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Sample records for point-of-care testing poct

  1. Point-of-care test (POCT) INR: hope or illusion?

    PubMed

    Dusse, Luci Maria Sant'Ana; Oliveira, Nataly Carvalho; Rios, Danyelle Romana Alves; Marcolino, Milena Soriano

    2012-01-01

    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, INR point-of-care test (POCT INR), is the main test of this new proposal. This test has great potential benefit in situations where the quick INR results influences clinical decision making, as in acute ischemic stroke, before surgical procedures and during cardiac surgery. The INR POCT has the potential to be used for self-monitoring of oral anticoagulation in patients under anticoagulant therapy. However, the precision and accuracy of INR POCT still need to be enhanced to increase effectiveness and efficiency of the test. Additionally, the RDC / ANVISA Number 302 makes clear that the POCT testing must be supervised by the technical manager of the Clinical Laboratory in the pre-analytical, analytical and post-analytical. In practice, the Clinical Laboratory does not participate in the implementation of POCT testing or release of the results. Clinicians have high expectation with the incorporation of INR POCT in clinical practice, despite the limitations of this method. These professionals are willing to train the patient to perform the test, but are not legally responsible for the quality of it and are not prepared for the maintenance of equipment. The definition of who is in charge for the test must be one to ensure the quality control. PMID:22996982

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

    PubMed Central

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

    2015-01-01

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

  3. Narrative review of primary care point-of-care testing (POCT) and antibacterial use in respiratory tract infection (RTI)

    PubMed Central

    Cooke, Jonathan; Butler, Christopher; Hopstaken, Rogier; Dryden, Matthew Scott; McNulty, Cliodna; Hurding, Simon; Moore, Michael; Livermore, David Martin

    2015-01-01

    Antimicrobial resistance is a global problem and is being addressed through national strategies to improve diagnostics, develop new antimicrobials and promote antimicrobial stewardship. A narrative review of the literature was undertaken to ascertain the value of C reactive protein (CRP) and procalcitonin, measurements to guide antibacterial prescribing in adult patients presenting to GP practices with symptoms of respiratory tract infection (RTI). Studies that were included were randomised controlled trials, controlled before and after studies, cohort studies and economic evaluations. Many studies demonstrated that the use of CRP tests in patients presenting with RTI symptoms reduces antibiotic prescribing by 23.3% to 36.16%. Procalcitonin is not currently available as a point-of-care testing (POCT), but has shown value for patients with RTI admitted to hospital. GPs and patients report a good acceptability for a CRP POCT and economic evaluations show cost-effectiveness of CRP POCT over existing RTI management in primary care. POCTs increase diagnostic precision for GPs in the better management of patients with RTI. CRP POCT can better target antibacterial prescribing by GPs and contribute to national antimicrobial resistance strategies. Health services need to develop ways to ensure funding is transferred in order for POCT to be implemented. PMID:25973210

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

    PubMed Central

    2014-01-01

    Background 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). Methods 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. Results 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. Conclusions 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. PMID:24433514

  5. Quality in point-of-care testing.

    PubMed

    Nichols, James H

    2003-09-01

    Point-of-care testing (POCT) is an increasingly popular means of providing laboratory testing at or near to the site of patient care. POCT provides rapid results and has the potential to improve patient outcome from earlier treatment. However, a faster result is not necessarily an equivalent result to traditional, core laboratory testing. Preanalytic, analytic and postanalytic factors can influence the quality of POCT and lead to misinterpretation. Concerns over the quality of POCT have resulted in a hierarchy of laboratory regulations in the USA and POCT guidelines are appearing in a number of countries worldwide. Quality POCT must control every aspect of the test and testing process that can affect the ultimate result. Laboratory quality regulations are very similar to industrial quality requirements and POCT can be viewed like any manufacturing business where the product being produced is the test result. Use of industrial management techniques, such as failure mode and effects analysis, can be applied to POCT to isolate and reduce the sources of testing error. Data management is fundamental to quality. Analyzing POCT data can show quality trends before they affect the result. Newer POCT devices have computerized data capture and storage functions that can collect the key information at the time the test is performed and later transmit that data to a POCT data manager or hospital information system. Recent standards, such as the National Committee for Clinical Laboratory Standards POCT1-A, provide a connectivity standard to allow different POCT devices to share a common interface and data manager system, reducing the cost of implementing and maintaining POCT. Guaranteeing POCT quality is resource-intensive and as healthcare budgets get tighter and staffing shortages grow, patient outcome must be weighed against available resources to determine optimum testing strategies. Use of the POCT literature can help establish an evidence-based justification to support

  6. Point-of-care testing in the cardiovascular operating theatre.

    PubMed

    Nydegger, Urs E; Gygax, Erich; Carrel, Thierry

    2006-01-01

    Point-of-care testing (POCT) remains under scrutiny by healthcare professionals because of its ill-tried, young history. POCT methods are being developed by a few major equipment companies based on rapid progress in informatics and nanotechnology. Issues as POCT quality control, comparability with standard laboratory procedures, standardisation, traceability and round robin testing are being left to hospitals. As a result, the clinical and operational benefits of POCT were first evident for patients on the operating table. For the management of cardiovascular surgery patients, POCT technology is an indispensable aid. Improvement of the technology has meant that clinical laboratory pathologists now recognise the need for POCT beyond their high-throughput areas. PMID:16958595

  7. Integration of target responsive hydrogel with cascaded enzymatic reactions and microfluidic paper-based analytic devices (µPADs) for point-of-care testing (POCT).

    PubMed

    Tian, Tian; Wei, Xiaofeng; Jia, Shasha; Zhang, Ruihua; Li, Jiuxing; Zhu, Zhi; Zhang, Huimin; Ma, Yanli; Lin, Zhenyu; Yang, Chaoyong James

    2016-03-15

    Paper based microfluidics (µPADs) with advantages of portability, low cost, and ease of use have attracted extensive attention. Here we describe a novel method that integrates glucoamylase-trapped aptamer-crosslinked hydrogel for molecular recognition with cascaded enzymatic reactions for signal amplification and a µPAD for portable readout. Upon target introduction, the hydrogel decomposes to release glucoamylase, which catalyzes the hydrolysis of amylose to produce a large amount of glucose. With a simple folding of the µPAD, the sample solution containing glucose product wicks and diffuses in parallel to each test-zone to carry out homogeneous assays, where glucose is used to produce I2 for brown color visualization through multiple enzymatic and chemical cascade reactions. Through color gradient changes based on different concentrations of the target, a semiquantitative assay is achieved by the naked eye, and quantitation can be obtained by handheld devices. Detection of cocaine in buffer and urine was performed to demonstrate the utility of the hydrogel-µPAD system. More importantly, the hydrogel-µPAD system can be extended to the detection of various targets by incorporating the corresponding aptamer into the hydrogel. The hydrogel-µPAD system reported here provides a new platform for portable, disposable and visual detection of a wide range of targets. PMID:26474094

  8. [Emergency department point of care testing: what are the benefits and for which patients?].

    PubMed

    Ramlawi, M; Delémont, C

    2011-08-24

    Laboratory tests contribute to patient length of stay in the emergency department. Therefore, rapid tests performed at the bedside (POCT or point of care testing) are attractive because they allow the emergency physician to obtain immediate biological, diagnostic and/or prognostic data. Userfriendly and with validated analytical performance, POCT have the potential to reduce laboratory time, patient length of stay and time to treatment or disposition. The expected benefit from POCT implementation will depend on the type of patients involved (inpatient or outpatient), their clinical condition and their overall care. Furthermore, logistical and economic implications should also be taken into account. PMID:21922724

  9. Point-of-care testing governance in New Zealand: a national framework.

    PubMed

    Musaad, Samarina M A; Herd, Geoff

    2013-09-27

    Point-of-care testing (POCT) devices are in-vitro diagnostic devices used near the patient and for the most part distant from the pathology laboratory. By definition they have a large scope of settings and user profiles. POCT optimises care pathways and overcomes geographical barriers but has a high potential for adverse incidents. A successful POCT service needs good clinical governance and a comprehensive quality management system. In New Zealand, Medsafe regulates medical devices including POCT devices in accordance with the Medicines Act 1981. A number of regulations impact on the use of devices but none address analytical and clinical performance. In 2015 PHARMAC will assume responsibility for management of medical devices. We propose a governance framework that optimises patient safety and maximises benefit from this indispensable technology. This is the first of two articles; the second will address point-of-care governance at healthcare provider level. PMID:24157993

  10. The state of point-of-care testing: a european perspective

    PubMed Central

    Greig-Pylypczuk, Roman; Huisman, Albert

    2015-01-01

    Point-of-care testing (POCT) refers to any diagnostic test administered outside the central laboratory at or near the location of the patient. By performing the sample collection and data analysis steps in the same location POCT cuts down on transport and processing delays, resulting in the rapid feedback of test results to medical decision-makers. Over the past decades the availability and use of POCT have steadily increased in Europe and throughout the international community. However, concerns about overall utility and the reliability of benefits to patient care have impeded the growth of POCT in some areas. While there is no agreed-upon standard for how success should be judged, the increases in speed and mobility provided by POCT can lead to substantial advantages over traditional laboratory testing. When properly utilized, POCT has been shown to yield measurable improvements in patient care, workflow efficiency, and even provide significant financial benefits. However, important organizational and quality assurance challenges must be addressed with the implementation of POCT in any health care environment. To ensure maximal benefits it may be necessary to evaluate critically and restructure existing clinical pathways to capitalize better on the rapid test turnaround times provided by POCT. PMID:25622619

  11. Existing and Emerging Technologies for Point-of-Care Testing

    PubMed Central

    St John, Andrew; Price, Christopher P

    2014-01-01

    The volume of point-of-care testing (PoCT) has steadily increased over the 40 or so years since its widespread introduction. That growth is likely to continue, driven by changes in healthcare delivery which are aimed at delivering less costly care closer to the patient’s home. In the developing world there is the challenge of more effective care for infectious diseases and PoCT may play a much greater role here in the future. PoCT technologies can be split into two categories, but in both, testing is generally performed by technologies first devised more than two decades ago. These technologies have undoubtedly been refined and improved to deliver easier-to-use devices with incremental improvements in analytical performance. Of the two major categories the first is small handheld devices, providing qualitative or quantitative determination of an increasing range of analytes. The dominant technologies here are glucose biosensor strips and lateral flow strips using immobilised antibodies to determine a range of parameters including cardiac markers and infectious pathogens. The second category of devices are larger, often bench-top devices which are essentially laboratory instruments which have been reduced in both size and complexity. These include critical care analysers and, more recently, small haematology and immunology analysers. New emerging devices include those that are utilising molecular techniques such as PCR to provide infectious disease testing in a sufficiently small device to be used at the point of care. This area is likely to grow with many devices being developed and likely to reach the commercial market in the next few years. PMID:25336761

  12. Selected topics in point-of-care testing. Urinalysis, pregnancy testing, microbiology, fecal occult blood, and other tests.

    PubMed

    Lee-Lewandrowski, E; Lewandrowski, K

    2001-06-01

    The menu of tests available at the point of care continues to expand. Many of these tests present unique opportunities to deploy point-of-care technologies in the home, outpatient, and hospital settings. The future will inevitably create new applications for POCT. The success of these efforts will be in part determined by how technologies for specific applications are selected and by the ability to manage new point-of-care tests as part of an organizational point-of-care program. The possibilities to improve patient care are obvious, provided adequate attention is paid to ensuring quality testing and to managing patient data from these novel technologies. PMID:11396091

  13. Point-of-care testing for disasters: needs assessment, strategic planning, and future design.

    PubMed

    Kost, Gerald J; Hale, Kristin N; Brock, T Keith; Louie, Richard F; Gentile, Nicole L; Kitano, Tyler K; Tran, Nam K

    2009-09-01

    Objective evidence-based national surveys serve as a first step in identifying suitable point-of-care device designs, effective test clusters, and environmental operating conditions. Preliminary survey results show the need for point-of-care testing (POCT) devices using test clusters that specifically detect pathogens found in disaster scenarios. Hurricane Katrina, the tsunami in southeast Asia, and the current influenza pandemic (H1N1, "swine flu") vividly illustrate lack of national and global preparedness. Gap analysis of current POCT devices versus survey results reveals how POCT needs can be fulfilled. Future thinking will help avoid the worst consequences of disasters on the horizon, such as extensively drug-resistant tuberculosis and pandemic influenzas. A global effort must be made to improve POC technologies to rapidly diagnose and treat patients to improve triaging, on-site decision making, and, ultimately, economic and medical outcomes. PMID:19840690

  14. Clinical governance and point-of-care testing at health provider level.

    PubMed

    Herd, Geoffrey; Musaad, Samarina M A

    2015-07-01

    Clinical governance provides a quality assurance and safety framework. A large proportion of point-of-care testing (POCT) activities in New Zealand are not subject to the same levels of regulation and accreditation that must be met by conventional medical laboratory testing. Providers who use POCT for diagnosis, monitoring and treatment need to develop programmes that are subject to effective clinical governance to ensure that POCT devices are suitable and safe for the clinical setting in which they are being used, and test results are consistently accurate and precise, ie reliable, at all times. POCT needs to be integrated with clinical management protocols and test results need to be accessible to healthcare personnel. Effective clinical governance of POCT by providers requires recognition by top management that the scale and scope of testing within New Zealand is large and expanding, and that there are associated risks and costs. Systematic input from laboratory, clinical and managerial stakeholders, and compliance with guidelines and standards is required to ensure that POCT is safe, clinically justified and cost effective. PMID:26149903

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

    PubMed

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

    2016-08-01

    The Royal College of Pathologists Australasia Quality Assurance Programs (RCPAQAP), have offered dedicated external quality assurance (EQA) for HIV point of care testing (PoCT) since 2011. Prior to this, EQA for these tests was available within the comprehensive human immunodeficiency virus (HIV) module. EQA testing for HIV has typically involved the supply of serum or plasma, while in the clinic or community based settings HIV PoCT is generally performed using whole blood obtained by capillary finger-stick collection. RCPAQAP has offered EQA for HIV PoCT using stabilised whole blood since 2014. A total of eight surveys have been undertaken over a period of 2 years from 2014 to 2015. Of the 962 responses received, the overall consensus rate was found to be 98% (941/962). A total of 21 errors were detected. The majority of errors were attributable to false reactive HIV p24 antigen results (9/21, 43%), followed by false reactive HIV antibody results (8/21, 38%). There were 4/21 (19%) false negative HIV antibody results and no false negative HIV p24 antigen results reported. Overall performance was observed to vary minimally between surveys, from a low of 94% up to 99% concordant. Encouraging levels of testing proficiency for HIV PoCT are indicated by these data, but they also confirm the need for HIV PoCT sites to participate in external quality assurance programs to ensure the ongoing provision of high quality patient care. PMID:27306578

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

    PubMed

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

    2013-12-01

    Point-of-care testing (POCT) refers to any laboratory testing performed outside the conventional reference laboratory and implies close proximity to patients. Instrumental POCT systems consist of small, handheld or benchtop analyzers. These have potential utility in many veterinary settings, including private clinics, academic veterinary medical centers, the community (eg, remote area veterinary medical teams), and for research applications in academia, government, and industry. Concern about the quality of veterinary in-clinic testing has been expressed in published veterinary literature; however, little guidance focusing on POCT is available. Recognizing this void, the ASVCP formed a subcommittee in 2009 charged with developing quality assurance (QA) guidelines for veterinary POCT. Guidelines were developed through literature review and a consensus process. Major recommendations include (1) taking a formalized approach to POCT within the facility, (2) use of written policies, standard operating procedures, forms, and logs, (3) operator training, including periodic assessment of skills, (4) assessment of instrument analytical performance and use of both statistical quality control and external quality assessment programs, (5) use of properly established or validated reference intervals, (6) and ensuring accurate patient results reporting. Where possible, given instrument analytical performance, use of a validated 13s control rule for interpretation of control data is recommended. These guidelines are aimed at veterinarians and veterinary technicians seeking to improve management of POCT in their clinical or research setting, and address QA of small chemistry and hematology instruments. These guidelines are not intended to be all-inclusive; rather, they provide a minimum standard for maintenance of POCT instruments in the veterinary setting. PMID:24320778

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

    PubMed

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

    2015-11-01

    Respiratory viruses are responsible for a large proportion of acute respiratory illness in adults as well as children, and are associated with a huge socio-economic burden worldwide. Development of accurate point-of-care tests (POCT) for respiratory viruses has been listed as a priority by the World Health Organisation and replacing the current paradigm of empirical antimicrobial use with directed use is a listed goal of the movement for reduction in antimicrobial resistance. POCTs for respiratory viruses have previously been limited by the poor sensitivity of antigen detection based tests and by a limited range of detectable viruses. Highly accurate molecular platforms are now able to test for a comprehensive range of viruses, can be operated by non-laboratory staff and can generate a result in approximately 1 h, making them potentially deployable as POCTs. The potential clinical benefits of POC testing for respiratory viruses in adults include a reduction in unnecessary antibiotic use, improved antiviral prescribing for influenza and rationalisation of isolation facilities. We review here the burden of disease, the currently available molecular platforms with potential for POCT use and the existing evidence for clinical and economic benefits of testing for respiratory viruses in adults. PMID:26215335

  18. Cardiac markers: a clear cause for point-of-care testing.

    PubMed

    Friess, Ulrich; Stark, Maik

    2009-03-01

    Point-of-care testing (POCT) in patients with ischemic heart disease is driven by the time-critical need for fast, specific, and accurate results to initiate therapy instantly. According to current guidelines, the results of the cardiac marker testing should be available to the physician within 30 min ("vein-to-brain" time) to initiate therapy within 60-90 min ("door-to-needle" time) after the patient has arrived at the emergency room or intensive care unit. This article reviews the current efforts to meet this goal (1) by implementing POCT of established biochemical markers such as cardiac troponins, creatine kinase MB, and myoglobin, in accelerated diagnosis and management workflow schemes, (2) by improving current POCT methods to obtain more accurate, more specific, and even faster tests through the integration of optical and electrochemical sensor technology, and (3) by identifying new markers for the very early and sensitive detection of myocardial ischemia and necrosis. Furthermore, the specific requirements for cardiac POCT in regard to analytical performance, comparability, and diagnostic sensitivity/specificity are discussed. For the future, the integration of new immunooptical and electrochemical chip technology might speed up diagnosis even further. However, every new development will have to meet the stringent method validation criteria set for corresponding central laboratory testing. PMID:19148628

  19. Point-of-care testing in the overcrowded emergency department--can it make a difference?

    PubMed

    Rooney, Kevin D; Schilling, Ulf Martin

    2014-01-01

    Emergency departments (EDs) face several challenges in maintaining consistent quality care in the face of steadily increasing public demand. Improvements in the survival rate of critically ill patients in the ED are directly related to the advancement of early recognition and treatment. Frequent episodes of overcrowding and prolonged waiting times force EDs to operate beyond their capacity and threaten to impact upon patient care. The objectives of this review are as follows: (a) to establish overcrowding as a threat to patient outcomes, person-centered care, and public safety in the ED; (b) to describe scenarios in which point-of-care testing (POCT) has been found to ameliorate factors thought to contribute to overcrowding; and (c) to discuss how POCT can be used directly, and indirectly, to expedite patient care and improve outcomes. Various studies have shown that overcrowding in the ED has profound effects on operational efficiency and patient care. Several reports have quantified overcrowding in the ED and have described a relationship between heightened periods of overcrowding and delays in treatment, increased incidence of adverse events, and an even greater probability of mortality. In certain scenarios, POCT has been found to increase the number of patients discharged in a timely manner, expedite triage of urgent but non-emergency patients, and decrease delays to treatment initiation. This review concludes that POCT, when used effectively, may alleviate the negative impacts of overcrowding on the safety, effectiveness, and person-centeredness of care in the ED. PMID:25672600

  20. Laboratory testing during critical care transport: point-of-care testing in air ambulances.

    PubMed

    Di Serio, Francesca; Petronelli, Maria Antonia; Sammartino, Eugenio

    2010-07-01

    Air and ground transport are used for prehospital transport of patients in acute life-threatening situations, and increasingly, critically ill patients undergo interhospital transportation. Results from clinical studies suggest that critical tests performed during the transport of critically ill patients presents a potential opportunity to improve patient care. Our project was to identify, according to the recommendations published at this time, a model of point-of-care testing (POCT) (arterial blood gases analysis and glucose, sodium, potassium, ionized calcium, hematocrit/hemoglobin measurements) in air ambulances. In order to identify the key internal and external factors that are important to achieving our objective, an analysis of the Strengths, Weaknesses, Opportunities, and Threats (SWOT analysis) was incorporated into our planning model prior to starting the project. To allow the entire POCT process (pre-, intra-, and post-analytic steps) to be under the control of the reference laboratory, an experimental model of information technology was applied. Real-time results during transport of critically ill patients must be considered to be an integral part of the patient care process and excellent channels of communication are needed between the intensive care units, emergency medical services and laboratories. With technological and computer advances, POCT during critical care transport will certainly increase in the future: this will be a challenge from a laboratory and clinical context. PMID:20406127

  1. Barriers to Implementation of Rapid and Point-of-Care Tests for Human Immunodeficiency Virus Infection

    PubMed Central

    Pai, Nitika Pant; Wilkinson, Samantha; Deli-Houssein, Roni; Vijh, Rohit; Vadnais, Caroline; Behlim, Tarannum; Steben, Marc; Engel, Nora; Wong, Tom

    2015-01-01

    Background Implementation of human immunodeficiency virus rapid and point-of-care tests (RDT/POCT) is understood to be impeded by many different factors that operate at 4 main levels—test devices, patients, providers, and health systems—yet a knowledge gap exists of how they act and interact to impede implementation. To fill this gap, and with a view to improving the quality of implementation, we conducted a systematic review. Methods Five databases were searched, 16,672 citations were retrieved, and data were abstracted on 132 studies by 2 reviewers. Findings Across 3 levels (ie, patients, providers, and health systems), a majority (59%, 112/190) of the 190 barriers were related to the integration of RDT/POCT, followed by test-device–related concern (ie, accuracy) at 41% (78/190). At the patient level, a lack of awareness about tests (15/54, 28%) and time taken to test (12/54, 22%) dominated. At the provider and health system levels, integration of RDT/POCT in clinical workflows (7/24, 29%) and within hospitals (21/34, 62%) prevailed. Accuracy (57/78, 73%) was dominant only at the device level. Interpretation Integration barriers dominated the findings followed by test accuracy. Although accuracy has improved during the years, an ideal implementation could be achieved by improving the integration of RDT/POCT within clinics, hospitals, and health systems, with clear protocols, training on quality assurance and control, clear communication, and linkage plans to improve health outcomes of patients. This finding is pertinent for a future envisioned implementation and global scale-up of RDT/POCT-based initiatives. PMID:26366129

  2. Perceptions on Point-of-Care Tests for Sexually Transmitted Infections - Comparison between Frontline Clinicians and Professionals in Industry.

    PubMed

    Hsieh, Yu-Hsiang; Gaydos, Charlotte A; Hogan, M Terry; Jackman, Joany; Jett-Goheen, Mary; Uy, O Manuel; Rompalo, Anne M

    2012-06-01

    OBJECTIVES: To determine if a gap exists between sexually transmitted infection (STI) clinicians and industry professionals regarding perceptions of the ideal types and characteristics of STI point-of-care tests (POCTs). METHODS: Our online survey design contained sections on demographics; barriers of use for available STI POCTs; characteristics of an ideal POCT, including prioritizing pathogens for targets; and "building your own POCT". Practicing clinicians and academic experts from two venues, STI-related international conference attendees and U.S. STD clinic clinicians, were invited to participate in the clinician survey. Professionals from industry in the STI diagnostic field were invited to participate in the industry survey. Chi-square test and conditional logistical regression were used for data analysis. RESULTS: Clinician survey participants (n=218) identified "the time frame required" (39.9%), "complexity" (31.2%), and "interruption of work flow" (30.3%) as the top three barriers making it difficult to use STI POCTs, while the industry survey participants (n=107) identified "complexity" (65.4%), "unreliability" (53.3%), and "difficulty in reading results" (34.6%) as the top three barriers (all p values <0.05). Sensitivity was always the most important attribute to be considered for a new STI POCT by both participant groups. Participants of the clinician group chose cost as the second priority attribute, while those of the industry group chose specificity as the second priority. CONCLUSION: We identified differences in the perceptions regarding barriers and ideal attributes for STI POCTs between frontline clinical providers and industry personnel. Tailored training is warranted to inform scientists, biomedical engineers, and other industry experts about characteristics that clinicians desire for STI POCTs. PMID:22844231

  3. Access and Quality of HIV-Related Point-of-Care Diagnostic Testing in Global Health Programs.

    PubMed

    Fonjungo, Peter N; Boeras, Debrah I; Zeh, Clement; Alexander, Heather; Parekh, Bharat S; Nkengasong, John N

    2016-02-01

    Access to point-of-care testing (POCT) improves patient care, especially in resource-limited settings where laboratory infrastructure is poor and the bulk of the population lives in rural settings. However, because of challenges in rolling out the technology and weak quality assurance measures, the promise of human immunodeficiency virus (HIV)-related POCT in resource-limited settings has not been fully exploited to improve patient care and impact public health. Because of these challenges, the Joint United Nations Programme on HIV/AIDS (UNAIDS), in partnership with other organizations, recently launched the Diagnostics Access Initiative. Expanding HIV programs, including the "test and treat" strategies and the newly established UNAIDS 90-90-90 targets, will require increased access to reliable and accurate POCT results. In this review, we examine various components that could improve access and uptake of quality-assured POC tests to ensure coverage and public health impact. These components include evaluation, policy, regulation, and innovative approaches to strengthen the quality of POCT. PMID:26423384

  4. Point-of-care PSA testing: an evaluation of PSAwatch.

    PubMed

    Karim, O; Rao, A; Emberton, M; Cochrane, D; Partridge, M; Edwards, P; Walker, I; Davidson, I

    2007-01-01

    We present a new quantitative prostate-specific antigen (PSA) assay using a portable, point-of-care test (PSAwatch) and reader system (BioScan) for measuring PSA concentrations in the range from 0.5 to < or =25 microg/l. Blood samples from patients (n=199) were submitted for laboratory PSA and also evaluated using PSAwatch and the BioScan system. PSA concentrations in 188 men were < or =25 microg/l and studied. Correlation between the two methods was good (R(2)=0.88) with a standard error of 1.588. The regression line had a bias of -0.02 at the concentration of 4.00 microg/l. This is the first report of a quantitative, portable, point-of-care PSA test and reader system. PSAwatch may reduce the number of hospital visits for patients with prostate disease. PMID:17353914

  5. Aptamer-based 'point-of-care testing'.

    PubMed

    Gopinath, Subash C B; Lakshmipriya, Thangavel; Chen, Yeng; Phang, Wai-Mei; Hashim, Uda

    2016-01-01

    Aptamers are single-stranded oligonucleotides that can be artificially generated by a method called Systematic evolution of ligands by exponential enrichment (SELEX). The generated aptamers have been assessed for high-performance sensing applications due to their appealing characteristics. With either aptamers alone or complementing with antibodies, several high sensitive and portable sensors have been demonstrated for use in 'point-of-care testing'. Due to their high suitability and flexibility, aptamers are conjugated with nanostructures and utilized in field applications. Moreover, aptamers are more amenable to chemical modifications, making them capable of utilization with most developed sensors. In this overview, we discuss novel, portable, and aptamer-based sensing strategies that are suitable for 'point-of-care testing'. PMID:26876017

  6. Point-of-Care Testing and Cardiac Biomarkers: The Standard of Care and Vision for Chest Pain Centers.

    PubMed

    Kost, Gerald J; Tran, Nam K

    2005-11-01

    Point-of-care testing (POCT) is defined as testing at or near the site of patient care. POCTdecreases therapeutic turnaround time (TTAT), increases clinical efficiency, and improves medical and economic outcomes. TTAT represents the time from test ordering to patient treatment. POC technologies have become ubiquitous in the United States, and, therefore,so has the potential for speed, convenience, and satisfaction, strong advantages for physicians, nurses, and patients in chest pain centers. POCT is applied most beneficially through the collaborative teamwork of clinicians and laboratorians who use integrative strategies, performance maps, clinical algorithms, and care paths (critical pathways). For example, clinical investigators have shown that on-site integration of testing for cardiac injury markers (myoglobin, creatinine kinase myocardial band [CKMB],and cardiac troponin I [cTnI]) in accelerated diagnostic algorithms produces effective screening, less hospitalization, and substantial savings. Chest pain centers, which now total over 150 accredited in the United States, incorporate similar types of protocol-driven performance enhancements. This optimization allows chest pain centers to improve patient evaluation, treatment, survival, and discharge. This article focuses on cardiac biomarker POCT for chest pain centers and emergency medicine. PMID:16278118

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

    PubMed

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

    2016-04-21

    Protease sensors for point-of-care testing (POCT) require simple operation, a detection period of less than 20 minutes, and a detection limit of less than 1 ng mL(-1). However, it is difficult to meet these requirements with protease sensors that are based on proteolytic cleavage. This paper reports a highly reproducible protease sensor that allows the sensitive and simple electrochemical detection of the botulinum neurotoxin type E light chain (BoNT/E-LC), which is obtained using (i) low nonspecific adsorption, (ii) high signal-to-background ratio, and (iii) one-step solution treatment. The BoNT/E-LC detection is based on two-step proteolytic cleavage using BoNT/E-LC (endopeptidase) and l-leucine-aminopeptidase (LAP, exopeptidase). Indium-tin oxide (ITO) electrodes are modified partially with reduced graphene oxide (rGO) to increase their electrocatalytic activities. Avidin is then adsorbed on the electrodes to minimize the nonspecific adsorption of proteases. Low nonspecific adsorption allows a highly reproducible sensor response. Electrochemical-chemical (EC) redox cycling involving p-aminophenol (AP) and dithiothreitol (DTT) is performed to obtain a high signal-to-background ratio. After adding a C-terminally AP-labeled oligopeptide, DTT, and LAP simultaneously to a sample solution, no further treatment of the solution is necessary during detection. The detection limits of BoNT/E-LC in phosphate-buffered saline are 0.1 ng mL(-1) for an incubation period of 15 min and 5 fg mL(-1) for an incubation period of 4 h. The detection limit in commercial bottled water is 1 ng mL(-1) for an incubation period of 15 min. The developed sensor is selective to BoNT/E-LC among the four types of BoNTs tested. These results indicate that the protease sensor meets the requirements for POCT. PMID:26980003

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

    NASA Astrophysics Data System (ADS)

    Robbins, Hannah; Hu, Sijung; Liu, Changqing

    2015-03-01

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

  9. 'The waiting game': are current chlamydia and gonorrhoea near-patient/point-of-care tests acceptable to service users and will they impact on treatment?

    PubMed

    Atkinson, Lindsay M; Vijeratnam, Dayan; Mani, Reena; Patel, Raj

    2016-07-01

    The objective of this study was to assess the length of time service users were prepared to wait for chlamydia and gonorrhoea (CT/GC) near-patient/point-of-care test (NP-POCT) results and to determine the possible effect on management. Individuals attending two UK clinics from November 2013 to February 2014 were surveyed asking the maximum length of time they would wait for CT/GC NP-POCT results after consultation. Linked CT/GC prevalence and treatment rates were analysed. A total of 1817 participants were surveyed, and 1356 provided CT/GC NAAT samples, in which it was found that 115 (8.5%) could wait over 90 minutes in clinic for their result. 115 received treatment at consultation, of which 50 were CT/GC negative and 12 were treated for urethritis or cervicitis; 38 attended as CT/GC contacts. Six of this population would have waited over 90 minutes were NP-POCTs available. A total of 129 tested CT/GC positive, of whom 65 were treated at their consultation, 61 at a later date, and three were untreated. Twelve of these 129 patients would also have waited over 90 minutes for a NP-POCT result. We conclude that 90-minute NP-POCTs are not acceptable to most clinic attendees and would not have impacted on treatment rates or inappropriate prescribing, and 20-minute NP-POCTs show a marginal benefit in treating CT/GC. While NP-POCTs for CT/GC are promising, they must meet client expectations and enhance disease management in order to be accepted by patients and clinicians. PMID:26092579

  10. Economic Evidence and Point-of-Care Testing

    PubMed Central

    St John, Andrew; Price, Christopher P

    2013-01-01

    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

  11. Point-of-care HIV tests done by peers, Brazil

    PubMed Central

    Dutra de Barros, Clarissa Habckost; Lobo, Tainah Dourado de Miranda; Pasini, Elisiane Nelcina; Comparini, Regina Aparecida; Caldas de Mesquita, Fábio

    2016-01-01

    Abstract Problem Early diagnosis of infections with human immunodeficiency virus (HIV) is needed – especially among key populations such as sex workers, transgender people, men who have sex with men and people who use drugs. Approach The Brazilian Ministry of Health developed a strategy called Viva Melhor Sabendo (“live better knowing”) to increase HIV testing among key populations. In partnership with nongovernmental organizations (NGOs), a peer point-of-care testing intervention, using an oral fluid rapid test, was introduced at social venues for key populations at different times of the day. Local setting Key populations in Brazil can have 40 times higher HIV prevalence than the general population (14.8% versus 0.4%). Relevant changes Legislation was reinterpreted, so that oral fluid rapid tests could be administered by any person trained in rapid testing by the health ministry. Between January 2014 and March 2015, 29 723 oral fluid tests were administered; 791 (2.7%) were positive. Among the key populations, transgender people had the greatest proportion of positive results (10.7%; 172/1612), followed by men who declared themselves as commercial sex workers (8.7%; 165/1889) and men who have sex with men (4.8%; 292/6055). Lessons learnt The strategy improved access to HIV testing. Testing done by peers at times and locations suitable for key populations increased acceptance of testing. Working with relevant NGOs is a useful approach when reaching out to these key populations. PMID:27516641

  12. Distance-based microfluidic quantitative detection methods for point-of-care testing.

    PubMed

    Tian, Tian; Li, Jiuxing; Song, Yanling; Zhou, Leiji; Zhu, Zhi; Yang, Chaoyong James

    2016-04-01

    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. PMID:26928571

  13. Point-of-care test for cervical cancer in LMICs

    PubMed Central

    Mohammed, Sulma I.; Ren, Wen; Flowers, Lisa; Rajwa, Bartek; Chibwesha, Carla J.; Parham, Groesbeck P.; Irudayaraj, Joseph M.K.

