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Sample records for point-of-care testing poct

  1. 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: Time, Location, Interpretation and Tempo. A framework is presented in this paper. There were several current and future challenges identified through the workshop. These broadly fall into the categories of technology development and implementation. More specifically these are in the areas of: 1) Design, 2) Patient driven demand and technology, 3) Information Characteristics and Presentation, 4) Health Information Systems, 5) Connectivity, 6) Workflow and implementation, 7) Maintenance/Cost, and 8) Quality Control. Definitions of these challenge areas and recommendations to address them are provided. PMID:25750593

  2. 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

  3. 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

  4. 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 POCT. PMID:14510177

  5. Recommendations of the German Working Group on medical laboratory testing (AML) on the introduction and quality assurance of procedures for Point-of-Care Testing (POCT) in hospitals.

    PubMed

    Briedigkeit, L; Müller-Plathe, O; Schlebusch, H; Ziems, J

    1999-09-01

    The following recommendations were drawn up by the Working Group "Point-of-Care Testing" of the DGKC and DGLM which was set up in 1997. This first document from the Working Group sets out the principles which should be observed when introducing point-of-care testing. These general recommendations are to be followed by further specific recommendations on individual procedures or groups of procedures, e.g. blood glucose, electrolytes in whole blood, blood gases, coagulation, toxicology, quality control and others, which will be drawn up by experts at the suggestion of the Working Group. PMID:10596959

  6. [Drug testing with use of POCT].

    PubMed

    Komiyama, Yutaka

    2012-12-01

    Drug testing with the use of point of care testing (POCT) has been widely used in Japan, especially in the field of drug abuse, poisoning, and anticoagulant therapy with warfarin. For evidence-based medicine of POCT, an interesting report was presented by the National Academy of Clinical Biochemistry in the United States as the guideline in 2006. Users of POCT devices should understand all limitations of the devices. This strength/consensus recommendation is strong and the level of evidence is high. In this field, cyan, arsenic, paraquat, organic phosphate, methanol, acetaminophen, barbiturates, benzodiazepines, antidepressants, and some other drugs were detected by POCT devices such as Triage DOA and a detector tube system and others in Japan. The usefulness of the organophosphorus pesticide detection kit in the accident of GYOZA POISONING from china was noteworthy. In the case of toluene intoxication, the detector tube system was useful as a screening test for the gas phase test of a 2-year-old patient's vomit and excreta without any information from his parents. In warfarin treatment, a POCT device was useful for small hospitals and clinics. Although the cost is not covered by the health insurance system in Japan, the emergency centers of hospitals use these POCT devices for clinical decision-making. This is the most important problem. PMID:23427699

  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. 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

  9. The state of point-of-care testing: a European perspective.

    PubMed

    Larsson, Anders; Greig-Pylypczuk, Roman; Huisman, Albert

    2015-03-01

    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

  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. Point-of-care testing in diabetes care.

    PubMed

    Matteucci, E; Giampietro, O

    2011-02-01

    Assessing modifiable risk factors for metabolic and cardiovascular diseases prior to the onset of disease could allow effective prevention initiatives. Equally, monitoring in diabetic people glucose, haemoglobin A1c, ketones, lipid profiles, and urinary microalbumin concentrations allows the prevention, early detection, and treatment of diabetes-related acute and chronic complications and has a positive impact on the process of care in the management of patients with diabetes. The point-of-care testing (PoCT) technology offers convenient aspects: immediate results, decision-making without the need for repeated visits, use of fingerstick blood samples. More patients could be identified at early stages of their disease/complication provided that pre-analytical, analytical, and post-analytical errors are minimised. Indeed, prediction requires instruments with proved precision, accuracy, validity, and reliability. Reference laboratory services are now available to manufacturers so to confirm PoCT results. There are several PoC devices on the market that may allow for "real time" screening, diagnosis, and monitoring in diabetes care. Tight glucose control has a key role in long-term health of diabetic people and in the primary prevention of diabetic chronic complications. Diabetic patients are currently educated to control capillary glucose levels daily in order to maintain them within target limits. Blood glucose meters are widely used not only by diabetic patients to self-manage their disease but also by physicians to monitor critically ill patients. Glycated haemoglobin A1c can now be measured with fast and easy automated PoCT instruments to monitor long-term serum glucose regulation. Urinalysis dipsticks and blood betahydroxybutyrate meter allow measuring urine and blood ketones to prevent ketoacidosis. Since the routine measurement of urinary albumin has been suggested in diabetes mellitus as a predictor of overt diabetic nephropathy, semi-quantitative visual dipsticks and quantitative automated methods of urine testing became available for bedside detection of urine albumin at low concentrations and for the determination of the microalbumin creatinine ratio. While the National Cholesterol Education Program recommends that all adults aged 20 years and over have their blood cholesterol checked at least once every 5 years, adult diabetic patients should measure fasting lipid profile at least annually or every two years in case of low-risk lipid values. There are PoCT devices on the market that provide a full lipid panel (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides). The overview summarises current state-of-the-art of PoCT in diabetes care. PMID:21222582

  13. 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

  14. Point-of-care testing in the United Kingdom.

    PubMed

    Creed, G M

    2001-05-01

    Point-of-care testing in the United Kingdom is currently at the embryo stage of development, and is approximately 10 years behind the United States in incorporation and application into clinical practice. Safeguards to ensure proper use are not in place within the UK at present, and there is no legal requirement for POCT users to be proficiency tested by an internal or external body before they can routinely use the equipment. Internal quality control and external quality assessment are not statutory requirements within the UK, leading to unease regarding the extent and range of point-of-care tests offered and whether the results are a true biochemical representation of the patient's clinical condition. Cost-benefit analysis is very sparse, but faster turnaround times can only lead to more rapid treatment of the patient, which will lead to fewer clinical complications. This will result in decreased hospital admissions by the emergency department and reduced length of hospital stay in ward-based patients. National Health Service (NHS) accountants will see this, as the way forward, as fewer patients being admitted into hospital and length of stay reduction will result in decreased expenditure by the service provider. PMID:11868694

  15. 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

  16. 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

  17. 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

  18. 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

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

    PubMed

    Parco, Sergio; Visconti, Patrizia; Vascotto, Fulvia

    2014-01-01

    Involvement of health personnel in a medical audit can reduce the number of errors in laboratory medicine. The checked control of point of care testing (POCT) could be an answer to developing a better medical service in the emergency department and decreasing the time taken to report tests. The performance of sanitary personnel from different disciplines was studied over an 18-month period in a children's hospital. Clinical errors in the emergency and laboratory departments were monitored by: nursing instruction using specific courses, POCT, and external quality control; improvement of test results and procedural accuracy; and reduction of hemolyzed and nonprotocol-conforming samples sent to the laboratory department. In January 2012, point of care testing (POCT) was instituted in three medical units (neonatology, resuscitation, delivery room) at the Children's Hospital in Trieste, northeast Italy, for analysis of hematochemical samples. In the same period, during the months of January 2012 and June 2013, 1,600 samples sent to central laboratory and their related preanalytical errors were examined for accuracy. External quality control for POCT was also monitored in the emergency department; three meetings were held with physicians, nurses, and laboratory technicians to highlight problems, ie, preanalytical errors and analytical methodologies associated with POCT. During the study, there was an improvement in external quality control for POCT from -3 or -2 standard deviations or more to one standard deviation for all parameters. Of 800 samples examined in the laboratory in January 2012, we identified 64 preanalytical errors (8.0%); in June 2013, there were 17 preanalytical errors (2.1%), representing a significant decrease (P<0.05, χ(2) test). Multidisciplinary management and clinical audit can be used as tools to detect errors caused by organizational problems outside the laboratory and improve clinical and economic outcomes. PMID:24474844

  20. CRP detection from serum for chip-based point-of-care testing system.

    PubMed

    Kim, Chang-Hoon; Ahn, Jae-Hyuk; Kim, Jee-Yeon; Choi, Ji-Min; Lim, Kyung-Choon; Park, Tae Jung; Heo, Nam Su; Lee, Hee Gu; Kim, Jong-Wan; Choi, Yang-Kyu

    2013-03-15

    Most of point-of-care testing (POCT) to improve facilitates in diagnosis, treatment, and monitoring of patients. POCT technique has still remained a quantitatively and accurately detective effect. In this article, we demonstrated that real human C-reactive protein (CRP) in serum was detected for a chip-based point-of-care testing application based on a nanogap-embedded field effect transistor (FET), and the results were compared with those obtained via the enzyme-linked immunosorbent assay (ELISA) method. The limit of detection (LOD), determined from the standard curve, was 0.1 ng/ml, which is comparable to that of commercialized ELISAs. We evaluated that an improved detection range (0.1 ng/ml to 100 ng/ml) was achieved by comparing with commercialized ELISA. Control experiments to determine selectivity and to discern false-positive/false-negative rates were also performed. This report is the first description of the detection of CRP in human serum using a silicon-based biosensor. PMID:23017687

  1. 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

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

    PubMed

    Lamb, L S

    1995-10-01

    The development of "user-friendly" laboratory analyzers, combined with the need for rapid assessment of critical care patients, has led to the performance of in vitro diagnostic testing at the point of care. This strategy has been well received by most physicians who desire rapid turnaround times for laboratory tests, especially in the critical care areas. Since the primary care-giver in most critical care units is the registered nurse, much point-of-care testing has been delegated to nursing personnel. This has resulted in questions of authority, responsibility, regulation, and conflict resolution. These areas are discussed along with alternative strategies, such as vacuum transport, stat and/or satellite laboratories, unit-based phelebotomists, or "super techs," designed to achieve the goals of bedside or near-bedside testing in the critical care setting. PMID:7487383

