simulation-based US workshop was an effective educational and assessment tool at our institution.
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.
Smalley, Courtney M; Browne, Vaughn; Kaplan, Bonnie; Russ, Brian; Wilson, Juliana; Lewiss, Resa E
In preparing for medical school admissions, premedical students seek opportunities to expand their medical knowledge. Knowing what students seek and what point-of-care ultrasound offers, we created a novel educational experience using point-of-care ultrasound. The innovation has 3 goals: (1) to use point-of-care ultrasound to highlight educational concepts such as the flipped classroom, simulation, hands-on interaction, and medical exposure; (2) to work collaboratively with peers; and (3) to expose premedical students to mentoring for the medical school application process. We believe that this course could be used to encourage immersive innovation with point-of-care ultrasound, progressive education concepts, and preparation for medical admissions. © 2016 by the American Institute of Ultrasound in Medicine.
Houlbert, C; Annaix, V; Szymanowicz, A; Vassault, A; Guimont, M C; Pernet, P
In this paper, guidelines are proposed to fulfill the requirements of EN ISO 22870 standard regarding the management of point-of-care testing (POCT) nonconformities. In the first part, the main nonconformities that may affect POCT are given, the means for resolution and the control of adverse events are proposed. In the second part, we propose recommendations in case of unavailability of a point-of-care testing device from the occurring of the adverse event, to the restarting of the device.
Shah, Kevin; Terracciano, Garrett J.; Jiang, Kevin; Maisel, Alan S.; Fitzgerald, Robert L.
Objectives: Heart failure is one of the leading causes of death in the U.S. The incorporation of B-type natriuretic peptide (BNP) measurements when triaging patients presenting with shortness of breath has improved the diagnostic and prognostic ability of physicians. Currently, there are no point-of-care systems for quantifying BNP that can be used without sacrificing accuracy. We compared the analytical performance of the Abbott i-STAT analyzer, a handheld point-of-care system for measuring ...
Hysong, Sylvia J; Che, Xinxuan; Weaver, Sallie J; Petersen, Laura A
The need for deliberately coordinated care is noted by many national-level organizations. The Department of Veterans Affairs (VA) recently transitioned primary care clinics nationwide into Patient Aligned Care Teams (PACTs) to provide more accessible, coordinated, comprehensive, and patient-centered care. To better serve this purpose, PACTs must be able to successfully sequence and route interdependent tasks to appropriate team members while also maintaining collective situational awareness (coordination). Although conceptual frameworks of care coordination exist, few explicitly articulate core behavioral markers of coordination or the related information needs of team members attempting to synchronize complex care processes across time for a shared patient population. Given this gap, we partnered with a group of frontline primary care personnel at ambulatory care sites to identify the specific information needs of PACT members that will enable them to coordinate their efforts to provide effective, coordinated care. The study has three objectives: (1) development of measurable, prioritized point-of-care criteria for effective PACT coordination; (2) identifying the specific information needed at the point of care to optimize coordination; and (3) assessing the effect of adopting the aforementioned coordination standards on PACT clinicians' coordination behaviors. The study consists of three phases. In phase 1, we will employ the Productivity Measurement and Enhancement System (ProMES), a structured approach to performance measure creation from industrial/organizational psychology, to develop coordination measures with a design team of 6-10 primary care personnel; in phase 2, we will conduct focus groups with the phase 1 design team to identify point-of-care information needs. Phase 3 is a two-arm field experiment (n PACT = 28/arm); intervention arm PACTs will receive monthly feedback reports using the measures developed in phase 1 and attend brief monthly
Salez, Nicolas; Nougairede, Antoine; Ninove, Laetitia; Zandotti, Christine; de Lamballerie, Xavier; Charrel, Rémi N
Respiratory infections, particularly those caused by influenza viruses, represent the third-most important cause of death in the world due to infectious diseases. Nevertheless, despite the enormous publicity attracted by epidemics due to these viruses, laboratory diagnosis, documentation and recording of respiratory diseases is still unsatisfactory. Available diagnostic tests capable of providing results rapidly are either limited and insufficiently sensitive or highly sensitive and specific but insufficiently rapid. Considerable investment and research efforts have been made towards the development of new diagnostics for influenza A and B viruses and the Xpert(®) Flu assay (Cepheid(®), CA, USA) has emerged as one of the most promising. In this article, we review current knowledge of the Xpert Flu test, discuss its potential value as a point-of-care test and outline the potential leads for future development.
without the need for a specialised laboratory. Other fields of application are for example health care projects in developing countries where access to modern high-throughput facilities is often impossible or sectors not related to the medical field, like environmental monitoring or food safety. The aim......Personalised medicine and diagnostics is a rapidly growing field of research and general interest. Important tools for individual patient care are so called point-of-care devices. These typically simple and inexpensive instruments allow the untrained user to perform simple diagnostic analyses...... 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...
Existing centralized labs do not serve patients adequately in remote areas. To enable universal timely healthcare, there is a need to develop low cost, portable systems that can diagnose multiple disease (Point-of-Care (POC) devices). Future POC diagnostics can be more multi-functional if medical device vendors can develop interoperability standards. This thesis developed the following medical diagnostic modules: Plasma from 25 microl blood was extracted through a filter membrane to demonstrate a 3D printed sample preparation module. Sepsis biomarker, C - reactive protein, was quantified through adsorption on nylon beads to demonstrate bead-based assay suitable for 3D printed disposable cartridge module. Finally, a modular fluorescent detection kit was built using 3D printed parts to detect CD4 cells in a disposable cartridge from ChipCare Corp. Due to the modularity enabled by 3D printing technique, the developed units can be easily adapted to detect other diseases.
Walsh, David I; Murthy, Shashi K; Russom, Aman
Point-of-care (POC) microfluidic devices often lack the integration of common sample preparation steps, such as preconcentration, which can limit their utility in the field. In this technology brief, we describe a system that combines the necessary sample preparation methods to perform sample-to-result analysis of large-volume (20 mL) biopsy model samples with staining of captured cells. Our platform combines centrifugal-paper microfluidic filtration and an analysis system to process large, dilute biological samples. Utilizing commercialization-friendly manufacturing methods and materials, yielding a sample throughput of 20 mL/min, and allowing for on-chip staining and imaging bring together a practical, yet powerful approach to microfluidic diagnostics of large, dilute samples. © 2016 Society for Laboratory Automation and Screening.
Full Text Available A 15-day-old male who was born at term presented with non-bilious projectile vomiting. He was nontoxic and his abdomen was benign without masses. Point-of-care ultrasound (POCUS showed hypertrophic pyloric stenosis (HPS. Typical findings include target sign; pyloric muscle thickness greater than three millimeters (mm; channel length greater than 15–18 mm; and lack of gastric emptying. The patient was admitted; consultative ultrasound (US was negative, but repeated 48 hours later for persistent vomiting. This second US was interpreted as HPS, which was confirmed surgically. Pyloromyotomy was successful. Few reports describe POCUS by general emergency physicians to diagnose HPS. Here, we emphasize the value in repeat US for patients with persistent symptoms.
Gils, Charlotte; Ramanathan, R.; Breindahl, T.
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...
Choi, Charles J; Wu, Hsin-Yu; George, Sherine; Weyhenmeyer, Jonathan; Cunningham, Brian T
In medical facilities, there is strong motivation to develop detection systems that can provide continuous analysis of fluids in medical tubing used to either deliver or remove fluids from a patient's body. Possible applications include systems that increase the safety of intravenous (IV) drug injection and point-of-care health monitoring. In this work, we incorporated a surface-enhanced Raman scattering (SERS) sensor comprised of an array of closely spaced metal nanodomes into flexible tubing commonly used for IV drug delivery and urinary catheters. The nanodome sensor was fabricated by a low-cost, large-area process that enables single use disposable operation. As exemplary demonstrations, the sensor was used to kinetically detect promethazine (pain medication) and urea (urinary metabolite) within their clinically relevant concentration ranges. Distinct SERS peaks for each analyte were used to demonstrate separate detection and co-detection of the analytes.
Azrul Syafiq Zainol Abidin
Full Text Available Anxiety is a psychological problem that often emerges during the normal course of human life. The detection of anxiety often involves a physical exam and a self-reporting questionnaire. However, these approaches have limitations, as the data might lack reliability and consistency upon application to the same population over time. Furthermore, there might be varying understanding and interpretations of the particular question by the participant, which necessitating the approach of using biomarker-based measurement for stress diagnosis. The most prominent biomarker related to stress, hormone cortisol, plays a key role in the fight-or-flight situation, alters the immune response, and suppresses the digestive and the reproductive systems. We have taken the endeavour to review the available aptamer-based biosensor (aptasensor for cortisol detection. The potential point-of-care diagnostic strategies that could be harnessed for the aptasensing of cortisol were also envisaged.
Bøtker, Morten Thingemann
dyspnea in the ambulance requires identification of high-risk groups and early correct treatment. Bringing forward simplified versions of advanced diagnostic modalities known from the hospital as point-of-care diagnostics already in the ambulance may aid the discrimination of underlying conditions causing......, we included all patients dialing the emergency number (1-1-2) due to a medical emergency in three of five Danish regions. For identification of highrisk patients and evaluation of electrocardiogram-based triage, we compared short-term mortality between patients included in the first study based...... that are highly prioritized in emergency medical services – including chest pain and trauma. Whether this increased mortality can be ascribed to an older age and comorbidity among patients suffering dyspnea, or if modifiable risk factors are also present, is unsettled. Improving outcome for patients suffering...
Guan, Weihua; Reed, Mark A
An enzyme-free redox potential sensor using off-chip extended-gate field effect transistor (EGFET) with a ferrocenyl-alkanethiol modified gold electrode has been used to quantify uric acid concentration in human serum and urine. Hexacyanoferrate (II) and (III) ions are used as redox reagent. The potentiometric sensor measures the interface potential on the ferrocene immobilized gold electrode, which is modulated by the redox reaction between uric acid and hexacyanoferrate ions. The device shows a near Nernstian response to uric acid and is highly specific to uric acid in human serum and urine. The interference that comes from glucose, bilirubin, ascorbic acid, and hemoglobin is negligible in the normal concentration range of these interferents. The sensor also exhibits excellent long term reliability and is regenerative. This extended gate field effect transistor based sensor is promising for point-of-care detection of uric acid due to the small size, low cost, and low sample volume consumption.
Peeling, Rosanna W; McNerney, Ruth
Emerging molecular technologies to diagnose infectious diseases at the point at which care is delivered have the potential to save many lives in developing countries where access to laboratories is poor. Molecular tests are needed to improve the specificity of syndromic management, monitor progress towards disease elimination and screen for asymptomatic infections with the goal of interrupting disease transmission and preventing long-term sequelae. In simplifying laboratory-based molecular assays for use at point-of-care, there are inevitable compromises between cost, ease of use and test performance. Despite significant technological advances, many challenges remain for the development of molecular diagnostics for resource-limited settings. There needs to be more advocacy for these technologies to be applied to infectious diseases, increased efforts to lower the barriers to market entry through streamlined and harmonized regulatory approaches, faster policy development for adoption of new technologies and novel financing mechanisms to enable countries to scale up implementation.
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.
Haldrup, Steffen; Thomsen, Reimar W.; Bro, Flemming
BACKGROUND: Point-of-care testing (POCT) in primary care may improve rational antibiotic prescribing. We examined use of POCT in Denmark, including patient- and general practitioner (GP)-related predictors. METHODS: We linked nationwide health care databases to assess POCT use (C-reactive protein...... (CRP), group A streptococcal (GAS) antigen swabs, bacteriological cultures, and urine test strips) per 1,000 overall GP consultations, 2004-2013. We computed odds ratios (OR) of POCT in patients prescribed antibiotics according to patient and GP age and sex, GP practice type, location, and workload....... RESULTS: The overall use of POCT in Denmark increased by 45.8% during 2004-2013, from 147.2 per 1,000 overall consultations to 214.8. CRP tests increased by 132%, bacteriological cultures by 101.7% while GAS swabs decreased by 8.6%. POCT preceded 28% of antibiotic prescriptions in 2004 increasing to 44...
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.
Full Text Available Radiological imaging plays an essential role in the evaluation of a patient with suspected small bowel obstruction (SBO. In a few studies, point-of-care ultrasound (POCUS has been utilized as a primary imaging modality in patients with suspected SBO. POCUS has been shown to be an accurate tool in the diagnosis of SBO with multiple research studies noting a consistent high sensitivity with a range of 94–100% and specificity of 81–100%. Specific sonographic findings that increase the likelihood of SBO include dilatation of small bowel loops > 25 mm, altered intestinal peristalsis, increased thickness of the bowel wall, and intraperitoneal fluid accumulation. Studies also reported that emergency physicians could apply this technique with limited and short-term ultrasound training. In this article, we aim to review the sensitivity and specificity of ultrasound examinations performed by emergency physicians in patients with suspected SBO.
The utility of personal digital assistants (PDA) as a point of care resource in health care practice and education presents new challenges for nursing faculty. While there is a plethora of PDA resources available, little is known about the variables that effect student learning and technology adoption. In this study nursing students used PDA software programs which included a drug guide, medical dictionary, laboratory manual and nursing diagnosis manual during acute care clinical experiences. Analysis of student journals comparative reflective statements about the PDA as an adjunct to other available resources in clinical practice are presented. The benefits of having a PDA included readily available data, validation of thinking processes, and facilitation of care plan re-evaluation. Students reported increased frequency of use and independence. Significant correlations between user perceptions and computer self-efficacy suggested greater confidence in abilities with technology resulting in increased self-awareness and achievement of learning outcomes.
Safavieh, Mohammadali; Coarsey, Chad; Esiobu, Nwadiuto; Memic, Adnan; Vyas, Jatin Mahesh; Shafiee, Hadi; Asghar, Waseem
Invasive candidiasis remains one of the most serious community and healthcare-acquired infections worldwide. Conventional Candida detection methods based on blood and plate culture are time-consuming and require at least 2–4 days to identify various Candida species. Despite considerable advances for candidiasis detection, the development of simple, compact and portable point-of-care diagnostics for rapid and precise testing that automatically performs cell lysis, nucleic acid extraction, purification and detection still remains a challenge. Here, we systematically review most prominent conventional and nonconventional techniques for the detection of various Candida species, including Candida staining, blood culture, serological testing and nucleic acid-based analysis. We also discuss the most advanced lab on a chip devices for candida detection. PMID:27093473
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.
Full Text Available During the last two decades silicon and MEMs technology had been the mainstay of early microfluidic devices. However, recent times have brought into focus the need for low cost and readily available materials capable of achieving the expected microfluidics physical and chemical requirements. Also what mentioning is the rapid improvement in microfabrication technology over the years, which has significantly aided new and cheaper ways to produce microfluidic Point-Of-Care-Testing devices commercially or for research purposes. This review article discusses the usefulness of a wide range of available materials and their unique properties suitability in microfluidic applications. Likewise, advantages and drawbacks of manufacturing procedures and outputs of different fabrication methods are also brought into focus.
Konstantinov, Konstantin N; Rubin, Robert L
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.
Tang, Rui Hua; Yang, Hui; Choi, Jane Ru; Gong, Yan; Feng, Shang Sheng; Pingguan-Murphy, Belinda; Huang, Qing Sheng; Shi, Jun Ling; Mei, Qi Bing; Xu, Feng
In recent years, paper-based point-of-care testing (POCT) has been widely used in medical diagnostics, food safety and environmental monitoring. However, a high-cost, time-consuming and equipment-dependent sample pretreatment technique is generally required for raw sample processing, which are impractical for low-resource and disease-endemic areas. Therefore, there is an escalating demand for a cost-effective, simple and portable pretreatment technique, to be coupled with the commonly used paper-based assay (e.g. lateral flow assay) in POCT. In this review, we focus on the importance of using paper as a platform for sample pretreatment. We firstly discuss the beneficial use of paper for sample pretreatment, including sample collection and storage, separation, extraction, and concentration. We highlight the working principle and fabrication of each sample pretreatment device, the existing challenges and the future perspectives for developing paper-based sample pretreatment technique.
Holm, Anne; Cordoba, Gloria; Sørensen, Tina Møller
OBJECTIVE: To assess the clinical accuracy (sensitivity (SEN), specificity (SPE), positive predictive value and negative predictive value) of two point-of-care (POC) urine culture tests for the identification of urinary tract infection (UTI) in general practice. DESIGN: Prospective diagnostic...... uncomplicated, symptomatic UTI. MAIN OUTCOME MEASURES: (1) Overall accuracy of POC urine culture in general practice. (2) Individual accuracy of each of the two POC tests in this study. (3) Accuracy of POC urine culture in general practice with enterococci excluded, since enterococci are known to multiply...... general practices recruited 341 patients with suspected uncomplicated UTI. The overall agreement between index test and reference was 0.76 (CI: 0.71-0.80), SEN 0.88 (CI: 0.83-0.92) and SPE 0.55 (CI: 0.46-0.64). The two POC tests produced similar results individually. Overall agreement with enterococci...
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
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.
Lewiss, Resa E; Hoffmann, Beatrice; Beaulieu, Yanick; Phelan, Mary Beth
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.
Amber, Kyle T; Dhiman, Gaurav; Goodman, Kenneth W
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Levy, Jason A; Waltzman, Mark; Monuteaux, Michael C; Bachur, Richard G
Children with gastroenteritis often develop dehydration with metabolic acidosis. Serum ketones are frequently elevated in this population. The goal was to determine the relationship between initial serum ketone concentration and both the degree of dehydration and the magnitude of acidosis. This was a secondary analysis of a prospective trial of crystalloid administration for rapid rehydration. Children 6 months to 6 years of age with gastroenteritis and dehydration were enrolled. A point-of-care serum ketone (beta-hydroxybutyrate) concentration was obtained at the time of study enrollment. The relationship between initial serum ketone concentration and a prospectively assigned and previously validated clinical dehydration score, and serum bicarbonate concentration, was analyzed. A total of 188 patients were enrolled. The median serum ketone concentration was elevated at 3.1 mmol/L (interquartile range [IQR] = 1.2 to 4.6 mmol/L), and the median dehydration score was consistent with moderate dehydration. A significant positive relationship was found between serum ketone concentration and the clinical dehydration score (Spearman's rho = 0.22, p = 0.003). Patients with moderate dehydration had a higher median serum ketone concentration than those with mild dehydration (3.6 mmol/L vs. 1.4 mmol/L, p = 0.007). Additionally, the serum ketone concentration was inversely correlated with serum bicarbonate concentration (ρ = -0.26, p Children with gastroenteritis and dehydration have elevated serum ketone concentrations that correlate with both degree of dehydration and magnitude of metabolic acidosis. Point-of-care serum ketone measurement may be a useful tool to inform management decisions at the point of triage or in the initial evaluation of children with gastroenteritis and dehydration. © 2013 by the Society for Academic Emergency Medicine.
Full Text Available Srikar Adhikari,1 Richard Amini,1 Lori A Stolz,1 Michael Blaivas2 1Department of Emergency Medicine, University of Arizona Medical Center, Tucson, AZ, 2Department of Internal Medicine, University of South Carolina School of Medicine, Columbia, SC, USA Abstract: The use of point-of-care (POC ultrasonography has rapidly expanded in recent years, in both academic and community settings. It is one of the few diagnostic modalities that can be performed rapidly at the bedside by a physician and has significant impact on patient outcomes. It is portable, readily accessible, and cost-effective, and has no risk of ionizing radiation. There is an abundance of evidence that supports the use of POC ultrasound by physicians in different subspecialties. Multiple studies have documented the diagnostic accuracy of POC ultrasound and its ability to decrease the time to definitive treatment. As ultrasound technology has advanced, POC ultrasound applications have also evolved from being used solely in patients with blunt abdominal trauma to applications for nearly every clinical scenario imaginable. From performing procedures more safely to diagnosing pathology more quickly, POC ultrasound is radically changing clinical practice, patient outcomes, and the overall quality of patient care a clinician can provide. Recently, there has been a paradigm shift involving a symptom-based approach to POC ultrasound. This unique symptom-based ultrasound approach has led to improved quality of care in a variety of clinical settings. Keywords: point-of-care ultrasound, ultrasonography, bedside ultrasound, emergency physician, emergency department, quality, symptom-based
Smith, Suzanne; Naidoo, Thegaran; Davies, Emlyn; Fourie, Louis; Nxumalo, Zandile; Swart, Hein; Marais, Philip; Land, Kevin; Roux, Pieter
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 , and can be particularly beneficial for blood cell count tests, which are often the starting point in the process of diagnosing a patient . The initial focus of this work is on total white and red blood cell counts, using a microfluidic cartridge  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  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 . The results using the first iteration microfluidic device  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.
Metcalfe, Michael J; Petros, Firas G; Rao, Priya; Mork, Maureen E; Xiao, Lianchun; Broaddus, Russell R; Matin, Surena F
Patients with Lynch syndrome are at risk for upper tract urothelial carcinoma. We sought to identify the incidence and most reliable means of point of care screening for Lynch syndrome in patients with upper tract urothelial carcinoma. A total of 115 consecutive patients with upper tract urothelial carcinoma without a history of Lynch syndrome were universally screened during followup from January 2013 through July 2016. We evaluated patient and family history using AMS (Amsterdam criteria) I and II, and tumor immunohistochemistry for mismatch repair proteins and microsatellite instability. Patients who were positive for AMS I/II, microsatellite instability or immunohistochemistry were classified as potentially having Lynch syndrome and referred for clinical genetic analysis and counseling. Patients with known Lynch syndrome served as positive controls. Of the 115 patients 16 (13.9%) screened positive for potential Lynch syndrome. Of these patients 7.0% met AMS II criteria, 11.3% had loss of at least 1 mismatch repair protein and 6.0% had high microsatellite instability. All 16 patients were referred for germline testing, 9 completed genetic analysis and counseling, and 6 were confirmed to have Lynch syndrome. All 7 patients with upper tract urothelial carcinoma who had a known history of Lynch syndrome were positive for AMS II criteria and at least a single mismatch repair protein loss while 5 of 6 had high microsatellite instability. We identified 13.9% of upper tract urothelial carcinoma cases as potential Lynch syndrome and 5.2% as confirmed Lynch syndrome at the point of care. These findings have important implications for universal screening of upper tract urothelial carcinoma, representing one of the highest rates of undiagnosed genetic disease in a urological cancer. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Burrs, S. L.; Sidhu, R.; Bhargava, M.; Kiernan-Lewis, J.; Schwalb, N.; Rong, Y.; Gomes, C.; Claussen, J.; Vanegas, D. C.; McLamore, E. S.
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.
Engel, Nora; Ganesh, Gayatri; Patil, Mamata; Yellappa, Vijayashree; Pant Pai, Nitika; Vadnais, Caroline; Pai, Madhukar
Background Successful point-of-care testing, namely ensuring the completion of the test and treat cycle in the same encounter, has immense potential to reduce diagnostic and treatment delays, and impact patient outcomes. However, having rapid tests is not enough, as many barriers may prevent their successful implementation in point-of-care testing programs. Qualitative research on diagnostic practices may help identify such barriers across different points of care in health systems. Methods In this exploratory qualitative study, we conducted 78 semi-structured interviews and 13 focus group discussions in an urban and rural area of Karnataka, India, with healthcare providers (doctors, nurses, specialists, traditional healers, and informal providers), patients, community health workers, test manufacturers, laboratory technicians, program managers and policy-makers. Participants were purposively sampled to represent settings of hospitals, peripheral labs, clinics, communities and homes, in both the public and private sectors. Results In the Indian context, the onus is on the patient to ensure successful point-of-care testing across homes, clinics, labs and hospitals, amidst uncoordinated providers with divergent and often competing practices, in settings lacking material, money and human resources. We identified three overarching themes affecting point-of-care testing: the main theme is ‘relationships’ among providers and between providers and patients, influenced by the cross-cutting theme of ‘infrastructure’. Challenges with both result in ‘modified practices’ often favouring empirical (symptomatic) treatment over treatment guided by testing. Conclusions Even if tests can be conducted on the spot and infrastructure challenges have been resolved, relationships among providers and between patients and providers are crucial for successful point-of-care testing. Furthermore, these barriers do not act in isolation, but are interlinked and need to be examined
Full Text Available Successful point-of-care testing, namely ensuring the completion of the test and treat cycle in the same encounter, has immense potential to reduce diagnostic and treatment delays, and impact patient outcomes. However, having rapid tests is not enough, as many barriers may prevent their successful implementation in point-of-care testing programs. Qualitative research on diagnostic practices may help identify such barriers across different points of care in health systems.In this exploratory qualitative study, we conducted 78 semi-structured interviews and 13 focus group discussions in an urban and rural area of Karnataka, India, with healthcare providers (doctors, nurses, specialists, traditional healers, and informal providers, patients, community health workers, test manufacturers, laboratory technicians, program managers and policy-makers. Participants were purposively sampled to represent settings of hospitals, peripheral labs, clinics, communities and homes, in both the public and private sectors.In the Indian context, the onus is on the patient to ensure successful point-of-care testing across homes, clinics, labs and hospitals, amidst uncoordinated providers with divergent and often competing practices, in settings lacking material, money and human resources. We identified three overarching themes affecting point-of-care testing: the main theme is 'relationships' among providers and between providers and patients, influenced by the cross-cutting theme of 'infrastructure'. Challenges with both result in 'modified practices' often favouring empirical (symptomatic treatment over treatment guided by testing.Even if tests can be conducted on the spot and infrastructure challenges have been resolved, relationships among providers and between patients and providers are crucial for successful point-of-care testing. Furthermore, these barriers do not act in isolation, but are interlinked and need to be examined as such. Also, a test alone has only
Harrenstien, Lisa A; Tornquist, Susan J; Miller-Morgan, Timothy J; Fodness, Brian G; Clifford, Kevin E
To compare values of blood parameters in rockfish obtained by use of a point-of-care portable blood analyzer with values determined by a veterinary diagnostic laboratory, calculate reference ranges for various blood parameters in black rockfish, and compare values of blood parameters in clinically normal fish with those of fish with clinical abnormalities. Prospective study. 41 captive adult black rockfish (Sebastes melanops) and 4 captive adult blue rockfish (Sebastes mystinus). Rockfish were anesthetized with tricaine methanesulfonate for collection of blood samples. Heparinized blood samples were immediately analyzed with a point-of-care analyzer. Blood sodium, potassium, chloride, urea nitrogen, and glucose concentrations; Hct; pH; partial pressure of carbon dioxide; total carbon dioxide concentration; bicarbonate concentration; base excess; and hemoglobin concentration were determined. A microhematocrit technique was used to determine PCV, and a refractometer was used to estimate total plasma protein concentration. Paired heparinized blood samples were transported to a veterinary diagnostic laboratory for analyses. Data obtained with the point-of-care analyzer were reproducible; however, values for most blood parameters were significantly different from those obtained by the veterinary diagnostic laboratory. Fish with poor body condition had several blood parameter values that were lower than corresponding values in clinically normal fish. Point-of-care blood analyses may prove useful in rockfish. Point-of-care data for a large number of clinically normal fish must be obtained for reference ranges to be calculated, and further assessments of clinically abnormal fish are necessary to determine the relevance of the data.
Jousi, Milla; Saikko, Simo; Nurmi, Jouni
Point-of-care (POC) testing is highly useful when treating critically ill patients. In case of difficult vascular access, the intraosseous (IO) route is commonly used, and blood is aspirated to confirm the correct position of the IO-needle. Thus, IO blood samples could be easily accessed for POC analyses in emergency situations. The aim of this study was to determine whether IO values agree sufficiently with arterial values to be used for clinical decision making. Two samples of IO blood were drawn from 31 healthy volunteers and compared with arterial samples. The samples were analysed for sodium, potassium, ionized calcium, glucose, haemoglobin, haematocrit, pH, blood gases, base excess, bicarbonate, and lactate using the i-STAT® POC device. Agreement and reliability were estimated by using the Bland-Altman method and intraclass correlation coefficient calculations. Good agreement was evident between the IO and arterial samples for pH, glucose, and lactate. Potassium levels were clearly higher in the IO samples than those from arterial blood. Base excess and bicarbonate were slightly higher, and sodium and ionised calcium values were slightly lower, in the IO samples compared with the arterial values. The blood gases in the IO samples were between arterial and venous values. Haemoglobin and haematocrit showed remarkable variation in agreement. POC diagnostics of IO blood can be a useful tool to guide treatment in critical emergency care. Seeking out the reversible causes of cardiac arrest or assessing the severity of shock are examples of situations in which obtaining vascular access and blood samples can be difficult, though information about the electrolytes, acid-base balance, and lactate could guide clinical decision making. The analysis of IO samples should though be limited to situations in which no other option is available, and the results should be interpreted with caution, because there is not yet enough scientific evidence regarding the agreement of IO
Maslow, Andrew; Bert, Arthur; Singh, Arun; Sweeney, Joseph
Point-of-care (POC) testing allows rapid assessment of hemoglobin (Hgb) and hematocrit (Hct) values. This study compared 3 POC testing devices--the Radical-7 pulse oximeter (Radical-7, Neuchȃtel, Switzerland), the i-STAT (Abbott Point of Care, Princeton, NJ), and the GEM 4000 (Instrumentation Laboratory, Bedford, MA)--to the hospital reference device, the UniCel DxH 800 (Beckman Coulter, Brea, CA) in cardiac surgery patients. Prospective study. Tertiary care cardiovascular center. Twenty-four consecutive elective adult cardiac surgery patients. Hgb and Hct values were measured using 3 POC devices (the Radical-7, i-STAT, and GEM 4000) and a reference laboratory device (UniCel DxH 800). Data were collected simultaneously before surgery, after heparin administration, after heparin reversal with protamine, and after sternal closure. Data were analyzed using bias analyses. POC testing data were compared with that of the reference laboratory device. Hgb levels ranged from 6.8 to 15.1 g/dL, and Hct levels ranged from 20.1% to 43.8%. The overall mean bias was lowest with the i-STAT (Hct, 0.22%; Hgb 0.05 g/dL) compared with the GEM 4000 (Hct, 2.15%; Hgb, 0.63 g/dL) and the Radical-7 (Hgb 1.16 g/dL). The range of data for the i-STAT and Radical-7 was larger than that with the GEM 4000, and the pattern or slopes changed significantly with the i-STAT and Radical-7, whereas that of the GEM 4000 remained relatively stable. The GEM 4000 demonstrated a consistent overestimation of laboratory data, which tended to improve after bypass and at lower Hct/Hgb levels. The i-STAT bias changed from overestimation to underestimation, the latter in the post-cardiopulmonary bypass period and at lower Hct/Hgb levels. By contrast, the Radical-7 biases increased during the surgical procedure and in the lower ranges of Hgb. Important clinical differences and limitations were found among the 3 POC testing devices that should caution clinicians from relying on these data as sole determinants of
Ren, Xiang; Yan, Junrong; Wu, Dan; Wei, Qin; Wan, Yakun
Alzheimer's disease (AD) biomarkers can reflect the neurochemical indicators used to estimate the risk in clinical nephrology. Apolipoprotein E (ApoE) is an early biomarker for AD in clinical diagnosis. In this research, through bactrian camel immunization, lymphocyte isolation, RNA extraction, and library construction, ApoE-specific Nbs with high affinity were successfully separated from an immune phage display nanobody library. Herein, a colorimetric immunosensor was developed for the point-of-care testing of ApoE by layer-by-layer nanoassembly techniques and novel nanobodies (Nbs). Using highly oriented Nbs as the capture and detection antibodies, an on-site immunosensor was developed by detecting the mean gray value of fade color due to the glutaraldehyde@3-aminopropyltrimethoxysilane oxidation by H 2 O 2 . The detection limit of AopE is 0.42 pg/mL, and the clinical analysis achieves a good performance. The novel easily operated immunosensor may have potential application in the clinical diagnosis and real-time monitoring for AD.
Kazura, Evan; Lubbers, Brad R; Dawson, Elliott; Phillips, John A; Baudenbacher, Franz
Point of care (POC) diagnostics represents one of the fastest growing health care technology segments. Developments in microfabrication have led to the development of highly-sensitive nanocalorimeters ideal for directly measuring heat generated in POC biosensors. Here we present a novel nano-calorimeter-based biosensor design with differential sensing to eliminate common mode noise and capillary microfluidic channels for sample delivery to the thermoelectric sensor. The calorimeter has a resolution of 1.4 ± 0.2 nJ/(Hz) 1/2 utilizing a 27 junction bismuth/titanium thermopile, with a total Seebeck coefficient of 2160 μV/K. Sample is wicked to the calorimeter through a capillary channel making it suitable for monitoring blood obtained through a finger prick (performance in a model assay using catalase, achieving a threshold for hydrogen peroxide quantification of 50 μM. The potential for our device as a POC blood test for metabolic diseases is shown through the quantification of phenylalanine (Phe) in serum, an unmet necessary service in the management of Phenylketonuria (PKU). Pegylated phenylalanine ammonia-lyase (PEG-PAL) was utilized to react with Phe, but reliable detection was limited to <5 mM due to low enzymatic activity. The POC biosensor concept can be multiplexed and adapted to a large number of metabolic diseases utilizing different immobilized enzymes.
Smith, Andrew; Parsons, Michael; Renouf, Tia; Boyd, Sarah; Rogers, Peter
Point of Care Ultrasound (PoCUS) is well established within emergency medicine, however, the availability of formal training for other clinical disciplines is limited. Memorial University has established a cost-efficient, multidisciplinary PoCUS training program focusing on training residents' discipline-specific ultrasound skills. This study evaluates the skills, knowledge, and attitudes of residents who participated in the program. Analysis was conducted using a mixed-methods, sequential exploratory approach. Initially, a focus group of seven first year residents was conducted to generate themes that were used to guide development of a survey administered to residents over a two-year period. Thirty residents responded to the survey (response rate 63.8%) with 53.3% meeting the training requirements for focused assessment using sonography in trauma, 43.3% for pleural effusion, 40.0% for aortic aneurysms, and 40.0% for cardiac scans. Early pregnancy assessment was the skill of least interest with 46.6% not interested. Over half the residents (53.6%) agreed or strongly agreed that a multidisciplinary program met their needs while 21.4% disagreed. The focus group found the multidisciplinary approach adequate. A single PoCUS curriculum has been shown to meet the needs and expectations of a majority of residents from multiple disciplines. It can enhance collaboration and bridge gaps between increasingly compartmentalized practices of medicine.
Ereku, Luck Tosan; Mackay, Ruth E; Craw, Pascal; Naveenathayalan, Angel; Stead, Thomas; Branavan, Manorharanehru; Balachandran, Wamadeva
A point of care device utilising Lab-on-a-Chip technologies that is applicable for biological pathogens was designed, fabricated and tested showing sample in to answer out capabilities. The purpose of the design was to develop a cartridge with the capability to perform nucleic acid extraction and purification from a sample using a chitosan membrane at an acidic pH. Waste was stored within the cartridge with the use of sodium polyacrylate to solidify or gelate the sample in a single chamber. Nucleic acid elution was conducted using the RPA amplification reagents (alkaline pH). Passive valves were used to regulate the fluid flow and a multiplexer was designed to distribute the fluid into six microchambers for amplification reactions. Cartridges were produced using soft lithography of silicone from 3D printed moulds, bonded to glass substrates. The isothermal technique, RPA is employed for amplification. This paper shows the results from two separate experiments: the first using the RPA control nucleic acid, the second showing successful amplification from Chlamydia Trachomatis. Endpoint analysis conducted for the RPA analysis was gel electrophoresis that showed 143 base pair DNA was amplified successfully for positive samples whilst negative samples did not show amplification. End point analysis for Chlamydia Trachomatis samples was fluorescence detection that showed successful detection of 1 copy/μL and 10 copies/μL spiked in a MES buffer. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.
Boaz, Mona; Matas, Zipora; Chaimy, Tova; Landau, Zohar; Bar Dayan, Yosefa; Berlovitz, Yitzhak; Wainstein, Julio
Acute physiological stress has been shown to impair glucose homeostasis. War is a period of acute psychological stress, and its effect on glucose control is unknown. In this study random point-of-care (POC) glucose levels were measured using an automated, institutional glucometer in hospitalized adult patients prior to versus during the Israeli Pillar of Defense campaign (November 7-10, 2012). Random POC glucose values measured with the institutional blood glucose monitoring system were obtained 1 week prior to the Pillar of Defense campaign (November 7-10, 2012) and compared with values to those obtained during the first 4 days of the war (November 14-17, 2012). In total, 3,573 POC glucose measures were included: 1,865 during the pre-war period and 1,708 during the campaign. POC glucose measures were significantly higher during the war compared with the week preceding the war: 9.7±4.7 versus 9.3±4.2 mmol/L (P=0.02). In a general linear model, period (pre-war vs. during war) persisted as a significant predictor of POC glucose even after controlling for age, sex, and department type (internal medicine vs. surgical). Acute stress, such as a wartime situation, is associated with a significant increase in random blood glucose values in a population of hospitalized adults. Long-term follow-up of the individuals hospitalized during these two periods can reveal differences in morbidity and mortality trends.
Kanakasabapathy, Manoj Kumar; Sadasivam, Magesh; Singh, Anupriya; Preston, Collin; Thirumalaraju, Prudhvi; Venkataraman, Maanasa; Bormann, Charles L.; Draz, Mohamed Shehata; Petrozza, John C.; Shafiee, Hadi
Male infertility affects up to 12% of the world’s male population and is linked to various environmental and medical conditions. Manual microscope-based testing and computer-assisted semen analysis (CASA) are the current standard methods to diagnose male infertility; however, these methods are labor-intensive, expensive, and laboratory-based. Cultural and socially dominated stigma against male infertility testing hinders a large number of men from getting tested for infertility, especially in resource-limited African countries. We describe the development and clinical testing of an automated smartphone-based semen analyzer designed for quantitative measurement of sperm concentration and motility for point-of-care male infertility screening. Using a total of 350 clinical semen specimens at a fertility clinic, we have shown that our assay can analyze an unwashed, unprocessed liquefied semen sample with smartphone capabilities, can make remote semen quality testing accessible to people in both developed and developing countries who have access to smartphones. PMID:28330865
Full Text Available Limited adoption of mobile technology for informal learning and continuing professional development within Australian healthcare environments has been explained primarily as an issue of insufficient digital and ehealth literacy of healthcare professionals. This study explores nurse supervisors’ use of mobile technology for informal learning and continuing professional development both for their own professional practice, and in their role in modelling digital knowledge transfer, by facilitating the learning and teaching of nursing students in the workplace. A convenience sample of 27 nurse supervisors involved with guiding and supporting undergraduate nurses participated in one of six focus groups held in two states of Australia. Expanding knowledge emerged as the key theme of importance to this group of clinicians. Although nurse supervisors regularly browsed Internet sources for learning and teaching purposes, a mixed understanding of the mobile learning activities that could be included as informal learning or part of formal continuing professional development was detected. Participants need educational preparation and access to mobile learning opportunities to improve and maintain their digital and ehealth literacy to appropriately model digital professionalism with students. Implementation of mobile learning at point of care to enable digital knowledge transfer, augment informal learning for students and patients, and support continuing professional development opportunities is necessary. Embedding digital and ehealth literacy within nursing curricula will promote mobile learning as a legitimate nursing function and advance nursing practice.
Devadhasan, Jasmine P.; Kim, Sanghyo
Complementary metal oxide semiconductor (CMOS) image sensors are received great attention for their high efficiency in biological applications. The present work describes a CMOS image sensor-based whole blood glucose monitoring system through a point-of-care (POC) approach. A simple poly-ethylene terephthalate (PET) film chip was developed to carry out the enzyme kinetic reaction at various concentrations of blood glucose. In this technique, assay reagent was adsorbed onto amine functionalized silica (AFSiO2) nanoparticles in order to achieve glucose oxidation on the PET film chip. The AFSiO2 nanoparticles can immobilize the assay reagent with an electrostatic attraction and eased to develop the opaque platform which was technically suitable chip to analyze by the camera module. The oxidized glucose then produces a green color according to the glucose concentration and is analyzed by the camera module as a photon detection technique. The photon number decreases with increasing glucose concentration. The simple sensing approach, utilizing enzyme immobilized AFSiO2 nanoparticle chip and assay detection method was developed for quantitative glucose measurement.
Brannelly, N T; Killard, A J
The level of ammonia in blood is relevant in a number of medical conditions. While ammonia is a marker of dysfunction, elevated ammonia is itself a serious medical emergency and can lead to significant and permanent neurological impairment if not addressed quickly. Blood ammonia testing is typically performed in the central laboratory. While a number of point of care devices have been developed, these are based on classical enzymatic or colorimetric principles and have not been widely adopted. In this work, an electrochemical sensor device was developed for measuring blood ammonia. The device was based on the deposition of polyaniline nanoparticle films onto screen printed interdigitated electrodes using inkjet printing and their integration into a polymer microfabricated device with a polytetrafluoroethylene membrane. The device required a 52µL serum sample and measured the change in impedance of the sensor with respect to air at 1kHz, 5mV rms. The device was capable of the measurement of ammonia in serum across the physiologically relevant range of 25-200µM (r 2 =0.9984) and had a limit of detection of 12µM (n =3). The device showed no significant issues with common electrochemical interferences in blood. The device was also validated against a commercial spectrophotometric assay which resulted in excellent correlation (r =0.9699, pair (n =12) and could be stored in desiccant for at least five months. Copyright © 2017 Elsevier B.V. All rights reserved.
Coarsey, Chad T; Esiobu, Nwadiuto; Narayanan, Ramswamy; Pavlovic, Mirjana; Shafiee, Hadi; Asghar, Waseem
Ebola virus disease (EVD) is a devastating, highly infectious illness with a high mortality rate. The disease is endemic to regions of Central and West Africa, where there is limited laboratory infrastructure and trained staff. The recent 2014 West African EVD outbreak has been unprecedented in case numbers and fatalities, and has proven that such regional outbreaks can become a potential threat to global public health, as it became the source for the subsequent transmission events in Spain and the USA. The urgent need for rapid and affordable means of detecting Ebola is crucial to control the spread of EVD and prevent devastating fatalities. Current diagnostic techniques include molecular diagnostics and other serological and antigen detection assays; which can be time-consuming, laboratory-based, often require trained personnel and specialized equipment. In this review, we discuss the various Ebola detection techniques currently in use, and highlight the potential future directions pertinent to the development and adoption of novel point-of-care diagnostic tools. Finally, a case is made for the need to develop novel microfluidic technologies and versatile rapid detection platforms for early detection of EVD.
Mendez, Ivar; Song, Michael; Chiasson, Paula; Bustamante, Luis
The expansion of neuromodulation and its indications has resulted in hundreds of thousands of patients with implanted devices worldwide. Because all patients require programming, this growth has created a heavy burden on neuromodulation centers and patients. Remote point-of-care programming may provide patients with real-time access to neuromodulation expertise in their communities. To test the feasibility of remotely programming a neuromodulation device using a remote-presence robot and to determine the ability of an expert programmer to telementor a nonexpert in programming the device. A remote-presence robot (RP-7) was used for remote programming. Twenty patients were randomly assigned to either conventional programming or a robotic session. The expert remotely mentored 10 nurses with no previous experience to program the devices of patients assigned to the remote-presence sessions. Accuracy of programming, adverse events, and satisfaction scores for all participants were assessed. There was no difference in the accuracy or clinical outcomes of programming between the standard and remote-presence sessions. No adverse events occurred in any session. The patients, nurses, and the expert programmer expressed high satisfaction scores with the remote-presence sessions. This study establishes the proof-of-principle that remote programming of neuromodulation devices using telepresence and expert telementoring of an individual with no previous experience to accurately program a device is feasible. We envision a time in the future when patients with implanted devices will have real-time access to neuromodulation expertise from the comfort of their own home.