    2016-01-01

    Cervical cancer screening using Papanicolaou's smear test has been highly effective in reducing death from this disease. However, this test is unaffordable in low- and middle-income countries, and its complexity has limited wide-scale uptake. Alternative tests, such as visual inspection with acetic acid or Lugol's iodine and human papillomavirus DNA, are sub-optimal in terms of specificity and sensitivity, thus sensitive and affordable tests with high specificity for on-site reporting are needed. Using proteomics and bioinformatics, we have identified valosin-containing protein (VCP) as differentially expressed between normal specimens and those with cervical intra-epithelial neoplasia grade 2/3 (CIN2/CIN3+) or worse. VCP-specific immunohistochemical staining (validated by a point-of-care technology) provided sensitive (93%) and specific (88%) identification of CIN2/CIN3+ and may serve as a critical biomarker for cervical-cancer screening. Future efforts will focus on further refinements to enhance analytic sensitivity and specificity of our proposed test, as well as on prototype development. PMID:26934314

  14. Point-of-care test for cervical cancer in LMICs.

    PubMed

    Mohammed, Sulma I; Ren, Wen; Flowers, Lisa; Rajwa, Bartek; Chibwesha, Carla J; Parham, Groesbeck P; Irudayaraj, Joseph M K

    2016-04-01

    Cervical cancer screening using Papanicolaou's smear test has been highly effective in reducing death from this disease. However, this test is unaffordable in low- and middle-income countries, and its complexity has limited wide-scale uptake. Alternative tests, such as visual inspection with acetic acid or Lugol's iodine and human papillomavirus DNA, are sub-optimal in terms of specificity and sensitivity, thus sensitive and affordable tests with high specificity for on-site reporting are needed. Using proteomics and bioinformatics, we have identified valosin-containing protein (VCP) as differentially expressed between normal specimens and those with cervical intra-epithelial neoplasia grade 2/3 (CIN2/CIN3+) or worse. VCP-specific immunohistochemical staining (validated by a point-of-care technology) provided sensitive (93%) and specific (88%) identification of CIN2/CIN3+ and may serve as a critical biomarker for cervical-cancer screening. Future efforts will focus on further refinements to enhance analytic sensitivity and specificity of our proposed test, as well as on prototype development. PMID:26934314

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

    PubMed Central

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

    2015-01-01

    Objective Various point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection in general practice. Setting All testing procedures were performed at a diagnostic centre for primary care in the Netherlands. Urine samples were collected at four general practices. Primary and secondary outcome measures Analytical performance and agreement of the POCT analysers regarding nitrite, leucocytes and erythrocytes, with the laboratory reference standard, was the primary outcome measure, and analysed by calculating sensitivity, specificity, positive and negative predictive value, and Cohen's κ coefficient for agreement. Secondary outcome measures were the user-friendliness of the POCT analysers, in addition to other characteristics of the analysers. Results The following six POCT analysers were evaluated: Uryxxon Relax (Macherey Nagel), Urisys 1100 (Roche), Clinitek Status (Siemens), Aution 11 (Menarini), Aution Micro (Menarini) and Urilyzer (Analyticon). Analytical performance was good for all analysers. Compared with laboratory reference standards, overall agreement was good, but differed per parameter and per analyser. Concerning the nitrite test, the most important test for clinical practice, all but one showed perfect agreement with the laboratory standard. For leucocytes and erythrocytes specificity was high, but sensitivity was considerably lower. Agreement for leucocytes varied between good to very good, and for the erythrocyte test between fair and good. First-time users indicated that the analysers were easy to use. They expected higher productivity and accuracy when using these analysers in daily practice. Conclusions The overall performance and user-friendliness of all six commercially available POCT urine analysers was sufficient to justify routine

  16. Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research

    PubMed Central

    King, Kevin; Grazette, Luanda P.; Paltoo, Dina N.; McDevitt, John T.; Sia, Samuel K.; Barrett, Paddy M.; Apple, Fred S.; Gurbel, Paul A.; Weissleder, Ralph; Leeds, Hilary; Iturriaga, Erin J.; Rao, Anupama; Adhikari, Bishow; Desvigne-Nickens, Patrice; Galis, Zorina S.; Libby, Peter

    2016-01-01

    Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engineers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed opportunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care providers, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care. PMID:26977455

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

    PubMed Central

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

    2016-01-01

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

  18. Au@Pt nanoparticle encapsulated target-responsive hydrogel with volumetric bar-chart chip readout for quantitative point-of-care testing.

    PubMed

    Zhu, Zhi; Guan, Zhichao; Jia, Shasha; Lei, Zhichao; Lin, Shuichao; Zhang, Huimin; Ma, Yanli; Tian, Zhong-Qun; Yang, Chaoyong James

    2014-11-10

    Point-of-care testing (POCT) with the advantages of speed, simplicity, portability, and low cost is critical for the measurement of analytes in a variety of environments where access to laboratory infrastructure is lacking. While qualitative POCTs are widely available, quantitative POCTs present significant challenges. Here we describe a novel method that integrates an Au core/Pt shell nanoparticle (Au@PtNP) encapsulated target-responsive hydrogel with a volumetric bar-chart chip (V-Chip) for quantitative POCT. Upon target introduction, the hydrogel immediately dissolves and releases Au@PtNPs, which can efficiently catalyze the decomposition of H2 O2 to generate a large volume of O2 to move of an ink bar in the V-Chip. The concentration of the target introduced can be visually quantified by reading the traveling distance of the ink bar. This method has the potential to be used for portable and quantitative detection of a wide range of targets without any external instrument. PMID:25113247

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

    PubMed Central

    Weigl, Bernhard; Fitzpatrick, Annette; Ide, Nicole

    2016-01-01

    Current frameworks for evaluating diagnostic tests are constrained by a focus on diagnostic accuracy, and assume that all aspects of the testing process and test attributes are discrete and equally important. Determining the balance between the benefits and harms associated with new or existing tests has been overlooked. Yet, this is critically important information for stakeholders involved in developing, testing, and implementing tests. This is particularly important for point of care tests (POCTs) where tradeoffs exist between numerous aspects of the testing process and test attributes. We developed a new model that multiple stakeholders (e.g., clinicians, patients, researchers, test developers, industry, regulators, and health care funders) can use to visualize the multiple attributes of tests, the interactions that occur between these attributes, and their impacts on health outcomes. We use multiple examples to illustrate interactions between test attributes (test availability, test experience, and test results) and outcomes, including several POCTs. The model could be used to prioritize research and development efforts, and inform regulatory submissions for new diagnostics. It could potentially provide a way to incorporate the relative weights that various subgroups or clinical settings might place on different test attributes. Our model provides a novel way that multiple stakeholders can use to visualize test attributes, their interactions, and impacts on individual and population outcomes. We anticipate that this will facilitate more informed decision making around diagnostic tests. PMID:27574576

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

    PubMed

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

    2016-01-01

    Current frameworks for evaluating diagnostic tests are constrained by a focus on diagnostic accuracy, and assume that all aspects of the testing process and test attributes are discrete and equally important. Determining the balance between the benefits and harms associated with new or existing tests has been overlooked. Yet, this is critically important information for stakeholders involved in developing, testing, and implementing tests. This is particularly important for point of care tests (POCTs) where tradeoffs exist between numerous aspects of the testing process and test attributes. We developed a new model that multiple stakeholders (e.g., clinicians, patients, researchers, test developers, industry, regulators, and health care funders) can use to visualize the multiple attributes of tests, the interactions that occur between these attributes, and their impacts on health outcomes. We use multiple examples to illustrate interactions between test attributes (test availability, test experience, and test results) and outcomes, including several POCTs. The model could be used to prioritize research and development efforts, and inform regulatory submissions for new diagnostics. It could potentially provide a way to incorporate the relative weights that various subgroups or clinical settings might place on different test attributes. Our model provides a novel way that multiple stakeholders can use to visualize test attributes, their interactions, and impacts on individual and population outcomes. We anticipate that this will facilitate more informed decision making around diagnostic tests. PMID:27574576

  1. Issues in the practical implementation of POCT: overcoming challenges.

    PubMed

    Wiencek, Joesph; Nichols, James

    2016-01-01

    There are many challenges in implementing a successful point-of-care testing (POCT) program. When compared to traditional testing, POCT results are faster and allow for rapid patient treatment. Unfortunately, the excitement of this technology is often lost due to an assortment of practical obstacles. Implementation of POCT requires consideration of the regulatory complexity and amount of documentation to be compliant. As more tests move to the site of patient care, the number of operators that need to be trained and assessed will grow. An effective POCT program rests solely on the foundation of education and training of each operator, but assuring regular competency updates for a large number of staff can be a management issue. Discussed in this article are several of the key obstacles to implementing a POCT program including laboratory quality regulations, compliance documentation and operational management challenges. PMID:26783053

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

    PubMed

    Holt, Helen; Freedman, Danielle B

    2016-03-01

    ISO 22870 standards require protocols for performance of internal quality control for all point-of-care testing devices and training of users in its theory and practice. However, the unique setting of point-of-care testing (i.e. processes conducted by non-scientific users) means that laboratory internal quality control programmes do not easily translate to point-of-care testing. In addition, while the evidence base for internal quality control within the laboratory has been increasing, the equivalent literature surrounding point-of-care testing is very limited. This has led to wide variation in what is considered acceptable practice for internal quality control at the point of care. Indeed, it has been demonstrated that internal quality control is an area of deficiency in point-of-care testing. Internal quality control protocols used at point-of-care testing should be defined based on risk management. The protocol will therefore be dependent on analyser complexity and availability of inbuilt system checks, the risk associated with release of an incorrect patient result as well as frequency of use. The emphasis should be on designing an effective internal quality control protocol as opposed to the inherent tendency of introducing high-frequency quality control. Typically a simple pass or fail criterion is used for internal quality control in point-of-care testing based on whether internal quality control results fall within assigned ranges. While simply taught, such criteria can require broad internal quality control ranges to decrease the probability of false rejection (also reducing the probability of error detection). Customized internal quality control ranges, two-tier acceptance systems and assay-specific internal quality control can be used to improve error detection rates. PMID:26486440

  3. Pt@AuNPs integrated quantitative capillary-based biosensors for point-of-care testing application.

    PubMed

    Wu, Ze; Fu, Qiangqiang; Yu, Shiting; Sheng, Liangrong; Xu, Meng; Yao, Cuize; Xiao, Wei; Li, Xiuqing; Tang, Yong

    2016-11-15

    Current diagnostic technologies primarily rely on bulky and costly analytical instruments. Therefore, cost-effective and portable diagnosis tools that can be used for point-of-care tests (POCT) are highly desirable. In this study, we report a cost-effective, portable capillary-based biosensor for quantitative detection of biomarkers by the naked eye. This capillary-based biosensor was tested by measuring the distance of blue ink movement, which was directly correlated with the oxygen (O2) produced by efficient core-shell Pt@Au nanoparticles (Pt@AuNPs) catalysts decomposed hydrogen peroxide (H2O2). By linking the Pt@AuNPs with antibodies, capillary-based biosensor sandwich immunoassays were constructed. The concentrations of the target proteins were positively correlated with the distances of ink movement. To demonstrate their performance, the biosensors were used to detect the cancer biomarker sprostate-specific antigen (PSA) and carcinoembryonic antigen (CEA). The linear detection range (LDR) of the capillary-based biosensor for detecting PSA was from 0.02 to 2.5ng/mL, and the limit of detection (LOD) was 0.017ng/mL. LDR of the biosensor for detecting CEA was from 0.063 to 16ng/mL, and the LOD was 0.044ng/mL. For detection of PSA and CEA in clinical serum samples, the detection results of the capillary-based biosensor were well correlate with the results from of chemiluminescence immunoassays (CLIAs). Thus, the capillary-based biosensor may potentially be a useful strategy for point-of-care testing, in addition to being portable and cost effective. PMID:27240013

  4. 78 FR 73553 - Prospective Grant of Exclusive License: Development of Cripto-1 Point of Care (POC) Tests and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-06

    ... Cripto-1 Point of Care (POC) Tests and Kits for the Detection of Colon and Rectal Cancer, Breast Cancer... 510K cleared Point of Care (POC) tests and kits for the purpose of disease state recognition,...

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

    PubMed Central

    Park, Ki Sang; Heo, Hyuk

    2013-01-01

    Objectives The purpose of this study was to design an integrated data management system based on the POCT1-A2, LIS2-A, LIS2-A2, and HL7 standard to ensure data interoperability between mobile equipment, such as point-of-care testing equipment and the existing hospital data system, its efficiency was also evaluated. Methods The method of this study was intended to design and realize a data management system which would provide a solution for the problems that occur when point-of-care testing equipment is introduced to existing hospital data, after classifying such problems into connectivity, integration, and interoperability. This study also checked if the data management system plays a sufficient role as a bridge between the point-of-care testing equipment and the hospital information system through connection persistence and reliability testing, as well as data integration and interoperability testing. Results In comparison with the existing system, the data management system facilitated integration by improving the result receiving time, improving the collection rate, and by enabling the integration of disparate types of data into a single system. And it was found out that we can solve the problems related to connectivity, integration and interoperability through generating the message in standardized types. Conclusions It is expected that the proposed data management system, which is designed to improve the integration point-of-care testing equipment with existing systems, will establish a solid foundation on which better medical service may be provided by hospitals by improving the quality of patient service. PMID:24175121

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

    PubMed

    Marquardt, Udo; Apau, Daniel

    2015-09-01

    Overcrowding and prolonged patient stays in emergency departments (EDs) affect patients' experiences and outcomes, and increase healthcare costs. One way of addressing these problems is through using point-of-care blood tests, laboratory testing undertaken near patient locations with rapidly available results. D-dimer tests are used to exclude venous thromboembolism (VTE), a common presentation in EDs, in low-risk patients. However, data on the effects of point-of-care D-dimer testing in EDs and other urgent care settings are scarce. This article reports the results of a literature review that examined the benefits to patients of point-of-care D-dimer testing in terms of reduced turnaround times (time to results), and time to diagnosis, discharge or referral. It also considers the benefits to organisations in relation to reduced ED crowding and increased cost effectiveness. The review concludes that undertaking point-of-care D-dimer tests, combined with pre-test probability scores, can be a quick and safe way of ruling out VTE and improving patients' experience. PMID:26344541

  7. Minding the Gap: An approach to determine critical drivers in the development of Point of Care diagnostics

    PubMed Central

    Jackman, Joany; Uy, Manny; Hsieh, Yu-Hsiang; Rompalo, Anne; Hogan, Terry; Huppert, Jill; Jett-Goheen, Mary; Gaydos, Charlotte

    2012-01-01

    Introduction A point of care test (POCT) for Chlamydia trachomatis detection is an urgent public health need. Technology advances in diagnostics have made solutions possible. Yet no reliable POCT exist. Our goal was to address the gap between chlamydia POCT needs and successful POCT development by determining which characteristics of POCT tests are most critical and if any flexibility in the attributes assigned those characteristics exist between technology developer and end user. Methods We employed a process known as WALEX (Warfare Analysis Laboratory Exercise) in combination with Design of Experiment (DOE) methodology using discrete choice experiments (DCE), to describe the attributes of the most realistic, rather than the most ideal POCT. The WALEX was conducted as interactive oral and simultaneous electronic discussion among experts with differing expertise, but linked by a common interest in development of a chlamydia POCT. Results Our studies demonstrated which features of the ideal chlamydia POCT were considered critical to test acceptance by users and which were open to negotiation. In particular, end users were more lenient on the requirement for the fastest ideal test and the lowest one time instrument costs, if the requirement for higher throughput, lowest cost and vaginal sample source collection were preserved. DOE methods used in forced choice question design provided confirmation of opinions derived from oral and electronic WALEX comments Conclusions The WALEX in combination with DCE helped us achieve our goal in identifying the gaps in the chlamydia POCT and determining the most realistic solutions to bridge those gaps. PMID:22919287

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

    PubMed

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

    2016-02-01

    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. PMID:26759062

  9. [Quality proceedings in point-of-care testing: tetanus test example].

    PubMed

    Descamps-Pouchelle, Isabelle-Marie; Mortreux, François; Sergent-Roumier, Anne-Sophie; Gressier, Bernard

    2010-01-01

    In front of the increase of frequentation of emergency departments for pathological situations associated with tetanic risk, and the difficulty to know if the patients are immunized or not, the consequence is an unsuitable consumption of vaccination and/or antitetanic immunoglobulins. At the emergency department of Armentieres's hospital, in a perspective of an accreditation and following a medical request, we wanted to improve patient's care with tetanic risk wound by using a quick test for the detection of specific antitetanic antibodies (tetanos Fumouze test), under laboratory's authority. This test would allow a quickly and reliable immunity evaluation of patients with tetanic risk wound. The use of this point-of-care test was made possible with a good cooperation between clinicians, biologists and nurses. After six months, we wanted to evaluate monitoring and respect for qualities procedures established by laboratory and the medical and cost impact of this test. PMID:20650748

  10. Rapid visual identification of PCR amplified nucleic acids by centrifugal gel separation: Potential use for molecular point-of-care tests.

    PubMed

    Hwang, Sang-Hyun; Kim, Dong-Eun; Im, Ji-Hyun; Kang, Su-Jin; Lee, Do-Hoon; Son, Sang Jun

    2016-05-15

    Recently, nucleic acid amplification and detection techniques have progressed based on advances in in microfluidics, microelectronics, and optical systems. Nucleic acids amplification based point-of-care test (POCT) in resource-limited settings requires simple visual detection methods. Several biosensing methods including lateral flow immunoassays (LFIA) were previously used to visually detect nucleic acids. However, prolonged assay time, several washing steps, and a need for specific antibodies limited their use. Here we developed a novel, rapid method to visualize amplified nucleic acids with naked eyes in clinical samples. First, we optimized conditions based on separation using very low centrifugal force and a density medium to detect human papillomavirus (HPV)-16 DNA in cervical specimens. After DNA extraction, HPV16 PCR was performed with biotin-labeled forward primer and Cy3-labeled reverse primer. PCR amplicon was mixed with streptavidin-magnetic beads, introduced into the density medium. After two-minute centrifugation, the result was visually identified. This system showed identical results with commercial HPV real-time PCR for 30 clinical samples and could detect up to 10(2)copies/mL of HPV DNA without any optical instruments. This robust and sensitive visual detection system is suitable for non-specialist personnel and point-of-care diagnosis in low-resource settings. PMID:26774997

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

    PubMed

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

    2015-09-01

    Molecular genetics now plays a crucial role in diagnosis, the identification of prognostic markers, and monitoring of hematological malignancies. Demonstration of acquired changes such as the JAK2 V617F mutation within myeloproliferative neoplasms (MPN) has quickly moved from a research setting to the diagnostic laboratory. Microfluidics-based assays can reduce the assay time and sample/reagent consumption and enhance the reaction efficiency; however, no current assay has integrated isothermal amplification for point-of-care MPN JAK2 V617F mutation testing with a microchip. In this report, an integrated microchip that performs the whole human blood genomic DNA extraction, loop-mediated isothermal nucleic acid amplification (LAMP) and visual detection for point-of-care genetic mutation testing is demonstrated. This method was validated on DNA from cell lines as well as on whole blood from patients with MPN. The results were compared with those obtained by unlabeled probe melting curve analysis. This chip enjoys a high accuracy, operability, and cost/time efficiency within 1h. All these benefits provide the chip with a potency toward a point-of-care genetic analysis. All samples identified as positive by unlabeled probe melting curve analysis (n=27) proved positive when tested by microchip assay. None of the 30 negative controls gave false positive results. In addition, a patient with polycythemia vera diagnosed as being JAK2 V617F-negative by unlabeled probe melting curve analysis was found to be positive by the microchip. This microchip would possibly be very attractive in developing a point-of-care platform for quick preliminary diagnosis of MPN or other severe illness in resource-limited settings. PMID:26235214

  12. Economic evaluations of point of care testing strategies for active tuberculosis.

    PubMed

    Zwerling, Alice; Dowdy, David

    2013-06-01

    Point of care (POC) diagnostics are often hailed as having the potential to transform tuberculosis (TB) control efforts. However, POC testing is better conceptualized as a system of diagnosis and treatment, not simply a test that can provide rapid, deployable results. Economic evaluations may help decision makers allocate scarce resources for TB control, but evaluations of POC testing face unique challenges that include evaluating the full diagnostic system, incorporating implementation costs, translating diagnostic results into health and accounting for downstream treatment costs. For economic evaluations to reach their full potential as decision-making tools for POC testing in TB, these challenges must be understood and addressed. PMID:23763529

  13. The Matrix Metalloproteinase 9 Point-of-Care Test in Dry Eye.

    PubMed

    Lanza, Nicole L; Valenzuela, Felipe; Perez, Victor L; Galor, Anat

    2016-04-01

    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. PMID:26850527

  14. A Point-of-Care Prothrombin Time Test on a Microfluidic Disk Analyzer Using Alternate Spinning.

    PubMed

    Lin, Chia-Hui; Lin, Kun-Wei; Yen, Daniel; Shih, Chih-Hsin; Lu, Chien-Hsing; Wang, Jiunn-Min; Lin, Chi-Yu

    2015-02-01

    In this study, we conducted a fully integrated point-of-care prothrombin time test on a microfluidic disk analyzer. The microfluidic functions integrated on the disk were capable of separating whole blood, decanting plasma, and mixing it with reagents in sequence under alternate spinning. The assay protocol was completed by alternate spinning without using microvalves or surface modification. Clinical sample tests on prothrombin time measurement were conducted by both the microfluidic disk analyzer and the reference instrument used in medical centers. The test results showed a good correlation and agreement between the two instruments. PMID:26353663

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

    PubMed

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

    2014-01-01

    Improved access to anti-retroviral therapy increases the need for affordable monitoring using assays such as CD4 and/or viral load in resource-limited settings. Barriers to accessing treatment, high rates of loss to initiation and poor retention in care are prompting the need to find alternatives to conventional centralized laboratory testing in certain countries. Strong advocacy has led to a rapidly expanding repertoire of point-of-care tests for HIV. point-of-care testing is not without its challenges: poor regulatory control, lack of guidelines, absence of quality monitoring and lack of industry standards for connectivity, to name a few. The management of HIV increasingly requires a multidisciplinary testing approach involving hematology, chemistry, and tests associated with the management of non-communicable diseases, thus added expertise is needed. This is further complicated by additional human resource requirements and the need for continuous training, a sustainable supply chain, and reimbursement strategies. It is clear that to ensure appropriate national implementation either in a tiered laboratory model or a total decentralized model, clear country-specific assessments need to be conducted. PMID:25197773

  16. Development of a digital microfluidic platform for point of care testing

    PubMed Central

    Sista, Ramakrishna; Hua, Zhishan; Thwar, Prasanna; Sudarsan, Arjun; Srinivasan, Vijay; Eckhardt, Allen; Pollack, Michael; Pamula, Vamsee

    2009-01-01

    Point of care testing is playing an increasingly important role in improving the clinical outcome in health care management. The salient features of a point of care device are quick results, integrated sample preparation and processing, small sample volumes, portability, multifunctionality and low cost. In this paper, we demonstrate some of these salient features utilizing an electrowetting-based Digital Microfluidic platform. We demonstrate the performance of magnetic bead-based immunoassays (cardiac troponin I) on a digital microfluidic cartridge in less than 8 minutes using whole blood samples. Using the same microfluidic cartridge, a 40-cycle real-time polymerase chain reaction was performed within 12 minutes by shuttling a droplet between two thermal zones. We further demonstrate, on the same cartridge, the capability to perform sample preparation for bacterial and fungal infectious disease pathogens (methicillin-resistance Staphylococcus aureus and Candida albicans) and for human genomic DNA using magnetic beads. In addition to rapid results and integrated sample preparation, electrowetting-based digital microfluidic instruments are highly portable because fluid pumping is performed electronically. All the digital microfluidic chips presented here were fabricated on printed circuit boards utilizing mass production techniques that keep the cost of the chip low. Due to the modularity and scalability afforded by digital microfluidics, multifunctional testing capability, such as combinations within and between immunoassays, DNA amplification, and enzymatic assays, can be brought to the point of care at a relatively low cost because a single chip can be configured in software for different assays required along the path of care. PMID:19023472

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

    PubMed

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

    2013-04-15

    A low-cost, fully integrated sample-to-answer, quantitative PCR (qPCR) system that can be used for detection of HIV-1 proviral DNA in infants at the point-of-care in resource-limited settings has been developed and tested. The system is based on a novel DNA extraction method, which uses a glass fiber membrane, a disposable assay card that includes on-board reagent storage, provisions for thermal cycling and fluorescence detection, and a battery-operated portable analyzer. The system is capable of automated PCR mix assembly using a novel reagent delivery system and performing qPCR. HIV-1 and internal control targets are detected using two spectrally separated fluorophores, FAM and Quasar 670. In this report, a proof-of-concept of the platform is demonstrated. Initial results with whole blood demonstrate that the test is capable of detecting HIV-1 in blood samples containing greater than 5000 copies of HIV-1. In resource-limited settings, a point-of-care HIV-1 qPCR test would greatly increase the number of test results that reach the infants caregivers, allowing them to pursue anti-retroviral therapy. PMID:23202333

  18. Quality Assurance and Quality Control in Point-of-Care Testing.

    PubMed

    Newman, Ashleigh W; Behling-Kelly, Erica

    2016-03-01

    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. PMID:27451043

  19. Integration between the tele-cardiology unit and the central laboratory: methodological and clinical evaluation of point-of-care testing cardiac marker in the ambulance.

    PubMed

    Di Serio, Francesca; Lovero, Roberto; Leone, Massimo; De Sario, Rosalia; Ruggieri, Vincenzo; Varraso, Lucia; Pansini, Nicola

    2006-01-01

    The aim of this study was to identify patients with myocardial necrosis in pre-hospital phase during transport by ambulance, without ST-segment elevation (NSTE) on the ambulance ECG. The analytical performance of the i-STAT troponin I (cTnI) method was assessed. A total of 53 NSTE ambulance ECG patients admitted to hospital were followed. The ambulance had experimental software able to receive data from the i-STAT device and transmit it to a protected address and server. cTnI mean values from 2.0 to 34 microg/L showed a total CV of 3.0-5.6%. The detection limit was 0.016 microg/L. A mean cTnI concentration of 0.09 microg/L was associated with a CV of 8.0% (decision limit). The i-STAT cTnI method was linear for concentrations from 0 to 35 microg/L. There was no effect (p<0.05) of interfering substances. For point-of-care testing (POCT), cTnI was >0.09 microg/L in 20 AMI patients (91%). The median ambulance turnaround time (TAT) was 12 min and median hospital TAT was 40 min, a difference of 28 min. The high sensitivity of the i-STAT cTnI method integrated with tele-medicine procedures could play an important role in the management of acute coronary syndrome patients related to the pre-hospital phase (early diagnosis and treatment in the ambulance). These approaches may allow improvements in patient outcomes and continuous monitoring of the POCT network in the central laboratory, thus meeting quality requirements. PMID:16729867

  20. Preferences for rapid point-of-care HIV testing in primary care.

    PubMed

    Schwandt, Michael; Nicolle, Eileen; Dunn, Sheila

    2012-01-01

    Although the identification of individuals infected with HIV is an important element of treatment and prevention programs, many people living with HIV are unaware of their status. Thus, individuals are unable to benefit from treatment, and preventable HIV transmission continues to occur. Rapid point-of-care testing for HIV has been found to be preferred by patients in some contexts. However, few studies have examined preferences in primary care populations. This study investigates HIV testing preferences within an urban primary care clinic. Employing a cross-sectional design, data were collected on demographic characteristics, HIV risk factors, and testing history and preferences of participants. A total of 81% of participants stated that they would prefer rapid testing to standard testing, a finding that is consistent across demographic variables and risk factors examined. Increased availability of this modality may decrease barriers to HIV testing, with positive implications both for clinical management of HIV infection and prevention of HIV transmission. PMID:22247336

  1. Direct writing electrodes using a ball pen for paper-based point-of-care testing.

    PubMed

    Li, Zedong; Li, Fei; Hu, Jie; Wee, Wei Hong; Han, Yu Long; Pingguan-Murphy, Belinda; Lu, Tian Jian; Xu, Feng

    2015-08-21

    The integration of paper with an electrochemical device has attracted growing attention for point-of-care testing, where it is of great importance to fabricate electrodes on paper in a low-cost, easy and versatile way. In this work, we report a simple strategy for directly writing electrodes on paper using a pressure-assisted ball pen to form a paper-based electrochemical device (PED). This method is demonstrated to be capable of fabricating electrodes on paper with good electrical conductivity and electrochemical performance, holding great potential to be employed in point-of-care applications, such as in human health diagnostics and food safety detection. As examples, the PEDs fabricated using the developed method are applied for detection of glucose in artificial urine and melamine in sample solutions. Furthermore, our developed strategy is also extended to fabricate PEDs with multi-electrode arrays and write electrodes on non-planar surfaces (e.g., paper cup, human skin), indicating the potential application of our method in other fields, such as fabricating biosensors, paper electronics etc. PMID:26079757

  2. Commercial dengue rapid diagnostic tests for point-of-care application: recent evaluations and future needs?

    PubMed

    Blacksell, Stuart D

    2012-01-01

    Dengue fever, dengue haemorrhagic fever, and dengue shock syndrome (DF/DHF/DSS) are tropical diseases that cause significant humanitarian and economic hardship. It is estimated that more than 2.5 billion people are at risk of infection and more than 100 countries have endemic dengue virus transmission. Laboratory tests are essential to provide an accurate diagnosis of dengue virus infection so that appropriate treatment and patient management may be administered. In many dengue endemic settings, laboratory diagnostic resources are limited and simple rapid diagnostic tests (RDTs) provide opportunities for point-of-care diagnosis. This paper addresses current issues relating to the application of commercial dengue RDTs for the diagnosis of acute dengue virus infection, recent diagnostic evaluations, and identifies future needs. PMID:22654479

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

    PubMed Central

    Reid, Steven D; Fidler, Sarah J; Cooke, Graham S

    2013-01-01

    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 to effectively monitor those on ART. Diagnostics used to initiate and monitor treatment are now moving out of the laboratory and into the field. These new point-of-care

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

    PubMed

    Reid, Steven D; Fidler, Sarah J; Cooke, Graham S

    2013-01-01

    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 to effectively monitor those on ART. Diagnostics used to initiate and monitor treatment are now moving out of the laboratory and into the field. These new point-of-care

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  7. Time-critical neurological emergencies: the unfulfilled role for point-of-care testing

    PubMed Central

    Knight, William A.; Clark, Joseph F.; Beyette, Fred R.; Pancioli, Arthur

    2010-01-01

    Background Neurological emergencies are common and frequently devastating. Every year, millions of Americans suffer an acute stroke, severe traumatic brain injury, subarachnoid hemorrhage, status epilepticus, or spinal cord injury severe enough to require medical intervention. Aims Full evaluation of the diseases in the acute setting often requires advanced diagnostics, and treatment frequently necessitates transfer to specialized centers. Delays in diagnosis and/or treatment may result in worsened outcomes; therefore, optimization of diagnostics is critical. Methods Point-of-care (POC) testing brings advanced diagnostics to the patient’s bedside in an effort to assist medical providers with real-time decisions based on real-time information. POC testing is usually associated with blood tests (blood glucose, troponin, etc.), but can involve imaging, medical devices, or adapting existing technologies for use outside of the hospital. Noticeably missing from the list of current point-of-care technologies are real-time bedside capabilities that address neurological emergencies. Results Unfortunately, the lack of these technologies may result in delayed identification of patients of these devastating conditions and contribute to less aggressive therapies than is seen with other disease processes. Development of time-dependent technologies appropriate for use with the neurologically ill patient are needed to improve therapies and outcomes. Conclusion POC-CENT is designed to support the development of novel ideas focused on improving diagnostic or prognostic capabilities for acute neurological emergencies. Eligible examples include biomarkers of traumatic brain injury, non-invasive measurements of intracranial pressure or cerebral vasospasm, and improved detection of pathological bacteria in suspected meningitis. PMID:20606822

  8. Point-of-care testing: false elevation of cardiac troponin I assayed in the emergency department.

    PubMed

    Pernet, Pascal; Bénéteau-Burnat, Bénédicte; Hermand, Christelle; Vaubourdolle, Michel

    2008-10-01

    In October 2007, an 18-year-old woman with no cardiac history was admitted to the emergency department for a major epigastric pain. The chest pain led to assay cardiac troponin I (cTnI) with the emergency department point-of-care testing analyzer (Stratus CS), which disclosed a value of 0.70 ng/mL, discordant with the atypical clinical presentation and the noncontributive electrocardiography. The biologist contacted for biological advice controlled cTnI with an Access II, which disclosed a value less than 0.04 ng/mL. These findings were confirmed with the discordant results of a new sample assayed on both analyzers. The interference of heterophilic antibodies (HAs) was suspected because these antianimal antibodies may lead to analytical errors in sandwich immunoassays using animal sources of immunoglobulins and can cause false-positive results. In this case, the HAs bind to the capture antibody and the conjugate antibody, simulating cTnI. The diagnosis of HA involvement was confirmed using Heterophilic Blocking Tube, a device that contains a blocking reagent composed of specific binders that attach HA. After treatment in Heterophilic Blocking Tube, the cTnI concentration measured by the Stratus CS decreased from 0.62 to 0.05 ng/mL. Finally, potentially invasive test or this patient's unnecessary hospitalization in cardiology was avoided. Our experience supports that collaboration between staffs of laboratories and medical departments owning point-of-care testing analyzers is essential to avoid mistaken diagnosis linked to analytical interferences and to ensure quality of results assayed outside the laboratory. PMID:18926374

  9. An exothermic chip for point-of-care testing using a forehead thermometer as a readout.

    PubMed

    Gao, Bingbing; Liu, Hong; Gu, Zhongze

    2016-02-01

    We report an exothermic chip for quantitative point-of-care testing using a forehead thermometer as a readout. The chip has a capillary channel that directs an aqueous sample into an exothermic reservoir. NaOH powders are preloaded in the reservoir as the exothermic reagent. At the inlet of the capillary channel, a microvalve is fabricated using an aptamer-modified hydrogel which is responsive to a specific analyte. When the aqueous sample comes in contact with the hydrogel valve, the hydrogel shrinks due to the selective analyte-hydrogel interaction. The volume reduction of the hydrogel increases the capillary flow rate, and thus increases the heat produced by NaOH dissolution. A forehead thermometer is used to measure the temperature increment which is correlated with the analyte concentration. Using this method, heavy metal ions (Hg(2+) and Pb(2+)) in different real samples are quantitatively analyzed. PMID:26726852

  10. Simulation in coagulation testing using rotational thromboelastometry: A fast emerging, reliable point of care technique

    PubMed Central

    Gorlinger, Klaus; Bhardwaj, Vandana; Kapoor, Poonam Malhotra

    2016-01-01

    Computer simulations can come in handy to train medical personnel with necessary skills to face the clinical scenarios involving various coagulopathies. Now a days, point of care (POC) devices such as thromboelastography, Sonoclot analyzer and newly approved rotational thromboelastometry (ROTEM) with faster results to assess coagulopathies are available on bedside of patients. ROTEM is emerging as a quick, portable, and well-validated device to evaluate coagulopathy in critical care and perioperative setup. A novel platelet-aggregometry integrated module enables simultaneous analysis of platelets as well as coagulation tests on the same screen. The entire gamut of POC signature curves obtained with different coagulation defects can be learned with graphical simulations. These simulations can be a valuable strategy to elucidate latent conditions, for which simulation interventions can then be designed to mimic different clinical scenarios. PMID:27397458

  11. Simulation in coagulation testing using rotational thromboelastometry: A fast emerging, reliable point of care technique.

    PubMed

    Gorlinger, Klaus; Bhardwaj, Vandana; Kapoor, Poonam Malhotra

    2016-01-01

    Computer simulations can come in handy to train medical personnel with necessary skills to face the clinical scenarios involving various coagulopathies. Now a days, point of care (POC) devices such as thromboelastography, Sonoclot analyzer and newly approved rotational thromboelastometry (ROTEM) with faster results to assess coagulopathies are available on bedside of patients. ROTEM is emerging as a quick, portable, and well-validated device to evaluate coagulopathy in critical care and perioperative setup. A novel platelet-aggregometry integrated module enables simultaneous analysis of platelets as well as coagulation tests on the same screen. The entire gamut of POC signature curves obtained with different coagulation defects can be learned with graphical simulations. These simulations can be a valuable strategy to elucidate latent conditions, for which simulation interventions can then be designed to mimic different clinical scenarios. PMID:27397458

  12. Miniaturized Lensless Imaging Systems for Cell and Microorganism Visualization in Point-of-Care Testing

    PubMed Central

    Gurkan, Umut Atakan; Moon, Sangjun; Geckil, Hikmet; Xu, Feng; Wang, Shuqi; Lu, Tian Jian; Demirci, Utkan

    2011-01-01

    Low-cost, robust, and user-friendly diagnostic capabilities at the point-of-care (POC) are critical for treating infectious diseases and preventing their spread in developing countries. Recent advances in micro- and nano-scale technologies have enabled the merger of optical and fluidic technologies (optofluidics) paving the way for cost-effective lensless imaging and diagnosis for POC testing in resource limited settings. Applications of the emerging lensless imaging technologies include detecting and counting cells of interest, which allows rapid and affordable diagnostic decisions. This review presents the advances in lensless imaging and diagnostic systems, and their potential clinical applications in developing countries. The emerging technologies are reviewed from a POC perspective considering cost-effectiveness, portability, sensitivity, throughput and ease of use for resource-limited settings. PMID:21298800

  13. [Coagulation therapy in multiple trauma without point-of-care testing].