  3. Point-of-care testing in diabetes mellitus.

    PubMed

    Price, Christopher P

    2003-09-01

    Diabetes mellitus is an excellent case study of the evolution, and successful application, of point-of-care testing. It offers a valuable history of the way in which technology has evolved, and continues to evolve, to meet the needs of patients whilst also providing for a more optimal delivery of care. Diabetes mellitus is also a good exemplar of where test and treatment regimes must operate in complete harmony in order to achieve the greatest benefit. Thus whilst the measurement of blood glucose is central to the screening, diagnosis and management of diabetes, it is in the latter use, largely related to supporting compliance with therapy, that point-of-care testing is of greatest relevance. In addition, there are other tests, more associated with the management of diabetes and early detection of the complications associated with diabetes, that are appropriate to the point-of-care testing modality. This Review will focus on the developments in technology and the harnessing of this innovation to support the delivery of clinical, organisational and economic benefits in the care of patients with diabetes mellitus. PMID:14598871

  4. Point-of-care testing for pandemic influenza and biothreats.

    PubMed

    Louie, Richard F; Kitano, Tyler; Brock, T Keith; Derlet, Robert; Kost, Gerald J

    2009-12-01

    New and reemerging infectious diseases, such as pandemic viruses and resistant bacteria, pose a serious threat in the 21st century. Some of these agents represent global security threats. This review provides an overview of diagnostic challenges presented by pandemic influenza and biothreat agents. The article summarizes recent pandemics and disease outbreaks, point-of-care influenza diagnostic tests, biothreat agents, biothreat instrument systems, and technologies in development. It highlights how medical innovation and health care initiatives can help prepare health care professionals and public health personnel to handle future crises. Based on gap analysis for current point-of-care testing deficiencies, it concludes with policy recommendations that will enhance preparedness. PMID:19797963

  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 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

  7. A point-of-care test for measles diagnosis: detection of measles-specific IgM antibodies and viral nucleic acid

    PubMed Central

    Slibinskas, Rimantas; Chua, Kaw Bing; Nigatu, Wondatir; Brown, Kevin E; Sasnauskas, Kestutis; Samuel, Dhanraj; Brown, David

    2011-01-01

    Abstract Objective To evaluate the performance of a newly developed point-of-care test (POCT) for the detection of measles-specific IgM antibodies in serum and oral fluid specimens and to assess if measles virus nucleic acid could be recovered from used POCT strips. Methods The POCT was used to test 170 serum specimens collected through measles surveillance or vaccination programmes in Ethiopia, Malaysia and the Russian Federation: 69 were positive for measles immunoglobulin M (IgM) antibodies, 74 were positive for rubella IgM antibodies and 7 were positive for both. Also tested were 282 oral fluid specimens from the measles, mumps and rubella (MMR) surveillance programme of the United Kingdom of Great Britain and Northern Ireland. The Microimmune measles IgM capture enzyme immunoassay was the gold standard for comparison. A panel of 24 oral fluids was used to investigate if measles virus haemagglutinin (H) and nucleocapsid (N) genes could be amplified by polymerase chain reaction directly from used POCT strips. Findings With serum POCT showed a sensitivity and specificity of 90.8% (69/76) and 93.6% (88/94), respectively; with oral fluids, sensitivity and specificity were 90.0% (63/70) and 96.2% (200/208), respectively. Both H and N genes were reliably detected in POCT strips and the N genes could be sequenced for genotyping. Measles virus genes could be recovered from POCT strips after storage for 5 weeks at 20–25 °C. Conclusion The POCT has the sensitivity and specificity required of a field-based test for measles diagnosis. However, its role in global measles control programmes requires further evaluation. PMID:21897488

  8. Implementation, management and continuous quality improvement of point-of-care testing in an academic health care setting.

    PubMed

    Jacobs, E; Hinson, K A; Tolnai, J; Simson, E

    2001-05-01

    Point-of-care testing (POCT) has economic and medical benefits in the areas of immediate medical management, resource utilization and time management. Starting with bedside glucose, the Mount Sinai Medical Center has, over the past 11 years, implemented 23 POC tests, spanning complexity from blood gas/electrolyte testing to occult blood, in compliance with all regulatory and accreditation requirements. QC data are reviewed on a daily and weekly basis and all patient results are in the electronic medical record. A variety of healthcare workers; nurses, physicians, respiratory therapists and technologists, perform testing. Since POCT impacts on a variety of hospital departments, proper implementation and management requires a multi-disciplinary team approach with focus on the financial, regulatory, quality assurance and data integration issues. Established in 1996, the institutional committee, with laboratory leadership, handles the establishment, compliance review and future direction setting of the program. In 1999, over 1300 individuals performed over 440,000 POC tests within the institution. A formalized continuous quality improvement (CQI) program for the POCT program was developed in the fall of 1999. All testing sites are reviewed on a monthly basis for various quality indicators that cover QC performance, maintenance performance, proficiency testing, patient identification, and alert value confirmations. PMID:11369337

  9. Canadian Public Health Laboratory Network laboratory guidelines for the use of point-of-care tests for the diagnosis of syphilis in Canada

    PubMed Central

    Singh, Ameeta E; Chernesky, Max A; Morshed, Muhammad; Wong, Tom

    2015-01-01

    Syphilis point-of-care tests (POCT) are widely available in developing countries enabling early diagnosis, treatment and support. The majority of commercially available tests use treponemal antigens and the presence of antibodies does not distinguish between current and past infection, which may lead to unnecessary antibiotic use and stigmatization of having a current STI. In hard-to-reach populations, the benefits may outweigh the risks. Available studies show reasonable performance of POCT with median sensitivity of 86%, specificity of 99% and positive predictive values >80% when prevalence was >0.3%. Although no syphilis POCT are approved in Canada at this time, a single study in an outreach setting in Alberta showed limited benefit due to a high prevalence of previous infection but more studies are needed. Newer dual tests employing treponemal and nontreponemal antigens look promising. PMID:25798163

  10. 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

  11. [Quality Management of Pre-Testing Step of POCT].

    PubMed

    Yamazaki, Ieharu

    2015-02-01

    To maintain a trusting relationship between clinical and hospital laboratory staff, highly reliable reporting based on precise quality control of the test results is required. Testing work is divided into 3 steps: pre-testing, testing, and post-testing. Quality control (QC) of laboratory testing has been performed to improve the precision and accuracy of measurements after sample collection, mainly in the testing step. However, various factors influencing the measurement results are present in the process from requests for testing to the reporting of the test results, and it is necessary to make efforts to minimize these factors. The characteristics of POCT devices and reagents are their simple operation method, compact size, and use at sites other than laboratories, and most users are physicians and nurses. Sample measurement rooms have opened at sites other than medical institutions, and testing using POCT-compatible devices and reagents has been rapidly spreading. It is very important to clarify factors leading to false high and low values in the pre-testing step. The results of investigating reasons for predicted events were presented, and the necessity of quality management in the pre-testing step was clarified. If the pre-testing step is not properly performed, accuracy cannot be assured even though quality management of the testing and post-testing steps is optimal. PMID:26529972

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

    PubMed

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

    2015-12-01

    Blood and oral fluid (OF) samples were collected from 103 suspected measles cases between February and November 2010 during a nationwide measles outbreak in Zimbabwe. Siemens measles IgM enzyme immunoassay (EIA) on serum, Microimmune measles IgM capture EIA on OF, real-time haemagglutinin (H) gene PCR and nested nucleocapsid (N) gene PCR on OF were performed, confirming 75 measles cases. These samples were then used to evaluate a newly developed point of care test (POCT) for measles and determine its potential for identifying measles cases in outbreaks. After performing POCTs on OF samples, nucleic acid was extracted from the used test strips and the measles H and N genes amplified by RT-PCR. The sensitivity, specificity, positive and negative predictive values of the POCT for IgM in OF was 75·0% [95% confidence interval (CI) 63·4-84·5], 96·2% (95% CI 80·4-99·9), 98·2% (95% CI 90·3-100) and 58·1% (95% CI 42·1-73·0), respectively. The N gene sequences showed high level of agreement between original OF and corresponding POCT strips. Measles genotype B3 was identified in all cases. We conclude that the measles POCT has the potential to be used, at the point of contact, in outbreak situations and provide molecular characterization of the virus at a later date. PMID:25865645

  13. 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.

  14. 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

  15. Integrating Microfluidics and Lensless Imaging for Point-of-Care Testing

    PubMed Central

    Moon, SangJun; Keles, Hasan Onur; Ozcan, Aydogan; Khademhosseini, Ali; Hæggstrom, Edward; Kuritzkes, Daniel; Demirci, Utkan

    2009-01-01

    We demonstrate an integrated platform that merges a microfluidic chip with lensless imaging to target CD4+ T-lymphocyte counts for HIV point-of-care testing at resource-limited settings. The chips were designed and fabricated simply with a laser cutter without using expensive cleanroom equipment. To capture CD4+ T lymphocytes from blood, anti-CD4 antibody was immobilized on only one side of the microfluidic chip. These captured cells were detected through an optically clear chip using a charge coupled device (CCD) sensor by lensless shadow imaging techniques. Gray scale image of the captured cells in a 24 mm × 4 mm × 50 μm microfluidic chip was obtained by the lensless imaging platform. The automatic cell counting software enumerated the captured cells in three seconds. Captured cells were also imaged with a fluorescence microscope and manually counted to characterize functionality of the integrated platform. The integrated platform achieved 70.2 ± 6.5% capture efficiency, 88.8 ± 5.4% capture specificity for CD4+ T-lymphocytes, 96 ± 1.6% CCD efficiency, and 83.5 ± 2.4% overall platform performance (n = 9 devices) compared to the gold standard, i.e. flow cytometry count. The integrated system gives a CD4 count from blood within 10 minutes. The integrated platform points a promising direction for point-of-care testing (POCT) to rapidly capture, image and count subpopulations of cells from blood samples in an automated matter. PMID:19467854