Kimura, Bruce J
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. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Drain, Paul K; Hyle, Emily P; Noubary, Farzad; Freedberg, Kenneth A; Wilson, Douglas; Bishai, William; Rodriguez, William; Bassett, Ingrid V
Diagnostic point-of-care (POC) testing is intended to minimize the time to obtain a test result, thereby allowing clinicians and patients to make an expeditious clinical decision. As POC tests expand into resource-limited settings (RLS), the benefits must outweigh the costs. To optimize POC testing in RLS, diagnostic POC tests need rigorous evaluations focused on relevant clinical outcomes and operational costs, which differ from evaluations of conventional diagnostic tests. Here, we reviewed published studies on POC testing in RLS, and found no clearly defined metric for the clinical utility of POC testing. Therefore, we propose a framework for evaluating POC tests, and suggest and define the term “test efficacy” to describe a diagnostic test’s capacity to support a clinical decision within its operational context. We also proposed revised criteria for an ideal diagnostic POC test in resource-limited settings. Through systematic evaluations, comparisons between centralized diagnostic testing and novel POC technologies can be more formalized, and health officials can better determine which POC technologies represent valuable additions to their clinical programs. PMID:24332389
Berner, Marcel; Hilbig, Urs; Schubert, Markus B.; Gauglitz, Günter
Point-of-care testing (POCT) devices for continuous low-cost monitoring of critical patient parameters require miniaturized and integrated setups for performing quick high-sensitivity analyses, away from central clinical laboratories. This work presents a novel and promising laser-induced fluorescence platform for measurements in direct optical test formats that leads towards such powerful POCT devices based on fluorescence-labeled immunoassays. Ultimate sensitivity of thin film photodetectors, integrated with microfluidics, and a comprehensive optimization of all system components aim at low-level signal detection in the targeted biosensor application. The setup acquires fluorescence signals from the volume of a microfluidic channel. An innovative sandwiching process forms a flow channel in the microfluidic chips by embedding laser-cut double-sided adhesive tapes. The custom fit of amorphous silicon based photodiode arrays to the geometry of the flow channel enables miniaturization, fully adequate for POCT devices. A free-beam laser excitation with line focus provides excellent alignment stability, allows for easy and reliable swapping of the disposable microfluidic chips, and therewith greatly improves the ease of use of the resulting integrated device. As a proof-of-concept of this novel in-volume measurement approach, the limit of detection for the dye DY636-COOH in pure water as a model fluorophore is examined and found to be 26 nmol l-1 .
Marks, Haley; Schechinger, Monika; Garza, Javier; Locke, Andrea; Coté, Gerard
Point-of-care (POC) device development is a growing field that aims to develop low-cost, rapid, sensitive in-vitro diagnostic testing platforms that are portable, self-contained, and can be used anywhere - from modern clinics to remote and low resource areas. In this review, surface enhanced Raman spectroscopy (SERS) is discussed as a solution to facilitating the translation of bioanalytical sensing to the POC. The potential for SERS to meet the widely accepted "ASSURED" (Affordable, Sensitive, Specific, User-friendly, Rapid, Equipment-free, and Deliverable) criterion provided by the World Health Organization is discussed based on recent advances in SERS in vitro assay development. As SERS provides attractive characteristics for multiplexed sensing at low concentration limits with a high degree of specificity, it holds great promise for enhancing current efforts in rapid diagnostic testing. In outlining the progression of SERS techniques over the past years combined with recent developments in smart nanomaterials, high-throughput microfluidics, and low-cost paper diagnostics, an extensive number of new possibilities show potential for translating SERS biosensors to the POC.
Lam, Hugh S; Chan, Michael H M; Ng, Pak C; Wong, William; Cheung, Robert C K; So, Alan K W; Fok, Tai F; Lam, Christopher W K
To investigate clinically significant analytical interference in point-of-care electrolyte analysis caused by contamination of blood specimens with hand disinfectant. Six different hand hygiene products were added separately to heparinised blood samples in varying amounts as contaminant. The contaminated samples were analysed by three different blood gas and electrolyte analysers for assessing interference on measured whole blood sodium and potassium concentrations. There were significant analytical interferences caused by hand hygiene product contamination that varied depending on the combination of disinfectant and analyser. Small amounts of Microshield Antibacterial Hand Gel contamination caused large increases in measured sodium concentration. Such effect was much greater compared with the other five products tested, and started to occur at much lower levels of contamination. There was a trend towards lower sodium results in blood samples contaminated with Hexol Antiseptic Lotion (Hexol), the hand hygiene product that we used initially. Apart from AiE Hand Sanitizer, all the other hand disinfectants, especially Hexol, significantly elevated the measured potassium concentration, particularly when a direct ion-selective electrode method was used for measurement. Hand disinfectant products can significantly interfere with blood electrolyte analysis. Proper precautions must be taken against contamination since the resultant errors can adversely affect the clinical management of patients.
Castellanos-Gonzalez, Alejandro; Saldarriaga, Omar A.; Tartaglino, Lilian; Gacek, Rosana; Temple, Elissa; Sparks, Hayley; Melby, Peter C.; Travi, Bruno L.
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
Walczak, Rafał; Krüger, Jan; Moynihan, Shane
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.
Joubert, J; van Zyl, M C; Raubenheimer, J
Point-of-care International Normalised Ratio (INR) testing is used frequently. We evaluated the microINR ® POC system for accuracy, precision and measurement repeatability, and investigated instrument and test chip variability and error rates. Venous blood INRs of 210 patients on warfarin were obtained with Thromborel ® S on the Sysmex CS-2100i ® analyser and compared with capillary blood microINR ® values. Precision was assessed using control materials. Measurement repeatability was calculated on 51 duplicate finger-prick INRs. Triplicate finger-prick INRs using three different instruments (30 patients) and three different test chip lots (29 patients) were used to evaluate instrument and test chip variability. Linear regression analysis of microINR ® and Sysmex CS2100i ® values showed a correlation coefficient of 0.96 (P < .0001) and a positive proportional bias of 4.4%. Dosage concordance was 93.8% and clinical agreement 95.7%. All acceptance criteria based on ISO standard 17593:2007 system accuracy requirements were met. Control material coefficients of variation (CV) varied from 6.2% to 16.7%. The capillary blood measurement repeatability CV was 7.5%. No significant instrument (P = .93) or test chip (P = .81) variability was found, and the error rate was low (2.8%). The microINR ® instrument is accurate and precise for monitoring warfarin therapy. © 2017 John Wiley & Sons Ltd.
Zuluaga, Andres F.; Pierce, Mark C.; MacAulay, Calum E.
Cytology tests, whether performed on body fluids, aspirates, or scrapings are commonly used to detect, diagnose, and monitor a wide variety of health conditions. Complete blood counts (CBCs) quantify the number of red and white blood cells in a blood volume, as well as the different types of white blood cells. There is a critical unmet need for an instrument that can perform CBCs at the point of care (POC), and there is currently no product in the US that can perform this test at the bedside. We have developed a system that is capable of tomographic images with sub-cellular resolution with consumer-grade broadband (LED) sources and CMOS detectors suitable for POC implementation of CBC tests. The systems consists of cascaded static Michelson and Sagnac interferometers that map phase (encoding depth) and a transverse spatial dimension onto a two-dimensional output plane. Our approach requires a 5 microliter sample, can be performed in 5 minutes or less, and does not require staining or other processing as it relies on intrinsic contrast. We will show results directly imaging and differentiating unstained blood cells using supercontinuum fiber lasers and LEDs as sources and CMOS cameras as sensors. We will also lay out the follow up steps needed, including image segmentation, analysis and classification, to verify performance and advance toward CBCs that can be performed bedside and do not require CLIA-certified laboratories.
Inan, Hakan; Poyraz, Muhammet; Inci, Fatih; Lifson, Mark A; Baday, Murat; Cunningham, Brian T; Demirci, Utkan
Biosensors are extensively employed for diagnosing a broad array of diseases and disorders in clinical settings worldwide. The implementation of biosensors at the point-of-care (POC), such as at primary clinics or the bedside, faces impediments because they may require highly trained personnel, have long assay times, large sizes, and high instrumental cost. Thus, there exists a need to develop inexpensive, reliable, user-friendly, and compact biosensing systems at the POC. Biosensors incorporated with photonic crystal (PC) structures hold promise to address many of the aforementioned challenges facing the development of new POC diagnostics. Currently, PC-based biosensors have been employed for detecting a variety of biotargets, such as cells, pathogens, proteins, antibodies, and nucleic acids, with high efficiency and selectivity. In this review, we provide a broad overview of PCs by explaining their structures, fabrication techniques, and sensing principles. Furthermore, we discuss recent applications of PC-based biosensors incorporated with emerging technologies, including telemedicine, flexible and wearable sensing, smart materials and metamaterials. Finally, we discuss current challenges associated with existing biosensors, and provide an outlook for PC-based biosensors and their promise at the POC.
Kumar, Suveen; Kumar, Saurabh; Ali, Md Azahar; Anand, Pinki; Agrawal, Ved Varun; John, Renu; Maji, Sagar; Malhotra, Bansi D
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. Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Huddy, Jeremy R; Ni, Melody Z; Markar, Sheraz R; Hanna, George B
Point-of-care (POC) tests enable rapid results and are well established in medical practice. Recent advances in analytical techniques have led to a new generation of POC devices that will alter gastrointestinal diagnostic pathways. This review aims to identify current and new technologies for the POC diagnosis of gastrointestinal cancer. A structured search of the Embase and Medline databases was performed. Papers reporting diagnostic tests for gastrointestinal cancer available as a POC device or containing a description of feasibility for POC application were included. Studies recovered were heterogeneous and therefore results are presented as a narrative review. Six diagnostic methods were identified (fecal occult blood, fecal proteins, volatile organic compounds, pyruvate kinase isoenzyme type M2, tumour markers and DNA analysis). Fecal occult blood testing has a reported sensitivity of 66%-85% and specificity greater than 95%. The others are at a range of development and clinical application. POC devices have a proven role in the diagnosis of gastrointestinal cancer. Barriers to their implementation exist and the transition from experimental to clinical medicine is currently slow. New technologies demonstrate potential to provide accurate POC tests and an ability to diagnose gastrointestinal cancer at an early stage with improved clinical outcome and survival.
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.
Gallagher, Rachel A; Levy, Jason A
Point-of-care ultrasound (POCUS) has become an integral part of emergency medicine practice. Research evaluating POCUS in the care of pediatric patients has improved the understanding of its potential role in clinical care. Recent work has investigated the ability of pediatric emergency medicine (PEM) physicians to perform a wide array of diagnostic and procedural applications in POCUS ultrasound. Studies have demonstrated that PEM providers are able to identify an array of diseases, including intussusception, pyloric stenosis and appendicitis. Novel applications of ultrasound, such as a cardiac evaluation in the acutely ill patient or identification of skull fractures in the assessment of a patient with head injury, have shown excellent promise in recent studies. These novel applications have the potential to reshape pediatric diagnostic algorithms. Key applications in PEM have been investigated in the recent publications. Further exploration of the ability to integrate ultrasound into routine practice will require larger-scale studies and continued growth of education in the field. The use of ultrasound in clinical practice has the potential to improve safety and efficiency of care in the pediatric emergency department.
Weigl, Bernhard H; Gaydos, Charlotte A; Kost, Gerald; Beyette, Fred R; Sabourin, Stephanie; Rompalo, Anne; de Los Santos, Tala; McMullan, Jason T; Haller, John
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.
Hu, Wei-Cai; Xu, Lei; Zhang, Quan; Wei, Li; Zhang, Wei
This study was designed to assess the accuracy of point-of-care ultrasound in determining the position of double-lumen tubes (DLTs).A total of 103 patients who required DLT intubation were enrolled into the study. After DLTs were tracheal intubated in the supine position, an auscultation researcher and ultrasound researcher were sequentially invited in the operating room to conduct their evaluation of the DLT. After the end of their evaluation, fiberscope researchers (FRs) were invited in the operating room to evaluate the position of DLT using a fiberscope. After the patients were changed to the lateral position, the same evaluation process was repeated. These 3 researchers were blind to each other when they made their conclusions. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were obtained by statistical analysis.When left DLTs (LDLTs) were used, the accuracy of ultrasound (84.2% [72.1%, 92.5%]) was higher than the accuracy of auscultation (59.7% [45.8%, 72.4%]) (P auscultation (67.4% [52.0%, 80.5%]) (P auscultation (54.4% [40.7%, 67.6%]) (P auscultation (47.8% [32.9%, 63.1%]) (P auscultation in determining the position of DLTs.
Özkan, Behzat; Ünlüer, Erden E; Akyol, Pinar Y; Karagöz, Arif; Bayata, Mehmet S; Akoğlu, Haldun; Oyar, Orhan; Dalli, Ayşe; Topal, Fatih E
We aimed to determine the accuracies of point-of-care ultrasound (PoCUS) and stethoscopes as part of the physical examinations of patients with dyspnea. Three emergency medicine specialists in each of two groups of ultrasound and stethoscope performers underwent didactic and hands-on training on PoCUS and stethoscope usage. All the patients enrolled were randomized to one of two predetermined PoCUS or stethoscope groups. The diagnostic performance of ultrasonography was higher than that of the stethoscope in the diagnoses of heart failure (90 vs. 86%, 1.00 vs. 0.89, and 5.00 vs. 4.92, respectively) and pneumonia (90 vs. 86.7%, 0.75 vs. 0.73, and 16.50 vs. 13.82, respectively). No significant differences were observed in the utility parameters of these modalities in these diagnoses. Although some authors argue that it is time to abandon the 'archaic tools' of past centuries, we believe that it is too early to discontinue the use of the stethoscope.
Sandstrom, Paul; Denny, Thomas N.; Hurlston, Mackenzie; Ball, Terry B.; Peeling, Rosanna W.; Boeras, Debrah I.
In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of people infected with HIV to become aware of their status, access antiretroviral therapies and ultimately be virally suppressed. To achieve these goals, countries may need to scale up point-of-care (POC) testing in addition to strengthening central laboratory services. While decentralising testing increases patient access to diagnostics, it presents many challenges with regard to training and assuring the quality of tests and testing. To ensure synergies, the London School of Hygiene & Tropical Medicine held a series of consultations with countries with an interest in quality assurance and their implementing partners, and agreed on an external quality assessment (EQA) programme to ensure reliable results so that the results lead to the best possible care for HIV patients. As a result of the consultations, EQA International was established, bringing together EQA providers and implementers to develop a strategic plan for countries to establish national POC EQA programmes and to estimate the cost of setting up and maintaining the programme. With the dramatic increase in the number of proficiency testing panels required for thousands of POC testing sites across Africa, it is important to facilitate technology transfer from global EQA providers to a network of regional EQA centres in Africa for regional proficiency testing panel production. EQA International will continue to identify robust and cost-effective EQA technologies for quality POC testing, integrating novel technologies to support sustainable country-owned EQA programmes in Africa. PMID:28879133
Sasha Herbst de Cortina
Full Text Available Objectives. Systematic review of point of care (POC diagnostic tests for sexually transmitted infections: Chlamydia trachomatis (CT, Neisseria gonorrhoeae (NG, and Trichomonas vaginalis (TV. Methods. Literature search on PubMed for articles from January 2010 to August 2015, including original research in English on POC diagnostics for sexually transmitted CT, NG, and/or TV. Results. We identified 33 publications with original research on POC diagnostics for CT, NG, and/or TV. Thirteen articles evaluated test performance, yielding at least one test for each infection with sensitivity and specificity ≥90%. Each infection also had currently available tests with sensitivities <60%. Three articles analyzed cost effectiveness, and five publications discussed acceptability and feasibility. POC testing was acceptable to both providers and patients and was also demonstrated to be cost effective. Fourteen proof of concept articles introduced new tests. Conclusions. Highly sensitive and specific POC tests are available for CT, NG, and TV, but improvement is possible. Future research should focus on acceptability, feasibility, and cost of POC testing. While pregnant women specifically have not been studied, the results available in nonpregnant populations are encouraging for the ability to test and treat women in antenatal care to prevent adverse pregnancy and neonatal outcomes.
Shiparski, Laurie; Authier, Philip
Frontline managers in health care are the keepers of culture, the gateway to evoking a grass roots intelligence network, and they hold a pivotal role in advancing innovation at the point of care. Their roles are ever expanding and include knowledge and skills in managing the business, leading the people, and advancing their own leadership development. In all 3 areas, the impact of their leadership exponentially increases if they maximize innovative thinking and action. Health care executives need to establish the expectations for an innovative culture and the role of frontline managers. They must model the behaviors they promote and take the time to develop these frontline managers who are the hub for innovative success in the organization. This article offers insights and practical applications while exploring the innovation keystones of the following: creating an organizational culture of innovation, igniting collaboration that fuels diverse thinking and creativity, utilizing meaningful data to drive innovative decisions, and assessing and monitoring the ongoing climate and outcomes of innovation.
Nguyen, J; Cascione, M; Noori, S
Point-of-care ultrasonography (POCUS) is becoming increasingly available for neonatologists and pediatric subspecialists (PSS); however, concerns over potential litigation from possible missed diagnoses or incorrect management have been documented. This study aims to define the extent and quality of lawsuits filed against neonatologists and PSS related to POCUS. We conducted a retrospective study of all United States reported state and federal cases in the Westlaw database from January 1990 through October 2015. Cases were reviewed and included if either a neonatologist or PSS were accused of misconduct or the interpretation or failure to perform an ultrasound/echocardiogram was discussed. Descriptive statistics were used to evaluate the data. Our search criteria returned 468 results; 2 cases were determined to be relevant to the study objective. The two cases alleged a failure to perform a diagnostic test and implicated POCUS as an option. There were no cases of neonatologists and PSS being sued for POCUS performance or interpretation. This study of a major legal database suggests that POCUS use and interpretation is not a significant cause of lawsuits against neonatologists and PSS.
Full Text Available Point-of-care (POC testing for chlamydia (CT and gonorrhoea (NG offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings.In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise.Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection.The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines.
Natoli, Lisa; Maher, Lisa; Shephard, Mark; Hengel, Belinda; Tangey, Annie; Badman, Steven G.; Ward, James; Guy, Rebecca J.
Objectives Point-of-care (POC) testing for chlamydia (CT) and gonorrhoea (NG) offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs) in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings. Methods In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise. Results Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection. Conclusions The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines. PMID:24956111
Tientadakul, P; Chuntarut, A
Effective warfarin therapy management has gained national interest, resulting in the increased use of point-of-care testing (POCT) for international normalized ratio (INR). External quality assessment (EQA) is recommended to ensure quality of the testing. CoaguChek XS and CoaguChek XS Plus are the only commonly available POCT INR monitors in Thailand. Therefore, Thailand NEQAS for Blood Coagulation initiated the scheme for POCT INR in 2013, including only hospitals using these devices. Questionnaires were sent to the hospitals, enquiring about their interest in EQA participation. Two surveys were distributed; each included five certified European Concerted Action on Anticoagulation (ECAA) INR plasma sets. Unsatisfactory performance was indicated by a 15% deviation from the certified mean INR value. There were 156 hospitals using the devices. Thirty-five hospitals responded to the questionnaires. Medical personnel undertaking POCT INR were limited to laboratory staff in 29 (83%) of these centers, and 31 hospitals actually participated. The medians of results from participants were the same or nearly the same as the certified mean INRs. External quality assessment for POCT INR in Thailand is feasible using the ECAA plasmas as control materials. The results therefore appear encouraging to other developing countries to establish their own EQA schemes. © 2014 John Wiley & Sons Ltd.
Fahy, Brenda G
Technology advances continue to impact patient care and physician workflow. To enable more efficient performance of billing activities, a point-of-care (POC) handheld computer technology replaced a paper-based system on an acute pain management service. Using a handheld personal digital assistant (PDA) and software from MDeverywhere (MDe, MDeverywhere, Long Island, NY), we performed a 1-yr prospective observational study of an anesthesiology acute pain management service billings and collections. Seventeen anesthesiologists providing billable acute pain services were trained and entered their charges on a PDA. Twelve months of data, just before electronic implementation (pre-elec), were compared to a 12-m period after implementation (post-elec). The total charges were 4883 for 890 patients pre-elec and 5368 for 1128 patients post-elec. With adoption of handheld billing, the charge lag days decreased from 29.3 to 7.0 (P billing using PDAs to replace a paper-based billing system improved the collection rate and decreased the number of charge lag days with a positive return on investment. The handheld PDA billing system provided POC support for physicians during their daily clinical (e.g., patient locations, rounding lists) and billing activities, improving workflow.
Full Text Available Point-of-care (POC device development is a growing field that aims to develop low-cost, rapid, sensitive in-vitro diagnostic testing platforms that are portable, self-contained, and can be used anywhere – from modern clinics to remote and low resource areas. In this review, surface enhanced Raman spectroscopy (SERS is discussed as a solution to facilitating the translation of bioanalytical sensing to the POC. The potential for SERS to meet the widely accepted “ASSURED” (Affordable, Sensitive, Specific, User-friendly, Rapid, Equipment-free, and Deliverable criterion provided by the World Health Organization is discussed based on recent advances in SERS in vitro assay development. As SERS provides attractive characteristics for multiplexed sensing at low concentration limits with a high degree of specificity, it holds great promise for enhancing current efforts in rapid diagnostic testing. In outlining the progression of SERS techniques over the past years combined with recent developments in smart nanomaterials, high-throughput microfluidics, and low-cost paper diagnostics, an extensive number of new possibilities show potential for translating SERS biosensors to the POC.
Stavelin, Anne; Sandberg, Sverre
Noklus is a non-profit quality improvement organization that focuses to improve all elements in the total testing process. The aim is to ensure that all medical laboratory examinations are ordered, performed and interpreted correctly and in accordance with the patients' needs for investigation, treatment and follow-up. For 25 years, Noklus has focused on point-of-care (POC) testing in primary healthcare laboratories and has more than 3100 voluntary participants. The Noklus quality system uses different tools to obtain harmonization and improvement: (1) external quality assessment for the pre-examination, examination and postexamination phase to monitor the harmonization process and to identify areas that need improvement and harmonization, (2) manufacturer-independent evaluations of the analytical quality and user-friendliness of POC instruments and (3) close interactions and follow-up of the participants through site visits, courses, training and guidance. Noklus also recommends which tests that should be performed in the different facilities like general practitioner offices, nursing homes, home care, etc. About 400 courses with more than 6000 delegates are organized annually. In 2017, more than 21,000 e-learning programs were completed.
Schumacher, Soeren; Sartorius, Dorian; Ehrentreich-Förster, Eva; Bier, Frank F
Platform technologies for the changing need of diagnostics are one of the main challenges in medical device technology. From one point-of-view the demand for new and more versatile diagnostic is increasing due to a deeper knowledge of biomarkers and their combination with diseases. From another point-of-view a decentralization of diagnostics will occur since decisions can be made faster resulting in higher success of therapy. Hence, new types of technologies have to be established which enables a multiparameter analysis at the point-of-care. Within this review-like article a system called Fraunhofer ivD-platform is introduced. It consists of a credit-card sized cartridge with integrated reagents, sensors and pumps and a read-out/processing unit. Within the cartridge the assay runs fully automated within 15-20 minutes. Due to the open design of the platform different analyses such as antibody, serological or DNA-assays can be performed. Specific examples of these three different assay types are given to show the broad applicability of the system.
Full Text Available The Southern states experience the highest rates of HIV and AIDS in the US, and point-of-care (POC testing outside of primary care may contribute to status awareness in medically underserved populations in this region. To evaluate POC screening and linkage to care at an urban south site, analyses were performed on a dataset of 3,651 individuals from an integrated rapid-result HIV testing and linkage program to describe this test-seeking cohort and determine trends associated with screening, results, and linkage to care. Four percent of the population had positive results. We observed significant differences by test result for age, race and gender, reported risk behaviors, test location, and motivation for screening. The overall linkage rate was 86%, and we found significant differences for clients who were linked to HIV care versus persons whose linkage could not be confirmed with respect to race and gender, location, and motivation. The linkage rate for POC testing that included a comprehensive intake visit and colocated primary care services for in-state residents was 97%. Additional research on integrated POC screening and linkage methodologies that provide intake services at time of testing is essential for increasing status awareness and improving linkage to HIV care in the US.
Engel, Nora; Davids, Malika; Blankvoort, Nadine; Pai, Nitika Pant; Dheda, Keertan; Pai, Madhukar
Successful point-of-care (POC) testing (completion of test-and-treat cycle in one patient encounter) has immense potential to reduce diagnostic and treatment delays, and improve patient and public health outcomes. We explored what tests are done and how in public/private, rural/urban hospitals and clinics in South Africa and whether they can ensure successful POC testing. This qualitative research study examined POC testing across major diseases in Cape Town, Durban and Eastern Cape. We conducted 101 semi-structured interviews and seven focus group discussions with doctors, nurses, community health workers, patients, laboratory technicians, policymakers, hospital managers and diagnostic manufacturers. In South Africa, diagnostics are characterised by a centralised system. Most tests conducted on the spot can be made to work successfully as POC tests. The majority of public/private clinics and smaller hospitals send samples via couriers to centralised laboratories and retrieve results the same way, via internet, fax or phone. The main challenge to POC testing lies in transporting samples and results, while delays risk patient loss from diagnostic/treatment pathways. Strategies to deal with associated delays create new problems, such as artificially prolonged turnaround times, strains on human resources and quality of testing, compounding additional diagnostic and treatment delays. For POC testing to succeed, particular characteristics of diagnostic ecosystems and adaptations of professional practices to overcome associated challenges must be taken into account. © 2014 John Wiley & Sons Ltd.
Hsiao, Nei-yuan; Dunning, Lorna; Kroon, Max; Myer, Landon
Early infant diagnosis (EID) and prompt linkage to care are critical to minimise the high morbidity and mortality associated with infant HIV infection. Attrition in the "EID cascade" is common; however, point-of-care (POC) EID assays with same-day result could facilitate prompt linkage of HIV-infected infant to treatment. Despite a number of POC EID assays in development, few have been independently evaluated and data on new technologies are urgently needed to inform policy. We compared Alere q 1/2 Detect POC system laboratory test characteristics with the local standard of care (SOC), Roche CAP/CTM HIV-1 qualitative PCR in an independent laboratory-based evaluation in Cape Town, South Africa. Routinely EID samples collected between November 2013 and September 2014 were each tested by both SOC and POC systems. Repeat testing was done to troubleshoot any discrepancy between POC and SOC results. Overall, 1098 children with a median age of 47 days (IQR, 42-117) were included. Birth PCR (age laboratory. The high specificity and thus high positive predictive value would suggest a positive POC result may be adequate for immediate infant ART initiation. While POC testing for EID may have particular utility for birth testing at delivery facilities, the lower sensitivity and error rate requires further attention, as does field implementation of POC EID technologies in other clinical care settings.
Wang, Li-Ju; Chang, Yu-Chung; Sun, Rongrong; Li, Lei
Current reported smartphone spectrometers are only used to monitor or measure one sample at a time. For the first time, we demonstrate a multichannel smartphone spectrometer (MSS) as an optical biosensor that can simultaneously optical sense multiple samples. In this work, we developed a novel method to achieve the multichannel optical spectral sensing with nanometer resolution on a smartphone. A 3D printed cradle held the smartphone integrated with optical components. This optical sensor performed accurate and reliable spectral measurements by optical intensity changes at specific wavelength or optical spectral shifts. A custom smartphone multi-view App was developed to control the optical sensing parameters and to align each sample to the corresponding channel. The captured images were converted to the transmission spectra in the visible wavelength range from 400nm to 700nm with the high resolution of 0.2521nm per pixel. We validated the performance of this MSS via measuring the concentrations of protein and immunoassaying a type of human cancer biomarker. Compared to the standard laboratory instrument, the results sufficiently showed that this MSS can achieve the comparative analysis detection limits, accuracy and sensitivity. We envision that this multichannel smartphone optical biosensor will be useful in high-throughput point-of-care diagnostics with its minimizing size, light weight, low cost and data transmission function. Copyright Â© 2016 Elsevier B.V. All rights reserved.
Kanakasabapathy, Manoj Kumar; Sadasivam, Magesh; Singh, Anupriya; Preston, Collin; Thirumalaraju, Prudhvi; Venkataraman, Maanasa; Bormann, Charles L; Draz, Mohamed Shehata; Petrozza, John C; Shafiee, Hadi
Male infertility affects up to 12% of the world's male population and is linked to various environmental and medical conditions. Manual microscope-based testing and computer-assisted semen analysis (CASA) are the current standard methods to diagnose male infertility; however, these methods are labor-intensive, expensive, and laboratory-based. Cultural and socially dominated stigma against male infertility testing hinders a large number of men from getting tested for infertility, especially in resource-limited African countries. We describe the development and clinical testing of an automated smartphone-based semen analyzer designed for quantitative measurement of sperm concentration and motility for point-of-care male infertility screening. Using a total of 350 clinical semen specimens at a fertility clinic, we have shown that our assay can analyze an unwashed, unprocessed liquefied semen sample with time and provide the user a semen quality evaluation based on the World Health Organization (WHO) guidelines with ~98% accuracy. The work suggests that the integration of microfluidics, optical sensing accessories, and advances in consumer electronics, particularly smartphone capabilities, can make remote semen quality testing accessible to people in both developed and developing countries who have access to smartphones. Copyright © 2017, American Association for the Advancement of Science.
Kim, Gi-Duck; Yoon, Changhan; Kye, Sang-Bum; Lee, Youngbae; Kang, Jeeun; Yoo, Yangmo; Song, Tai-kyong
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.
Tian, Tian; Li, Jiuxing; Song, Yanling; Zhou, Leiji; Zhu, Zhi; Yang, Chaoyong James
Equipment-free devices with quantitative readout are of great significance to point-of-care testing (POCT), which provides real-time readout to users and is especially important in low-resource settings. Among various equipment-free approaches, distance-based visual quantitative detection methods rely on reading the visual signal length for corresponding target concentrations, thus eliminating the need for sophisticated instruments. The distance-based methods are low-cost, user-friendly and can be integrated into portable analytical devices. Moreover, such methods enable quantitative detection of various targets by the naked eye. In this review, we first introduce the concept and history of distance-based visual quantitative detection methods. Then, we summarize the main methods for translation of molecular signals to distance-based readout and discuss different microfluidic platforms (glass, PDMS, paper and thread) in terms of applications in biomedical diagnostics, food safety monitoring, and environmental analysis. Finally, the potential and future perspectives are discussed.
Minichiello, Alexa; Swab, Michelle; Chongo, Meck; Marshall, Zack; Gahagan, Jacqueline; Maybank, Allison; Hot, Aurélie; Schwandt, Michael; Gaudry, Sonia; Hurley, Oliver; Asghari, Shabnam
HIV point-of-care testing (POCT) was approved for use in Canada in 2005 and provides important public health benefits by providing rapid screening results rather than sending a blood sample to a laboratory and waiting on test results. Access to test results soon after testing (or during the same visit) is believed to increase the likelihood that individuals will receive their results and improve access to confirmatory testing and linkages to care. This paper reviews the literature on the utilization of HIV POCT across Canadian provinces. We searched OVID Medline, Embase, EBM Reviews, PsycINFO, CINAHL, and 20 electronic grey literature databases. All empirical studies investigating HIV POCT programs in Canada published in French or English were included. Searches of academic databases identified a total of 6,091 records. After removing duplicates and screening for eligibility, 27 records were included. Ten studies are peer-reviewed articles, and 17 are grey literature reports. HIV POCT in Canada is both feasible and accepted by Canadians. It is preferred to conventional HIV testing (ranging from 81.1 to 97%), and users are highly satisfied with the testing process (ranging between 96 and 100%). The majority of studies demonstrate that HIV POCT is feasible, preferred, and accepted by diverse populations in Canada. Losses to follow-up and linkage rates are also good. However, more research is needed to understand how best to scale up HIV POCT in contexts that currently have very limited or no access to testing.
Lee, Hyeong Suk; Kim, Jeongeun
This study aimed to derive specific user requirements and barriers in a real medical environment to define the essential elements and functions of two types of point-of-care (POC) robot: a telepresence robot as a tool for teleconsultation, and a bedside robot to provide emotional care for patients. An analysis of user requirements was conducted; user needs were gathered and identified, and detailed, realistic scenarios were created. The prototype robots were demonstrated in physical environments for envisioning and evaluation. In all, three nurses and three clinicians participated as evaluators to observe the demonstrations and evaluate the robot systems. The evaluators were given a brief explanation of each scene and the robots' functionality. Four major functions of the teleconsultation robot were defined and tested in the demonstration. In addition, four major functions of the bedside robot were evaluated. Among the desired functions for a teleconsultation robot, medical information delivery and communication had high priority. For a bedside robot, patient support, patient monitoring, and healthcare provider support were the desired functions. The evaluators reported that the teleconsultation robot can increase support from and access to specialists and resources. They mentioned that the bedside robot can improve the quality of hospital life. Problems identified in the demonstration were those of space conflict, communication errors, and safety issues. Incorporating this technology into healthcare services will enhance communication and teamwork skills across distances and thereby facilitate teamwork. However, repeated tests will be needed to evaluate and ensure improved performance.
Das, Sayantan; Mandal, Subhamoy; Das, Debnath; Malviya, Richa; Garud, Hrushikesh T.; Ray, Ajoy K.
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.
Friedman, B A
A new term, the laboratory information float, should be substituted for turnaround-time when evaluating the performance of the clinical laboratory because it includes the time necessary to make test results both available (ready to use) and accessible (easy to use) to clinicians ordering tests. The laboratory information float can be greatly reduced simply by telescoping the analytic phase of laboratory testing into the preanalytic phase. Significant costs are incurred by such a change, some of which can be reduced by developing a mobile clinical laboratory (sometimes referred to as a "lab-on-a-slab" or "rolling thunder") to transport the analytic devices directly to patient care units. The mobile clinical laboratory should be equipped with an integrated personal computer that can communicate continuously with the host laboratory information system and achieve some semblance of continuous flow processing despite test performance in point-of-care venues. Equipping clinicians with palmtop computers will allow the mobile clinician to access test results and order tests on the run. Such devices can be easily configured to operate in a passive mode, accessing relevant information automatically instead of forcing clinicians to query the laboratory information system periodically for the test results necessary to render care to their patients. The laboratory information float of the year 2,000 will surely be measured in minutes through the judicious deployment of relevant technology such as mobile clinical laboratories and palmtop computers.
Marks, Michael; Mabey, David Cw
Syphilis remains an important and preventable cause of stillbirth and neonatal mortality. About 1 million women with active syphilis become pregnant each year. Without treatment, 25% of them will deliver a stillborn baby and 33% a low birth weight baby with an increased chance of dying in the first month of life. Adverse pregnancy outcomes due to syphilis can be prevented by screening pregnant women, and treating those who test positive with a single dose of penicillin before 28 weeks' gestation. Areas covered: This manuscript covers the impact of syphilis on pregnancy outcome, the diagnosis of syphilis, with a special focus on point of care (POC) tests, and challenges to the introduction of POC tests, and their potential impact on the control and prevention of syphilis in resource limited settings. Expert commentary: POC tests for syphilis are available which meet the ASSURED criteria, and could make syphilis screening accessible to all women anywhere in the world who attend an antenatal clinic. High quality dual POC tests for HIV and syphilis could ensure that well-funded programmes for the prevention of mother to child transmission of HIV can contribute towards increased coverage of antenatal syphilis screening, and prevent more than 300,000 adverse pregnancy outcomes due to syphilis annually. Alongside investment to increase availability of syphilis POC tests, operational research is needed to understand how best to improve screening of pregnant women and to translate test availability into improved pregnancy outcomes.
Yang, Hao; Li, Ding; He, Rong; Guo, Qin; Wang, Kan; Zhang, Xueqing; Huang, Peng; Cui, Daxiang
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.
Weigl, Bernhard H.; Gaydos, Charlotte A.; Kost, Gerald; Beyette, Fred R.; Sabourin, Stephanie; Rompalo, Anne; de los Santos, Tala; McMullan, Jason T.; Haller, John
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. PMID:23935405
Kakuya, Fujio; Kinebuchi, Takahiro; Fujiyasu, Hiroaki; Tanaka, Ryosuke; Kano, Hiroki
Mycoplasma pneumoniae (MP) is a major pathogen of lower respiratory tract infection (LRTI) in children. A rapid diagnostic method during the acute phase is required for the prescription of effective antibiotics. A prospective, single-centered study was conducted on community-acquired LRTI in children. We regarded the day of fever onset as the first day of illness. In part 1, we studied 191 patients with signs of LRTI. We compared diagnostic reliability using loop-mediated isothermal amplification (LAMP) assay and serological testing at the first visit. In part 2, we evaluated the clinical characteristics of 117 patients with positive LAMP assay. In part 1, 31 patients met the definite MP infection criteria. LAMP assay had a sensitivity of 96.8% and specificity of 100%, whereas enzyme immunoassay had a sensitivity of 38.7% and specificity of 76.9%, and particle agglutination test had a sensitivity of 19.4% and specificity of 93.1%. In part 2, of 106 patients with fever, 100 patients were diagnosed by the day 7 of illness. The diagnosis was made a mean of 3.5 ± 2.1 days after the onset of fever. LAMP assay had excellent sensitivity and specificity for the detection of acute MP infection at the first visit. This assay can diagnose MP infection during the very acute phase. LAMP assay is appropriate for genetic point-of-care diagnosis of MP infection in hospital laboratories. © 2014 Japan Pediatric Society.
Brock, T Keith; Mecozzi, Daniel M; Sumner, Stephanie; Kost, Gerald J
To define pathogen tests and device specifications needed for emerging point-of-care (POC) technologies used in disasters. Surveys included multiple-choice and ranking questions. Multiple-choice questions were analyzed with the chi2 test for goodness-of-fit and the binomial distribution test. Rankings were scored and compared using analysis of variance and Tukey's multiple comparison test. Disaster care experts on the editorial boards of the American Journal of Disaster Medicine and the Disaster Medicine and Public Health Preparedness, and the readers of the POC Journal. Vibrio cholera and Staphylococcus aureus were top-ranked pathogens for testing in disaster settings. Respondents felt that disaster response teams should be equipped with pandemic infectious disease tests for novel 2009 H1N1 and avian H5N1 influenza (disaster care, p disaster settings, respondents preferred self-contained test cassettes (disaster care, p disaster care, p disaster care scenarios, in which Vibrio cholera, methicillin-sensitive and methicillin-resistant Staphylococcus aureus, and Escherichia coli ranked the highest. POC testing should incorporate setting-specific design criteria such as safe disposable cassettes and direct blood sampling at the site of care.
Gounden, Verena; George, Jaya
South Africa has the largest prevalence of HIV infected individuals in the world. The introduction of point of care testing to anti-retroviral (ARV) clinic sites is hoped to fast track initiation of patients on ARVs and to allow for earlier recognition of adverse effects such as dyslipidaemia, renal and hepatic dysfunction. We evaluated six instruments for the following analytes: glucose, lactate, creatinine, cholesterol, triglycerides, HDL-cholesterol, alanine transaminase (ALT), and glycated haemoglobin. Comparisons with the central laboratory analyser were performed as well as precision studies. A scoring system was developed by the authors to evaluate the instruments in terms of analytical performance, cost, ease of use, and other operational characteristics. As one of the goals of the placement of these instruments was that their operation was simple enough to be used by non-laboratory staff, ease of use contributed a large proportion to the final scoring. Analytical performance of the POC analysers were generally similar, however, there were significant differences in operational characteristics and ease of use. Bias for the different analytes when compared to the laboratory analyser ranged from -27% to 14%. Calculated total errors for all analytes except for HDL cholesterol were within total allowable error recommendations. The two instruments (Roche Reflotron and Cholestech LDX) with the highest overall total points achieved the highest scores for ease of use. This pilot study has led to the development of a scoring system for the evaluation of POC instruments.
Adrienne F.A. Meyers
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.
Torregrosa, María-Eugenia; Molina, Juan; Argente, Carlos R; Ena, Javier
Use of hemoglobin A1c point-of-care devices in physician offices provides immediate results and reduces inconveniences for the patients. We compared the analytical performances of 3 point-of-care HbA1c analyzers to high pressure liquid chromatography (HPLC). We preselected a pool of 40 EDTA-preserved whole blood samples from our laboratory with HbA1c results obtained by HPLC (mean 6.6% [49 mmol/mol] and range: 4.6-9.9% [27-87 mmol/mol]). Aliquots of theses samples were tested by Afinion AS100, DCA Vantage and In2it point-of-care systems. According the Clinical Laboratory Standards Institute EP-09 protocol we determined linearity (linear regression and correlation coefficient between point-of-care and reference methods), bias (Bland-Altman analysis) and coefficient of variation (%). We used the acceptability criteria endorsed by the National Glycohemoglobin Standardization Program. The calculated correlation coefficients (r) were 0.98, 0.98 and 0.83 for Afinion AS100, DCA Vantage and In2it systems, respectively. The 95% confidence interval of the error between point-of-care systems and the reference method was -0.41% and +0.34% (p =.22) for Afinion AS100, -0.62% and +0.05% (p =.57) for DCA Vantage, and -1.15% and +1.26% (p<.001) for the In2it. The coefficients of variation for Afinion AS100, DCA Vantage and In2it systems were 1.80, 3.74 and 7.14%, respectively. Only the Afinion AS100 point-of-care system met all NGSP performance criteria. Copyright © 2015 SEEN. Published by Elsevier España, S.L.U. All rights reserved.
Ahn, Hong Joon; Lee, Jun Wan; Joo, Ki Hyuk; You, Yeon Ho; Ryu, Seung; Lee, Jin Woong; Kim, Seung Whan
Cannulation of the great vessels is required for extracorporeal membrane oxygenation (ECMO). Currently, there is no guideline for optimal imaging modalities during percutaneous cannulation of ECMO. The purpose of this study was to describe percutaneous cannulation guided by point-of-care ultrasound (POCUS) for ECMO and compare it with fluoroscopy and landmark guidance. Three groups (POCUS-, fluoroscopy-, and landmark-guided) of percutaneous cannulation for ECMO were analyzed retrospectively in a tertiary academic hospital. In the POCUS-guided group, visual confirmation of guidewire and cannula by ultrasound in both the access and return cannula were essential for successful cannulation. Fluoroscopy- and landmark-guided groups were cannulated with the conventional technique. A total of 128 patients were treated by ECMO during the study period, of which 94 (73.4%) cases were venoarterial ECMO. This included 56 cases of extracorporeal cardiopulmonary resuscitation. Also, there were 30 (23.4%) cases of venovenous ECMO and 4 (3.1%) cases of venoarteriovenous ECMO. A total of 71 (55.5%) patients were cannulated under POCUS guidance, and 43 (33.6%) patients were cannulated under fluoroscopy guidance and 14 (10.9%) patients were cannulated by landmark guidance. No surgical cut downs were required. Misplacement of cannula occurred in 3 (2.3%) cases. All three occurred in the landmark-guided group. POCUS-guided cannulation is comparable to fluoroscopy-guided cannulation in terms of avoiding cannula misplacement. In our experience, POCUS-guided cannulation is a useful strategy over fluoroscopy- and landmark-guided cannulation during peripheral ECMO. Copyright © 2017 Elsevier Inc. All rights reserved.
Patou, François; AlZahra’a Alatraktchi, Fatima; Kjægaard, Claus; Dimaki, Maria; Madsen, Jan; Svendsen, Winnie E.
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
Diane M Tshikudi
Full Text Available Anticoagulant overdose is associated with major bleeding complications. Rapid coagulation sensing may ensure safe and accurate anticoagulant dosing and reduce bleeding risk. Here, we report the novel use of Laser Speckle Rheology (LSR for measuring anticoagulation and haemodilution status in whole blood. In the LSR approach, blood from 12 patients and 4 swine was placed in disposable cartridges and time-varying intensity fluctuations of laser speckle patterns were measured to quantify the viscoelastic modulus during clotting. Coagulation parameters, mainly clotting time, clot progression rate (α-angle and maximum clot stiffness (MA were derived from the clot viscoelasticity trace and compared with standard Thromboelastography (TEG. To demonstrate the capability for anticoagulation sensing in patients, blood samples from 12 patients treated with warfarin anticoagulant were analyzed. LSR clotting time correlated with prothrombin and activated partial thromboplastin time (r = 0.57-0.77, p<0.04 and all LSR parameters demonstrated good correlation with TEG (r = 0.61-0.87, p<0.04. To further evaluate the dose-dependent sensitivity of LSR parameters, swine blood was spiked with varying concentrations of heparin, argatroban and rivaroxaban or serially diluted with saline. We observed that anticoagulant treatments prolonged LSR clotting time in a dose-dependent manner that correlated closely with TEG (r = 0.99, p<0.01. LSR angle was unaltered by anticoagulation whereas TEG angle presented dose-dependent diminution likely linked to the mechanical manipulation of the clot. In both LSR and TEG, MA was largely unaffected by anticoagulation, and LSR presented a higher sensitivity to increased haemodilution in comparison to TEG (p<0.01. Our results establish that LSR rapidly and accurately measures the response of various anticoagulants, opening the opportunity for routine anticoagulation monitoring at the point-of-care or for patient self-testing.