    PubMed

    Lier, H; Hinkelbein, J

    2014-02-01

    Analysis of blood coagulation with thrombelastometry (ROTEM™) and thrombelastography (TEG™) and analysis of thrombocyte function by a Multiplate™ assay is possible in only a few hospitals in Germany. Recently, the grade of recommendation (GoR) for point-of-care (POC) testing in official guidelines was increased and is now classified as GoR 1C. If a POC-based option is not available alternatives must be used. Besides blood products (RBC, FFP, TC), coagulation factor concentrates are used to treat trauma-induced coagulopathy. The benefits of therapy with factor concentrates are fewer immunological and infection side effects as well as faster effects after administration of specific coagulation factors. A good outcome in patients with multiple trauma is only possible by an adequate transfusion regime and administration of coagulation factors. PMID:24482058

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

    PubMed Central

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

    2016-01-01

    Objectives. Systematic review of point of care (POC) diagnostic tests for sexually transmitted infections: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Methods. Literature search on PubMed for articles from January 2010 to August 2015, including original research in English on POC diagnostics for sexually transmitted CT, NG, and/or TV. Results. We identified 33 publications with original research on POC diagnostics for CT, NG, and/or TV. Thirteen articles evaluated test performance, yielding at least one test for each infection with sensitivity and specificity ≥90%. Each infection also had currently available tests with sensitivities <60%. Three articles analyzed cost effectiveness, and five publications discussed acceptability and feasibility. POC testing was acceptable to both providers and patients and was also demonstrated to be cost effective. Fourteen proof of concept articles introduced new tests. Conclusions. Highly sensitive and specific POC tests are available for CT, NG, and TV, but improvement is possible. Future research should focus on acceptability, feasibility, and cost of POC testing. While pregnant women specifically have not been studied, the results available in nonpregnant populations are encouraging for the ability to test and treat women in antenatal care to prevent adverse pregnancy and neonatal outcomes. PMID:27313440

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

    PubMed

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

    2016-01-01

    Objectives. Systematic review of point of care (POC) diagnostic tests for sexually transmitted infections: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Methods. Literature search on PubMed for articles from January 2010 to August 2015, including original research in English on POC diagnostics for sexually transmitted CT, NG, and/or TV. Results. We identified 33 publications with original research on POC diagnostics for CT, NG, and/or TV. Thirteen articles evaluated test performance, yielding at least one test for each infection with sensitivity and specificity ≥90%. Each infection also had currently available tests with sensitivities <60%. Three articles analyzed cost effectiveness, and five publications discussed acceptability and feasibility. POC testing was acceptable to both providers and patients and was also demonstrated to be cost effective. Fourteen proof of concept articles introduced new tests. Conclusions. Highly sensitive and specific POC tests are available for CT, NG, and TV, but improvement is possible. Future research should focus on acceptability, feasibility, and cost of POC testing. While pregnant women specifically have not been studied, the results available in nonpregnant populations are encouraging for the ability to test and treat women in antenatal care to prevent adverse pregnancy and neonatal outcomes. PMID:27313440

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

    PubMed Central

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

    2014-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2010-05-01

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

  18. A Novel Quantum Dots–Based Point of Care Test for Syphilis

    PubMed Central

    2010-01-01

    One-step lateral flow test is recommended as the first line screening of syphilis for primary healthcare settings in developing countries. However, it generally shows low sensitivity. We describe here the development of a novel fluorescent POC (Point Of Care) test method to be used for screening for syphilis. The method was designed to combine the rapidness of lateral flow test and sensitiveness of fluorescent method. 50 syphilis-positive specimens and 50 healthy specimens conformed by Treponema pallidum particle agglutination (TPPA) were tested with Quantum Dot-labeled and colloidal gold-labeled lateral flow test strips, respectively. The results showed that both sensitivity and specificity of the quantum dots–based method reached up to 100% (95% confidence interval [CI], 91–100%), while those of the colloidal gold-based method were 82% (95% CI, 68–91%) and 100% (95% CI, 91–100%), respectively. In addition, the naked-eye detection limit of quantum dot–based method could achieve 2 ng/ml of anti-TP47 polyclonal antibodies purified by affinity chromatography with TP47 antigen, which was tenfold higher than that of colloidal gold–based method. In conclusion, the quantum dots were found to be suitable for labels of lateral flow test strip. Its ease of use, sensitiveness and low cost make it well-suited for population-based on-the-site syphilis screening. PMID:20672123

  19. A novel quantum dots-based point of care test for syphilis.

    PubMed

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

    2010-01-01

    One-step lateral flow test is recommended as the first line screening of syphilis for primary healthcare settings in developing countries. However, it generally shows low sensitivity. We describe here the development of a novel fluorescent POC (Point Of Care) test method to be used for screening for syphilis. The method was designed to combine the rapidness of lateral flow test and sensitiveness of fluorescent method. 50 syphilis-positive specimens and 50 healthy specimens conformed by Treponema pallidum particle agglutination (TPPA) were tested with Quantum Dot-labeled and colloidal gold-labeled lateral flow test strips, respectively. The results showed that both sensitivity and specificity of the quantum dots-based method reached up to 100% (95% confidence interval [CI], 91-100%), while those of the colloidal gold-based method were 82% (95% CI, 68-91%) and 100% (95% CI, 91-100%), respectively. In addition, the naked-eye detection limit of quantum dot-based method could achieve 2 ng/ml of anti-TP47 polyclonal antibodies purified by affinity chromatography with TP47 antigen, which was tenfold higher than that of colloidal gold-based method. In conclusion, the quantum dots were found to be suitable for labels of lateral flow test strip. Its ease of use, sensitiveness and low cost make it well-suited for population-based on-the-site syphilis screening. PMID:20672123

  20. POINT-OF-CARE HEMATOLOGY AND COAGULATION TESTING IN PRIMARY, RURAL EMERGENCY, AND DISASTER CARE SCENARIOS

    PubMed Central

    Curtis, Corbin M.; Kost, Gerald J.; Louie, Richard F.; Sonu, Rebecca J.; Ammirati, Erika B.; Sumner, Stephanie

    2012-01-01

    The purpose of this article is to review current principles and criteria for obtaining Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) waiver, identify existing point-of-care (POC) coagulation and hematology technologies, and analyze regulatory challenges regarding CLIA-waiver for those and future devices. CLIA ’88 documentation requires tests performed by laboratories with a Certificate of Waiver to be so simple that the likelihood of erroneous results by the user is negligible, or poses no unreasonable risk of harm to the patient if performed incorrectly as determined by the Secretary of Health and Human Services. “Simple” means that the test uses unprocessed samples, has a direct read-out of test results, does not have specifications for user training, and includes instructions for confirmatory testing when advisable. Currently the CLIA-waived hematology and coagulation POC devices only test for hemoglobin (Hb), hematocrit (Hct), and prothrombin time/international normalized ratio (PT/INR). The problem with these devices is the lack of multiplexing. POC coagulation and hematology devices face challenges for obtaining a waiver. These challenges include the lack of clinical needs assessment, miniturized assays that correct for interfering substances, and assays simple enough to be combined in a multiplex platform. Several scenarios demonstrate how POC coagulation or hematology devices can improve crisis care. Industry should perform needs assessment on clinicians and emergency responders to determine which analytes to incorporate on multiplex POC coagulation and hematology devices, and produce devices that address confounding factors. PMID:23843728

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

    PubMed Central

    Maw, Lwin Zar; Chowwiwat, Nongnud; Bansil, Pooja; Domingo, Gonzalo J.; Htun, Moh Moh; Thant, Kyaw Zin; Htut, Ye; Nosten, Francois

    2016-01-01

    Primaquine and other 8-amnoquinoline based anti-malarials can cause haemolysis in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Correct diagnosis of G6PD status in patients is crucial for safe treatment of both relapsing stages of Plasmodium vivax and transmitting forms of Plasmodium falciparum. Lack of suitable point-of-care tests has hampered a much needed wide use of primaquine for malaria elimination. In this study we have assessed the performances of two qualitative tests, the fluorescent spot test (FST) and the G6PD CareStart test (CST), against the gold standard quantitative spectrophotometric assay in a population of 1000 random adult healthy volunteers living in Yangon, Myanmar. The prevalence of G6PD deficiency in the Bamar, Karen and in the whole sample set was 6.6% (10.1% in males), 9.2% (21.0% in males) and 6.8% (11.1% in males) respectively. The FST and CST showed comparable performances with sensitivity over 95% and specificity over 90%, however for cases with severe G6PD activity the FTS had improved performance. If used with a conservative interpretation of the signal, the CareStart test has the potential to be used in the field and, by allowing a wider use of primaquine, to help malaria elimination. PMID:27035821

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

    PubMed

    Oo, Nwe Nwe; Bancone, Germana; Maw, Lwin Zar; Chowwiwat, Nongnud; Bansil, Pooja; Domingo, Gonzalo J; Htun, Moh Moh; Thant, Kyaw Zin; Htut, Ye; Nosten, Francois

    2016-01-01

    Primaquine and other 8-amnoquinoline based anti-malarials can cause haemolysis in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Correct diagnosis of G6PD status in patients is crucial for safe treatment of both relapsing stages of Plasmodium vivax and transmitting forms of Plasmodium falciparum. Lack of suitable point-of-care tests has hampered a much needed wide use of primaquine for malaria elimination. In this study we have assessed the performances of two qualitative tests, the fluorescent spot test (FST) and the G6PD CareStart test (CST), against the gold standard quantitative spectrophotometric assay in a population of 1000 random adult healthy volunteers living in Yangon, Myanmar. The prevalence of G6PD deficiency in the Bamar, Karen and in the whole sample set was 6.6% (10.1% in males), 9.2% (21.0% in males) and 6.8% (11.1% in males) respectively. The FST and CST showed comparable performances with sensitivity over 95% and specificity over 90%, however for cases with severe G6PD activity the FTS had improved performance. If used with a conservative interpretation of the signal, the CareStart test has the potential to be used in the field and, by allowing a wider use of primaquine, to help malaria elimination. PMID:27035821

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

    PubMed

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

    2015-11-01

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

  4. Point-of-care testing in the diagnosis of gastrointestinal cancers: Current technology and future directions

    PubMed Central

    Huddy, Jeremy R; Ni, Melody Z; Markar, Sheraz R; Hanna, George B

    2015-01-01

    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. PMID:25892860

  5. Field tested milliliter-scale blood filtration device for point-of-care applications

    PubMed Central

    Gong, Max M.; MacDonald, Brendan D.; Vu Nguyen, Trung; Van Nguyen, Kinh; Sinton, David

    2013-01-01

    In this paper, we present a low cost and equipment-free blood filtration device capable of producing plasma from blood samples with mL-scale capacity and demonstrate its clinical application for hepatitis B diagnosis. We report the results of in-field testing of the device with 0.8–1 ml of undiluted, anticoagulated human whole blood samples from patients at the National Hospital for Tropical Diseases in Hanoi, Vietnam. Blood cell counts demonstrate that the device is capable of filtering out 99.9% of red and 96.9% of white blood cells, and the plasma collected from the device contains lower red blood cell counts than plasma obtained from a centrifuge. Biochemistry and immunology testing establish the suitability of the device as a sample preparation unit for testing alanine transaminase (ALT), aspartate transaminase (AST), urea, hepatitis B “e” antigen (HBeAg), hepatitis B “e” antibody (HBe Ab), and hepatitis B surface antibody (HBs Ab). The device provides a simple and practical front-end sample processing method for point-of-care microfluidic diagnostics, enabling sufficient volumes for multiplexed downstream tests. PMID:24404044

  6. Point-of-Care Testing as an Influenza Surveillance Tool: Methodology and Lessons Learned from Implementation

    PubMed Central

    Gren, Lisa H.; Porucznik, Christina A.; Joy, Elizabeth A.; Lyon, Joseph L.; Staes, Catherine J.; Alder, Stephen C.

    2013-01-01

    Objectives. Disease surveillance combines data collection and analysis with dissemination of findings to decision makers. The timeliness of these activities affects the ability to implement preventive measures. Influenza surveillance has traditionally been hampered by delays in both data collection and dissemination. Methods. We used statistical process control (SPC) to evaluate the daily percentage of outpatient visits with a positive point-of-care (POC) influenza test in the University of Utah Primary Care Research Network. Results. Retrospectively, POC testing generated an alert in each of 4 seasons (2004–2008, median 16 days before epidemic onset), suggesting that email notification of clinicians would be 9 days earlier than surveillance alerts posted to the Utah Department of Health website. In the 2008-09 season, the algorithm generated a real-time alert 19 days before epidemic onset. Clinicians in 4 intervention clinics received email notification of the alert within 4 days. Compared with clinicians in 6 control clinics, intervention clinicians were 40% more likely to perform rapid testing (P = 0.105) and twice as likely to vaccinate for seasonal influenza (P = 0.104) after notification. Conclusions. Email notification of SPC-generated alerts provided significantly earlier notification of the epidemic onset than traditional surveillance. Clinician preventive behavior was not significantly different in intervention clinics. PMID:23691297

  7. Gene-Z: a device for point of care genetic testing using a smartphone.

    PubMed

    Stedtfeld, Robert D; Tourlousse, Dieter M; Seyrig, Gregoire; Stedtfeld, Tiffany M; Kronlein, Maggie; Price, Scott; Ahmad, Farhan; Gulari, Erdogan; Tiedje, James M; Hashsham, Syed A

    2012-04-21

    By 2012, point of care (POC) testing will constitute roughly one third of the $59 billion in vitro diagnostics market. The ability to carry out multiplexed genetic testing and wireless connectivity are emerging as key attributes of future POC devices. In this study, an inexpensive, user-friendly and compact device (termed Gene-Z) is presented for rapid quantitative detection of multiple genetic markers with high sensitivity and specificity. Using a disposable valve-less polymer microfluidic chip containing four arrays of 15 reaction wells each with dehydrated primers for isothermal amplification, the Gene-Z enables simultaneous analysis of four samples, each for multiple genetic markers in parallel, requiring only a single pipetting step per sample for dispensing. To drastically reduce the cost and size of the real-time detector necessary for quantification, loop-mediated isothermal amplification (LAMP) was performed with a high concentration of SYTO-81, a non-inhibiting fluorescent DNA binding dye. The Gene-Z is operated using an iPod Touch, which also receives data and carries out automated analysis and reporting via a WiFi interface. This study presents data pertaining to performance of the device including sensitivity and reproducibility using genomic DNA from Escherichia coli and Staphylococcus aureus. Overall, the Gene-Z represents a significant step toward truly inexpensive and compact tools for POC genetic testing. PMID:22374412

  8. Point-of-Care Testing of Troponin Levels Compared With Automated Laboratory Evaluation: A Reliability Study.

    PubMed

    Sardi, Adacilis Ramirez; Lamoureux, Julie A; Cohn, Tanya M; Phillip-Samuel, Shirley G

    2016-01-01

    Traditionally, troponin levels are measured in the blood using an automated laboratory protocol, but the use of a faster technology, the point-of-care (POC) testing of troponin levels, has shown promise in the effective differential diagnosis of cardiac injury. The purpose of this study was to compare the 2 methods. A total of 1567 patients were seen in the emergency department who were tested with both the POC iSTAT troponin and laboratory troponin from a secondary analysis of retrospective data collected between June 2012 and December 2012. The values for laboratory troponin varied between 0 and 30 with a mean and standard deviation of 0.060 ± 0.842 and the values for POC testing varied between 0 and 17.2 with a mean and standard deviation of 0.042 ± 0.492. The Bland-Altman analysis showed a systematic negative bias for the POC values compared with the laboratory troponin values. Lowering the POC cut-off value for troponin to 0.035 yielded 3 out of 4 better validity coefficients compared with those with the suggested manufacturer's cut-off value of 0.08 when predicting the gold standard. The POC troponin can be used to measure troponin level and similar diagnosis if the cut-off value for the POC troponin is lowered to 0.035 instead of the 0.08 suggested manufacturer's cut-off. PMID:27575797

  9. Point-of-Care Testing as an Influenza Surveillance Tool: Methodology and Lessons Learned from Implementation.

    PubMed

    Gren, Lisa H; Porucznik, Christina A; Joy, Elizabeth A; Lyon, Joseph L; Staes, Catherine J; Alder, Stephen C

    2013-01-01

    Objectives. Disease surveillance combines data collection and analysis with dissemination of findings to decision makers. The timeliness of these activities affects the ability to implement preventive measures. Influenza surveillance has traditionally been hampered by delays in both data collection and dissemination. Methods. We used statistical process control (SPC) to evaluate the daily percentage of outpatient visits with a positive point-of-care (POC) influenza test in the University of Utah Primary Care Research Network. Results. Retrospectively, POC testing generated an alert in each of 4 seasons (2004-2008, median 16 days before epidemic onset), suggesting that email notification of clinicians would be 9 days earlier than surveillance alerts posted to the Utah Department of Health website. In the 2008-09 season, the algorithm generated a real-time alert 19 days before epidemic onset. Clinicians in 4 intervention clinics received email notification of the alert within 4 days. Compared with clinicians in 6 control clinics, intervention clinicians were 40% more likely to perform rapid testing (P = 0.105) and twice as likely to vaccinate for seasonal influenza (P = 0.104) after notification. Conclusions. Email notification of SPC-generated alerts provided significantly earlier notification of the epidemic onset than traditional surveillance. Clinician preventive behavior was not significantly different in intervention clinics. PMID:23691297

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

    PubMed

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

    2015-12-01

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

  11. ENHANCING CRISIS STANDARDS OF CARE USING INNOVATIVE POINT-OF-CARE TESTING

    PubMed Central

    Kost, Gerald J.; Sakaguchi, Ann; Curtis, Corbin; Tran, Nam K.; Katip, Pratheep; Louie, Richard F.

    2011-01-01

    Objective To identify strategies with tactics that enable point-of-care (POC) testing (medical testing at or near the site of care) to improve outcomes effectively in emergencies, disasters, and public health crises, especially where community infrastructure is compromised. Design Logic model-critical path-feedback identified needs for improving practices. Reverse stress analysis showed POC should be integrated, responders properly trained, and devices staged in small-world networks (SWNs). We summarize first responder POC resources, strategize test clusters, address assay environmental vulnerabilities, and design tactics useful for SWNs, alternate care facilities, shelters, point-of-distribution centers, and community hospitals. Participants and Environment Emergency-disaster needs assessment survey respondents and Center experience. Outcomes Important tactics are: a) develop training/education courses and “just-in-time” on-line web resources to assure the competency of POC coordinators and high quality testing performance; b) protect equipment from environmental extremes by sealing reagents, controlling temperature and humidity to which they are exposed, and establishing near-patient testing in defined environments that operate within current FDA licensing claims (illustrated with HIV-1/2 tests); c) position testing in defined sites within SWNs and other environments; d) harden POC devices and reagents to withstand wider ranges of environmental extremes in field applications; e) promote new POC technologies for pathogen detection and other assays, per needs assessment results; and f) select tests according to mission objectives and value propositions. Conclusions Careful implementation of POC testing will facilitate evidence-based triage, diagnosis, treatment, and monitoring of victims and patients, while advancing standards of care in emergencies and disasters, as well as public health crises. PMID:22338316

  12. Evaluating Operational Specifications of Point-of-Care Diagnostic Tests: A Standardized Scorecard

    PubMed Central

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

    2012-01-01

    The expansion of HIV antiretroviral therapy into decentralized rural settings will increasingly require simple point-of-care (POC) diagnostic tests that can be used without laboratory infrastructure and technical skills. New POC test devices are becoming available but decisions around which technologies to deploy may be biased without systematic assessment of their suitability for decentralized healthcare settings. To address this, we developed a standardized, quantitative scorecard tool to objectively evaluate the operational characteristics of POC diagnostic devices. The tool scores devices on a scale of 1–5 across 30 weighted characteristics such as ease of use, quality control, electrical requirements, shelf life, portability, cost and service, and provides a cumulative score that ranks products against a set of ideal POC characteristics. The scorecard was tested on 19 devices for POC CD4 T-lymphocyte cell counting, clinical chemistry or hematology testing. Single and multi-parameter devices were assessed in each of test categories. The scores across all devices ranged from 2.78 to 4.40 out of 5. The tool effectively ranked devices within each category (p<0.01) except the CD4 and multi-parameter hematology products. The tool also enabled comparison of different characteristics between products. Agreement across the four scorers for each product was high (intra-class correlation >0.80; p<0.001). Use of this tool enables the systematic evaluation of diagnostic tests to facilitate product selection and investment in appropriate technology. It is particularly relevant for countries and testing programs considering the adoption of new POC diagnostic tests. PMID:23118871

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

    PubMed Central

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

    2016-01-01

    Introduction Point-of-care (POC) pregnancy testing is commonly performed in the emergency department (ED). One prior study demonstrated equivalent accuracy between urine and whole blood for one common brand of POC pregnancy testing. Our study sought to determine the difference in result times when comparing whole blood versus urine for the same brand of POC pregnancy testing. Methods We conducted a prospective, observational study at an urban, academic, tertiary care hospital comparing the turnaround time between order and result for urine and whole blood pregnancy tests collected according to standard protocol without intervention from the investigators. After the blood was collected, the nurse would place three drops onto a Beckman Coulter ICON 25 Rapid HCG bedside pregnancy test and set a timer for 10 minutes. At the end of the 10 minutes, the result and time were recorded on an encoded data sheet and not used clinically. The same make and model analyzer was also used for urine tests in the lab located within the ED. The primary outcome was the difference in mean turnaround time between whole blood in the ED and urine testing in the adjacent lab results. Concordance between samples was assessed as a secondary outcome. Results 265 total patients were included in the study. The use of whole blood resulted in a mean time savings of 21 minutes (95% CI 16–25 minutes) when compared with urine (p<0.001). There was 99.6% concordance between results, with one false negative urine specimen with a quantitative HCG level of 81 mIU/L. Conclusion Our results suggest that the use of whole blood in place of urine for bedside pregnancy testing may reduce the total result turnaround time without significant changes in accuracy in this single-center study. PMID:27429695

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

    PubMed

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

    2016-07-01

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

  15. Concept of a point of care test to detect new oral anticoagulants in urine samples

    PubMed Central

    2013-01-01

    New oral anticoagulants (NOAC) are approved for several indications for prophylaxis and treatment of venous thromboembolism and for prevention of embolism in atrial fibrillation at fixed daily doses without need of laboratory guided dose adjustment. Due to their low molecular weight of about 500 to 600 Dalton and their hydrophilicity free anticoagulant is excreted immediately through glomerular filtration into the urine. Impairment of renal function may increase the plasma concentration of the anticoagulants and lowered creatinine clearance is a declared contraindication. In contrast to the initial aim of development the anticoagulant effect is required to be determined in special clinical situations. Several specific and non-specific assays using plasma samples are currently undergoing standardization. As all NOACs are excreted into the urine, specific assays were developed for this matrix to determine them quantitatively of qualitatively. Urine samples can be easily and repetitively obtained avoiding problems and risks associated with blood sampling. The qualitative assay can be performed as a point of care test (POC) also by the patient by judging the different colours for the absence or presence of the drugs with the naked eye. The test is rapid (results available within 15 min), sensitive, specific and accurate and does not require a purified NOAC as control. The tests may be a tool for clinicians who need to know for treatment decisions if a NOAC is on board or not. As the tests are specific for oral direct thrombin inhibitors and for oral direct factor Xa inhibitors, the indication does not interfere with other qualitative POC test in development using clotting systems. The test may be indicated for patients at acute hospitalization, before surgery or central nervous system puncture anaesthesia, if fibrinolytic therapy is indicated, acute deterioration of renal function, and for control of adherence to therapy. PMID:23915217

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

    PubMed Central

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

    2013-01-01

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

  17. Immunosensor for the ultrasensitive and quantitative detection of bladder cancer in point of care testing.

    PubMed

    Chuang, Cheng-Hsin; Du, Yi-Chun; Wu, Ting-Feng; Chen, Cheng-Ho; Lee, Da-Huei; Chen, Shih-Min; Huang, Ting-Chi; Wu, Hsun-Pei; Shaikh, Muhammad Omar

    2016-10-15

    An ultrasensitive and real-time impedance based immunosensor has been fabricated for the quantitative detection of Galectin-1 (Gal-1) protein, a biomarker for the onset of multiple oncological conditions, especially bladder cancer. The chip consists of a gold annular interdigitated microelectrode array (3×3 format with a sensing area of 200µm) patterned using standard microfabrication processes, with the ability to electrically address each electrode individually. To improve sensitivity and immobilization efficiency, we have utilized nanoprobes (Gal-1 antibodies conjugated to alumina nanoparticles through silane modification) that are trapped on the microelectrode surface using programmable dielectrophoretic manipulations. The limit of detection of the immunosensor for Gal-1 protein is 0.0078mg/ml of T24 (Grade III) cell lysate in phosphate buffered saline, artificial urine and human urine samples. The normalized impedance variations show a linear dependence on the concentration of cell lysate present while specificity is demonstrated by comparing the immunosensor response for two different grades of bladder cancer cell lysates. We have also designed a portable impedance analyzing device to connect the immunosensor for regular checkup in point of care testing with the ability to transfer data over the internet using a personal computer. We believe that this diagnostic system would allow for improved public health monitoring and aid in early cancer diagnosis. PMID:26777732

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

    NASA Astrophysics Data System (ADS)

    Walczak, Rafał; Krüger, Jan; Moynihan, Shane

    2015-08-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2016-02-01

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

  20. Point-of-care platelet function tests: detection of platelet inhibition induced by nonopioid analgesic drugs.

    PubMed

    Scharbert, Gisela; Gebhardt, Kristina; Sow, Zacharia; Duris, Monika; Deusch, Engelbert; Kozek-Langenecker, Sibylle

    2007-12-01

    Detection of platelet inhibition is of clinical relevance in the preinterventional risk-benefit assessment in chronic low-back-pain patients scheduled for invasive pain therapy. We evaluated the sensitivity of various point-of-care platelet function tests for the detection of platelet inhibition induced by nonopioid analgesic drugs. After Institutional Review Board approval and informed consent, citrated whole blood from 40 patients with chronic unspecific low back pain was investigated before and 30 min after intravenous infusion of the study medication consisting of diclofenac 75 mg (plus orphenadrin 30 mg; Neodolpasse; Fresenius Kabi Austria GmbH, Austria), parecoxib 40 mg (Dynastat; Pharmacia Europe EEIG, UK), paracetamol 1 g (Perfalgan; Bieffe Medital S.P.A., Italy), or normal saline in a randomized, cross-over, double-blinded, placebo-controlled study. Platelet function was assessed using the PFA-100 platelet function analyzer and thromboelastometry, as well as impedance aggregometry (in the last 17 patients recruited after it became commercially available). Sensitivity for detecting diclofenac-induced platelet inhibition was 85% for the PFA-100 using epinephrine as agonist and 94% for arachidonic acid-induced impedance aggregometry. ADP-induced platelet function tests, as well as cytochalasin D-modified thromboelastometry were unreliable. All tests had a low incidence of false-positive test results after normal saline. Paracetamol and parecoxib had no significant platelet inhibiting effect. The PFA-100 using epinephrine as agonist and arachidonic acid-induced impedance aggregometry are recommended for the detection of cyclooxygenase-I-inhibiting effects of nonsteroidal anti-inflammatory drugs such as diclofenac. Our findings confirm that a single rescue dose of paracetamol and parecoxib has no antiplatelet effect. PMID:17982319

  1. Future Connectivity for Disaster and Emergency Point of Care

    PubMed Central

    Yu, Jimmy N.; Brock, Terry Keith; Mecozzi, Daniel M.; Tran, Nam K.; Kost, Gerald J.

    2011-01-01

    Objective The goal of this paper is to identify strategies for connectivity that will optimize point-of-care testing (POCT) organized as small-world networks in disaster settings. Methods We evaluated connectivity failures during the 2010 Haiti Earthquake, applied small-world network concepts, and reviewed literature for point-of-care (POC) connectivity systems. Results Medical teams responding to the Haiti Earthquake faced connectivity failures that affected patient outcomes. Deploying robust wireless connectivity systems can enhance the efficiency of the disaster response by improving health care delivery, medical documentation, logistics, response coordination, communication, and telemedicine. Virtual POC connectivity education and training programs can enhance readiness of disaster responders. Conclusions The admirable humanitarian efforts of more than 4000 organizations substantially impacted the lives of earthquake victims in Haiti. However, the lack of connectivity and small-world network strategies, combined with communication failures, during early stages of the relief effort must be addressed for future disaster preparedness. PMID:21547239

  2. Future Connectivity for Disaster and Emergency Point of Care.

    PubMed

    Yu, Jimmy N; Brock, Terry Keith; Mecozzi, Daniel M; Tran, Nam K; Kost, Gerald J

    2010-12-01

    OBJECTIVE: The goal of this paper is to identify strategies for connectivity that will optimize point-of-care testing (POCT) organized as small-world networks in disaster settings. METHODS: We evaluated connectivity failures during the 2010 Haiti Earthquake, applied small-world network concepts, and reviewed literature for point-of-care (POC) connectivity systems. RESULTS: Medical teams responding to the Haiti Earthquake faced connectivity failures that affected patient outcomes. Deploying robust wireless connectivity systems can enhance the efficiency of the disaster response by improving health care delivery, medical documentation, logistics, response coordination, communication, and telemedicine. Virtual POC connectivity education and training programs can enhance readiness of disaster responders. CONCLUSIONS: The admirable humanitarian efforts of more than 4000 organizations substantially impacted the lives of earthquake victims in Haiti. However, the lack of connectivity and small-world network strategies, combined with communication failures, during early stages of the relief effort must be addressed for future disaster preparedness. PMID:21547239

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

    NASA Astrophysics Data System (ADS)

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

    2014-03-01

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

  4. Comparison of Rapid Point-of-Care Tests for Detection of Antibodies to Hepatitis C Virus

    PubMed Central

    Fisher, Dennis G.; Hess, Kristen L.; Erlyana, Erlyana; Reynolds, Grace L.; Cummins, Catherine A.; Alonzo, Todd A.