  16. Where we are with point-of-care testing.

    PubMed

    Johannessen, A

    2015-04-01

    Viral hepatitis claims one million lives each year. Scaling up treatment for hepatitis B and C in resource-limited settings is not possible without access to reliable diagnostic tools. This article gives an overview of current technologies and the pipeline for easy-to-use assays for serological and virological analyses, which can be performed at the site of patient care ('point-of-care assays'). Furthermore, the utility of dried blood spots for hepatitis B and C viral load testing is discussed. In addition to simple and reliable diagnostics, there is a need for a sustainable funding scheme and generic production of antiviral drugs to reduce the burden of viral hepatitis worldwide. PMID:25762459

  17. Where we are with point-of-care testing

    PubMed Central

    Johannessen, A

    2015-01-01

    Viral hepatitis claims one million lives each year. Scaling up treatment for hepatitis B and C in resource-limited settings is not possible without access to reliable diagnostic tools. This article gives an overview of current technologies and the pipeline for easy-to-use assays for serological and virological analyses, which can be performed at the site of patient care (‘point-of-care assays’). Furthermore, the utility of dried blood spots for hepatitis B and C viral load testing is discussed. In addition to simple and reliable diagnostics, there is a need for a sustainable funding scheme and generic production of antiviral drugs to reduce the burden of viral hepatitis worldwide. PMID:25762459

  18. 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

    2016-03-23

    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

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

    PubMed

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

    2013-05-01

    A fully automated point-of-care testing (POCT) system with a surface acoustic wave (SAW) immunosensor was developed for rapid and sensitive detection of cardiac troponin I (cTnI) in body fluid (plasma and whole blood). The assay, based on gold nanoparticle sandwich immunoassay and subsequent gold staining, was performed on the SAW immunosensor packaged inside a disposable microfluidic cartridge. The entire fluidic process, including plasma separation, reagent transport, metering, and mixing, was carried out by controlling the centrifugal force acting on the rotating cartridge and laser-irradiated ferrowax microvalves. On investigation of sensor response to various cTnI concentrations, the system exhibited a high performance with a detection limit of 6.7 pg mL(-1), and the coefficient of variation was less than 10% over the entire test range (10 pg mL(-1) to 25 ng mL(-1)). On comparing this POCT system with a clinically utilized system in a physical laboratory (Centaur XP; Siemens), a correlation coefficient of 0.998 was found, validating the diagnostic capability of the SAW immunosensor. PMID:23478433

  20. 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

  1. 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

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

    PubMed

    Wiencek, Joesph; Nichols, James

    2016-04-01

    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

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

    PubMed

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

    2014-10-01

    Over the last few years, hepatitis C virus (HCV) infection has emerged as one of the most significant causes of chronic liver disease worldwide, with an estimated prevalence ranging from 2.2 to 3.0%. In Italy, approximately 2% of subjects are infected with HCV. Considering that acute HCV infection is usually asymptomatic, early diagnosis is rare. Those people who develop chronic infection, even though undiagnosed, may suffer serious liver damage, making chronic HCV infection a major health problem. New initiatives are needed to identify a submerged portion of patients with chronic viral hepatitis and to propose controls and antiviral treatments to avoid the progression to liver cirrhosis or hepatocellular carcinoma (HCC). Since January 2011, the Infectious Diseases Department of San Raffaele Scientific Institute in Milan has been carrying out a prevention program called "EASY test project", using a new oral test, the OraQuick® HCV rapid antibody test (OraSure technologies, Inc.). The main objective of the project is to evaluate the acceptability of an alternative, free and anonymous HCV test offer, available in different settings (Points of Care, STDs Prevention clinics and General Practitioner clinics). From January 2011 to April 2014, 29,600 subjects were approached to inform them about HCV infection and other sexually transmitted diseases; 4,507 (15.2% of the contacted subjects) of them, total eligible volunteers, performed HCV tests on saliva and completed the interview in the alternative POCTs. Twenty-seven subjects (0.6% of the total) turned HCV oral test reactive (27/4.507) during the evaluation period; all of them were confirmed by conventional test. All 27 patients were asymptomatic and without a history of HCV-re- lated symptoms. The results from this analysis suggest that the promotion of alternative HCV test screening has not yet been fully developed as a strategy to increase levels of HCV testing among people at risk for HCV infection. Increasing awareness of these alternative tests among individuals at risk and providers may be an appropriate strategy to increase the number of people who know their serological status. The recent introduction of rapid oral HCV antibody test could completely change the HCV diagnosis approach by facilitating the possibility of testing millions of people worldwide (in particular in the developing countries). PMID:25387283

  4. 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

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

    PubMed Central

    2014-01-01

    Background The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control for the management of this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements. Objectives To review the correlation between point-of-care HbA1c testing and laboratory HbA1c measurement in patients with diabetes in clinical settings. Data Sources The literature search included studies published between January 2003 and June 2013. Search terms included glycohemoglobin, hemoglobin A1c, point of care, and diabetes. Review Methods Studies were included if participants had diabetes; if they compared point-of-care HbA1c devices (licensed by Health Canada and available in Canada) with laboratory HbA1c measurement (reference method); if they performed point-of-care HbA1c testing using capillary blood samples (finger pricks) and laboratory HbA1c measurement using venous blood samples within 7 days; and if they reported a correlation coefficient between point-of-care HbA1c and laboratory HbA1c results. Results Three point-of-care HbA1c devices were reviewed in this analysis: Bayer's A1cNow+, Bio-Rad's In2it, and Siemens’ DCA Vantage. Five observational studies met the inclusion criteria. The pooled results showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement (correlation coefficient, 0.967; 95% confidence interval, 0.960–0.973). Limitations Outcomes were limited to the correlation coefficient, as this was a commonly reported measure of analytical performance in the literature. Results should be interpreted with caution due to risk of bias related to selection of participants, reference standards, and the multiple steps involved in POC HbA1c testing. Conclusions Moderate quality evidence showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement. Five observational studies compared 3 point-of-care HbA1c devices with laboratory HbA1c assays, and all reported strong correlation between the 2 tests. PMID:26316922

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

    PubMed Central

    Chadee, A; Blackhouse, G; Goeree, R

    2014-01-01

    Background The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control as part of managing this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements. Objectives To estimate the budget impact of point-of-care HbA1c testing to replace laboratory HbA1c measurement for monitoring glycemic control in patients with diabetes in 2013/2014. Review Methods This analysis compared the average testing cost of 3 point-of-care HbA1c devices licensed by Health Canada and available on the market in Canada (Bayer's A1cNow+, Siemens's DCA Vantage, and Bio Rad's In2it), with that of the laboratory HbA1c reference method. The cost difference between point-of-care HbA1c testing and laboratory HbA1c measurement was calculated. Costs and the corresponding range of net impact were estimated in sensitivity analyses. Results The total annual costs of laboratory HbA1c measurement and point-of-care HbA1c testing for 2013/2014 were $91.5 million and $86.8 million, respectively. Replacing all laboratory HbA1c measurements with point-of-care HbA1c testing would save approximately $4.7 million over the next year. Savings could be realized by the health care system at each level that point-of-care HbA1c testing is substituted for laboratory HbA1c measurement. If physician fees were excluded from the analysis, the health care system would incur a net impact from using point-of-care HbA1c testing instead of laboratory A1c measurement. Limitations Point-of-care HbA1c technology is already in use in the Ontario health care system, but the current uptake is unclear. Knowing the adoption rate and market share of point-of-care HbA1c technology would allow for a more accurate estimate of budget impact. Conclusions Replacing laboratory HbA1c measurement with point-of-care HbA1c testing or using point-of-care HbA1c testing in combination with laboratory HbA1c measurement to monitor glycemic control in patients with diabetes could have saved the province $1,175,620 to $4,702,481 in 2013/2014. PMID:26316923

  7. 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

  8. 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

  9. 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

    2016-01-26

    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

  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. 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

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

    PubMed Central

    Kaman, Wendy E; Andrinopoulou, Eleni-Rosalina; Hays, John P

    2013-01-01

    Background The proper development and implementation of point-of-care (POC) diagnostics requires knowledge of the perceived requirements and barriers to their implementation. To determine the current requirements and perceived barriers to the introduction of POC diagnostics in the field of medical microbiology (MM)-POC a prospective online survey (TEMPOtest-QC) was established. Methods and results The TEMPOtest-QC survey was online between February 2011 and July 2012 and targeted the medical community, POC test diagnostic manufacturers, general practitioners, and the general public. In total, 293 individuals responded to the survey, including 91 (31%) medical microbiologists, 39 (13%) nonmedical microbiologists, 25 (9%) employees of POC test manufacturers, and 138 (47%) members of the general public. Responses were received from 18 different European countries, with the largest percentage of these living in The Netherlands (52%). The majority (>50%) of medical specialists regarded the development of MM-POC for blood culture and hospital acquired infections as “absolutely necessary”, but were much less favorable towards their use in the home environment. Significant differences in perceptions between medical specialists and the general public included the: (1) Effect on quality of patient care; (2) Ability to better monitor patients; (3) Home testing and the doctor-patient relationship; and (4) MM-POC interpretation. Only 34.7% of the general public is willing to pay more than a€10 ($13) for a single MM-POC test, with 85.5% preferring to purchase their MM-POC test from a pharmacy. Conclusion The requirements for the proper implementation of MM-POC were found to be generally similar between medical specialists and POC test kit manufacturers. The general public was much more favorable with respect to a perceived improvement in the quality of healthcare that these tests would bring to the hospital and home environment. PMID:23814465

  13. Rapid Point-Of-Care Breath Test for Biomarkers of Breast Cancer and Abnormal Mammograms

    PubMed Central

    Phillips, Michael; Beatty, J. David; Cataneo, Renee N.; Huston, Jan; Kaplan, Peter D.; Lalisang, Roy I.; Lambin, Philippe; Lobbes, Marc B. I.; Mundada, Mayur; Pappas, Nadine; Patel, Urvish