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.
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.
Monteiro, Tiago; Rodrigues, Patrícia R; Gonçalves, Ana Luisa; Moura, José J G; Jubete, Elena; Añorga, Larraitz; Piknova, Barbora; Schechter, Alan N; Silveira, Célia M; Almeida, M Gabriela
In this paper we aim to demonstrate, as a proof-of-concept, the feasibility of the mass production of effective point of care tests for nitrite quantification in environmental, food and clinical samples. Following our previous work on the development of third generation electrochemical biosensors based on the ammonia forming nitrite reductase (ccNiR), herein we reduced the size of the electrodes' system to a miniaturized format, solved the problem of oxygen interference and performed simple quantification assays in real samples. In particular, carbon paste screen printed electrodes (SPE) were coated with a ccNiR/carbon ink composite homogenized in organic solvents and cured at low temperatures. The biocompatibility of these chemical and thermal treatments was evaluated by cyclic voltammetry showing that the catalytic performance was higher with the combination acetone and a 40°C curing temperature. The successful incorporation of the protein in the carbon ink/solvent composite, while remaining catalytically competent, attests for ccNiR's robustness and suitability for application in screen printed based biosensors. Because the direct electrochemical reduction of molecular oxygen occurs when electroanalytical measurements are performed at the negative potentials required to activate ccNiR (ca.-0.4V vs Ag/AgCl), an oxygen scavenging system based on the coupling of glucose oxidase and catalase activities was successfully used. This enabled the quantification of nitrite in different samples (milk, water, plasma and urine) in a straightforward way and with small error (1-6%). The sensitivity of the biosensor towards nitrite reduction under optimized conditions was 0.55 A M(-1) cm(-2) with a linear response range 0.7-370 μM. Copyright © 2015 Elsevier B.V. All rights reserved.
Liao, Shao-Feng; Chen, Pai-Jung; Chaou, Chung-Hsien; Lee, Ching-Hsing
Point-of-care ultrasound (POCUS) has been a rapidly growing and broadly used modality in recent decades. The purpose of this study was to determine how POCUS is incorporated into clinical medicine by analyzing trends of use in the published literature. POCUS-related publications were retrieved from the Web of Science (WoS) database. The search results were ranked according to the number of times an article was cited during three time frames and average annual number of citations. Of the top 100 most cited publications in the four rankings, information regarding the publication journal, publication year, first author's nationality, field of POCUS application, and number of times the article was cited was recorded for trend analysis. A total of 7860 POCUS-related publications were retrieved, and publications related to POCUS increased from 8 in 1990 to 754 in 2016. The top 148 cited publications from the four ranking groups were included in this study. Trauma was the leading application field in which POCUS was studied prior to 2001. After 2004, thorax, cardiovascular, and procedure-guidance were the leading fields in POCUS research. >79% (118/148) of the top-cited publications were conducted by authors in the United States, Italy, and France. The majority of publications were published in critical care medicine and emergency medicine journals. In recent years, publications relating to POCUS have increased. POCUS-related research has mainly been performed in thorax, cardiovascular, and procedure-guidance ultrasonography fields, replacing trauma as the major field in which POCUS was previously studied. Copyright © 2018 Elsevier Inc. All rights reserved.
Bhattacharjee, Mitradip; Nemade, Harshal B; Bandyopadhyay, Dipankar
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. Copyright © 2017 Elsevier B.V. All rights reserved.
Socransky, Steve; Lang, Eddy; Bryce, Rhonda; Betz, Martin
Point-of-care ultrasound (POCUS) is a novel technique for the assessment of jugular venous pressure. Distance education may allow for efficient dissemination of this technique. We compared online learning to a live course for teaching ultrasonography jugular venous pressure (u-JVP) to determine if these teaching methods yielded different levels of comfort with and use of u-JVP. This was an interventional trial of Canadian emergency physicians who had taken a basic POCUS course. The participants were in one of three Groups: online learning (Group OL), live teaching (Group LT), control (Group C). Group LT participants also took an advanced course prior to the study that included instruction in u-JVP. The participants who took the basic course were randomized to Group OL or Group C. Group OL was subject to the intervention, online learning. Group C only received an article citation regarding u-JVP. Questionnaires were completed before and after the intervention. The primary outcome was physician self-reported use and comfort with the technique of u-JVP after online learning compared to live teaching. Of the 287 advanced course participants, 42 completed the questionnaires (Group LT). Of the 3303 basic course participants, 47 who were assigned to Group OL completed the questionnaires and 47 from Group C completed the questionnaires. Use of u-JVP increased significantly in Group OL (from 15% to 55%) and Group C (from 21% to 47%) with the intervention. The comfort with use did not differ between Group LT and Group OL (p=0.14). The frequency of use remained higher in Group LT than Group OL (p=0.07). Online learning increases the use and comfort with performing u-JVP for emergency physicians with prior POCUS experience. Although the comfort with use of u-JVP was similar in Groups LT and OL, online learning appears to yield levels of use that are less than those of a live course.
Park, Paul H; Chege, Patrick; Hagedorn, Isabel C; Kwena, Arthur; Bloomfield, Gerald S; Pastakia, Sonak D
The prevalence of hyperlipidaemia, along with other non-communicable diseases, is on the rise in low- and middle-income countries. CardioChek PA is a point-of-care lipid measuring device, which seeks to overcome laboratory-based diagnostic barriers by providing immediate results without dependency on significant laboratory infrastructure. However, it has not been validated in Kenya. In this study, we assess the accuracy of CardioChek PA with respect to the gold standard laboratory-based testing. In Webuye, Kenya, two blood samples were collected from 246 subjects to simultaneously measure the lipid levels via both CardioChek PA and the gold standard. All subjects were adults, and geographic stratified sampling methods were applied. Statistical analysis of the device's accuracy was based on per cent bias parameters, as established by the United States National Institutes of Health (NIH). The NIH recommends that per cent bias be ≤±3% for low-density lipoprotein (LDL) cholesterol, ≤±5% for high-density lipoprotein (HDL) cholesterol, ≤±5% for total cholesterol (TC) and ≤±4% for triglycerides (TG). Risk group misclassification rates were also analysed. The CardioChek PA analyzer was substantially inaccurate for LDL cholesterol (-25.9% bias), HDL cholesterol (-8.2% bias) and TC (-15.9% bias). Moreover, those patients at higher risk of complications from hyperlipidaemia were most likely to be misclassified into a lower risk category. CardioChek PA is inaccurate and not suitable for our clinical setting. Furthermore, our findings highlight the need to validate new diagnostic tools in the appropriate setting prior to scale up regardless of their potential for novel utility. © 2015 John Wiley & Sons Ltd.
Full Text Available A rapid test to identify patients with sickle cell disease could have important benefits in low-resource settings. Sickle cell anemia (SCA affects about 300,000 newborns each year, the majority of whom are born in sub-Saharan Africa. Low-cost therapies are available to treat SCA, but most countries in sub-Saharan Africa lack robust neonatal screening programs needed to identify patients in need of treatment. To address this need, we developed and evaluated a competitive lateral flow assay that identifies patients with SCA (genotype HbSS in 15 minutes using undiluted whole blood. A small volume of blood (0.5 μL- 3 μL is mixed with antibody-coated blue latex beads in a tube and applied to the strip. Strips are then placed in a well of running buffer and allowed to run for 10 minutes. Laboratory evaluation with samples containing different proportions of hemoglobin A (HbA and hemoglobin S (HbS indicated that the test should enable identification of SCA patients but not persons with sickle cell trait (SCT. We evaluated the test using 41 samples from individuals with SCA, SCT, and normal blood. With visual inspection or quantitative analysis, we found a 98% accuracy when differentiating SCA from normal and SCT samples as a group (90% sensitivity and 100% specificity for identifying SCA. This work demonstrates important steps towards making a lateral flow test for hemoglobinopathies more appropriate for point-of-care use; further work is needed before the test is appropriate for clinical use.
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.
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
Weibrich, Gernot; Kleis, Wilfried K G; Streckbein, Philipp; Moergel, Maximilian; Hitzler, Walter E; Hafner, Gerd
This study analyzed the concentrations of platelets and growth factors in platelet-rich plasma (PRP), which are likely to depend on the method used for its production. The cellular composition and growth factor content of platelet concentrates (platelet-rich plasma) produced by six different procedures were quantitatively analyzed and compared. Platelet and leukocyte counts were determined on an automatic cell counter, and analysis of growth factors was performed using enzyme-linked immunosorbent assay. The principal differences between the analyzed PRP production methods (blood bank method of intermittent flow centrifuge system/platelet apheresis and by the five point-of-care methods) and the resulting platelet concentrates were evaluated with regard to resulting platelet, leukocyte, and growth factor levels. The platelet counts in both whole blood and PRP were generally higher in women than in men; no differences were observed with regard to age. Statistical analysis of platelet-derived growth factor AB (PDGF-AB) and transforming growth factor β1 (TGF-β1) showed no differences with regard to age or gender. Platelet counts and TGF-β1 concentration correlated closely, as did platelet counts and PDGF-AB levels. There were only rare correlations between leukocyte counts and PDGF-AB levels, but comparison of leukocyte counts and PDGF-AB levels demonstrated certain parallel tendencies. TGF-β1 levels derive in substantial part from platelets and emphasize the role of leukocytes, in addition to that of platelets, as a source of growth factors in PRP. All methods of producing PRP showed high variability in platelet counts and growth factor levels. The highest growth factor levels were found in the PRP prepared using the Platelet Concentrate Collection System manufactured by Biomet 3i.
Clerc, O; Greub, G
Point-of-care (POC) tests offer potentially substantial benefits for the management of infectious diseases, mainly by shortening the time to result and by making the test available at the bedside or at remote care centres. Commercial POC tests are already widely available for the diagnosis of bacterial and viral infections and for parasitic diseases, including malaria. Infectious diseases specialists and clinical microbiologists should be aware of the indications and limitations of each rapid test, so that they can use them appropriately and correctly interpret their results. The clinical applications and performance of the most relevant and commonly used POC tests are reviewed. Some of these tests exhibit insufficient sensitivity, and should therefore be coupled to confirmatory tests when the results are negative (e.g. Streptococcus pyogenes rapid antigen detection test), whereas the results of others need to be confirmed when positive (e.g. malaria). New molecular-based tests exhibit better sensitivity and specificity than former immunochromatographic assays (e.g. Streptococcus agalactiae detection). In the coming years, further evolution of POC tests may lead to new diagnostic approaches, such as panel testing, targeting not just a single pathogen, but all possible agents suspected in a specific clinical setting. To reach this goal, the development of serology-based and/or molecular-based microarrays/multiplexed tests will be needed. The availability of modern technology and new microfluidic devices will provide clinical microbiologists with the opportunity to be back at the bedside, proposing a large variety of POC tests that will allow quicker diagnosis and improved patient care.
Cohen-Bacrie, Stéphan; Ninove, Laetitia; Nougairède, Antoine; Charrel, Rémi; Richet, Hervé; Minodier, Philippe; Badiaga, Sékéné; Noël, Guilhem; La Scola, Bernard; de Lamballerie, Xavier; Drancourt, Michel; Raoult, Didier
Clinical microbiology may direct decisions regarding hospitalization, isolation and anti-infective therapy, but it is not effective at the time of early care. Point-of-care (POC) tests have been developed for this purpose. One pilot POC-lab was located close to the core laboratory and emergency ward to test the proof of concept. A second POC-lab was located inside the emergency ward of a distant hospital without a microbiology laboratory. Twenty-three molecular and immuno-detection tests, which were technically undemanding, were progressively implemented, with results obtained in less than four hours. From 2008 to 2010, 51,179 tests yielded 6,244 diagnoses. The second POC-lab detected contagious pathogens in 982 patients who benefited from targeted isolation measures, including those undertaken during the influenza outbreak. POC tests prevented unnecessary treatment of patients with non-streptococcal tonsillitis (n = 1,844) and pregnant women negative for Streptococcus agalactiae carriage (n = 763). The cerebrospinal fluid culture remained sterile in 50% of the 49 patients with bacterial meningitis, therefore antibiotic treatment was guided by the molecular tests performed in the POC-labs. With regard to enterovirus meningitis, the mean length-of-stay of infected patients over 15 years old significantly decreased from 2008 to 2010 compared with 2005 when the POC was not in place (1.43±1.09 versus 2.91±2.31 days; p = 0.0009). Altogether, patients who received POC tests were immediately discharged nearly thrice as often as patients who underwent a conventional diagnostic procedure. The on-site POC-lab met physicians' needs and influenced the management of 8% of the patients that presented to emergency wards. This strategy might represent a major evolution of decision-making regarding the management of infectious diseases and patient care.
Prakash Ranjan Mishra
Full Text Available Introduction: Airway and breathing management play critical role in trauma resuscitation. Early identification of esophageal intubation and detection of fatal events is critical. Authors studied the utility of integration of point-of-care ultrasound (POCUS during different phases of rapid sequence intubation (RSI in trauma resuscitation. Methods: It was prospective, randomized single-centered study conducted at the Emergency Department of a level one trauma center. Patients were divided into ultrasonography (USG and clinical examination (CE arm. The objectives were to study the utility of POCUS in endotracheal tube placement and confirmations and identification of potentially fatal conditions as tracheal injury, midline vessels, paratracheal hematoma, vocal cord pathology, pneumothorax, and others during RSI. Patient >1 year of age were included. Time taken for procedure, number of incorrect intubations, and pathologies detected were noted. The data were collected in Microsoft Excel spread sheets and analyzed using Stata (version 11.2, Stata Corp, Texas, U. S. A software. Results: One hundred and six patients were recruited. The mean time for primary survey USG versus CE arm was (20 ± 10.01 vs. 18 ± 11.03 seconds. USG detected four pneumothorax, one tracheal injury, and one paratracheal hematoma. The mean procedure time USG versus CE arm was (37.3 ± 21.92 vs. 58 ± 32.04 seconds. Eight esophageal intubations were identified in USG arm by POCUS and two in CE arm by EtCO2 values. Conclusion: Integration of POCUS was useful in all three phases of RSI. It identified paratracheal hematoma, tracheal injury, and pneumothorax. It also identified esophageal intubation and confirmed main stem tracheal intubation in less time compared to five-point auscultation and capnography.
Kaushik, Ajeet; Tiwari, Sneham; Jayant, Rahul Dev; Marty, Aileen; Nair, Madhavan
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 6 hours 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 ~40 minute compared to 3 days of ELISA test at nM levels. PMID:26319169
Van Cleave, Jeanne; Le, Thuy-Tien; Perrin, James M
Since 2005, after a pilot program, the Massachusetts Child Psychiatry Access Project (MCPAP) has provided point-of-care psychiatry expertise and referral assistance by telephone to primary care providers. We examined its adoption and use and the practice characteristics associated with different adoption timelines and use patterns. We merged data on calls to MCPAP in 2005 to 2011 with practice data (enrollment year, panel size, regional team assignment). We categorized practices' days from enrollment to first call (adoption) (0-100, 101-365, > 365 days) and quartile of call frequency (use) (annual highest, middle, and lowest quartiles of number of calls per 1000 empanelled patients). We determined associations between adoption and use and practice characteristics using multivariate models. Among 285 practices, adoption and use varied: 55% called 0 to 100 days from enrollment and 16% called >365 days from enrollment. Practices in the highest quartile of use made a mean 15.5 calls/year per 1000 patients, whereas the lowest quartile made 0.4 calls/year per 1000 patients. Adoption within 100 days was associated with enrollment during or after 2007 (odds ratio [OR] 4.09, 95% confidence interval [CI] 2.23-7.49) and assignment to the team at the pilot site (OR 4.42, 95% CI 2.16-9.04 for central Massachusetts). Highest-quartile use was associated with team assignment (OR 3.58, 95% CI 1.86-6.87 for central Massachusetts) and panel size (OR 0.10, 95% CI 0.03-0.31 for ≥ 10,000 vs < 2000 patients). Adoption and use of MCPAP varied widely. Timing of enrollment, assignment to the team from the program's pilot site, and panel size were associated with patterns of adoption and use. Findings may help other programs design effective implementation strategies. Copyright © 2015 by the American Academy of Pediatrics.
Liao, Shih-Chuan; Peng, Jing; Mauk, Michael G; Awasthi, Sita; Song, Jinzhao; Friedman, Harvey; Bau, Haim H; Liu, Changchun
Nucleic acid amplification-based diagnostics offer rapid, sensitive, and specific means for detecting and monitoring the progression of infectious diseases. However, this method typically requires extensive sample preparation, expensive instruments, and trained personnel. All of which hinder its use in resource-limited settings, where many infectious diseases are endemic. Here, we report on a simple, inexpensive, minimally-instrumented, smart cup platform for rapid, quantitative molecular diagnostics of pathogens at the point of care. Our smart cup takes advantage of water-triggered, exothermic chemical reaction to supply heat for the nucleic acid-based, isothermal amplification. The amplification temperature is regulated with a phase-change material (PCM). The PCM maintains the amplification reactor at a constant temperature, typically, 60-65°C, when ambient temperatures range from 12 to 35°C. To eliminate the need for an optical detector and minimize cost, we use the smartphone's flashlight to excite the fluorescent dye and the phone camera to record real-time fluorescence emission during the amplification process. The smartphone can concurrently monitor multiple amplification reactors and analyze the recorded data. Our smart cup's utility was demonstrated by amplifying and quantifying herpes simplex virus type 2 (HSV-2) with LAMP assay in our custom-made microfluidic diagnostic chip. We have consistently detected as few as 100 copies of HSV-2 viral DNA per sample. Our system does not require any lab facilities and is suitable for use at home, in the field, and in the clinic, as well as in resource-poor settings, where access to sophisticated laboratories is impractical, unaffordable, or nonexistent.
Yilmaz, Hayri Levent; Özkaya, Ahmet Kağan; Sarı Gökay, Sinem; Tolu Kendir, Özlem; Şenol, Hande
To present lung ultrasound findings in children assessed with suspected pneumonia in the emergency department and to show the benefit of lung ultrasound in diagnosing pneumonia in comparison with chest X-rays. This observational prospective study was performed in the pediatric emergency department of a single center. Point of care lung ultrasound was performed on each child by an independent sonographer blinded to the patient's clinical and chest X-ray findings. Community acquired pneumonia was established as a final diagnosis by two clinicians based on the recommendations in the British Thoracic Society guideline. One hundred sixty children with a mean age of 3.3±4years and a median age of 1.4years (min-max 0.08-17.5years) were investigated. Final diagnosis in 149 children was community-acquired pneumonia. Lung ultrasound findings were compatible with pneumonia in 142 (95.3%) of these 149 children, while chest X-ray findings were compatible with pneumonia in 132 (88.5%). Pneumonia was confirmed with lung ultrasound in 15 of the 17 patients (11.4%) not evaluated as compatible with pneumonia at chest X-ray. While pneumonia could not be confirmed with lung ultrasound in seven (4.6%) patients, findings compatible with pneumonia were not determined at chest X-ray in two of these patients. When lung ultrasound and chest X-ray were compared as diagnostic tools, a significant difference was observed between them (p=0.041). This study shows that lung ultrasound is at least as useful as chest X-ray in diagnosing children with community-acquired pneumonia. Copyright © 2017 Elsevier Inc. All rights reserved.
Eastham, John H; Mason, Debra; Barnes, Deborah L; Kollins, Jerry
This study determined the prevalence of interfering substances with a glucometer using the glucose dehydrogenase pyrroloquinolinequinone method of point-of-care glucose testing (POCGT) and identified the percentage of patients with orders for an insulin product during the interference time interval. A retrospective chart review was conducted for all inpatients with biochemically-identified interfering substances over a 12-month period. The interfering substance report identified all patients with serum uric acid concentrations greater than 10 mg/dL, hematocrit less than 20% or greater than 55%, serum total bilirubin concentrations greater than 20 mg/dL, serum acetaminophen concentrations greater than 8 mg/dL, and serum triglyceride concentrations greater than 5000 mg/dL. Of 6885 hospital admissions during the 12-month study period, 84 patients (1.2%) were identified as having interfering substances. Interfering substances were identified an average mean +/- S.D. of 4.88 +/- 15.56 days following hospital admission. Two patients had interfering substances identified in the emergency department before hospital admission. Five patients (four with total bilirubin and one with uric acid) had initial concentrations below the interference threshold. These concentrations increased during hospitalization to high enough levels to cause interference with POCGT. Since the average length of stay for the identified patients was 10.49 days, an average of 17% of the hospital stay was impacted by an interfering substance. Substances remained at interfering concentrations until the time of discharge in 30% of the patients. Over a 12-month period, interfering substance were identified in1.2% of patients admitted to a hospital. Thirty-six percent of those patients had an active order for an insulin product during the interference time interval.
Patou, François; AlZahra'a Alatraktchi, Fatima; Kjægaard, Claus; Dimaki, Maria; Madsen, Jan; Svendsen, Winnie E
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.
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.
Dorshow, Richard B.; Shieh, Jeng-Jong; Rogers, Thomas E.; Hall-Moore, Carla; Shaikh, Nurmohammad; Talcott, Michael; Tarr, Phillip I.
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.
Full Text Available BACKGROUND: Clinical microbiology may direct decisions regarding hospitalization, isolation and anti-infective therapy, but it is not effective at the time of early care. Point-of-care (POC tests have been developed for this purpose. METHODS AND FINDINGS: One pilot POC-lab was located close to the core laboratory and emergency ward to test the proof of concept. A second POC-lab was located inside the emergency ward of a distant hospital without a microbiology laboratory. Twenty-three molecular and immuno-detection tests, which were technically undemanding, were progressively implemented, with results obtained in less than four hours. From 2008 to 2010, 51,179 tests yielded 6,244 diagnoses. The second POC-lab detected contagious pathogens in 982 patients who benefited from targeted isolation measures, including those undertaken during the influenza outbreak. POC tests prevented unnecessary treatment of patients with non-streptococcal tonsillitis (n = 1,844 and pregnant women negative for Streptococcus agalactiae carriage (n = 763. The cerebrospinal fluid culture remained sterile in 50% of the 49 patients with bacterial meningitis, therefore antibiotic treatment was guided by the molecular tests performed in the POC-labs. With regard to enterovirus meningitis, the mean length-of-stay of infected patients over 15 years old significantly decreased from 2008 to 2010 compared with 2005 when the POC was not in place (1.43±1.09 versus 2.91±2.31 days; p = 0.0009. Altogether, patients who received POC tests were immediately discharged nearly thrice as often as patients who underwent a conventional diagnostic procedure. CONCLUSIONS: The on-site POC-lab met physicians' needs and influenced the management of 8% of the patients that presented to emergency wards. This strategy might represent a major evolution of decision-making regarding the management of infectious diseases and patient care.
Whitney, Rachel E; Santucci, Karen; Hsiao, Allen; Chen, Lei
Acute gastroenteritis (AGE) and subsequent dehydration account for a large proportion of pediatric emergency department (PED) visits. Point-of-care (POC) testing has been used in conjunction with clinical assessment to determine the degree of dehydration. Despite the wide acceptance of POC testing, little formal cost-effective analysis of POC testing in the PED exists. We aim to examine the cost-effectiveness of using POC electrolyte testing vs traditional serum chemistry testing in the PED for children with AGE. This was a cost-effective analysis using data from a randomized control trial of children with AGE. A decision analysis model was constructed to calculate cost-savings from the point of view of the payer and the provider. We used parameters obtained from the trial, including cost of testing, admission rates, cost of admission, and length of stay. Sensitivity analyses were performed to evaluate the stability of our model. Using the data set of 225 subjects, POC testing results in a cost savings of $303.30 per patient compared with traditional serum testing from the point of the view of the payer. From the point-of-view of the provider, POC testing results in consistent mean savings of $36.32 ($8.29-$64.35) per patient. Sensitivity analyses demonstrated the stability of the model and consistent savings. This decision analysis provides evidence that POC testing in children with gastroenteritis-related moderate dehydration results in significant cost savings from the points of view of payers and providers compared to traditional serum chemistry testing. Copyright © 2016 Elsevier Inc. All rights reserved.
Tayo, Adeoluwa; Ellis, Joanna; Linden Phillips, Luan; Simpson, Sue; Ward, Derek J
Point of care tests (POCTs) for influenza potentially offer earlier diagnosis, enabling specific treatment, infection control measures and greater patient convenience and satisfaction. Current POCTs have limited sensitivity, some cannot distinguish influenza types, none differentiate subtypes and are relatively expensive. To identify and characterise influenza POCTs expected to be available for clinical use in the U.K. by mid-2013, highlighting those with potential benefits over existing tests. Potential developers of influenza POCTs were identified through known manufacturers' websites, Medical Technology trade associations, the EuroScan International Network, an expert advisory group and by searching relevant online sources. Identified companies were asked to provide standard information on relevant technologies. Fifty-six companies were identified, and 29 (52%) responded, identifying 57 potentially relevant technologies. Of these, 40 (70%) were already available or had undetermined status and 5 (9%) were excluded as time to results took over 60 minutes. Of the remaining 12 emerging POCTs, 10 (83%) reportedly enabled differentiation of influenza types and eight differentiation of A subtypes. Nasopharyngeal swabs were the most commonly acceptable sample type; the sample volume ranging from 80 μl to 1.4 ml. Most identified emerging influenza POCTs offered differentiation of influenza type and subtype. Tests claiming this capability include several incorporating reverse transcription polymerase chain reaction assays; though, these also had the longest time to result. However, whilst some identified POCTs exhibit high sensitivity and specificity, most lack published clinical data for assessment, and the overall costs of these technologies remains largely unknown. © 2011 Blackwell Publishing Ltd.
Leary, James F.
Design of inexpensive and portable hand-held microfluidic flow/image cytometry devices for initial medical diagnostics at the point of initial patient contact by emergency medical personnel in the field requires careful design in terms of power/weight requirements to allow for realistic portability as a hand-held, point-of-care medical diagnostics device. True portability also requires small micro-pumps for high-throughput capability. Weight/power requirements dictate use of super-bright LEDs and very small silicon photodiodes or nanophotonic sensors that can be powered by batteries. Signal-to-noise characteristics can be greatly improved by appropriately pulsing the LED excitation sources and sampling and subtracting noise in between excitation pulses. The requirements for basic computing, imaging, GPS and basic telecommunications can be simultaneously met by use of smartphone technologies, which become part of the overall device. Software for a user-interface system, limited real-time computing, real-time imaging, and offline data analysis can be accomplished through multi-platform software development systems that are well-suited to a variety of currently available cellphone technologies which already contain all of these capabilities. Microfluidic cytometry requires judicious use of small sample volumes and appropriate statistical sampling by microfluidic cytometry or imaging for adequate statistical significance to permit real-time (typically medical decisions for patients at the physician's office or real-time decision making in the field. One or two drops of blood obtained by pin-prick should be able to provide statistically meaningful results for use in making real-time medical decisions without the need for blood fractionation, which is not realistic in the field.
Ma, Jian; Ohira, Shin-Ichi; Mishra, Santosh K.; Puanngam, Mahitti; Dasgupta, Purnendu K.; Mahon, Sari B.; Brenner, Matthew; Blackledge, William; Boss, Gerry R.
A simple, sensitive optical analyzer for the rapid determination of cyanide in blood in point of care applications is described. HCN is liberated by the addition of 20% H3PO4 and is absorbed by a paper filter impregnated with borate-buffered (pH 9.0) hydroxoaquocobinamide Hereinafter called cobinamide). Cobinamide on the filter changes color from orange (λmax = 510 nm) to violet (λmax = 583 nm) upon reaction with cyanide. This color change is monitored in the transmission mode by a light emitting diode (LED) with a 583 nm emission maximum and a photodiode detector. The observed rate of color change increases 10x when the cobinamide solution for filter impregnation is prepared in borate-buffer rather than in water. The use of a second LED emitting at 653 nm and alternate pulsing of the LEDs improve the limit of detection by 4x to ~ 0.5 μM for a 1 mL blood sample. Blood cyanide levels of imminent concern (≥ 10 μM) can be accurately measured in ~ 2 min. The response is proportional to the mass of cyanide in the sample – smaller sample volumes can be successfully used with proportionate change in the concentration LODs. Bubbling air through the blood-acid mixture was found effective for mixing of the acid with the sample and the liberation of HCN. A small amount of ethanol added to the top of the blood was found to be the most effective means to prevent frothing during aeration. The relative standard deviation (RSD) for repetitive determination of blood samples containing 9 μM CN was 1.09% (n=5). The technique was compared blind with a standard microdiffusion-spectrophotometric method used for the determination of cyanide in rabbit blood. The results showed good correlation (slope 1.05, r2 0.9257); independent calibration standards were used. PMID:21553921
Gaieski, David G
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.
Wolde, Mistire; Tarekegn, Getahun; Kebede, Tedla
Point-of-care glucometer (PoCG) devices play a significant role in self-monitoring of the blood sugar level, particularly in the follow-up of high blood sugar therapeutic response. The aim of this study was to evaluate blood glucose test results performed with four randomly selected glucometers on diabetes and control subjects versus standard wet chemistry (hexokinase) methods in Addis Ababa, Ethiopia. A prospective cross-sectional study was conducted on randomly selected 200 study participants (100 participants with diabetes and 100 healthy controls). Four randomly selected PoCG devices (CareSens N, DIAVUE Prudential, On Call Extra, i-QARE DS-W) were evaluated against hexokinase method and ISO 15197:2003 and ISO 15197:2013 standards. The minimum and maximum blood sugar values were recorded by CareSens N (21 mg/dl) and hexokinase method (498.8 mg/dl), respectively. The mean sugar values of all PoCG devices except On Call Extra showed significant differences compared with the reference hexokinase method. Meanwhile, all four PoCG devices had strong positive relationship (>80%) with the reference method (hexokinase). On the other hand, none of the four PoCG devices fulfilled the minimum accuracy measurement set by ISO 15197:2003 and ISO 15197:2013 standards. In addition, the linear regression analysis revealed that all four selected PoCG overestimated the glucose concentrations. The overall evaluation of the selected four PoCG measurements were poorly correlated with standard reference method. Therefore, before introducing PoCG devices to the market, there should be a standardized evaluation platform for validation. Further similar large-scale studies on other PoCG devices also need to be undertaken.
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.
Liu, Changchun; Mauk, Michael; Gross, Robert; Bushman, Frederic D; Edelstein, Paul H; Collman, Ronald G; Bau, Haim H
Often, high-sensitivity, point-of-care (POC) clinical tests, such as HIV viral load, require large volumes of plasma. Although centrifuges are ubiquitously used in clinical laboratories to separate plasma from whole blood, centrifugation is generally inappropriate for on-site testing. Suitable alternatives are not readily available to separate the relatively large volumes of plasma from milliliters of blood that may be needed to meet stringent limit-of-detection specifications for low-abundance target molecules. We report on a simple-to-use, low-cost, pump-free, membrane-based, sedimentation-assisted plasma separator capable of separating a relatively large volume of plasma from undiluted whole blood within minutes. This plasma separator consists of an asymmetric, porous, polysulfone membrane housed in a disposable chamber. The separation process takes advantage of both gravitational sedimentation of blood cells and size exclusion-based filtration. The plasma separator demonstrated a "blood in-plasma out" capability, consistently extracting 275 ± 33.5 μL of plasma from 1.8 mL of undiluted whole blood within less than 7 min. The device was used to separate plasma laden with HIV viruses from HIV virus-spiked whole blood with recovery efficiencies of 95.5% ± 3.5%, 88.0% ± 9.5%, and 81.5% ± 12.1% for viral loads of 35,000, 3500, and 350 copies/mL, respectively. The separation process is self-terminating to prevent excessive hemolysis. The HIV-laden plasma was then injected into our custom-made microfluidic chip for nucleic acid testing and was successfully subjected to reverse-transcriptase loop-mediated isothermal amplification (RT-LAMP), demonstrating that the plasma is sufficiently pure to support high-efficiency nucleic acid amplification.
Christ, Michael; Geier, Felicitas; Blaschke, Sabine; Giannitsis, Evangelos; Khellaf, Mehdi; Mair, Johannes; Pariente, David; Scharnhorst, Volkher; Semjonow, Veronique; Hausfater, Pierre
We evaluated the clinical performance of the Minicare cardiac troponin-I (cTnI), a new point-of-care (POC) cTnI test for the diagnosis of acute myocardial infarction (AMI) in a prospective, multicentre study (ISRCTN77371338). Of 474 patients (≥18 years) admitted to an emergency department (ED) or chest pain unit (CPU) with symptoms suggestive of acute coronary syndrome (ACS; ≤12 h from symptom onset), 465 were eligible. Minicare cTnI was tested immediately, 3 h and 6 h after presentation. AMI diagnoses were adjudicated independently based on current guidelines. The diagnostic performance of the Minicare cTnI test at 3 h was similar for whole blood and in plasma: sensitivity 0.92 vs. 0.90; specificity 0.91 vs. 0.90; positive predictive value (PPV) 0.68 vs. 0.66; negative predictive value (NPV) 0.98 vs. 0.98; positive likelihood ratio (LR+) 10.18 vs. 9.41; negative likelihood ratio (LR-) 0.09 vs. 0.11. The optimal diagnostic performance was obtained at 3 h using cut-offs cTnI >43 ng/L plus cTnI change from admission ≥18.5 ng/L: sensitivity 0.90, specificity 0.96, PPV 0.81, NPV 0.98, and LR+ 21.54. The area under the receiver operating characteristics (ROC) curve for cTnI whole blood baseline value and absolute change after 3 h curve was 0.93. These data support the clinical usefulness of Minicare cTnI within a 0 h/3 h-blood sampling protocol supported by current guidelines for the evaluation of suspected ACS.
Zanobetti, Maurizio; Scorpiniti, Margherita; Gigli, Chiara; Nazerian, Peiman; Vanni, Simone; Innocenti, Francesca; Stefanone, Valerio T; Savinelli, Caterina; Coppa, Alessandro; Bigiarini, Sofia; Caldi, Francesca; Tassinari, Irene; Conti, Alberto; Grifoni, Stefano; Pini, Riccardo
Acute dyspnea is a common symptom in the ED. The standard approach to dyspnea often relies on radiologic and laboratory results, causing excessive delay before adequate therapy is started. Use of an integrated point-of-care ultrasonography (PoCUS) approach can shorten the time needed to formulate a diagnosis, while maintaining an acceptable safety profile. Consecutive adult patients presenting with dyspnea and admitted after ED evaluation were prospectively enrolled. The gold standard was the final diagnosis assessed by two expert reviewers. Two physicians independently evaluated the patient; a sonographer performed an ultrasound evaluation of the lung, heart, and inferior vena cava, while the treating physician requested traditional tests as needed. Time needed to formulate the ultrasound and the ED diagnoses was recorded and compared. Accuracy and concordance of the ultrasound and the ED diagnoses were calculated. A total of 2,683 patients were enrolled. The average time needed to formulate the ultrasound diagnosis was significantly lower than that required for ED diagnosis (24 ± 10 min vs 186 ± 72 min; P = .025). The ultrasound and the ED diagnoses showed good overall concordance (κ = 0.71). There were no statistically significant differences in the accuracy of PoCUS and the standard ED evaluation for the diagnosis of acute coronary syndrome, pneumonia, pleural effusion, pericardial effusion, pneumothorax, and dyspnea from other causes. PoCUS was significantly more sensitive for the diagnosis of heart failure, whereas a standard ED evaluation performed better in the diagnosis of COPD/asthma and pulmonary embolism. PoCUS represents a feasible and reliable diagnostic approach to the patient with dyspnea, allowing a reduction in time to diagnosis. This protocol could help to stratify patients who should undergo a more detailed evaluation. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
Stossel, Lauren M; Segar, Nora; Gliatto, Peter; Fallar, Robert; Karani, Reena
Many patient education materials (PEMs) available on the internet are written at high school or college reading levels, rendering them inaccessible to the average US resident, who reads at or below an 8(th) grade level. Currently, electronic health record (EHR) providers partner with companies that produce PEMs, allowing clinicians to access PEMs at the point of care. To assess the readability of PEMs provided by a popular EHR vendor as well as the National Library of Medicine (NLM). We included PEMs from Micromedex, EBSCO, and MedlinePlus. Micromedex and EBSCO supply PEMs to Meditech, a popular EHR supplier in the US. MedlinePlus supplies the NLM. These PEM databases have high market penetration and accessibility. Grade reading level of the PEMs was calculated using three validated indices: Simple Measure of Gobbledygook (SMOG), Gunning Fog (GFI), and Flesch-Kincaid (FKI). The percentage of documents above target readability and average readability scores from each database were calculated. We randomly sampled 100 disease-matched PEMs from three databases (n = 300 PEMs). Depending on the readability index used, 30-100% of PEMs were written above the 8(th) grade level. The average reading level for MedlinePlus, EBSCO, and Micromedex PEMs was 10.2 (1.9), 9.7 (1.3), and 8.6 (0.9), respectively (p ≤ 0.000) as estimated by the GFI. Estimates of readability using SMOG and FKI were similar. The majority of PEMS available through the NLM and a popular EHR were written at reading levels considerably higher than that of the average US adult.
Daniël Jacobus van Hoving
Conclusions: This study indicates a mismatch between the current point-of-care ultrasound curriculum and the clinical burden of disease experienced. Disease burden, disease impact, technical difficulty of ultrasound applications, and logistical barriers need to be incorporated when considering a change in the curriculum to make it more appropriate for the South African setting.
Schwartz, Linda Matula; Iobst, Barbara
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.
Teerenstra, S.; Steinfelder-Visscher, J.; Gunnewiek, J.K.; Weerwind, P.W.
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.
Ricks, Esmeralda; Benjamin, Valencia; Williams, Margaret
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. This study explored and described how registered nurses experienced accessing information at the point-of-care via mobile computing devices (MCDs). 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. 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. 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.
Kristensen, Troels; Waldorff, Frans Boch; Nexøe, Jørgen
Background: Point-of-care testing (POCT) of HbA1c may result in improved diabetic control, better patient outcomes, and enhanced clinical efficiency with fewer patient visits and subsequent reductions in costs. In 2008, the Danish regulators created a framework agreement regarding a new fee-for-s...
Kristensen, Troels; Rose Olsen, Kim; Skovsgaard, Christian
Background: Point-of-care testing (POCT) of HbA1c may result in improved diabetic control, better patient outcomes and enhanced clinical efficiency with fewer patient visits and subsequent reductions in hospitalizations and costs. In 2008, the Danish regulators agreed to create a new tariff for t...
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...
Ruano-Lopez, J.M.; Agirregabiria, M.; Olabarria, G.
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...... equipment where LOCs will be fabricated at a low cost....
Stolz, Lori A; Muruganandan, Krithika M; Bisanzo, Mark C; Sebikali, Mugisha J; Dreifuss, Bradley A; Hammerstedt, Heather S; Nelson, Sara W; Nayabale, Irene; Adhikari, Srikar; Shah, Sachita P
To describe the outcomes and curriculum components of an educational programme to train non-physician clinicians working in a rural, Ugandan emergency department in the use of POC ultrasound. The use of point-of-care ultrasound was taught to emergency care providers through lectures, bedsides teaching and hands-on practical sessions. Lectures were tailored to care providers' knowledge base and available therapeutic means. Every ultrasound examination performed by these providers was recorded over 4.5 years. Findings of these examinations were categorised as positive, negative, indeterminate or procedural. Other radiologic studies ordered over this same time period were also recorded. A total of 22,639 patients were evaluated in the emergency department by emergency care providers, and 2185 point-of-care ultrasound examinations were performed on 1886 patients. Most commonly used were the focused assessment with sonography in trauma examination (53.3%) and echocardiography (16.4%). Point-of-care ultrasound studies were performed more frequently than radiology department-performed studies. Positive findings were documented in 46% of all examinations. We describe a novel curriculum for point-of-care ultrasound education of non-physician emergency practitioners in a resource-limited setting. These non-physician clinicians integrated ultrasound into clinical practice and utilised this imaging modality more frequently than traditional radiology department imaging with a large proportion of positive findings. © 2015 John Wiley & Sons Ltd.
Full Text Available 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...
Ávila Muñoz, Mónica; Eijkel, Jan C.T.; Floris, J.; Staal, S.S.; Ríos, Ángel; van den Berg, Albert
We report on the determination of creatinine in human serum using a point-of-care device suitable for the use by untrained operators, the Medimate Multireader®. This device is based on electrophoretic separation and conductivity detection and its prefilled microfluidic chip has a single opening for
Verhees, Bart; van Kuijk, Kees; Simonse, W.L.
Point-of-care testing (POCT)—laboratory tests performed with new mobile devices and online technologies outside of the central laboratory—is rapidly outpacing the traditional laboratory test market, growing at a rate of 12 to 15% each year. POCT impacts the diagnostic process of care providers by
Full Text Available Major depressive disorder (MDD has been associated with biased memory formation for mood-congruent information, which may be related to altered monoamine levels. The piccolo (PCLO gene, involved in monoaminergic neurotransmission, has previously been linked to depression in a genome-wide association study. Here, we investigated the role of the PCLO risk allele on functional magnetic resonance imaging (MRI correlates of emotional memory in a sample of 89 MDD patients (64 PCLO risk allele carriers and 29 healthy controls (18 PCLO risk allele carriers. During negative word encoding, risk allele carriers showed significant lower activity relative to non-risk allele carriers in the insula, and trend-wise in the anterior cingulate cortex and inferior frontal gyrus. Moreover, depressed risk allele carriers showed significant lower activity relative to non-risk allele carriers in the striatum, an effect which was absent in healthy controls. Finally, amygdalar response during processing new positive words vs. known words was blunted in healthy PCLO+ carriers and in MDD patients irrespective of genotype, which may indicate that signalling of salient novel information does not occur to the same extent in PCLO+ carriers and MDD patients. The PCLO risk allele may increase vulnerability for MDD by modulating local brain function with regard to responsiveness to salient stimuli (i.e. insula and processing novel negative information. Also, depression-specific effects of PCLO on dorsal striatal activation during negative word encoding and the absence of amygdalar salience signalling for novel positive information further suggest a role of PCLO in symptom maintenance in MDD.
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
Full Text Available Diagnosing scrub typhus clinically is difficult, hence laboratory tests play a very important role in diagnosis. As performing sophisticated laboratory tests in resource-limited settings is not feasible, accurate point-of-care testing (POCT for scrub typhus diagnosis would be invaluable for patient diagnosis and management. Here we summarise the existing evidence on the accuracy of scrub typhus POCTs to inform clinical practitioners in resource-limited settings of their diagnostic value.Studies on POCTs which can be feasibly deployed in primary health care or outpatient settings were included. Thirty-one studies were identified through PubMed and manual searches of reference lists. The quality of the studies was assessed with the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2. About half (n = 14/31 of the included studies were of moderate quality. Meta-analysis showed the pooled sensitivity and specificity of commercially available immunochromatographic tests (ICTs were 66.0% (95% CI 0.37-0.86 and 92.0% (95% CI 0.83-0.97, respectively. There was a significant and high degree of heterogeneity between the studies (I2 value = 97.48%, 95% CI 96.71-98.24 for sensitivity and I2 value = 98.17%, 95% CI 97.67-98.67 for specificity. Significant heterogeneity was observed for total number of samples between studies (p = 0.01, study design (whether using case-control design or not, p = 0.01, blinding during index test interpretation (p = 0.02, and QUADAS-2 score (p = 0.01.There was significant heterogeneity between the scrub typhus POCT diagnostic accuracy studies examined. Overall, the commercially available scrub typhus ICTs demonstrated better performance when 'ruling in' the diagnosis. There is a need for standardised methods and reporting of diagnostic accuracy to decrease between-study heterogeneity and increase comparability among study results, as well as development of an affordable and accurate antigen-based POCT to tackle the
Blass, Keith A; Kraus, Marc S; Rishniw, Mark; Mann, Sabine; Mitchell, Lisa M; Divers, Thomas J
Myocardial disease in camelids is poorly characterized. Nutritional (selenium deficiency) and toxic (ionophore toxicity) myocardial disease have been reported in camelids. Diagnosis and management of these and other myocardial diseases might be enhanced by evaluating cardiac troponin I (cTnI) concentrations. No information about cTnI reference intervals in camelids is currently available. (A) To determine cTnI concentrations obtained using a point of care i-STAT(®)1 analyzer (Heska Corporation) in healthy alpacas; (B) to compare alpaca cTnI concentrations between heparinized whole blood and plasma samples and between 2 different storage conditions (4 °C for 24 h or -80 °C for 30 days); (C) to examine assay reproducibility using the i-STAT(®)1. 23 healthy alpacas were evaluated. Blood and plasma samples were analyzed by the i-STAT(®)1 within 1 h of collection. Aliquots of plasma were stored at either 4 °C for 24 h or -80 °C for 30 days, and then analyzed. Assay reproducibility was determined by comparing 2 plasma or whole blood cTnI concentrations measured on the same sample over a 10 min period. Analyzer-specific plasma cTnI concentrations in clinically normal alpacas had a median of blood concentrations showed good agreement. Storage did not affect cTnI concentrations (p > 0.75). Plasma cTnI concentrations had coefficient of repeatability of 0.02 ng/mL. The i-STAT(®)1 can measure cTnI in alpacas on both plasma and whole blood and provides similar values for both samples. Storage at 4 °C for 24 h or -80 °C for 30 days does not affect estimates of plasma cTnI. Evaluation of cTnI might be of value in assessing cardiac disease in this species. Copyright © 2011 Elsevier B.V. All rights reserved.