    2015-01-01

    Background. Hepatitis C is one of the most prevalent blood-borne diseases in the United States. Despite the benefits of early screening, among 3.2 million Americans who are infected with hepatitis C virus (HCV), 50%–70% are unaware of their infection status. Methods. Data were collected between 2011 and 2014, from 1048 clients who were in the following groups: (1) injection drug users, (2) women at sexual risk, (3) gay and bisexual men, and (4) transgender individuals. The sensitivity and specificity of point-of-care tests included (1) the MedMira rapid human immunodeficiency virus (HIV)/HCV antibody test, (2) MedMira hepatitis B (HBV)/HIV/HCV antibody test, (3) Chembio HCV Screen Assay used with both whole blood and (4) oral specimens, (5) Chembio HIV-HCV Assay also used with both whole blood and (6) oral specimens, (7) Chembio HIV-HCV-Syphilis Assay, and (8) OraSure HCV Rapid Antibody Test used with whole blood. The gold standard for the HCV tests were HCV enzyme immunoassay (EIA) 2.0. Results. OraSure had the highest sensitivity at 92.7% (95% confidence interval [CI] = 88.8%–96.5%) followed closely by Chembio's 3 blood tests at 92.1% (95% CI = 87.7%–96.4%), 91.5% (95% CI = 87.2%–95.7%), and 92.3% (95% CI = 88.4%–96.2%). The sensitivities of MedMira HIV/HCV and MedMira HIV/HCV/HBV tests were the lowest, at 79.1% (95% CI = 72.6%–85.5%), and 81.5% (95% CI = 75.2%–87.8%), respectively. Specificity for the OraSure was 99.8% (95% CI = 99.4%–100%); specificity for the Chembio blood tests was 99.2% (95% CI = 98.6%–99.9%), 99.4% (95% CI = 98.8%–99.9%), and 99.3% (95% CI = 98.8%–99.9%); and specificity for the MedMira was100% and 100%. False-negative results were associated with HIV and hepatitis B core antibody serostatus. Conclusions. The OraSure and Chembio blood tests (including those multiplexed with HIV and syphilis) appear to good performance characteristics. This study has identified potential limitations of rapid testing in those

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

    PubMed Central

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

    2014-01-01

    Introduction Point-of-care testing for CD4 cell count is considered a promising way of reducing the time to eligibility assessment for antiretroviral therapy (ART) and of increasing retention in care prior to treatment initiation. In this review, we assess the available evidence on the patient and programme impact of point-of-care CD4 testing. Methods We searched nine databases and two conference sites (up until 26 October 2013) for studies reporting patient and programme outcomes following the introduction of point-of-care CD4 testing. Where appropriate, results were pooled using random-effects methods. Results Fifteen studies, mainly from sub-Saharan Africa, were included for review, providing evidence for adults, adolescents, children and pregnant women. Compared to conventional laboratory-based testing, point-of-care CD4 testing increased the likelihood of having CD4 measured [odds ratio (OR) 4.1, 95% CI 3.5–4.9, n=2] and receiving a CD4 result (OR 2.8, 95% CI 1.5–5.6, n=6). Time to being tested was significantly reduced, by a median of nine days; time from CD4 testing to receiving the result was reduced by as much as 17 days. Evidence for increased treatment initiation was mixed. Discussion The results of this review suggest that point-of-care CD4 testing can increase retention in care prior to starting treatment and can also reduce time to eligibility assessment, which may result in more eligible patients being initiated on ART. PMID:24447595

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

    PubMed

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

    2015-09-01

    In this paper we aim to demonstrate, as a proof-of-concept, the feasibility of the mass production of effective point of care tests for nitrite quantification in environmental, food and clinical samples. Following our previous work on the development of third generation electrochemical biosensors based on the ammonia forming nitrite reductase (ccNiR), herein we reduced the size of the electrodes' system to a miniaturized format, solved the problem of oxygen interference and performed simple quantification assays in real samples. In particular, carbon paste screen printed electrodes (SPE) were coated with a ccNiR/carbon ink composite homogenized in organic solvents and cured at low temperatures. The biocompatibility of these chemical and thermal treatments was evaluated by cyclic voltammetry showing that the catalytic performance was higher with the combination acetone and a 40°C curing temperature. The successful incorporation of the protein in the carbon ink/solvent composite, while remaining catalytically competent, attests for ccNiR's robustness and suitability for application in screen printed based biosensors. Because the direct electrochemical reduction of molecular oxygen occurs when electroanalytical measurements are performed at the negative potentials required to activate ccNiR (ca.-0.4V vs Ag/AgCl), an oxygen scavenging system based on the coupling of glucose oxidase and catalase activities was successfully used. This enabled the quantification of nitrite in different samples (milk, water, plasma and urine) in a straightforward way and with small error (1-6%). The sensitivity of the biosensor towards nitrite reduction under optimized conditions was 0.55 A M(-1) cm(-2) with a linear response range 0.7-370 μM. PMID:26003719

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

    PubMed

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

    2015-01-01

    The increasing prevalence of acquired and transmitted HIV-1 drug resistance is an obstacle to successful antiretroviral therapy (ART) in the low- and middle-income countries (LMICs) hardest hit by the HIV-1 pandemic. Genotypic drug resistance testing could facilitate the choice of initial ART in areas with rising transmitted drug resistance (TDR) and enable care-providers to determine which individuals with virological failure (VF) on a first- or second-line ART regimen require a change in treatment. An inexpensive near point-of-care (POC) genotypic resistance test would be useful in settings where the resources, capacity, and infrastructure to perform standard genotypic drug resistance testing are limited. Such a test would be particularly useful in conjunction with the POC HIV-1 viral load tests that are currently being introduced in LMICs. A POC genotypic resistance test is likely to involve the use of allele-specific point mutation assays for detecting drug-resistance mutations (DRMs). This study proposes that two major nucleoside reverse transcriptase inhibitor (NRTI)-associated DRMs (M184V and K65R) and four major NNRTI-associated DRMs (K103N, Y181C, G190A, and V106M) would be the most useful for POC genotypic resistance testing in LMIC settings. One or more of these six DRMs was present in 61.2% of analyzed virus sequences from ART-naïve individuals with intermediate or high-level TDR and 98.8% of analyzed virus sequences from individuals on a first-line NRTI/NNRTI-containing regimen with intermediate or high-level acquired drug resistance. The detection of one or more of these DRMs in an ART-naïve individual or in a individual with VF on a first-line NRTI/NNRTI-containing regimen may be considered an indication for a protease inhibitor (PI)-containing regimen or closer virological monitoring based on cost-effectiveness or country policy. PMID:26717411

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

    PubMed Central

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

    2015-01-01

    The increasing prevalence of acquired and transmitted HIV-1 drug resistance is an obstacle to successful antiretroviral therapy (ART) in the low- and middle-income countries (LMICs) hardest hit by the HIV-1 pandemic. Genotypic drug resistance testing could facilitate the choice of initial ART in areas with rising transmitted drug resistance (TDR) and enable care-providers to determine which individuals with virological failure (VF) on a first- or second-line ART regimen require a change in treatment. An inexpensive near point-of-care (POC) genotypic resistance test would be useful in settings where the resources, capacity, and infrastructure to perform standard genotypic drug resistance testing are limited. Such a test would be particularly useful in conjunction with the POC HIV-1 viral load tests that are currently being introduced in LMICs. A POC genotypic resistance test is likely to involve the use of allele-specific point mutation assays for detecting drug-resistance mutations (DRMs). This study proposes that two major nucleoside reverse transcriptase inhibitor (NRTI)-associated DRMs (M184V and K65R) and four major NNRTI-associated DRMs (K103N, Y181C, G190A, and V106M) would be the most useful for POC genotypic resistance testing in LMIC settings. One or more of these six DRMs was present in 61.2% of analyzed virus sequences from ART-naïve individuals with intermediate or high-level TDR and 98.8% of analyzed virus sequences from individuals on a first-line NRTI/NNRTI-containing regimen with intermediate or high-level acquired drug resistance. The detection of one or more of these DRMs in an ART-naïve individual or in a individual with VF on a first-line NRTI/NNRTI-containing regimen may be considered an indication for a protease inhibitor (PI)-containing regimen or closer virological monitoring based on cost-effectiveness or country policy. PMID:26717411

  9. The efficacy of computer reminders on external quality assessment for point-of-care testing in Danish general practice: rationale and methodology for two randomized trials

    PubMed Central

    2011-01-01

    Background Point-of-care testing (POCT) is increasingly being used in general practice to assist general practitioners (GPs) in their management of patients with diseases. However, low adherence to quality guidelines in terms of split test procedures has been observed among GPs in parts of the Capital Region in Denmark. Computer reminders embedded in GPs electronic medical records (ComRem) may facilitate improved quality control behaviour, but more research is needed to identify what types of reminders work and when. The overall aim of this study is to evaluate the efficacy of ComRem to improve GPs adherence to quality guidelines. This article describes the rationale and methods of the study that constitute this research project. Methods/design The study is conducted as two randomised controlled trials (RCTs) among general practices in two districts of the Capital Region in Denmark. These districts contain a total of 739 GPs in 567 practices with a total of 1.1 million patients allocated to practice lists. In the first RCT (RCT A), ComRem is compared to postal reminder letters. In the second RCT (RCT B), ComRem is compared to usual activities (no reminders) with a crossover approach. In both of these studies, outcomes are measured by the number of split tests received by the laboratory. Conclusions This study will contribute to knowledge on the efficacy of ComRem in primary care. Because the study does not explore GPs' perceptions and experiences with regard to ComRem, we will subsequently conduct a qualitative survey focusing on these aspects. Trial registrations Study A: ClinicalTrials.gov identifier: NCT01152151 Study B: ClinicalTrials.gov identifier: NCT01152177 PMID:21781338

  10. Field evaluation of a prototype paper-based point-of-care fingerstick transaminase test.

    PubMed

    Pollock, Nira R; McGray, Sarah; Colby, Donn J; Noubary, Farzad; Nguyen, Huyen; Nguyen, The Anh; Khormaee, Sariah; Jain, Sidhartha; Hawkins, Kenneth; Kumar, Shailendra; Rolland, Jason P; Beattie, Patrick D; Chau, Nguyen V; Quang, Vo M; Barfield, Cori; Tietje, Kathy; Steele, Matt; Weigl, Bernhard H

    2013-01-01

    Monitoring for drug-induced liver injury (DILI) via serial transaminase measurements in patients on potentially hepatotoxic medications (e.g., for HIV and tuberculosis) is routine in resource-rich nations, but often unavailable in resource-limited settings. Towards enabling universal access to affordable point-of-care (POC) screening for DILI, we have performed the first field evaluation of a paper-based, microfluidic fingerstick test for rapid, semi-quantitative, visual measurement of blood alanine aminotransferase (ALT). Our objectives were to assess operational feasibility, inter-operator variability, lot variability, device failure rate, and accuracy, to inform device modification for further field testing. The paper-based ALT test was performed at POC on fingerstick samples from 600 outpatients receiving HIV treatment in Vietnam. Results, read independently by two clinic nurses, were compared with gold-standard automated (Roche Cobas) results from venipuncture samples obtained in parallel. Two device lots were used sequentially. We demonstrated high inter-operator agreement, with 96.3% (95% C.I., 94.3-97.7%) agreement in placing visual results into clinically-defined "bins" (<3x, 3-5x, and >5x upper limit of normal), >90% agreement in validity determination, and intraclass correlation coefficient of 0.89 (95% C.I., 0.87-0.91). Lot variability was observed in % invalids due to hemolysis (21.1% for Lot 1, 1.6% for Lot 2) and correlated with lots of incorporated plasma separation membranes. Invalid rates <1% were observed for all other device controls. Overall bin placement accuracy for the two readers was 84% (84.3%/83.6%). Our findings of extremely high inter-operator agreement for visual reading-obtained in a target clinical environment, as performed by local practitioners-indicate that the device operation and reading process is feasible and reproducible. Bin placement accuracy and lot-to-lot variability data identified specific targets for device

  11. Field Evaluation of a Prototype Paper-Based Point-of-Care Fingerstick Transaminase Test

    PubMed Central

    Pollock, Nira R.; McGray, Sarah; Colby, Donn J.; Noubary, Farzad; Nguyen, Huyen; Nguyen, The Anh; Khormaee, Sariah; Jain, Sidhartha; Hawkins, Kenneth; Kumar, Shailendra; Rolland, Jason P.; Beattie, Patrick D.; Chau, Nguyen V.; Quang, Vo M.; Barfield, Cori; Tietje, Kathy; Steele, Matt; Weigl, Bernhard H.

    2013-01-01

    Monitoring for drug-induced liver injury (DILI) via serial transaminase measurements in patients on potentially hepatotoxic medications (e.g., for HIV and tuberculosis) is routine in resource-rich nations, but often unavailable in resource-limited settings. Towards enabling universal access to affordable point-of-care (POC) screening for DILI, we have performed the first field evaluation of a paper-based, microfluidic fingerstick test for rapid, semi-quantitative, visual measurement of blood alanine aminotransferase (ALT). Our objectives were to assess operational feasibility, inter-operator variability, lot variability, device failure rate, and accuracy, to inform device modification for further field testing. The paper-based ALT test was performed at POC on fingerstick samples from 600 outpatients receiving HIV treatment in Vietnam. Results, read independently by two clinic nurses, were compared with gold-standard automated (Roche Cobas) results from venipuncture samples obtained in parallel. Two device lots were used sequentially. We demonstrated high inter-operator agreement, with 96.3% (95% C.I., 94.3–97.7%) agreement in placing visual results into clinically-defined “bins” (<3x, 3–5x, and >5x upper limit of normal), >90% agreement in validity determination, and intraclass correlation coefficient of 0.89 (95% C.I., 0.87–0.91). Lot variability was observed in % invalids due to hemolysis (21.1% for Lot 1, 1.6% for Lot 2) and correlated with lots of incorporated plasma separation membranes. Invalid rates <1% were observed for all other device controls. Overall bin placement accuracy for the two readers was 84% (84.3%/83.6%). Our findings of extremely high inter-operator agreement for visual reading–obtained in a target clinical environment, as performed by local practitioners–indicate that the device operation and reading process is feasible and reproducible. Bin placement accuracy and lot-to-lot variability data identified specific targets for

  12. Prospects for the commercialization of chemiluminescence-based point-of-care and on-site testing devices.

    PubMed

    Park, Jason Y; Kricka, Larry J

    2014-09-01

    Chemiluminescent reactions have found application in a number of commercial point-of-care and on-site testing devices. Notable examples include allergy tests (e.g., MASTpette, OPTIGEN® systems), flu tests (e.g., ZstatFlu®-II), cartridge-based immunoassay systems (FastPack® IP System, PATHFAST®), forensic tests for bloodstains, portable analyzers for biochip array assays (Evidence MultiStat), water quality tests (Eclox), air pollutants (e.g., oxides of nitrogen), and handheld devices for detecting explosives (e.g., E3500 Chemilux®). Many other point-of-care or on-site testing devices with a chemiluminescent end point have been devised on the basis of a variety of formats (e.g., cuvette, cassette, dipstick, test strip, microchip), but most have not progressed beyond a proof-of-principle or prototype stage. PMID:24658468

  13. Point-of-Care Blood Glucose Testing for Diabetes Care in Hospitalized Patients

    PubMed Central

    Rajendran, Rajesh

    2014-01-01

    Glycemic control in hospitalized patients with diabetes requires accurate near-patient glucose monitoring systems. In the past decade, point-of-care blood glucose monitoring devices have become the mainstay of near-patient glucose monitoring in hospitals across the world. In this article, we focus on its history, accuracy, clinical use, and cost-effectiveness. Point-of-care devices have evolved from 1.2 kg instruments with no informatics to handheld lightweight portable devices with advanced connectivity features. Their accuracy however remains a subject of debate, and new standards for their approval have now been issued by both the International Organization for Standardization and the Clinical and Laboratory Standards Institute. While their cost-effectiveness remains to be proved, their clinical value for managing inpatients with diabetes remains unchallenged. This evidence-based review provides an overall view of its use in the hospital setting. PMID:25355711

  14. [Internal Quality Control and External Quality Assessment on POCT].

    PubMed

    Kuwa, Katsuhiko

    2015-02-01

    The quality management (QM) of POCT summarizes its internal quality control (IQC) and external quality assessment (EQA). For QM requirements in POCT, ISO 22870-Point-of-care testing (POCT) -Requirements for quality and competence and ISO 15189-Medical laboratories-Requirements for quality and competence, it is performed under the guidance of the QM committee. The role of the POC coordinator and/or medical technologist of the clinical laboratory is important. On measurement performance of POCT devices, it is necessary to confirm data on measurement performance from the manufacturer other than those in the inserted document. In the IQC program, the checking and control of measurement performance are the targets. On measurements of QC samples by the manufacturer, it is essential to check the function of devices. In addition, regarding the EQA program, in 2 neighboring facilities, there is an effect to confirm the current status of measurement and commutability assessment in these laboratories using whole blood along with residual blood samples from daily examinations in the clinical laboratory. PMID:26529974

  15. Operations research study to implement HIV and syphilis point-of-care tests and assess client perceptions in a marginalised area of Lima, Peru.

    PubMed

    Flores, Elaine C; Lluque, Maria E; Chiappe, Marina; Lino, Rosabel; Bayer, Angela M

    2015-09-01

    In Peru, a significant proportion of people tested for HIV and syphilis do not receive timely results. Our objective was to assess the institutional feasibility of implementing simultaneous HIV/syphilis point-of-care tests and client perceptions regarding these point-of-care tests. Point-of-care tests were implemented in a hospital consultation room in a marginalised zone of Lima. A time-series design was used to compare the proportion of tested clients who received timely results, with and without the point-of-care test intervention. Experience and satisfaction with point-of-care tests was evaluated with 149 people. In the 6 months without intervention, 69% and 61% of clients tested for HIV and syphilis, respectively, received their results within the required 45-minute window. During the 2-month point-of-care test intervention, all clients tested for HIV (n = 387) and syphilis (n = 398) received their results within 45 minutes. All clients surveyed were completely satisfied (52%) or satisfied (48%) with the simultaneous HIV/syphilis point-of-care test screening process. Additionally, 73% strongly agreed with the statement 'I feel satisfied with the rapid testing process.' Screening using point-of-care tests represents an important opportunity to reduce the time, resource and cost burden for users and institutions and increase the proportion of users receiving their test results in a timely manner. PMID:25258394

  16. Plan for Quality to Improve Patient Safety at the Point of Care

    PubMed Central

    Ehrmeyer, Sharon S.

    2011-01-01

    The U.S. Institute of Medicine (IOM) much publicized report in “To Err is Human” (2000, National Academy Press) stated that as many as 98 000 hospitalized patients in the U.S. die each year due to preventable medical errors. This revelation about medical error and patient safety focused the public and the medical community's attention on errors in healthcare delivery including laboratory and point-of-care-testing (POCT). Errors introduced anywhere in the POCT process clearly can impact quality and place patient's safety at risk. While POCT performed by or near the patient reduces the potential of some errors, the process presents many challenges to quality with its multiple tests sites, test menus, testing devices and non-laboratory analysts, who often have little understanding of quality testing. Incoherent or no regulations and the rapid availability of test results for immediate clinical intervention can further amplify errors. System planning and management of the entire POCT process are essential to reduce errors and improve quality and patient safety. PMID:21808107

  17. Estimating Implementation and Operational Costs of an Integrated Tiered CD4 Service including Laboratory and Point of Care Testing in a Remote Health District in South Africa

    PubMed Central

    Cassim, Naseem; Coetzee, Lindi M.; Schnippel, Kathryn; Glencross, Deborah K.

    2014-01-01

    Background An integrated tiered service delivery model (ITSDM) has been proposed to provide ‘full-coverage’ of CD4 services throughout South Africa. Five tiers are described, defined by testing volumes and number of referring health-facilities. These include: (1) Tier-1/decentralized point-of-care service (POC) in a single site; Tier-2/POC-hub servicing processing <30–40 samples from 8–10 health-clinics; Tier-3/Community laboratories servicing ∼50 health-clinics, processing <150 samples/day; high-volume centralized laboratories (Tier-4 and Tier-5) processing <300 or >600 samples/day and serving >100 or >200 health-clinics, respectively. The objective of this study was to establish costs of existing and ITSDM-tiers 1, 2 and 3 in a remote, under-serviced district in South Africa. Methods Historical health-facility workload volumes from the Pixley-ka-Seme district, and the total volumes of CD4 tests performed by the adjacent district referral CD4 laboratories, linked to locations of all referring clinics and related laboratory-to-result turn-around time (LTR-TAT) data, were extracted from the NHLS Corporate-Data-Warehouse for the period April-2012 to March-2013. Tiers were costed separately (as a cost-per-result) including equipment, staffing, reagents and test consumable costs. A one-way sensitivity analyses provided for changes in reagent price, test volumes and personnel time. Results The lowest cost-per-result was noted for the existing laboratory-based Tiers- 4 and 5 ($6.24 and $5.37 respectively), but with related increased LTR-TAT of >24–48 hours. Full service coverage with TAT <6-hours could be achieved with placement of twenty-seven Tier-1/POC or eight Tier-2/POC-hubs, at a cost-per-result of $32.32 and $15.88 respectively. A single district Tier-3 laboratory also ensured ‘full service coverage’ and <24 hour LTR-TAT for the district at $7.42 per-test. Conclusion Implementing a single Tier-3/community laboratory to extend and improve delivery

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

    PubMed

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

    2016-01-01

    With a call to increase the accessibility of HIV testing, point-of-care testing for HIV is being readily adopted, but little attention has been paid to the experiences of people being tested at HIV point-of-care sites. Some testing environments, such as bathhouses, promote testing for HIV in higher-risk groups. In this narrative inquiry study we explored the experiences of people testing positive for HIV through point-of-care while at a bathhouse. Three narrative threads for reconsidering the practice were identified: (a) seeing complexities, understanding testing decisions in relation to time, place, and social context; (b) recognizing the impact and significance of secret and silent stories; and (c) tentative and tension-filled connections to care. It is important to understand testing experiences across time, place, and in diverse social contexts. These experiences are embedded within the larger life histories of people and raise questions about adequate support, follow-up, and counseling. PMID:26900014

  19. Diagnostic Accuracy of Point-of-Care Tests for Hepatitis C Virus Infection: A Systematic Review and Meta-Analysis

    PubMed Central

    Khuroo, Mehnaaz Sultan; Khuroo, Naira Sultan; Khuroo, Mohammad Sultan

    2015-01-01

    Background 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. Methods 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. Findings 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. Conclusions Performances varied widely among individual point-of-care tests

  20. Use of CLIA-waived point-of-care tests for infectious diseases in community pharmacies in the United States.

    PubMed

    Weber, Natalie C; Klepser, Michael E; Akers, Julie M; Klepser, Donald G; Adams, Alex J

    2016-01-01

    Review of point-of-care (POC) testing in community pharmacies, availability and specifications of CLIA-waived infectious disease POC tests, and provide recommendations for future community pharmacy POC models in an effort to improve patient outcomes while reducing antibiotic resistance. PubMed and Medscape were searched for the following keywords: infectious disease, community pharmacy, rapid diagnostic tests, rapid assay, and POC tests. All studies utilizing POC tests in community pharmacies for infectious disease were included. Studies, articles, recommendations, and posters were reviewed and information categorized into general implementation of POC testing in community pharmacies, CLIA-waived tests available, Influenza, Group A Streptococcus pharyngitis, Helicobacter pylori, HIV and Hepatitis C. POC testing provides a unique opportunity for community pharmacists to implement collaborative disease management programmes for infectious diseases and reduce over-prescribing of antibiotics and improve patient outcomes through early detection, treatment and/or referral to a specialist. PMID:26560318

  1. The impact of new trends in POCTs for companion diagnostics, non-invasive testing and molecular diagnostics.

    PubMed

    Huckle, David

    2015-06-01

    Point-of-care diagnostics have been slowly developing over several decades and have taken on a new importance in current healthcare delivery for both diagnostics and development of new drugs. Molecular diagnostics have become a key driver of technology change and opened up new areas in companion diagnostics for use alongside pharmaceuticals and in new clinical approaches such as non-invasive testing. Future areas involving smartphone and other information technology advances, together with new developments in molecular biology, microfluidics and surface chemistry are adding to advances in the market. The focus for point-of-care tests with molecular diagnostic technologies is focused on advancing effective applications. PMID:25990929

  2. A paper-based multiplexed transaminase test for low-cost, point-of-care liver function testing

    PubMed Central

    Pollock, Nira R.; Rolland, Jason P.; Kumar, Shailendra; Beattie, Patrick D.; Jain, Sidhartha; Noubary, Farzad; Wong, Vicki L.; Pohlmann, Rebecca A.; Ryan, Una S.; Whitesides, George M.

    2013-01-01

    In developed nations, monitoring for drug-induced liver injury via serial measurements of serum transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) in at-risk individuals is the standard of care. Despite the need, monitoring for drug-related hepatotoxicity in resource-limited settings is often limited by expense and logistics, even for patients at highest risk. This manuscript describes the development and clinical testing of a paper-based, multiplexed microfluidic assay designed for rapid, semi-quantitative measurement of AST and ALT in a fingerstick specimen. Using 223 clinical specimens obtained by venipuncture and 10 fingerstick specimens from healthy volunteers, we have shown that our assay can, in 15 minutes, provide visual measurements of AST and ALT in whole blood or serum which allow the user to place those values into one of three readout “bins” (<3x upper limit of normal (ULN), 3-5x ULN, and >5x ULN, corresponding to tuberculosis/HIV treatment guidelines) with >90% accuracy. These data suggest that the ultimate point-of-care fingerstick device will have high impact on patient care in low-resource settings. PMID:22993296

  3. Field Trial Evaluation of the Performances of Point-of-Care Tests for Screening G6PD Deficiency in Cambodia

    PubMed Central

    Roca-Feltrer, Arantxa; Khim, Nimol; Kim, Saorin; Chy, Sophy; Canier, Lydie; Kerleguer, Alexandra; Tor, Pety; Chuor, Char Meng; Kheng, Sim; Siv, Sovannaroth; Kachur, Patrick S.; Taylor, Walter R. J.; Hwang, Jimee; Menard, Didier

    2014-01-01

    Background User-friendly, accurate, point-of-care rapid tests to detect glucose-6-phosphate dehydrogenase deficiency (G6PDd) are urgently needed at peripheral level to safely recommend primaquine for malaria elimination. Methods The CareStart G6PD RDT (AccessBio, New Jersey, USA), a novel rapid diagnostic test and the most commonly used test, the fluorescent spot test (FST) were assessed against the quantitatively measured G6PD enzyme activity for detecting G6PDd. Subjects were healthy males and non-pregnant females aged 18 years or older residing in six villages in Pailin Province, western Cambodia. Findings Of the 938 subjects recruited, 74 (7.9%) were severe and moderately severe G6PD deficient (enzyme activity <30%), mostly in male population; population median G6PD activity was 12.0 UI/g Hb. The performances of the CareStart G6PD RDT and the FST, according to different cut-off values used to define G6PDd were very similar. For the detection of severe and moderately severe G6PDd (enzyme activity <30%, <3.6 UI/g Hb) in males and females, sensitivity and negative (normal status) predictive value were 100% for both point-of-care tools. When the G6PDd cut-off value increased (from <40% to <60%), the sensitivity for both PoCs decreased: 93.3% to 71.7% (CareStart G6PD RDT, p = 10−6) and 95.5% to 73.2% (FST, p = 10−6) while the specificity for both PoCs remained similar: 97.4% to 98.3% (CareStart G6PD RDT, p = 0.23) and 98.7% to 99.6% (FST, p = 0.06). The cut-off values for classifying individuals as normal were 4.0 UI/g Hb and 4.3 UI/g Hb for the CareStart G6PD RDT and the FST, respectively. Conclusions The CareStart G6PD RDT reliably detected moderate and severe G6PD deficient individuals (enzyme activity <30%), suggesting that this novel point-of-care is a promising tool for tailoring appropriate primaquine treatment for malaria elimination by excluding individuals with severe G6PDd for primaquine treatment. PMID:25541721

  4. The emergence of point-of-care blood-based biomarker testing for psychiatric disorders: enabling personalized medicine.

    PubMed

    Guest, Francesca L; Guest, Paul C; Martins-de-Souza, Daniel

    2016-04-01

    For psychiatric disorders, repeated failures in converting scientific discoveries into novel drugs has precipitated a crisis and eroded confidence in drug discovery. This review describes how current and future innovations driven by application of biomarkers can help to re-initiate research in this area. This will have positive impact on the field of psychiatry and result in application of sensitive and specific biochemical tests in parallel with the traditional questionnaires for improved diagnosis. Furthermore, application of emerging biosensor tools will facilitate point-of-care testing by fusion of biochemical and clinical data. In this way, patient data will be comprised of past medical histories, biopatterns and prognosis information, resulting in personalized profiles or molecular fingerprints for patients with these conditions. PMID:26999493

  5. Human Immunodeficiency Virus (HIV)-Infected Patients Accept Finger Stick Blood Collection for Point-Of-Care CD4 Testing

    PubMed Central

    Scott, Lesley; Potgieter, Joachim; Kestens, Luc; Stevens, Wendy

    2016-01-01

    Introduction HIV-infected patients require antiretroviral treatment for life. To improve access to care, CD4 enumeration and viral load tests have been redesigned to be used as point-of-care techniques using finger-stick blood. Accurate CD4 counting in capillary blood requires a free flowing blood drop that is achieved by blade incision. The aim of this study was to assess the attitude of the patients toward blade-based finger-stick blood donation. Methods Four hundred and ninety-nine patients were included (299 patients from South Africa and 200 from Belgium). They completed a questionnaire to express their preference for finger stick or venipuncture, after undergoing both. The South African patient cohort was divided in two groups, receiving either single or multiple finger stick for CD4 and other HIV-related tests. The Belgian patients received a single finger stick for CD4 testing, and were asked to respond directly and again after two days. Results The majority of the patients preferred the finger stick to the venipuncture. The perceived pain using the blade was superior to a small needle, but similar to a large needle. They preferred up to three finger sticks over one venipuncture. Up to 30% of the patients changed their mind over two days. The main reason for choosing a finger stick was continued bleeding after venipuncture. The most cited objection to finger stick was pain/soreness. Conclusion Patient perceptions support the implementation of donating capillary blood with blade-based finger stick during CD4 point-of-care testing. PMID:27556894

  6. A sensitive chemiluminescent immunoassay for point-of-care testing of repaglinide in natural dietary supplements and serum.

    PubMed

    Zheng, Lei; Wang, Jing; Wang, Yufen; Song, Zhaorui; Dong, Yaqing; Yin, Yongmei; Eremin, Sergei A; Meng, Meng; Xi, Rimo

    2015-03-01

    For point-of-care testing of the illegal fortification of repaglinide (Rep) in natural dietary supplements, a competitive chemiluminescent immunoassay (CLIA) was established, using a horseradish peroxidase (HRP)-luminol-H2O2 system for signal amplification. Polyclonal antibodies for Rep were produced via immunization technique. Following optimization of the enzyme reaction time and concentrations of antibody and coating antigen, the method showed a limit of quantification (LOQ) of 1.0 ng/mL in PBS and limit of detection (LOD) of 8.3 ng/mL in serum and 6.0 ng/mL in blank tablets. When applied in natural dietary supplements, the method provided results consistent with those from HPLC, suggesting that the proposed method could be used for rapid screening of Rep in natural dietary supplements and detecting Rep in serum after administration. PMID:25656849

  7. Perspectives on Introduction and Implementation of New Point-of-Care Diagnostic Tests

    PubMed Central

    Palamountain, Kara M.; Baker, Jeff; Cowan, Elliot P.; Essajee, Shaffiq; Mazzola, Laura T.; Metzler, Mutsumi; Schito, Marco; Stevens, Wendy S.; Young, Gloria J.

    2012-01-01

    In recent years, there has been significant investment from both the private and public sectors in the development of diagnostic technologies to meet the need for human immunodeficiency virus (HIV) and tuberculosis testing in low-resource settings. Future investments should ensure that the most appropriate technologies are adopted in settings where they will have a sustainable impact. Achieving these aims requires the involvement of many stakeholders, as their needs, operational constraints, and priorities are often distinct. Here, we discuss these considerations from different perspectives representing those of various stakeholders involved in the development, introduction, and implementation of diagnostic tests. We also discuss some opportunities to address these considerations. PMID:22402038

  8. Use of Rapid, Point-of-Care Assays by Private Practitioners in Chennai, India: Priorities for Tuberculosis Diagnostic Testing

    PubMed Central

    Ananthakrishnan, Ramya; Sukumar, Sumanya; Augustine, Sheela; Krishnan, Nalini; Pai, Madhukar; Dowdy, David W.

    2016-01-01

    Setting Private practitioners are frequently the first point of healthcare contact for patients with tuberculosis (TB) in India. As new molecular tests are developed for point-of-care (POC) diagnosis of TB, it is imperative to understand these individuals’ practices and preferences for POC testing. Objective To evaluate rapid testing practices and identify priorities for novel POC TB tests among private practitioners in Chennai. Design We conducted a cross-sectional survey of 228 practitioners practicing in the private sector from January 2014 to February 2015 who saw at least one TB patient in the previous year. Practitioners were randomly selected from both the general community and a list of practitioners who referred patients to a public-private mix program for TB treatment. We used standardized questionnaires to collect data on current practices related to point-of-care diagnosis and interest in hypothetical POC tests. We used multivariable Poisson regression with robust estimates of standard error to calculate measures of association. Results Among 228 private practitioners, about half (48%) utilized any rapid testing in their current practice, most commonly for glucose (43%), pregnancy (21%), and malaria (5%). Providers using POC tests were more likely to work in hospitals (56% vs. 43%, P = 0.05) and less likely to be chest specialists (21% vs. 54%, P<0.001). Only half (51%) of providers would use a hypothetical POC test for TB that was accurate, equipment-free, and took 20 minutes to complete. Chest specialists were half as likely to express interest in performing the hypothetical POC TB test in-house as other practitioners (aPR 0.5, 95%CI: 0.2–0.9). Key challenges to performing POC testing for TB in this study included time constraints, easy access to local private labs and lack of an attached lab facility. Conclusion As novel POC tests for TB are developed and scaled up, attention must be paid to integrating these diagnostics into healthcare

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

    PubMed

    Jewett, A; Al-Tayyib, A A; Ginnett, L; Smith, B D

    2013-01-01

    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. PMID:24455220

  10. Evaluation of a Point-of-Care Test, BVBlue, and Clinical and Laboratory Criteria for Diagnosis of Bacterial Vaginosis

    PubMed Central

    Bradshaw, C. S.; Morton, A. N.; Garland, S. M.; Horvath, L. B.; Kuzevska, I.; Fairley, C. K.

    2005-01-01

    Bacterial vaginosis (BV) remains the most common cause of abnormal vaginal discharge in women of reproductive age and is associated with increased susceptibility to human immunodeficiency virus and sexually transmitted infections and preterm delivery. Present diagnostic methods require access to microscopy and laboratory expertise; however, the majority of women, particularly those in populations with a high prevalence of BV, do not have access to clinical services with on-site microscopy capabilities. We evaluated a point-of-care test for the diagnosis of BV, the BVBlue test, with 288 women attending a sexual health service with symptoms of abnormal vaginal discharge and/or odor. The BVBlue test performed well compared with conventional diagnostic methods for the assessment of women with symptoms suggestive of BV at the bedside and significantly better than other simple tests, such as vaginal pH determination and the amine test, that do not require microscopy. The BVBlue test was sensitive (88%; 95% confidence interval [CI], 81 to 93%) and specific (95%; 95% CI, 91 to 98%) compared to the method of Nugent et al. (R. P. Nugent, M. A. Krohn, and S. L. Hillier, J. Clin. Microbiol. 29:297-301, 1991) and performed well compared with the method of Amsel et al. (R. Amsel, P. A. Totten, C. A. Spiegel, K. C. Chen, D. Eschenbach, and K. K. Holmes, Am. J. Med. 74:14-22, 1983), with a sensitivity of 88% (95% CI, 81 to 93%) and a specificity of 91% (95% CI, 85 to 94%). The BVBlue test is a simple, rapid, and objective test for the diagnosis of BV and has the potential to facilitate prompt diagnosis and appropriate treatment of BV in the absence of microscopy. The majority of women at the greatest risk for the sequelae of BV are not in settings where the conventional diagnostic methods are either practical or possible, and they would greatly benefit from access to rapid and reliable point-of-care tests to improve the diagnosis and management of BV. PMID:15750100

  11. Reducing medical errors through barcoding at the point of care.

    PubMed

    Nichols, James H; Bartholomew, Cathy; Brunton, Mary; Cintron, Carlos; Elliott, Sheila; McGirr, Joan; Morsi, Deborah; Scott, Sue; Seipel, Joseph; Sinha, Daisy

    2004-01-01

    Medical errors are a major concern in health care today. Errors in point-of-care testing (POCT) are particularly problematic because the test is conducted by clinical operators at the site of patient care and immediate medical action is taken on the results prior to review by the laboratory. The Performance Improvement Program at Baystate Health System, Springfield, Massachusetts, noted a number of identification errors occurring with glucose and blood gas POCT devices. Incorrect patient account numbers that were attached to POCT results prevented the results from being transmitted to the patient's medical record and appropriately billed. In the worst case, they could lead to results being transferred to the wrong patient's chart and inappropriate medical treatment. Our first action was to lock-out operators who repeatedly made identification errors (3-Strike Rule), requiring operators to be counseled and retrained after their third error. The 3-Strike Rule significantly decreased our glucose meter errors (p = 0.014) but did not have an impact on the rate of our blood gas errors (p = 0.378). Neither device approached our ultimate goal of zero tolerance. A Failure Mode and Effects Analysis (FMEA) was conducted to determine the various processes that could lead to an identification error. A primary source of system failure was the manual entry of 14 digits for each test, five numbers for operator and nine numbers for patient account identification. Patient barcoding was implemented to automate the data entry process, and after an initial familiarization period, resulted in significant improvements in error rates for both the glucose (p = 0.0007) and blood gas devices (p = 0.048). Despite the improvements, error rates with barcoding still did not achieve zero errors. Operators continued to utilize manual data entry when the barcode scan was unsuccessful or unavailable, and some patients were found to have incorrect patient account numbers due to hospital transfer

  12. Point of care HIV testing with oral fluid among returnee migrants in a rural area of Bangladesh

    PubMed Central

    Alam, Md Shah; Khan, Sharful I.; Reza, Masud; Shahriar, Ahmed; Sarker, Md Safiullah; Rahman, Anisur; Rahman, Mustafizur; Azim, Tasnim

    2016-01-01

    Objectives To determine HIV prevalence and assess the acceptability of HIV testing using oral fluid as a point of care (PoC) test method among returnee migrants in a rural area of Bangladesh. Design A cross-sectional study. Methods Matlab is a rural area southeast of Dhaka where icddr,b hosts a health and demographic surveillance system covering 225 826 people of whom 934 are returnee migrants. The sample size of 304 was proportionately distributed among randomly selected households. HIV antibodies in oral fluid were tested using OraQuick Rapid HIV 1/2 antibody test. To understand reasons of acceptability a short questionnaire was applied and 32 in-depth interviews were conducted. Results Of 304 returnee migrants approached, 97.4% accepted the test. The prevalence of HIV was 0.3% without a confirmatory blood test. Reasons for acceptance included easy accessibility of the test at the door-step which saved resources (i.e., time and money), comfortable test-procedure without any pain and fear, and receiving quick results with confidentiality. Some described knowing HIV status as a way to ‘get certified’ (of sexual fidelity) and to confront a prevailing silent stigma against migrants. Acceptability was moreover found to be grounded in icddr,b's institutional reputation and its close relationship with the local community. Conclusions The PoC oral fluid test for HIV has shown for the first time that assessment of HIV prevalence in rural-based returnee migrants is possible. Findings also suggest that PoC oral fluid test has the potential of increasing accessibility to HIV testing as it was found to be highly acceptable. PMID:26945144

  13. Performance of a New Rapid Immunoassay Test Kit for Point-of-Care Diagnosis of Significant Bacteriuria.

    PubMed

    Stapleton, Ann E; Cox, Marsha E; DiNello, Robert K; Geisberg, Mark; Abbott, April; Roberts, Pacita L; Hooton, Thomas M

    2015-09-01

    Urinary tract infections (UTIs) are frequently encountered in clinical practice and most commonly caused by Escherichia coli and other Gram-negative uropathogens. We tested RapidBac, a rapid immunoassay for bacteriuria developed by Silver Lake Research Corporation (SLRC), compared with standard bacterial culture using 966 clean-catch urine specimens submitted to a clinical microbiology laboratory in an urban academic medical center. RapidBac was performed in accordance with instructions, providing a positive or negative result in 20 min. RapidBac identified as positive 245/285 (sensitivity 86%) samples with significant bacteriuria, defined as the presence of a Gram-negative uropathogen or Staphylococcus saprophyticus at ≥10(3) CFU/ml. The sensitivities for Gram-negative bacteriuria at ≥10(4) CFU/ml and ≥10(5) CFU/ml were 96% and 99%, respectively. The specificity of the test, detecting the absence of significant bacteriuria, was 94%. The sensitivity and specificity of RapidBac were similar on samples from inpatient and outpatient settings, from male and female patients, and across age groups from 18 to 89 years old, although specificity was higher in men (100%) compared with that in women (92%). The RapidBac test for bacteriuria may be effective as an aid in the point-of-care diagnosis of UTIs especially in emergency and primary care settings. PMID:26063858

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

    PubMed

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

    2016-01-01

    In this study, we developed a new type of paper-based analytical device (PAD), the three-dimensional (3D) slip-PAD, to detect infectious human norovirus for global healthcare. The 3D configuration of the papers combined with a slip design provides unique features and versatility that overcome the limitations of fluidic manipulation and sensitivity in point-of-care (POC) tests. The assay can be carried out in a single step based on a moveable slip design, making it suitable for unskilled users. The 3D fluidic network developed by layered construction of wax-patterned papers provides different fluidic paths for the sequential delivery of multiple fluids without the need for peripheral equipment. The release and mixing of enhancement reagents on the device improved the sensitivity and detection limit. The assay results could be visualized by naked eye within 10 min, with subsequent amplification of the signal over time (<60 min). The device showed a broad dynamic range of detection and high sensitivity, with a detection limit of 9.5 × 10(4) copies ml(-1) for human norovirus. These results demonstrate that the 3D slip-PAD is a sensitive diagnostic assay for detecting human norovirus infection that is particularly suitable for POC testing in regions where resources are scarce. PMID:27174731

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

    NASA Astrophysics Data System (ADS)

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

    2016-05-01

    In this study, we developed a new type of paper-based analytical device (PAD), the three-dimensional (3D) slip-PAD, to detect infectious human norovirus for global healthcare. The 3D configuration of the papers combined with a slip design provides unique features and versatility that overcome the limitations of fluidic manipulation and sensitivity in point-of-care (POC) tests. The assay can be carried out in a single step based on a moveable slip design, making it suitable for unskilled users. The 3D fluidic network developed by layered construction of wax-patterned papers provides different fluidic paths for the sequential delivery of multiple fluids without the need for peripheral equipment. The release and mixing of enhancement reagents on the device improved the sensitivity and detection limit. The assay results could be visualized by naked eye within 10 min, with subsequent amplification of the signal over time (<60 min). The device showed a broad dynamic range of detection and high sensitivity, with a detection limit of 9.5 × 104 copies ml‑1 for human norovirus. These results demonstrate that the 3D slip-PAD is a sensitive diagnostic assay for detecting human norovirus infection that is particularly suitable for POC testing in regions where resources are scarce.