    2014-01-01

    Background Previous studies have reported volatile organic compounds (VOCs) in breath as biomarkers of breast cancer and abnormal mammograms, apparently resulting from increased oxidative stress and cytochrome p450 induction. We evaluated a six-minute point-of-care breath test for VOC biomarkers in women screened for breast cancer at centers in the USA and the Netherlands. Methods 244 women had a screening mammogram (93/37 normal/abnormal) or a breast biopsy (cancer/no cancer 35/79). A mobile point-of-care system collected and concentrated breath and air VOCs for analysis with gas chromatography and surface acoustic wave detection. Chromatograms were segmented into a time series of alveolar gradients (breath minus room air). Segmental alveolar gradients were ranked as candidate biomarkers by C-statistic value (area under curve [AUC] of receiver operating characteristic [ROC] curve). Multivariate predictive algorithms were constructed employing significant biomarkers identified with multiple Monte Carlo simulations and cross validated with a leave-one-out (LOO) procedure. Results Performance of breath biomarker algorithms was determined in three groups: breast cancer on biopsy versus normal screening mammograms (81.8% sensitivity, 70.0% specificity, accuracy 79% (73% on LOO) [C-statistic value], negative predictive value 99.9%); normal versus abnormal screening mammograms (86.5% sensitivity, 66.7% specificity, accuracy 83%, 62% on LOO); and cancer versus no cancer on breast biopsy (75.8% sensitivity, 74.0% specificity, accuracy 78%, 67% on LOO). Conclusions A pilot study of a six-minute point-of-care breath test for volatile biomarkers accurately identified women with breast cancer and with abnormal mammograms. Breath testing could potentially reduce the number of needless mammograms without loss of diagnostic sensitivity. PMID:24599224

  14. 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

  15. 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

  16. HPV Genotyping 9G Membrane Test: A Point-of-Care Diagnostic Platform

    PubMed Central

    Song, Keumsoo; Nimse, Satish Balasaheb; An, Heejung; Kim, Taisun

    2014-01-01

    The results of HPV detection in 550 cervical samples by cervical cytology were compared with the sequencing analysis and HPV genotyping 9G membrane test. The HPV genotyping 9G membrane test can efficiently identify and discriminate five HR-HPV genotypes. The 100% identical results of HPV genotyping 9G membrane tests with the sequencing results in 550 clinical samples ensure its wide clinical applicability. The simple handling steps and the portable scanning device make the HPV genotyping 9G membrane test applicable in point-of-care settings. Moreover, the HPV genotyping 9G membrane test allows one to obtain final results in 30 min at 25 °C by simply loading the hybridization and washing solution and scanning the membranes without any drying steps or special handling. The clinical sensitivity and specificity of the HPV genotyping 9G membrane test was found to be 100%, which is much higher than cervical cytology. PMID:25320905

  17. Development of Point-of-Care Testing for Disaster-Related Infectious Diseases.

    PubMed

    Hattori, Toshio; Chagan-Yasutan, Haorile; Shiratori, Beata; Egawa, Shinichi; Izumi, Takako; Kubo, Toru; Nakajima, Chie; Suzuki, Yasuhiko; Niki, Toshiro; Alisjahbana, Bachti; Telan, Elizabeth

    2016-01-01

    After disaster, the victims lose their safe lives and are even exposed to nature where they could suffer from animal bites and vectors followed by suffering from zoonosis or vector-born diseases. Because of the urgent need for rapid and cheap diagnosis for infectious diseases after disaster, anonymous questionnaire clarified that leptospirosis, dengue, diarrhea, and cholera were recognized as common disaster-related infections in the Philippines, while diarrhea and pneumonia were more common in Indonesia. It should also be noted that infectious disease itself such as tuberculosis associated with acquired immune deficiency syndrome in South Africa is a disaster. Thus, the possible occurrence of similar situation in Asia should be prevented. We have conducted an international collaborative research in the Philippines and Indonesia on dengue virus, leptospira and mycobacterium tuberculosis (MTB) infectious diseases. Development of point-of-care testing for molecular diagnosis and disease severity was the principal purpose of the research. Loop-mediated isothermal amplification assay, which does not require a source of electricity, was developed for leptospirosis, dengue and MTB and has been proved to be useful where resource is limited. The plasma levels of matricellular proteins, including galectin-9 and osteopontin, were found to reflect the disease severities in dengue virus and MTB infection, probably because matricellular proteins are one of the most functional extracellular proteins that are associated with inflammatory edema. The study on disaster-related infectious disease facilitates the international cooperation for development of point-of-care testing for tropical infectious diseases. PMID:27020774

  18. Emerging nucleic acid-based tests for point-of-care detection of malaria.

    PubMed

    Cordray, Michael S; Richards-Kortum, Rebecca R

    2012-08-01

    Malaria remains a serious disease in the developing world. There is a growing consensus that new diagnostics are needed in low-resource settings. The ideal malaria diagnostic should be able to speciate; measure parasitemia; low-cost, quick, and simple to use; and capable of detecting low-level infections. A promising development are nucleic acid tests (NATs) for the diagnosis of malaria, which are well suited for point-of-care use because of their ability to detect low-level infections and speciate, and because they have high sensitivity and specificity. The greatest barrier to NAT use in the past has been its relatively high cost, and the amount of infrastructure required in the form of equipment, stable power, and reagent storage. This review describes recent developments to decrease the cost and run time, and increase the ease of use of NAT while maintaining their high sensitivity and specificity and low limit of detection at the point-of-care. PMID:22855751

  19. 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

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

    PubMed

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

    2015-10-01

    Medical reasoning must be constructed on clinical evidence-based biology and follow a process of a priori assumptions. The introduction of a solution of point-of-care testing must result from any work involving clinicians, biologists, and administration. Several solutions of point-of-care testing allow the dosage of cardiac enzymes (CPK, myoglobin, and troponin) or BNP in less than half an hour time. The point-of-care testing saves time in obtaining the results earlier. It seems to allow timesaving on the overall care of the patient and the duration of his stay in the emergency department. By its technique and the relevance of its results, point-of-care testing is suitable for prehospital use. PMID:26567809

  1. Development of paper-based analytical kit for point-of-care testing.

    PubMed

    Shah, Pratikkumar; Zhu, Xuena; Li, Chen-zhong

    2013-01-01

    Paper-based analytical devices have been widely used for biomedical, environmental and food-quality testing. This review focuses on paper-based tests for biomarkers and bacterial detection with a brief introduction about various fabrication techniques and designs, biological and nonbiological probes and detection methods. Paper is relatively cheap and available in abundance. Moreover, properties of paper such as it being disposable, easy to use and store, and that it is easy to transport and modify draw significant attention to it as a platform for the development of paper-based analytical devices. These traits make paper-based analytical devices a strong candidate in point-of-care devices for rapid and economical testing near the site of patients. PMID:23256705

  2. Commercial Dengue Rapid Diagnostic Tests for Point-of-Care Application: Recent Evaluations and Future Needs?

    PubMed Central

    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. Optimization of a cell counting algorithm for mobile point-of-care testing platforms.

    PubMed

    Ahn, DaeHan; Kim, Nam Sung; Moon, SangJun; Park, Taejoon; Son, Sang Hyuk

    2014-01-01

    In a point-of-care (POC) setting, it is critically important to reliably count the number of specific cells in a blood sample. Software-based cell counting, which is far faster than manual counting, while much cheaper than hardware-based counting, has emerged as an attractive solution potentially applicable to mobile POC testing. However, the existing software-based algorithm based on the normalized cross-correlation (NCC) method is too time- and, thus, energy-consuming to be deployed for battery-powered mobile POC testing platforms. In this paper, we identify inefficiencies in the NCC-based algorithm and propose two synergistic optimization techniques that can considerably reduce the runtime and, thus, energy consumption of the original algorithm with negligible impact on counting accuracy. We demonstrate that an AndroidTM smart phone running the optimized algorithm consumes 11.5× less runtime than the original algorithm. PMID:25195851

  4. Optimization of a Cell Counting Algorithm for Mobile Point-of-Care Testing Platforms

    PubMed Central

    Ahn, DaeHan; Kim, Nam Sung; Moon, SangJun; Park, Taejoon; Son, Sang Hyuk

    2014-01-01

    In a point-of-care (POC) setting, it is critically important to reliably count the number of specific cells in a blood sample. Software-based cell counting, which is far faster than manual counting, while much cheaper than hardware-based counting, has emerged as an attractive solution potentially applicable to mobile POC testing. However, the existing software-based algorithm based on the normalized cross-correlation (NCC) method is too time- and, thus, energy-consuming to be deployed for battery-powered mobile POC testing platforms. In this paper, we identify inefficiencies in the NCC-based algorithm and propose two synergistic optimization techniques that can considerably reduce the runtime and, thus, energy consumption of the original algorithm with negligible impact on counting accuracy. We demonstrate that an Android smart phone running the optimized algorithm consumes 11.5 less runtime than the original algorithm. PMID:25195851

  5. 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 tests for viral load and CD4 are poised to further transform the disease and shift the treatment paradigm in low- and middle-income countries. PMID:24124392

  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. 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 as such. Also, a test alone has only limited power to overcome those difficulties. Test developers, policy-makers, healthcare providers and funders need to use these insights in overcoming barriers to point-of-care testing programs. PMID:26275231

  8. 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

  9. Miniaturized lensless imaging systems for cell and microorganism visualization in point-of-care testing.

    PubMed

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

    2011-02-01

    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 nanoscale 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

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

    PubMed

    Gao, Bingbing; Liu, Hong; Gu, Zhongze

    2016-01-26

    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

  11. Evaluating Diagnostic Point-of-Care Tests in Resource-Limited Settings

    PubMed Central

    Drain, Paul K; Hyle, Emily P; Noubary, Farzad; Freedberg, Kenneth A; Wilson, Douglas; Bishai, William; Rodriguez, William; Bassett, Ingrid V