Schwartz, D; Pusterla, N; Jacobsen, S; Christopher, M M
Serum amyloid A (SAA) is a major acute phase protein in horses. A new point-of-care (POC) test for SAA (Stablelab) is available, but studies evaluating its analytical accuracy are lacking. To evaluate the analytical performance of the SAA POC test by 1) determining linearity and precision, 2) comparing results in whole blood with those in serum or plasma, and 3) comparing POC results with those obtained using a previously validated turbidimetric immunoassay (TIA). Assay validation. Analytical validation of the POC test was done in accordance with American Society of Veterinary Clinical Pathology guidelines using residual equine serum/plasma and whole blood samples from the Clinical Pathology Laboratory at the University of California-Davis. A TIA was used as the reference method. We also evaluated the effect of haematocrit (HCT). The POC test was linear for SAA concentrations of up to at least 1000 μg/mL (r = 0.991). Intra-assay CVs were 13, 18 and 15% at high (782 μg/mL), intermediate (116 μg/mL) and low (64 μg/mL) concentrations. Inter-assay (inter-batch) CVs were 45, 14 and 15% at high (1372 μg/mL), intermediate (140 μg/mL) and low (56 μg/mL) concentrations. SAA results in whole blood were significantly lower than those in serum/plasma (P = 0.0002), but were positively correlated (r = 0.908) and not affected by HCT (P = 0.261); proportional negative bias was observed in samples with SAA>500 μg/mL. The difference between methods exceeded the 95% confidence interval of the combined imprecision of both methods (15%). Analytical validation could not be performed in whole blood, the sample most likely to be used stall side. The POC test has acceptable accuracy and precision in equine serum/plasma with SAA concentrations of up to at least 1000 μg/mL. Low inter-batch precision at high concentrations may affect serial measurements, and the use of the same test batch and sample type (serum/plasma or whole blood) is recommended. Comparison of results between the
Sandhu, Adarsh; Handa, Hiroshi; Abe, Masanori
' 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)
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)
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)
van Delft, Sanne; Goedhart, Annelijn; Spigt, Mark; van Pinxteren, Bart; de Wit, Niek; Hopstaken, Rogier
Point-of-care testing (POCT) urinalysis might reduce errors in (subjective) reading, registration and communication of test results, and might also improve diagnostic outcome and optimise patient management. Evidence is lacking. In the present study, we have studied the analytical performance of automated urinalysis and visual urinalysis compared with a reference standard in routine general practice. The study was performed in six general practitioner (GP) group practices in the Netherlands. Automated urinalysis was compared with visual urinalysis in these practices. Reference testing was performed in a primary care laboratory (Saltro, Utrecht, The Netherlands). Analytical performance of automated and visual urinalysis compared with the reference laboratory method was the primary outcome measure, analysed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and Cohen's κ coefficient for agreement. Secondary outcome measure was the user-friendliness of the POCT analyser. Automated urinalysis by experienced and routinely trained practice assistants in general practice performs as good as visual urinalysis for nitrite, leucocytes and erythrocytes. Agreement for nitrite is high for automated and visual urinalysis. κ's are 0.824 and 0.803 (ranked as very good and good, respectively). Agreement with the central laboratory reference standard for automated and visual urinalysis for leucocytes is rather poor (0.256 for POCT and 0.197 for visual, respectively, ranked as fair and poor). κ's for erythrocytes are higher: 0.517 (automated) and 0.416 (visual), both ranked as moderate. The Urisys 1100 analyser was easy to use and considered to be not prone to flaws. Automated urinalysis performed as good as traditional visual urinalysis on reading of nitrite, leucocytes and erythrocytes in routine general practice. Implementation of automated urinalysis in general practice is justified as automation is expected to reduce
Full Text Available History of present illness: A 57-year-old male with a history of intravenous drug use presented to the emergency department with four days of progressively worsening pain and swelling to his left buttock after injecting heroin subcutaneously (i.e., “skin popping”. Labs were significant for a white blood cell count (WBC of 26,700/mm3. Using the high frequency, linear probe, a point-of-care ultrasound (POCUS was performed and revealed a large soft tissue abscess. Significant findings: POCUS reveals a large, hypoechoic soft tissue abscess with debris and tracks extending to the bottom of the image. Furthermore, when compressed, movement of the abscess contents is appreciated. There is also superficial cobble-stoning consistent with overlying cellulitis and soft tissue edema. Discussion: In the United States, there are over 14 million outpatient visits per year related to soft tissue infections, with nearly one-third being seen in the emergency department.1,2 22%-65% of intravenous drug users experience abscesses and cellulitis.3 Soft tissue abscesses are commonly encountered in the emergency department and the diagnosis is often made by history and physical exam.5 However, imaging modalities are more accurate than physical exam alone. When comparing ultrasound to physical exam in the diagnosis of soft tissue abscesses, one study suggests that ultrasound has a sensitivity and specificity of 96% and 87%, respectively. The sensitivity and specificity of the physical exam is 84% and 60%, respectively.4 Another study comparing computed tomography (CT to ultrasound in the diagnosis of abscesses found ultrasound to have a sensitivity and specificity of 96.7% and 85.7%, respectively, while the overall sensitivity and specificity of CT was 76.7% and 91.4%, respectively. Ultrasound was superior in overall image detail ratings and demonstrated more visible detail within the abscess cavity. 5 When utilizing POCUS to evaluate for an abscess, look for an
Toskin, Igor; Blondeel, Karel; Peeling, Rosanna W; Deal, Carolyn; Kiarie, James
WHO recognises the global impact of sexually transmitted infections (STIs) on global public health and individual sexual and reproductive health and well-being. As a component of the WHO Global Health Sector Strategy for the control and prevention of STIs, there has been a growing recognition of the importance of integrating point-of-care tests (POCTs) into overall strategic planning. The process of integrating STI POCTs, in addition to providing a definitive diagnosis and appropriate treatment in a single visit, also includes innovative delivery options, such as on-site delivery, community-based testing (including screening), as well as self-testing at home after purchase of a test online or over-the-counter. WHO organised two technical consultations in May 2014 and July 2015. This article summarises the discussions of the meeting participants on advancing the use of POCTs to control and prevent STIs. The following priorities were identified: the need for pathogens' target discovery; encouragement of multiplexing, miniaturisation, simplification and connectivity; promotion of standardisation of evaluation of new diagnostic platforms across all stages of the evaluation pipeline; the need for an investment case, modelling and scenarios to ensure buy-in among key stakeholders, including developers and the private sector; the need for norms and standards, including guidelines, to support introduction of STI POCTs in programmes; anticipating potential tensions between different parties at the implementation level; and leveraging on the global initiative, Sustainable Development Goals (SDGs)/global health sector STI strategy, to sustain investment in STI POCT programmes. There is a rich pipeline of diagnostic products, but some have stalled in development. An approach to accelerate the evaluation of new diagnostics is to set up a competent network of evaluation sites ahead of time, harmonise regulatory approval processes with development of models to estimate cost
Todsen, Tobias; Jensen, Morten Lind; Tolsgaard, Martin Grønnebæk
BACKGROUND: Clinicians are increasingly using point-of-care ultrasonography for bedside examinations of patients. However, proper training is needed in this technique, and it is unknown whether the skills learned from focused Ultrasonography courses are being transferred to diagnostic performance...... test and binary logistic regression, respectively. RESULTS: There was a significant difference in the performance score between the intervention group (27.4%) and the control group (18.0%, P = .004) and the diagnostic accuracy between the intervention group (65%) and the control group (39%, P = .014......). CONCLUSIONS: Clinicians could successfully transfer learning from an Ultrasonography course to improve diagnostic performance on patients. However, our results also indicate a need for more training when new technologies such as point-of-care ultrasonography are introduced....
With the rising number of patients who rely on medical care, it is necessary to use evolving health care technology appropriately, to control health care costs, and to enhance the well-being of patients in the home care setting. Point of care testing (POCT)is instrumental system for such demands for home care; however, this term remains relatively unknown in Japan. For this research, I conducted a qualitative analysis of factors based on stories obtained through group interviews of 11 experienced home visiting nurses who work at three home-visit nursing stations for the purpose of clarifying issues in the introduction of POCT. The results of the research identified five categories and 16 subcategories for issues in the introduction of POCT. The identified categories are expected to be useful for the spread of POCT in the future. Key words: Point of care testing, Home care nursing.
Daniel C. Kolinsky
Full Text Available Minoxidil is a strong oral vasodilator that is used to treat patients with hypertension refractory to first-line medications. We report a case of minoxidil-associated subacute cardiac tamponade diagnosed by point-of-care ultrasound (POCUS in a hypertensive patient. A 30-year-old male with a past medical history of poorly controlled hypertension (treated with minoxidil and chronic kidney disease presented with 2–3 days of chest pain and shortness of breath with markedly elevated blood pressures. A point-of-care transthoracic echocardiogram revealed a massive pericardial effusion with sonographic tamponade physiology. We review the risk factors for developing pericardial effusions that progress to cardiac tamponade, the utility of diagnosing these patients by POCUS, and the incidence of patients who present with sonographic signs of cardiac tamponade without hypotension.
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.
Saldarriaga, Enrique M; Vodicka, Elisabeth; La Rosa, Sayda; Valderrama, Maria; Garcia, Patricia J
Prevention and control of chronic diseases is a high priority for many low- and middle-income countries. This study evaluated the feasibility and acceptability of training pharmacy workers to provide point-of-care testing for 3 chronic diseases-hypertension, diabetes, and anemia-to improve disease detection and awareness through private pharmacies. We developed a multiphase training curriculum for pharmacists and pharmacy technicians to build capacity for identification of risk factors, patient education, point-of-care testing, and referral for abnormal results. We conducted a pre-post evaluation with participants and evaluated results using Student t test for proportions. We conducted point-of-care testing with pharmacy clients and evaluated acceptability by patient characteristics (age, gender, and type of patient) using multiple logistic regression. In total, 72 pharmacy workers (66%) completed the full training curriculum. Pretest scores indicated that pharmacists had more knowledge and skills in chronic disease risk factors, patient education, and testing than pharmacy technicians. All participants improved their knowledge and skills after the training, and post-test scores indicated that pharmacy technicians achieved the same level of competency as pharmacists (P anemia than a traditional health center. Fast service was very important: 41% ranked faster results and 30% ranked faster attention as the most important factor for receiving diagnostic testing in the pharmacy. We found that it is both feasible for pharmacies and acceptable to clients to train pharmacy workers to provide point-of-care testing for anemia, diabetes, and hypertension. This innovative approach holds potential to increase early detection of risk factors and bolster disease prevention and management efforts in Peru and other low- and middle-income settings. Copyright © 2017. Published by Elsevier Inc.
Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent
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...... practices using INR POCT in the management of patients in warfarin treatment provided good quality of care. Sampling interval and diagnostic coding were significantly correlated with treatment quality....
Grant, D.A.; Dunseath, G.J.; Churm, R.; Luzio, S.D.
Aims: As the use of Point of Care Testing (POCT) devices for measurement of glycated haemoglobin (HbA1c) increases, it is imperative to determine how their performance compares to laboratory methods. This study compared the performance of the automated Quo-Test POCT device (EKF Diagnostics), which uses boronate fluorescence quenching technology, with a laboratory based High Performance Liquid Chromatography (HPLC) method (Biorad D10) for measurement of HbA1c. Methods: Whole blood EDTA samples...
Mazzotta, Cosimo; Traversi, Claudio; Mellace, Pierfrancesco; Bagaglia, Simone A; Zuccarini, Silvio; Mencucci, Rita; Jacob, Soosan
To assess keratoconus (KC) progression in patients with allergies who also tested positive to surface matrix metalloproteinase 9 (MMP-9) point-of-care test. Prospective comparative study including 100 stage I-II keratoconic patients, mean age 16.7±4.6 years. All patients underwent an anamnestic questionnaire for concomitant allergic diseases and were screened with the MMP-9 point-of-care test. Patients were divided into two groups: patients KC with allergies (KC AL) and patients KC without allergies (KC NAL). Severity of allergy was established by papillary subtarsal response grade and KC progression assessed by Scheimpflug corneal tomography, corrected distance visual acuity (CDVA) measurement in a 12-month follow-up. The KC AL group included 52 patients and the KC NAL group 48. In the KC AL group, 42/52 of patients (81%) were positive to MMP-9 point-of-care test versus two positive patients in the KC NAL group (4%). The KC AL group data showed a statistically significant decrease of average CDVA, from 0.155±0.11 to 0.301±0.2 logarithm of the minimum angle of resolution (Paverage. The KC NAL group revealed a slight KC progression without statistically significant changes. Pearson correlation test showed a high correlation between Kmax worsening and severity of PSR in the KC AL group. The study demonstrated a statistically significant progression of KC in patients with concomitant allergies, positive to MMP-9 point-of-care test versus negative. A high correlation between severity of allergy and KC progression was documented.
Novo, P; Chu, V; Conde, J P
The miniaturization of biosensors using microfluidics has potential in enabling the development of point-of-care devices, with the added advantages of reduced time and cost of analysis with limits-of-detection comparable to those obtained through traditional laboratory techniques. Interfacing microfluidic devices with the external world can be difficult especially in aspects involving fluid handling and the need for simple sample insertion that avoids special equipment or trained personnel. In this work we present a point-of-care prototype system by integrating capillary microfluidics with a microfabricated photodiode array and electronic instrumentation into a hand-held unit. The capillary microfluidic device is capable of autonomous and sequential fluid flow, including control of the average fluid velocity at any given point of the analysis. To demonstrate the functionality of the prototype, a model chemiluminescence ELISA was performed. The performance of the integrated optical detection in the point-of-care prototype is equal to that obtained with traditional bench-top instrumentation. The photodiode signals were acquired, displayed and processed by a simple graphical user interface using a computer connected to the microcontroller through USB. The prototype performed integrated chemiluminescence ELISA detection in about 15 min with a limit-of-detection of ≈2 nM with an antibody-antigen affinity constant of ≈2×10(7) M(-1). Copyright © 2014 Elsevier B.V. All rights reserved.
van de Wetering, G.; Hummel, J. Marjan; van Montfort, Augustinus P.W.P.; Montfoort, A.; IJzerman, Maarten Joost
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
Schols, Angel M R; Dinant, Geert-Jan; Hopstaken, Rogier; Price, Christopher P; Kusters, Ron; Cals, Jochen W L
The use of point-of-care tests (POCTs) in family practice is increasing, and the term POCT is often used in medical literature and clinical practice. Yet, no widely supported definition by several professional fields exists. To reach consensus on an international definition of a POCT in family practice. We performed a modified international e-Delphi procedure of four rounds among expert panel members from different professional backgrounds-family practitioners, laboratory specialists, policymakers, researchers and manufacturers. Of 27 panel members from seven different countries, 26 participated in all rounds. Most panel members were active in POCT research or policymaking and 70% worked in family medicine. After choosing important components, structuring of answers and feedback, the following definition was chosen as the best or second best definition by 81% of panel members: a point-of-care test in family practice is a test to support clinical decision making, which is performed by a qualified member of the practice staff nearby the patient and on any part of the patient's body or its derivatives, during or very close to the time of consultation, to help the patient and physician to decide upon the best suited approach, and of which the results should be known at the time of the clinical decision making. The definition emerging from this study can inform family practitioners, laboratory specialists, policymakers and manufacturers on the most widely supported and recognized definition and could act as a clear starting point for the organization and execution of professional point-of-care testing in family practice worldwide. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: email@example.com.
Severe hypoglycemia (SH) is a common problem in type 1 diabetes (T1D). Annually, nearly 1 of 5 persons with long-standing T1D will have SH. Though injections of glucagon are effective in treating SH, liquid formulations of glucagon are biochemically very unstable. For this reason, available preparations of glucagon are lyophilized; the powder and the diluent must be mixed at the point of care prior to administration and any remaining drug must be discarded. The process of mixing and delivery ...
Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent
collected retrospectively for a period of six months. For each patient, time in therapeutic range (TTR) was calculated and correlated with practice and patient characteristics using multilevel linear regression models. RESULTS: We identified 447 patients in warfarin treatment in the 20 practices using POCT......INTRODUCTION: Oral anticoagulation treatment (OACT) with warfarin is common in general practice. Increasingly, international normalised ratio (INR) point of care testing (POCT) is being used to manage patients. The aim of this study was to describe and analyse the quality of OACT with warfarin...
Haenssgen, Marco J; Charoenboon, Nutcha; Althaus, Thomas; Greer, Rachel C; Intralawan, Daranee; Lubell, Yoel
New and affordable point-of-care testing (POCT) solutions are hoped to guide antibiotic prescription and to help limit antimicrobial resistance (AMR)-especially in low- and middle-income countries where resource constraints often prevent extensive diagnostic testing. Anthropological and sociological research has illuminated the role and impact of rapid point-of-care malaria testing. This paper expands our knowledge about the social implications of non-malarial POCT, using the case study of a C-reactive-protein point-of-care testing (CRP POCT) clinical trial with febrile patients at primary-care-level health centres in Chiang Rai province, northern Thailand. We investigate the social role of CRP POCT through its interactions with (a) the healthcare workers who use it, (b) the patients whose routine care is affected by the test, and (c) the existing patient-health system linkages that might resonate or interfere with CRP POCT. We conduct a thematic analysis of data from 58 purposively sampled pre- and post-intervention patients and healthcare workers in August 2016 and May 2017. We find widespread positive attitudes towards the test among patients and healthcare workers. Patients' views are influenced by an understanding of CRP POCT as a comprehensive blood test that provides specific diagnosis and that corresponds to notions of good care. Healthcare workers use the test to support their negotiations with patients but also to legitimise ethical decisions in an increasingly restrictive antibiotic policy environment. We hypothesise that CRP POCT could entail greater patient adherence to recommended antibiotic treatment, but it could also encourage riskier health behaviour and entail potentially adverse equity implications for patients across generations and socioeconomic strata. Our empirical findings inform the clinical literature on increasingly propagated point-of-care biomarker tests to guide antibiotic prescriptions, and we contribute to the anthropological and
Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent
INTRODUCTION: Oral anticoagulation treatment (OACT)with warfarin is common in general practice. Increasingly,international normalised ratio (INR) point of care testing(POCT) is being used to manage patients. The aim of thisstudy was to describe and analyse the quality of OACT withwarfarin...... in 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...
Kang, Jeeun; Yoon, Changhan; Lee, Jaejin; Kye, Sang-Bum; Lee, Yongbae; Chang, Jin Ho; Kim, Gi-Duck; Yoo, Yangmo; Song, Tai-kyong
In this paper, we present a novel system-on-chip (SOC) solution for a portable ultrasound imaging system (PUS) for point-of-care applications. The PUS-SOC includes all of the signal processing modules (i.e., the transmit and dynamic receive beamformer modules, mid- and back-end processors, and color Doppler processors) as well as an efficient architecture for hardware-based imaging methods (e.g., dynamic delay calculation, multi-beamforming, and coded excitation and compression). The PUS-SOC was fabricated using a UMC 130-nm NAND process and has 16.8 GFLOPS of computing power with a total equivalent gate count of 12.1 million, which is comparable to a Pentium-4 CPU. The size and power consumption of the PUS-SOC are 27×27 mm(2) and 1.2 W, respectively. Based on the PUS-SOC, a prototype hand-held US imaging system was implemented. Phantom experiments demonstrated that the PUS-SOC can provide appropriate image quality for point-of-care applications with a compact PDA size ( 200×120×45 mm(3)) and 3 hours of battery life.
Herbert, R; Ashraf, A N; Yates, T A; Spriggs, K; Malinnag, M; Durward-Brown, E; Phillips, D; Mewse, E; Daniel, A; Armstrong, M; Kidd, I M; Waite, J; Wilks, P; Burns, F; Bailey, R; Brown, M
Early diagnosis of HIV infection reduces morbidity and mortality associated with late presentation. Despite UK guidelines, the HIV testing rate has not increased. We have introduced universal HIV screening in an open-access returning traveller clinic. Data were prospectively recorded for all patients attending the open-access returning traveller clinic between August 2008 and December 2010. HIV testing was offered to all patients from May 2009; initially testing with laboratory samples (phase 1) and subsequently a point-of-care test (POCT) (phase 2). A total of 4965 patients attended the clinic; 1342 in phase 0, 792 in phase 1 and 2831 in phase 2. Testing rates for HIV increased significantly from 2% (38 of 1342) in phase 0 to 23.1% (183 of 792) in phase 1 and further increased to 44.5% (1261 of 2831) during phase 2 (P travelling to the Middle East and Europe were less likely to accept an HIV test with POCT. A nurse-delivered universal point-of-care HIV testing service has been successfully introduced and sustained in an acute medical clinic in a low-prevalence country. Caution is required in communicating reactive results in low-prevalence settings where there may be alternative diagnoses or a low population prevalence of HIV infection. © 2012 British HIV Association.
Linda C. Rogers
Full Text Available Objective Accurate and timely diagnosis of rupture of membranes (ROM is imperative to allow for gestational age-specific interventions. This study compared the diagnostic performance characteristics between two methods used for the detection of ROM as measured in the same patient. Methods Vaginal secretions were evaluated using the conventional fern test as well as a point-of-care monoclonal/polyclonal immunoassay test (ROM Plus® in 75 pregnant patients who presented to labor and delivery with complaints of leaking amniotic fluid. Both tests were compared to analytical confirmation of ROM using three external laboratory tests. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV, negative predictive value (NPV, and accuracy. Results Diagnostic performance characteristics uniformly favored ROM detection using the immunoassay test compared to the fern test: sensitivity (100% vs. 77.8%, specificity (94.8% vs. 79.3%, PPV (75% vs. 36.8%, NPV (100% vs. 95.8%, and accuracy (95.5% vs. 79.1%. Conclusions The point-of-care immunoassay test provides improved diagnostic accuracy for the detection of ROM compared to fern testing. It has the potential of improving patient management decisions, thereby minimizing serious complications and perinatal morbidity.
Yao, Jianchu; Schmitz, Ryan; Warren, Steve
A point-of-care system for continuous health monitoring should be wearable, easy to use, and affordable to promote patient independence and facilitate acceptance of new home healthcare technology. Reconfigurability, interoperability, and scalability are important. Standardization supports these requirements, and encourages an open market where lower product prices result from vendor competition. This paper first discusses candidate standards for wireless communication, plug-and-play device interoperability, and medical information exchange in point-of-care systems. It then addresses the design and implementation of a wearable, plug-and-play system for home care which adopts the IEEE 1073 Medical Information Bus (MIB) standards, and uses Bluetooth as the wireless communication protocol. This standards-based system maximizes user mobility by incorporating a three-level architecture populated by base stations, wearable data loggers, and wearable sensors. Design issues include the implementation of the MIB standards on microcontroller-driven embedded devices, low power consumption, wireless data exchange, and data storage and transmission in a reconfigurable body-area network.
Mollenkopf, Maximilian; Tait, Noel
Point-of-care ultrasound scanning or POCUS is a focused ultrasound (US) scan, performed by non-imaging clinicians during physical examination, an invasive procedure or surgery. As this technology becomes cheaper, smaller and easier to use, its scope for use by surgeons grows, a trend that may generate a gap between use and training. Opportunities for enhanced general surgery skill sets may be reduced unless consideration is given to inclusion of POCUS in general surgery training. To stimulate discussion regarding inclusion of POCUS in the general surgery curriculum; to resource this discussion with an overview of current trends and issues around POCUS; and to discuss concerns and controversies that may arise if POCUS was adopted into general surgery training. A literature search was performed using PUBMED, MEDLINE, Google and Google Scholar, using the terms 'ultrasound', 'point-of-care-ultrasound', 'bedside ultrasound', 'portable ultrasound' and 'hand-held ultrasound'. Literature, references and non-literature resources found were reviewed for relevance to US education in general surgery. Increasingly, medical students are graduating with basic POCUS skills. Specialty-specific uses of POCUS are proliferating. Training and assessment resources are not keeping up, in accessibility or standardization. A learned surgical college led training and accreditation process would require aligned education in anatomy and US technology and collaboration with the specialist imaging community to ensure appropriate standards are clarified and met. Research is also required into how general surgery trainees can best achieve and maintain POCUS competence. © 2013 Royal Australasian College of Surgeons.
Full Text Available Background. Traumatic Pneumothorax (PTX is a potentially life-threatening injury. It requires a fast and accurate diagnosis and treatment, but diagnostic tools are limited. A new point-of-care device (PneumoScan based on micropower impulse radar (MIR promises to diagnose a PTX within seconds. In this study, we compare standard diagnostics with PneumoScan during shock-trauma-room management. Patients and Methods. Patients with blunt or penetrating chest trauma were consecutively included in the study. All patients were examined including clinical examination with auscultation (CE and supine chest radiography (CXR. In addition, PneumoScan-readings and thoracic ultrasound scan (US were performed. Computed tomography (CT served as gold standard. Results. CT scan revealed PTX in 11 patients. PneumoScan detected two PTX correctly but missed nine. 15 false-positive results were found by PneumoScan, leading to a sensitivity of 20% and specificity of 80%. Six PTX were detected through CE (sensitivity: 54,5%. CXR detected four (sensitivity: 27,3% and thoracic US two PTX correctly (sensitivity: 25%. Conclusion. The unblinded PneumoScan prototype did not confirm the promising results of previous studies. The examined standard diagnostics and thoracic US showed rather weak sensitivity as well. Until now, there is no appropriate point-of-care tool to rule out PTX.
Gao, Yali; Lam, Albert W Y; Chan, Warren C W
The impact of detecting multiple infectious diseases simultaneously at point-of-care with good sensitivity, specificity, and reproducibility would be enormous for containing the spread of diseases in both resource-limited and rich countries. Many barcoding technologies have been introduced for addressing this need as barcodes can be applied to detecting thousands of genetic and protein biomarkers simultaneously. However, the assay process is not automated and is tedious and requires skilled technicians. Barcoding technology is currently limited to use in resource-rich settings. Here we used magnetism and microfluidics technology to automate the multiple steps in a quantum dot barcode assay. The quantum dot-barcoded microbeads are sequentially (a) introduced into the chip, (b) magnetically moved to a stream containing target molecules, (c) moved back to the original stream containing secondary probes, (d) washed, and (e) finally aligned for detection. The assay requires 20 min, has a limit of detection of 1.2 nM, and can detect genetic targets for HIV, hepatitis B, and syphilis. This study provides a simple strategy to automate the entire barcode assay process and moves barcoding technologies one step closer to point-of-care applications.
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.
Nelson, Bret P; Hojsak, Joanne; Dei Rossi, Elizabeth; Karani, Reena; Narula, Jagat
Point-of-care ultrasound has been a novel addition to undergraduate medical education at a few medical schools. The impact is not fully understood, and few rigorous assessments of educational outcomes exist. This study assessed the impact of a point-of-care ultrasound curriculum on image acquisition, interpretation, and student and faculty perceptions of the course. All 142 first-year medical students completed a curriculum on ultrasound physics and instrumentation, cardiac, thoracic, and abdominal imaging. A flipped classroom model of preclass tutorials and tests augmenting live, hands-on scanning sessions was incorporated into the physical examination course. Students and faculty completed surveys on impressions of the curriculum, and all students under-went competency assessments with standardized patients. The curriculum was a mandatory part of the physical examination course and was taught by experienced clinician-sonographers as well as faculty who do not routinely perform sonography in their clinical practice. Students and faculty agreed that the physical examination course was the right time to introduce ultrasound (87% and 80%). Students demonstrated proper use of the ultrasound machine functions (M score = 91.55), and cardiac, thoracic, and abdominal system assessments (M score = 80.35, 79.58, and 71.57, respectively). Students and faculty valued the curriculum, and students demonstrated basic competency in performance and interpretation of ultrasound. Further study is needed to determine how to best incorporate this emerging technology into a robust learning experience for medical students.
Leis, Jerome A; Palmay, Lesley; Ho, Grace; Raybardhan, Sumit; Gill, Suzanne; Kan, Tiffany; Campbell, Jackie; Kiss, Alex; McCready, Janine B; Das, Pavani; Minnema, Brian; Powis, Jeff E; Walker, Sandra A N; Ferguson, Heather; Wong, Benny; Weber, Elizabeth
Beta-lactam allergy skin testing (BLAST) is recommended by antimicrobial stewardship program (ASP) guidelines, yet few studies have systematically evaluated its impact when delivered at point-of-care. We conducted a pragmatic multicenter prospective evaluation of the use of point-of-care BLAST by ASPs. In staggered 3-month intervals, ASP teams at three hospitals received training by allergists to offer BLAST for eligible patients with infectious diseases receiving non-preferred beta-lactam therapy due to severity of their allergy. The primary outcome was the proportion of patients receiving the preferred beta-lactam therapy. Of 827 patients with reported beta-lactam allergy over 15-months, beta-lactam therapy was preferred among 632(76%). During baseline periods, 50% (124/246) received preferred beta-lactam therapy based on history, compared with 60% (232/386) during the intervention periods (p=0.02), which improved further to 81% (313/386) upon provision of BLAST (pcare across three hospital ASPs resulted in greater use of preferred beta-lactam therapy without increasing the risk of adverse drug reactions. Longer term studies are needed to better assess the safety and clinical impact of this ASP intervention. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: firstname.lastname@example.org.
Cui, Xingye; Hu, Jie; Choi, Jane Ru; Huang, Yalin; Wang, Xuemin [The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Science and Technology, Xi' an Jiaotong University, Xi' an, 710049 (China); Bioinspired Engineering and Biomechanics Center (BEBC), Xi' an Jiaotong University, Xi' an, 710049 (China); Lu, Tian Jian, E-mail: email@example.com [Bioinspired Engineering and Biomechanics Center (BEBC), Xi' an Jiaotong University, Xi' an, 710049 (China); Xu, Feng, E-mail: firstname.lastname@example.org [The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Science and Technology, Xi' an Jiaotong University, Xi' an, 710049 (China); Bioinspired Engineering and Biomechanics Center (BEBC), Xi' an Jiaotong University, Xi' an, 710049 (China)
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. - Highlights: • The meter chip is a standalone point-of-care diagnostic tool with visible readouts of quantification results. • A fast and low cost fabrication protocol (~3 min and ~$0.2 per chip) of meter chip was proposed. • The chip may hold the potential for rapid scaning of bovine mastitis in cattle farms for food safety control.
Cui, Xingye; Hu, Jie; Choi, Jane Ru; Huang, Yalin; Wang, Xuemin; Lu, Tian Jian; Xu, Feng
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. - Highlights: • The meter chip is a standalone point-of-care diagnostic tool with visible readouts of quantification results. • A fast and low cost fabrication protocol (~3 min and ~$0.2 per chip) of meter chip was proposed. • The chip may hold the potential for rapid scaning of bovine mastitis in cattle farms for food safety control.
Westman, Mark E; Malik, Richard; Hall, Evelyn; Sheehy, Paul A; Norris, Jacqueline M
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. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
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.
Smart, Luke R; Ambrose, Emmanuela E; Raphael, Kevin C; Hokororo, Adolfine; Kamugisha, Erasmus; Tyburski, Erika A; Lam, Wilbur A; Ware, Russell E; McGann, Patrick T
Both anemia and sickle cell disease (SCD) are highly prevalent across sub-Saharan Africa, and limited resources exist to diagnose these conditions quickly and accurately. The development of simple, inexpensive, and accurate point-of-care (POC) assays represents an important advance for global hematology, one that could facilitate timely and life-saving medical interventions. In this prospective study, Robust Assays for Point-of-care Identification of Disease (RAPID), we simultaneously evaluated a POC immunoassay (Sickle SCAN™) to diagnose SCD and a first-generation POC color-based assay to detect anemia. Performed at Bugando Medical Center in Mwanza, Tanzania, RAPID tested 752 participants (age 1 day to 20 years) in four busy clinical locations. With minimally trained medical staff, the SCD POC assay diagnosed SCD with 98.1% sensitivity and 91.1% specificity. The hemoglobin POC assay had 83.2% sensitivity and 74.5% specificity for detection of severe anemia (Hb ≤ 7 g/dL). Interobserver agreement was excellent for both POC assays (r = 0.95-0.96). Results for the hemoglobin POC assay have informed the second-generation assay design to be more suitable for low-resource settings. RAPID provides practical feasibility data regarding two novel POC assays for the diagnosis of anemia and SCD in real-world field evaluations and documents the utility and potential impact of these POC assays for sub-Saharan Africa.
Conclusion: Our results met standard requirements and the 12 analyzers were assessed as suitable for point-of-care testing in services of academic medical centers, as exemplified at Clermont-Ferrand hospital.
Shah, Kevin; Terracciano, Garrett J; Jiang, Kevin; Maisel, Alan S; Fitzgerald, Robert L
Objectives: Heart failure is one of the leading causes of death in the U.S. The incorporation of B-type natriuretic peptide (BNP) measurements when triaging patients presenting with shortness of breath has improved the diagnostic and prognostic ability of physicians. Currently, there are no point-of-care systems for quantifying BNP that can be used without sacrificing accuracy. We compared the analytical performance of the Abbott i-STAT analyzer, a handheld point-of-care system for measuring ...
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
Matthew Fields, J; Davis, Joshua; Alsup, Carl; Bates, Amanda; Au, Arthur; Adhikari, Srikar; Farrell, Isaac
The use of ultrasonography (US) to diagnose appendicitis is well established. More recently, point-of-care ultrasonography (POCUS) has also been studied for the diagnosis of appendicitis, which may also prove a valuable diagnostic tool. The purpose of this study was through systematic review and meta-analysis to identify the test characteristics of POCUS, specifically US performed by a nonradiologist physician, in accurately diagnosing acute appendicitis in patients of any age. We conducted a thorough and systematic literature search of English language articles published on point-of-care, physician-performed transabdominal US used for the diagnosis of acute appendicitis from 1980 to May, 2015 using OVID MEDLINE In-Process & Other Non-indexed Citations and Scopus. Studies were selected and subsequently independently abstracted by two trained reviewers. A random-effects pooled analysis was used to construct a hierarchical summary receiver operator characteristic curve, and a meta-regression was performed. Quality of studies was assessed using the QUADAS-2 tool. Our search yielded 5,792 unique studies and we included 21 of these in our final review. Prevalence of disease in this study was 29.8%, (range = 6.4%-75.4%). The sensitivity and specificity for POCUS in diagnosing appendicitis were 91% (95% confidence interval [CI] = 83%-96%) and 97% (95% CI = 91%-99%), respectively. The positive and negative predictive values were 91 and 94%, respectively. Studies performed by emergency physicians had slightly lower test characteristics (sensitivity = 80%, specificity = 92%). There was significant heterogeneity between studies (I 2 = 99%, 95% CI = 99%-100%) and the quality of the reported studies was moderate, mostly due to unclear reporting of blinding of physicians and timing of scanning and patient enrollment. Several of the studies were performed by a single operator, and the education and training of the operators were variably reported. Point-of-care US has relatively
Tricoli, Antonio; Neri, Giovanni
This review reports the latest achievements in point-of-care (POC) sensor technologies for the monitoring of ammonia, creatinine and urea in patients suffering of chronic kidney diseases (CKDs). Abnormal levels of these nitrogen biomarkers are found in the physiological fluids, such as blood, urine and sweat, of CKD patients. Delocalized at-home monitoring of CKD biomarkers via integration of miniaturized, portable, and low cost chemical- and bio-sensors in POC devices, is an emerging approach to improve patients' health monitoring and life quality. The successful monitoring of CKD biomarkers, performed on the different body fluids by means of sensors having strict requirements in term of size, cost, large-scale production capacity, response time and simple operation procedures for use in POC devices, is reported and discussed.
Full Text Available This review reports the latest achievements in point-of-care (POC sensor technologies for the monitoring of ammonia, creatinine and urea in patients suffering of chronic kidney diseases (CKDs. Abnormal levels of these nitrogen biomarkers are found in the physiological fluids, such as blood, urine and sweat, of CKD patients. Delocalized at-home monitoring of CKD biomarkers via integration of miniaturized, portable, and low cost chemical- and bio-sensors in POC devices, is an emerging approach to improve patients’ health monitoring and life quality. The successful monitoring of CKD biomarkers, performed on the different body fluids by means of sensors having strict requirements in term of size, cost, large-scale production capacity, response time and simple operation procedures for use in POC devices, is reported and discussed.
Barbosa, Cátia; Dong, Tao
Due to great use of touchscreens in mobile telephones and other electronic devices, there has been great evolution in this technology. Its wide applicability makes the touch sensor technology suitable for detection of specific components in urine, responsible for urinary tract infection (UTI). Integration of a touch sensor in a disposable probe tip to be used in UTI detection represents a powerful tool to develop new point-of-care testing (POCT) devices. The simplified structure of an electrodes array touch screen was simulated using the software COMSOL Multiphysics to prove that capacitive based touch screens can be used for detection of UTI. Besides we assumed presence of E.coli, one of the major causes of UTI urine. Results show that global capacitance increases if an E.coli sphere is present near the active electrodes, remaining approximately constant when further apart electrodes are excited. The output simulated voltage varies according to the capacitance value, decreasing when the capacitance is increased.
Elfer, Katherine; Sholl, Andrew; Miller, Christopher; Brown, J. Quincy
Histological assessment of freshly removed tissue specimens requires accurate and fast analysis in clinical procedures such as diagnostic biopsy and surgical tumor resection. Current histological assessment methods are either time-consuming or damage the tissue beyond the ability to re-analyze post-procedure. We demonstrate a novel dual-stain fluorescent analogue to brightfield Hematoxylin and Eosin for in-procedure histopathology that is both time-efficient and preserves the analyzed tissue for later analysis. H&E-like images are created from the combination of DRAQ5 and Eosin applied to human prostate tissue and animal muscle tissue under confocal microscopy. D&E images are pseduocolored to match H&E coloring, showing near-identical features to brightfield H&E of the same tissue. The histological accuracy, short staining time, and tissue preservation aspects of this dual-stain technique demonstrates its potential to be adopted for use in point-of-care pathology.
Menychtas, Andreas; Tsanakas, Panayiotis
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. PMID:27222731
Corti, Caspar; Fally, Markus; Fabricius-Bjerre, Andreas
BACKGROUND: This study was conducted to investigate whether point-of-care (POC) procalcitonin (PCT) measurement can reduce redundant antibiotic treatment in patients hospitalized with acute exacerbation of COPD (AECOPD). METHODS: One-hundred and twenty adult patients admitted with AECOPD were...... in the PCT-arm vs 8.5 (IQR 1-11) days in the control arm (P=0.0169, Wilcoxon) for the intention-to-treat population. The proportion of patients using antibiotics for ≥5 days within the 28-day follow-up was 41.9% (PCT-arm) vs 67.2% (P=0.006, Fisher's exact) in the intention-to-treat population. For the per...... no apparent difference. CONCLUSION: Our study shows that the implementation of a POC PCT-guided algorithm can be used to substantially reduce antibiotic exposure in patients hospitalized with AECOPD, with no apparent harm....
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.
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.
Tsakalakis, Michail; Bourbakis, Nicolaos G
Continuous, real-time remote monitoring through medical point--of--care (POC) systems appears to draw the interest of the scientific community for healthcare monitoring and diagnostic applications the last decades. Towards this direction a significant merit has been due to the advancements in several scientific fields. Portable, wearable and implantable apparatus may contribute to the betterment of today's healthcare system which suffers from fundamental hindrances. The number and heterogeneity of such devices and systems regarding both software and hardware components, i.e sensors, antennas, acquisition circuits, as well as the medical applications that are designed for, is impressive. Objective of the current study is to present the major technological advancements that are considered to be the driving forces in the design of such systems, to briefly state the new aspects they can deliver in healthcare and finally, the identification, categorization and a first level evaluation of them.
Menychtas, Andreas; Tsanakas, Panayiotis; Maglogiannis, Ilias
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.
Marimuthu, Mohana; Kandasamy, Karthikeyan; Ahn, Chang Geun; Sung, Gun Yong; Kim, Min-Gon; Kim, Sanghyo
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.
Furlan, Andrea D; Reardon, Rhoda; Salach, Lena
The Opioid Manager is designed to be used as a point-of-care tool for providers prescribing opioids for chronic noncancer pain. It condenses the key elements from the Canadian Opioid Guideline and can be used as a chart insert. The Opioid Manager has been validated and is available for download from the Guideline's Web site http://nationalpaincentre.mcmaster.ca/opioidmanager/. The Opioid Manager is divided into the following four parts: A) before you write the first script, B) initiation trial, C) maintenance and monitoring, and D) when is it time to decrease the dose or stop the opioid completely? The Opioid Manager has been downloaded by 1,432 users: 47 percent family physicians, 18 percent pharmacists, 13 percent other physicians, and 22 percent miscellaneous. To show how to use the Opioid Manager, the authors created a 10-minute video that is available on the Internet. The Opioid Manager is being translated to French, Spanish, Portuguese, and Farsi.
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.