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

    PubMed Central

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

    2016-01-01

    In this study, we developed a new type of paper-based analytical device (PAD), the three-dimensional (3D) slip-PAD, to detect infectious human norovirus for global healthcare. The 3D configuration of the papers combined with a slip design provides unique features and versatility that overcome the limitations of fluidic manipulation and sensitivity in point-of-care (POC) tests. The assay can be carried out in a single step based on a moveable slip design, making it suitable for unskilled users. The 3D fluidic network developed by layered construction of wax-patterned papers provides different fluidic paths for the sequential delivery of multiple fluids without the need for peripheral equipment. The release and mixing of enhancement reagents on the device improved the sensitivity and detection limit. The assay results could be visualized by naked eye within 10 min, with subsequent amplification of the signal over time (<60 min). The device showed a broad dynamic range of detection and high sensitivity, with a detection limit of 9.5 × 104 copies ml−1 for human norovirus. These results demonstrate that the 3D slip-PAD is a sensitive diagnostic assay for detecting human norovirus infection that is particularly suitable for POC testing in regions where resources are scarce. PMID:27174731

  17. Operator Influence on Blinded Diagnostic Accuracy of Point-of-Care Antigen Testing for Group A Streptococcal Pharyngitis.

    PubMed

    Penney, Carla; Porter, Robert; O'Brien, Mary; Daley, Peter

    2016-01-01

    Background. Acute pharyngitis caused by Group A Streptococcus (GAS) is a common presentation to pediatric emergency departments (ED). Diagnosis with conventional throat culture requires 18-24 hours, which prevents point-of-care treatment decisions. Rapid antigen detection tests (RADT) are faster, but previous reports demonstrate significant operator influence on performance. Objective. To measure operator influence on the diagnostic accuracy of a RADT when performed by pediatric ED nurses and clinical microbiology laboratory technologists, using conventional culture as the reference standard. Methods. Children presenting to a pediatric ED with suspected acute pharyngitis were recruited. Three pharyngeal swabs were collected at once. One swab was used to perform the RADT in the ED, and two were sent to the clinical microbiology laboratory for RADT and conventional culture testing. Results. The RADT when performed by technologists compared to nurses had a 5.1% increased sensitivity (81.4% versus 76.3%) (p = 0.791) (95% CI for difference between technologists and nurses = -11% to +21%) but similar specificity (97.7% versus 96.6%). Conclusion. The performance of the RADT was similar between technologists and ED nurses, although adequate power was not achieved. RADT may be employed in the ED without clinically significant loss of sensitivity. PMID:27579047

  18. Operator Influence on Blinded Diagnostic Accuracy of Point-of-Care Antigen Testing for Group A Streptococcal Pharyngitis

    PubMed Central

    O'Brien, Mary

    2016-01-01

    Background. Acute pharyngitis caused by Group A Streptococcus (GAS) is a common presentation to pediatric emergency departments (ED). Diagnosis with conventional throat culture requires 18–24 hours, which prevents point-of-care treatment decisions. Rapid antigen detection tests (RADT) are faster, but previous reports demonstrate significant operator influence on performance. Objective. To measure operator influence on the diagnostic accuracy of a RADT when performed by pediatric ED nurses and clinical microbiology laboratory technologists, using conventional culture as the reference standard. Methods. Children presenting to a pediatric ED with suspected acute pharyngitis were recruited. Three pharyngeal swabs were collected at once. One swab was used to perform the RADT in the ED, and two were sent to the clinical microbiology laboratory for RADT and conventional culture testing. Results. The RADT when performed by technologists compared to nurses had a 5.1% increased sensitivity (81.4% versus 76.3%) (p = 0.791) (95% CI for difference between technologists and nurses = −11% to +21%) but similar specificity (97.7% versus 96.6%). Conclusion. The performance of the RADT was similar between technologists and ED nurses, although adequate power was not achieved. RADT may be employed in the ED without clinically significant loss of sensitivity. PMID:27579047

  19. Acceptability of Rapid Point-of-Care Hepatitis C Tests Among People Who Inject Drugs and Utilize Syringe-Exchange Programs

    PubMed Central

    Barocas, Joshua A.; Linas, Benjamin P.; Kim, Arthur Y.; Fangman, John; Westergaard, Ryan P.

    2016-01-01

    People who inject drugs may benefit from point-of-care hepatitis C virus (HCV) testing offered at syringe exchanges. We sought to understand whether this population would be willing to undergo rapid HCV testing. We found that there was broad support for rapid HCV testing, especially among younger people who inject drugs with high perceived risk. PMID:27191007

  20. Twelve-Month Prospective Randomized Study of Pharmacists Utilizing Point-Of-Care Testing for Metabolic Syndrome and Related Conditions in Subjects Prescribed Antipsychotics

    PubMed Central

    Shuster, Sara M.; Davey, Cynthia S.

    2014-01-01

    Objective: Determine the percentage of subjects taking antipsychotics who meet criteria for metabolic syndrome based on point-of-care testing analyses. Evaluate pharmacist comprehensive medication management services using point-of-care tests to reduce the mean difference in number of metabolic syndrome risk parameters at 6 and 12 months. Method: This 12-month, prospective, multisite, randomized, controlled study included 120 subjects taking antipsychotics (mean [SD] age of 42.9 [11.3] years) recruited from 3 community mental health clinics in Minnesota. Subjects consented to receive either pharmacist (PCS; n = 60) or no pharmacist (NCS; n = 60) comprehensive medication management services. Data were collected from February 2010 to January 2012. Results: No statistical differences in metabolic syndrome based on point-of-care tests were observed between the 2 groups at baseline (PCS: 85.2%, n = 46 versus NCS: 71.2%, n = 42, P = .073) or at 12 months (PCS: 84.4%, n = 38 versus NCS: 70.2%, n = 33, P = .104). Subjects, overall, screened positive at baseline for dyslipidemia (85.8%, n = 106), hypertension (52.5%, n = 63), and diabetes (22.5%, n = 27) based on point-of-care testing for metabolic risk criteria. After 12 months, a nonsignificant (P = .099) higher adjusted mean number of metabolic syndrome parameters in PCS subjects compared to NCS subjects (mean difference [95% CI] = 0.41 [−0.08 to 0.90]) were found. Conclusions: A relatively high proportion of subjects met criteria for metabolic syndrome, although no significant improvement was observed between the groups after 12 months. Point-of-care test analyses identified a high proportion of subjects meeting criteria for dyslipidemia, hypertension, and diabetes. Utilizing point-of-care tests in mental health settings and fostering interprofessional partnerships with comprehensive medication management pharmacists may improve identification and long-term management of metabolic risks among patients prescribed

  1. Opinion paper on utility of point-of-care biomarkers in the emergency department pathways decision making.

    PubMed

    Di Somma, Salvatore; Zampini, Giorgio; Vetrone, Francesco; Soto-Ruiz, Karina M; Magrini, Laura; Cardelli, Patrizia; Ronco, Claudio; Maisel, Alan; Peacock, Frank W

    2014-10-01

    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. PMID:24864300

  2. A new rapid method for Clostridium difficile DNA extraction and detection in stool: toward point-of-care diagnostic testing.

    PubMed

    Freifeld, Alison G; Simonsen, Kari A; Booth, Christine S; Zhao, Xing; Whitney, Scott E; Karre, Teresa; Iwen, Peter C; Viljoen, Hendrik J

    2012-01-01

    We describe a new method for the rapid diagnosis of Clostridium difficile infection, with stool sample preparation and DNA extraction by heat and physical disruption in a single-use lysis microreactor (LMR), followed by a rapid PCR amplification step. All steps can be accomplished in <20 minutes overall. Gel electrophoresis is currently used to detect the amplification product, pending real-time availability with an ultra-rapid thermocycler. Compared with the dual enzyme immunoassay (EIA) screening test (C. diff Quik Chek Complete; Techlab, Blacksburg, VA), the novel LMR/PCR assay showed complete concordance with all glutamate dehydrogenase (GDH) results (GDH(+)/toxin(+), n = 48; GDH(-)/toxin(-), n = 81). All 69 stool samples with discordant EIA results (GDH(+)/toxin(-)) were tested by both the LMR/PCR assay and the loop-mediated isothermal amplification test (LAMP) (Illumigene C. difficile; Meridian Bioscience, Cincinnati, OH). In 64/69 EIA-discordant samples, LAMP and LMR/PCR results matched (both positive in 29 sample and both negative in 35 samples); in the remaining 5 samples, results were discrepant between the LAMP assay (all five negative) and the LMR/PCR assay (all 5 positive). Overall, LMR/PCR testing matched the current algorithm of EIA and/or LAMP reflex testing in 193/198 (97.5%) samples. The present proof-of-concept study suggests that the novel LMR/PCR technique described here may be developed as an inexpensive, rapid, and reliable point-of-care diagnostic test for C. difficile infection and other infectious diseases. PMID:22402170

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

    NASA Astrophysics Data System (ADS)

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

    2016-03-01

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

  4. Polydimethylsiloxane-Paper Hybrid Lateral Flow Assay for Highly Sensitive Point-of-Care Nucleic Acid Testing.

    PubMed

    Choi, Jane Ru; Liu, Zhi; Hu, Jie; Tang, Ruihua; Gong, Yan; Feng, Shangsheng; Ren, Hui; Wen, Ting; Yang, Hui; Qu, Zhiguo; Pingguan-Murphy, Belinda; Xu, Feng

    2016-06-21

    In nucleic acid testing (NAT), gold nanoparticle (AuNP)-based lateral flow assays (LFAs) have received significant attention due to their cost-effectiveness, rapidity, and the ability to produce a simple colorimetric readout. However, the poor sensitivity of AuNP-based LFAs limits its widespread applications. Even though various efforts have been made to improve the assay sensitivity, most methods are inappropriate for integration into LFA for sample-to-answer NAT at the point-of-care (POC), usually due to the complicated fabrication processes or incompatible chemicals used. To address this, we propose a novel strategy of integrating a simple fluidic control strategy into LFA. The strategy involves incorporating a piece of paper-based shunt and a polydimethylsiloxane (PDMS) barrier to the strip to achieve optimum fluidic delays for LFA signal enhancement, resulting in 10-fold signal enhancement over unmodified LFA. The phenomena of fluidic delay were also evaluated by mathematical simulation, through which we found the movement of fluid throughout the shunt and the tortuosity effects in the presence of PDMS barrier, which significantly affect the detection sensitivity. To demonstrate the potential of integrating this strategy into a LFA with sample-in-answer-out capability, we further applied this strategy into our prototype sample-to-answer LFA to sensitively detect the Hepatitis B virus (HBV) in clinical blood samples. The proposed strategy offers great potential for highly sensitive detection of various targets for wide application in the near future. PMID:27012657

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

    PubMed

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

    2015-11-01

    Here we report a smartphone-based potentiometric biosensor for point-of-care testing of salivary α-amylase (sAA), which is one of the most sensitive indices of autonomic nervous system activity, and therefore a promising non-invasive biomarker for mental health. The biosensing system includes a smartphone having a sAA-detection App, a potentiometric reader and a sensing chip with preloaded reagents. The saliva sample wicks into the reaction zone on the sensing chip so that the sAA reacts with the preloaded reagents, resulting in conversion of an electron mediator Fe(CN)6(3-) to Fe(CN)6(4-). The sensing chip is then pressed by fingers to push the reaction mixture into the detection zone for the potentiometric measurement. The potential measured by the smartphone-powered potentiometric reader is sent to the smartphone App via the USB port, and converted into sAA concentration based on a calibration curve. Using our method, sAA in real human sample is quantitatively analyzed within 5 min. The results are in good agreement with that obtained using a reference method, and correlated to psychological states of the subjects. PMID:26415134

  6. Cellphone-Based Hand-Held Microplate Reader for Point-of-Care Testing of Enzyme-Linked Immunosorbent Assays.

    PubMed

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

    2015-08-25

    Standard microplate based enzyme-linked immunosorbent assays (ELISA) are widely utilized for various nanomedicine, molecular sensing, and disease screening applications, and this multiwell plate batched analysis dramatically reduces diagnosis costs per patient compared to nonbatched or nonstandard tests. However, their use in resource-limited and field-settings is inhibited by the necessity for relatively large and expensive readout instruments. To mitigate this problem, we created a hand-held and cost-effective cellphone-based colorimetric microplate reader, which uses a 3D-printed opto-mechanical attachment to hold and illuminate a 96-well plate using a light-emitting-diode (LED) array. This LED light is transmitted through each well, and is then collected via 96 individual optical fibers. Captured images of this fiber-bundle are transmitted to our servers through a custom-designed app for processing using a machine learning algorithm, yielding diagnostic results, which are delivered to the user within ∼1 min per 96-well plate, and are visualized using the same app. We successfully tested this mobile platform in a clinical microbiology laboratory using FDA-approved mumps IgG, measles IgG, and herpes simplex virus IgG (HSV-1 and HSV-2) ELISA tests using a total of 567 and 571 patient samples for training and blind testing, respectively, and achieved an accuracy of 99.6%, 98.6%, 99.4%, and 99.4% for mumps, measles, HSV-1, and HSV-2 tests, respectively. This cost-effective and hand-held platform could assist health-care professionals to perform high-throughput disease screening or tracking of vaccination campaigns at the point-of-care, even in resource-poor and field-settings. Also, its intrinsic wireless connectivity can serve epidemiological studies, generating spatiotemporal maps of disease prevalence and immunity. PMID:26159546

  7. A point-of-care paper-based fingerstick transaminase test: towards low-cost “lab-on-a-chip” technology for the developing world

    PubMed Central

    Pollock, Nira R.; Colby, Donn; Rolland, Jason P.

    2013-01-01

    There is currently great need for high-quality, low-cost, point-of-care diagnostics that can benefit patients in resource-limited settings, and correspondingly growing interest in the diagnostic utility of microfluidic platforms based on paper. We describe the development, early clinical testing, and potential clinical impact of a novel paper-based, multiplexed microfluidic assay designed for rapid, semi-quantitative measurement of AST and ALT in a fingerstick specimen. This device ultimately holds promise for providing universal access to affordable point-of-care screening for drug-induced liver injury in resource-limited settings, and opens the door to development of similar point-of-care clinical assays for other important analytes. PMID:23466712

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

    PubMed Central

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

    2015-01-01

    Guidelines highlight the need to increase HIV testing among men who have sex with men (MSM) and novel point-of-care testing provides new possibilities for delivery of care. However, it is unclear how point-of-care testing should be used to best effect. This study aimed to increase understanding of sexual risk-taking behaviour, service use, and attitudes to point-of-care testing among MSM sauna clients. Data were collected within two saunas for MSM in south west England using a self-completion survey (n = 134). Though this sample of MSM sauna clients are at high risk of acquiring a sexually transmitted infection, the testing frequency among the majority of those reporting unprotected anal intercourse is not in keeping with national guidelines. For almost all participants the introduction of rapid point-of-care testing for both genital and blood-borne infection was likely to increase testing and for the majority NHS specialist services was the preferred setting. PMID:25907347

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

    PubMed

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

    2016-03-01

    Guidelines highlight the need to increase HIV testing among men who have sex with men (MSM) and novel point-of-care testing provides new possibilities for delivery of care. However, it is unclear how point-of-care testing should be used to best effect. This study aimed to increase understanding of sexual risk-taking behaviour, service use, and attitudes to point-of-care testing among MSM sauna clients. Data were collected within two saunas for MSM in south west England using a self-completion survey (n = 134). Though this sample of MSM sauna clients are at high risk of acquiring a sexually transmitted infection, the testing frequency among the majority of those reporting unprotected anal intercourse is not in keeping with national guidelines. For almost all participants the introduction of rapid point-of-care testing for both genital and blood-borne infection was likely to increase testing and for the majority NHS specialist services was the preferred setting. PMID:25907347

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

    PubMed Central

    Thomas, Ranjeeta; Fraser, Christophe; Cori, Anne

    2016-01-01

    Rapid diagnostic tools have been shown to improve linkage of patients to care. In the context of infectious diseases, assessing the impact and cost-effectiveness of such tools at the population level, accounting for both direct and indirect effects, is key to informing adoption of these tools. Point-of-care (POC) CD4 testing has been shown to be highly effective in increasing the proportion of HIV positive patients who initiate ART. We assess the impact and cost-effectiveness of introducing POC CD4 testing at the population level in South Africa in a range of care contexts, using a dynamic compartmental model of HIV transmission, calibrated to the South African HIV epidemic. We performed a meta-analysis to quantify the differences between POC and laboratory CD4 testing on the proportion linking to care following CD4 testing. Cumulative infections averted and incremental cost-effectiveness ratios (ICERs) were estimated over one and three years. We estimated that POC CD4 testing introduced in the current South African care context can prevent 1.7% (95% CI: 0.4% - 4.3%) of new HIV infections over 1 year. In that context, POC CD4 testing was cost-effective 99.8% of the time after 1 year with a median estimated ICER of US$4,468/DALY averted. In healthcare contexts with expanded HIV testing and improved retention in care, POC CD4 testing only became cost-effective after 3 years. The results were similar when, in addition, ART was offered irrespective of CD4 count, and CD4 testing was used for clinical assessment. Our findings suggest that even if ART is expanded to all HIV positive individuals and HIV testing efforts are increased in the near future, POC CD4 testing is a cost-effective tool, even within a short time horizon. Our study also illustrates the importance of evaluating the potential impact of such diagnostic technologies at the population level, so that indirect benefits and costs can be incorporated into estimations of cost-effectiveness. PMID:27391129

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

    PubMed

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

    2016-01-01

    Rapid diagnostic tools have been shown to improve linkage of patients to care. In the context of infectious diseases, assessing the impact and cost-effectiveness of such tools at the population level, accounting for both direct and indirect effects, is key to informing adoption of these tools. Point-of-care (POC) CD4 testing has been shown to be highly effective in increasing the proportion of HIV positive patients who initiate ART. We assess the impact and cost-effectiveness of introducing POC CD4 testing at the population level in South Africa in a range of care contexts, using a dynamic compartmental model of HIV transmission, calibrated to the South African HIV epidemic. We performed a meta-analysis to quantify the differences between POC and laboratory CD4 testing on the proportion linking to care following CD4 testing. Cumulative infections averted and incremental cost-effectiveness ratios (ICERs) were estimated over one and three years. We estimated that POC CD4 testing introduced in the current South African care context can prevent 1.7% (95% CI: 0.4% - 4.3%) of new HIV infections over 1 year. In that context, POC CD4 testing was cost-effective 99.8% of the time after 1 year with a median estimated ICER of US$4,468/DALY averted. In healthcare contexts with expanded HIV testing and improved retention in care, POC CD4 testing only became cost-effective after 3 years. The results were similar when, in addition, ART was offered irrespective of CD4 count, and CD4 testing was used for clinical assessment. Our findings suggest that even if ART is expanded to all HIV positive individuals and HIV testing efforts are increased in the near future, POC CD4 testing is a cost-effective tool, even within a short time horizon. Our study also illustrates the importance of evaluating the potential impact of such diagnostic technologies at the population level, so that indirect benefits and costs can be incorporated into estimations of cost-effectiveness. PMID:27391129

  12. A newly designed optical biochip for a TDM-POCT device

    NASA Astrophysics Data System (ADS)

    Berrettoni, C.; Trono, C.; Berneschi, S.; Giannetti, A.; Tombelli, S.; Bernini, R.; Grimaldi, A.; Persichetti, G.; Testa, G.; Bolzoni, L.; Porro, G.; Becker, H.; Gärtner, C.; Baldini, F.

    2014-03-01

    The design of a novel therapeutic drug monitoring (TDM) point-of-care-testing (POCT) biochip for immunosuppressants detection in transplanted patients is described. The chip consists of two polymeric parts, a top PMMA slide and a bottom ZEONOR® thin foil, bonded together by means of a pressure sensitive adhesive tape. The tape, with lower refractive index, is shaped in order to obtain a microfluidic multi-channel array. The optical signal, coming from an external light source and travelling along the ZEONOR® thin foil, excites the fluorescent sensing layer immobilized onto the fluidic channels. Preliminary tests with the bioassay implementation for tacrolimus detection are reported.

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

    PubMed

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

    2014-09-01

    Routine viral-load (VL) testing of HIV-infected individuals on antiretroviral therapy (ART) is used to monitor treatment efficacy. However, due to logistical challenges, implementation of VL has been difficult in resource-limited settings. The aim of this study was to evaluate the performance of the SAMBA semi-Q (simple amplification-based assay semiquantitative test for HIV-1) in London, Malawi, and Uganda. The SAMBA semi-Q can distinguish between patients with VLs above and below 1,000 copies/ml. The SAMBA semi-Q was validated with diluted clinical samples and blinded plasma samples collected from HIV-1-positive individuals. SAMBA semi-Q results were compared with results from the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 test, v2.0. Testing of 96 2- to 10-fold dilutions of four samples containing HIV-1 subtype C as well as 488 samples from patients in the United Kingdom, Malawi, and Uganda yielded an overall accuracy for the SAMBA semi-Q of 99% (95% confidence interval [CI], 93.8 to 99.9%) and 96.9% (95% CI 94.9 to 98.3%), respectively, compared to to the Roche test. Analysis of VL data from patients in Malawi and Uganda showed that the SAMBA cutoff of 1,000 copies/ml appropriately distinguished treated from untreated individuals. Furthermore, analysis of the viral loads of 232 patients on ART in Malawi and Uganda revealed similar patterns for virological control, defined as either <1,000 copies/ml (SAMBA cutoff) or <5,000 copies/ml (WHO 2010 criterion; WHO, Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach, 2010). This study suggests that the SAMBA semi-Q has adequate concurrency with the gold standard measurements for viral load. This test can allow VL monitoring of patients on ART at the point of care in resource-limited settings. PMID:25031444

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

    PubMed Central

    Beissner, Marcus; Phillips, Richard Odame; Battke, Florian; Bauer, Malkin; Badziklou, Kossi; Sarfo, Fred Stephen; Maman, Issaka; Rhomberg, Agata; Piten, Ebekalisai; Frimpong, Michael; Huber, Kristina Lydia; Symank, Dominik; Jansson, Moritz; Wiedemann, Franz Xaver; Banla Kere, Abiba; Herbinger, Karl-Heinz; Löscher, Thomas; Bretzel, Gisela

    2015-01-01

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

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

    PubMed Central

    Abdel-Rahman, Susan M.; Breitkreutz, Matthew L.; Bi, Charlie; Matzuka, Brett J.; Dalal, Jignesh; Casey, K. Leigh; Garg, Uttam; Winkle, Sara; Leeder, J. Steven; Breedlove, JeanAnn; Rivera, Brian

    2016-01-01

    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

  16. Utility of point of care test devices for infectious disease testing of blood and oral fluid and application to rapid testing in the field

    NASA Astrophysics Data System (ADS)

    Lee, Stephen R.; Kardos, Keith W.; Yearwood, Graham D.; Guillon, Geraldine B.; Kurtz, Lisa A.; Mokkapati, Vijaya K.

    2008-04-01

    Rapid, point of care (POC) testing has been increasingly deployed as an aid in the diagnosis of infectious disease, due to its ability to deliver rapid, actionable results. In the case of HIV, a number of rapid test devices have been FDA approved and CLIA-waived in order to enable diagnosis of HIV infection outside of traditional laboratory settings. These settings include STD clinics, community outreach centers and mobile testing units, as well as identifying HIV infection among pregnant women and managing occupational exposure to infection. The OraQuick ® rapid test platform has been widely used to identify HIV in POC settings, due to its simplicity, ease of use and the ability to utilize oral fluid as an alternative specimen to blood. More recently, a rapid test for antibodies to hepatitis C virus (HCV) has been developed on the same test platform which uses serum, plasma, finger-stick blood, venous blood and oral fluid. Clinical testing using this POC test device has shown that performance is equivalent to state of the art, laboratory based tests. These devices may be suitable for rapid field testing of blood and other body fluids for the presence of infectious agents.

  17. Validation of Rapid Point-of-Care (POC) Tests for Detection of Hepatitis B Surface Antigen in Field and Laboratory Settings in the Gambia, Western Africa

    PubMed Central

    Njai, Harr Freeya; Shimakawa, Yusuke; Sanneh, Bakary; Ferguson, Lynne; Ndow, Gibril; Mendy, Maimuna; Sow, Amina; Lo, Gora; Toure-Kane, Coumba; Tanaka, Junko; Taal, Makie; D'alessandro, Umberto; Njie, Ramou; Thursz, Mark

    2015-01-01

    Hepatitis B virus (HBV) infection is a leading cause of death in sub-Saharan Africa (SSA). Point-of-care tests for hepatitis B surface antigen (HBsAg) could be an ideal tool for a large-scale HBV screening/treatment program in SSA. Using data from the PROLIFICA (Prevention of Liver Fibrosis and Cancer in Africa) program, we conducted a cross-sectional study to assess the diagnostic accuracy of three point-of-care tests (Determine, Vikia, and Espline) for the detection of HBsAg in the field or a laboratory setting in the Gambia. In the field, we used finger-prick whole blood for the Determine and Vikia tests and dried blood spots for the reference standard test (AxSYM HBsAg enzyme-linked immunosorbent assay [ELISA]). In the laboratory we used serum for the Determine, Espline, and reference test (Architect chemiluminescent microparticle immunoassay). Of 773 participants recruited at the community and 227 known chronic HBV carriers (1,000 subjects in total), 293 were positive for HBsAg. The sensitivity and specificity of the Determine test were 88.5% and 100% in the field and 95.3% and 93.3% in the laboratory setting, respectively. The sensitivity and specificity were 90.0% and 99.8% for the Vikia test (in the field) and 93.9% and 94.7% for the Espline test (in the laboratory). There was no evidence that one kit was better than another. Most of the patients with false-negative results (18/19) were classified as inactive chronic carriers. In summary, the three point-of-care tests had acceptable ranges of diagnostic accuracy. These tests may represent accurate, rapid, and inexpensive alternatives to serology testing for the screening of HBV infection at field level in SSA. PMID:25631805

  18. Clinical versus Rapid Molecular HIV Diagnosis in Hospitalized African Infants: A Randomized Controlled Trial Simulating Point-of-Care Infant Testing

    PubMed Central

    McCollum, Eric D.; Preidis, Geoffrey A.; Maliwichi, Madalitso; Olson, Dan; McCrary, L. Madeline; Kazembe, Peter N.; van der Horst, Charles; Hoffman, Irving; Hosseinipour, Mina C.

    2014-01-01

    Objective Many African infants fail to receive their diagnostic HIV molecular test results and subsequently, antiretroviral therapy (ART). To determine whether a point-of-care molecular HIV test increases ART access for hospitalized Malawian infants, we simulated a point-of-care test using rapid HIV RNA polymerase chain reaction (Rapid PCR) and compared patient outcomes to an optimized standard care that included assessment with the World Health Organization (WHO) clinical algorithm for HIV infection plus a DNA PCR with a turnaround time of several weeks (standard care). Design Randomized controlled trial. Methods Hospitalized HIV-exposed Malawian infants <12 months old were randomized into Rapid PCR or standard care. Rapid PCR infants obtained molecular test results within 48 hours to facilitate immediate ART, similar to a point-of-care test. Standard care infants meeting clinical criteria were also offered inpatient ART. The primary outcome was appropriate in-hospital ART for DNA or RNA PCR-confirmed HIV-infected infants. Results 300 infants were enrolled. A greater proportion of HIV-infected infants receiving Rapid PCR, versus standard care, started inpatient ART (72.3% vs 47.8%, p=0.016). Among molecular test-negative infants, 26.9% receiving standard care unnecessarily initiated inpatient ART, versus 0.0% receiving Rapid PCR (p<0.001). Rapid PCR modestly reduced the median days to ART (3.0 vs 6.5, p=0.001) but did not influence outpatient follow-up for HIV-infected infants (78.1% vs 82.4%, P = 0.418). Conclusions Rapid PCR, versus an optimized standard care, increased the proportion of hospitalized HIV-infected infants initiating ART and reduced ART exposure in molecular test-negative infants, without meaningfully impacting time to ART initiation or follow-up rates. PMID:24326604

  19. Rapid point of care diagnostic tests for viral and bacterial respiratory tract infections--needs, advances, and future prospects.

    PubMed

    Zumla, Alimuddin; Al-Tawfiq, Jaffar A; Enne, Virve I; Kidd, Mike; Drosten, Christian; Breuer, Judy; Muller, Marcel A; Hui, David; Maeurer, Markus; Bates, Matthew; Mwaba, Peter; Al-Hakeem, Rafaat; Gray, Gregory; Gautret, Philippe; Al-Rabeeah, Abdullah A; Memish, Ziad A; Gant, Vanya

    2014-11-01

    Respiratory tract infections rank second as causes of adult and paediatric morbidity and mortality worldwide. Respiratory tract infections are caused by many different bacteria (including mycobacteria) and viruses, and rapid detection of pathogens in individual cases is crucial in achieving the best clinical management, public health surveillance, and control outcomes. Further challenges in improving management outcomes for respiratory tract infections exist: rapid identification of drug resistant pathogens; more widespread surveillance of infections, locally and internationally; and global responses to infections with pandemic potential. Developments in genome amplification have led to the discovery of several new respiratory pathogens, and sensitive PCR methods for the diagnostic work-up of these are available. Advances in technology have allowed for development of single and multiplexed PCR techniques that provide rapid detection of respiratory viruses in clinical specimens. Microarray-based multiplexing and nucleic-acid-based deep-sequencing methods allow simultaneous detection of pathogen nucleic acid and multiple antibiotic resistance, providing further hope in revolutionising rapid point of care respiratory tract infection diagnostics. PMID:25189349

  20. Prospective, observational study comparing automated and visual point-of-care urinalysis in general practice

    PubMed Central

    van Delft, Sanne; Goedhart, Annelijn; Spigt, Mark; van Pinxteren, Bart; de Wit, Niek; Hopstaken, Rogier

    2016-01-01

    Objective 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. Setting 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). Primary and secondary outcome measures 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. Results 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. Conclusions Automated urinalysis performed as good as traditional visual urinalysis on reading of nitrite, leucocytes and erythrocytes in routine general practice. Implementation of automated

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

    PubMed Central

    Corti, Caspar; Fally, Markus; Fabricius-Bjerre, Andreas; Mortensen, Katrine; Jensen, Birgitte Nybo; Andreassen, Helle F; Porsbjerg, Celeste; Knudsen, Jenny Dahl; Jensen, Jens-Ulrik

    2016-01-01

    Background This study was conducted to investigate whether point-of-care (POC) procalcitonin (PCT) measurement can reduce redundant antibiotic treatment in patients hospitalized with acute exacerbation of COPD (AECOPD). Methods One-hundred and twenty adult patients admitted with AECOPD were enrolled in this open-label randomized trial. Patients were allocated to either the POC PCT-guided intervention arm (n=62) or the control arm, in which antibiotic therapy followed local guidelines (n=58). Results The median duration of antibiotic exposure was 3.5 (interquartile range [IQR] 0–10) days 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-protocol population, the proportions were 21.1% (PCT-arm) vs 73.9% (P<0.00001, Fisher’s exact). Within 28-day follow-up, one patient died in the PCT-arm and two died in the control arm. A composite harm end point consisting of death, rehospitalization, or intensive care unit admission, all within 28 days, showed 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. PMID:27382274

  2. A nanoliter self-priming compartmentalization chip for point-of-care digital PCR analysis.

    PubMed

    Song, Qi; Gao, Yibo; Zhu, Qiangyuan; Tian, Qingchang; Yu, Bingwen; Song, Bofan; Xu, Yanan; Yuan, Maokai; Ma, Congcong; Jin, Wei; Zhang, Tao; Mu, Ying; Jin, Qinhan

    2015-01-01

    A nanoliter self-priming compartmentalization (SPC) microfluidic chip suited for the digital polymerase chain reaction (dPCR) analysis in point-of-care testing (POCT) has been developed. This dPCR chip is fabricated of polydimethylsiloxane (PDMS). After the dPCR chip is evacuated, there will be a negative pressure environment in the chip because of the gas solubility of PDMS. The negative pressure environment can provide a self-priming power so that the sample solutions can be sucked into each reaction chamber sequentially. The whole sampling process requires no external power and is valve-free. Channels that contain water are designed around each sample panel to prevent the solvent (water) from evaporating during dPCR process. A glass coverslip is also used as a waterproof layer, which is more convenient and more efficient than other waterproof methods seen in literature. This dPCR chip allows three samples to be amplified at the same time. Each sample is distributed into 1040 reaction chambers, and each chamber is only 2.08 nL. Human β-actin DNA solutions of known concentrations are used as the templates for the dPCR analyses to verify the sensitivity and accuracy of the method. Template DNA solutions diluted to concentrations of 300, 100 and 10 copies/μL are tested and shown that this simple, portable and self-priming dPCR chip can be used at any clinic as a real POCT technique. PMID:26022215

  3. A nanoliter self-priming compartmentalization chip for point-of-care digital PCR analysis.

    PubMed

    Song, Qi; Gao, Yibo; Zhu, Qiangyuan; Tian, Qingchang; Yu, Bingwen; Song, Bofan; Xu, Yanan; Yuan, Maokai; Ma, Congcong; Jin, Wei; Zhang, Tao; Mu, Ying; Jin, Qinhan

    2015-01-01

    A nanoliter self-priming compartmentalization (SPC) microfluidic chip suited for the digital polymerase chain reaction (dPCR) analysis in point-of-care testing (POCT) has been developed. This dPCR chip is fabricated of polydimethylsiloxane (PDMS). After the dPCR chip is evacuated, there will be a negative pressure environment in the chip because of the gas solubility of PDMS. The negative pressure environment can provide a self-priming power so that the sample solutions can be sucked into each reaction chamber sequentially. The whole sampling process requires no external power and is valve-free. Channels that contain water are designed around each sample panel to prevent the solvent (water) from evaporating during dPCR process. A glass coverslip is also used as a waterproof layer, which is more convenient and more efficient than other waterproof methods seen in literature. This dPCR chip allows three samples to be amplified at the same time. Each sample is distributed into 1040 reaction chambers, and each chamber is only 2.08 nL. Human β-actin DNA solutions of known concentrations are used as the templates for the dPCR analyses to verify the sensitivity and accuracy of the method. Template DNA solutions diluted to concentrations of 300, 100 and 10 copies/μL are tested and shown that this simple, portable and self-priming dPCR chip can be used at any clinic as a real POCT technique. PMID:26029750

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

    PubMed

    Dunne, Simon; Gallagher, Pamela; Matthews, Anne

    2015-01-01

    Using a terror management theory framework, this study investigated if providing mortality reminders or self-esteem threats would lead participants to exhibit avoidant responses toward a point-of-care testing device for cardiovascular disease risk and if the nature of the device served to diminish the existential threat of cardiovascular disease. One hundred and twelve participants aged 40-55 years completed an experimental questionnaire. Findings indicated that participants were not existentially threatened by established terror management methodologies, potentially because of cross-cultural variability toward such methodologies. Highly positive appraisals of the device also suggest that similar technologies may beneficially affect the uptake of screening behaviors. PMID:24972015

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

    PubMed

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

    2014-01-01

    Background Acute respiratory infections (ARIs) are by far the most common reason for prescribing an antibiotic in primary care, even though the majority of ARIs are of viral or non-severe bacterial aetiology. Unnecessary antibiotic use will, in many cases, not be beneficial to the patients' 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

  6. A lab-on-a-chip system integrating tissue sample preparation and multiplex RT-qPCR for gene expression analysis in point-of-care hepatotoxicity assessment.