    2014-01-01

    Diagnostic point-of-care (POC) testing is intended to minimize the time to obtain a test result, thereby allowing clinicians and patients to make an expeditious clinical decision. As POC tests expand into resource-limited settings (RLS), the benefits must outweigh the costs. To optimize POC testing in RLS, diagnostic POC tests need rigorous evaluations focused on relevant clinical outcomes and operational costs, which differ from evaluations of conventional diagnostic tests. Here, we reviewed published studies on POC testing in RLS, and found no clearly defined metric for the clinical utility of POC testing. Therefore, we propose a framework for evaluating POC tests, and suggest and define the term “test efficacy” to describe a diagnostic test’s capacity to support a clinical decision within its operational context. We also proposed revised criteria for an ideal diagnostic POC test in resource-limited settings. Through systematic evaluations, comparisons between centralized diagnostic testing and novel POC technologies can be more formalized, and health officials can better determine which POC technologies represent valuable additions to their clinical programs. PMID:24332389

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

    PubMed

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

    2015-03-01

    Acute respiratory infections represent common pediatric emergencies. Infection control warrants immediate and accurate diagnoses. In the past, first-generation respiratory syncytial virus (RSV) rapid tests (strip tests) have shown suboptimal sensitivities. In 2013, the Food and Drug Administration licensed a second-generation RSV rapid test providing user-independent readouts (SOFIA™-RSV) using automated fluorescence assay technology known to yield superior results with influenza rapid testing. We are reporting the first point-of-care evaluation of the SOFIA™-RSV rapid test. In the Charité Influenza-Like Disease Cohort, 686 nasopharyngeal samples were tested in parallel with SOFIA™-RSV and SOFIA™-Influenza A+B. Compared to real-time PCR, SOFIA™-RSV sensitivities/specificities were 78.6%/93.9%, respectively (SOFIA™-Influenza A: 80.6%/99.3%). Performance was greatest in patients below 2 years of age with a test sensitivity of 81.8%. RSV sensitivities were highest (85%) in the first 2 days of illness and with nasopharyngeal compared to nasal swabs (P=0.055, McNemar's test). Second-generation RSV and influenza rapid testing provides highly accurate results facilitating timely patient cohortation and management. PMID:25583129

  13. Point-of-Care HIV Testing and Linkage in an Urban Cohort in the Southern US

    PubMed Central

    Dougherty, Sarah M.; Ross-Davis, Kelly L.; Raper, James L.

    2013-01-01

    The Southern states experience the highest rates of HIV and AIDS in the US, and point-of-care (POC) testing outside of primary care may contribute to status awareness in medically underserved populations in this region. To evaluate POC screening and linkage to care at an urban south site, analyses were performed on a dataset of 3,651 individuals from an integrated rapid-result HIV testing and linkage program to describe this test-seeking cohort and determine trends associated with screening, results, and linkage to care. Four percent of the population had positive results. We observed significant differences by test result for age, race and gender, reported risk behaviors, test location, and motivation for screening. The overall linkage rate was 86%, and we found significant differences for clients who were linked to HIV care versus persons whose linkage could not be confirmed with respect to race and gender, location, and motivation. The linkage rate for POC testing that included a comprehensive intake visit and colocated primary care services for in-state residents was 97%. Additional research on integrated POC screening and linkage methodologies that provide intake services at time of testing is essential for increasing status awareness and improving linkage to HIV care in the US. PMID:24159384

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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

  19. Point-of-care HIV early infant diagnosis: is test sensitivity everything?

    PubMed Central

    Dunning, Lorna; Hsiao, Nei-yuan; Myer, Landon

    2015-01-01

    Despite improvements in PMTCT services in low- and middle-income countries, there are still almost 200,000 new paediatric HIV infections annually in sub-Saharan Africa. This has led to early infant HIV diagnosis (EID) programmes becoming a public health priority, but until recently, EID has required specialist laboratory equipment and trained personnel which is only feasible in urban, centralized facilities. It is thought that the successful implementation of a point-of-care (POC) test for EID has the potential to increase access to virological tests and address some of the barriers regarding retention of infants in care. However, POC evaluation has not integrated focus on performance characteristics with the health systems issues surrounding the adoption of and optimum use of these new technologies. We propose that moderate improvements in linkage to care can more than offset suboptimal sensitivity of a POC EID test which could be critical in adjusting the focus for EID programme management away from test performance and towards their ability to facilitate successful linkage to antiretroviral therapy (ART) services. These findings also highlight the urgent need to explore the implementation and operational aspects of emerging POC tests in order to fully realize the potential benefits of new technologies in practice. PMID:26344017

  20. 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

  1. Sensitivity and Specificity of Point-of-Care Rapid Combination Syphilis-HIV-HCV Tests

    PubMed Central

    Hess, Kristen L.; Fisher, Dennis G.; Reynolds, Grace L.

    2014-01-01

    Background New rapid point-of-care (POC) tests are being developed that would offer the opportunity to increase screening and treatment of several infections, including syphilis. This study evaluated three of these new rapid POC tests at a site in Southern California. Methods Participants were recruited from a testing center in Long Beach, California. A whole blood specimen was used to evaluate the performance of the Dual Path Platform (DPP) Syphilis Screen & Confirm, DPP HIV-Syphilis, and DPP HIV-HCV-Syphilis rapid tests. The gold-standard comparisons were Treponema pallidum passive particle agglutination (TPPA), rapid plasma reagin (RPR), HCV enzyme immunoassay (EIA), and HIV-1/2 EIA. Results A total of 948 whole blood specimens were analyzed in this study. The sensitivity of the HIV tests ranged from 95.7–100% and the specificity was 99.7–100%. The sensitivity and specificity of the HCV test were 91.8% and 99.3%, respectively. The treponemal-test sensitivity when compared to TPPA ranged from 44.0–52.7% and specificity was 98.7–99.6%. The non-treponemal test sensitivity and specificity when compared to RPR was 47.8% and 98.9%, respectively. The sensitivity of the Screen & Confirm test improved to 90.0% when cases who were both treponemal and nontreponemal positive were compared to TPPA+/RPR ≥1∶8. Conclusions The HIV and HCV on the multi-infection tests showed good performance, but the treponemal and nontreponemal tests had low sensitivity. These results could be due to a low prevalence of active syphilis in the sample population because the sensitivity improved when the gold standard was limited to those more likely to be active cases. Further evaluation of the new syphilis POC tests is required before implementation into testing programs. PMID:25375138

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

    PubMed

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

    2015-04-14

    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

  3. 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

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

    PubMed Central

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

    2008-01-01

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

  5. Paper-based analytical devices for point-of-care infectious disease testing.

    PubMed

    Rozand, C

    2014-02-01

    Paper-based devices provide an alternative technology for simple, low-cost, portable, and disposable or recyclable diagnostic tools for many applications, including clinical diagnosis, food quality control, and environmental monitoring. The present review focuses on new paper-based tests for point-of-care (POC) infectious disease testing. This review provides a brief presentation of the fabrication techniques and the main sample preparation procedures. Recent immunological and molecular testing formats based on new paper-based solutions which go beyond conventional lateral flow formats are also added. Emphasis is placed on how paper systems could be used for detecting whole and viable bacteria associated to infectious diseases. Paper has recently become attractive, since it is a ubiquitous and extremely cheap material. It is easy to store, easy to use, and is compatible with many (bio)chemical and (bio)medical applications. Paper absorbs and transports liquids by capillary force without additional mechanical assistance. Hence, paper-based analytical devices are promising and possibly game-changing, even if they still suffer from limitations, including accuracy and sensitivity. It is anticipated that, in the near future, with advances in fabrication procedures and associated analytical techniques, there will be a continuous flow of innovative paper-based diagnostics kits. PMID:23982665

  6. 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

  7. 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

  8. 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

  9. 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

  10. The BD FACSPresto Point of Care CD4 Test Accurately Enumerates CD4+ T Cell Counts

    PubMed Central

    Bwana, Priska; Vojnov, Lara; Adhiambo, Maureen; Akinyi, Catherine; Mwende, Joy; Prescott, Marta; Mwau, Matilu

    2015-01-01

    Objective Currently 50% of ART eligible patients are not yet receiving life-saving antiretroviral therapy (ART). Financial constraints do not allow most developing countries to adopt a universal test and offer ART strategy. Decentralizing CD4+ T cell testing may, therefore, provide greater access to testing, ART, and better patient management. We evaluated the technical performance of a new point-of-care CD4+ T cell technology, the BD FACSPresto, in a field methods comparison study. Methods 264 HIV-positive patients were consecutively enrolled and included in the study. The BD FACSPresto POC CD4+ T cell technology was placed in two rural health care facilities and operated by health care facility staff. We compared paired finger-prick and venous samples using the BD FACSPresto and several existing reference technologies, respectively. Results The BD FACSPresto had a mean bias of 67.29 cells/ul and an r2 of 0.9203 compared to the BD FACSCalibur. At ART eligibility thresholds of 350 and 500 cells/ul, the sensitivity to define treatment eligibility were 81.5% and 77.2% and the specificities were 98.9% and 100%, respectively. Similar results were observed when the BD FACSPresto was compared to the BD FACSCount and Alere Pima. The coefficient of variation (CV) was less than 7% for both the BD FACSCalibur and BD FACSPresto. CD4+ T cell testing by nurses using the BD FACSPresto at rural health care facilities showed high technical similarity to test results generated by laboratory technicians using the BD FACSPresto in a high functioning laboratory. Conclusions The BD FACSPresto performed favorably in the laboratory setting compared to the conventional reference standard technologies; however, the lower sensitivities indicated that up to 20% of patients tested in the field in need of treatment would be missed. The BD FACSPresto is a technology that can allow for greater decentralization and wider access to CD4+ T cell testing and ART. PMID:26720601

  11. 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

  12. 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.