Remco van Horssen
Full Text Available Objectives: Lactate is a major parameter in medical decision making. During labor, it is an indicator for fetal acidosis and immediate intervention. In the Emergency Department (ED, rapid analysis of lactate/blood gas is crucial for optimal patient care. Our objectives were to cross-compare-for the first time-two point-of-care testing (POCT lactate devices with routine laboratory results using novel tight precision targets and evaluate different lactate cut-off concentrations to predict metabolic acidosis. Design and methods: Blood samples from the delivery room (n=66 and from the ED (n=85 were analyzed on two POCT devices, the StatStrip-Lactate (Nova Biomedical and the iSTAT-1 (CG4+ cassettes, Abbott, and compared to the routine laboratory analyzer (ABL-735, Radiometer. Lactate concentrations were cross-compared between these analyzers. Results: The StatStrip correlated well with the ABL-735 (R=0.9737 and with the iSTAT-1 (R=0.9774 for lactate in umbilical cord blood. Lactate concentrations in ED samples measured on the iSTAT-1 and ABL-735 showed a correlation coefficient of R=0.9953. Analytical imprecision was excellent for lactate and pH, while for pO2 and pCO2 the coefficient of variation was relatively high using the iSTAT-1. Conclusion: Both POCT devices showed adequate analytical performance to measure lactate. The StatStrip can indicate metabolic acidosis in 1 Î¼l blood and will be implemented at the delivery room. Keywords: Lactate, Point-of-care testing, Blood gas, Fetal acidosis
Levy, J K; Crawford, P Cynda; Tucker, S J
More than 3 million cats in the United States are infected with FeLV or FIV. The cornerstone of control is identification and segregation of infected cats. To compare test performance with well-characterized clinical samples of currently available FeLV antigen/FIV antibody combination test kits. Surplus serum and plasma from diagnostic samples submitted by animal shelters, diagnostic laboratories, veterinary clinics, and cat research colonies. None of the cats had been vaccinated against FIV. The final sample set included 146 FeLV+, 154 FeLV-, 94 FIV+, and 97 FIV- samples. Prospective, blind comparison to a gold standard: Samples were evaluated in 4 different point-of-care tests by ELISA antigen plate tests (FeLV) and virus isolation (FIV) as the reference standards. All test results were visually read by 2 blinded observers. Sensitivity and specificity, respectively, for FeLV were SNAP ® (100%/100%), WITNESS ® (89.0%/95.5%), Anigen ® (91.8%/95.5%), and VetScan ® (85.6%/85.7%). Sensitivity and specificity for FIV were SNAP ® (97.9%/99.0%), WITNESS ® (94.7%/100%), Anigen ® (96.8%/99.0%), and VetScan ® (91.5%/99.0%). The SNAP ® test had the best performance for FeLV, but there were no significant differences for FIV. In typical cat populations with seroprevalence of 1-5%, a majority of positive results reported by most point-of-care test devices would be false-positives. This could result in unnecessary segregation or even euthanasia. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
Weir, Nichola-Jane M; Pattison, Sally H; Kearney, Paddy; Stafford, Bob; Gormley, Gerard J; Crockard, Martin A; Gilpin, Deirdre F; Tunney, Michael M; Hughes, Carmel M
Urinary Tract Infections (UTIs) are common bacterial infections, second only to respiratory tract infections and particularly prevalent within primary care. Conventional detection of UTIs is culture, however, return of results can take between 24 and 72 hours. The introduction of a point of care (POC) test would allow for more timely identification of UTIs, facilitating improved, targeted treatment. This study aimed to obtain consensus on the criteria required for a POC UTI test, to meet patient need within primary care. Criteria for consideration were compiled by the research team. These criteria were validated through a two-round Delphi process, utilising an expert panel of healthcare professionals from across Europe and United States of America. Using web-based questionnaires, panellists recorded their level of agreement with each criterion based on a 5-point Likert Scale, with space for comments. Using median response, interquartile range and comments provided, criteria were accepted/rejected/revised depending on pre-agreed cut-off scores. The first round questionnaire presented thirty-three criteria to the panel, of which 22 were accepted. Consensus was not achieved for the remaining 11 criteria. Following response review, one criterion was removed, while after revision, the remaining 10 criteria entered the second round. Of these, four were subsequently accepted, resulting in 26 criteria considered appropriate for a POC test to detect urinary infections. This study generated an approved set of criteria for a POC test to detect urinary infections. Criteria acceptance and comments provided by the healthcare professionals also supports the development of a multiplex point of care UTI test.
Dedov, Vadim N; Dedova, Irina V
Recent advances in information and communication technology have prompted development of Web-based health tools to promote physical activity, the key component of cardiac rehabilitation and chronic disease management. Mobile apps can facilitate behavioral changes and help in exercise monitoring, although actual training usually takes place away from the point of care in specialized gyms or outdoors. Daily participation in conventional physical activities is expensive, time consuming, and mostly relies on self-management abilities of patients who are typically aged, overweight, and unfit. Facilitation of sustained exercise training at the point of care might improve patient engagement in cardiac rehabilitation. In this study we aimed to test the feasibility of execution and automatic monitoring of several exercise regimens on-site using a Web-enabled leg training system. The MedExercise leg rehabilitation machine was equipped with wireless temperature sensors in order to monitor its usage by the rise of temperature in the resistance unit (Δt°). Personal electronic devices such as laptop computers were fitted with wireless gateways and relevant software was installed to monitor the usage of training machines. Cloud-based software allowed monitoring of participant training over the Internet. Seven healthy participants applied the system at various locations with training protocols typically used in cardiac rehabilitation. The heart rates were measured by fingertip pulse oximeters. Exercising in home chairs, in bed, and under an office desk was made feasible and resulted in an intensity-dependent increase of participants' heart rates and Δt° in training machine temperatures. Participants self-controlled their activities on smart devices, while a supervisor monitored them over the Internet. Individual Δt° reached during 30 minutes of moderate-intensity continuous training averaged 7.8°C (SD 1.6). These Δt° were used as personalized daily doses of exercise with
Bosl, William; Mandel, Joshua; Jonikas, Magdalena; Ramoni, Rachel Badovinac; Kohane, Isaac S; Mandl, Kenneth D
Non-adherence to prescribed medications is a serious health problem in the United States, costing an estimated $100 billion per year. While poor adherence should be addressable with point of care health information technology, integrating new solutions with existing electronic health records (EHR) systems require customization within each organization, which is difficult because of the monolithic software design of most EHR products. The objective of this study was to create a published algorithm for predicting medication adherence problems easily accessible at the point of care through a Web application that runs on the Substitutable Medical Apps, Reusuable Technologies (SMART) platform. The SMART platform is an emerging framework that enables EHR systems to behave as "iPhone like platforms" by exhibiting an application programming interface for easy addition and deletion of third party apps. The app is presented as a point of care solution to monitoring medication adherence as well as a sufficiently general, modular application that may serve as an example and template for other SMART apps. The widely used, open source Django framework was used together with the SMART platform to create the interoperable components of this app. Django uses Python as its core programming language. This allows statistical and mathematical modules to be created from a large array of Python numerical libraries and assembled together with the core app to create flexible and sophisticated EHR functionality. Algorithms that predict individual adherence are derived from a retrospective study of dispensed medication claims from a large private insurance plan. Patients' prescription fill information is accessed through the SMART framework and the embedded algorithms compute adherence information, including predicted adherence one year after the first prescription fill. Open source graphing software is used to display patient medication information and the results of statistical prediction
Chan, Tommy C Y; Ye, Cong; Chan, Kwok Ping; Chu, Kai On; Jhanji, Vishal
To evaluate the performance of a point-of-care test for detection of matrix metalloproteinase 9 (MMP-9) levels in post-laser-assisted in situ keratomileusis (LASIK) dry eyes. A comparative study between patients with mild to moderate post-LASIK dry eyes and age-matched normal subjects was conducted. Ocular surface disease index (OSDI), tear break-up time (TBUT), and tear film MMP-9 and total protein levels were compared between the two groups. A point-of-care test device (RPS InflammaDry, Sarasota, Florida, USA) was utilised to confirm elevated MMP-9 levels in tear film. Fourteen post-LASIK dry eyes and 34 normal eyes were included. There was no significant difference in age and gender between both groups (p>0.175). The OSDI was significantly higher (25.5±7.7 vs 7.4±2.5; pdry eye compared with normal subjects. The tear film MMP-9 levels were 52.7±32.5 ng/mL in dry eyes and 4.1±2.1 ng/mL in normal eyes (p40 ng/mL in 7/14 (50.0%) post-LASIK dry eyes. The InflammaDry was positive in 8/14 (57.1%) post-LASIK eyes. All positive cases had tear film MMP-9 levels ≥38.03 ng/mL. Agreement between InflammaDry and MMP-9 was excellent with Cohen κ value of 0.857 in post-LASIK dry eyes. Only half of post-LASIK dry eyes were found to have significant inflammation associated with elevated MMP-9. The OSDI is useful to non-specifically identify patients with symptomatic dry eye while the InflammaDry determined which patients with dry eye were associated with significant inflammation that may guide therapeutic management decisions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Kenngott, Hannes Götz; Preukschas, Anas Amin; Wagner, Martin; Nickel, Felix; Müller, Michael; Bellemann, Nadine; Stock, Christian; Fangerau, Markus; Radeleff, Boris; Kauczor, Hans-Ulrich; Meinzer, Hans-Peter; Maier-Hein, Lena; Müller-Stich, Beat Peter
Augmented reality (AR) systems are currently being explored by a broad spectrum of industries, mainly for improving point-of-care access to data and images. Especially in surgery and especially for timely decisions in emergency cases, a fast and comprehensive access to images at the patient bedside is mandatory. Currently, imaging data are accessed at a distance from the patient both in time and space, i.e., at a specific workstation. Mobile technology and 3-dimensional (3D) visualization of radiological imaging data promise to overcome these restrictions by making bedside AR feasible. In this project, AR was realized in a surgical setting by fusing a 3D-representation of structures of interest with live camera images on a tablet computer using marker-based registration. The intent of this study was to focus on a thorough evaluation of AR. Feasibility, robustness, and accuracy were thus evaluated consecutively in a phantom model and a porcine model. Additionally feasibility was evaluated in one male volunteer. In the phantom model (n = 10), AR visualization was feasible in 84% of the visualization space with high accuracy (mean reprojection error ± standard deviation (SD): 2.8 ± 2.7 mm; 95th percentile = 6.7 mm). In a porcine model (n = 5), AR visualization was feasible in 79% with high accuracy (mean reprojection error ± SD: 3.5 ± 3.0 mm; 95th percentile = 9.5 mm). Furthermore, AR was successfully used and proved feasible within a male volunteer. Mobile, real-time, and point-of-care AR for clinical purposes proved feasible, robust, and accurate in the phantom, animal, and single-trial human model shown in this study. Consequently, AR following similar implementation proved robust and accurate enough to be evaluated in clinical trials assessing accuracy, robustness in clinical reality, as well as integration into the clinical workflow. If these further studies prove successful, AR might revolutionize data access at patient
Hempel, Dorothea; Haunhorst, Stephanie; Sinnathurai, Sivajini; Seibel, Armin; Recker, Florian; Heringer, Frank; Michels, Guido; Breitkreutz, Raoul
Point-of-care ultrasound (POC-US) is gaining importance in almost all specialties. E-learning has been used to teach theoretical knowledge and pattern recognition. As social media are universally available, they can be utilized for educational purposes. We wanted to evaluate the utility of the sandwich e-learning approach defined as a pre-course e-learning and a post-course learning activity using Facebook after a one-day point-of-care ultrasound (POC-US) course and its effect on the retention of knowledge. A total of 62 medial students were recruited for this study and randomly assigned to one of four groups. All groups received an identical hands-on training and performed several tests during the study period. The hands-on training was performed in groups of five students per instructor with the students scanning each other. Group 1 had access to pre-course e-learning, but not to post-course e-learning. Instead of a pre-course e-learning, group 2 listened to presentations at the day of the course (classroom teaching) and had access to the post-course learning activity using Facebook. Group 3 had access to both pre- and post-course e-learning (sandwich e-learning) activities, while group 4 listened classroom presentations only (classroom teaching only). Therefore only groups 2 and 3 had access to post-course learning via Facebook by joining a secured group. Posts containing ultrasound pictures and videos were published to this group. The students were asked to "like" the posts to monitor attendance. Knowledge retention was assessed 6 weeks after the course. After 6 weeks, group 3 achieved comparable results when compared to group 2 (82.2 % + -8.2 vs. 84.3 + -8.02) (p = 0.3). Students who participated in the post-course activity were more satisfied with the overall course than students without post-course learning (5.5 vs. 5.3 on a range from 1 to 6). In this study, the sandwich e-learning approach led to equal rates of knowledge retention compared to
Full Text Available Aims: As the use of Point of Care Testing (POCT devices for measurement of glycated haemoglobin (HbA1c increases, it is imperative to determine how their performance compares to laboratory methods. This study compared the performance of the automated Quo-Test POCT device (EKF Diagnostics, which uses boronate fluorescence quenching technology, with a laboratory based High Performance Liquid Chromatography (HPLC method (Biorad D10 for measurement of HbA1c. Methods: Whole blood EDTA samples from subjects (n=100 with and without diabetes were assayed using a BioRad D10 and a Quo-Test analyser. Intra-assay variation was determined by measuring six HbA1c samples in triplicate and inter-assay variation was determined by assaying four samples on 4 days. Stability was determined by assaying three samples stored at â20Â Â°C for 14 and 28 days post collection. Results: Median (IQR HbA1c was 60 (44.0â71.2 mmol/mol (7.6 (6.17â8.66 % and 62 (45.0â69.0 mmol/mol (7.8 (6.27â8.46 % for D10 and Quo-Test, respectively, with very good agreement (R2=0.969, P<0.0001. Mean (range intra- and inter-assay variation was 1.2% (0.0â2.7% and 1.6% (0.0â2.7% for the D10 and 3.5% (0.0â6.7% and 2.7% (0.7â5.1% for the Quo-Test. Mean change in HbA1c after 28 days storage at â20Â Â°C was â0.7% and +0.3% for D10 and Quo-Test respectively. Compared to the D10, Quo-Test showed 98% agreement for diagnosis of glucose intolerance (IGT and T2DM and 100% for diagnosis of T2DM. Conclusion: Good agreement between the D10 and Quo-Test was seen across a wide HbA1c range. The Quo-Test POCT device provided similar performance to a laboratory based HPLC method. Keywords: Point of care testing, HbA1c measurement
Point-of-Care Healthcare Databases Are an Overall Asset to Clinicians, but Different Databases May Vary in Usefulness Based on Personal Preferences. A Review of: Chan, R. & Stieda, V. (2011). Evaluation of three point-of-care healthcare databases: BMJ Point-of-Care, Clin-eguide and Nursing Reference Centre. Health and Information Libraries Journal, 28(1), 50-58. doi: 10.1111/j.1471-1842.2010.00920.x
Carol D. Howe
Objective – To evaluate the usefulness of three point-of-care healthcare databases (BMJ Point-of-Care, Clin-eguide, and Nursing Reference Centre) in clinical practice.Design – A descriptive study analyzing questionnaire results.Setting – Hospitals within Alberta, Canada’s two largest health regions (at the time of this study), with a third health region submitting a small number of responses.Subjects – A total of 46 Alberta hospital personnel answered the questionnaire, including 19 clinician...
Rasmussen, Martin B; Stengaard, Carsten; Sørensen, Jacob T
-of-care cardiac troponin T measurements (11.0%) had a value ≥50 ng/l, including 966 with acute myocardial infarction (sensitivity: 44.2%, specificity: 92.8%). Patients presenting with a prehospital point-of-care cardiac troponin T value ≥50 ng/l had a one-year mortality of 24% compared with 4.8% in those...... with values analysis: point-of-care cardiac troponin T≥50 ng/l (hazard ratio 2.10, 95% confidence interval: 1.90-2.33), congestive heart failure (hazard ratio 1.93, 95% confidence interval: 1......OBJECTIVE: The purpose of this study was to determine the predictive value of routine prehospital point-of-care cardiac troponin T measurement for diagnosis and risk stratification of patients with suspected acute myocardial infarction. METHODS AND RESULTS: All prehospital emergency medical service...
Morita, Satoru; Suzuki, Kazufumi; Masukawa, Ai; Ueno, Eiko
The aim of this prospective study was to assess the reliability of a rapid, handy, point-of-care whole blood creatinine meter (PCM) in patients who were scheduled to undergo contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). Among patients scheduled to undergo contrast-enhanced CT or MRI examinations, 113 patients who did not have creatinine data from the prescribed intervals before the examination day (in principle, 90 days for scheduled outpatients and 7 days for inpatients and urgent patients) were included. The estimated glomerular filtration rate (eGFR) was calculated using the creatinine values measured with the PCM and those from central laboratory measurements (LAB). The two eGFR values were compared statistically with the paired t-test, Pearson's correlation coefficient, and the Bland-Altman analysis. The mean eGFR measured with the PCM was slightly higher than the LAB value (81.2±24.6 vs. 70.2±19.7 ml/min/1.73 m 2 , P 2 ; limits of agreement were -22.4 to +44.4 ml/min/1.73 m 2 ) showed a moderate agreement with some degree of dispersion. The PCM can rapidly assess renal function using a small amount of blood almost equally to that of determined in the laboratory, which may help reduce the risk of contrast material-induced complications. (author)
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.
Jang, Dasom; Shin, Soo-Yong; Seo, Dong-Woo; Joo, Segyeong; Huh, Soo-Jin
Managing test results is an important issue in hospitals because of the increasing use of point-of-care testing (POCT). Here, we propose a smartphone-based system for automatically managing POCT test results. We developed the system to provide convenience to the medical staffs. The system recognizes the patient identification or prescription number of the test by reading barcodes and provides a countdown to indicate when the results will be ready. When the countdown in finished, a picture of the test result is transferred to the electronic medical record server using the Health Level 7 protocol. Human immunodeficiency virus (HIV) kits were selected in this research because HIV is a life-threatening infectious virus, especially for the medical staff who treat undiagnosed patients. The performance of the system was verified from a survey of the users. The performance of the system was tested at the emergency room (ER) for 10 months using commercially available POCT kits for detecting HIV. The survey showed that, in total, 80% and 0% of users reported positive or negative feedback, respectively. The staff also reported that the system reduced total processing time by approximately 32 min, in addition to reducing workload. The developed automated management system was successfully tested at an ER for 10 months. The survey results show that the system is effective and that medical staff members who used the system are satisfied with using the system at the ER.
Krõlov, Katrin; Uusna, Julia; Grellier, Tiia; Andresen, Liis; Jevtuševskaja, Jekaterina; Tulp, Indrek; Langel, Ülo
A variety of sample preparation techniques are used prior to nucleic acid amplification. However, their efficiency is not always sufficient and nucleic acid purification remains the preferred method for template preparation. Purification is difficult and costly to apply in point-of-care (POC) settings and there is a strong need for more robust, rapid, and efficient biological sample preparation techniques in molecular diagnostics. Here, the authors applied antimicrobial peptides (AMPs) for urine sample preparation prior to isothermal loop-mediated amplification (LAMP). AMPs bind to many microorganisms such as bacteria, fungi, protozoa and viruses causing disruption of their membrane integrity and facilitate nucleic acid release. The authors show that incubation of E. coli with antimicrobial peptide cecropin P1 for 5 min had a significant effect on the availability of template DNA compared with untreated or even heat treated samples resulting in up to six times increase of the amplification efficiency. These results show that AMPs treatment is a very efficient sample preparation technique that is suitable for application prior to nucleic acid amplification directly within biological samples. Furthermore, the entire process of AMPs treatment was performed at room temperature for 5 min thereby making it a good candidate for use in POC applications.
Hatchette, Todd F; Bastien, Nathalie; Berry, Jody; Booth, Tim F; Chernesky, Max; Couillard, Michel; Drews, Steven; Ebsworth, Anthony; Fearon, Margaret; Fonseca, Kevin; Fox, Julie; Gagnon, Jean-Nicolas; Guercio, Steven; Horsman, Greg; Jorowski, Cathy; Kuschak, Theodore; Li, Yan; Majury, Anna; Petric, Martin; Ratnam, Sam; Smieja, Marek; Van Caeseele, Paul
As the world prepares for the next influenza pandemic, governments have made significant funding commitments to vaccine development and antiviral stockpiling. While these are essential components to pandemic response, rapid and accurate diagnostic testing remains an often neglected cornerstone of pandemic influenza preparedness. Clinicians and Public Health Practitioners need to understand the benefits and drawbacks of different influenza tests in both seasonal and pandemic settings. Culture has been the traditional gold standard for influenza diagnosis but requires from 1-10 days to generate a positive result, compared to nucleic acid detection methods such as real time reverse transcriptase polymerase chain reaction (RT-PCR). Although the currently available rapid antigen detection kits can generate results in less than 30 minutes, their sensitivity is suboptimal and they are not recommended for the detection of novel influenza viruses. Until point-of-care (POC) tests are improved, PILPN recommends that the best option for pandemic influenza preparation is the enhancement of nucleic acid-based testing capabilities across Canada.
Kang, Mijeong; Kim, Eunkyoung; Winkler, Thomas E; Banis, George; Liu, Yi; Kitchen, Christopher A; Kelly, Deanna L; Ghodssi, Reza; Payne, Gregory F
Clozapine is one of the most promising medications for managing schizophrenia but it is under-utilized because of the challenges of maintaining serum levels in a safe therapeutic range (1-3μM). Timely measurement of serum clozapine levels has been identified as a barrier to the broader use of clozapine, which is however challenging due to the complexity of serum samples. We demonstrate a robust and reusable electrochemical sensor with graphene-chitosan composite for rapidly measuring serum levels of clozapine. Our electrochemical measurements in clinical serum from clozapine-treated and clozapine-untreated schizophrenia groups are well correlated to centralized laboratory analysis for the readily detected uric acid and for the clozapine which is present at 100-fold lower concentration. The benefits of our electrochemical measurement approach for serum clozapine monitoring are: (i) rapid measurement (≈20min) without serum pretreatment; (ii) appropriate selectivity and sensitivity (limit of detection 0.7μM); (iii) reusability of an electrode over several weeks; and (iv) rapid reliability testing to detect common error-causing problems. This simple and rapid electrochemical approach for serum clozapine measurements should provide clinicians with the timely point-of-care information required to adjust dosages and personalize the management of schizophrenia. Copyright © 2017 Elsevier B.V. All rights reserved.
Lalande, Élizabeth; Guimont, Chantal; Émond, Marcel; Parent, Marc Charles; Topping, Claude; Kuimi, Brice Lionel Batomen; Boucher, Valérie; Le Sage, Natalie
The main objective of this study was to evaluate the feasibility of emergency department (ED) point-of-care ultrasound (PoCUS) for rib fracture diagnosis in patients with minor thoracic injury (mTI). Secondary objectives were to 1) evaluate patients' pain during the PoCUS procedure, 2) identify the limitations of the use of PoCUS technique, and 3) compare the diagnosis obtained with PoCUS to radiography results. Adult patients who presented with clinical suspicion of rib fractures after mTI were included. All patients underwent PoCUS performed by emergency physicians (EPs) prior to a rib view X-ray. A visual analogue scale (VAS) ranging from 0 to 100 was used to ascertain feasibility, patients' pain and clinicians' degree of certitude. Feasibility was defined as a score of more than 50 on the VAS. We documented the radiologists' interpretation of rib view X-ray. Radiologists were blinded to the PoCUS results. Ninety-six patients were included. A majority (65%) of EPs concluded that the PoCUS technique to diagnose rib fracture was feasible (VAS score > 50). Median score for feasibility was 63. Median score was 31 (Interquartile range [IQR] 5-57) for patients' pain related to the PoCUS. The main limiting factor of the PoCUS technique was pain during patient examination (15%). PoCUS examination appears to be a feasible technique for a rib fracture diagnosis in the ED.
Boppart, Stephen A; Richards-Kortum, Rebecca
Leveraging advances in consumer electronics and wireless telecommunications, low-cost, portable optical imaging devices have the potential to improve screening and detection of disease at the point of care in primary health care settings in both low- and high-resource countries. Similarly, real-time optical imaging technologies can improve diagnosis and treatment at the point of procedure by circumventing the need for biopsy and analysis by expert pathologists, who are scarce in developing countries. Although many optical imaging technologies have been translated from bench to bedside, industry support is needed to commercialize and broadly disseminate these from the patient level to the population level to transform the standard of care. This review provides an overview of promising optical imaging technologies, the infrastructure needed to integrate them into widespread clinical use, and the challenges that must be addressed to harness the potential of these technologies to improve health care systems around the world. Copyright © 2014, American Association for the Advancement of Science.
Wilk, S; Michalowski, W; O'Sullivan, D; Farion, K; Sayyad-Shirabad, J; Kuziemsky, C; Kukawka, B
The purpose of this study was to create a task-based support architecture for developing clinical decision support systems (CDSSs) that assist physicians in making decisions at the point-of-care in the emergency department (ED). The backbone of the proposed architecture was established by a task-based emergency workflow model for a patient-physician encounter. The architecture was designed according to an agent-oriented paradigm. Specifically, we used the O-MaSE (Organization-based Multi-agent System Engineering) method that allows for iterative translation of functional requirements into architectural components (e.g., agents). The agent-oriented paradigm was extended with ontology-driven design to implement ontological models representing knowledge required by specific agents to operate. The task-based architecture allows for the creation of a CDSS that is aligned with the task-based emergency workflow model. It facilitates decoupling of executable components (agents) from embedded domain knowledge (ontological models), thus supporting their interoperability, sharing, and reuse. The generic architecture was implemented as a pilot system, MET3-AE--a CDSS to help with the management of pediatric asthma exacerbation in the ED. The system was evaluated in a hospital ED. The architecture allows for the creation of a CDSS that integrates support for all tasks from the task-based emergency workflow model, and interacts with hospital information systems. Proposed architecture also allows for reusing and sharing system components and knowledge across disease-specific CDSSs.
Corl, Dawn; Yin, Tom; Ulibarri, May; Lien, Heather; Tylee, Tracy; Chao, Jing; Wisse, Brent E
Hospitals rely on point-of-care (POC) blood glucose (BG) values to guide important decisions related to insulin administration and glycemic control. Evaluation of POC BG in hospitalized patients is associated with measurement and operator errors. Based on a previous quality improvement (QI) project we introduced an option for operators to delete and repeat POC BG values suspected as erroneous. The current project evaluated our experience with deleted POC BG values over a 2-year period. A retrospective QI project included all patients hospitalized at two regional academic medical centers in the Pacific Northwest during 2014 and 2015. Laboratory Medicine POC BG data were reviewed to evaluate all inpatient episodes of deleted and repeated POC BG. Inpatient operators choose to delete and repeat only 0.8% of all POC BG tests. Hypoglycemic and extreme hyperglycemic BG values are more likely to be deleted and repeated. Of initial values values (18% of all values) are errors. Of values >400 mg/dL, 40% of deleted values (5% of all values) are errors. Not all repeated POC BG values are first deleted. Optimal use of the option to delete and repeat POC BG values values that are measurement/operator errors. Eliminating these errors significantly reduces documented rates of severe hypoglycemia and hyperglycemia, and has the potential to improve patient safety.
Zhao, Ning; Spencer, John; Schmitt, Margaret A; Fisk, John D
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. Copyright © 2017 Elsevier Inc. All rights reserved.
Gunsolus, Ian L; Love, Sara A; Kohl, Louis P; Schmidt, Martin; Apple, Fred S
The present study addressed the accuracy of calculated oxygen saturation (sO2) using point-of-care (POC) testing compared with measured values on a blood gas analyzer. In total, 3,323 sO2 values were measured in 1,180 patients using a CO-oximeter (ABL 800 Flex; Radiometer, Copenhagen, Denmark). Measured parameters were then used to calculate an expected sO2 for the POC method (Abbott i-STAT; Abbott POC, Princeton, NJ). Cases in which calculated sO2 differed from measured sO2 by 10% or more were analyzed. Of the 3,323 comparisons performed, 260 (8%) showed discrepancies (± ≥10%) between measured and calculated sO2 values. Ninety-four of discrepant measurements (245 of 260) occurred when pO2 was less than 50 mm Hg. pH and bicarbonate distributions shifted to lower values in discrepant vs nondiscrepant cases. Our results suggest that the likelihood of discrepant sO2 is 27% among patients with pO2 less than 50 mm Hg. Direct measurement of sO2 by CO-oximetry is strongly suggested in this clinical scenario. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: email@example.com
Bayer, Angela M; Najarro, Lizzete; Zevallos, Mercedes; García, Patricia J
Globally, no qualitative studies have explored the perspectives of women and their partners about the integration of technology - and specifically diagnostic testing technologies - into antenatal care. The study objective was to describe the demand side for pregnancy-related diagnostic tests from the perspective of Peruvian consumers, including female and male community members, by engaging participants about their awareness of and care-seeking for pregnancy-related diagnostic tests and their preferred characteristics and testing conditions for pregnancy-related point-of-care diagnostic tests (POCTs). Sixty-seven mothers and fathers of children under one from the peri-urban coast and the peri-urban and rural highlands and jungle of Peru participated in ten focus groups. Participants think that pregnancy-related diagnostic tests are important and they and their fellow community members are committed to ensuring that pregnant women receive the tests they need. Participants expressed clear demands for pregnancy-related POCTs, including important characteristics for the tests themselves (certification, rapid, reliable results) and for test implementation (well-trained, personable good communicators as test administrators at well-equipped, convenient testing sites). Participants emphasized the importance of short waiting times and explained that many people have some ability to pay for POCTs, particularly if they are innovative, rapid or multiplex. Engaging future POCT users as consumers who are able to make key decisions about the development and implementation of pregnancy-related POCTs is valuable and informative.
Sabath, Bruce F; Singh, Gurkeerat
Point-of-care (POC) ultrasonography is considered fundamental in emergency medicine training and recently has become a milestone in critical care fellowship programs as well. Currently, there is no such standard requirement for internal medicine residency programs in the United States. We present a new case and briefly review another case at our institution - a community hospital - in which internal medicine house staff trained in ultrasonography were able to uncover unexpected and critical diagnoses that significantly changed patient care and outcomes. We also review the growing evidence of the application of ultrasound in the diagnosis of a myriad of conditions encountered in general internal medicine as well as the mounting data on the ability of internal medicine residents to apply this technology accurately at the bedside. We advocate that the literature has sufficiently established the role of POC ultrasonography in general internal medicine that there should no longer be any delay in giving this an official place in the development of internal medicine trainees. This may be particularly useful in the community hospital setting where 24-h echocardiography or other sonography may not be readily available.
Ma, Irene W Y; Arishenkoff, Shane; Wiseman, Jeffrey; Desy, Janeve; Ailon, Jonathan; Martin, Leslie; Otremba, Mirek; Halman, Samantha; Willemot, Patrick; Blouw, Marcus
Bedside point-of-care ultrasound (POCUS) is increasingly used to assess medical patients. At present, no consensus exists for what POCUS curriculum is appropriate for internal medicine residency training programs. This document details the consensus-based recommendations by the Canadian Internal Medicine Ultrasound (CIMUS) group, comprising 39 members, representing 14 institutions across Canada. Guiding principles for selecting curricular content were determined a priori. Consensus was defined as agreement by at least 80% of the members on POCUS applications deemed appropriate for teaching and assessment of trainees in the core (internal medicine postgraduate years [PGY] 1-3) and expanded (general internal medicine PGY 4-5) training programs. We recommend four POCUS applications for the core PGY 1-3 curriculum (inferior vena cava, lung B lines, pleural effusion, and abdominal free fluid) and three ultrasound-guided procedures (central venous catheterization, thoracentesis, and paracentesis). For the expanded PGY 4-5 curriculum, we recommend an additional seven applications (internal jugular vein, lung consolidation, pneumothorax, knee effusion, gross left ventricular systolic function, pericardial effusion, and right ventricular strain) and four ultrasound-guided procedures (knee arthrocentesis, arterial line insertion, arterial blood gas sampling, and peripheral venous catheterization). These recommendations will provide a framework for training programs at a national level.
Mauk, Michael G.; Song, Jinzhao; Liu, Changchun; Bau, Haim H.
Designs and applications of microfluidics-based devices for molecular diagnostics (Nucleic Acid Amplification Tests, NAATs) in infectious disease testing are reviewed, with emphasis on minimally instrumented, point-of-care (POC) tests for resource-limited settings. Microfluidic cartridges (‘chips’) that combine solid-phase nucleic acid extraction; isothermal enzymatic nucleic acid amplification; pre-stored, paraffin-encapsulated lyophilized reagents; and real-time or endpoint optical detection are described. These chips can be used with a companion module for separating plasma from blood through a combined sedimentation-filtration effect. Three reporter types: Fluorescence, colorimetric dyes, and bioluminescence; and a new paradigm for end-point detection based on a diffusion-reaction column are compared. Multiplexing (parallel amplification and detection of multiple targets) is demonstrated. Low-cost detection and added functionality (data analysis, control, communication) can be realized using a cellphone platform with the chip. Some related and similar-purposed approaches by others are surveyed. PMID:29495424
Oppong, Raymond; Jit, Mark; Smith, Richard D; Butler, Christopher C; Melbye, Hasse; Mölstad, Sigvard; Coast, Joanna
Background Point-of-care C-reactive protein (POCCRP) is a biomarker of inflammation that offers clinicians a rapid POC test to guide antibiotic prescribing decisions for acute cough and lower respiratory tract infections (LRTI). However, evidence that POCCRP is cost-effective is limited, particularly outside experimental settings. Aim To assess the cost-effectiveness of POCCRP as a diagnostic tool for acute cough and LRTI from the perspective of the health service. Design and setting Observational study of the presentation, management, and outcomes of patients with acute cough and LRTI in primary care settings in Norway and Sweden. Method Using hierarchical regression, data were analysed in terms of the effect on antibiotic use, cost, and patient outcomes (symptom severity after 7 and 14 days, time to recovery, and EQ-5D), while controlling for patient characteristics (self-reported symptom severity, comorbidities, and health-related quality of life) at first attendance. Results POCCRP testing is associated with non-significant positive reductions in antibiotic prescribing (P = 0.078) and increased cost (P = 0.092). Despite the uncertainty, POCCRP testing is also associated with a cost per quality-adjusted life year (QALY) gain of €9391. At a willingness-to-pay threshold of €30 000 per QALY gained, there is a 70% probability of CRP being cost-effective. Conclusion POCCRP testing is likely to provide a cost-effective diagnostic intervention both in terms of reducing antibiotic prescribing and in terms of QALYs gained. PMID:23834883
Li, Feng-Fei; Xie, Yun; Shi, Bing-Yin; Niu, Min; Guo, Hui; Cao, Yan; Liu, Bing-Li; Yan, Reng-Na; Su, Xiao-Fei; Wu, Jin-Dan; Zhang, Dan-Feng; Chen, Li-Ming; Ma, Jian-Hua
The blood glucose point-of-care testing (POCT) system is important in the decision-making process involving patients suspected of having hypoglycemia. To investigate the real world of the POCT system being used in teaching hospitals in China. The survey was conducted by Hisend Research Group from May 2015 to July 2015 in four teaching hospitals in China. The survey questions were referred to the ISO 15197:2013 standard requirements for the use of the POCT system in a hospital setting. A total of 170 subjects were included from 4 hospitals, which included nursing staff, nurse unit managers, employees from the department of medical instruments, and staff members employed by the clinical laboratories in the Tianjin Metabolism Hospital, Nanjing First Hospital, First Affiliated Hospital of Dalian Medical University, and the First hospital affiliated with the Xi'an Transportation University. The average score for the four hospitals surveyed in this study was 66.6, which varied from 46.1 to 79.7. The main factors influencing the scores were the multiple choices of blood-glucose meters, and the quality control assessment. Our data indicates that the real world use of the POCT system in hospital settings in China needs more closer adherence to a quality management framework.
Mtapuri-Zinyowera, Sekesai; Chiyaka, Edward T.; Mushayi, Wellington; Musuka, Godfrey; Naluyinda-Kitabire, Florence; Mushavi, Angella; Chikwasha, Vasco
An evaluation was commissioned to generate evidence on the impact of PIMA point-of-care CD4+ count machines in maternal and new-born child health settings in Zimbabwe; document best practices, lessons learned, challenges, and recommendations related to scale up of this new technology. A mixed methodology approach that included 31 in-depth interviews with stakeholders involved in procurement, distribution, and use of the POC machines was employed. Additionally, data was also abstracted from 207 patient records from 35 sites with the PIMA POC CD4+ count machines and 10 other comparative sites without the machine. A clearer training strategy was found to be necessary. The average time taken to initiate clients on antiretroviral treatment (ART) was substantially less, 15 days (IQR-1-149) for sites with a PIMA POC machine as compared to 32.7 days (IQR-1-192) at sites with no PIMA POC machine. There was general satisfaction because of the presence of the PIMA POC CD4+ count machine at sites that also initiated ART. PMID:24847177
Gray, J W; Milner, P J; Edwards, E H; Daniels, J P; Khan, K S
Point-of-care testing (POCT) is one of the fastest growing sectors of laboratory diagnostics. Most tests in routine use are haematology or biochemistry tests that are of low complexity. Microbiology POCT has been constrained by a lack of tests that are both accurate and of low complexity. We describe our experience of the practical issues around using more complex POCT for detection of Group B streptococci (GBS) in swabs from labouring women. We evaluated two tests for their feasibility in POCT: an optical immune assay (Biostar OIA Strep B, Inverness Medical, Princetown, NJ) and a PCR (IDI-Strep B, Cepheid, Sunnyvale, CA), which have been categorised as being of moderate and high complexity, respectively. A total of 12 unqualified midwifery assistants (MA) were trained to undertake testing on the delivery suite. A systematic approach to the introduction and management of POC testing was used. Modelling showed that the probability of test results being available within a clinically useful timescale was high. However, in the clinical setting, we found it impossible to maintain reliable availability of trained testers. Implementation of more complex POC testing is technically feasible, but it is expensive, and may be difficult to achieve in a busy delivery suite.
Full Text Available Most point-of-care (POC and patient self-testing (PST devices are based on the analysis of whole blood taken from a finger prick. Whole blood contains a bountiful of information about the donor’s health. We analyze here two particularities of microsystems for blood analysis: the blood non-Newtonian behavior, and the capillary flow in reagent-coated channels. Capillarity is the most commonly used method to move fluids in portable systems. It is shown first that the capillary flow of blood does not follow the Lucas-Washburn-Rideal law when the capillary flow velocity is small, due to its non-Newtonian rheology and to the formation of rouleaux of RBCs. In a second step, the capillary flow of blood on reagent-coated surfaces is investigated; first experimentally by observing the spreading of a droplet of blood on different reagent-coated substrates; second theoretically and numerically using the general law for spontaneous capillary flows and the Evolver numerical program.
Gaydos, Charlotte A; Klausner, Jeffrey D; Pai, Nitika Pant; Kelly, Helen; Coltart, Cordelia; Peeling, Rosanna W
Trichomonasvaginalis (TV) is a highly prevalent parasitic infection worldwide. It is associated with many adverse reproductive health outcomes. Many infections are asymptomatic and syndromic management leads to underdetection of TV. Traditional methods of TV detection such as wet preparation are insensitive. New rapid, point-of-care (POC) tests can enhance the diagnosis of trichomoniasis. The authors reviewed the literature and discuss older POC tests for TV detection, as well as the OSOM lateral flow test, the AmpliVue test, the Solana test and the GeneXpert test as well as the limitations of wet preparation and culture for detection of TV. The OSOM test is easy to perform, compared with other POC tests, and is Clinical Laboratory Improvement Amendments (CLIA)-waived, equipment-free, has sensitivities of 83%-86% compared with nucleic acid amplification tests (NAATs) and can be performed in 15 min. The AmpliVue and the Solana tests are not CLIA waived and require small pieces of equipment. They are molecular amplified assays and can be completed in TV test for women and men is a moderately complex test, requires a small platform and can be performed in women and one is available for detection of TV in men. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Mashamba-Thompson, Tivani P; Jama, Ngcwalisa A; Sartorius, Benn; Drain, Paul K; Thompson, Rowan M
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. 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. 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. 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.
Baird, J Kevin
Malaria caused by Plasmodium vivax threatens over 2 billion people globally and sickens tens of millions annually. Recent clinical evidence discredits the long-held notion of this infection as intrinsically benign revealing an often threatening course associated with mortality. Most acute attacks by this species derive from latent forms in the human liver called hypnozoites. Radical cure for P. vivax malaria includes therapy aimed both at the acute attack (blood schizontocidal) and against future attacks (hypnozoitocidal). The only hypnozoitocide available is primaquine, a drug causing life-threatening acute hemolytic anemia in patients with the inherited blood disorder glucose-6-phosphate dehydrogenase (G6PD) deficiency. This disorder affects 400 million people worldwide, at an average prevalence of 8 % in malaria-endemic nations. In the absence of certain knowledge regarding the G6PD status of patients infected by P. vivax, providers must choose between the risk of harm caused by primaquine and that caused by the parasite by withholding therapy. Resolving this dilemma requires the availability of point-of-care G6PD diagnostics practical for use in the impoverished rural tropics where the vast majority of malaria patients seek care.
Pfreundt, Andrea; Zulfiqar, Azeem; Patou, François
Silicon nanowire and nanoribbon biosensors have shown great promise in the detection of biomarkers at very low concentrations. Their high sensitivity makes them ideal candidates for use in early-stage medical diagnostics and further disease monitoring where low amounts of biomarkers need to be de......Silicon nanowire and nanoribbon biosensors have shown great promise in the detection of biomarkers at very low concentrations. Their high sensitivity makes them ideal candidates for use in early-stage medical diagnostics and further disease monitoring where low amounts of biomarkers need...... to be detected. However, in order to translate this technology from the bench to the bedside, a number of key issues need to be taken into consideration: Integrating nanobiosensors-based technology requires to overcome the difficult tradeoff between imperatives for high device reproducibilty and associated...... rising fabrication costs. Also the translation of nano-scale sensor technology into daily-use point-of-care devices requires acknowledgement of the end-user requirements, making device portability and human-interfacing a focus point in device development. Sample handling or purification for instance...
Di Somma, Salvatore; Zampini, Giorgio; Vetrone, Francesco; Soto-Ruiz, Karina M; Magrini, Laura; Cardelli, Patrizia; Ronco, Claudio; Maisel, Alan; Peacock, Frank W
Overcrowding of the emergency department (ED) is rapidly becoming a global challenge and a major source of concern for emergency physicians. The evaluation of cardiac biomarkers is critical for confirming diagnoses and expediting treatment decisions to reduce overcrowding, however, physicians currently face the dilemma of choosing between slow and accurate central-based laboratory tests, or faster but imprecise assays. With improvements in technology, point-of-care testing (POCT) systems facilitate the efficient and high-throughput evaluation of biomarkers, such as troponin (cTn), brain natriuretic peptide (BNP) and neutrophil gelatinase-associated lipocalin (NGAL). In this context, POCT may help ED physicians to confirm a diagnosis of conditions, such as acute coronary syndrome, heart failure or kidney damage. Compared with classic laboratory methods, the use of cTn, BNP, and NGAL POCT has shown comparable sensitivity, specificity and failure rate, but with the potential to provide prompt and accurate diagnosis, shorten hospital stay, and alleviate the burden on the ED. Despite this potential, the full advantages of rapid delivery results will only be reached if POCT is implemented within hospital standardized procedures and ED staff receive appropriate training.
Cui, Xingye; Hu, Jie; Choi, Jane Ru; Huang, Yalin; Wang, Xuemin; Lu, Tian Jian; Xu, Feng
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. Copyright © 2016 Elsevier B.V. All rights reserved.
Joh, Daniel Y.; Hucknall, Angus M.; Wei, Qingshan; Mason, Kelly A.; Lund, Margaret L.; Fontes, Cassio M.; Hill, Ryan T.; Blair, Rebecca; Zimmers, Zackary; Achar, Rohan K.; Tseng, Derek; Gordan, Raluca; Freemark, Michael; Ozcan, Aydogan; Chilkoti, Ashutosh
The ELISA is the mainstay for sensitive and quantitative detection of protein analytes. Despite its utility, ELISA is time-consuming, resource-intensive, and infrastructure-dependent, limiting its availability in resource-limited regions. Here, we describe a self-contained immunoassay platform (the “D4 assay”) that converts the sandwich immunoassay into a point-of-care test (POCT). The D4 assay is fabricated by inkjet printing assay reagents as microarrays on nanoscale polymer brushes on glass chips, so that all reagents are “on-chip,” and these chips show durable storage stability without cold storage. The D4 assay can interrogate multiple analytes from a drop of blood, is compatible with a smartphone detector, and displays analytical figures of merit that are comparable to standard laboratory-based ELISA in whole blood. These attributes of the D4 POCT have the potential to democratize access to high-performance immunoassays in resource-limited settings without sacrificing their performance.
Ko, Byuk Sung; Kim, Won Young; Ryoo, Seung Mok; Ahn, Shin; Sohn, Chang Hwan; Seo, Dong Woo; Lee, Yoon-Seon; Lim, Kyoung Soo; Jung, Hwoon-Yong
It is difficult to assess risk in normotensive patients with upper gastrointestinal bleeding. The aim of this study was to evaluate whether the initial lactate value can predict the in-hospital occurrence of hypotension in stable patients with acute nonvariceal upper gastrointestinal bleeding. Retrospective, observational, single-center study. Emergency department of a tertiary-care, university-affiliated hospital during a 5-year period. Medical records of 3,489 patients with acute upper gastrointestinal bleeding who were normotensive at presentation to the emergency department. We analyzed the ability of point-of-care testing of lactate at emergency department admission to predict hypotension development (defined as systolic blood pressure upper gastrointestinal bleeding, 157 patients experienced hypotension within 24 hours. Lactate was independently associated with hypotension development (odds ratio, 1.6; 95% CI, 1.4-1.7), and the risk of hypotension significantly increased as the lactate increased from 2.5-4.9 mmol/L (odds ratio, 2.2) to 5.0-7.4 mmol/L (odds ratio, 4.0) and to greater than or equal to 7.5 mmol/L (odds ratio, 39.2) (pupper gastrointestinal bleeding. However, subsequently, prospective validate research will be required to clarify this.