    PubMed

    Lim, Geok Soon; Chang, Joseph S; Lei, Zhang; Wu, Ruige; Wang, Zhiping; Cui, Kemi; Wong, Stephen

    2015-10-21

    A truly practical lab-on-a-chip (LOC) system for point-of-care testing (POCT) hepatotoxicity assessment necessitates the embodiment of full-automation, ease-of-use and "sample-in-answer-out" diagnostic capabilities. To date, the reported microfluidic devices for POCT hepatotoxicity assessment remain rudimentary as they largely embody only semi-quantitative or single sample/gene detection capabilities. In this paper, we describe, for the first time, an integrated LOC system that is somewhat close to a practical POCT hepatotoxicity assessment device - it embodies both tissue sample preparation and multiplex real-time RT-PCR. It features semi-automation, is relatively easy to use, and has "sample-in-answer-out" capabilities for multiplex gene expression analysis. Our tissue sample preparation module incorporating both a microhomogenizer and surface-treated paramagnetic microbeads yielded high purity mRNA extracts, considerably better than manual means of extraction. A primer preloading surface treatment procedure and the single-loading inlet on our multiplex real-time RT-PCR module simplify off-chip handling procedures for ease-of-use. To demonstrate the efficacy of our LOC system for POCT hepatotoxicity assessment, we perform a preclinical animal study with the administration of cyclophosphamide, followed by gene expression analysis of two critical protein biomarkers for liver function tests, aspartate transaminase (AST) and alanine transaminase (ALT). Our experimental results depict normalized fold changes of 1.62 and 1.31 for AST and ALT, respectively, illustrating up-regulations in their expression levels and hence validating their selection as critical genes of interest. In short, we illustrate the feasibility of multiplex gene expression analysis in an integrated LOC system as a viable POCT means for hepatotoxicity assessment. PMID:26329655

  7. The Clinical and Economic Impact of Point-of-Care CD4 Testing in Mozambique and Other Resource-Limited Settings: A Cost-Effectiveness Analysis

    PubMed Central

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

    2014-01-01

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

  8. The role of point-of-care platelet function testing in predicting postoperative bleeding following cardiac surgery: a systematic review and meta-analysis.

    PubMed

    Corredor, C; Wasowicz, M; Karkouti, K; Sharma, V

    2015-06-01

    This systematic review and meta-analysis appraises the utility of point-of-care platelet function tests for predicting blood loss and transfusion requirements in cardiac surgical patients, and analyses whether their use within a transfusion management algorithm is associated with improved patient outcomes. We included 30 observational studies incorporating 3044 patients in the qualitative assessment, and nine randomised controlled trials including 1057 patients in the meta-analysis. Platelet function tests demonstrated significant variability in their ability to predict blood loss and transfusion requirements. Their use within a blood transfusion algorithm demonstrated a reduction in blood loss at longest follow-up (mean difference -102.9 ml (95% CI -149.9 to -56.1 ml), p < 0.001), and transfusion of packed red cells (RR 0.86 (95% CI 0.78-0.94), p = 0.001) and fresh frozen plasma (RR 0.42 (95% CI 0.30-0.59), p < 0.001). Viscoelastic methods used in combination with other platelet function tests achieved greater reduction in blood loss (mean difference -111.8 ml (95% CI -174.9 to -49.1 ml), p = 0.0005) compared with their use alone (mean difference -90.6 ml (95% CI 166.1-15.0 ml), p = 0.02). We conclude that incorporation of point-of-care platelet function tests into transfusion management algorithms is associated with a reduction in blood loss and transfusion requirements in cardiac surgery patients. PMID:25916344

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

    PubMed Central

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

    2013-01-01

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

  10. Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing.

    PubMed

    Leon, S R; Ramos, L B; Vargas, S K; Kojima, N; Perez, D G; Caceres, C F; Klausner, J D

    2016-02-01

    We assessed the laboratory performance of the Chembio dual-path platform HIV-syphilis rapid immunodiagnostic test and electronic reader for detection of HIV and Treponema pallidum antibodies in 450 previously characterized serum specimens. For visual or electronic reader HIV antibody detection, the sensitivity was 100% and the specificity was 98.7%. For visual T. pallidum antibody detection, the test sensitivity was 94.7% and the specificity was 100.0%; with the electronic reader, the sensitivity was 94.7% and the specificity was 99.7%. PMID:26659215

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

    PubMed

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

    2016-01-01

    Applications of near-patient testing have developed rapidly during the last years. It offers quick test results and minimal preanalytical interference, having the potential to improve patient outcomes, even when still under scrutiny by laboratory and healthcare professionals. Near-patient diagnostics are currently also used increasingly in developing countries, due to the burden of inadequate healthcare services in resource-constrained settings. This review describes the underlying emerging techniques that are based on advanced microfluidics and nanomaterials, device miniaturization, and multiplexing the detection mode. The organizational concepts for reasonable applications, contributing significantly to the future perspectives of this nascent diagnostic modality, are supplementary portrayed. PMID:26808189

  12. Design and Testing of a Single-Element Ultrasound Viscoelastography System for Point-of-Care Edema Quantification.

    PubMed

    Pitre, John J; Koziol, Leo B; Kruger, Grant H; Vollmer, Alan; Ophir, Jonathan; Ammann, Jean-Jacques; Weitzel, William F; Bull, Joseph L

    2016-09-01

    Management of fluid overload in patients with end-stage renal disease represents a unique challenge to clinical practice because of the lack of accurate and objective measurement methods. Currently, peripheral edema is subjectively assessed by palpation of the patient's extremities, ostensibly a qualitative indication of tissue viscoelastic properties. New robust quantitative estimates of tissue fluid content would allow clinicians to better guide treatment, minimizing reactive treatment decision making. Ultrasound viscoelastography (UVE) can be used to estimate strain in viscoelastic tissue, deriving material properties that can help guide treatment. We are developing and testing a simple, low-cost UVE system using a single-element imaging transducer that is simpler and less computationally demanding than array-based systems. This benchtop validation study tested the feasibility of using the UVE system by measuring the mechanical properties of a tissue-mimicking material under large strains. We generated depth-dependent creep curves and viscoelastic parameter maps of time constants and elastic moduli for the Kelvin model of viscoelasticity. During testing, the UVE system performed well, with mean UVE-measured strain matching standard mechanical testing with maximum absolute errors ≤4%. Motion tracking revealed high correlation and signal-to-noise ratios, indicating that the system is reliable. PMID:27222246

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

    PubMed

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

    2016-07-01

    Hantaviruses are etiologic agents of a zoonotic disease transmitted mainly from wild rodents to humans, causing Hemorrhagic Fever with Renal Syndrome in Eurasia and the Hantavirus Cardiopulmonary Syndrome in the Americas (HCPS), reaching a lethality rate of 40% in Brazil. Hantavirus diagnostic and seroprevalence are often based on the presence of IgM and IgG antibodies against the virus. Here we propose a rapid test assay able to identify hantavirus antibodies with sensibility and specificity similar to ELISA assays. We analyzed five groups of samples, including healthy human population and small mammals of endemic areas, suspected cases of HCPS, patients with non-related infections and a serum panel from a different geographical region. The test presented good rates of sensibility (87-100%) and specificity (97-100%) for all groups, being a promising tool suitable for both rodent and human hantavirus epidemiological surveys. PMID:27155935

  14. Analytical and clinical performance of a new point of care LABGEOIB D-dimer test for diagnosis of venous thromboembolism.

    PubMed

    Song, Jaewoo; Kweon, Tae Dong; Song, Yeajin; Lee, Eun Young; Kim, Sue Jung; Park, Rojin

    2014-01-01

    LABGEO(IB) D-dimer Test is a newly developed POC D-dimer assay and the first commercially available POC immunoassay instrument that exploits the disk rotation method for extraction of plasma. Citrate plasma was obtained from 201 apparently healthy subjects and 91 patients suspected for VTE, and their D-dimer level was measured by the LABGEO(IB) D-Dimer Test (LABGEO D-dimer) and HemosIL D-dimer test as a comparative method. To examine the effect of blood cells and anticoagulant, paired blood samples anticoagulated by heparin and citrate were obtained from various postoperative patients. The overall diagnostic performance of LABGEO(IB) D-dimer and HemosIL was comparable with similar area under ROC curve (p=0.79). The cut-off levels recommended by manufacturers (LABGEO D-dimer: 0.45 μg/ml fibrinogen equivalent unit (FEU), HemosIL: 0.23 μg/ml D-dimer unit (DDU)) and those yielding highest diagnostic efficiency (LABGEO D-dimer: 1.41 μg/ml FEU; HemosIL: 0.85 μg/ml DDU), were chosen for the evaluation. For LABGEO D-dimer negative predictive value (NPV), positive predictive value (PPV), sensitivity, specificity, and negative likelihood ratio (LR-neg) were 93-100%, 67-89%, 93-100%, 53-89% and 0.00-0.08. For HemosIL D-dimer, NPV, PPV, sensitivity, specificity and LR-neg were 90 - 100%, 76-95%, 89-100%, 70-96% and 0.00-0.12, all comparable to results for LABGEO D-dimer. LABGEO D-dimer test demonstrated acceptable performance when used for the VTE diagnostic work-up. PMID:25117092

  15. Assessment of Haemostasis in Disseminated Intravascular Coagulation by Use of Point-of-Care Assays and Routine Coagulation Tests, in Critically Ill Patients; A Prospective Observational Study

    PubMed Central

    Kander, Thomas; Larsson, Anna; Taune, Victor; Schött, Ulf; Tynngård, Nahreen

    2016-01-01

    Background Disseminated intravascular coagulopathy (DIC) relates to the consumption of coagulation factors and platelets with bleeding and micro thrombosis events. Aim The aim of this study was to compare haemostasis parameters in critically ill patients with DIC versus patients without DIC, and in survivors versus non-survivors over time. Correlations between the DIC-score, the degree of organ failure and the haemostasis were assessed. Method Patients admitted to the intensive care unit with a condition known to be associated with DIC and with an expected length of stay of >3 days were included. Routine laboratory tests, prothrombin time, activated partial thromboplastin time, platelet count, fibrinogen concentration and D-dimer were measured. Coagulation and platelet function were assessed with two point-of-care devices; Multiplate and ROTEM. DIC scores were calculated according to the International Society on Thrombosis and Haemostasis and Japanese Association for Acute Medicine. Results Blood was sampled on days 0–1, 2–3 and 4–10 from 136 patients with mixed diagnoses during 290 sampling events. The point-of-care assays indicated a hypocoagulative response (decreased platelet aggregation and reduced clot strength) in patients with DIC and, over time, in non-survivors compared to survivors. Patients with DIC as well as non-survivors had decreased fibrinolysis as shown by ROTEM. DIC scores were higher in non-survivors than in survivors. Conclusions Patients with DIC displayed signs of a hypocoagulative response and impaired fibrinolysis, which was also evident over time in non-survivors. Patients with DIC had a higher mortality rate than non-DIC patients, and DIC scores were higher in non-survivors than in survivors. PMID:26959974

  16. Comparison of computed tomography pulmonary angiography and point-of-care tests for pulmonary thromboembolism diagnosis in dogs

    PubMed Central

    Goggs, R; Chan, D L; Benigni, L; Hirst, C; Kellett-Gregory, L; Fuentes, V L

    2014-01-01

    Objectives To evaluate the feasibility of CT pulmonary angiography for identification of naturally occurring pulmonary thromboembolism in dogs using predefined diagnostic criteria and to assess the ability of echocardiography, cardiac troponins, D-dimers and kaolin-activated thromboelastography to predict the presence of pulmonary thromboembolism in dogs. Methods Twelve dogs with immune-mediated haemolytic anaemia and evidence of respiratory distress were prospectively evaluated. Dogs were sedated immediately before CT pulmonary angiography using intravenous butorphanol. Spiral CT pulmonary angiography was performed with a 16 detector-row CT scanner using a pressure injector to infuse contrast media through peripheral intravenous catheters. Pulmonary thromboembolism was diagnosed using predefined criteria. Contemporaneous tests included echocardiography, arterial blood gas analysis, kaolin-activated thromboelastography, D-dimers and cardiac troponins. Results Based on predefined criteria, four dogs were classified as pulmonary thromboembolism positive, three dogs were suspected to have pulmonary thromboembolism and the remaining five dogs had negative scans. The four dogs identified with pulmonary thromboembolism all had discrete filling defects in main or lobar pulmonary arteries. None of the contemporaneous tests was discriminant for pulmonary thromboembolism diagnosis, although the small sample size was limiting. Clinical Significance CT pulmonary angiography can be successfully performed in dogs under sedation, even in at-risk patients with respiratory distress and can both confirm and rule out pulmonary thromboembolism in dogs. PMID:24521253

  17. Performance of a New Meter Designed for Assisted Monitoring of Blood Glucose and Point-of-Care Testing

    PubMed Central

    MacRury, Sandra; Srinivasan, Aparna; Mahoney, John J.

    2013-01-01

    Background Blood glucose (BG) meters used for assisted monitoring of blood glucose (AMBG) require different attributes compared with meters designed for home use. These include safety considerations (i.e., minimized risk of blood-borne pathogen transmission), capability for testing multiple blood sample types, and enhanced performance specifications. The OneTouch® Verio™Pro+ BG meter is designed to incorporate all of these attributes. Methods Meter accuracy was assessed in clinical studies with arterial, venous, and capillary blood samples with a hematocrit range of 22.9–59.8%. The effect of interferents, including anticoagulants, on accuracy was evaluated. The meter disinfection protocol was validated, and instructions for use and user acceptance of the system were assessed. Results A total of 97% (549/566) of BG measures from all blood sample types and 95.5% (191/200) of arterial blood samples were within ±12 mg/dl or 12.5% of reference measurements. The system was unaffected by 4 anticoagulants and 57 of 59 endogenous and exogenous compounds; it was affected by 2 compounds: pralidoxime iodide and xylose. Bleach wipes were sufficient to disinfect the meter. Users felt that the meter's quality control (QC) prompts would help them to comply with regulatory requirements. Conclusions The meter provided accurate measurements of different blood samples over a wide hematocrit range and was not affected by 57 physiologic and therapeutic compounds. The QC prompts and specific infection-mitigating design further aid to make this meter system practical for AMBG in care facilities. PMID:23566997

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

    PubMed Central

    2013-01-01

    Background Computer reminders are increasingly being applied in efforts to improve quality and patient safety. However, research is still needed to establish the effectiveness of different kinds of reminders in various settings. This study aimed to evaluate the effectiveness of computer reminders for improving adherence to a quality assessment scheme for point-of-care testing in general practice. Method The study was conducted as a randomized controlled crossover trial among general practices in the Capital Region of Denmark. The intervention consisted of sending computer reminders (ComRem) to practices not adhering to the guideline recommendations of split testing for hemoglobin and glucose. Practices were randomly allocated into two groups. During the first follow-up period, one of the groups received the ComRem intervention together with the general implementation activities (GIA), while the other group only received the GIA. For the second follow-up period, the intervention was switched between the two groups. Outcomes were measured as split test procedure adherence. Results A total of 142 practices were randomly allocated to the early intervention group and 144 practices to the late intervention group (the control group in the first follow-up period). In the first intervention period, the mean number of split tests performed in the group receiving ComRem group increased from 1.22 to 3.76 (out of eight possible tests) while the mean number of split tests increased from 1.11 to 2.35 in the group targeted by GIA only (p = 0.0059). After the crossover, a similar effect of reminders was observed. Furthermore, the developments in outcome measures over time showed a strong effect of computer reminders beyond the intervention periods. Conclusion There was a significant effect of computer reminders on adherence to the quality assessment scheme for point-of-care testing. Thus, computer reminders seem to be useful for supporting the implementation of relatively simple

  19. Evaluating the Utility of Rapid Point-of-Care Potassium Testing for the Early Identification of Hyperkalemia in Patients with Chronic Kidney Disease in the Emergency Department

    PubMed Central

    You, Je Sung; Park, Yoo Seok; Chung, Hyun Soo; Lee, Hye Sun; Joo, Youngseon; Park, Jong Woo; Lee, Shin Ho; Lee, Hahn Shick

    2014-01-01

    Purpose Severe hyperkalemia leads to significant morbidity and mortality if it is not immediately recognized and treated. The concentration of potassium (K+) in the serum increases along with deteriorating renal function. The use of point-of-care K+ (POC-K+) in chronic kidney disease (CKD) could reduce the time for an accurate diagnosis and treatment, saving lives. We hypothesized that POC-K+ would accurately report K+ serum level without significant differences compared to reference testing, regardless of the renal function of the patient. Materials and Methods The retrospective study was performed between January 2008 and September 2011 at an urban hospital in Seoul. The screening program using POC was conducted as a critical pathway for rapid evaluation and treatment of hyperkalemia since 2008. When a patient with CKD had at least one warning symptom or sign of hyperkalemia, both POC-K+ and routine laboratory tests were simultaneously ordered. The reliability of the two assays for serum-creatinine was assessed by intra-class correlation coefficient (ICC) analysis using absolute agreement of two-way mixed model. Results High levels of reliability were found between POC and the laboratory reference tests for K+ (ICC=0.913, 95% CI 0.903-0.922) and between two tests for K+ according to changes in the serum-creatinine levels in CKD patients. Conclusion The results of POC-K+ correlate well with values obtained from reference laboratory tests and coincide with changes in serum-creatinine of patients with CKD. PMID:25048495

  20. Measurement of Circulating Filarial Antigen Levels in Human Blood with a Point-of-Care Test Strip and a Portable Spectrodensitometer.

    PubMed

    Chesnais, Cédric B; Vlaminck, Johnny; Kunyu-Shako, Billy; Pion, Sébastien D; Awaca-Uvon, Naomi-Pitchouna; Weil, Gary J; Mumba, Dieudonné; Boussinesq, Michel

    2016-06-01

    The Alere Filariasis Test Strip (FTS) is a qualitative, point-of-care diagnostic tool that detects Wuchereria bancrofti circulating filarial antigen (CFA) in human blood, serum, or plasma. The Global Program to Eliminate Lymphatic Filariasis employs the FTS for mapping filariasis-endemic areas and assessing the success of elimination efforts. The objective of this study was to explore the relationship between the intensity of positive test lines obtained by FTS with CFA levels as determined by enzyme-linked immunosorbent assay (ELISA) with blood and plasma samples from 188 individuals who live in a filariasis-endemic area. The intensity of the FTS test line was assessed visually to provide a semiquantitative score (visual Filariasis Test Strip [vFTS]), and line intensity was measured with a portable spectrodensitometer (quantitative Filariasis Test Strip [qFTS]). These results were compared with antigen levels measured by ELISA in plasma from the same subjects. qFTS measurements were highly correlated with vFTS scores (ρ = 0.94; P < 0.001) and with plasma CFA levels (ρ = 0.91; P < 0.001). Thus, qFTS assessment is a convenient method for quantifying W. bancrofti CFA levels in human blood, which are correlated with adult worm burdens. This tool may be useful for assessing the impact of treatment on adult filarial worms in individuals and communities. PMID:27114288

  1. Measurement of Circulating Filarial Antigen Levels in Human Blood with a Point-of-Care Test Strip and a Portable Spectrodensitometer

    PubMed Central

    Chesnais, Cédric B.; Vlaminck, Johnny; Kunyu-Shako, Billy; Pion, Sébastien D.; Awaca-Uvon, Naomi-Pitchouna; Weil, Gary J.; Mumba, Dieudonné; Boussinesq, Michel

    2016-01-01

    The Alere Filariasis Test Strip (FTS) is a qualitative, point-of-care diagnostic tool that detects Wuchereria bancrofti circulating filarial antigen (CFA) in human blood, serum, or plasma. The Global Program to Eliminate Lymphatic Filariasis employs the FTS for mapping filariasis-endemic areas and assessing the success of elimination efforts. The objective of this study was to explore the relationship between the intensity of positive test lines obtained by FTS with CFA levels as determined by enzyme-linked immunosorbent assay (ELISA) with blood and plasma samples from 188 individuals who live in a filariasis-endemic area. The intensity of the FTS test line was assessed visually to provide a semiquantitative score (visual Filariasis Test Strip [vFTS]), and line intensity was measured with a portable spectrodensitometer (quantitative Filariasis Test Strip [qFTS]). These results were compared with antigen levels measured by ELISA in plasma from the same subjects. qFTS measurements were highly correlated with vFTS scores (ρ = 0.94; P < 0.001) and with plasma CFA levels (ρ = 0.91; P < 0.001). Thus, qFTS assessment is a convenient method for quantifying W. bancrofti CFA levels in human blood, which are correlated with adult worm burdens. This tool may be useful for assessing the impact of treatment on adult filarial worms in individuals and communities. PMID:27114288

  2. Suitability of Capillary Blood for Quantitative Assessment of G6PD Activity and Performances of G6PD Point-of-Care Tests

    PubMed Central

    Bancone, Germana; Chu, Cindy S.; Chowwiwat, Nongnud; Somsakchaicharoen, Raweewan; Wilaisrisak, Pornpimon; Charunwatthana, Prakaykaew; Bansil, Pooja; McGray, Sarah; Domingo, Gonzalo J.; Nosten, François H.

    2015-01-01

    The use of primaquine and other 8-aminoquinolines for malaria elimination is hampered by, among other factors, the limited availability of point-of-care tests for the diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency. Historically, the most used source of blood for G6PD analyses is venous blood, whereas diagnostic devices used in the field require the use of capillary blood; data have shown that the two sources of blood often differ with respect to hemoglobin concentration and number of red blood cells. Therefore, we have analyzed, in both capillary and venous blood drawn from the same healthy donors, the correlation of G6PD activity assessed by two qualitative tests (the Fluorescent Spot test and the CareStart test) with the gold standard quantitative spectrophotometric assay. Results obtained on 150 subjects with normal, intermediate, and deficient G6PD phenotypes show that, although differences exist between the aforementioned characteristics in capillary and venous blood, these do not impact on the quantitative assessment of G6PD activity after corrected for hemoglobin concentration or red blood cell count. Furthermore, we have assessed the sensitivity and specificity of the two qualitative tests against the gold standard spectrophotometric assay at different activity thresholds of residual enzymatic activity in both blood sources. PMID:25646252

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

    PubMed

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

    2016-02-01

    On the shores of Lake Chad, schistosomiasis among mobile pastoralists was investigated in a field laboratory. Point-of-care circulating cathodic antigen (POC-CCA) cassette test, reagent strip, and filtration were conducted on urine samples. Fresh stool samples were subjected to the Kato-Katz technique, and fixed samples were examined with an ether-concentration method at a reference laboratory. POC-CCA urine cassette tests revealed a Schistosoma mansoni prevalence of 6.9%, compared with only 0.5% by stool microscopy. Three pregnant women with otherwise negative urine and stool testing had positive POC-CCA. This observation raises concern of cross-reactivity in pregnancy. Hence, two pregnant women in Switzerland with no history of schistosomiasis were subjected to POC-CCA and one tested positive. Our data suggest that POC-CCA can be performed under extreme Sahelian conditions (e.g., temperatures > 40°C), and it is more sensitive than stool microscopy for S. mansoni diagnosis. However, potential cross-reactivity in pregnancy needs further investigation. PMID:26556831

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

    PubMed

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

    2016-04-15

    In this manuscript, a microfluidic detection module, which allows a sensitive readout of biological assays in point-of-care (POC) tests, is presented. The proposed detection module consists of a microfluidic flow cell with an integrated Complementary Metal-Oxide-Semiconductor (CMOS)-based single photon counting optical sensor. Due to the integrated sensor-based readout, the detection module could be implemented as the core technology in stand-alone POC tests, for use in mobile or rural settings. The performance of the detection module was demonstrated in three assays: a peptide, a protein and an antibody detection assay. The antibody detection assay with readout in the detection module proved to be 7-fold more sensitive that the traditional colorimetric plate-based ELISA. The protein and peptide assay showed a lower limit of detection (LLOD) of 200 fM and 460 fM respectively. Results demonstrate that the sensitivity of the immunoassays is comparable with lab-based immunoassays and at least equal or better than current mainstream POC devices. This sensitive readout holds the potential to develop POC tests, which are able to detect low concentrations of biomarkers. This will broaden the diagnostic capabilities at the clinician's office and at patient's home, where currently only the less sensitive lateral flow and dipstick POC tests are implemented. PMID:26599482

  5. Accuracy of point-of-care testing for circulatory cathodic antigen in the detection of schistosome infection: systematic review and meta-analysis

    PubMed Central

    Minton, Jonathan; Boamah, Daniel; Otchere, Joseph; Asmah, Richard H; Rodgers, Mark; Bosompem, Kwabena M; Eusebi, Paolo; De Vlas, Sake J

    2016-01-01

    Abstract Objective To assess the accuracy of point-of-care testing for circulatory cathodic antigen in the diagnosis of schistosome infection. Methods We searched MEDLINE, EMBASE, LILACS and other bibliographic databases for studies published until 30 September 2015 that described circulatory cathodic antigen testing compared against one to three Kato–Katz tests per subject – for Schistosoma mansoni – or the filtration of one 10-ml urine sample per subject – for S. haematobium. We extracted the numbers of true positives, false positives, true negatives and false negatives for the antigen testing and performed meta-analyses using a bivariate hierarchical regression model. Findings Twenty-six studies published between 1994 and 2014 met the inclusion criteria. In the detection of S. mansoni, a single antigen test gave a pooled sensitivity of 0.90 (95% confidence interval, CI: 0.84–0.94) and a pooled specificity of 0.56 (95% CI: 0.39–0.71; n = 7) when compared against a single Kato–Katz test. The corresponding values from comparisons with two to three Kato–Katz tests per subject were 0.85 (95% CI: 0.80–0.88) and 0.66 (95% CI: 0.53–0.76; n = 14), respectively. There appeared to be no advantage in using three antigen tests per subject instead of one. When compared against the results of urine filtration, antigen testing for S. haematobium showed poor sensitivity and poor specificity. The performance of antigen testing was better in areas of high endemicity than in settings with low endemicity. Conclusion Antigen testing may represent an effective tool for monitoring programmes for the control of S. mansoni. PMID:27429491

  6. Acceptability, predictors and attitudes of Canadian women in labour toward point-of-care HIV testing at a single labour and delivery unit

    PubMed Central

    Iqbal, Salikah; De Souza, Leanne R; Yudin, Mark H

    2014-01-01

    OBJECTIVE: To assess attitudes and opinions surrounding point-of-care HIV testing among Canadian women, and to determine predictors for acceptance of testing. METHODS: A survey assessing acceptability and attitudes toward rapid HIV testing was distributed on the labour and delivery unit in an academic hospital (St Michael’s Hospital) in Toronto, Ontario, in 2011. Information collected included demographic data, health and pregnancy history, willingness to undergo rapid HIV testing while in labour and barriers to testing. RESULTS: Responses in 92 completed questionnaires were analyzed. The mean age of respondents was 32 years and all were HIV negative. Twelve percent of patients reported having at least one risk factor for HIV transmission. The study showed that only 59% of women were willing to be tested at the time of survey completion, and these women stated that they would accept saliva, urine or serum testing. If found to be positive, 96% would accept antiretroviral treatment and 94% would formula feed their infants. Of the 41% who were not willing to be tested, their reasons for refusal included “don’t want to know” (39%) and being in “too much labour pain” (29%). Regardless of willingness to be tested, the most frequently cited barriers to testing were social stigma (64%) and reaction from partners (69%). CONCLUSIONS: Canadian women in labour were willing to undergo rapid HIV testing via urine, saliva or serum. If found to be positive, women were willing to undergo treatment and to formula feed to prevent mother-to-child transmission of HIV. PMID:25285124

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

    PubMed Central

    Jenum, Synne; Dhanasekaran, S.; Lodha, Rakesh; Mukherjee, Aparna; Kumar Saini, Deepak; Singh, Sarman; Singh, Varinder; Medigeshi, Guruprasad; Haks, Marielle C.; Ottenhoff, Tom H. M.; Doherty, Timothy Mark; Kabra, Sushil K.; Ritz, Christian; Grewal, Harleen M. S.

    2016-01-01

    The World Health Organization (WHO) calls for an accurate, rapid, and simple point-of-care (POC) test for the diagnosis of pediatric tuberculosis (TB) in order to make progress “Towards Zero Deaths”. Whereas the sensitivity of a POC test based on detection of Mycobacterium tuberculosis (MTB) is likely to have poor sensitivity (70–80% of children have culture-negative disease), host biomarkers reflecting the on-going pathological processes across the spectrum of MTB infection and disease may hold greater promise for this purpose. We analyzed transcriptional immune biomarkers direct ex-vivo and translational biomarkers in MTB-antigen stimulated whole blood in 88 Indian children with intra-thoracic TB aged 6 months to 15 years, and 39 asymptomatic siblings. We identified 12 biomarkers consistently associated with either clinical groups “upstream” towards culture-positive TB on the TB disease spectrum (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, CD3E, CD14, FPR1, IL4, TGFBR2, TIMP2 and TNFRSF1B separated children with TB from asymptomatic siblings (AUC of 88%). PMID:26725873

  8. Primary PCI for ST-segment elevation myocardial infarction in a patient treated with subcutaneous enoxaparin utilizing point-of-care Enox test.

    PubMed

    Veerappan, Balaji; Latif, Faisal; Patibandla, Sushmitha; Hennebry, Thomas; Ghani, Mohammed; Saucedo, Jorge; Schechter, Eliot; Sadanandan, Saihari

    2003-05-01

    The superiority of enoxaparin compared with unfractionated heparin in the medical management of patients with non-ST elevation acute coronary syndromes (NSTE ACS) has been demonstrated in clinical trials. Further, enoxaparin has been shown to be safe and effective during PCI, including in combination with glycoprotein IIb/IIIa inhibitors. Whether enoxaparin is superior to unfractionated heparin in patients with NSTE ACS under-going early invasive strategy is currently being tested in a large clinical trial. Data on the use of enoxaparin in patients undergoing primary angioplasty for ST-segment elevation myocardial infarction are limited. Unlike patients who present to the catheterization laboratory after several doses of enoxaparin where in a steady state anticoagulation might have been achieved, patients who present early after administration of a single dose of subcutaneous enoxaparin may not have an adequate level of anticoagulation for PCI. The ability to monitor activity of enoxaparin in such patients using a point-of-care test might be useful. This report describes a patient with ST-segment elevation myocardial infarction who presented for primary angioplasty 75 minutes after administration of subcutaneous enoxaparin. The Rapidpoint Enox test measured 135 seconds and the patient's corresponding serum anti-Xa level was 0.12 IU/mL indicating a suboptimal level of anticoagulation for PCI. Procedural success was attained using additional 0.3-mg/kg intravenous enoxaparin. PMID:12784820

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

    PubMed Central

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

    2015-01-01

    Objectives With accurate molecular tests now available for diagnosis of chlamydia and gonorrhoea (Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG)) at the point-of-care (POC), we aimed to explore the public health implications (benefits and barriers) of their integration into remote primary care in Australia. Methods Qualitative interviews were conducted with a purposively selected group of 18 key informants reflecting sexual health, primary care, remote Aboriginal health and laboratory expertise. Results Participants believed that POC testing may decrease community prevalence of sexually transmitted infections (STIs), and associated morbidity by reducing the time to treatment and infectious period and expediting partner notification. Also, POC testing could improve acceptability of STI testing, increase testing coverage and result in more targeted prescribing, thereby minimising the risk of antibiotic resistance. Conversely, some felt the immediacy of diagnosis could deter certain young people from being tested. Participants also noted that POC testing may reduce the completeness of communicable disease surveillance data given the current dependence on reporting from pathology laboratories. Others expressed concern about the need to maintain and improve the flow of NG antibiotic sensitivity data, already compromised by the shift to nucleic acid-based testing. This is particularly relevant to remote areas where culture viability is problematic. Conclusions Results indicate a high level of support from clinicians and public health practitioners for wider access to CT/NG POC tests citing potential benefits, including earlier, more accurate treatment decisions and reductions in ongoing transmission. However, the data also highlight the need for new systems to avoid adverse impact on disease surveillance. Trial registration number Australian and New Zealand Clinical Trials Registry: ACTRN12613000808741. PMID:25922100

  10. Development and evaluation of rapid point-of-care tests for detection of Enterovirus 71 and Coxsackievirus A16 specific immunoglublin M antibodies.