  13. Point-of-care cardiac troponin test accurately predicts heat stroke severity in rats.

    PubMed

    Audet, Gerald N; Quinn, Carrie M; Leon, Lisa R

    2015-11-15

    Heat stroke (HS) remains a significant public health concern. Despite the substantial threat posed by HS, there is still no field or clinical test of HS severity. We suggested previously that circulating cardiac troponin (cTnI) could serve as a robust biomarker of HS severity after heating. In the present study, we hypothesized that (cTnI) point-of-care test (ctPOC) could be used to predict severity and organ damage at the onset of HS. Conscious male Fischer 344 rats (n = 16) continuously monitored for heart rate (HR), blood pressure (BP), and core temperature (Tc) (radiotelemetry) were heated to maximum Tc (Tc,Max) of 41.9 ± 0.1°C and recovered undisturbed for 24 h at an ambient temperature of 20°C. Blood samples were taken at Tc,Max and 24 h after heat via submandibular bleed and analyzed on ctPOC test. POC cTnI band intensity was ranked using a simple four-point scale via two blinded observers and compared with cTnI levels measured by a clinical blood analyzer. Blood was also analyzed for biomarkers of systemic organ damage. HS severity, as previously defined using HR, BP, and recovery Tc profile during heat exposure, correlated strongly with cTnI (R(2) = 0.69) at Tc,Max. POC cTnI band intensity ranking accurately predicted cTnI levels (R(2) = 0.64) and HS severity (R(2) = 0.83). Five markers of systemic organ damage also correlated with ctPOC score (albumin, alanine aminotransferase, blood urea nitrogen, cholesterol, and total bilirubin; R(2) > 0.4). This suggests that cTnI POC tests can accurately determine HS severity and could serve as simple, portable, cost-effective HS field tests. PMID:26290107

  14. Disposable platform provides visual and color-based point-of-care anemia self-testing

    PubMed Central

    Tyburski, Erika A.; Gillespie, Scott E.; Stoy, William A.; Mannino, Robert G.; Weiss, Alexander J.; Siu, Alexa F.; Bulloch, Rayford H.; Thota, Karthik; Cardenas, Anyela; Session, Wilena; Khoury, Hanna J.; O’Connor, Siobhán; Bunting, Silvia T.; Boudreaux, Jeanne; Forest, Craig R.; Gaddh, Manila; Leong, Traci; Lyon, L. Andrew; Lam, Wilbur A.

    2014-01-01

    BACKGROUND. Anemia, or low blood hemoglobin (Hgb) levels, afflicts 2 billion people worldwide. Currently, Hgb levels are typically measured from blood samples using hematology analyzers, which are housed in hospitals, clinics, or commercial laboratories and require skilled technicians to operate. A reliable, inexpensive point-of-care (POC) Hgb test would enable cost-effective anemia screening and chronically anemic patients to self-monitor their disease. We present a rapid, stand-alone, and disposable POC anemia test that, via a single drop of blood, outputs color-based visual results that correlate with Hgb levels. METHODS. We tested blood from 238 pediatric and adult patients with anemia of varying degrees and etiologies and compared hematology analyzer Hgb levels with POC Hgb levels, which were estimated via visual interpretation using a color scale and an optional smartphone app for automated analysis. RESULTS. POC Hgb levels correlated with hematology analyzer Hgb levels (r = 0.864 and r = 0.856 for visual interpretation and smartphone app, respectively), and both POC test methods yielded comparable sensitivity and specificity for detecting any anemia (n = 178) (<11 g/dl) (sensitivity: 90.2% and 91.1%, specificity: 83.7% and 79.2%, respectively) and severe anemia (n = 10) (<7 g/dl) (sensitivity: 90.0% and 100%, specificity: 94.6% and 93.9%, respectively). CONCLUSIONS. These results demonstrate the feasibility of this POC color-based diagnostic test for self-screening/self-monitoring of anemia. TRIAL REGISTRATION. Not applicable. FUNDING. This work was funded by the FDA-funded Atlantic Pediatric Device Consortium, the Georgia Research Alliance, Children’s Healthcare of Atlanta, the Georgia Center of Innovation for Manufacturing, and the InVenture Prize and Ideas to Serve competitions at the Georgia Institute of Technology. PMID:25157824

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

    PubMed

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

    2016-02-18

    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. PMID:26854217

  16. [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

  17. 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

  18. 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

  19. 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

  20. 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.

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

    PubMed

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

    2015-09-01

    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 testing positive for HIV and HBcAb. There should be discussion of updates to the 2013 CDC guidance. PMID:26269795

  2. 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 testing positive for HIV and HBcAb. There should be discussion of updates to the 2013 CDC guidance. PMID:26269795

  3. Point-of-Care Urine Tests for Smoking Status and Isoniazid Treatment Monitoring in Adult Patients

    PubMed Central

    Nicolau, Ioana; Tian, Lulu; Menzies, Dick; Ostiguy, Gaston; Pai, Madhukar

    2012-01-01

    Background Poor adherence to isoniazid (INH) preventive therapy (IPT) is an impediment to effective control of latent tuberculosis (TB) infection. TB patients who smoke are at higher risk of latent TB infection, active disease, and TB mortality, and may have lower adherence to their TB medications. The objective of our study was to validate IsoScreen and SmokeScreen (GFC Diagnostics, UK), two point-of-care tests for monitoring INH intake and determining smoking status. The tests could be used together in the same individual to help identify patients with a high-risk profile and provide a tailored treatment plan that includes medication management, adherence interventions, and smoking cessation programs. Methodology/Principal Findings 200 adult outpatients attending the TB and/or the smoking cessation clinic were recruited at the Montreal Chest Institute. Sensitivity and specificity were measured for each test against the corresponding composite reference standard. Test reliability was measured using kappa statistic for intra-rater and inter-rater agreement. Univariate and multivariate logistic regression models were used to explore possible covariates that might be related to false-positive and false-negative test results. IsoScreen had a sensitivity of 93.2% (95% confidence interval [CI] 80.3, 98.2) and specificity of 98.7% (94.8, 99.8). IsoScreen had intra-rater agreement (kappa) of 0.75 (0.48, 0.94) and inter-rater agreement of 0.61 (0.27, 0.90). SmokeScreen had a sensitivity of 69.2% (56.4, 79.8), specificity of 81.6% (73.0, 88.0), intra-rater agreement of 0.77 (0.56, 0.94), and inter-rater agreement of 0.66 (0.42, 0.88). False-positive SmokeScreen tests were strongly associated with INH treatment. Conclusions IsoScreen had high validity and reliability, whereas SmokeScreen had modest validity and reliability. SmokeScreen tests did not perform well in a population receiving INH due to the association between INH treatment and false-positive SmokeScreen test results. Development of the next generation SmokeScreen assay should account for this potential interference. PMID:23029310

  4. 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

  5. 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

  6. 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..., diagnosis, monitoring, association and risk-stratification of colon and rectal cancer, breast cancer, and..., pancreas, stomach, gallbladder, breast, lung, endometrium and cervix. Current methodologies of...

  7. 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 device optimization and material quality control. This is the first field study performed with a patterned paper-based microfluidic device and opens the door to development of similar assays for other important analytes. PMID:24098705

  8. Viewpoint: Why do we need a point-of-care CD4 test for low-income countries?

    PubMed

    Zachariah, R; Reid, S D; Chaillet, P; Massaquoi, M; Schouten, E J; Harries, A D

    2011-01-01

    In this paper, we discuss the reasons why we urgently need a point-of-care (POC) CD4 test, elaborate the problems we have experienced with the current technology which hampers CD4-count coverage and highlight the ideal characteristics of a universal CD4 POC test. It is high-time that CD4 technology is simplified and adapted for wider use in low-income countries to change the current paradigm of restricted access once and for all. PMID:21371207

  9. 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

  10. 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

  11. 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

  12. 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 of services in Pixley-ka-Seme, with an estimated local ∼12–24-hour LTR-TAT, is ∼$2 more than existing referred services per-test, but 2–4 fold cheaper than implementing eight Tier-2/POC-hubs or providing twenty-seven Tier-1/POCT CD4 services. PMID:25517412

  13. 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

    2016-02-01

    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

  14. 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

  15. 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

  16. 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

  17. Performance of Rapid Point-of-Care and Laboratory Tests for Acute and Established HIV Infection in San Francisco

    PubMed Central

    Pilcher, Christopher D.; Louie, Brian; Facente, Shelley; Keating, Sheila; Hackett, John; Vallari, Ana; Hall, Chris; Dowling, Teri; Busch, Michael P.; Klausner, Jeffrey D.; Hecht, Frederick M.; Liska, Sally; Pandori, Mark W.