Jose Antonio Miñarro-Giménez
Full Text Available 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.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.The MSC system provides a novel approach for enabling the implementation of personalized medicine in clinical routine.
Tivani P. Mashamba-Thompson
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.
Full Text Available To determine the prevalence and correlates of syphilis among pregnant women in rural areas of South China.Point-of-care syphilis testing was provided at 71 health facilities in less developed, rural areas of Guangdong Province. Positive samples were confirmed at a local referral center by toluidine red unheated serum tests (TRUST and Treponema pallidum particle agglutination (TPPA tests.Altogether 27,150 pregnant women in rural Guangdong were screened for syphilis. 106 (0.39% syphilis cases were diagnosed, of which 78 (73.6% received treatment for syphilis. Multivariate analysis revealed that older pregnant women (31-35 years old, aOR 2.7, 95% CI 0.99-7.32; older than 35 years old, aOR 5.9, 95% CI 2.13-16.34 and those with a history of adverse pregnant outcomes (aOR 3.64, 95% CI 2.30-5.76 were more likely to be infected with syphilis.A high prevalence of syphilis exists among pregnant women living in rural areas of South China. Enhanced integration of syphilis screening with other routine women's health services (OB GYN, family planning may be useful for controlling China's syphilis epidemic.
Michael G. Mauk
Full Text Available Designs and applications of microfluidics-based devices for molecular diagnostics (Nucleic Acid Amplification Tests, NAATs in infectious disease testing are reviewed, with emphasis on minimally instrumented, point-of-care (POC tests for resource-limited settings. Microfluidic cartridges (‘chips’ that combine solid-phase nucleic acid extraction; isothermal enzymatic nucleic acid amplification; pre-stored, paraffin-encapsulated lyophilized reagents; and real-time or endpoint optical detection are described. These chips can be used with a companion module for separating plasma from blood through a combined sedimentation-filtration effect. Three reporter types: Fluorescence, colorimetric dyes, and bioluminescence; and a new paradigm for end-point detection based on a diffusion-reaction column are compared. Multiplexing (parallel amplification and detection of multiple targets is demonstrated. Low-cost detection and added functionality (data analysis, control, communication can be realized using a cellphone platform with the chip. Some related and similar-purposed approaches by others are surveyed.
Leong, Waiian; Chen, Lianxiang; Yu, Ping; Wei, Bohua; Wang, Cuicui; Ying, Yilin; Jiang, Jie; Tong, Jianjing; Zhu, Dingliang; Ye, Jing; Lu, Yiming
We assessed the efficiency of point-of-care (POC) tests in the emergency department (ED) by comparing them with the international standard. We recorded the turnaround times (TATs) for processing laboratory biomarkers to assess laboratory efficiency from 17 EDs in national/regional hospitals. We also compared patient components between national and regional hospitals. Although the 17 enrolled hospitals expanded their EDs, they contained only five POC machines among them. The P50 (P25, P75) of the TATs for POC tests was 47 min (39, 55.5 min) for cardiac troponin T, which was much longer than the international standard (30 min). The TATs of other cardiac biomarkers were also longer than 30 min. The low efficiency of TATs for POC tests was a common feature in both regional and national hospitals (p > 0.05). Myocardial infarction was diagnosed in 61% of investigated ED patients who visited national hospitals, which is more frequently than those diagnosed at regional hospitals (46%, p administrative management of EDs. This issue should be addressed in the next version of the medical reform policy. © 2014 Society for Laboratory Automation and Screening.
Duran-Nelson, Alisa; Gladding, Sophia; Beattie, Jim; Nixon, L James
To determine which resources residents use at the point-of-care (POC) for decision making, the drivers for selection of these resources, and how residents use Google/Google Scholar to answer clinical questions at the POC. In January 2012, 299 residents from three internal medicine residencies were sent an electronic survey regarding resources used for POC decision making. Resource use frequency and factors influencing choice were determined using descriptive statistics. Binary logistic regression analysis was performed to determine relationships between the independent variables. A total of 167 residents (56%) responded; similar numbers responded at each level of training. Residents most frequently reported using UpToDate and Google at the POC at least daily (85% and 63%, respectively), with speed and trust in the quality of information being the primary drivers of selection. Google, used by 68% of residents, was used primarily to locate Web sites and general information about diseases, whereas Google Scholar, used by 30% of residents, tended to be used for treatment and management decisions or locating a journal article. The findings suggest that internal medicine residents use UpToDate most frequently, followed by consultation with faculty and the search engines Google and Google Scholar; speed, trust, and portability are the biggest drivers for resource selection; and time and information overload appear to be the biggest barriers to resources such as Ovid MEDLINE. Residents frequently used Google and may benefit from further training in information management skills.
Li, Zedong; Li, Fei; Xing, Yue; Liu, Zhi; You, Minli; Li, Yingchun; Wen, Ting; Qu, Zhiguo; Ling Li, Xiao; Xu, Feng
Paper-based microfluidic biosensors have recently attracted increasing attentions in point-of-care testing (POCT) territories benefiting from their affordable, accessible and eco-friendly features, where technologies for fabricating such biosensors are preferred to be equipment free, easy-to-operate and capable of rapid prototyping. In this work, we developed a pen-on-paper (PoP) strategy based on two custom-made pens, i.e., a wax pen and a conductive-ink pen, to fully write paper-based microfluidic biosensors through directly writing both microfluidic channels and electrodes. Particularly, the proposed wax pen is competent to realize one-step fabrication of wax channels on paper, as the melted wax penetrates into paper during writing process without any post-treatments. The practical applications of the fabricated paper-based microfluidic biosensors are demonstrated by both colorimetric detection of Salmonella typhimurium DNA with detection limit of 1nM and electrochemical measurement of glucose with detection limit of 1mM. The developed PoP strategy for making microfluidic biosensors on paper characterized by true simplicity, prominent portability and excellent capability for rapid prototyping shows promising prospect in POCT applications. Copyright © 2017 Elsevier B.V. All rights reserved.
Steinfelder-Visscher, J; Weerwind, P W; Teerenstra, S; Brouwer, M H J
Recently, the GEM Premier blood gas analyser was upgraded to the GEM Premier 3000. In addition to pH, pCO2, pO2, Na+, K+, Ca2+, and hematocrit measurement, glucose and lactate can be measured on the GEM Premier 3000. In this prospective clinical study, the analytical performance of the GEM Premier 3000 was compared with the Ciba Corning 865 analyser for blood gas/electrolytes/metabolites, and for hematocrit with the Sysmex XE 2100 instrument. During a 6-month period, 127 blood samples were analysed on both the GEM Premier 3000 analyser and our laboratory analysers (Ciba Corning 865/Sysmex 2100 instrument), and compared using the agreement analysis for quantitative data. With the exception of K+, the other parameters (pCO2, pO2, Na+, Ca2+, hematocrit, glucose, and lactate) can be described in terms of the mean and standard deviation of the differences. For K+ measurement, a clear linear trend (r=0.79, panalyser seems to be suitable for point-of-care testing of electrolytes, metabolites, and blood gases during cardiopulmonary bypass. However, its downward bias in hematocrit values below 30% suggests that using the GEM Premier 3000 as a transfusion trigger leads to overtreatment with packed red cells.
Full Text Available Point-of-care testing (POCT—laboratory tests performed with new mobile devices and online technologies outside of the central laboratory—is rapidly outpacing the traditional laboratory test market, growing at a rate of 12 to 15% each year. POCT impacts the diagnostic process of care providers by yielding high efficiency benefits in terms of turnaround time and related quality improvements in the reduction of errors. However, the implementation of this disruptive eHealth technology requires the integration and transformation of diagnostic services across the boundaries of healthcare organizations. Research has revealed both advantages and barriers of POCT implementations, yet to date, there is no business model for the integration of POCT within general practice. The aim of this article is to contribute with a design for a care model that enables the integration of POCT in primary healthcare. In this research, we used a design modelling toolkit for data collection at five general practices. Through an iterative design process, we modelled the actors and value transactions, and designed an optimized care model for the dynamic integration of POCTs into the GP’s network of care delivery. The care model design will have a direct bearing on improving the integration of POCT through the connectivity and norm guidelines between the general practice, the POC technology, and the diagnostic centre.
Verhees, Bart; van Kuijk, Kees; Simonse, Lianne
Point-of-care testing (POCT)-laboratory tests performed with new mobile devices and online technologies outside of the central laboratory-is rapidly outpacing the traditional laboratory test market, growing at a rate of 12 to 15% each year. POCT impacts the diagnostic process of care providers by yielding high efficiency benefits in terms of turnaround time and related quality improvements in the reduction of errors. However, the implementation of this disruptive eHealth technology requires the integration and transformation of diagnostic services across the boundaries of healthcare organizations. Research has revealed both advantages and barriers of POCT implementations, yet to date, there is no business model for the integration of POCT within general practice. The aim of this article is to contribute with a design for a care model that enables the integration of POCT in primary healthcare. In this research, we used a design modelling toolkit for data collection at five general practices. Through an iterative design process, we modelled the actors and value transactions, and designed an optimized care model for the dynamic integration of POCTs into the GP's network of care delivery. The care model design will have a direct bearing on improving the integration of POCT through the connectivity and norm guidelines between the general practice, the POC technology, and the diagnostic centre.
Selleri, Paolo; Di Girolamo, Nicola
Point-of-care testing is an attractive option in rabbit medicine, because it permits rapid analysis of a panel of electrolytes, chemistries, blood gases, hemoglobin, and hematocrit, requiring only 65 μL of blood. The purpose of this study was to evaluate the performance of a portable clinical analyzer for measurement of pH, partial pressure of CO2, Na, chloride, potassium, blood urea nitrogen, glucose, hematocrit, and hemoglobin in healthy and diseased rabbits. Blood samples obtained from 30 pet rabbits were analyzed immediately after collection by the portable clinical analyzer (PCA) and immediately thereafter (time <20 sec) by a reference analyzer. Bland-Altman plots and Passing-Bablok regression analysis were used to compare the results. Limits of agreement were wide for all the variables studied, with the exception of pH. Most variables presented significant proportional and/or constant bias. The current study provides sufficient evidence that the PCA presents reliability for pH, although its low agreement with a reference analyzer for the other variables does not support their interchangeability. Limits of agreement provided for each variable allow researchers to evaluate if the PCA is reliable enough for their scope. To the authors' knowledge, the present is the first report evaluating a PCA in the rabbit.
Michel, Claude-Edouard C; Solomon, Anthony W; Magbanua, Jose P V; Massae, Patrick A; Huang, Ling; Mosha, Jonaice; West, Sheila K; Nadala, Elpidio C B; Bailey, Robin; Wisniewski, Craig; Mabey, David C W; Lee, Helen H
Trachoma results from repeated episodes of conjunctival infection with Chlamydia trachomatis and is the leading infectious cause of blindness. To eliminate trachoma, control programmes use the SAFE strategy (Surgery, Antibiotics, Face cleanliness, and Environmental improvement). The A component is designed to treat C trachomatis infection, and is initiated on the basis of the prevalence of the clinical sign trachomatous inflammation-follicular (TF). Unfortunately, TF correlates poorly with C trachomatis infection. We sought to assess a newly developed point-of-care (POC) assay compared with presence of TF for guiding the use of antibiotics for trachoma control. We compared performance outcomes of the POC assay and presence of TF using commercial PCR as a comparator in 664 children aged 1-9 years in remote, trachoma-endemic villages in Tanzania. Signs of trachoma were graded according to the WHO simplified trachoma grading system. Of 664 participants, 128 (19%) were positive for ocular C trachomatis infection by PCR. Presence of TF had a sensitivity of 64.1% (95% CI 55.8-72.4), specificity of 80.2% (76.8-83.6), and positive predictive value of 43.6% (36.5-50.7). By contrast, the POC assay had a sensitivity of 83.6% (77.2-90.0), specificity of 99.4% (98.8-100.0), and positive predictive value of 97.3% (94.2-100.3). Interagreements and intra-agreements between four novice operators were 0.988 (0.973-1.000) and 0.950 (0.894-1.000), respectively. The POC assay is substantially more accurate than TF prevalence in identifying the presence or absence of infection. Additional studies should assess the use of the assay in the planning and monitoring of trachoma control activities.
Hegener, Michael A; Li, Hua; Han, Daewoo; Steckl, Andrew J; Pauletti, Giovanni M
Vitamin K antagonists such as warfarin are the most widely used class of oral anticoagulants. Due to a narrow therapeutic window, patients on warfarin require regular monitoring. Self-testing using point-of-care (POC) diagnostic devices is available, but cost makes this monitoring method beyond reach for many. The main objective of this research was to assess the clinical utility of a low-cost, paper-based lateral flow POC diagnostic device developed for anticoagulation monitoring without the need for a separate electronic reader. Custom-fabricated lateral flow assay (LFA) test strips comprised of a glass fiber sample pad, a nitrocellulose analytical membrane, a cellulose wicking pad, and a plastic backing card were assembled in a plastic cassette. Healthy volunteers and patients on warfarin therapy were recruited for this prospective study. For each participant, a whole blood sample was collected via fingerstick to determine: (1) international normalized ratio (INR) using the CoaguChek® XS coagulometer, (2) hematocrit by centrifugation, and (3) red blood cell (RBC) travel distance on the experimental LFA device after 240 s using digital image analysis. RBC travel distance measured on the LFA device using blood samples obtained from warfarin patients positively correlated with increasing INR value and the LFA device had the capability to statistically distinguish between healthy volunteer INR values and those for patients groups with INR ≥ 2.6. From these data, it is predicted that this low-cost, paper-based LFA device can have clinical utility for identifying anticoagulated patients taking vitamin K antagonists who are outside of the desired therapeutic efficacy window.
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
Martin, J; Schuster, T; Moessmer, G; Kochs, E F; Wagner, K J
Thromboelastometry as point-of-care (POC) testing enables the analysis of the clotting process at the bedside, providing rapid results to guide haemostatic therapy. However, POC testing utilizes medical staff who are managing critically ill patients, as non-laboratory personnel may not be sufficiently trained to run the devices. To resolve these problems, thromboelastometry can be performed in the central laboratory and rapid transport of samples can be accomplished via a pneumatic tube system (PTS). This study compares thromboelastometry parameters of blood samples analysed immediately with those analysed after PTS transport. In patients with normal haemostasis, two arterial blood samples were collected from each patient (n=92) in citrated plastic tubes to investigate the assays INTEM (n=35), EXTEM (n=27), and FIBTEM (n=30). One blood sample was analysed immediately, the other sample after PTS transport. Thromboelastometry was performed using a single ROTEM(®) device. The mean clot firmness values were significantly lower for PTS samples in both the INTEM (-0.7 mm cf. -1.1 mm) and EXTEM (-1.4 cf. -1.7 mm) assays. INTEM coagulation time (CT) was significantly lower in PTS samples with a mean difference of -13 s. EXTEM CT was significantly higher in PTS samples with a mean difference of +3.9 s. Thromboelastometry parameters of blood samples analysed after PTS transport are significantly altered compared with those analysed immediately. However, in patients with normal haemostasis, the alterations were small and without clinical consequence, implying that analysis after PTS transport is an acceptable alternative to prompt analysis at the bedside. Further studies should focus on patients with impaired haemostasis.
Cross, Robert W.; Boisen, Matthew L.; Millett, Molly M.; Nelson, Diana S.; Oottamasathien, Darin; Hartnett, Jessica N.; Jones, Abigal B.; Goba, Augustine; Momoh, Mambu; Fullah, Mohamed; Bornholdt, Zachary A.; Fusco, Marnie L.; Abelson, Dafna M.; Oda, Shunichiro; Brown, Bethany L.; Pham, Ha; Rowland, Megan M.; Agans, Krystle N.; Geisbert, Joan B.; Heinrich, Megan L.; Kulakosky, Peter C.; Shaffer, Jeffrey G.; Schieffelin, John S.; Kargbo, Brima; Gbetuwa, Momoh; Gevao, Sahr M.; Wilson, Russell B.; Saphire, Erica Ollmann; Pitts, Kelly R.; Khan, Sheik Humarr; Grant, Donald S.; Geisbert, Thomas W.; Branco, Luis M.; Garry, Robert F.
Background. Ebola virus disease (EVD) is a severe viral illness caused by Ebola virus (EBOV). The 2013–2016 EVD outbreak in West Africa is the largest recorded, with >11 000 deaths. Development of the ReEBOV Antigen Rapid Test (ReEBOV RDT) was expedited to provide a point-of-care test for suspected EVD cases. Methods. Recombinant EBOV viral protein 40 antigen was used to derive polyclonal antibodies for RDT and enzyme-linked immunosorbent assay development. ReEBOV RDT limits of detection (LOD), specificity, and interference were analytically validated on the basis of Food and Drug Administration (FDA) guidance. Results. The ReEBOV RDT specificity estimate was 95% for donor serum panels and 97% for donor whole-blood specimens. The RDT demonstrated sensitivity to 3 species of Ebolavirus (Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus) associated with human disease, with no cross-reactivity by pathogens associated with non-EBOV febrile illness, including malaria parasites. Interference testing exhibited no reactivity by medications in common use. The LOD for antigen was 4.7 ng/test in serum and 9.4 ng/test in whole blood. Quantitative reverse transcription–polymerase chain reaction testing of nonhuman primate samples determined the range to be equivalent to 3.0 × 105–9.0 × 108 genomes/mL. Conclusions. The analytical validation presented here contributed to the ReEBOV RDT being the first antigen-based assay to receive FDA and World Health Organization emergency use authorization for this EVD outbreak, in February 2015. PMID:27587634
Reynolds, Teri Ann; Amato, Stas; Kulola, Irene; Chen, Chuan-Jay Jeffrey; Mfinanga, Juma; Sawe, Hendry Robert
Point of care ultrasound (PoCUS) is an efficient, inexpensive, safe, and portable imaging modality that can be particularly useful in resource-limited settings. However, its impact on clinical decision making in such settings has not been well studied. The objective of this study is to describe the utilization and impact of PoCUS on clinical decision making at an urban emergency department in Dar es Salaam, Tanzania. This was a prospective descriptive cross-sectional study of patients receiving PoCUS at Muhimbili National Hospital's Emergency Medical Department (MNH EMD). Data on PoCUS studies during a period of 10 months at MNH EMD was collected on consecutive patients during periods when research assistants were available. Data collected included patient age and sex, indications for ultrasound, findings, interpretations, and provider-reported diagnostic impression and disposition plan before and after PoCUS. Descriptive statistics, including medians and interquartile ranges, and counts and percentages, are reported. Pearson chi squared tests and p-values were used to evaluate categorical data for significant differences. PoCUS data was collected for 986 studies performed on 784 patients. Median patient age was 32 years; 56% of patients were male. Top indications for PoCUS included trauma, respiratory presentations, and abdomino-pelvic pain. The most frequent study types performed were eFAST, cardiac, and obstetric or gynaecologic studies. Overall, clinicians reported that the use of PoCUS changed either diagnostic impression or disposition plan in 29% of all cases. Rates of change in diagnostic impression or disposition plan increased to 45% in patients for whom more than one PoCUS study type was performed. In resource-limited emergency care settings, PoCUS can be utilized for a wide range of indications and has substantial impact on clinical decision making, especially when more than one study type is performed.
Cédric B Chesnais
Full Text Available The Global Programme to Eliminate Lymphatic Filariasis uses point-of-care tests for circulating filarial antigenemia (CFA to map endemic areas and for monitoring and evaluating the success of mass drug administration (MDA programs. We compared the performance of the reference BinaxNOW Filariasis card test (ICT, introduced in 1997 with the Alere Filariasis Test Strip (FTS, introduced in 2013 in 5 endemic study sites in Africa.The tests were compared prior to MDA in two study sites (Congo and Côte d'Ivoire and in three sites that had received MDA (DRC and 2 sites in Liberia. Data were analyzed with regard to % positivity, % agreement, and heterogeneity. Models evaluated potential effects of age, gender, and blood microfilaria (Mf counts in individuals and effects of endemicity and history of MDA at the village level as potential factors linked to higher sensitivity of the FTS. Lastly, we assessed relationships between CFA scores and Mf in pre- and post-MDA settings.Paired test results were available for 3,682 individuals. Antigenemia rates were 8% and 22% higher by FTS than by ICT in pre-MDA and in post-MDA sites, respectively. FTS/ICT ratios were higher in areas with low infection rates. The probability of having microfilaremia was much higher in persons with CFA scores >1 in untreated areas. However, this was not true in post-MDA settings.This study has provided extensive new information on the performance of the FTS compared to ICT in Africa and it has confirmed the increased sensitivity of FTS reported in prior studies. Variability in FTS/ICT was related in part to endemicity level, history of MDA, and perhaps to the medications used for MDA. These results suggest that FTS should be superior to ICT for mapping, for transmission assessment surveys, and for post-MDA surveillance.
Gubbins, Paul O; Klepser, Michael E; Adams, Alex J; Jacobs, David M; Percival, Kelly M; Tallman, Gregory B
Health care professionals must continually identify collaborative ways to combat antibiotic resistance while improving community health and health care delivery. Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived point-of-care (POC) testing (POCT) services for infectious disease conducted in community pharmacies provide a means for pharmacists to collaborate with prescribers and/or public health officials combating antibiotic resistance while improving community health and health care delivery. To provide a comprehensive literature review that explores the potential for pharmacists to collaborate with public health professionals and prescribers using pharmacy-based CLIA-waived POCT services for infectious diseases. Comprehensive literature review. PubMed and Google Scholar were searched for manuscripts and meeting abstracts for the following key words: infectious disease, community pharmacy, rapid diagnostic tests, rapid assay, and POC tests. All relevant manuscripts and meeting abstracts utilizing POCT in community pharmacies for infectious disease were reviewed. Information regarding the most contemporary evidence regarding CLIA-waived POC infectious diseases tests for infectious diseases and their use in community pharmacies was synthesized to highlight and identify opportunities to develop future collaborations using community pharmacy-based models for such services. Evidence demonstrates that pharmacists in collaboration with other health care professionals can leverage their knowledge and accessibility to provide CLIA-waived POCT services for infectious diseases. Testing for influenza may augment health departments' surveillance efforts, help promote rationale antiviral use, and avoid unnecessary antimicrobial therapy. Services for human immunodeficiency virus infection raise infection status awareness, increase access to health care, and facilitate linkage to appropriate care. Testing for group A streptococcal pharyngitis may curb inappropriate
Kim, Changsun; Kim, Hansol
Comparing a point-of-care (POC) test using the capillary blood obtained from skin puncture with conventional laboratory tests. In this study, which was conducted at the emergency department of a tertiary care hospital in April-July 2017, 232 patients were enrolled, and three types of blood samples (capillary blood from skin puncture, arterial and venous blood from blood vessel puncture) were simultaneously collected. Each blood sample was analyzed using a POC analyzer (epoc® system, USA), an arterial blood gas analyzer (pHOx®Ultra, Nova biomedical, USA) and venous blood analyzers (AU5800, DxH2401, Beckman Coulter, USA). Twelve parameters were compared between the epoc and reference analyzers, with an equivalence test, Bland-Altman plot analysis and linear regression employed to show the agreement or correlation between the two methods. The pH, HCO 3 , Ca 2+ , Na + , K + , Cl - , glucose, Hb and Hct measured by the epoc were equivalent to the reference values (95% confidence interval of mean difference within the range of the agreement target) with clinically inconsequential mean differences and narrow limits of agreement. All of them, except pH, had clinically acceptable agreements between the two methods (results within target value ≥80%). Of the remaining three parameters (pCO 2, pO 2 and lactate), the epoc pCO 2 and lactate values were highly correlated with the reference device values, whereas pO 2 was not. (pCO 2 : R 2 =0.824, y=-1.411+0.877·x; lactate: R 2 =0.902, y=-0.544+0.966·x; pO 2 : R 2 =0.037, y=61.6+0.431·x). Most parameters, except only pO 2 , measured by the epoc were equivalent to or correlated with those from the reference method. Copyright © 2017 Elsevier Inc. All rights reserved.
Lau, Michelle S; Mooney, Peter D; White, William L; Rees, Michael A; Wong, Simon H; Hadjivassiliou, Marios; Green, Peter H R; Lebwohl, Benjamin; Sanders, David S
Celiac disease (CD) is common yet under-detected. A point of care test (POCT) may improve CD detection. We aimed to assess the diagnostic performance of an IgA/IgG-deamidated gliadin peptide (DGP)-based POCT for CD detection, patient acceptability, and inter-observer variability of the POCT results. From 2013-2017, we prospectively recruited patients referred to secondary care with gastrointestinal symptoms, anemia and/or weight loss (group 1); and patients with self-reported gluten sensitivity with unknown CD status (group 2). All patients had concurrent POCT, IgA-tissue transglutaminase (IgA-TTG), IgA-endomysial antibodies (IgA-EMA), total IgA levels, and duodenal biopsies. Five hundred patients completed acceptability questionnaires, and inter-observer variability of the POCT results was compared among five clinical staff for 400 cases. Group 1: 1000 patients, 58.5% female, age 16-91, median age 57. Forty-one patients (4.1%) were diagnosed with CD. The sensitivities of the POCT, IgA-TTG, and IgA-EMA were 82.9, 78.1, and 70.7%; the specificities were 85.4, 96.3, and 99.8%. Group 2: 61 patients, 83% female; age 17-73, median age 35. The POCT had 100% sensitivity and negative predictive value in detecting CD in group 2. Most patients preferred the POCT to venepuncture (90.4% vs. 2.8%). There was good inter-observer agreement on the POCT results with a Fleiss Kappa coefficient of 0.895. The POCT had comparable sensitivities to serology, and correctly identified all CD cases in a gluten sensitive cohort. However, its low specificity may increase unnecessary investigations. Despite its advantage of convenience and rapid results, it may not add significant value to case finding in an office-based setting.
Griffey, Richard T; Trent, Caleb J; Bavolek, Rebecca A; Keeperman, Jacob B; Sampson, Christopher; Poirier, Robert F
Failure to detect pregnancy in the emergency department (ED) can have important consequences. Urine human chorionic gonadotropin (uhCG) point-of-care (POC) assays are valued for rapidly detecting early pregnancy with high sensitivity. However, under certain conditions, POC uhCG tests can fail to detect pregnancy. In investigating a series of late first-trimester false-negative pregnancy tests in our ED, a novel and distinct causative phenomenon was recently elucidated in our institution. We discuss uhCG POC tests, review our false-negative rate, and describe mechanisms for false negatives and potential remedies. The false-negative POC uhCG rate is very low, but in the setting of a large volume of tests, the numbers are worth consideration. In positive uhCG POC tests, free and fixed antibodies bind hCG to form a "sandwich"; hCG is present in several variant forms that change in their concentrations at different stages of pregnancy. When in excess, intact hCG can saturate the antibodies, preventing sandwich formation (hook effect phenomenon). Some assays may include an antibody that does not recognize certain variants present in later stages of pregnancy. When this variant is in excess, it can bind one antibody avidly and the other not at all, resulting in a false-negative test (hook-like phenomenon). In both situations, dilution is key to an accurate test. Manufacturers should consider that uhCG tests are routinely used at many stages of pregnancy. Characterizing uhCG variants recognized by their tests and eliminating lot-to-lot variability may help improve uhCG test performance. Clinicians need to be aware of and familiarize themselves with the limitations of the specific type of uhCG POC tests used in their practice, recognizing that under certain circumstances, false-negative tests can occur. Copyright © 2013 Elsevier Inc. All rights reserved.
Fei, Yang; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo
The aim of this study was to use Six Sigma(SM) (Motorola Trademark Holdings, Libertyville, IL) techniques to analyze the quality of point-of-care (POC) glucose testing measurements quantitatively and to provide suggestions for improvement. In total, 151 laboratories in China were included in this investigation in 2014. Bias and coefficient of variation were collected from an external quality assessment and an internal quality control program, respectively, for POC glucose testing organized by the National Center for Clinical Laboratories. The σ values and the Quality Goal Index were used to evaluate the performance of POC glucose meters. There were 27, 30, 57, and 37 participants in the groups using Optium Xceed™ (Abbott Diabetes Care, Alameda, CA), Accu-Chek(®) Performa (Roche, Basel, Switzerland), One Touch Ultra(®) (Abbott), and "other" meters, respectively. The median of the absolute value of percentage difference varied among different lots and different groups. Among all the groups, the Abbott One Touch Ultra group had the smallest median of absolute value of percentage difference except for lot 201411, whereas the "other" group had the largest median in all five lots. More than 85% of participate laboratories satisfied the total allowable error (TEa) requirement in International Organization for Standardization standard 15197:2013, and 85.43% (129/151) of laboratories obtained intralaboratory coefficient of variations less than 1/3TEa. However, Six Sigma techniques suggested that 41.72% (63/151) to 65.56% (99/151) of the laboratories needed to improve their POC glucose testing performance, in either precision, trueness, or both. Laboratories should pay more attention on the practice of POC glucose testing and take actions to improve their performance. Only in this way can POC glucose testing really function well in clinical practice.
Full Text Available HIV prevalence among people who inject drugs (PWID in Ottawa is estimated at about 10%. The successful integration of peers into outreach efforts and wider access to HIV point-of-care testing (POCT create opportunities to explore the role of peers in providing HIV testing. The PROUD study, in partnership with Ottawa Public Health (OPH, sought to develop a model for community-based peer-administered HIV POCT.PROUD draws on community-based participatory research methods to better understand the HIV risk environment of people who use drugs in Ottawa. From March-October 2013, 593 people who reported injecting drugs or smoking crack cocaine were enrolled through street-based recruitment. Trained peer or medical student researchers administered a quantitative survey and offered an HIV POCT (bioLytical INSTI test to participants who did not self-report as HIV positive.550 (92.7% of the 593 participants were offered a POCT, of which 458 (83.3% consented to testing. Of those participants, 74 (16.2% had never been tested for HIV. There was no difference in uptake between testing offered by a peer versus a non-peer interviewer (OR = 1.05; 95% CI = 0.67-1.66. Despite testing those at high risk for HIV, only one new reactive test was identified.The findings from PROUD demonstrate high uptake of community-based HIV POCT. Peers were able to successfully provide HIV POCT and reach participants who had not previously been tested for HIV. Community-based and peer testing models provide important insights on ways to scale-up HIV prevention and testing among people who use drugs.
Kim, Chloe S; Vanture, Sarah; Cho, Margaret; Klapperich, Catherine M; Wang, Catharine; Huang, Franklin W
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.
Giannone, Domenico; Kazmierczak, Andrzej; Dortu, Fabian; Vivien, Laurent; Sohlström, Hans
We present here research work on two optical biosensors which have been developed within two separate European projects (6th and 7th EU Framework Programmes). The biosensors are based on the idea of a disposable biochip, integrating photonics and microfluidics, optically interrogated by a multichannel interrogation platform. The objective is to develop versatile tools, suitable for performing screening tests at Point of Care or for example, at schools or in the field. The two projects explore different options in terms of optical design and different materials. While SABIO used Si3N4/SiO2 ring resonators structures, P3SENS aims at the use of photonic crystal devices based on polymers, potentially a much more economical option. We discuss both approaches to show how they enable high sensitivity and multiple channel detection. The medium term objective is to develop a new detection system that has low cost and is portable but at the same time offering high sensitivity, selectivity and multiparametric detection from a sample containing various components (e.g. blood, serum, saliva, etc.). Most biological sensing devices already present on the market suffer from limitations in multichannel operation capability (either the detection of multiple analytes indicating a given pathology or the simultaneous detection of multiple pathologies). In other words, the number of different analytes that can be detected on a single chip is very limited. This limitation is a main issue addressed by the two projects. The excessive cost per test of conventional bio sensing devices is a second issue that is addressed.
Ramsingh, Davinder; Frank, Ethan; Haughton, Robert; Schilling, John; Gimenez, Kimberly M; Banh, Esther; Rinehart, Joseph; Cannesson, Maxime
Unrecognized malposition of the endotracheal tube (ETT) can lead to severe complications in patients under general anesthesia. The focus of this double-blinded randomized study was to assess the accuracy of point-of-care ultrasound in verifying the correct position of the ETT and to compare it with the accuracy of auscultation. Forty-two adult patients requiring general anesthesia with ETT were consented. Patients were randomized to right main bronchus, left main bronchus, or tracheal intubation. After randomization, the ETT was placed via fiber-optic visualization. Next, the location of the ETT was assessed using auscultation by a separate blinded anesthesiologist, followed by an ultrasound performed by a third blinded anesthesiologist. Ultrasound examination included assessment of tracheal dilation via cuff inflation with air and evaluation of pleural lung sliding. Statistical analysis included sensitivity, specificity, positive predictive value, negative predictive value, and interobserver agreement for the ultrasound examination (95% CI). In differentiating tracheal versus bronchial intubations, auscultation showed a sensitivity of 66% (0.39 to 0.87) and a specificity of 59% (0.39 to 0.77), whereas ultrasound showed a sensitivity of 93% (0.66 to 0.99) and specificity of 96% (0.79 to 1). Identification of tracheal versus bronchial intubation was 62% (26 of 42) in the auscultation group and 95% (40 of 42) in the ultrasound group (P = 0.0005) (CI for difference, 0.15 to 0.52), and the McNemar comparison showed statistically significant improvement with ultrasound (P auscultation in determining the location of ETT.
Kost, Gerald J; Ferguson, William J; Hoe, Jackie; Truong, Anh-Thu; Banpavichit, Arirat; Kongpila, Surin
To present a vision where point-of-care testing (POCT) accelerates an Ebola Spatial Care Path™ (SCP) and future molecular diagnostics enable facilitated-access self-testing (FAST POC); to design an alternate care facility (ACF) for the SCP; to innovate an Ebola diagnostic center (DC); and to propel rapid POCT to the frontline to create resilience that stops future outbreaks. PubMed, literature, and web searches. Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Medicine Without Frontiers, and World Health Organization (WHO) document analyses. Investigations in China, the Philippines, Thailand, and the United States. Review of SE Asia, US, and West Africa isolation-treatment centers. Innovation of a SCP, ACF, and DC suitable for American and other communities. The authors designed an ACF and DC to integrate SCP principles for urgent Ebola care. FDA emergency use authorizations for Ebola molecular diagnostics were discovered, but no portable, handheld, or self-contained molecular POC instruments are yet available, although feasible. The WHO initiated design criteria and an acceptance protocol for testing. Financial investment in POCT will downsize Ebola outbreaks. POCT is facilitating global health. Now, global health problems are elevating POCT to new levels of importance for accelerating diagnosis and evidence-based decision making during disease outbreaks. Authorities concur that rapid diagnosis has potential to stop disease spread. With embedded POCT, strategic SCPs planned by communities fulfill CDC recommendations. POC devices should consolidate multiplex test clusters supporting patients with Ebola in isolation. The ultimate future solution is FAST POC. New technologies offer minimally significant risks. Diagnostic centers in ACFs and transportable formats also will optimize Ebola SCPs.
Choi, Jane Ru; Hu, Jie; Tang, Ruihua; Gong, Yan; Feng, Shangsheng; Ren, Hui; Wen, Ting; Li, XiuJun; Wan Abas, Wan Abu Bakar; Pingguan-Murphy, Belinda; Xu, Feng
With advances in point-of-care testing (POCT), lateral flow assays (LFAs) have been explored for nucleic acid detection. However, biological samples generally contain complex compositions and low amounts of target nucleic acids, and currently require laborious off-chip nucleic acid extraction and amplification processes (e.g., tube-based extraction and polymerase chain reaction (PCR)) prior to detection. To the best of our knowledge, even though the integration of DNA extraction and amplification into a paper-based biosensor has been reported, a combination of LFA with the aforementioned steps for simple colorimetric readout has not yet been demonstrated. Here, we demonstrate for the first time an integrated paper-based biosensor incorporating nucleic acid extraction, amplification and visual detection or quantification using a smartphone. A handheld battery-powered heating device was specially developed for nucleic acid amplification in POC settings, which is coupled with this simple assay for rapid target detection. The biosensor can successfully detect Escherichia coli (as a model analyte) in spiked drinking water, milk, blood, and spinach with a detection limit of as low as 10-1000 CFU mL(-1), and Streptococcus pneumonia in clinical blood samples, highlighting its potential use in medical diagnostics, food safety analysis and environmental monitoring. As compared to the lengthy conventional assay, which requires more than 5 hours for the entire sample-to-answer process, it takes about 1 hour for our integrated biosensor. The integrated biosensor holds great potential for detection of various target analytes for wide applications in the near future.
Yin, C.; Glaser, A.K.; Leigh, S. Y.; Chen, Y.; Wei, L.; Pillai, P. C. S.; Rosenberg, M. C.; Abeytunge, S.; Peterson, G.; Glazowski, C.; Sanai, N.; Mandella, M. J.; Rajadhyaksha, M.; Liu, J. T. C.
There is a need for miniature optical-sectioning microscopes to enable in vivo interrogation of tissues as a real-time and noninvasive alternative to gold-standard histopathology. Such devices could have a transformative impact for the early detection of cancer as well as for guiding tumor-resection procedures. Miniature confocal microscopes have been developed by various researchers and corporations to enable optical sectioning of highly scattering tissues, all of which have necessitated various trade-offs in size, speed, depth selectivity, field of view, resolution, image contrast, and sensitivity. In this study, a miniature line-scanned (LS) dual-axis confocal (DAC) microscope, with a 12-mm diameter distal tip, has been developed for clinical point-of-care pathology. The dual-axis architecture has demonstrated an advantage over the conventional single-axis confocal configuration for reducing background noise from out-of-focus and multiply scattered light. The use of line scanning enables fast frame rates (16 frames/sec is demonstrated here, but faster rates are possible), which mitigates motion artifacts of a hand-held device during clinical use. We have developed a method to actively align the illumination and collection beams in a DAC microscope through the use of a pair of rotatable alignment mirrors. Incorporation of a custom objective lens, with a small form factor for in vivo clinical use, enables our device to achieve an optical-sectioning thickness and lateral resolution of 2.0 and 1.1 microns respectively. Validation measurements with reflective targets, as well as in vivo and ex vivo images of tissues, demonstrate the clinical potential of this high-speed optical-sectioning microscopy device. PMID:26977337
Cross, Robert W; Boisen, Matthew L; Millett, Molly M; Nelson, Diana S; Oottamasathien, Darin; Hartnett, Jessica N; Jones, Abigal B; Goba, Augustine; Momoh, Mambu; Fullah, Mohamed; Bornholdt, Zachary A; Fusco, Marnie L; Abelson, Dafna M; Oda, Shunichiro; Brown, Bethany L; Pham, Ha; Rowland, Megan M; Agans, Krystle N; Geisbert, Joan B; Heinrich, Megan L; Kulakosky, Peter C; Shaffer, Jeffrey G; Schieffelin, John S; Kargbo, Brima; Gbetuwa, Momoh; Gevao, Sahr M; Wilson, Russell B; Saphire, Erica Ollmann; Pitts, Kelly R; Khan, Sheik Humarr; Grant, Donald S; Geisbert, Thomas W; Branco, Luis M; Garry, Robert F
Ebola virus disease (EVD) is a severe viral illness caused by Ebola virus (EBOV). The 2013-2016 EVD outbreak in West Africa is the largest recorded, with >11 000 deaths. Development of the ReEBOV Antigen Rapid Test (ReEBOV RDT) was expedited to provide a point-of-care test for suspected EVD cases. Recombinant EBOV viral protein 40 antigen was used to derive polyclonal antibodies for RDT and enzyme-linked immunosorbent assay development. ReEBOV RDT limits of detection (LOD), specificity, and interference were analytically validated on the basis of Food and Drug Administration (FDA) guidance. The ReEBOV RDT specificity estimate was 95% for donor serum panels and 97% for donor whole-blood specimens. The RDT demonstrated sensitivity to 3 species of Ebolavirus (Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus) associated with human disease, with no cross-reactivity by pathogens associated with non-EBOV febrile illness, including malaria parasites. Interference testing exhibited no reactivity by medications in common use. The LOD for antigen was 4.7 ng/test in serum and 9.4 ng/test in whole blood. Quantitative reverse transcription-polymerase chain reaction testing of nonhuman primate samples determined the range to be equivalent to 3.0 × 10 5 -9.0 × 10 8 genomes/mL. The analytical validation presented here contributed to the ReEBOV RDT being the first antigen-based assay to receive FDA and World Health Organization emergency use authorization for this EVD outbreak, in February 2015. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail firstname.lastname@example.org.
Hedlin, Gunilla; Moreno, Carmen; Petersson, Carl Johan; Lilja, Gunnar; Toledano, Félix Lorente; García, Antonio Nieto; Nordvall, Lennart; Palmqvist, Mona; Rak, Sabina; Ahlstedt, Staffan; Borres, Magnus P
: Allergy is a serious problem affecting approximately 1 of 4 individuals. The symptoms with and without allergy etiology are often difficult to distinguish from each other without using an IgE antibody test. The aim of this study was to investigate the performance of a new point-of-care (POC) test for IgE antibodies to relevant allergens in Europe. : IgE antibodies from children and adults with allergies recruited from allergy clinics in Sweden and Spain were analyzed for 10 allergens, suitable for the age groups, using the new POC test and ImmunoCAP laboratory test. The IgE antibody level best discriminating between positive and negative results (the cutoff point) for the different allergens of the POC test and the efficacy of the POC and the ImmunoCAP laboratory tests for diagnosing allergy compared with that of clinical diagnosis were investigated. : The estimated cutoffs for the different allergens in the POC test ranged from 0.70 to 2.56 kUA/L. Taking into account all positive allergen results in a given patient, the POC test could identify 95% of the patients with allergies. Seventy-eight percent of the allergen-specific physicians' diagnoses were identified and 97% of the negative ones. Most allergens exhibited good performance, identifying about 80% of clinically relevant cases. However, dog, mugwort, and wall pellitory would benefit from improvement. : The POC test will be a valuable adjunct in the identification or exclusion of patients with allergies and their most likely offending allergens, both in specialist and general care settings.
Fischer, Lisa M; Woo, Michael Y; Lee, A Curtis; Wiss, Ray; Socransky, Steve; Frank, Jason R
Emergency medicine point-of-care ultrasonography (EM-PoCUS) is a core competency for residents in the Royal College of Physicians and Surgeons of Canada and College of Family Physicians of Canada emergency medicine (EM) training programs. Although EM-PoCUS fellowships are currently offered in Canada, there is little consensus regarding what training should be included in a Canadian EM-PoCUS fellowship curriculum or how this contrasts with the training received in an EM residency.Objectives To conduct a systematic needs assessment of major stakeholders to define the essential elements necessary for a Canadian EM-PoCUS fellowship training curriculum. We carried out a national survey of experts in EM-PoCUS, EM residency program directors, and EM residents. Respondents were asked to identify competencies deemed either nonessential to EM practice, essential for general EM practice, essential for advanced EM practice, or essential for EM-PoCUS fellowship trained (‘‘expert’’) practice. The response rate was 81% (351 of 435). PoCUS was deemed essential to general EM practice for basic cardiac, aortic, trauma, and procedural imaging. PoCUS was deemed essential to advanced EM practice in undifferentiated symptomatology, advanced chest pathologies, and advanced procedural applications. Expert-level PoCUS competencies were identified for administrative, pediatric, and advanced gynecologic applications. Eighty-seven percent of respondents indicated that there was a need for EM-PoCUS fellowships, with an ideal length of 6 months. This is the first needs assessment of major stakeholders in Canada to identify competencies for expert training in EM-PoCUS. The competencies should form the basis for EM-PoCUS fellowship programs in Canada.