    PubMed

    Zhang, Jing; Weng, Zuxing; Du, Hailian; Xu, Feihai; He, Shuizhen; He, Delei; Cheng, Tong; Zhang, Jun; Ge, Shengxiang; Xia, Ningshao

    2016-05-01

    Two colloidal gold immunochromatographic assays (CGIAs) for detection of EV71- and CA16- immunoglobulin M (IgM) were developed and evaluated. A total of 1465 sera collected from children with hand, foot, and mouth disease (HFMD), non-HFMD patients and healthy children. The sensitivity of IgM CGIA tests for EV71 and CA16 were 97.6% (330/338) and 91.6% (296/323) respectively, compared to those who were viral RNA positive by PCR. Their performances were comparable to those of commercial ELISA kits, with agreement of 98.1% for EV71-IgM and 97.3% for CA16-IgM. In addition, for EV71- and CA16-IgM CGIAs, the results of whole blood samples were 99.6% (248/249) and 100% (191/191) concordant to those with serum samples, respectively. As rapid point-of-care (POC) tests, the two CGIAs were suitable to be used in community clinic units, especially in resource-poor areas and will facilitate the control of HFMD. PMID:26912234

  11. Detection of Group A Streptococcus from Pharyngeal Swab Samples by Bacterial Culture Is Challenged by a Novel mariPOC Point-of-Care Test

    PubMed Central

    Koskinen, Janne O.; Brandt, Annika; Muotiala, Anna; Liukko, Viivi; Soittu, Sari; Meriluoto, Siiri; Vesalainen, Marika; Huovinen, Pentti; Irjala, Kerttu

    2015-01-01

    mariPOC is a novel point-of-care test system for rapid detection of respiratory tract infections. We compared the performance of the mariPOC test to that of bacterial culture for detecting group A streptococcus (GAS) in 219 pharyngitis patients (ages 1–64 years) and 109 healthy asymptomatic controls (ages 19–69 years). In addition, 42 patient samples were analyzed by quantitative PCR (qPCR). Of the 219 pharyngeal patient samples, 32 were positive in a GAS bacterial culture (prevalence 15%) and 65 (30%) in the mariPOC test. The amount of GAS in samples reported positive by the mariPOC test and negative by culture was, on average, 10-fold less than that of those positive in both methods. This indicated that the negative results in bacterial cultures were due to lower sensitivity. The qPCR results were positive and in line with the mariPOC results in 43% of the discordant samples studied. Two GAS culture-positive samples were negative by the mariPOC test. The prevalences of GAS in the control subjects were 2% and 6% by culture and mariPOC results, respectively. We conclude that the mariPOC antigen detection test is more sensitive than the conventional bacterial culture for the detection of GAS among symptomatic pharyngitis patients. The higher prevalence of GAS by the mariPOC test among symptomatic patients was probably not due to carriership, since among the control patients, the difference in the prevalence of GAS by the mariPOC test and culture was not nearly as high, 15% versus 4%, respectively. Clinical trials are needed to show the clinical importance of our findings. PMID:25903570

  12. International normalized ratio monitoring of vitamin K antagonist therapy: comparative performance of point-of-care and laboratory-derived testing.

    PubMed

    Bonar, Roslyn; Mohammed, Soma; Favaloro, Emmanuel J

    2015-04-01

    The monitoring of warfarin therapy using the international normalized ratio (INR) has now moved outside the laboratory's control by use of point-of-care (POC) devices. Although this provides patients with the convenience of immediate results and clinical assessment, POC-INRs are often performed by nonlaboratory staff with little experience in quality control. The Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP) Haematology has devised a POC-INR external quality assessment (EQA) program that is suitable for both laboratory and nonlaboratory operators (e.g., nurses) to perform INR testing with good accuracy and precision. A comparison of the performance of the POC versus the laboratory-derived INR testing over the past 8 years has shown that the variation in test results (expressed as coefficient of variation; CV) for laboratory INRs increases with more prolonged INR values, whereas CVs for the POC-INR testing were generally lower, with a reduced dependency on INR values. In our program, the CoaguChek XS (Roche, Basel, Switzerland) showed the best performance among the POC devices. A comparative assessment with other EQA providers showed agreement and disparity with our data in terms of comparative CVs obtained between the laboratory and POC-INRs. The growth of the RCPAQAP POC-INR program from 29 to 360 in the past 12 years highlights the importance of providing suitable EQA for POC-INR staff who are unfamiliar with laboratory practice. This helps maintaining consistent results, which have important implications for the therapeutic management of patients on vitamin K antagonist therapy. PMID:25839866

  13. Point-of-Care CD4 Testing to Inform Selection of Antiretroviral Medications in South African Antenatal Clinics: A Cost-Effectiveness Analysis

    PubMed Central

    Ciaranello, Andrea L.; Myer, Landon; Kelly, Kathleen; Christensen, Sarah; Daskilewicz, Kristen; Doherty, Katie; Bekker, Linda-Gail; Hou, Taige; Wood, Robin; Francke, Jordan A.; Wools-Kaloustian, Kara; Freedberg, Kenneth A.; Walensky, Rochelle P.

    2015-01-01

    Background Many prevention of mother-to-child HIV transmission (PMTCT) programs currently prioritize antiretroviral therapy (ART) for women with advanced HIV. Point-of-care (POC) CD4 assays may expedite the selection of three-drug ART instead of zidovudine, but are costlier than traditional laboratory assays. Methods We used validated models of HIV infection to simulate pregnant, HIV-infected women (mean age 26 years, gestational age 26 weeks) in a general antenatal clinic in South Africa, and their infants. We examined two strategies for CD4 testing after HIV diagnosis: laboratory (test rate: 96%, result-return rate: 87%, cost: $14) and POC (test rate: 99%, result-return rate: 95%, cost: $26). We modeled South African PMTCT guidelines during the study period (WHO “Option A”): antenatal zidovudine (CD4 ≤350/μL) or ART (CD4>350/μL). Outcomes included MTCT risk at weaning (age 6 months), maternal and pediatric life expectancy (LE), maternal and pediatric lifetime healthcare costs (2013 USD), and cost-effectiveness ($/life-year saved). Results In the base case, laboratory led to projected MTCT risks of 5.7%, undiscounted pediatric LE of 53.2 years, and undiscounted PMTCT plus pediatric lifetime costs of $1,070/infant. POC led to lower modeled MTCT risk (5.3%), greater pediatric LE (53.4 years) and lower PMTCT plus pediatric lifetime costs ($1,040/infant). Maternal outcomes following laboratory were similar to POC (LE: 21.2 years; lifetime costs: $23,860/person). Compared to laboratory, POC improved clinical outcomes and reduced healthcare costs. Conclusions In antenatal clinics implementing Option A, the higher initial cost of a one-time POC CD4 assay will be offset by cost-savings from prevention of pediatric HIV infection. PMID:25756498

  14. A systematic review and meta-analysis of the diagnostic accuracy of point-of-care tests for the detection of hyperketonemia in dairy cows.

    PubMed

    Tatone, Elise H; Gordon, Jessica L; Hubbs, Jessie; LeBlanc, Stephen J; DeVries, Trevor J; Duffield, Todd F

    2016-08-01

    Several rapid tests for use on farm have been validated for the detection of hyperketonemia (HK) in dairy cattle, however the reported sensitivity and specificity of each method varies and no single study has compared them all. Meta-analysis of diagnostic test accuracy is becoming more common in human medical literature but there are few veterinary examples. The objective of this work was to perform a systematic review and meta-analysis to determine the point-of-care testing method with the highest combined sensitivity and specificity, the optimal threshold for each method, and to identify gaps in the literature. A comprehensive literature search resulted in 5196 references. After removing duplicates and performing relevance screening, 23 studies were included for the qualitative synthesis and 18 for the meta-analysis. The three index tests evaluated in the meta-analysis were: the Precision Xtra(®) handheld device measuring beta-hydroxybutyrate (BHB) concentration in whole blood, and Ketostix(®) and KetoTest(®) semi-quantitative strips measuring the concentration of acetoacetate in urine and BHB in milk, respectively. The diagnostic accuracy of the 3 index tests relative to the reference standard measurement of BHB in serum or whole blood between 1.0-1.4mmol/L was compared using the hierarchical summary receiver operator characteristic (HSROC) method. Subgroup analysis was conducted for each index test to examine the accuracy at different thresholds. The impact of the reference standard threshold, the reference standard method, the prevalence of HK in the population, the primary study source and risk of bias of the primary study was explored using meta-regression. The Precision Xtra(®) device had the highest summary sensitivity in whole blood BHB at 1.2mmol/L, 94.8% (CI95%: 92.6-97.0), and specificity, 97.5% (CI95%: 96.9-98.1). The threshold employed (1.2-1.4mmol/L) did not impact the diagnostic accuracy of the test. The Ketostix(®) and KetoTest(®) strips had

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

    PubMed Central

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

    2013-01-01

    Introduction Despite the rapid expansion of antiretroviral therapy (ART) programmes in developing countries, pre-treatment losses from care remain a challenge to improving access to treatment. Youth and adolescents have been identified as a particularly vulnerable group, at greater risk of loss from both pre-ART and ART care. Point-of-care (POC) CD4 testing has shown promising results in improving linkage to ART care. In Khayelitsha township, South Africa, POC CD4 testing was implemented at a clinic designated for youth aged 12–25 years. We assessed whether there was an associated reduction in attrition between HIV testing, assessment for eligibility and ART initiation. Methods A before-and-after observational study was conducted using routinely collected data. These were collected on patients from May 2010 to April 2011 (Group A) when baseline CD4 count testing was performed in a laboratory and results were returned to the clinic within two weeks. Same-day POC CD4 testing was implemented in June 2011, and data were collected on patients from August 2011 to July 2012 (Group B). Results A total of 272 and 304 youth tested HIV-positive in Group A and Group B, respectively. Group B patients were twice as likely to have their ART eligibility assessed compared to Group A patients: 275 (90%) vs. 183 (67%) [relative risk (RR)=2.4, 95% CI: 1.8–3.4, p<0.0001]. More patients in World Health Organization (WHO) Stage 1 disease (85% vs. 69%), with CD4 counts≥350 cells/µL (58% vs. 35%) and more males (13% vs. 7%) were detected in Group B. The proportion of eligible patients who initiated ART was 50% and 44% (p=0.6) in Groups B and A, respectively; and 50% and 43% (p=0.5) when restricted to patients with baseline CD4 count≤250 cells/µL. Time between HIV-testing and ART initiation was reduced from 36 to 28 days (p=0.6). Discussion POC CD4 testing significantly improved assessment for ART eligibility. The improvement in the proportion initiating ART and the reduction in

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

    PubMed

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

    2015-01-01

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

  17. Evaluation of point-of-care testing in critically unwell patients: comparison with clinical laboratory analysers and applicability to patients with Ebolavirus infection.

    PubMed

    Kok, Jen; Ng, Jimmy; Li, Stephen C; Giannoutsos, John; Nayyar, Vineet; Iredell, Jonathan R; Dwyer, Dominic E; Chen, Sharon C-A

    2015-08-01

    Data on the performance of point-of-care (POC) or near-patient devices in the management of critically unwell patients are limited, meaning that there are demands for confirming POC test results in the routine clinical laboratory and so potentially leading to delay in treatment provision. We evaluated the performance of the i-STAT CHEM 8+ and CG4+, Hemochron Signature Elite, HemoCue Hb 201+ and WBC Diff Systems on whole blood collected from medical and surgical patients admitted to the intensive care unit at an Australian tertiary care hospital. Measurements obtained for haematology, coagulation, biochemistry and arterial blood gas parameters using POC devices were compared against clinical laboratory analysers (XE-5000, STA-R Evolution, Dimension Vista 1500 and ABL800 FLEX). Bland-Altman and Passing-Bablok regression plots were constructed to assess agreement. Good correlation was defined as a bias of <10% between the POC device and the reference method. Forty arterial blood samples were collected from 28 patients. There was good correlation demonstrated for sodium, potassium, chloride, ionised calcium, glucose, urea, haemoglobin and haematocrit values (i-STAT Chem 8+); pH, pCO(2), bicarbonate and oxygen saturation (i-STAT CG4+); haemoglobin, white cell, neutrophil count and lymphocyte counts (Hemocue); and internationalised normal ratio (INR; Hemochron Signature Elite), but not creatinine, anion gap, pO(2), base excess, lactate, eosinophil count, prothrombin and activated partial thromboplastin time. POC devices were comparable to clinical laboratory analysers in measuring the majority of haematology, biochemistry and coagulation parameters in critically unwell patients, including those with infections. These devices may be deployed at the bedside to allow 'real-time' testing to improve patient care. PMID:26126049

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

    PubMed Central

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

    2015-01-01

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

  19. Microfluidic Distance Readout Sweet Hydrogel Integrated Paper-Based Analytical Device (μDiSH-PAD) for Visual Quantitative Point-of-Care Testing.

    PubMed

    Wei, Xiaofeng; Tian, Tian; Jia, Shasha; Zhu, Zhi; Ma, Yanli; Sun, Jianjun; Lin, Zhenyu; Yang, Chaoyong James

    2016-02-16

    A disposable, equipment-free, versatile point-of-care testing platform, microfluidic distance readout sweet hydrogel integrated paper-based analytical device (μDiSH-PAD), was developed for portable quantitative detection of different types of targets. The platform relies on a target-responsive aptamer cross-linked hydrogel for target recognition, cascade enzymatic reactions for signal amplification, and microfluidic paper-based analytic devices (μPADs) for visual distance-based quantitative readout. A "sweet" hydrogel with trapped glucoamylase (GA) was synthesized using an aptamer as a cross-linker. When target is present in the sample, the "sweet" hydrogel collapses and releases enzyme GA into the sample, generating glucose by amylolysis. A hydrophilic channel on the μPADs is modified with glucose oxidase (GOx) and colorless 3,3'-diaminobenzidine (DAB) as the substrate. When glucose travels along the channel by capillary action, it is converted to H2O2 by GOx. In addition, DAB is converted into brown insoluble poly-3,3'-diaminobenzidine [poly(DAB)] by horseradish peroxidase, producing a visible brown bar, whose length is positively correlated to the concentration of targets. The distance-based visual quantitative platform can detect cocaine in urine with high selectivity, sensitivity, and accuracy. Because the target-induced cascade reaction is triggered by aptamer/target recognition, this method is widely suitable for different kinds of targets. With the advantages of low cost, ease of operation, general applicability, and disposability with quantitative readout, the μDiSH-PAD holds great potential for portable detection of trace targets in environmental monitoring, security inspection, personalized healthcare, and clinical diagnostics. PMID:26765320

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

    PubMed Central

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

    2013-01-01

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

  1. Diagnostic Accuracy of a Prototype Point-of-Care Test for Ocular Chlamydia trachomatis under Field Conditions in The Gambia and Senegal

    PubMed Central

    Harding-Esch, Emma M.; Holland, Martin J.; Schémann, Jean-François; Molina, Sandra; Sarr, Isatou; Andreasen, Aura A.; Roberts, Chrissy h.; Sillah, Ansumana; Sarr, Boubacar; Harding, Edward F.; Edwards, Tansy; Bailey, Robin L.; Mabey, David C. W.

    2011-01-01

    Background The clinical signs of active trachoma are often present in the absence of ocular Chlamydia trachomatis infection in low prevalence and mass treated settings. Treatment decisions are currently based on the prevalence of clinical signs, and this may result in the unnecessary distribution of mass antibiotic treatment. We aimed to evaluate the diagnostic accuracy of a prototype point-of-care (POC) test, developed for field diagnosis of ocular C. trachomatis, in low prevalence settings of The Gambia and Senegal. Methodology/Principal Findings Three studies were conducted, two in The Gambia and one in Senegal. Children under the age of 10 years were screened for the clinical signs of trachoma. Two ocular swabs were taken from the right eye. The first swab was tested by the POC test in the field and the result independently graded by two readers. The second swab was tested for the presence of C. trachomatis by Amplicor Polymerase Chain Reaction. In Senegal, measurements of humidity and temperature in the field were taken. A total of 3734 children were screened, 950 in the first and 1171 in the second Gambian study, and 1613 in Senegal. The sensitivity of the prototype POC test ranged between 33.3–67.9%, the specificity between 92.4–99.0%, the positive predictive value between 4.3–21.0%, and the negative predictive value between 98.0–99.8%. The rate of false-positives increased markedly at temperatures above 31.4°C and relative humidities below 11.4%. Conclusions/Significance In its present format, this prototype POC test is not suitable for field diagnosis of ocular C. trachomatis as its specificity decreases in hot and dry conditions: the environment in which trachoma is predominantly found. In the absence of a suitable test for infection, trachoma diagnosis remains dependent on clinical signs. Under current WHO recommendations, this is likely resulting in the continued mass treatment of non-infected communities. PMID:21829735

  2. Antenatal Syphilis Screening Using Point-Of-Care Testing in Low- and Middle-Income Countries in Asia and Latin America: A Cost-Effectiveness Analysis

    PubMed Central

    Kuznik, Andreas; Muhumuza, Christine; Komakech, Henry; Marques, Elsa M. R.; Lamorde, Mohammed

    2015-01-01

    Background Untreated syphilis in pregnancy is associated with adverse clinical outcomes to the infant. In low- and middle-income countries in Asia and Latin America, 20%-30% of women are not tested for syphilis during pregnancy. We evaluated the cost-effectiveness of increasing the coverage for antenatal syphilis screening in 11 Asian and 20 Latin American countries, using a point-of-care immunochromatographic strip (ICS) test. Methods The decision analytical cost-effectiveness models reported incremental costs per disability-adjusted life years (DALYs) averted from the perspectives of the national health care payer. Clinical outcomes were stillbirths, neonatal deaths, and congenital syphilis. DALYs were computed using WHO disability weights. Costs included the ICS test, three injections of benzathine penicillin, and nurse wages. Country-specific inputs included the antenatal prevalence of syphilis and the proportion of women in the antenatal care setting that are screened for syphilis infection as reported in the 2014 WHO baseline report on global sexually transmitted infection surveillance. Country-specific data on the annual number of live births, proportion of women with at least one antenatal care visit, and per capita gross national income were also included in the model. Results The incremental cost/DALY averted of syphilis screening is US$53 (range: US$10-US$332; Prob<1*per capita GDP=99.71%) in Asia and US$60 (range: US$5-US$225; Prob<1*per capita GDP=99.77%) in Latin America. Universal screening may reduce the annual number of stillbirths by 20,344 and 4,270, neonatal deaths by 8,201 and 1,721, cases of congenital syphilis by 10,952 and 2,298, and avert 925,039 and 197,454 DALYs in the aggregate Asian and Latin American panel, respectively. Conclusion Antenatal syphilis screening is highly cost-effective in all the 11 Asian and 20 Latin American countries assessed. Our findings support the decision to expand syphilis screening in countries with currently

  3. Laboratory Evaluation of the Liat HIV Quant (IQuum) Whole-Blood and Plasma HIV-1 Viral Load Assays for Point-of-Care Testing in South Africa

    PubMed Central

    Gous, Natasha; Carmona, Sergio; Stevens, Wendy

    2015-01-01

    Point-of-care (POC) HIV viral load (VL) testing offers the potential to reduce turnaround times for antiretroviral therapy monitoring, offer near-patient acute HIV diagnosis in adults, extend existing centralized VL services, screen women in labor, and prompt pediatrics to early treatment. The Liat HIV Quant plasma and whole-blood assays, prerelease version, were evaluated in South Africa. The precision, accuracy, linearity, and agreement of the Liat HIV Quant whole-blood and plasma assays were compared to those of reference technologies (Roche CAP CTMv2.0 and Abbott RealTime HIV-1) on an HIV verification plasma panel (n = 42) and HIV clinical specimens (n = 163). HIV Quant plasma assay showed good performance, with a 2.7% similarity coefficient of variation (CV) compared to the Abbott assay and a 1.8% similarity CV compared to the Roche test on the verification panel, and 100% specificity. HIV Quant plasma had substantial agreement (pc [concordance correlation] = 0.96) with Roche on clinical specimens and increased variability (pc = 0.73) in the range of <3.0 log copies/ml range with the HIV Quant whole-blood assay. HIV Quant plasma assay had good linearity (2.0 to 5.0 log copies/ml; R2 = 0.99). Clinical sensitivity at a viral load of 1,000 copies/ml of the HIV Quant plasma and whole-blood assays compared to that of the Roche assay (n = 94) was 100% (confidence interval [CI], 95.3% to 100%). The specificity of HIV Quant plasma was 88.2% (CI, 63.6% to 98.5%), and that for whole blood was 41.2% (CI, 18.4% to 67.1%). No virological failure (downward misclassification) was missed. Liat HIV Quant plasma assay can be interchanged with existing VL technology in South Africa. Liat HIV Quant whole-blood assay would be advantageous for POC early infant diagnosis at birth and adult adherence monitoring and needs to be evaluated further in this clinical context. LIAT cartridges currently require cold storage, but the technology is user-friendly and robust. Clinical cost and

  4. Implementation of Point-of-Care Diagnostics Leads to Variable Uptake of Syphilis, Anemia and CD4+ T-Cell Count Testing in Rural Maternal and Child Health Clinics

    PubMed Central

    De Schacht, Caroline; Lucas, Carlota; Sitoe, Nádia; Machekano, Rhoderick; Chongo, Patrina; Temmerman, Marleen; Tobaiwa, Ocean; Guay, Laura; Kassaye, Seble; Jani, Ilesh V.

    2015-01-01

    Introduction Anemia, syphilis and HIV are high burden diseases among pregnant women in sub-Saharan Africa. A quasi-experimental study was conducted in four health facilities in Southern Mozambique to evaluate the effect of point-of-care technologies for hemoglobin quantification, syphilis testing and CD4+ T-cell enumeration performed within maternal and child health services on testing and treatment coverage, and assessing acceptability by health workers. Methods Demographic and testing data on women attending first antenatal care services were extracted from existing records, before (2011; n = 865) and after (2012; n = 808) introduction of point-of-care testing. Study outcomes per health facility were compared using z-tests (categorical variables) and Wilcoxon rank-sum test (continuous variables), while inverse variance weights were used to adjust for possible cluster effects in the pooled analysis. A structured acceptability-assessment interview was conducted with health workers before (n = 22) and after (n = 19). Results After implementation of point-of-care testing, there was no significant change in uptake of overall hemoglobin screening (67.9% to 83.0%; p = 0.229), syphilis screening (80.8% to 87.0%; p = 0.282) and CD4+ T-cell testing (84.9% to 83.5%; p = 0.930). Initiation of antiretroviral therapy for treatment eligible women was similar in the weighted analysis before and after, with variability among the sites. Time from HIV diagnosis to treatment initiation decreased (median of 44 days to 17 days; p<0.0001). A generally good acceptability for point-of-care testing was seen among health workers. Conclusions Point-of-care CD4+ T-cell enumeration resulted in a decreased time to initiation of antiretroviral therapy among treatment eligible women, without significant increase in testing coverage. Overall hemoglobin and syphilis screening increased. Despite the perception that point-of-care technologies increase access to health services, the variability in

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

    PubMed Central

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

    2015-01-01

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

  6. Different Influences of Hematocrit on the Results of Two Point-Of-Care Platelet Function Tests, the VerifyNow Assay and Multiple Electrode Platelet Aggregometry

    PubMed Central

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

    2014-01-01

    Objective Previous studies have reported a considerable association between the VerifyNow (Accumetrics, San Diego, CA, USA) P2Y12 assay results and hematocrit. No reports, however, have described an association between the multiple electrode platelet aggregometry (MEA; Dynabyte, Munich, Germany) adenosine diphosphate (ADP) assay results and hematocrit. This study was conducted to evaluate the influence of hematocrit on the results of 2 different point-of-care platelet function tests. Methods A total of 462 consecutive patients who were undergoing percutaneous coronary intervention were enrolled. Platelet function was evaluated with both the VerifyNow P2Y12 and MEA ADP assays. Results Anemic patients (n = 152, 32.9%) demonstrated a significantly higher rate of cardiac death, myocardial infarction, and stroke (5.3% vs. 2.3%, p = 0.046) during the follow-up (median: 18.8 months). Although the VerifyNow P2Y12 assay results demonstrated a significant inverse correlation with hematocrit (r = −0.409, p<0.001), there was no such correlation between the MEA ADP assay results and hematocrit (r = 0.039, p = 0.401). In the multivariate analysis, anemia was an independent predictor of high on-treatment platelet reactivity, defined as a VerifyNow P2Y12 reaction unit level of ≥252.5 (odds ratio = 2.21, 95% confidence interval = 1.39–3.52; p = 0.001). Importantly, this association was independent of an intrinsic change in platelet reactivity as measured by the MEA ADP assay. Adjusting for the influence of hematocrit improved the strength of the correlation between the VerifyNow P2Y12 and MEA ADP assay results. Conclusions Hematocrit significantly influenced the VerifyNow P2Y12 assay results, a phenomenon that was presumably in-vitro. Hematocrit level should therefore be considered when interpreting results of the VerifyNow P2Y12 assay. PMID:25427105

  7. An integrated lateral flow assay for effective DNA amplification and detection at the point of care.

    PubMed

    Choi, Jane Ru; Hu, Jie; Gong, Yan; Feng, Shangsheng; Wan Abas, Wan Abu Bakar; Pingguan-Murphy, Belinda; Xu, Feng

    2016-05-10

    Lateral flow assays (LFAs) have been extensively explored in nucleic acid testing (NAT) for medical diagnostics, food safety analysis and environmental monitoring. However, the amount of target nucleic acid in a raw sample is usually too low to be directly detected by LFAs, necessitating the process of amplification. Even though cost-effective paper-based amplification techniques have been introduced, they have always been separately performed from LFAs, hence increasing the risk of reagent loss and cross-contaminations. To date, integrating paper-based nucleic acid amplification into colorimetric LFA in a simple, portable and cost-effective manner has not been introduced. Herein, we developed an integrated LFA with the aid of a specially designed handheld battery-powered system for effective amplification and detection of targets in resource-poor settings. Interestingly, using the integrated paper-based loop-mediated isothermal amplification (LAMP)-LFA, we successfully performed highly sensitive and specific target detection, achieving a detection limit of as low as 3 × 10(3) copies of target DNA, which is comparable to the conventional tube-based LAMP-LFA in an unintegrated format. The device may serve in conjunction with a simple paper-based sample preparation to create a fully integrated paper-based sample-to-answer diagnostic device for point-of-care testing (POCT) in the near future. PMID:27010033

  8. Combining rapid diagnostic tests and dried blood spot assays for point-of-care testing of human immunodeficiency virus, hepatitis B and hepatitis C infections in Burkina Faso, West Africa.

    PubMed

    Kania, D; Bekalé, A M; Nagot, N; Mondain, A-M; Ottomani, L; Meda, N; Traoré, M; Ouédraogo, J B; Ducos, J; Van de Perre, P; Tuaillon, E

    2013-12-01

    People screened for human immunodeficiency virus (HIV) using rapid diagnostic tests (RDTs) in Africa remain generally unaware of their status for hepatitis B (HBV) and hepatitis C (HCV) infections. We evaluated a two-step screening strategy in Burkina Faso, using both HIV RDTs and Dried Blood Spot (DBS) assays to confirm an HIV-positive test, and to test for HBV and HCV infections. HIV counselling and point-of-care testing were performed at a voluntary counselling and testing centre with HBV, HCV status and HIV confirmation using DBS specimens, being assessed at a central laboratory. Serological testing on plasma was used as the reference standard assay to control for the performance of DBS assays. Nineteen out of 218 participants included in the study were positive for HIV using RDTs. A fourth-generation HIV ELISA and immunoblot assays on DBS confirmed HIV status. Twenty-four out of 25 participants infected with HBV were found positive for hepatitis B surface antigen (HBsAg) using DBS. One sample with a low HBsAg concentration on plasma was not detected on DBS. Five participants tested positive for HCV antibodies were confirmed positive with an immunoblot assay using DBS specimens. Laboratory results were communicated within 7 days to participants with no loss to follow up of participants between the first and second post-test counselling sessions. In conclusion, DBS collection during HIV point-of-care testing enables screening and confirmation of HBV, HCV and HIV infections. Diagnosis using DBS may assist with implementation of national programmes for HBV, HCV and HIV screening and clinical care in middle- to low-income countries. PMID:23902574

  9. Development of Point of Care Testing Device for Neurovascular Coupling From Simultaneous Recording of EEG and NIRS During Anodal Transcranial Direct Current Stimulation

    PubMed Central

    Jindal, Utkarsh; Sood, Mehak; Dutta, Anirban; Chowdhury, Shubhajit Roy

    2015-01-01

    This paper presents a point of care testing device for neurovascular coupling (NVC) from simultaneous recording of electroencephalogram (EEG) and near infrared spectroscopy (NIRS) during anodal transcranial direct current stimulation (tDCS). Here, anodal tDCS modulated cortical neural activity leading to hemodynamic response can be used to identify the impaired cerebral microvessels functionality. The impairments in the cerebral microvessels functionality may lead to impairments in the cerebrovascular reactivity (CVR), where severely reduced CVR predicts the chances of transient ischemic attack and ipsilateral stroke. The neural and hemodynamic responses to anodal tDCS were studied through joint imaging with EEG and NIRS, where NIRS provided optical measurement of changes in tissue oxy-(\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$HbO2)$ \\end{document} and deoxy-(\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$Hb$ \\end{document}) hemoglobin concentration and EEG captured alterations in the underlying neuronal current generators. Then, a cross-correlation method for the assessment of NVC underlying the site of anodal tDCS is presented. The feasibility studies on healthy subjects and stroke survivors showed detectable changes in the EEG and the NIRS responses to a 0.526 A/\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$\\mathrm{m}^{2}$ \\end{document} of anodal tDCS. The NIRS system

  10. A perspective on point of care systems.

    PubMed

    Andrew, W F

    1994-05-01

    Point of care technology is finally being accepted in health care organizations. Portable wireless computers and database interoperability are facilitating this acceptance. Using point of care devices, caregivers can access and input patient data whenever, wherever, and however required. This technology will improve patient data access, improve quality, and reduce costs of health care. PMID:10134755

  11. A Colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) Detection Platform for a Point-of-Care Dengue Detection System on a Lab-on-Compact-Disc

    PubMed Central

    Thiha, Aung; Ibrahim, Fatimah

    2015-01-01

    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

  12. A Colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) Detection Platform for a Point-of-Care Dengue Detection System on a Lab-on-Compact-Disc.

    PubMed

    Thiha, Aung; Ibrahim, Fatimah

    2015-01-01

    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

  13. C-reactive protein point-of-care testing and antibiotic prescribing for acute respiratory tract infections in rural primary health centres of North Ethiopia: a cross-sectional study

    PubMed Central

    Yebyo, Henock; Medhanyie, Araya Abrha; Spigt, Mark; Hopstaken, Rogier

    2016-01-01

    Unjustified antibiotic prescribing for acute upper respiratory infections (URTIs) is probably more common in poor-resource settings where physicians are scarce. Introducing C-reactive protein (CRP) point-of-care testing in such settings could reduce the misuse of antibiotics, which could avert antibiotic resistance. However, information useful for the applicability of CRP test in resource-limited settings is lacking. This study aimed to elicit the frequency of antibiotic prescribing and distribution of CRP levels in remote, rural settings in Ethiopia. We included 414 patients with acute URTIs from four health centres. Health professionals recorded the clinical features of the patients, but the laboratory professionals measured the CRP levels of all patients at the point of care. The most prominent respiratory causes for consultation were acute URTIs combined (44.4%), and lower respiratory tract infections—pneumonia (29.71%) and acute bronchitis (25.84%). The CRP distribution was <20 mg/l, 20–99 mg/l and 100 mg/l or more in 66.6%, 27.9% and 5.5% of the patients, respectively. The CRP levels were significantly different among these clinical diagnoses (X2=114.3, P<0.001, d.f.=4). A wide range of antibiotics was administered for 87.8% of the patients, regardless of the diagnostic or prognostic nature of their diseases. Antibiotic prescribing for acute URTIs in the rural areas of Ethiopia is unduly high, with high proportions of mild, self-limiting illness, mostly URTIs. Implementation of CRP point-of-care testing in such resource-constrained settings, with low- or middle-grade healthcare professionals, could help reconcile the inappropriate use of antibiotics by withholding from patients who do not benefit from antibiotic treatment. PMID:26769226

  14. C-reactive protein point-of-care testing and antibiotic prescribing for acute respiratory tract infections in rural primary health centres of North Ethiopia: a cross-sectional study.

    PubMed

    Yebyo, Henock; Medhanyie, Araya Abrha; Spigt, Mark; Hopstaken, Rogier

    2016-01-01

    Unjustified antibiotic prescribing for acute upper respiratory infections (URTIs) is probably more common in poor-resource settings where physicians are scarce. Introducing C-reactive protein (CRP) point-of-care testing in such settings could reduce the misuse of antibiotics, which could avert antibiotic resistance. However, information useful for the applicability of CRP test in resource-limited settings is lacking. This study aimed to elicit the frequency of antibiotic prescribing and distribution of CRP levels in remote, rural settings in Ethiopia. We included 414 patients with acute URTIs from four health centres. Health professionals recorded the clinical features of the patients, but the laboratory professionals measured the CRP levels of all patients at the point of care. The most prominent respiratory causes for consultation were acute URTIs combined (44.4%), and lower respiratory tract infections-pneumonia (29.71%) and acute bronchitis (25.84%). The CRP distribution was <20 mg/l, 20-99 mg/l and 100 mg/l or more in 66.6%, 27.9% and 5.5% of the patients, respectively. The CRP levels were significantly different among these clinical diagnoses (X(2)=114.3, P<0.001, d.f.=4). A wide range of antibiotics was administered for 87.8% of the patients, regardless of the diagnostic or prognostic nature of their diseases. Antibiotic prescribing for acute URTIs in the rural areas of Ethiopia is unduly high, with high proportions of mild, self-limiting illness, mostly URTIs. Implementation of CRP point-of-care testing in such resource-constrained settings, with low- or middle-grade healthcare professionals, could help reconcile the inappropriate use of antibiotics by withholding from patients who do not benefit from antibiotic treatment. PMID:26769226

  15. Point of Care Assessment of Coagulation.

    PubMed

    Hyatt, Clare E; Brainard, Benjamin M

    2016-03-01

    Disorders of hemostasis can be difficult to fully elucidate but can severely affect patient outcome. The optimal therapy for coagulopathies is also not always clear. Point of care (POC) testing in veterinary medicine can assist in the diagnosis of hemostatic disorders and also direct treatment. Advantages of POC testing include rapid turnaround times, ease of use, and proximity to the patient. Disadvantages include differences in analytic performance compared with reference laboratory devices, the potential for operator error, and limited test options per device. Conventional coagulation tests such as prothrombin time, activated partial thromboplastin time, and activated clotting time can be measured by POC devices and can accurately diagnose hypocoagulability, but they cannot detect hypercoagulability or disorders of fibrinolysis. Viscoelastic POC coagulation testing more accurately evaluates in vivo coagulation, and can detect hypocoagulability, hypercoagulability, and alterations in fibrinolysis. POC platelet function testing methodologies can detect platelet adhesion abnormalities including von Willebrand disease, and can be used to monitor the efficacy of antiplatelet drugs. It is unlikely that a single test would be ideal for assessing the complete coagulation status of all patients; therefore, the ideal combination of tests for a specific patient needs to be determined based on an understanding of the underlying disease, and protocols must be standardized to minimize interoperator and interinstitutional variability. PMID:27451044

  16. Point-of-Care Glucose and Ketone Monitoring.

    PubMed

    Chong, Siew Kim; Reineke, Erica L

    2016-03-01

    Early and rapid identification of hypo- and hyperglycemia as well as ketosis is essential for the practicing veterinarian as these conditions can be life threatening and require emergent treatment. Point-of-care testing for both glucose and ketone is available for clinical use and it is important for the veterinarian to understand the limitations and potential sources of error with these tests. This article discusses the devices used to monitor blood glucose including portable blood glucose meters, point-of-care blood gas analyzers and continuous glucose monitoring systems. Ketone monitoring options discussed include the nitroprusside reagent test strips and the 3-β-hydroxybutyrate ketone meter. PMID:27451045

  17. Near point-of-care administration by the attending physician of the rapid influenza antigen detection immunochromatography test and the fully automated respiratory virus nucleic acid test: contribution to patient management.