    2013-01-01

    Background Current laboratory and point-of-care tests for HIV detect different analytes and use different sample types. Some have fast turnaround times (<1 hour). We investigated how HIV test choice could impact case finding by testing programs. Methods We analyzed 21,234 consecutive HIV tests with venous blood obtained by San Francisco HIV testing programs from 2003 to 2008. For a subset, oral fluid (n = 6446) or fingerstick blood (n = 8127) samples were also obtained for rapid testing. In all cases, HIV status was determined using an HIV antibody-plus-RNA test algorithm. We assessed how the screening antibody tests performed individually versus the gold standard of the full algorithm. We then evaluated the potential ability of other tests (including new tests) to detect more cases, by re-testing all specimens that had negative/discrepant antibody results on initial screening. Findings The antibody-RNA algorithm identified 58 acute and 703 established HIV infection cases. 1st-generation (Vironostika) and 3rd-generation (Genetic Systems) immunoassays had 92 and 96 percent sensitivity, respectively. The Oraquick rapid test had clinical sensitivity of only 86 percent on oral fluid samples, but 92 percent on finger-stick blood. Newer 4th-generation, antigen-antibody combo rapid immunoassay (ARCHITECT) detected HIV in 87 percent of all the acute cases that had been missed by one of the previous screening assays. A point-of-care 4th generation antigen-antibody combo rapid test (Determine) detected about 54 percent of such acute cases. Conclusions Our study suggests that some rapid antibody blood tests will give similar case detection to laboratory antibody tests, but that oral fluid testing greatly reduces ability to detect HIV. New 4th-generation combo tests can detect the majority of acute infections detectable by HIV RNA but with rapid results. Using these tests as a primary screening assay in high-risk HIV testing programs could reduce or eliminate the need for HIV RNA testing. PMID:24349007

  18. 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

  19. 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

  20. 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

  1. Multisite Evaluation of Point of Care CD4 Testing in Papua New Guinea

    PubMed Central

    Malagun, Malin; Nano, Gideon; Chevallier, Caroline; Opina, Ragagalo; Sawiya, Gola; Kivavia, Joseph; Kalinoe, Albina; Nathaniel, Kathalina; Kaminiel, Oscillah; Millan, John; Carmone, Andrea; Dini, Mary; Palou, Theresa; Topma, Kum; Lavu, Evelyn; Markby, Jessica

    2014-01-01

    Laboratory-based CD4 monitoring of HIV patients presents challenges in resource limited settings (RLS) including frequent machine breakdown, poor engineering support and limited cold chain and specimen transport logistics. This study assessed the performance of two CD4 tests designed for use in RLS; the Dynal assay and the Alere PIMA test (PIMA). Accuracy of Dynal and PIMA using venous blood was assessed in a centralised laboratory by comparison to BD FACSCount (BD FACS). Dynal had a mean bias of −50.35 cells/µl (r2 = 0.973, p<0.0001, n = 101) and PIMA −22.43 cells/µl (r2 = 0.964, p<0.0001, n = 139) compared to BD FACS. Similar results were observed for PIMA operated by clinicians in one urban (n = 117) and two rural clinics (n = 98). Using internal control beads, PIMA precision was 10.34% CV (low bead mean 214.24 cells/µl) and 8.29% (high bead mean 920.73 cells/µl) and similar %CV results were observed external quality assurance (EQA) and replicate patient samples. Dynal did not perform using EQA and no internal controls are supplied by the manufacturer, however duplicate testing of samples resulted in r2 = 0.961, p<0.0001, mean bias = −1.44 cells/µl. Using the cut-off of 350 cells/µl compared to BD FACS, PIMA had a sensitivity of 88.85% and specificity of 98.71% and Dynal 88.61% and 100%. A total of 0.44% (2/452) of patient samples were misclassified as “no treat” and 7.30% (33/452) “treat” using PIMA whereas with Dynal 8.91% (9/101) as “treat” and 0% as “no treat”. In our setting PIMA was found to be accurate, precise and user-friendly in both laboratory and clinic settings. Dynal performed well in initial centralized laboratory evaluation, however lacks requisite quality control measures, and was technically more difficult to use, making it less suitable for use at lower tiered laboratories. PMID:25426710

  2. Point-of-care genetic profiling and/or platelet function testing in acute coronary syndrome.

    PubMed

    Collet, Jean-Philippe; Kerneis, Mathieu; Hulot, Jean-Sébastien; O'Connor, Stephen A; Silvain, Johanne; Mansencal, Nicolas; Brugier, Delphine; Abtan, Jérémie; Barthélémy, Olivier; Vignalou, Jean-Baptiste; Payot, Laurent; Rousseau, Hélène; Vicaut, Eric; Montalescot, Gilles

    2016-01-27

    Our aim was to demonstrate that the sequential use of the Verigene® rapid CYP2C19 test for genetic profiling and the VerifyNowTM bedside test for platelet function measurement in ACS patients may optimise P2Y12 inhibition. "Rapid" (CYP2C19*1/*1 or CYP2C19*17 carriers, n=211) and "slow" metabolisers (CYP2C19*2 carriers, n=58) were first put on clopidogrel and prasugrel for ≥ 2 weeks, respectively. Patients with low platelet reactivity (PRU< 30) on prasugrel or high platelet reactivity (> 208 PRU) on clopidogrel were then switched to clopidogrel and prasugrel, respectively. Our objectives were (i) to demonstrate that the proportion of "rapid" metabolisers on 75 mg of clopidogrel within 30-208 (PRU) of P2Y12 inhibition is non-inferior to "slow" metabolisers on prasugrel 10 mg and (ii) to evaluate the same end-point after switching drugs. The proportion of "rapid" and "slow" metabolisers within 30-208 PRU of P2Y12 inhibition was 71 % and 56.9 %, respectively, an absolute difference of +14.1 % (95 % CI, -0.05 % to 28.28 %) with a non-inferiority margin greater than the predefined margin of -10 %. Among patients out of target, all but one "slow" metabolisers displayed low-on prasugrel platelet reactivity while the majority of "rapid" metabolisers (68 %) displayed high-on clopidogrel platelet reactivity. After switching, the proportion of patients within 30-208 PRU of P2Y12 inhibition was 83.6 % and 79.3 % in "rapid" and "slow" metabolisers, respectively (+4.3 %, 95 % CI -7.3 % to 15.9 %). In conclusion, this study demonstrates a loose relationship between genotype and platelet function phenotype approaches but that they are complementary to select prasugrel or clopidogrel MD in stented ACS patients. PMID:26423110

  3. 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

  4. Patients Can Accurately Perform Their Own Rapid HIV Point-of-Care Test in the Emergency Department

    PubMed Central

    Nour, Samah; Hsieh, Yu-Hsiang; Rothman, Richard E.; Jett-Goheen, Mary; Langhorne, Ophelia; Wu, Lan; Peterson, Stephen; Gaydos, Charlotte A.

    2013-01-01

    Objective The objective of this study was to evaluate the feasibility, acceptability, and accuracy of having emergency department (ED) patients perform a rapid, point-of-care (POC) self-test for HIV before routine HIV testing. Methods Patients aged 18 to 65 years were recruited to perform a rapid POC HIV oral fluid at The Johns Hopkins ED in conjunction with the standard-of-care HIV POC test. Acceptability and ease of use were assessed by a questionnaire. Results A total of 259 patients were approached for testing, and 249 (96.1%) consented to perform a self POC HIV test. Of patients performing a self-test, 100% had concordant results with those obtained by the health care worker. Four females (1.6%) were newly identified as HIV positive. Median participant age was 41 years, and 58% of patients were female; 83% were African American, and 16% were white. Overall, greater than 90% of patients reported trust of the test results, ease of testing, and willingness to test again. Approximately 35% of patients indicated they would pay up to a maximum price of $30 for testing. Overall, 46.9% of patients preferred self-testing, and 39.5% preferred health care professional testing. Regarding preferred location for testing, 51.0% preferred home self-testing, 39.5% preferred clinic/ED self-testing (P > 0.05), and 9.5% had no preference. Conclusions A significant proportion of patients offered POC testing in the ED agreed to perform a self–HIV test. Patients’ results were concordant with those obtained by the health care worker; 1.6% were HIV positive. The majority of participants believed the veracity of their results. A greater number of patients preferred self-testing. PMID:24031999

  5. Evaluation of CareSens POCT Devices for Glucose Testing in the Routine Hospital Setting

    PubMed Central

    Huysal, Kagan; Demirci, Hakan; nelge, Mehmet Ali

    2015-01-01

    Introduction Glucose meters are used routinely in hospital wards to manage blood glucose levels in patients requiring frequent monitoring of blood glucose. Objective Our institution has 50 POC instruments utilized by diverse population of all ages and medical conditions. The primary objective of our study was to investigate whether all these CareSens glucose meters (I-sense Inc, Seoul, South Korea) results in hospitalized patients during routine clinical care jointly satisfy the specified quality specifications, as defined by Clinical and Laboratory Standards Institute (CLSI) guideline POCT12-A3. Materials and Methods The records of hospitalized patients who underwent simultaneous measures of glucose levels with both glucose meters and a central laboratory analyser between January and June 2013 were retrospectively analysed. We also performed a prospective evaluation of the accuracy of the CareSens glucose Strip. Results Glucose concentrations measured in 840 patients ranged from 1.66 to 31.72 mmol/L The BlandAltman difference plot between the auto analyser and all the 50 CareSens glucosemeters revealed a mean bias of -2.2%, with analytical biases for the two methods varying from ?31.1% to 26.8%. Eighty four percent of the glucose meters glucose values were within 12.5% for values 5.54 mmol/L of the comparative laboratory glucose values and 93% of the results were within 20% of the reference for glucose >4.2 mmol/L and 65% of the results were within 0.8 mmol/L for glucose <4.2 mmol/L. Conclusion CareSens glucose meter readings in hospital settings, especially in hypoglycaemic patients, should be confirmed by central laboratory analysers whenever possible. PMID:26557509

  6. 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

  7. Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers.

    PubMed

    Louie, Richard F; Ferguson, William J; Curtis, Corbin M; Vy, John H; Kost, Gerald J

    2014-03-01

    Strategic integration of point-of-care (POC) diagnostic tools during crisis response can accelerate triage and improve management of victims. Timely differential diagnosis is essential wherever care is provided to rule out or rule in disease, expedite life-saving treatment, and improve utilization of limited resources. POC testing needs to be accurate in any environment in which it is used. Devices are exposed to potentially adverse storage and operating conditions, such as high/low temperature and humidity during emergencies and field rescues. Therefore, characterizing environmental conditions allows technology developers, operators, and responders to understand the broad operational requirements of test reagents, instruments, and equipment in order to improve the quality and delivery of care in complex emergencies, disasters, and austere environmental settings. This review aims to describe the effects of environmental stress on POC testing performance and its impact on decision-making, to describe how to study the effects, and to summarize ways to mitigate the effects of environmental stresses through good laboratory practice, development of robust reagents, and novel thermal packaging solutions. PMID:24114917

  8. Development and validation of a pressure-type automated quantitative sensory testing system for point-of-care pain assessment.