Alkasab, Tarik K; Bizzo, Bernardo C; Berland, Lincoln L; Nair, Sujith; Pandharipande, Pari V; Harvey, H Benjamin
Decreasing unnecessary variation in radiology reporting and producing guideline-concordant reports is fundamental to radiology's success in value-based payment models and good for patient care. In this article, we present an open authoring system for point-of-care clinical decision support tools integrated into the radiologist reporting environment referred to as the computer-assisted reporting and decision support (CAR/DS) framework. The CAR/DS authoring system, described herein, includes: (1) a definition format for representing radiology clinical guidelines as structured, machine-readable Extensible Markup Language documents and (2) a user-friendly reference implementation to test the fidelity of the created definition files with the clinical guideline. The proposed definition format and reference implementation will enable content creators to develop CAR/DS tools that voice recognition software (VRS) vendors can use to extend the commercial tools currently in use. In making the definition format and reference implementation software freely available, we hope to empower individual radiologists, expert groups such as the ACR, and VRS vendors to develop a robust ecosystem of CAR/DS tools that can further improve the quality and efficiency of the patient care that our field provides. We hope that this initial effort can serve as the basis for a community-owned open standard for guideline definition that the imaging informatics and VRS vendor communities will embrace and strengthen. To this end, the ACR Assist™ initiative is intended to make the College's clinical content, including the Incidental Findings Committee White Papers, available for decision support tool creation based upon the herein described CAR/DS framework. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.
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.
Wallis, Lee; Blessing, Paul; Dalwai, Mohammed; Shin, Sang Do
While the field represents a wide spectrum of products and services, many aspects of mHealth have great promise within resource-poor settings: there is an extensive range of cheap, widely available tools which can be used at the point of care delivery. However, there are a number of conditions which need to be met if such solutions are to be adequately integrated into existing health systems; we consider these from regulatory, technological and user perspectives. We explore the need for an appropriate legislative and regulatory framework, to avoid 'work around' solutions, which threaten patient confidentiality (such as the extensive use of instant messaging services to deliver sensitive clinical information and seek diagnostic and management advice). In addition, we will look at other confidentiality issues such as the need for applications to remove identifiable information (such as photos) from users' devices. Integration is dependent upon multiple technological factors, and we illustrate these using examples such as products made available specifically for adoption in low- and middle-income countries. Issues such as usability of the application, signal loss, data volume utilization, need to enter passwords, and the availability of automated or in-app context-relevant clinical advice will be discussed. From a user perspective, there are three groups to consider: experts, front-line clinicians, and patients. Each will accept, to different degrees, the use of technology in care - often with cultural or regional variation - and this is central to integration and uptake. For clinicians, ease of integration into daily work flow is critical, as are familiarity and acceptability of other technology in the workplace. Front-line staff tend to work in areas with more challenges around cell phone signal coverage and data availability than 'back-end' experts, and the effect of this is discussed.
Chibwesha, Carla J; Ford, Catherine E; Mollan, Katie R; Stringer, Jeffrey S A
In the absence of early infant diagnosis (EID) and immediate antiretroviral therapy (ART), some 50% of untreated HIV-infected infants die before age 2. Conventional EID requires sophisticated instruments that are typically placed in centralized or reference laboratories. In low-resource settings, centralized systems often lead to result turnaround times of several months, long delays in diagnosis, and adverse outcomes for HIV-infected children. Our clinical trial tests the effectiveness of a new point-of-care (POC) diagnostic technology to identify HIV-infected infants and start providing them life-saving ART as soon as possible. The study uses a randomized, controlled design to test whether the Alere q platform for HIV DNA polymerase chain reaction (PCR) testing improves outcomes of HIV-infected children in Zambia. We aim to enroll 2867 HIV-exposed infants aged 4-12 weeks and to follow those who are HIV infected for 12 months as they receive HIV care at 6 public health facilities in Lusaka. The trial's primary endpoint is the proportion of HIV-infected infants in each study arm who start ART and remain alive, in care, and virally suppressed 12 months after their diagnostic blood draw. Our trial will provide evidence for the incremental benefit of implementing a POC EID strategy in low-resource settings where only off-site PCR services are currently available. The results will be useful in guiding future decisions regarding investments in POC virologic testing as part of overall pediatric AIDS mitigation strategies in sub-Saharan Africa. clinicaltrials.gov NCT02682810.
Lam, Christopher T.; Krieger, Marlee S.; Gallagher, Jennifer E.; Asma, Betsy; Muasher, Lisa C.; Schmitt, John W.; Ramanujam, Nimmi
Introduction Current guidelines by WHO for cervical cancer screening in low- and middle-income countries involves visual inspection with acetic acid (VIA) of the cervix, followed by treatment during the same visit or a subsequent visit with cryotherapy if a suspicious lesion is found. Implementation of these guidelines is hampered by a lack of: trained health workers, reliable technology, and access to screening facilities. A low cost ultra-portable Point of Care Tampon based digital colposcope (POCkeT Colposcope) for use at the community level setting, which has the unique form factor of a tampon, can be inserted into the vagina to capture images of the cervix, which are on par with that of a state of the art colposcope, at a fraction of the cost. A repository of images to be compiled that can be used to empower front line workers to become more effective through virtual dynamic training. By task shifting to the community setting, this technology could potentially provide significantly greater cervical screening access to where the most vulnerable women live. The POCkeT Colposcope’s concentric LED ring provides comparable white and green field illumination at a fraction of the electrical power required in commercial colposcopes. Evaluation with standard optical imaging targets to assess the POCkeT Colposcope against the state of the art digital colposcope and other VIAM technologies. Results Our POCkeT Colposcope has comparable resolving power, color reproduction accuracy, minimal lens distortion, and illumination when compared to commercially available colposcopes. In vitro and pilot in vivo imaging results are promising with our POCkeT Colposcope capturing comparable quality images to commercial systems. Conclusion The POCkeT Colposcope is capable of capturing images suitable for cervical lesion analysis. Our portable low cost system could potentially increase access to cervical cancer screening in limited resource settings through task shifting to community
Ejilemele, Adetoun; Unabia, Jamie; Ju, Hyunsu; Petersen, John R
HbA1c is an important part of assessing the diabetic control and since the use of point-of-care devices for monitoring HbA1c is increasing, it is important to determine how these devices compare to the central laboratory. One hundred and twenty patient samples were analyzed on the Bio-Rad Variant™II and one POC analyzer (Sakae A1c Gear). Three patient sample pools containing ~5%, ~7%, and ~10% HbA1c levels were run over 20 days. Three reagent lots and three instruments were evaluated for the A1c Gear. The 120 patient samples showed strong correlation (R(2)>0.989) when compared to the Variant™II with means=8.06% and 7.81%, for Variant IIand A1c Gear, respectively. Changing reagent lots or instruments had no impact for the A1c Gear. The ~5%, ~7%, and ~10% pools within-run and between-run imprecision was between 0.87-1.33% and 1.03-1.32%, and 1.41-2.35% and 1.24-1.89% with total imprecision of 1.67-2.35% and 1.61-2.31% for the A1c Gear and Variant II, respectively. The A1c Gear showed a small negative bias (0.25% HbA1c) across HbA1c measurement ranges of Gear meets the criteria of total CV Gear can give results as precise as the laboratory at the POC. Copyright © 2015. Published by Elsevier B.V.
Traditional flow cytometry designs tend to be bulky systems with a complex optical-fluidic sub-system and often require trained personnel for operation. This makes them difficult to readily translate to remote site testing applications. A new compact and portable fiber-optic flow cell (FOFC) technology has been developed at INO. We designed and engineered a specialty optical fiber through which a square hole is transversally bored by laser micromachining. A capillary is fitted into that hole to flow analyte within the fiber square cross-section for detection and counting. With demonstrated performance benchmarks potentially comparable to commercial flow cytometers, our FOFC provides several advantages compared to classic free-space con-figurations, e.g., sheathless flow, low cost, reduced number of optical components, no need for alignment (occurring in the fabrication process only), ease-of-use, miniaturization, portability, and robustness. This sheathless configuration, based on a fiber optic flow module, renders this cytometer amenable to space-grade microgravity environments. We present our recent results for an all-fiber approach to achieve a miniature FOFC to translate flow cytometry from bench to a portable, point-of-care device for deployment in remote settings. Our unique fiber approach provides the capability to illuminate a large surface with a uniform intensity distri-bution, independently of the initial shape originating from the light source, and without loss of optical power. The CVs and sensitivities are measured and compared to industry benchmarks. Finally, integration of LEDs enable several advantages in cost, compactness, and wavelength availability.
Bongard, E; Frimodt-Møller, N; Gal, M; Wootton, M; Howe, R; Francis, N; Goossens, H; Butler, C C
Currently available point-of-care (POC) diagnostic tests for managing urinary tract infections (UTIs) in general practice are limited by poor performance characteristics, and laboratory culture generally provides results only after a few days. This laboratory evaluation compared the analytic performance of the POC UK Flexicult(™) (Statens Serum Institut) (SSI) urinary kit for quantification, identification and antibiotic susceptibility testing and routine UK National Health Service (NHS) urine processing to an advanced urine culture method. Two hundred urine samples routinely submitted to the Public Health Wales Microbiology Laboratory were divided and: (1) analysed by routine NHS microbiological tests as per local laboratory standard operating procedures, (2) inoculated onto the UK Flexicult(™) SSI urinary kit and (3) spiral plated onto Colorex Orientation UTI medium (E&O Laboratories Ltd). The results were evaluated between the NHS and Flexicult(™ )methods, and discordant results were compared to the spiral plating method. The UK Flexicult(™) SSI urinary kit was compared to routine NHS culture for identification of a pure or predominant uropathogen at ≥ 10(5) cfu/mL, with a positive discordancy rate of 13.5% and a negative discordancy rate of 3%. The sensitivity and specificity were 86.7% [95% confidence interval (CI) 73.8-93.7] and 82.6% (95% CI 75.8-87.7), respectively. The UK Flexicult(™) SSI urinary kit was comparable to routine NHS urine processing in identifying microbiologically positive UTIs in this laboratory evaluation. However, the number of false-positive samples could lead to over-prescribing of antibiotics in clinical practice. The Flexicult(™) SSI kit could be useful as a POC test for UTIs in primary care but further pragmatic evaluations are necessary.
Megahed, A A; Hiew, M W H; Townsend, J R; Messick, J B; Constable, P D
The Precision Xtra(®) meter is a promising low cost electrochemical point-of-care unit for measuring blood glucose concentration ([gluc]) in cattle blood. The meter uses an algorithm that assumes the intra-erythrocyte [gluc] equals the plasma [gluc] on a molal basis, and that the hematocrit is similar in humans and cattle. The primary objective was to determine the accuracy of the meter for measuring plasma [gluc] in dairy cattle. Secondary objectives were to characterize the influence of hematocrit and sample temperature on the measured value for [gluc]. A total of 106 periparturient Holstein-Friesian cattle. Blood and plasma samples (1,109) were obtained and Deming regression and Bland-Altman plots were used to determine the accuracy of the meter against the reference method (plasma hexokinase assay). Multivariable regression and linear regression were used to determine the effect of hematocrit and sample temperature on the plasma [gluc] measured by the meter. Intra-erythrocyte [gluc] was 18% of plasma [gluc] on a molar basis. Sample temperature had a significant linear effect on plasma [gluc] as measured by the meter for 3/5 plasma samples when measured [gluc] > 160 mg/dL. The meter utilizes an algorithm that is optimized for human blood and is inaccurate when applied to bovine blood. Until a cattle-specific algorithm is developed, we recommend using plasma as the analyte instead of blood and calculating plasma [gluc] using the equation: [gluc] = 0.66 × [gluc]p-meter + 15, where [gluc]p-meter is the value reported by the meter. If blood is measured, then we recommend using the equation: [gluc] = 0.90 × [gluc]b-meter + 15. Copyright © 2015 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
Gish, R G; Gutierrez, J A; Navarro-Cazarez, N; Giang, K; Adler, D; Tran, B; Locarnini, S; Hammond, R; Bowden, S
Early identification of chronic hepatitis B is important for optimal disease management and prevention of transmission. Cost and lack of access to commercial hepatitis B surface antigen (HBsAg) immunoassays can compromise the effectiveness of HBV screening in resource-limited settings and among marginalized populations. High-quality point-of-care (POC) testing may improve HBV diagnosis in these situations. Currently available POC HBsAg assays are often limited in sensitivity. We evaluated the NanoSign(®) HBs POC chromatographic immunoassay for its ability to detect HBsAg of different genotypes and with substitutions in the 'a' determinant. Thirty-seven serum samples from patients with HBV infection, covering HBV genotypes A-G, were assessed for HBsAg titre with the Roche Elecsys HBsAg II quantification assay and with the POC assay. The POC assay reliably detected HBsAg at a concentration of at least 50 IU/mL for all genotypes, and at lower concentrations for some genotypes. Eight samples with substitutions in the HBV 'a' determinant were reliably detected after a 1/100 dilution. The POC strips were used to screen serum samples from 297 individuals at risk for HBV in local clinical settings (health fairs and outreach events) in parallel with commercial laboratory HBsAg testing (Quest Diagnostics EIA). POC testing was 73.7% sensitive and 97.8% specific for detection of HBsAg. Although the POC test demonstrated high sensitivity over a range of genotypes, false negatives were frequent in a clinical setting. Nevertheless, the POC assay offers advantages for testing in both developed and resource-limited countries due to its low cost (0.50$) and immediately available results. © 2014 John Wiley & Sons Ltd.
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
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.
Grant, D A; Dunseath, G J; Churm, R; Luzio, S D
As the use of Point of Care Testing (POCT) devices for measurement of glycated haemoglobin (HbA1c) increases, it is imperative to determine how their performance compares to laboratory methods. This study compared the performance of the automated Quo-Test POCT device (EKF Diagnostics), which uses boronate fluorescence quenching technology, with a laboratory based High Performance Liquid Chromatography (HPLC) method (Biorad D10) for measurement of HbA1c. Whole blood EDTA samples from subjects (n=100) with and without diabetes were assayed using a BioRad D10 and a Quo-Test analyser. Intra-assay variation was determined by measuring six HbA1c samples in triplicate and inter-assay variation was determined by assaying four samples on 4 days. Stability was determined by assaying three samples stored at -20 °C for 14 and 28 days post collection. Median (IQR) HbA1c was 60 (44.0-71.2) mmol/mol (7.6 (6.17-8.66) %) and 62 (45.0-69.0) mmol/mol (7.8 (6.27-8.46) %) for D10 and Quo-Test, respectively, with very good agreement (R 2 =0.969, Pglucose intolerance (IGT and T2DM) and 100% for diagnosis of T2DM. Good agreement between the D10 and Quo-Test was seen across a wide HbA1c range. The Quo-Test POCT device provided similar performance to a laboratory based HPLC method.
Stoot, Lauren J; Cairns, Nicholas A; Cull, Felicia; Taylor, Jessica J; Jeffrey, Jennifer D; Morin, Félix; Mandelman, John W; Clark, Timothy D; Cooke, Steven J
Non-human vertebrate blood is commonly collected and assayed for a variety of applications, including veterinary diagnostics and physiological research. Small, often non-lethal samples enable the assessment and monitoring of the physiological state and health of the individual. Traditionally, studies that rely on blood physiology have focused on captive animals or, in studies conducted in remote settings, have required the preservation and transport of samples for later analysis. In either situation, large, laboratory-bound equipment and traditional assays and analytical protocols are required. The use of point-of-care (POC) devices to measure various secondary blood physiological parameters, such as metabolites, blood gases and ions, has become increasingly popular recently, due to immediate results and their portability, which allows the freedom to study organisms in the wild. Here, we review the current uses of POC devices and their applicability to basic and applied studies on a variety of non-domesticated species. We located 79 individual studies that focused on non-domesticated vertebrates, including validation and application of POC tools. Studies focused on a wide spectrum of taxa, including mammals, birds and herptiles, although the majority of studies focused on fish, and typical variables measured included blood glucose, lactate and pH. We found that calibrations for species-specific blood physiology values are necessary, because ranges can vary within and among taxa and are sometimes outside the measurable range of the devices. In addition, although POC devices are portable and robust, most require durable cases, they are seldom waterproof/water-resistant, and factors such as humidity and temperature can affect the performance of the device. Overall, most studies concluded that POC devices are suitable alternatives to traditional laboratory devices and eliminate the need for transport of samples; however, there is a need for greater emphasis on rigorous
Martin, Jan; Blobner, Manfred; Busch, Raymonde; Moser, Norman; Kochs, Eberhard; Luppa, Peter B
The aim of the study was to retrospectively investigate whether parameters of routine point-of-care testing (POCT) predict hospital mortality in critically ill surgical patients on admission to the intensive care unit (ICU). Arterial blood analyses of 1551 patients on admission to the adult surgical ICU of the Technical University Munich were reviewed. POCT was performed on a blood gas analyser. The association between acid-base status and mortality was evaluated. Metabolic acidosis was defined by base excess (BE) lactate >50% of BE, anion gap (AG)-acidosis by AG >16 mmol/L, hyperchloraemic acidosis by chloride >115 mmol/L. Metabolic alkalosis was defined by BE ≥3 mmol/L. Logistic regression analysis identified variables independently associated with mortality. Overall mortality was 8.8%. Mortality was greater in male patients (p=0.012). Mean age was greater in non-survivors (p55 mm Hg (mortality 23.1%). Three hundred and seventy-seven patients presented with acidosis (mortality 11.4%), thereof 163 patients with lactic acidosis (mortality 19%). Mortality for alkalosis (174 patients) was 12.1%. Mean blood glucose level for non-survivors was higher compared to survivors (plactate, glucose, age, male gender as independent predictors of mortality. Lactate and glucose on ICU admission independently predict mortality. BE and AG failed as prognostic markers. Lactic acidosis showed a high mortality rate implying that lactate levels should be obtained on ICU admission. Prevalence of hyperchloraemic acidosis was low. Metabolic alkalosis was associated with an increased mortality. Further studies on this disturbance and its attendant high mortality are warranted.
Smith, Stella Ifeanyi; Bamidele, Moses; Fowora, Muinah; Goodluck, Helen T.; Omonigbehin, Emmanuel A.; Akinsinde, Kehinde A.; Fesobi, Toun; Pastoor, Rob; Abdoel, Theresia H.; Smits, Henk L.
There is an urgent need for affordable point-of-care diagnostics for the differentiation of febrile illnesses and the confirmation of typhoid in endemic countries. Blood samples were collected from febrile patients with clinical suspicion of typhoid and screened for typhoid fever using the Widal and
Conclusions: The io® CT-assay is a 30-min, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care.
de Vries, Claudette; Doggen, Catharina Jacoba Maria; Hilbers, Ellen; Verheij, Robert; IJzerman, Maarten Joost; Geertsma, Robert; Kusters, Ron
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
Full Text Available We present a plug-and-play toolkit for the rapid assembly of paper-based microfluidic and electronic components for quick prototyping of paper-based components towards point-of-care diagnostic solutions. Individual modules, each with a specific...
Avolio, Manuela; Grosso, Shamanta; Bruschetta, Graziano; Camporese, Alessandro
We compared, in terms of microorganisms recovery, the discard of specimen collection swab, after swirling into its medium, directly at point of care, with its placing into the medium and vortexing on arrival in the laboratory. Our results show that these two procedures are overlapped in terms of bacterial recovery. Copyright © 2016 Elsevier B.V. All rights reserved.
Heringa, Mette; Floor-Schreudering, Annemieke; De Smet, Peter A G M; Bouvy, Marcel L
OBJECTIVE: The aim was to investigate the management of drug therapy alerts on safe use of antibiotics in elderly patients with (potential) renal impairment and the contribution of optional creatinine point of care testing (PoCT) in community pharmacy practice. METHODS: Community pharmacists used a
Schot, Marjolein J C; van Delft, Sanne; Kooijman-Buiting, Antoinette M J; de Wit, Niek J; Hopstaken, Rogier M
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
van Doorn, H. Rogier; Kinh, Nguyen Van; Tuan, Ha Manh; Tuan, Tran Anh; Minh, Ngo Ngoc Quang; Bryant, Juliet E.; Hang, Vu thi Ty; Uyen, Le thi Tham; Thinh, Le Quoc; Anh, Tran thi Ngoc; Lan, Nguyen Phu Huong; Trung, Nguyen Vu; Taylor, Walter; Merson, Laura; Wertheim, Heiman F. L.; Farrar, Jeremy; Wolbers, Marcel; Chau, Nguyen Van Vinh; de Jong, Menno D.
Point-of-care (POC) diagnostic tests for influenza can considerably shorten the time to clinical decision making. An investigational POC test based on a multiplexed immunoassay was developed by Meso Scale Diagnostics, LLC (MSD), with the objective to make a more sensitive rapid test that can also
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
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
Bui, H N; Bogers, J P A M; Cohen, D; Njo, T; Herruer, M H
We evaluated the performance of the HemoCue WBC DIFF, a point-of-care device for total and differential white cell count, primarily to test its suitability for the mandatory white blood cell monitoring in clozapine use. Leukocyte count and 5-part differentiation was performed by the point-of-care device and by routine laboratory method in venous EDTA-blood samples from 20 clozapine users, 20 neutropenic patients, and 20 healthy volunteers. From the volunteers, also a capillary sample was drawn. Intra-assay reproducibility and drop-to-drop variation were tested. The correlation between both methods in venous samples was r > 0.95 for leukocyte, neutrophil, and lymphocyte counts. The correlation between point-of-care (capillary sample) and routine (venous sample) methods for these cells was 0.772; 0.817 and 0.798, respectively. Only for leukocyte and neutrophil counts, the intra-assay reproducibility was sufficient. The point-of-care device can be used to screen for leukocyte and neutrophil counts. Because of the relatively high measurement uncertainty and poor correlation with venous samples, we recommend to repeat the measurement with a venous sample if cell counts are in the lower reference range. In case of clozapine therapy, neutropenia can probably be excluded if high neutrophil counts are found and patients can continue their therapy. © 2016 John Wiley & Sons Ltd.
Melchers, W.J.G.; Kuijpers, J; Sickler, J.J.; Rahamat-Langendoen, J.C.
Rapid diagnosis of influenza A and B is important for direct treatment decisions in patient care and for the reduction of in-hospital transmissions. The new real-time PCR based molecular point-of-care (POC) assay, the cobas(R) Influenza A/B test on the cobas(R) Liat(R) System (cobas(R) Liat(R)
Yoon, Christina; Semitala, Fred C; Atuhumuza, Elly; Katende, Jane; Mwebe, Sandra; Asege, Lucy; Armstrong, Derek T; Andama, Alfred O; Dowdy, David W; Davis, J Luke; Huang, Laurence; Kamya, Moses; Cattamanchi, Adithya
Symptom-based screening for tuberculosis is recommended for all people living with HIV. This recommendation results in unnecessary Xpert MTB/RIF testing in many individuals living in tuberculosis-endemic areas and thus poor implementation of intensified case finding and tuberculosis preventive therapy. Novel approaches to tuberculosis screening are needed to help achieve global targets for tuberculosis elimination. We assessed the performance of C-reactive protein (CRP) measured with a point-of-care assay as a screening tool for active pulmonary tuberculosis. For this prospective study, we enrolled adults (aged ≥18 years) living with HIV with CD4 cell count less than or equal to 350 cells per μL who were initiating antiretroviral therapy (ART) from two HIV/AIDS clinics in Uganda. CRP concentrations were measured at study entry with a point-of-care assay using whole blood obtained by fingerprick (concentration ≥10 mg/L defined as screen positive for tuberculosis). Sputum samples were collected for Xpert MTB/RIF testing and culture. We calculated the sensitivity and specificity of point-of-care CRP and WHO symptom-based screening in reference to culture results. We repeated the sensitivity analysis with Xpert MTB/RIF as the reference standard. Between July 8, 2013, and Dec 15, 2015, 1237 HIV-infected adults were enrolled and underwent point-of-care CRP testing. 60 (5%) patients with incomplete or contaminated cultures were excluded from the analysis. Of the remaining 1177 patients (median CD4 count 165 cells per μL [IQR 75-271]), 163 (14%) had culture-confirmed tuberculosis. Point-of-care CRP testing had 89% sensitivity (145 of 163, 95% CI 83-93) and 72% specificity (731 of 1014, 95% CI 69-75) for culture-confirmed tuberculosis. Compared with WHO symptom-based screening, point-of-care CRP testing had lower sensitivity (difference -7%, 95% CI -12 to -2; p=0·002) but substantially higher specificity (difference 58%, 95% CI 55 to 61; ptuberculosis screening test
Lin, Judith C; Crutchfield, Janelle M; Zurawski, Dana K; Stevens, Courtney
overall quality responses were overwhelmingly positive. Secured virtual visits can be conducted using commercially available hardware and software solutions. Synchronous telemedicine with point-of-care ultrasound is effective in evaluating common vascular conditions. Virtual care may be used for management of patients with chronic vascular disease. Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
Kristensen, Troels; Waldorff, Frans Boch; Nexøe, Jørgen; Skovsgaard, Christian Volmar; Olsen, Kim Rose
Background: Point-of-care testing (POCT) of HbA1c may result in improved diabetic control, better patient outcomes, and enhanced clinical efficiency with fewer patient visits and subsequent reductions in costs. In 2008, the Danish regulators created a framework agreement regarding a new fee-for-service fee for the remuneration of POCT of HbA1c in general practice. According to secondary research, only the Capital Region of Denmark has allowed GPs to use this new incentive for POCT. The aim of this study is to use patient data to characterize patients with diabetes who have received POCT of HbA1c and analyze the variation in the use of POCT of HbA1c among patients with diabetes in Danish general practice. Methods: We use register data from the Danish Drug Register, the Danish Health Service Register and the National Patient Register from the year 2011 to define a population of 44,981 patients with diabetes (type 1 and type 2 but not patients with gestational diabetes) from the Capital Region. The POCT fee is used to measure the amount of POCT of HbA1c among patients with diabetes. Next, we apply descriptive statistics and multilevel logistic regression to analyze variation in the prevalence of POCT at the patient and clinic level. We include patient characteristics such as gender, age, socioeconomic markers, health care utilization, case mix markers, and municipality classifications. Results: The proportion of patients who received POCT was 14.1% and the proportion of clinics which were "POCT clinics" was 26.9%. There were variations in the use of POCT across clinics and patients. A part of the described variation can be explained by patient characteristics. Male gender, age differences (older age), short education, and other ethnicity imply significantly higher odds for POCT. High patient costs in general practice and other parts of primary care also imply higher odds for POCT. In contrast, high patient costs for drugs and/or morbidity in terms of the Charlson
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.
Full Text Available Untreated syphilis in pregnancy is associated with adverse clinical outcomes for the infant. Most syphilis infections occur in sub-Saharan Africa (SSA, where coverage of antenatal screening for syphilis is inadequate. Recently introduced point-of-care syphilis tests have high accuracy and demonstrate potential to increase coverage of antenatal screening. However, country-specific cost-effectiveness data for these tests are limited. The objective of this analysis was to evaluate the cost-effectiveness and budget impact of antenatal syphilis screening for 43 countries in SSA and estimate the impact of universal screening on stillbirths, neonatal deaths, congenital syphilis, and disability-adjusted life years (DALYs averted.The decision analytic model reflected the perspective of the national health care system and was based on the sensitivity (86% and specificity (99% reported for the immunochromatographic strip (ICS test. Clinical outcomes of infants born to syphilis-infected mothers on the end points of stillbirth, neonatal death, and congenital syphilis were obtained from published sources. Treatment was assumed to consist of three injections of benzathine penicillin. Country-specific inputs included the antenatal prevalence of syphilis, annual number of live births, proportion of women with at least one antenatal care visit, per capita gross national income, and estimated hourly nurse wages. In all 43 sub-Saharan African countries analyzed, syphilis screening is highly cost-effective, with an average cost/DALY averted of US$11 (range: US$2-US$48. Screening remains highly cost-effective even if the average prevalence falls from the current rate of 3.1% (range: 0.6%-14.0% to 0.038% (range: 0.002%-0.113%. Universal antenatal screening of pregnant women in clinics may reduce the annual number of stillbirths by up to 64,000, neonatal deaths by up to 25,000, and annual incidence of congenital syphilis by up to 32,000, and avert up to 2.6 million
Susan M. Abdel-Rahman
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
Xu, J; Sisniega, A; Zbijewski, W; Dang, H; Stayman, J; Aygun, N; Koliatsos, V; Siewerdsen, J [Johns Hopkins University, Baltimore, MD (United States); Wang, X; Foos, D [Carestream Health, Rochester, New York (United States)
Purpose: This work reports the design, development, and first technical assessment of a cone-beam CT (CBCT) scanner developed specifically for imaging of acute intracranial hemorrhage (ICH) at the point of care, with target applications in diagnosis and monitoring of traumatic brain injury, stroke, and postsurgical hemorrhage. Methods: System design employed a task-based image quality model to quantify the influence of factors such as additive noise and high-gain (HG) detector readout on ICH detectability. Three bowtie filters with varying bare-beam attenuation strength and curvature were designed to enable HG readout without detector saturation, and a polyenergetic gain correction was developed to minimize artifacts from bowtie flood-field calibration. Image reconstruction used an iterative penalized weighted least squares (PWLS) method with artifact correction including Monte Carlo scatter estimation, Joseph-Spital beam hardening correction, and spatiotemporal deconvolution of detector glare and lag. Radiation dose was characterized for half-scan and full-scan protocols at various kV, and imaging performance was assessed in a head phantom presenting simulated ICH with diameter ranging 2–12 mm. Results: The image quality model guided system design and was validated by measurements on a CBCT imaging bench. Compared to low-gain readout without a bowtie filter, the combination of HG readout and a modest bowtie improved the contrast-to-noise ratio (CNR per unit square-root dose) by 20% in the center of the image but degraded noise performance near the periphery (20% reduction in CNR). Low-frequency bowtie artifacts (∼100 HU magnitude) were corrected by the polyenergetic gain correction. Image reconstructions on the prototype scanner demonstrate clear visibility of the smallest ICH insert (2 mm diameter) in both HG readout (with a bowtie) and dual-gain readout (without bowtie). Conclusion: Technical assessment of the prototype scanner suggests the capability for
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.
Bollepalli, S Chandra; Challa, S Sastry; Anumandla, Laxminarayana; Jana, Soumya
While cardiovascular diseases (CVDs) are prevalent across economic strata, the economically disadvantaged population is disproportionately affected due to the high cost of traditional CVD management, involving consultations, testing and monitoring at medical facilities. Accordingly, developing an ultra-low-cost alternative, affordable even to groups at the bottom of the economic pyramid, has emerged as a societal imperative. Against this backdrop, we propose an inexpensive yet accurate home-based electrocardiogram (ECG) monitoring service. Specifically, we seek to provide point-of-care monitoring of premature ventricular contractions (PVCs), high frequency of which could indicate the onset of potentially fatal arrhythmia. Note that the first-generation telecardiology system acquires the ECG, transmits it to a professional diagnostic center without processing, and nearly achieves the diagnostic accuracy of a bedside setup. In the process, such a system incurs high bandwidth cost and requires the physicians to process the entire record for diagnosis. To reduce cost, current telecardiology systems compress data before transmitting. However, the burden on physicians remains undiminished. In this context, we develop a dictionary-based algorithm that reduces not only the overall bandwidth requirement, but also the physicians workload by localizing anomalous beats. Specifically, we detect anomalous beats with high sensitivity and only those beats are then transmitted. In fact, we further compress those beats using class-specific dictionaries subject to suitable reconstruction/diagnostic fidelity. Finally, using Monte Carlo cross validation on MIT/BIH arrhythmia database, we evaluate the performance of the proposed system. In particular, with a sensitivity target of at most one undetected PVC in one hundred beats, and a percentage root mean squared difference less than 9% (a clinically acceptable level of fidelity), we achieved about 99.15% reduction in bandwidth cost
Fabre, Stéphanie; Clerson, Pierre; Launay, Jean-Marie; Gautier, Jean-François; Vidal-Trecan, Tiphaine; Riveline, Jean-Pierre; Platt, Adam; Abrahamsson, Anna; Miner, Jeffrey N; Hughes, Glen; Richette, Pascal; Bardin, Thomas
The uric acid (UA) level in patients with gout is a key factor in disease management and is typically measured in the laboratory using plasma samples obtained after venous puncture. This study aimed to assess the reliability of immediate UA measurement with capillary blood samples obtained by fingertip puncture with the HumaSens plus point-of-care meter. UA levels were measured using both the HumaSens plus meter in the clinic and the routine plasma UA method in the biochemistry laboratory of 238 consenting diabetic patients. HumaSens plus capillary and routine plasma UA measurements were compared by linear regression, Bland-Altman plots, intraclass correlation coefficient (ICC), and Lin's concordance coefficient. Values outside the dynamic range of the meter, low (LO) or high (HI), were analyzed separately. The best capillary UA thresholds for detecting hyperuricemia were determined by receiver operating characteristic (ROC) curves. The impact of potential confounding factors (demographic and biological parameters/treatments) was assessed. Capillary and routine plasma UA levels were compared to reference plasma UA measurements by liquid chromatography-mass spectrometry (LC-MS) for a subgroup of 67 patients. In total, 205 patients had capillary and routine plasma UA measurements available. ICC was 0.90 (95% confidence interval (CI) 0.87-0.92), Lin's coefficient was 0.91 (0.88-0.93), and the Bland-Altman plot showed good agreement over all tested values. Overall, 17 patients showed values outside the dynamic range. LO values were concordant with plasma values, but HI values were considered uninterpretable. Capillary UA thresholds of 299 and 340 μmol/l gave the best results for detecting hyperuricemia (corresponding to routine plasma UA thresholds of 300 and 360 μmol/l, respectively). No significant confounding factor was found among those tested, except for hematocrit; however, this had a negligible influence on the assay reliability. When capillary and routine
Shephard, Mark; Shephard, Anne; McAteer, Bridgit; Regnier, Tamika; Barancek, Kristina
Diabetes is a major health problem for Australia's Aboriginal and Torres Strait Islander peoples. Point-of-care testing for haemoglobin A1c (HbA1c) has been the cornerstone of a long-standing program (QAAMS) to manage glycaemic control in Indigenous people with diabetes and recently, to diagnose diabetes. The QAAMS quality management framework includes monthly testing of quality control (QC) and external quality assurance (EQA) samples. Key performance indicators of quality include imprecision (coefficient of variation [CV%]) and percentage acceptable results. This paper reports on the past 15years of quality testing in QAAMS and examines the performance of HbA1c POC testing at the 6.5% cut-off recommended for diagnosis. The total number of HbA1c EQA results submitted from 2002 to 2016 was 29,093. The median imprecision for EQA testing by QAAMS device operators averaged 2.81% (SD 0.50; range 2.2 to 3.9%) from 2002 to 2016 and 2.44% (SD 0.22; range 2.2 to 2.9%) from 2009 to 2016. No significant difference was observed between the median imprecision achieved in QAAMS and by Australasian laboratories from 2002 to 2016 (p=0.05; two-tailed paired t-test) and from 2009 to 2016 (p=0.17; two-tailed paired t-test). For QC testing from 2009 to 2016, imprecision averaged 2.5% and 3.0% for the two levels of QC tested. Percentage acceptable results averaged 90% for QA testing from 2002 to 2016 and 96% for QC testing from 2009 to 2016. The DCA Vantage was able to measure a patient and an EQA sample with an HbA1c value close to 6.5% both accurately and precisely. HbA1c POC testing in QAAMS has remained analytically sound, matched the quality achieved by Australasian laboratories and met profession-derived analytical goals for 15years. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
Zorzi, Antonella; Cordioli, Maddalena; Gios, Lorenzo; Del Bravo, Paola; Toskin, Igor; Peeling, Rosanna W; Blondeel, Karel; Cornaglia, Giuseppe; Kiarie, James; Ballard, Ronald; Mirandola, Massimo
The incidence of HIV and syphilis among men who have sex with men (MSM) in Europe has recently increased. Rapid point-of-care tests (POCTs) for syphilis can improve access to screening. The purpose of this study was to evaluate the performance of two syphilis POCTs compared with laboratory tests among MSM. The study was undertaken in Verona, Italy. Asymptomatic MSM, potentially exposed to syphilis, were enrolled prospectively. The POCTs evaluated were SD Bioline Syphilis 3.0 and Chembio DPP Syphilis Screen & Confirm Assay on both serum and fingerprick blood. The results of the POCTs were read by the naked eye by two independent readers and their concordance assessed. A total of 289 MSM were enrolled in the study. Based on laboratory tests, 35 MSM (12.1%) were TPPA-positive alone and 16 (5.5%) were both Treponema pallidum particle agglutination test (TPPA) and rapid plasma reagin (RPR)-positive. The specificities of both POCTs were above 99% on both serum and fingerstick blood specimens, while sensitivities varied considerably. The sensitivity of the SD Bioline test was lower on fingerprick blood (51.4% and 54.3%, readers 1 and 2, respectively) compared with that on serum (80.0% and 82.9%). In contrast, the Chembio test exhibited similar sensitivity values for serum and fingerprick samples (57.7% and 64.0% on serum vs 65.4% and 69.2% on fingerprick for the treponemal component; 63.6% on both samples by both readers for the non-treponemal component). The positive predictive value ranged between 100% and 93.9% for the treponemal component of both syphilis POCTs, but was lower (76.3%-100%)%) for the non-treponemal component of the Chembio POCT. The negative predictive value surpassed 90% for both tests on both samples. The agreement between readers was very high (>99%). The diagnostic performance of the syphilis POCTs was lower than expected; however, considering the prevalence of syphilis among MSM, POCTs should be recommended to improve syphilis detection among MSM
Full Text Available Caprella scaura is an epifaunal amphipod crustacean that originates in the western Indian Ocean and has spread throughout the world, but very little is known about fundamental aspects of its biology. This paper is the first presentation of its life history traits in an invaded region. The study was conducted in the Mar Piccolo basin (southern Italy, Ionian Sea, over a one-year period. All biological parameters showed a strong seasonal pattern, breeding peaked twice during the year and the number of eggs in the ventral brood pouch ranged from 5 to 72. The sex ratio was generally close to 1:1. A strong correlation between total length of ovigerous females and number of eggs was observed. The mean length of both mature males and mature females was 10.63 and 7.70 mm, respectively. The results of this study showed that the population dynamics of this species was not dissimilar to that of other caprellids or marine epifaunal Crustacea. This caprellid has given rise to a stable population in the Mar Piccolo; it was present all year round in the study area but its density suggests that it is not yet a strong invader.
Ferraro, L.; Rubino, F.; Frontalini, F.; Belmonte, M.; Di Leo, A.; Giandomenico, S.; Greco, M.; Lirer, F.; Spada, L.; Vallefuoco, M.
characteristic, cysts constitute a reservoir of potential biodiversity but can also be useful indicators of productivity, eutrophication and pollution in recent marine environments. In this way, the sampling sediments of a coastal marine area, allows to monitor the responses of both microplankton and microbenthos to possible disturbance events of the ecosystem. A preliminary study, preparatory to a more detailed sampling survey during winter 2013, was carried out in December 2011 in the Mar Piccolo of Taranto (Ionian Sea), on surface sediment samples which were analyzed to identify living benthic foraminiferal assemblages and dormant stages of plankton in order to establish the potentiality of these organisms as bio-indicators of environmental stress conditions.
McRae, Michael P; Simmons, Glennon; Wong, Jorge; McDevitt, John T
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
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” . 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.
Dorward, Jienchi; Garrett, Nigel; Quame-Amaglo, Justice; Samsunder, Natasha; Ngobese, Hope; Ngomane, Noluthando; Moodley, Pravikrishnen; Mlisana, Koleka; Schaafsma, Torin; Donnell, Deborah; Barnabas, Ruanne; Naidoo, Kogieleum; Abdool Karim, Salim; Celum, Connie; Drain, Paul K
Introduction Achieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shift...
Full Text Available A large gap for the support of point-of-care testing is the availability of reagents to support quality control (QC of diagnostic assays along the supply chain from the manufacturer to the end user. While reagents and systems exist to support QC of laboratory screening tests for glucose-6-phosphate dehydrogenase (G6PD deficiency, they are not configured appropriately to support point-of-care testing. The feasibility of using lyophilized recombinant human G6PD as a QC reagent in novel point-of-care tests for G6PD deficiency is demonstrated.Human recombinant G6PD (r-G6PD was expressed in Escherichia coli and purified. Aliquots were stored at -80°C. Prior to lyophilization, aliquots were thawed, and three concentrations of r-G6PD (representing normal, intermediate, and deficient clinical G6PD levels were prepared and mixed with a protective formulation, which protects the enzyme activity against degradation from denaturation during the lyophilization process. Following lyophilization, individual single-use tubes of lyophilized r-G6PD were placed in individual packs with desiccants and stored at five temperatures for one year. An enzyme assay for G6PD activity was used to ascertain the stability of r-G6PD activity while stored at different temperatures.Lyophilized r-G6PD is stable and can be used as a control indicator. Results presented here show that G6PD activity is stable for at least 365 days when stored at -80°C, 4°C, 30°C, and 45°C. When stored at 55°C, enzyme activity was found to be stable only through day 28.Lyophilized r-G6PD enzyme is stable and can be used as a control for point-of-care tests for G6PD deficiency.
Glasmacher, S A; Bonongwe, P; Stones, W
To achieve good outcomes in critically ill obstetric patients, it is necessary to identify organ dysfunction rapidly so that life-saving interventions can be appropriately commenced. However, timely access to clinical chemistry results is problematic, even in referral institutions, in the sub-Saharan African region. Reliable point-of-care tests licensed for clinical use are now available for lactate and creatinine. We aimed to assess whether implementation of point-of-care testing for lactate and creatinine is feasible in the obstetric unit at the Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi, by obtaining the opinions of clinical staff on the use of these tests in practice. During a two-month evaluation period nurse-midwives, medical interns, clinical officers, registrars, and consultants were given the opportunity to use StatStrip® and StatSensor® (Nova Biomedical, Waltham, USA) devices, for lactate and creatinine estimation, as part of their routine clinical practice in the obstetric unit. They were subsequently asked to complete a short questionnaire. Thirty-seven questionnaires were returned by participants: 22 from nurse-midwives and the remainder from clinicians. The mean satisfaction score for the devices was 7.6/10 amongst clinicians and 8.0/10 amongst nurse-midwives. The majority of participants stated that the obstetric high dependency unit (HDU) was the most suitable location for the devices. For lactate, 31 participants strongly agreed that testing should be continued and 24 strongly agreed that it would influence patient management. For creatinine, 29 strongly agreed that testing should be continued and 28 strongly agreed that it would influence their patient management. Twenty participants strongly agreed that they trust point-of-care devices. Point-of-care clinical chemistry testing was feasible, practical, and well received by staff, and was considered to have a useful role to play in the clinical care of sick obstetric patients at
Hamilton, Matthew T.; Finger, John W.; Winzeler, Megan E.; Tuberville, Tracey D.
The assessment of wildlife health has been enhanced by the ability of point-of-care (POC) blood analysers to provide biochemical analyses of non-domesticated animals in the field. However, environmental limitations (e.g. temperature, atmospheric humidity and rain) and lack of reference values may inhibit researchers from using such a device with certain wildlife species. Evaluating the use of alternative sample types, such as plasma, in a POC device may afford researchers the opportunity to d...
Wilson, Sean P; Mefford, Jason M; Lahham, Shadi; Lotfipour, Shahram; Subeh, Mohammad; Maldonado, Gracie; Spann, Sophie; Fox, John C
The established benefits of point-of-care ultrasound have given rise to multiple new and innovative curriculums to incorporate ultrasound teaching into medical education. This study sought to measure the educational success of a comprehensive and integrated 4-year point-of-care ultrasound curriculum. We integrated a curriculum consisting of traditional didactics combined with asynchronous learning modules and hands-on practice on live models with skilled sonographers into all 4 years of education at a Liaison Committee on Medical Education-accredited US Medical School. Each graduating student was administered an exit examination with 48 questions that corresponded to ultrasound milestones. Ninety-five percent (n = 84) of fourth-year medical students completed the exit examination. The mean score was 79.5% (SD, 10.2%), with mean scores on the ultrasound physics and anatomy subsections being 77.1% (SD, 11.0%) and 85.9% (SD, 21.0%), respectively. A comprehensive 4-year point-of-care ultrasound curriculum integrated into medical school may successfully equip graduating medical students with a fundamental understanding of ultrasound physics, anatomy, and disease recognition. © 2016 by the American Institute of Ultrasound in Medicine.