    PubMed

    Boku, Soushin; Naito, Toshio; Murai, Kenji; Tanei, Mika; Inui, Akihiro; Nisimura, Hidekazu; Isonuma, Hiroshi; Takahashi, Hiroshi; Kikuchi, Ken

    2013-08-01

    Rapid influenza antigen detection tests (RIADTs) using immunochromatography are the most readily available tools for the diagnosis and management of influenza. This study was designed to assess whether near point-of-care administration by primary care physicians of the RIADT and a fully automated respiratory virus nucleic acid test (Verigene Respiratory Virus Plus®; RV+) would contribute to improved patient management. When viral culture and RT-PCR/bi-directional sequencing were used as the gold standard, sensitivities and specificities for RIADT and RV+ were 58.3% and 90.9%, and 97.2% and 100%, respectively. Within 12 hours from onset of fever, sensitivities were 44.4% and 94.4%, respectively, for RIADT and RV+. In clinical situations where a higher-sensitivity test is needed, such as during pre-admission evaluations, for testing of hospital employees during the prodromal phase of infection, during the therapeutic decision-making process, and during outbreaks, we suggest that patients testing negative by the RIADT can be reassessed with the RV+ test to achieve maximal diagnostic accuracy. PMID:23743175

  18. Usefulness in clinical practice of a point-of-care rapid test for simultaneous detection of nontreponemal and Treponema pallidum-specific antibodies in patients suffering from documented syphilis.

    PubMed

    Guinard, Jérôme; Prazuck, Thierry; Péré, Hélène; Poirier, Claire; LeGoff, Jérôme; Boedec, Erwan; Guigon, Aurélie; Day, Nesrine; Bélec, Laurent

    2013-12-01

    The usefulness of a point-of-care immunochromatographic dual test for the simultaneous detection of both nontreponemal and Treponema pallidum-specific antibodies (Chembio Diagnostics Systems Inc., Medford, NY, USA) was assessed in various situations related to syphilis, by reference to conventional syphilis serology. Thawed sera were obtained from 100 adults including 36 primary syphilis, 6 secondary syphilis, 6 re-infection, 9 recently-treated syphilis, and 43 old syphilis. Doubtful reactivities for the treponemal line were considered positive; doubtful reactivities for the nontreponemal line were considered positive only when the treponemal line was present. The sensitivity, the specificity, and its concordance to gold standard serology of treponemal line were high, around 90%. The sensitivity of nontreponemal line was 96.3%, its specificity 76.7%, and its concordance 83.4%. In conclusion, the dual rapid test from Chembio Diagnostics Systems Inc. is useful for rapid point-of-care diagnosis in the various situations encountered with patients suffering from syphilis. PMID:23999937

  19. Surface Tension Triggered Wetting and Point of Care Sensor Design.

    PubMed

    Falde, Eric J; Yohe, Stefan T; Grinstaff, Mark W

    2015-08-01

    Rapid, simple, and inexpensive point-of-care (POC) medical tests are of significant need around the world. The transition between nonwetting and wetted states is used to create instrument-free surface tension sensors for POC diagnosis, using a layered electrospun mesh with incorporated dye to change color upon wetting. PMID:26097150

  20. Point-of-Care HbA1c Testing with the A1cNow Test Kit in General Practice Dental Clinics: A Pilot Study Involving Its Accuracy and Practical Issues in Its Use

    PubMed Central

    Strauss, Shiela M.; Rosedale, Mary; Pesce, Michael A.; Juterbock, Caroline; Kaur, Navjot; DePaola, Joe; Goetz, Deborah; Wolff, Mark S.; Malaspina, Dolores; Danoff, Ann

    2014-01-01

    With millions of at-risk people undiagnosed with pre-diabetes and diabetes, there is a need to identify alternate screening sites for out-of-range glucose values. We examined practical issues and accuracy (relative to High Performance Liquid Chromatography testing in a laboratory) in the use of the A1cNow point of care device for this screening in general practice dental clinics at a large University-based Dental College. Health care professionals obtained evaluable readings for only 70% of the subjects, even after two attempts, and its use according to manufacturer's instructions was often challenging in the busy environment of the dental clinic. At thresholds for pre-diabetes and diabetes established by the American Diabetes Association, sensitivities of the A1cNow kit relative to the HPLC method were 91.9% and 100%, respectively. However, specificities for pre-diabetes and diabetes were 66.7% and 82.4%, respectively, indicating many false positive results. A better strategy for diabetes screening may involve a laboratory-based analysis approach that is patient- and provider-friendly, with minimal burden to the dental team. PMID:25593546

  1. How to Estimate the Cost of Point-of-Care CD4 Testing in Program Settings: An Example Using the Alere Pima™ Analyzer in South Africa

    PubMed Central

    Larson, Bruce; Schnippel, Kathryn; Ndibongo, Buyiswa; Long, Lawrence; Fox, Matthew P.; Rosen, Sydney

    2012-01-01

    Integrating POC CD4 testing technologies into HIV counseling and testing (HCT) programs may improve post-HIV testing linkage to care and treatment. As evaluations of these technologies in program settings continue, estimates of the costs of POC CD4 tests to the service provider will be needed and estimates have begun to be reported. Without a consistent and transparent methodology, estimates of the cost per CD4 test using POC technologies are likely to be difficult to compare and may lead to erroneous conclusions about costs and cost-effectiveness. This paper provides a step-by-step approach for estimating the cost per CD4 test from a provider's perspective. As an example, the approach is applied to one specific POC technology, the Pima™ Analyzer. The costing approach is illustrated with data from a mobile HCT program in Gauteng Province of South Africa. For this program, the cost per test in 2010 was estimated at $23.76 (material costs = $8.70; labor cost per test = $7.33; and equipment, insurance, and daily quality control = $7.72). Labor and equipment costs can vary widely depending on how the program operates and the number of CD4 tests completed over time. Additional costs not included in the above analysis, for on-going training, supervision, and quality control, are likely to increase further the cost per test. The main contribution of this paper is to outline a methodology for estimating the costs of incorporating POC CD4 testing technologies into an HCT program. The details of the program setting matter significantly for the cost estimate, so that such details should be clearly documented to improve the consistency, transparency, and comparability of cost estimates. PMID:22532854

  2. Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers’ Perspectives on Testing, Training and Quality Assurance

    PubMed Central

    Ansbro, Éimhín M.; Gill, Michelle M.; Reynolds, Joanna; Shelley, Katharine D.; Strasser, Susan; Sripipatana, Tabitha; Ncube, Alexander Tshaka; Tembo Mumba, Grace; Terris-Prestholt, Fern; Peeling, Rosanna W.; Mabey, David

    2015-01-01

    Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new

  3. Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers' Perspectives on Testing, Training and Quality Assurance.

    PubMed

    Ansbro, Éimhín M; Gill, Michelle M; Reynolds, Joanna; Shelley, Katharine D; Strasser, Susan; Sripipatana, Tabitha; Tshaka Ncube, Alexander; Tembo Mumba, Grace; Terris-Prestholt, Fern; Peeling, Rosanna W; Mabey, David

    2015-01-01

    Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new

  4. A Survey on Use of Rapid Tests and Tuberculosis Diagnostic Practices by Primary Health Care Providers in South Africa: Implications for the Development of New Point-of-Care Tests

    PubMed Central

    Davids, Malika; Dheda, Keertan; Pant Pai, Nitika; Cogill, Dolphina; Pai, Madhukar; Engel, Nora

    2015-01-01

    Background Effective infectious disease control requires early diagnosis and treatment initiation. Point-of-care testing offers rapid turn-around-times, facilitating same day clinical management decisions. To maximize the benefits of such POC testing programs, we need to understand how rapid tests are used in everyday clinical practice. Methods In this cross-sectional survey study, 400 primary healthcare providers in two cities in South Africa were interviewed on their use of rapid tests in general, and tuberculosis diagnostic practices, between September 2012 and June 2013. Public healthcare facilities were selected using probability-sampling techniques and private healthcare providers were randomly selected from the Health Professional Council of South Africa list. To ascertain differences between the two healthcare sectors 2-sample z-tests were used to compare sample proportions. Results The numbers of providers interviewed were equally distributed between the public (n = 200) and private sector (n = 200). The most frequently reported tests in the private sector include blood pressure (99.5%), glucose finger prick (89.5%) and urine dipstick (38.5%); and in the public sector were pregnancy (100%), urine dipstick (100%), blood pressure (100%), glucose finger prick (99%) and HIV rapid test (98%). The majority of TB testing occurs in the public sector, where significantly more providers prefer Xpert MTB/RIF assay, the designated clinical TB diagnostic tool by the national TB program, as compared to the private sector (87% versus 71%, p-value >0.0001). Challenges with regard to TB diagnosis included the long laboratory turn-around-time, difficulty in obtaining sputum samples and lost results. All providers indicated that a new POC test for TB should be rapid and cheap, have good sensitivity and specificity, ease of sample acquisition, detect drug-resistance and work in HIV-infected persons. Conclusion/significance The existing centralized laboratory services, poor

  5. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage.

    PubMed

    Bottero, Julie; Boyd, Anders; Gozlan, Joel; Carrat, Fabrice; Nau, Jean; Pauti, Marie-Dominique; Rougier, Hayette; Girard, Pierre-Marie; Lacombe, Karine

    2015-12-01

    Background.  In Europe and the United States, more than two thirds of individuals infected with hepatitis B virus (HBV) or hepatitis C virus (HCV) and 15%-30% of human immunodeficiency virus (HIV)-positive individuals are unaware of their infection status. Simultaneous HIV-, HBV-, and HCV-rapid tests could help improve infection awareness and linkage-to-care in particularly vulnerable populations. Methods.  The OptiScreen III study was a single-center, randomized, control trial conducted at a free clinic ("Médecins du Monde", Paris, France). Participants were randomized 1:1 to receive 1 of 2 interventions testing for HIV, HBV, and HCV: standard serology-based testing (S-arm) or point-of-care rapid testing (RT-arm). The main study endpoints were the proportion of participants who became aware of their HIV, HBV, and HCV status and who were linked to care when testing positive. Results.  A total of 324 individuals, representing mainly African immigrants, were included. In the S-arm, 115 of 162 (71.0%) participants performed a blood draw and 104 of 162 (64.2%) retrieved their test result. In comparison, 159 of 162 (98.2%) of participants randomized to the RT-arm obtained their results (P < .001). Of the 38 (11.7%) participants testing positive (HIV, n = 7; HBV, n = 23; HCV, n = 8), 15 of 18 (83.3%) in the S-arm and 18 of 20 (90.0%) in the RT-arm were linked-to-care (P = .7). In post hoc analysis assuming the same disease prevalence in those without obtaining test results, difference in linkage-to-care was more pronounced (S-arm = 60.0% vs RT-arm = 90.0%; P = .04). Conclusions.  In a highly at-risk population for chronic viral infections, the simultaneous use of HIV, HBV, and HCV point-of-care tests clearly improves the "cascade of screening" and quite possibly linkage-to-care. PMID:26668814

  6. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage

    PubMed Central

    Bottero, Julie; Boyd, Anders; Gozlan, Joel; Carrat, Fabrice; Nau, Jean; Pauti, Marie-Dominique; Rougier, Hayette; Girard, Pierre-Marie; Lacombe, Karine

    2015-01-01

    Background. In Europe and the United States, more than two thirds of individuals infected with hepatitis B virus (HBV) or hepatitis C virus (HCV) and 15%–30% of human immunodeficiency virus (HIV)-positive individuals are unaware of their infection status. Simultaneous HIV-, HBV-, and HCV-rapid tests could help improve infection awareness and linkage-to-care in particularly vulnerable populations. Methods. The OptiScreen III study was a single-center, randomized, control trial conducted at a free clinic (“Médecins du Monde”, Paris, France). Participants were randomized 1:1 to receive 1 of 2 interventions testing for HIV, HBV, and HCV: standard serology-based testing (S-arm) or point-of-care rapid testing (RT-arm). The main study endpoints were the proportion of participants who became aware of their HIV, HBV, and HCV status and who were linked to care when testing positive. Results. A total of 324 individuals, representing mainly African immigrants, were included. In the S-arm, 115 of 162 (71.0%) participants performed a blood draw and 104 of 162 (64.2%) retrieved their test result. In comparison, 159 of 162 (98.2%) of participants randomized to the RT-arm obtained their results (P < .001). Of the 38 (11.7%) participants testing positive (HIV, n = 7; HBV, n = 23; HCV, n = 8), 15 of 18 (83.3%) in the S-arm and 18 of 20 (90.0%) in the RT-arm were linked-to-care (P = .7). In post hoc analysis assuming the same disease prevalence in those without obtaining test results, difference in linkage-to-care was more pronounced (S-arm = 60.0% vs RT-arm = 90.0%; P = .04). Conclusions. In a highly at-risk population for chronic viral infections, the simultaneous use of HIV, HBV, and HCV point-of-care tests clearly improves the “cascade of screening” and quite possibly linkage-to-care. PMID:26668814

  7. Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens.

    PubMed

    Toliman, P; Badman, S G; Gabuzzi, J; Silim, S; Forereme, L; Kumbia, A; Kombuk, B; Kombati, Z; Allan, J; Munnull, G; Ryan, C; Vallely, L M; Kelly-Hanku, A; Wand, H; Mola, G D L; Guy, R; Siba, P; Kaldor, J M; Tabrizi, S N; Vallely, A J

    2016-07-01

    The World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both specimen types were tested at the point of care by using the Xpert HPV test. Women were given their cervical test result the same day. Those with a positive hrHPV test and positive examination upon visual inspection of the cervix with acetic acid were offered same-day cervical cryotherapy. A total of 1,005 women were enrolled, with 124 (12.3%; 95% confidence interval [CI], 10.3%, 14.4%) being positive for any hrHPV infection. There was a 99.4% overall percent agreement (OPA) between vaginal and cervical tests for HPV-16 (95% CI, 98.9%, 99.9%), a 98.5% OPA for HPV-18/45 (95% CI, 97.7%, 99.3%), a 94.4% OPA for other hrHPV infections (95% CI, 92.9%, 95.9%), and a 93.4% OPA for all hrHPV types combined (95% CI, 91.8%, 95.0%). Self-collected vaginal specimens had excellent agreement with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. This approach provides for the first time an opportunity to incorporate point-of-care hrHPV testing into clinical cervical screening algorithms in high-burden, low-income settings. PMID:27076663

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

    PubMed Central

    Adiguzel, Yekbun; Kulah, Haluk

    2012-01-01

    The burden of health-care related services in a global era with continuously increasing population and inefficient dissipation of the resources requires effective solutions. From this perspective, point-of-care diagnostics is a demanded field in clinics. It is also necessary both for prompt diagnosis and for providing health services evenly throughout the population, including the rural districts. The requirements can only be fulfilled by technologies whose productivity has already been proven, such as complementary metal-oxide-semiconductors (CMOS). CMOS-based products can enable clinical tests in a fast, simple, safe, and reliable manner, with improved sensitivities. Portability due to diminished sensor dimensions and compactness of the test set-ups, along with low sample and power consumption, is another vital feature. CMOS-based sensors for cell studies have the potential to become essential counterparts of point-of-care diagnostics technologies. Hence, this review attempts to inform on the sensors fabricated with CMOS technology for point-of-care diagnostic studies, with a focus on CMOS image sensors and capacitance sensors for cell studies. PMID:23112587

  9. Approved IFCC recommendation on reporting results for blood glucose: International Federation of Clinical Chemistry and Laboratory Medicine Scientific Division, Working Group on Selective Electrodes and Point-of-Care Testing (IFCC-SD-WG-SEPOCT).

    PubMed

    D'Orazio, Paul; Burnett, Robert W; Fogh-Andersen, Niels; Jacobs, Ellis; Kuwa, Katsuhiko; Külpmann, Wolf R; Larsson, Lasse; Lewenstam, Andrzej; Maas, Anton H J; Mager, Gerhard; Naskalski, Jerzy W; Okorodudu, Anthony O

    2006-01-01

    In current clinical practice, plasma and blood glucose are used interchangeably with a consequent risk of clinical misinterpretation. In human blood, glucose is distributed, like water, between erythrocytes and plasma. The molality of glucose (amount of glucose per unit water mass) is the same throughout the sample, but the concentration is higher in plasma, because the concentration of water and therefore glucose is higher in plasma than in erythrocytes. Different devices for the measurement of glucose may detect and report fundamentally different quantities. Different water concentrations in the calibrator, plasma, and erythrocyte fluid can explain some of the differences. Results for glucose measurements depend on the sample type and on whether the method requires sample dilution or uses biosensors in undiluted samples. If the results are mixed up or used indiscriminately, the differences may exceed the maximum allowable error for glucose determinations for diagnosing and monitoring diabetes mellitus, thus complicating patient treatment. The goal of the International Federation of Clinical Chemistry and Laboratory Medicine, Scientific Division, Working Group on Selective Electrodes and Point of Care Testing (IFCC-SD-WG-SEPOCT) is to reach a global consensus on reporting results. The document recommends reporting the concentration of glucose in plasma (in the unit mmol/L), irrespective of sample type or measurement technique. A constant factor of 1.11 is used to convert concentration in whole blood to the equivalent concentration in plasma. The conversion will provide harmonized results, facilitating the classification and care of patients and leading to fewer therapeutic misjudgments. PMID:17163827

  10. Point of Care Technologies for HIV

    PubMed Central

    Hewlett, Indira K.

    2014-01-01

    Effective prevention of HIV/AIDS requires early diagnosis, initiation of therapy, and regular plasma viral load monitoring of the infected individual. In addition, incidence estimation using accurate and sensitive assays is needed to facilitate HIV prevention efforts in the public health setting. Therefore, more affordable and accessible point-of-care (POC) technologies capable of providing early diagnosis, HIV viral load measurements, and CD4 counts in settings where HIV is most prevalent are needed to enable appropriate intervention strategies and ultimately stop transmission of the virus within these populations to achieve the future goal of an AIDS-free generation. This review discusses the available and emerging POC technologies for future application to these unmet public health needs. PMID:24579041

  11. Powering point-of-care diagnostic devices.

    PubMed

    Choi, Seokheun

    2016-01-01

    Effective and rapid point-of-care (POC) diagnostics have the capability to revolutionize public healthcare both in developed and developing countries. One of the key challenges that is critical to address in developing POC devices is to effectively and sufficiently power them. In developing countries, where the electricity grid is not well established and the use of batteries is not cost-effective, power supplies are the most problematic issue for stand-alone and self-sustained POC devices. In this review, we provide an overview of techniques for powering POC diagnostic devices for use in both developed and developing countries, as well as detailed discussions of recent advancements in POC devices. Then, we discuss next-generation POC diagnostics and their power source strategies. PMID:26631766

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

    PubMed Central

    Smallwood, Megan; Vijh, Rohit; Nauche, Bénédicte; Lebouché, Bertrand; Joseph, Lawrence; Pant Pai, Nitika

    2016-01-01

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

  13. Point of Care Measurement of Lactate.

    PubMed

    Di Mauro, Francesca Miranda; Schoeffler, Gretchen Lee

    2016-03-01

    Lactate is generated as a consequence of anaerobic glycolysis by all tissues of the body. Increased l-lactate, the isoform produced by most mammals, reflects increased anaerobic metabolism secondary to tissue hypoperfusion or tissue hypoxia in most clinical situations, and is called type A lactic acidosis. The utility of lactate measurement and serial lactate monitoring in veterinary patients has been demonstrated in multiple studies. Blood lactate concentration is significantly elevated in many disease processes including septic peritonitis, immune-mediated hemolytic anemia, Babesiosis, trauma, gastric dilation and volvulus, and intracranial disease. Lactate clearance can be used to assess response to fluid therapy, cardiovascular therapeutics, and blood product transfusion in patients affected by type A lactic acidosis. Lactate concentration in peritoneal, pericardial, and synovial fluid can also be used as a diagnostic tool. Point of care analyzers such as the Lactate Pro, Lactate Scout, Accutrend, iSTAT, and Lactate Plus have been shown to be accurate lactate measurement instruments in small animal patients. PMID:27451047

  14. The Point-of-Care Laboratory in Clinical Microbiology.

    PubMed

    Drancourt, Michel; Michel-Lepage, Audrey; Boyer, Sylvie; Raoult, Didier

    2016-07-01

    Point-of-care (POC) laboratories that deliver rapid diagnoses of infectious diseases were invented to balance the centralization of core laboratories. POC laboratories operate 24 h a day and 7 days a week to provide diagnoses within 2 h, largely based on immunochromatography and real-time PCR tests. In our experience, these tests are conveniently combined into syndrome-based kits that facilitate sampling, including self-sampling and test operations, as POC laboratories can be operated by trained operators who are not necessarily biologists. POC laboratories are a way of easily providing clinical microbiology testing for populations distant from laboratories in developing and developed countries and on ships. Modern Internet connections enable support from core laboratories. The cost-effectiveness of POC laboratories has been established for the rapid diagnosis of tuberculosis and sexually transmitted infections in both developed and developing countries. PMID:27029593

  15. Optical Imaging Techniques for Point-of-care Diagnostics

    PubMed Central

    Zhu, Hongying; Isikman, Serhan O.; Mudanyali, Onur; Greenbaum, Alon; Ozcan, Aydogan

    2012-01-01

    Improving the access to effective and affordable healthcare has long been a global endeavor. In this quest, the development of cost-effective and easy-to-use medical testing equipment that enable rapid and accurate diagnosis is essential to reduce the time and costs associated with healthcare services. To this end, point-of-care (POC) diagnostics plays a crucial role in healthcare delivery in both the developed and developing countries by bringing medical testing to patients, or to sites near patients. As the diagnosis of a wide range of diseases, including various types of cancers and many endemics relies on optical techniques, numerous compact and cost-effective optical imaging platforms have been developed in recent years for use at the POC. Here, we review the state-of-the-art optical imaging techniques that can have significant impact on global health by facilitating effective and affordable POC diagnostics. PMID:23044793

  16. Internet Point of Care Learning at a Community Hospital

    ERIC Educational Resources Information Center

    Sinusas, Keith

    2009-01-01

    Introduction: Internet point of care (PoC) learning is a relatively new method for obtaining continuing medical education credits. Few data are available to describe physician utilization of this CME activity. Methods: We describe the Internet point of care system we developed at a medium-sized community hospital and report on its first year of…

  17. Point-of-care ultrasonography by pediatric emergency medicine physicians.

    PubMed

    Marin, Jennifer R; Lewiss, Resa E

    2015-04-01

    Emergency physicians have used point-of-care ultrasonography since the 1990 s. Pediatric emergency medicine physicians have more recently adopted this technology. Point-of-care ultrasonography is used for various scenarios, particularly the evaluation of soft tissue infections or blunt abdominal trauma and procedural guidance. To date, there are no published statements from national organizations specifically for pediatric emergency physicians describing the incorporation of point-of-care ultrasonography into their practice. This document outlines how pediatric emergency departments may establish a formal point-of-care ultrasonography program. This task includes appointing leaders with expertise in point-of-care ultrasonography, effectively training and credentialing physicians in the department, and providing ongoing quality assurance reviews. PMID:25825532

  18. Towards point of care testing for C. difficile infection by volatile profiling, using the combination of a short multi-capillary gas chromatography column with metal oxide sensor detection

    NASA Astrophysics Data System (ADS)

    McGuire, N. D.; Ewen, R. J.; de Lacy Costello, B.; Garner, C. E.; Probert, C. S. J.; Vaughan, K.; Ratcliffe, N. M.

    2014-06-01

    Rapid volatile profiling of stool sample headspace was achieved using a combination of short multi-capillary chromatography column (SMCC), highly sensitive heated metal oxide semiconductor sensor and artificial neural network software. For direct analysis of biological samples this prototype offers alternatives to conventional gas chromatography (GC) detectors and electronic nose technology. The performance was compared to an identical instrument incorporating a long single capillary column (LSCC). The ability of the prototypes to separate complex mixtures was assessed using gas standards and homogenized in house ‘standard’ stool samples, with both capable of detecting more than 24 peaks per sample. The elution time was considerably faster with the SMCC resulting in a run time of 10 min compared to 30 min for the LSCC. The diagnostic potential of the prototypes was assessed using 50 C. difficile positive and 50 negative samples. The prototypes demonstrated similar capability of discriminating between positive and negative samples with sensitivity and specificity of 85% and 80% respectively. C. difficile is an important cause of hospital acquired diarrhoea, with significant morbidity and mortality around the world. A device capable of rapidly diagnosing the disease at the point of care would reduce cases, deaths and financial burden.

  19. Augmenting Epidemiological Models with Point-Of-Care Diagnostics Data.

    PubMed

    Özmen, Özgür; Pullum, Laura L; Ramanathan, Arvind; Nutaro, James J

    2016-01-01

    Although adoption of newer Point-of-Care (POC) diagnostics is increasing, there is a significant challenge using POC diagnostics data to improve epidemiological models. In this work, we propose a method to process zip-code level POC datasets and apply these processed data to calibrate an epidemiological model. We specifically develop a calibration algorithm using simulated annealing and calibrate a parsimonious equation-based model of modified Susceptible-Infected-Recovered (SIR) dynamics. The results show that parsimonious models are remarkably effective in predicting the dynamics observed in the number of infected patients and our calibration algorithm is sufficiently capable of predicting peak loads observed in POC diagnostics data while staying within reasonable and empirical parameter ranges reported in the literature. Additionally, we explore the future use of the calibrated values by testing the correlation between peak load and population density from Census data. Our results show that linearity assumptions for the relationships among various factors can be misleading, therefore further data sources and analysis are needed to identify relationships between additional parameters and existing calibrated ones. Calibration approaches such as ours can determine the values of newly added parameters along with existing ones and enable policy-makers to make better multi-scale decisions. PMID:27096162

  20. Augmenting Epidemiological Models with Point-Of-Care Diagnostics Data

    PubMed Central

    2016-01-01

    Although adoption of newer Point-of-Care (POC) diagnostics is increasing, there is a significant challenge using POC diagnostics data to improve epidemiological models. In this work, we propose a method to process zip-code level POC datasets and apply these processed data to calibrate an epidemiological model. We specifically develop a calibration algorithm using simulated annealing and calibrate a parsimonious equation-based model of modified Susceptible-Infected-Recovered (SIR) dynamics. The results show that parsimonious models are remarkably effective in predicting the dynamics observed in the number of infected patients and our calibration algorithm is sufficiently capable of predicting peak loads observed in POC diagnostics data while staying within reasonable and empirical parameter ranges reported in the literature. Additionally, we explore the future use of the calibrated values by testing the correlation between peak load and population density from Census data. Our results show that linearity assumptions for the relationships among various factors can be misleading, therefore further data sources and analysis are needed to identify relationships between additional parameters and existing calibrated ones. Calibration approaches such as ours can determine the values of newly added parameters along with existing ones and enable policy-makers to make better multi-scale decisions. PMID:27096162

  1. Augmenting epidemiological models with point-of-care diagnostics data

    DOE PAGESBeta

    Pullum, Laura L.; Ramanathan, Arvind; Nutaro, James J.; Ozmen, Ozgur

    2016-04-20

    Although adoption of newer Point-of-Care (POC) diagnostics is increasing, there is a significant challenge using POC diagnostics data to improve epidemiological models. In this work, we propose a method to process zip-code level POC datasets and apply these processed data to calibrate an epidemiological model. We specifically develop a calibration algorithm using simulated annealing and calibrate a parsimonious equation-based model of modified Susceptible-Infected-Recovered (SIR) dynamics. The results show that parsimonious models are remarkably effective in predicting the dynamics observed in the number of infected patients and our calibration algorithm is sufficiently capable of predicting peak loads observed in POC diagnosticsmore » data while staying within reasonable and empirical parameter ranges reported in the literature. Additionally, we explore the future use of the calibrated values by testing the correlation between peak load and population density from Census data. Our results show that linearity assumptions for the relationships among various factors can be misleading, therefore further data sources and analysis are needed to identify relationships between additional parameters and existing calibrated ones. As a result, calibration approaches such as ours can determine the values of newly added parameters along with existing ones and enable policy-makers to make better multi-scale decisions.« less

  2. Pediatric Care Online: A Pediatric Point-of-Care Tool.

    PubMed

    Vardell, Emily

    2016-01-01

    Pediatric Care Online is the American Academy of Pediatrics' point-of-care tool designed for health care providers. Pediatric Care Online builds on content from Red Book Online and Pediatric Patient Education and features Quick Reference topic pages for more than 250 pediatric health care topics. The multitude of resources available within Pediatric Care Online will be reviewed in this column, and a sample search will be used to illustrate the type of information available within this point-of-care pediatric resource. PMID:27054536

  3. Point-of-care diagnostics for niche applications.

    PubMed

    Cummins, Brian M; Ligler, Frances S; Walker, Glenn M

    2016-01-01

    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. PMID:26837054

  4. [Utility of Ultrasonography in Point of Care for Cardiovascular Disease].

    PubMed

    Ishizu, Tomoko; Kawakami, Yasushi

    2015-06-01

    Echocardiography is a powerful noninvasive cardiovascular diagnostic tool. In the emergency room, an outpatient setting, and the intensive care unit, physician-performed point-of-care (POC) echocardiography is particularly important to understand the concurrent pathophysiology of unstable patients. In POC echocardiography, the purpose of examination should be clearly decided in advance by performing careful symptom assessment and physical examination, including heart and lung auscultation. In this article, heart failure, cardiac murmur-, ischemic heart disease, and acute pulmonary artery thromboembolism are selected and overviewed to assess the utility of POC cardiovascular ultrasound. In heart failure, visual assessments of the left ventricular ejection fraction, chamber size ratio, and inferior vena cava diameter are important. An ultrasound lung comet is a very useful finding, suggesting the presence of lung congestion. In patients with a cardiac murmur, the source of the abnormal sound can easily be confirmed by the color Doppler signal in conjunction with chamber size assessment. On the other hand, judgment of the severity of valvular heart disease should be reserved for detailed echocardiography. In acute coronary syndrome, POC echo is extremely important for prompt diagnosis and complication assessment. An understanding of the coronary artery territory and method to detect regional wall motion abnormality in ischemic heart disease is necessary. Papillary muscle rupture and ventricular septal perforation are both fatal complications of myocardial infarction, and they should be kept in mind and pan-systolic murmur should be detected before echocardiography. In acute pulmonary thromboembolism, the right heart size and characteristic wall motion abnormality should be focused on using echocardiography in addition to tricuspid regurgitant flow velocity measurement. Femoral vein ultrasonography with a compression test should be performed for all patients with acute

  5. A handheld point-of-care genomic diagnostic system.

    PubMed

    Myers, Frank B; Henrikson, Richard H; Bone, Jennifer M; Bone, Jennifer; Lee, Luke P

    2013-01-01

    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, CAD drawings

  6. ROM Plus(®): accurate point-of-care detection of ruptured fetal membranes.

    PubMed

    McQuivey, Ross W; Block, Jon E

    2016-01-01

    Accurate and timely diagnosis of rupture of fetal membranes is imperative to inform and guide gestational age-specific interventions to optimize perinatal outcomes and reduce the risk of serious complications, including preterm delivery and infections. The ROM Plus is a rapid, point-of-care, qualitative immunochromatographic diagnostic test that uses a unique monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations: alpha-fetoprotein and insulin-like growth factor binding protein-1. Clinical study results have uniformly demonstrated high diagnostic accuracy and performance characteristics with this point-of-care test that exceeds conventional clinical testing with external laboratory evaluation. The description, indications for use, procedural steps, and laboratory and clinical characterization of this assay are presented in this article. PMID:27274316

  7. ROM Plus®: accurate point-of-care detection of ruptured fetal membranes

    PubMed Central

    McQuivey, Ross W; Block, Jon E

    2016-01-01

    Accurate and timely diagnosis of rupture of fetal membranes is imperative to inform and guide gestational age-specific interventions to optimize perinatal outcomes and reduce the risk of serious complications, including preterm delivery and infections. The ROM Plus is a rapid, point-of-care, qualitative immunochromatographic diagnostic test that uses a unique monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations: alpha-fetoprotein and insulin-like growth factor binding protein-1. Clinical study results have uniformly demonstrated high diagnostic accuracy and performance characteristics with this point-of-care test that exceeds conventional clinical testing with external laboratory evaluation. The description, indications for use, procedural steps, and laboratory and clinical characterization of this assay are presented in this article. PMID:27274316

  8. Reconfigurable point-of-care systems designed with interoperability standards.

    PubMed

    Warren, Steve; Yao, Jianchu; Schmitz, Ryan; Lebak, Jeff

    2004-01-01

    Interoperability standards, if properly applied to medical system design, have the potential to decrease the cost of point-of-care monitoring systems while better matching systems to patient needs. This paper presents a brief editorial overview of future monitoring environments, followed by a short listing of smart-home and wearable-device efforts. This is followed by a summary of recent efforts in the Medical Component Design Laboratory at Kansas State University to address interoperability issues in point-of-care systems by incorporating the Bluetooth Host Controller Interface, the IEEE 1073 Medical Information Bus, and Health Level 7 (HL7) into a monitoring system that hosts wearable or nearby wireless devices. This wireless demonstration system includes a wearable electrocardiogram, wearable pulse oximeter, wearable data logger, weight scale, and LabVIEW base station. Data are exchanged between local and remote MySQL databases using the HL7 standard for medical information exchange. PMID:17270979

  9. Point-of-care ultrasound: seeing the future.

    PubMed

    Morris, Amy E

    2015-01-01

    Practitioners other than radiologists and certified sonographers are increasingly using ultrasound at the bedside to facilitate immediate patient management from both procedural and diagnostic standpoints. This editorial provides a brief overview of the use of point-of-care ultrasound in clinical practice, its potential to improve patient care, and some of the unanswered questions surrounding issues of training, scope of practice, and quality assurance. PMID:25064491

  10. What a difference a CRP makes. A prospective observational study on how point-of-care C-reactive protein testing influences antibiotic prescription for respiratory tract infections in Swedish primary health care

    PubMed Central

    Lindström, Johan; Nordeman, Lena; Hagström, Bertil

    2015-01-01

    Objective: To explore how C-reactive protein (CRP) tests serve to support physicians in decisions concerning antibiotic prescription to patients with respiratory tract infections (RTI). Design. Prospective observational study. Setting: Primary health care centres in western Sweden. Subjects. Physicians in primary health care. Patients with acute RTI. Main outcome measures: Physician willingness to measure CRP, their ability to estimate CRP, and changes in decision-making concerning antibiotic treatment based on error estimate and the physician’s opinion of whether CRP measurement was crucial. Results: Data from 340 consultations were gathered. CRP testing was found to be crucial in 130 cases. In 86% of visits decisions regarding antibiotic prescription were unchanged. Physicians considering CRP crucial and physicians making an error estimate of CRP altered their decisions concerning antibiotic prescription after CRP testing more often than those who considered CRP unnecessary, and those making a more accurate estimate. Physicians changed their decision on antibiotic prescription in 49 cases. In the majority of these 49 cases physicians underestimated CRP levels, and the majority of changes were from “no” to “yes” as to whether to prescribe antibiotics. Conclusion: CRP is an important factor in the decision on whether to prescribe antibiotics for RTIs. Error estimates of CRP and willingness to measure CRP are important factors leading to physicians changing decisions on antibiotic treatment.Key pointsThere is a generally low antibiotic prescription rate and a high frequency of C-reactive protein (CRP) testing for respiratory tract infections (RTIs) in Sweden.CRP testing was considered essential to further management in 38% of cases.In 86% of visits decisions concerning antibiotic prescription were unchanged.The strongest predictors for revised decisions on antibiotic treatment were error estimates of CRP and the physician’s opinion that CRP measurement