Ye, Xin; Xu, Jin; Lu, Lijuan; Li, Xinxin; Fang, Xueen; Kong, Jilie
The use of paper-based methods for clinical diagnostics is a rapidly expanding research topic attracting a great deal of interest. Some groups have attempted to realize an integrated nucleic acid test on a single microfluidic paper chip, including extraction, amplification, and readout functions. However, these studies were not able to overcome complex modification and fabrication requirements, long turn-around times, or the need for sophisticated equipment like pumps, thermal cyclers, or centrifuges. Here, we report an extremely simple paper-based test for the point-of-care diagnosis of rotavirus A, one of the most common pathogens that causes pediatric gastroenteritis. This paper-based test could perform nucleic acid extraction within 5 min, then took 25 min to amplify the target sequence, and the result was visible to the naked eye immediately afterward or quantitative by the UV-Vis absorbance. This low-cost method does not require extra equipment and is easy to use either in a lab or at the point-of-care. The detection limit for rotavirus A was found to be 1 × 10 3 copies/mL. In addition, 100% sensitivity and specificity were achieved when testing 48 clinical stool samples. In conclusion, the present paper-based test fulfills the main requirements for a point-of-care diagnostic tool, and has the potential to be applied to disease prevention, control, and precision diagnosis. Copyright © 2018 Elsevier B.V. All rights reserved.
Kirk, Jane; Kendall, Anson; Marx, James F; Pincock, Ted; Young, Elizabeth; Hughes, Jillian M; Landers, Timothy
Hand hygiene at the point of care is recognized as a best practice for promoting compliance at the moments when hand hygiene is most critical. The objective of this study was to compare knowledge, attitudes, and practices of US and Canadian frontline health care personnel regarding hand hygiene at the point of care. Physicians and nurses in US and Canadian hospitals were invited to complete a 32-question online survey based on evidence supporting point of care hand hygiene. Eligible health care personnel were in direct clinical practice at least 50% of the time. Three hundred fifty frontline caregivers completed the survey. Among respondents, 57.1% were from the United States and 42.9% were from Canada. Respondents were evenly distributed between physician and nurses. The US and Canadian respondents gave identical ranking to their perceived barriers to hand hygiene compliance. More than half of the respondents from both the United States and Canada agreed or strongly agreed that they would be more likely to clean their hands when recommended if alcohol-based handrub was closer to the patient. This survey demonstrates that similarities between Canada and the United States were more common than not, and the survey raises, or suggests, potential knowledge gaps that require further illumination. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
Schvartz, Gili; Epp, Tasha; Burgess, Hilary J; Chilton, Neil B; Pearl, David L; Lohmann, Katharina L
Equine granulocytic anaplasmosis (EGA) and Lyme borreliosis (LB) are an emerging concern in Canada. We estimated the seroprevalence of EGA and equine LB by testing 376 convenience serum samples from 3 provinces using a point-of-care SNAP(®) 4Dx(®) ELISA (IDEXX Laboratories, Westbrook, Maine, USA), and investigated the agreement between the point-of-care ELISA and laboratory-based serologic tests. The estimated seroprevalence for EGA was 0.53% overall (0.49% in Saskatchewan, 0.71% in Manitoba), while the estimated seroprevalence for LB was 1.6% overall (0.49% in Saskatchewan, 2.86% in Manitoba). There was limited agreement between the point-of-care ELISA and an indirect fluorescent antibody test for EGA (kappa 0.1, PABAK 0.47) and an ELISA/Western blot combination for LB (kappa 0.23, PABAK 0.71). While the SNAP(®) 4Dx(®) ELISA yielded expected seroprevalence estimates, further evaluation of serologic tests for the purposes of disease exposure recognition may be needed.
Pittini, Riccardo; Zhang, Zhe; Andersen, Michael A. E.
and development environment. Moreover, the interface board can operate with open hardware Arduino-like boards such as the ChipKit Uno32. The paper also describes how to enhance the performance of a ChipKit Uno32 with a dsPIC obtaining a more suitable solution for power electronics. The basic blocks and interfaces...... of the boards are presented in detail as well as the board main specifications. The board operation has been tested with three core platforms: TI Piccolo controlSTICK, a Microchip dsPIC and a ChipKit Uno32 (Arduino-like platform). The board was used for generating test signals for characterizing 1200 V Si...
Barwise, Amelia; Garcia-Arguello, Lisbeth; Dong, Yue; Hulyalkar, Manasi; Vukoja, Marija; Schultz, Marcus J; Adhikari, Neill K J; Bonneton, Benjamin; Kilickaya, Oguz; Kashyap, Rahul; Gajic, Ognjen; Schmickl, Christopher N
The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN) is an international collaborative project with the overall objective of standardizing the approach to the evaluation and treatment of critically ill patients world-wide, in accordance with best-practice principles. One of CERTAIN's key features is clinical decision support providing point-of-care information about common acute illness syndromes, procedures, and medications in an index card format. This paper describes 1) the process of developing and validating the content for point-of-care decision support, and 2) the content management system that facilitates frequent peer-review and allows rapid updates of content across different platforms (CERTAIN software, mobile apps, pdf-booklet) and different languages. Content was created based on survey results of acute care providers and validated using an open peer-review process. Over a 3 year period, CERTAIN content expanded to include 67 syndrome cards, 30 procedure cards, and 117 medication cards. 127 (59 %) cards have been peer-reviewed so far. Initially MS Word® and Dropbox® were used to create, store, and share content for peer-review. Recently Google Docs® was used to make the peer-review process more efficient. However, neither of these approaches met our security requirements nor has the capacity to instantly update the different CERTAIN platforms. Although we were able to successfully develop and validate a large inventory of clinical decision support cards in a short period of time, commercially available software solutions for content management are suboptimal. Novel custom solutions are necessary for efficient global point of care content system management.
Thoesen, Michael S; Berg-Foels, Wendy S Vanden; Stokol, Tracy; Rassnick, Kenneth M; Jacobson, May S; Kevy, Sherwin V; Todhunter, Rory J
To analyze a centrifugation-based, point-of-care device that concentrates canine platelets and bone marrow-derived cells. 19 adult sexually intact dogs. Anticoagulated peripheral blood (60 mL) and 60 mL of anticoagulated bone marrow aspirate (BMA) were concentrated by centrifugation with the centrifugation-based, point-of-care device to form a platelet and a bone marrow concentrate (BMC) from 11 dogs. Blood samples were analyzed on the basis of hemograms, platelet count, and PCV. The BMA and BMC were analyzed to determine PCV, total nucleated cell count, RBC count, and differential cell counts. The BMC stromal cells were cultured in an osteoinductive medium. Eight additional dogs were used to compare the BMC yield with that in which heparin was infused into the bone marrow before aspiration. The centrifugation-based, point-of-care device concentrated platelets by 6-fold over baseline (median recovery, 63.1%) with a median of 1,336 x 10(3) platelets/microL in the 7-mL concentrate. The nucleated cells in BMCs increased 7-fold (median recovery, 42.9%) with a median of 720 x 10(3) cells/microL in the 4-mL concentrate. The myeloid nucleated cells and mononuclear cells increased significantly in BMCs with a significant decrease in PCV, compared with that of BMAs. Stromal cell cultures expressed an osteoblastic phenotype in culture. Infusion of heparin into the bone marrow eliminated clot formation and created less variation in the yield (median recovery, 61.9%). Bone marrow-derived cell and platelet-rich concentrates may form bone if delivered in an engineered graft, thus decreasing the need for cancellous bone grafts.
Darlow Brian A
Full Text Available Abstract Background Increased survival of preterm infants in developing countries has often been accompanied by increased morbidity. A previous study found rates of severe retinopathy of prematurity varied widely between different neonatal units in Rio de Janeiro. Nurses have a key role in the care of high-risk infants but often do not have access to ongoing education programmes. We set out to design a quality improvement project that would provide nurses with the training and tools to decrease neonatal mortality and morbidity. The purpose of this report is to describe the methods and make the teaching package (POINTS of care--six modules addressing Pain control; optimal Oxygenation; Infection control; Nutrition interventions; Temperature control; Supportive care available to others. Methods/Design Six neonatal units, caring for 40% of preterm infants in Rio de Janeiro were invited to participate. In Phase 1 of the study multidisciplinary workshops were held in each neonatal unit to identify the neonatal morbidities of interest and to plan for data collection. In Phase 2 the teaching package was developed and tested. Phase 3 consisted of 12 months data collection utilizing a simple tick-sheet for recording. In Phase 4 (the Intervention all nurses were asked to complete all six modules of the POINTS of care package, which was supplemented by practical demonstrations. Phase 5 consisted of a further 12 months data collection. In Phase 1 it was agreed to include inborn infants with birthweight ≤ 1500 g or gestational age of ≤ 34 weeks. The primary outcome was death before discharge and secondary outcomes included retinopathy of prematurity and bronchopulmonary dysplasia. Assuming 400-450 infants in both pre- and post-intervention periods the study had 80% power at p = Discussion The results of the POINTS of Care intervention will be presented in a separate publication. Trial registration Current Controlled Trials: ISRCTN83110114
Roberts, Jason D; Wells, George A; Le May, Michel R; Labinaz, Marino; Glover, Chris; Froeschl, Michael; Dick, Alexander; Marquis, Jean-Francois; O'Brien, Edward; Goncalves, Sandro; Druce, Irena; Stewart, Alexandre; Gollob, Michael H; So, Derek Y F
Prospective assessment of pharmacogenetic strategies has been limited by an inability to undertake bedside genetic testing. The CYP2C19*2 allele is a common genetic variant associated with increased rates of major adverse events in individuals given clopidogrel after percutaneous coronary intervention (PCI). We used a novel point-of-care genetic test to identify carriers of the CYP2C19*2 allele and aimed to assess a pharmacogenetic approach to dual antiplatelet treatment after PCI. Between Aug 26, 2010, and July 7, 2011, 200 patients were enrolled into our prospective, randomised, proof-of-concept study. Patients undergoing PCI for acute coronary syndrome or stable angina were randomly assigned to rapid point-of-care genotyping or to standard treatment. Individuals in the rapid genotyping group were screened for the CYP2C19*2 allele. Carriers were given 10 mg prasugrel daily, and non-carriers and patients in the standard treatment group were given 75 mg clopidogrel daily. The primary endpoint was the proportion of CYP2C19*2 carriers with high on-treatment platelet reactivity (P2Y12 reactivity unit [PRU] value of more than 234) after 1 week of dual antiplatelet treatment, which is a marker associated with increased adverse cardiovascular events. Interventional cardiologists and data analysts were masked to genetic status and treatment. Patients were not masked to treatment allocation. All analyses were by intention to treat. This study is registered with ClinicalTrials.gov, NCT01184300. After randomisation, 187 patients completed follow-up (91 rapid genotyping group, 96 standard treatment). 23 individuals in each group carried at least one CYP2C19*2 allele. None of the 23 carriers in the rapid genotyping group had a PRU value of more than 234 at day 7, compared with seven (30%) given standard treatment (p=0·0092). The point-of-care genetic test had a sensitivity of 100% (95% CI 92·3-100) and a specificity of 99·3% (96·3-100). Point-of-care genetic testing after
Dunne, Simon; Gallagher, Pamela; Matthews, Anne
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.
Jenum, Synne; Dhanasekaran, S; Lodha, Rakesh
The World Health Organization (WHO) calls for an accurate, rapid, and simple point-of-care (POC) test for the diagnosis of pediatric tuberculosis (TB) in order to make progress "Towards Zero Deaths". Whereas the sensitivity of a POC test based on detection of Mycobacterium tuberculosis (MTB...... (CD14, FCGR1A, FPR1, MMP9, RAB24, SEC14L1, and TIMP2) or "downstream" towards a decreased likelihood of TB disease (BLR1, CD3E, CD8A, IL7R, and TGFBR2), suggesting a correlation with MTB-related pathology and high relevance to a future POC test for pediatric TB. A biomarker signature consisting of BPI...
Aabenhus, Rune; Jensen, Jens-Ulrik S; Jørgensen, Karsten Juhl; Hróbjartsson, Asbjørn; Bjerrum, Lars
Background Acute respiratory infections (ARIs) are by far the most common reason for prescribing an antibiotic in primary care, even though the majority of ARIs are of viral or non-severe bacterial aetiology. Unnecessary antibiotic use will, in many cases, not be beneficial to the patients' recovery and expose them to potential side effects. Furthermore, as a causal link exists between antibiotic use and antibiotic resistance, reducing unnecessary antibiotic use is a key factor in controlling this important problem. Antibiotic resistance puts increasing burdens on healthcare services and renders patients at risk of future ineffective treatments, in turn increasing morbidity and mortality from infectious diseases. One strategy aiming to reduce antibiotic use in primary care is the guidance of antibiotic treatment by use of a point-of-care biomarker. A point-of-care biomarker of infection forms part of the acute phase response to acute tissue injury regardless of the aetiology (infection, trauma and inflammation) and may in the correct clinical context be used as a surrogate marker of infection,possibly assisting the doctor in the clinical management of ARIs.Objectives To assess the benefits and harms of point-of-care biomarker tests of infection to guide antibiotic treatment in patients presenting with symptoms of acute respiratory infections in primary care settings regardless of age.Search methods We searched CENTRAL (2013, Issue 12), MEDLINE (1946 to January 2014), EMBASE (2010 to January 2014), CINAHL (1981 to January 2014), Web of Science (1955 to January 2014) and LILACS (1982 to January 2014).Selection criteria We included randomised controlled trials (RCTs) in primary care patients with ARIs that compared use of point-of-care biomarkers with standard of care. We included trials that randomised individual patients as well as trials that randomised clusters of patients(cluster-RCTs).Two review authors independently extracted data on the following outcomes: i
Gartrell, Kyungsook; Brennan, Caitlin W; Wallen, Gwenyth R; Liu, Fang; Smith, Karen G; Fontelo, Paul
Although evidence-based practice in healthcare has been facilitated by Internet access through wireless mobile devices, research on the effectiveness of clinical decision support for clinicians at the point of care is lacking. This study examined how evidence as abstracts and the bottom-line summaries, accessed with PubMed4Hh mobile devices, affected clinicians' decision making at the point of care. Three iterative steps were taken to evaluate the usefulness of PubMed4Hh tools at the NIH Clinical Center. First, feasibility testing was conducted using data collected from a librarian. Next, usability testing was carried out by a postdoctoral research fellow shadowing clinicians during rounds for one month in the inpatient setting. Then, a pilot study was conducted from February, 2016 to January, 2017, with clinicians using a mobile version of PubMed4Hh. Invitations were sent via e-mail lists to clinicians (physicians, physician assistants and nurse practitioners) along with periodic reminders. Participants rated the usefulness of retrieved bottom-line summaries and abstracts and indicated their usefulness on a 7-point Likert scale. They also indicated location of use (office, rounds, etc.). Of the 166 responses collected in the feasibility phase, more than half of questions (57%, n = 94) were answerable by both the librarian using various resources and by the postdoctoral research fellow using PubMed4Hh. Sixty-six questions were collected during usability testing. More than half of questions (60.6%) were related to information about medication or treatment, while 21% were questions regarding diagnosis, and 12% were specific to disease entities. During the pilot study, participants reviewed 34 abstracts and 40 bottom-line summaries. The abstracts' usefulness mean scores were higher (95% CI [6.12, 6.64) than the scores of the bottom-line summaries (95% CI [5.25, 6.10]). The most frequent reason given was that it confirmed current or tentative diagnostic or
Litster, A L; Pressler, B; Volpe, A; Dubovi, E
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. Copyright © 2012 Elsevier Ltd. All rights reserved.
Chan, Kamfai; Wong, Pui-Yan; Parikh, Chaitanya; Wong, Season
Traditionally, the majority of nucleic acid amplification-based molecular diagnostic tests are done in centralized settings. In recent years, point-of-care tests have been developed for use in low-resource settings away from central laboratories. While most experts agree that point-of-care molecular tests are greatly needed, their availability as cost-effective and easy-to-operate tests remains an unmet goal. In this article, we discuss our efforts to develop a recombinase polymerase amplification reaction-based test that will meet these criteria. First, we describe our efforts in repurposing a low-cost 3D printer as a platform that can carry out medium-throughput, rapid, and high-performing nucleic acid extraction. Next, we address how these purified templates can be rapidly amplified and analyzed using the 3D printer's heated bed or the deconstructed, low-cost thermal cycler we have developed. In both approaches, real-time isothermal amplification and detection of template DNA or RNA can be accomplished using a low-cost portable detector or smartphone camera. Last, we demonstrate the capability of our technologies using foodborne pathogens and the Zika virus. Our low-cost approach does not employ complicated and high-cost components, making it suitable for resource-limited settings. When integrated and commercialized, it will offer simple sample-to-answer molecular diagnostics. Copyright © 2018 Elsevier Inc. All rights reserved.
O'Kelly, R A
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.
Simpao, Allan F; Tan, Jonathan M; Lingappan, Arul M; Gálvez, Jorge A; Morgan, Sherry E; Krall, Michael A
Anesthesia information management systems (AIMS) are sophisticated hardware and software technology solutions that can provide electronic feedback to anesthesia providers. This feedback can be tailored to provide clinical decision support (CDS) to aid clinicians with patient care processes, documentation compliance, and resource utilization. We conducted a systematic review of peer-reviewed articles on near real-time and point-of-care CDS within AIMS using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies were identified by searches of the electronic databases Medline and EMBASE. Two reviewers screened studies based on title, abstract, and full text. Studies that were similar in intervention and desired outcome were grouped into CDS categories. Three reviewers graded the evidence within each category. The final analysis included 25 articles on CDS as implemented within AIMS. CDS categories included perioperative antibiotic prophylaxis, post-operative nausea and vomiting prophylaxis, vital sign monitors and alarms, glucose management, blood pressure management, ventilator management, clinical documentation, and resource utilization. Of these categories, the reviewers graded perioperative antibiotic prophylaxis and clinical documentation as having strong evidence per the peer reviewed literature. There is strong evidence for the inclusion of near real-time and point-of-care CDS in AIMS to enhance compliance with perioperative antibiotic prophylaxis and clinical documentation. Additional research is needed in many other areas of AIMS-based CDS.
Thiha, Aung; Ibrahim, Fatimah
The enzyme-linked Immunosorbent Assay (ELISA) is the gold standard clinical diagnostic tool for the detection and quantification of protein biomarkers. However, conventional ELISA tests have drawbacks in their requirement of time, expensive equipment and expertise for operation. Hence, for the purpose of rapid, high throughput screening and point-of-care diagnosis, researchers are miniaturizing sandwich ELISA procedures on Lab-on-a-Chip and Lab-on-Compact Disc (LOCD) platforms. This paper presents a novel integrated device to detect and interpret the ELISA test results on a LOCD platform. The system applies absorption spectrophotometry to measure the absorbance (optical density) of the sample using a monochromatic light source and optical sensor. The device performs automated analysis of the results and presents absorbance values and diagnostic test results via a graphical display or via Bluetooth to a smartphone platform which also acts as controller of the device. The efficacy of the device was evaluated by performing dengue antibody IgG ELISA on 64 hospitalized patients suspected of dengue. The results demonstrate high accuracy of the device, with 95% sensitivity and 100% specificity in detection when compared with gold standard commercial ELISA microplate readers. This sensor platform represents a significant step towards establishing ELISA as a rapid, inexpensive and automatic testing method for the purpose of point-of-care-testing (POCT) in resource-limited settings. PMID:25993517
Blois, Shauna L; Richardson, Danielle M; Abrams-Ogg, Anthony C G
Blood typing for the presence of Dog Erythrocyte Antigen (DEA) 1.1 is recommended in all donor and recipient dogs prior to transfusion of blood products. The objective of this study was to determine if a point-of-care DEA 1.1 blood typing cartridge could be used in place of the gel column typing method. Detection of DEA 1.1 was performed using a laboratory-based gel column method and a point-of-care cartridge. A convenience sample of 30 healthy blood donors, 13 dogs with immune-mediated hemolytic anemia (IMHA) (3 of which had concurrent immune-mediated thrombocytopenia [IMT]), and 44 dogs with other diseases was included in the study. Agreement was observed between the tests for normal dogs and dogs with nonimmune-mediated disease in 74/74 cases. Two dogs in the IMHA group had indeterminate gel column blood typing results; 1 dog in this group had a negative gel column test result but a positive cartridge test result. There was good agreement between the 2 methods for normal dogs and dogs with nonimmune-mediated disease. Blood typing methods in dogs with IMHA should be further investigated. © Veterinary Emergency and Critical Care Society 2013.
Full Text Available Objectives: Heart failure is one of the leading causes of death in the U.S. The incorporation of B-type natriuretic peptide (BNP measurements when triaging patients presenting with shortness of breath has improved the diagnostic and prognostic ability of physicians. Currently, there are no point-of-care systems for quantifying BNP that can be used without sacrificing accuracy. We compared the analytical performance of the Abbott i-STAT analyzer, a handheld point-of-care system for measuring BNP, with the lab-based system, the Abbott ARCHITECT.Methods: One-hundred fifty samples were collected from three clinical settings: 41 from the Emergency Department, 58 from the inpatient wards, and 51 from heart failure outpatient clinics. Linear regression and bias difference analyses were run to evaluate the accuracy of the i-STAT. Correlation between the i-STAT and Architect BNP values were made with values of BNP.Results: The correlation coefficient was r=0.977 (N=150, p<.0001. The average bias was significant (-36 and there were concentration-dependent differences at higher BNP values. Precision of the i-STAT was poor compared to the lab-based platform.Conclusion: Although the precision of the i-STAT was poor, there was good clinical agreement between the i-STAT and the lab-based platform. [West J Emerg Med. 2010; 11(1:44-48].
Hohmeier, Kenneth C; McDonough, Sharon L K; Wang, Junling
Point-of-care testing (POCT) is a specialty of laboratory medicine that occurs at the bedside or near the patient when receiving health services. Despite its established clinical utility and consumer demand in the community pharmacy, the implementation of POCT within this setting has remained modest for a variety of reasons. One possible solution to this problem is the concept of co-creation - the partnership between consumer and manufacturer in the development of value for a service or device. Using the theoretical underpinning of co-creation, this study aimed to investigate perceptions of point-of-care-testing (POCT) industry leadership on the community pharmacy market in the United States to uncover reasons for limited implementation within community pharmacies. Participants were recruited for this study through the use of snowball sampling. A series of semi-structured interviews were conducted with the participants via telephone. Interviews were recorded, transcribed, and entered into a qualitative analysis software program to summarize the data. Five key themes were uncovered: gaps in understanding, areas of positive impact, barriers to implementation, facilitators of implementation, and community pharmacy - a potential major player. Through uncovering gaps in perceptions, it may be possible to leverage the U.S. pharmacy industry's size, potential for scalability, and ease of patient access to further patient care. Copyright © 2016 Elsevier Inc. All rights reserved.
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.
Thiha, Aung; Ibrahim, Fatimah
The enzyme-linked Immunosorbent Assay (ELISA) is the gold standard clinical diagnostic tool for the detection and quantification of protein biomarkers. However, conventional ELISA tests have drawbacks in their requirement of time, expensive equipment and expertise for operation. Hence, for the purpose of rapid, high throughput screening and point-of-care diagnosis, researchers are miniaturizing sandwich ELISA procedures on Lab-on-a-Chip and Lab-on-Compact Disc (LOCD) platforms. This paper presents a novel integrated device to detect and interpret the ELISA test results on a LOCD platform. The system applies absorption spectrophotometry to measure the absorbance (optical density) of the sample using a monochromatic light source and optical sensor. The device performs automated analysis of the results and presents absorbance values and diagnostic test results via a graphical display or via Bluetooth to a smartphone platform which also acts as controller of the device. The efficacy of the device was evaluated by performing dengue antibody IgG ELISA on 64 hospitalized patients suspected of dengue. The results demonstrate high accuracy of the device, with 95% sensitivity and 100% specificity in detection when compared with gold standard commercial ELISA microplate readers. This sensor platform represents a significant step towards establishing ELISA as a rapid, inexpensive and automatic testing method for the purpose of point-of-care-testing (POCT) in resource-limited settings.
Barroso, Teresa G; Martins, Rui C; Fernandes, Elisabete; Cardoso, Susana; Rivas, José; Freitas, Paulo P
Tuberculosis is one of the major public health concerns. This highly contagious disease affects more than 10.4 million people, being a leading cause of morbidity by infection. Tuberculosis is diagnosed at the point-of-care by the Ziehl-Neelsen sputum smear microscopy test. Ziehl-Neelsen is laborious, prone to human error and infection risk, with a limit of detection of 10 4 cells/mL. In resource-poor nations, a more practical test, with lower detection limit, is paramount. This work uses a magnetoresistive biosensor to detect BCG bacteria for tuberculosis diagnosis. Herein we report: i) nanoparticle assembly method and specificity for tuberculosis detection; ii) demonstration of proportionality between BCG cell concentration and magnetoresistive voltage signal; iii) application of multiplicative signal correction for systematic effects removal; iv) investigation of calibration effectiveness using chemometrics methods; and v) comparison with state-of-the-art point-of-care tuberculosis biosensors. Results present a clear correspondence between voltage signal and cell concentration. Multiplicative signal correction removes baseline shifts within and between biochip sensors, allowing accurate and precise voltage signal between different biochips. The corrected signal was used for multivariate regression models, which significantly decreased the calibration standard error from 0.50 to 0.03log 10 (cells/mL). Results show that Ziehl-Neelsen detection limits and below are achievable with the magnetoresistive biochip, when pre-processing and chemometrics are used. Copyright © 2017 Elsevier B.V. All rights reserved.
Kellens, Sebastiaan; Verbrugge, Frederik H; Vanmechelen, Maxime; Grieten, Lars; Van Lierde, Johan; Dens, Joseph; Vrolix, Mathias; Vandervoort, Pieter
High-sensitivity cardiac troponin testing is used to detect myocardial damage in patients with acute chest pain. Heart-type fatty acid binding protein (H-FABP) may be an alternative, available as point-of-care test. Patients (n=203) referred by general practitioners for suspected acute coronary syndrome or presenting with typical chest pain and one major cardiovascular risk factor at the emergency department were prospectively included in a single-centre cohort study. High-sensitivity cardiac troponin T (hs-TnT) and point-of-care H-FABP testing were concomitantly performed at admission and after 6h. Maximal hs-TnT levels above the 99th percentile were observed in 152 patients (75%) with 127 (63%) fulfilling criteria for myocardial infarction. Upon admission, hs-TnT and H-FABP were associated with an area under the curve (95% CI) of 0.83 (0.77-0.89) and 0.79 (0.73-0.85), respectively, to predict myocardial infarction, which increased to 0.93 (0.90-0.97) and 0.88 (0.84-0.93), respectively, after 6h. The diagnostic accuracy for non-ST-segment elevation myocardial infarction was somewhat lower with an area under the curve (95% CI) of 0.80 (0.72-0.87), 0.90 (0.84-0.96), 0.73 (0.64-0.81) and 0.77 (0.67-0.86), respectively. When assessment was performed within 3h of chest pain onset, diagnostic accuracy of H-FABP versus hs-TnT was similar. Each standard deviation increase in admission H-FABP was associated with a 68% relative risk increase of all-cause mortality (p-value=0.027) during 666 ± 155 days of follow-up. Point-of-care H-FABP testing has lower diagnostic accuracy compared with hs-TnT assessment in patients with high pre-test acute coronary syndrome probability, but might be of interest when assessment is possible early after chest pain onset. © The European Society of Cardiology 2015.
Richman, Susan D; Southward, Katie; Chambers, Philip; Cross, Debra; Barrett, Jennifer; Hemmings, Gemma; Taylor, Morag; Wood, Henry; Hutchins, Gordon; Foster, Joseph M; Oumie, Assa; Spink, Karen G; Brown, Sarah R; Jones, Marc; Kerr, David; Handley, Kelly; Gray, Richard; Seymour, Matthew; Quirke, Philip
HER2 overexpression/amplification is linked to trastuzumab response in breast/gastric cancers. One suggested anti-EGFR resistance mechanism in colorectal cancer (CRC) is aberrant MEK-AKT pathway activation through HER2 up-regulation. We assessed HER2-amplification/overexpression in stage II-III and IV CRC patients, assessing relationships to KRAS/BRAF and outcome. Pathological material was obtained from 1914 patients in the QUASAR stage II-III trial and 1342 patients in stage IV trials (FOCUS and PICCOLO). Tissue microarrays were created for HER2 immunohistochemistry. HER2-amplification was assessed using FISH and copy number variation. KRAS/BRAF mutation status was assessed by pyrosequencing. Progression-free survival (PFS) and overall survival (OS) data were obtained for FOCUS/PICCOLO and recurrence and mortality for QUASAR; 29/1342 (2.2%) stage IV and 25/1914 (1.3%) stage II-III tumours showed HER2 protein overexpression. Of the HER2-overexpressing cases, 27/28 (96.4%) stage IV tumours and 20/24 (83.3%) stage II-III tumours demonstrated HER2 amplification by FISH; 41/47 (87.2%) also showed copy number gains. HER2-overexpression was associated with KRAS/BRAF wild-type (WT) status at all stages: in 5.2% WT versus 1.0% mutated tumours (p < 0.0001) in stage IV and 2.1% versus 0.2% in stage II-III tumours (p = 0.01), respectively. HER2 was not associated with OS or PFS. At stage II-III, there was no significant correlation between HER2 overexpression and 5FU/FA response. A higher proportion of HER2-overexpressing cases experienced recurrence, but the difference was not significant. HER2-amplification/overexpression is identifiable by immunohistochemistry, occurring infrequently in stage II-III CRC, rising in stage IV and further in KRAS/BRAF WT tumours. The value of HER2-targeted therapy in patients with HER2-amplified CRC must be tested in a clinical trial. © 2015 The Authors. Journal of Pathology published by John Wiley & Sons Ltd on behalf of Pathological Society
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.
Siersma, Volkert; Kousgaard, Marius Brostrøm; Reventlow, Susanne
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...... (Postal) if they did not perform a split test to check the quality of their INR POCT for each calendar month. The adherence of the practices was tracked during the subsequent 8 months subdivided into two 4-month periods both without intervention. Outcomes were measures of split test procedure adherence...
Full Text Available For the development of a novel, user-friendly and low cost point-of-care diagnostic device for the detection of disease specific biomarker a flow optimised design of the test system has to be investigated. The resulting test system is characterised by a reduced execution period, a reduction of execution steps and an integrated waste management. Based on previous results, the current study focused on the design implementation of the fluidic requirements, e. g. tightness, inside the test device. With the help of fluid flow simulations (CFD – computational fluid dynamics the flow behaviour inside the test device was analysed for different designs and arrangements. Prototypes generated from additive manufacturing technologies (PolyJet modeling are used for validating the simulation results and further experimental tests.
Venkatesh, K; Nair, P S; Hoechter, D J; Buscher, H
Haemostatic perturbations are commonly seen in extracorporeal membrane oxygenation (ECMO) patients and remain a clinical challenge, contributing significantly to morbidity and mortality. The approach to anticoagulation monitoring and the management of bleeding varies considerably across ECMO centres. Routine laboratory tests have their limitations in terms of turnaround time and specificity of information provided. Newer point-of-care testing (POCT) for coagulation may overcome these issues, as it provides information about the entire coagulation pathway from clot initiation to lysis. It is also possible to obtain qualitative information on platelet function from these tests. Furthermore, the ability to incorporate these results into a goal-directed algorithm to manage bleeding with targeted transfusion strategies appears particularly attractive and cost effective. Further studies are required to evaluate the utility of POCT to optimise bleeding and anticoagulation management in these complex patients.
van Staa, T-P; Klungel, O; Smeeth, L
A solid foundation of evidence of the effects of an intervention is a prerequisite of evidence-based medicine. The best source of such evidence is considered to be randomized trials, which are able to avoid confounding. However, they may not always estimate effectiveness in clinical practice. Databases that collate anonymized electronic health records (EHRs) from different clinical centres have been widely used for many years in observational studies. Randomized point-of-care trials have been initiated recently to recruit and follow patients using the data from EHR databases. In this review, we describe how EHR databases can be used for conducting large-scale simple trials and discuss the advantages and disadvantages of their use. © 2014 The Association for the Publication of the Journal of Internal Medicine.
Emily P Hyle
Full Text Available Point-of-care CD4 tests at HIV diagnosis could improve linkage to care in resource-limited settings. Our objective is to evaluate the clinical and economic impact of point-of-care CD4 tests compared to laboratory-based tests in Mozambique.We use a validated model of HIV testing, linkage, and treatment (CEPAC-International to examine two strategies of immunological staging in Mozambique: (1 laboratory-based CD4 testing (LAB-CD4 and (2 point-of-care CD4 testing (POC-CD4. Model outcomes include 5-y survival, life expectancy, lifetime costs, and incremental cost-effectiveness ratios (ICERs. Input parameters include linkage to care (LAB-CD4, 34%; POC-CD4, 61%, probability of correctly detecting antiretroviral therapy (ART eligibility (sensitivity: LAB-CD4, 100%; POC-CD4, 90% or ART ineligibility (specificity: LAB-CD4, 100%; POC-CD4, 85%, and test cost (LAB-CD4, US$10; POC-CD4, US$24. In sensitivity analyses, we vary POC-CD4-specific parameters, as well as cohort and setting parameters to reflect a range of scenarios in sub-Saharan Africa. We consider ICERs less than three times the per capita gross domestic product in Mozambique (US$570 to be cost-effective, and ICERs less than one times the per capita gross domestic product in Mozambique to be very cost-effective. Projected 5-y survival in HIV-infected persons with LAB-CD4 is 60.9% (95% CI, 60.9%-61.0%, increasing to 65.0% (95% CI, 64.9%-65.1% with POC-CD4. Discounted life expectancy and per person lifetime costs with LAB-CD4 are 9.6 y (95% CI, 9.6-9.6 y and US$2,440 (95% CI, US$2,440-US$2,450 and increase with POC-CD4 to 10.3 y (95% CI, 10.3-10.3 y and US$2,800 (95% CI, US$2,790-US$2,800; the ICER of POC-CD4 compared to LAB-CD4 is US$500/year of life saved (YLS (95% CI, US$480-US$520/YLS. POC-CD4 improves clinical outcomes and remains near the very cost-effective threshold in sensitivity analyses, even if point-of-care CD4 tests have lower sensitivity/specificity and higher cost than published
Llor, Carl; Bjerrum, Lars; Munck, Anders
BACKGROUND: General practitioners (GPs) often feel uncomfortable when patients request an antibiotic when there is likely little benefit. This study evaluates the effect of access to point-of-care tests on decreasing the prescription of antibiotics in respiratory tract infections in subjects who...... explicitly requested an antibiotic prescription. METHODS: Spanish GPs registered all cases of respiratory tract infections over a 3-week period before and after an intervention undertaken in 2008 and 2009. Patients with acute sinusitis, pneumonia, and exacerbations of COPD were excluded. Two types...... requesting antibiotics received a prescription before and 60% after the intervention, without statistical differences being observed. In the group of GPs assigned to the full intervention group, the percentages were 55.1% and 36.2%, respectively, with a difference of 18.9% (95% CI: 6.4%-30.6%, P
Holm, Anne; Cordoba, Gloria; Møller Sørensen, Tina
OBJECTIVES: To investigate the effect of adding point-of-care (POC) susceptibility testing to POC culture on appropriate use of antibiotics as well as clinical and microbiological cure for patients with suspected uncomplicated urinary tract infection (UTI) in general practice. DESIGN: Open......, individually randomised controlled trial. SETTING: General practice. PARTICIPANTS: Women with suspected uncomplicated UTI, including elderly patients above 65, patients with recurrent UTI and patients with diabetes. The sample size calculation predicted 600 patients were needed. INTERVENTIONS: Flexicult SSI......-Urinary Kit was used for POC culture and susceptibility testing and ID Flexicult was used for POC culture only. MAIN OUTCOME MEASURES: Primary outcome: appropriate antibiotic prescribing on the day after consultation defined as either (1) patient with UTI: to prescribe a first-line antibiotic to which...
Page, Michael M; Taranto, Mario; Ramsay, Duncan; van Schie, Greg; Glendenning, Paul; Gillett, Melissa J; Vasikaran, Samuel D
Objective Primary aldosteronism is a curable cause of hypertension which can be treated surgically or medically depending on the findings of adrenal vein sampling studies. Adrenal vein sampling studies are technically demanding with a high failure rate in many centres. The use of intraprocedural cortisol measurement could improve the success rates of adrenal vein sampling but may be impracticable due to cost and effects on procedural duration. Design Retrospective review of the results of adrenal vein sampling procedures since commencement of point-of-care cortisol measurement using a novel single-use semi-quantitative measuring device for cortisol, the adrenal vein sampling Accuracy Kit. Success rate and complications of adrenal vein sampling procedures before and after use of the adrenal vein sampling Accuracy Kit. Routine use of the adrenal vein sampling Accuracy Kit device for intraprocedural measurement of cortisol commenced in 2016. Results Technical success rate of adrenal vein sampling increased from 63% of 99 procedures to 90% of 48 procedures ( P = 0.0007) after implementation of the adrenal vein sampling Accuracy Kit. Failure of right adrenal vein cannulation was the main reason for an unsuccessful study. Radiation dose decreased from 34.2 Gy.cm 2 (interquartile range, 15.8-85.9) to 15.7 Gy.cm 2 (6.9-47.3) ( P = 0.009). No complications were noted, and implementation costs were minimal. Conclusions Point-of-care cortisol measurement during adrenal vein sampling improved cannulation success rates and reduced radiation exposure. The use of the adrenal vein sampling Accuracy Kit is now standard practice at our centre.
Pant Pai, Nitika; Chiavegatti, Tiago; Vijh, Rohit; Karatzas, Nicolaos; Daher, Jana; Smallwood, Megan; Wong, Tom; Engel, Nora
Objective Pilot (feasibility) studies form a vast majority of diagnostic studies with point-of-care technologies but often lack use of clear measures/metrics and a consistent framework for reporting and evaluation. To fill this gap, we systematically reviewed data to (a) catalog feasibility measures/metrics and (b) propose a framework. Methods For the period January 2000 to March 2014, 2 reviewers searched 4 databases (MEDLINE, EMBASE, CINAHL, Scopus), retrieved 1441 citations, and abstracted data from 81 studies. We observed 2 major categories of measures, that is, implementation centered and patient centered, and 4 subcategories of measures, that is, feasibility, acceptability, preference, and patient experience. We defined and delineated metrics and measures for a feasibility framework. We documented impact measures for a comparison. Findings We observed heterogeneity in reporting of metrics as well as misclassification and misuse of metrics within measures. Although we observed poorly defined measures and metrics for feasibility, preference, and patient experience, in contrast, acceptability measure was the best defined. For example, within feasibility, metrics such as consent, completion, new infection, linkage rates, and turnaround times were misclassified and reported. Similarly, patient experience was variously reported as test convenience, comfort, pain, and/or satisfaction. In contrast, within impact measures, all the metrics were well documented, thus serving as a good baseline comparator. With our framework, we classified, delineated, and defined quantitative measures and metrics for feasibility. Conclusions Our framework, with its defined measures/metrics, could reduce misclassification and improve the overall quality of reporting for monitoring and evaluation of rapid point-of-care technology strategies and their context-driven optimization. PMID:29333105
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.
Libby, Anne M; Pace, Wilson; Bryan, Cathy; Anderson, Heather Orton; Ellis, Samuel L; Allen, Richard Read; Brandt, Elias; Huebschmann, Amy G; West, David; Valuck, Robert J
The Distributed Ambulatory Research in Therapeutics Network (DARTNet) is a federated network of electronic health record (EHR) data, designed as a platform for next-generation comparative effectiveness research in real-world settings. DARTNet links information from nonintegrated primary care clinics that use EHRs to deliver ambulatory care to overcome limitations with traditional observational research. Test the ability to conduct a remote, electronic point of care study in DARTNet practices by prompting clinic staff to obtain specific information during a patient encounter. Prospective survey of patients identified through queries of clinical data repositories in federated network organizations. On patient visit, survey is triggered and data are relinked to the EHR, de-identified, and copied for evaluation. Adult patients diagnosed with diabetes mellitus that scheduled a clinic visit for any reason in a 2-week period in DARTNet primary care practices. Survey on hypoglycemic events (past month) and over-the-counter and herbal supplement use. DARTNet facilitated point of care data collection triggered by an electronic prompt for additional information at a patient visit. More than one-third of respondents (33% response rate) reported either mild (45%) or severe hypoglycemic events (5%) in the month before the survey; only 3 of those were also coded using the ICD-9 (a significant difference in detection rates 37% vs. 1%). Nearly one-quarter of patients reported taking an OTC/herbal, 4% specifically for the treatment of symptoms of diabetes. Prospective data collection is feasible in DARTNet and can enable comparative effectiveness and safety research.
Lee, Jong-Hwan; Seo, Hyuk Seong; Kwon, Jung-Hyuk; Kim, Hee-Tae; Kwon, Koo Chul; Sim, Sang Jun; Cha, Young Joo; Lee, Jeewon
Lateral flow assay (LFA) is an attractive method for rapid, simple, and cost-effective point of care diagnosis. For LFA-based multiplex diagnosis of three viral intractable diseases (acquired immune deficiency syndrome and hepatitis C and A), here we developed proteinticle-based 7 different 3D probes that display different viral antigens on their surface, which were synthesized in Escherichia coli by self-assembly of human ferritin heavy chain that was already engineered by genetically linking viral antigens to its C-terminus. Each of the three test lines on LFA strip contains the proteinticle probes to detect disease-specific anti-viral antibodies. Compared to peptide probes, the proteinticle probes were evidently more sensitive, and the proteinticle probe-based LFA successfully diagnosed all the 20 patient sera per each disease without a false negative signal, whereas the diagnostic sensitivities in the peptide probe-based LFAs were 65-90%. Duplex and triplex assays performed with randomly mixed patient sera gave only true positive signals for all the 20 serum mixtures without any false positive signals, indicating 100% sensitivity and 100% specificity. It seems that on the proteinticle surface the antigenic peptides have homogeneous orientation and conformation without inter-peptide clustering and hence lead to the enhanced diagnostic performance with solving the problems of traditional diagnostic probes. Although the multiplex diagnosis of three viral diseases above was demonstrated as proof-of-concept here, the proposed LFA system can be applied to multiplex point of care diagnosis of other intractable diseases. Copyright © 2015 Elsevier B.V. All rights reserved.
Pant Pai, Nitika; Chiavegatti, Tiago; Vijh, Rohit; Karatzas, Nicolaos; Daher, Jana; Smallwood, Megan; Wong, Tom; Engel, Nora
Pilot (feasibility) studies form a vast majority of diagnostic studies with point-of-care technologies but often lack use of clear measures/metrics and a consistent framework for reporting and evaluation. To fill this gap, we systematically reviewed data to ( a ) catalog feasibility measures/metrics and ( b ) propose a framework. For the period January 2000 to March 2014, 2 reviewers searched 4 databases (MEDLINE, EMBASE, CINAHL, Scopus), retrieved 1441 citations, and abstracted data from 81 studies. We observed 2 major categories of measures, that is, implementation centered and patient centered, and 4 subcategories of measures, that is, feasibility, acceptability, preference, and patient experience. We defined and delineated metrics and measures for a feasibility framework. We documented impact measures for a comparison. We observed heterogeneity in reporting of metrics as well as misclassification and misuse of metrics within measures. Although we observed poorly defined measures and metrics for feasibility, preference, and patient experience, in contrast, acceptability measure was the best defined. For example, within feasibility, metrics such as consent, completion, new infection, linkage rates, and turnaround times were misclassified and reported. Similarly, patient experience was variously reported as test convenience, comfort, pain, and/or satisfaction. In contrast, within impact measures, all the metrics were well documented, thus serving as a good baseline comparator. With our framework, we classified, delineated, and defined quantitative measures and metrics for feasibility. Our framework, with its defined measures/metrics, could reduce misclassification and improve the overall quality of reporting for monitoring and evaluation of rapid point-of-care technology strategies and their context-driven optimization.
Ward, Jessica L; Lisciandro, Gregory R; Keene, Bruce W; Tou, Sandra P; DeFrancesco, Teresa C
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.
Strudwick, Gillian; Booth, Richard G; Bjarnadottir, Ragnhildur I; Collins, Sarah; Srivastava, Rani
An increasing number of electronic health record (EHR) systems have been implemented in clinical practice environments where nurses work. Findings from previous studies have found that a number of intended benefits of the technology have not yet been realised to date, partially due to poor system adoption among health professionals such as nurses. Previous studies have suggested that nurse managers can support the effective adoption and use of the technology by nurses. However, no known studies have identified what role nurse ma