    PubMed

    Harte, Steven E; Mitra, Mainak; Ichesco, Eric A; Halvorson, Megan E; Clauw, Daniel J; Shih, Albert J; Kruger, Grant H

    2013-06-01

    Quantitative sensory testing (QST) can provide useful information about the underlying mechanisms involved in chronic pain. However, currently available devices typically employed suffer from operator-dependent effects, or are too cumbersome for routine clinical care. This paper presents the design and initial validation of a novel automated pressure-pain type QST platform, termed the multi-modal automated sensory testing (MAST) system. The MAST configuration presented consists of wireless, hand-held thumbnail pressure stimulators (with circular 10 mm² rubber tips) and graphical touch screen interface devices to manage the QST process and obtain patient feedback. Validation testing of the custom-designed force sensor showed a 1 % error for low forces increasing to 2 % error for larger loads up to 100 N (full-scale). Validation of the controller using three ramp rates (64, 248, and 496 kPa/s) and six pressures (32, 62, 124, 273, 620, and 1116 kPa) showed an overall mean error of 1.7 % for applied stimuli. Clinical evaluation revealed decreased pressure pain thresholds in chronic pain patients (98.07 ± SE 16.34 kPa) compared to pain free, healthy control subjects (259.88 ± SE 33.54 kPa, p = 0.001). The MAST system is portable and produces accurate, repeatable stimulation profiles indicating potential for point-of-care applications. PMID:23381890

  9. 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.; Grtner, 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.

  10. 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

  11. Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test

    PubMed Central

    Lawn, Stephen D; Mwaba, Peter; Bates, Matthew; Piatek, Amy; Alexander, Heather; Marais, Ben J; Cuevas, Luis E; McHugh, Timothy D; Zijenah, Lynn; Kapata, Nathan; Abubakar, Ibrahim; McNerney, Ruth; Hoelscher, Michael; Memish, Ziad A; Migliori, Giovanni Battista; Kim, Peter; Maeurer, Markus; Schito, Marco; Zumla, Alimuddin

    2015-01-01

    Rapid progress has been made in the development of new diagnostic assays for tuberculosis in recent years. New technologies have been developed and assessed, and are now being implemented. The Xpert MTB/RIF assay, which enables simultaneous detection of Mycobacterium tuberculosis (MTB) and rifampicin (RIF) resistance, was endorsed by WHO in December, 2010. This assay was specifically recommended for use as the initial diagnostic test for suspected drug-resistant or HIV-associated pulmonary tuberculosis. By June, 2012, two-thirds of countries with a high tuberculosis burden and half of countries with a high multidrug-resistant tuberculosis burden had incorporated the assay into their national tuberculosis programme guidelines. Although the development of the Xpert MTB/RIF assay is undoubtedly a landmark event, clinical and programmatic effects and cost-effectiveness remain to be defined. We review the rapidly growing body of scientific literature and discuss the advantages and challenges of using the Xpert MTB/RIF assay in areas where tuberculosis is endemic. We also review other prospects within the developmental pipeline. A rapid, accurate point-of-care diagnostic test that is affordable and can be readily implemented is urgently needed. Investment in the tuberculosis diagnostics pipeline should remain a major priority for funders and researchers. PMID:23531388

  12. 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

  13. Poor Reporting of Outcomes Beyond Accuracy in Point-of-Care Tests for Syphilis: A Call for a Framework

    PubMed Central

    Jafari, Yalda; Joseph, Lawrence; Vadnais, Caroline; Pant Pai, Nitika

    2014-01-01

    Background. Point-of-care (POC) diagnostics for syphilis can contribute to epidemic control by offering a timely knowledge of serostatus. Although accuracy data on POC syphilis tests have been widely published, few studies have evaluated broader outcomes beyond accuracy that impact patients and health systems. We comprehensively reviewed evidence and reporting of these implementation research outcomes (IROs), and proposed a framework to improve their quality. Methods. Three reviewers systematically searched 6 electronic databases from 1980 to 2014 for syphilis POC studies reporting IROs. Data were abstracted and findings synthesised narratively. Results. Of 71 studies identified, 38 documented IROs. IROs were subclassified into preference (7), acceptability (15), feasibility (15), barriers and challenges (15), impact (13), and prevalence (23). Using our framework and definitions, a pattern of incomplete documentation, inconsistent definitions, and lack of clarity was identified across all IROs. Conclusion. Although POC screening tests for syphilis were generally favourably evaluated across a range of outcomes, the quality of evidence was compromised by inconsistent definitions, poor methodology, and documentation of outcomes. A framework for standardized reporting of outcomes beyond accuracy was proposed and considered a necessary first step towards an effective implementation of these metrics in POC diagnostics research. PMID:24795821

  14. 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

  15. 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 antipsychotics. Trial Registration: ClinicalTrials.gov identifier: NCT02029989 PMID:25667811

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

    PubMed

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

    2014-01-01

    This study presents an optical inspection system for detecting a commercial point-of-care testing product and a new detection model covering from qualitative to quantitative analysis. Human chorionic gonadotropin (hCG) strips (cut-off value of the hCG commercial product is 25 mIU/mL) were the detection target in our study. We used a complementary metal-oxide semiconductor (CMOS) sensor to detect the colors of the test line and control line in the specific strips and to reduce the observation errors by the naked eye. To achieve better linearity between the grayscale and the concentration, and to decrease the standard deviation (increase the signal to noise ratio, S/N), the Taguchi method was used to find the optimal parameters for the optical inspection system. The pregnancy test used the principles of the lateral flow immunoassay, and the colors of the test and control line were caused by the gold nanoparticles. Because of the sandwich immunoassay model, the color of the gold nanoparticles in the test line was darkened by increasing the hCG concentration. As the results reveal, the S/N increased from 43.48 dB to 53.38 dB, and the hCG concentration detection increased from 6.25 to 50 mIU/mL with a standard deviation of less than 10%. With the optimal parameters to decrease the detection limit and to increase the linearity determined by the Taguchi method, the optical inspection system can be applied to various commercial rapid tests for the detection of ketamine, troponin I, and fatty acid binding protein (FABP). PMID:25256108

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

    PubMed Central

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

    2014-01-01

    This study presents an optical inspection system for detecting a commercial point-of-care testing product and a new detection model covering from qualitative to quantitative analysis. Human chorionic gonadotropin (hCG) strips (cut-off value of the hCG commercial product is 25 mIU/mL) were the detection target in our study. We used a complementary metal-oxide semiconductor (CMOS) sensor to detect the colors of the test line and control line in the specific strips and to reduce the observation errors by the naked eye. To achieve better linearity between the grayscale and the concentration, and to decrease the standard deviation (increase the signal to noise ratio, S/N), the Taguchi method was used to find the optimal parameters for the optical inspection system. The pregnancy test used the principles of the lateral flow immunoassay, and the colors of the test and control line were caused by the gold nanoparticles. Because of the sandwich immunoassay model, the color of the gold nanoparticles in the test line was darkened by increasing the hCG concentration. As the results reveal, the S/N increased from 43.48 dB to 53.38 dB, and the hCG concentration detection increased from 6.25 to 50 mIU/mL with a standard deviation of less than 10%. With the optimal parameters to decrease the detection limit and to increase the linearity determined by the Taguchi method, the optical inspection system can be applied to various commercial rapid tests for the detection of ketamine, troponin I, and fatty acid binding protein (FABP). PMID:25256108

  18. 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

  19. Amplification-free point of care immunosensor for detecting type V collagen at a concentration level of ng/ml

    NASA Astrophysics Data System (ADS)

    Chung, Pei-Yu; Bracho-Sanchez, Evelyn R.; Jiang, Peng; Seagrave, JeanClare; Duncan, Matthew R.; Grotendorst, Gary R.; Schultz, Gregory; Batich, Christopher

    2011-06-01

    Point-of-care testing (POCT) is applicable in the immediate vicinity of the patient, where timely diagnosis or prognostic information could help doctors decide the following treatment. Among types of developed POCT, gold nanoparticle based lateral flow strip technology provides advantages such as simple operation, cost-effectiveness, and a user-friendly platform. Therefore, this type of POCT is most likely to be used in battlefields and developing countries. However, conventional lateral flow strips suffer from low detection limits. Although enzyme-linked amplification was demonstrated to improve the detection limit and sensitivity by stronger visible lines or by permitting electrochemical analytical instrumentation, the enzyme labels have potential to cause interference with other enzymes in our body fluids. To eliminate this limitation, we developed an amplification-free gold nanoparticle-based immunosensor applied for detecting collagen type V, which is produced or released abnormally during rejection of lung transplants and sulfur mustard exposure. By using suitable blocking protein to stabilize gold nanoparticles as the reporter probe, a low detection limit of ng/ml was achieved. This strategy is a promising platform for clinical POCT, with potential applications in military or disaster response.

  20. 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

  1. Comparative performance assessment of point-of-care testing devices for measuring glucose and ketones at the patient bedside.

    PubMed

    Ceriotti, Ferruccio; Kaczmarek, Ewa; Guerra, Elena; Mastrantonio, Fabrizio; Lucarelli, Fausto; Valgimigli, Francesco; Mosca, Andrea

    2015-03-01

    Point-of-care (POC) testing devices for monitoring glucose and ketones can play a key role in the management of dysglycemia in hospitalized diabetes patients. The accuracy of glucose devices can be influenced by biochemical changes that commonly occur in critically ill hospital patients and by the medication prescribed. Little is known about the influence of these factors on ketone POC measurements. The aim of this study was to assess the analytical performance of POC hospital whole-blood glucose and ketone meters and the extent of glucose interference factors on the design and accuracy of ketone results. StatStrip glucose/ketone, Optium FreeStyle glucose/ketone, and Accu-Chek Performa glucose were also assessed and results compared to a central laboratory reference method. The analytical evaluation was performed according to Clinical and Laboratory Standards Institute (CLSI) protocols for precision, linearity, method comparison, and interference. The interferences assessed included acetoacetate, acetaminophen, ascorbic acid, galactose, maltose, uric acid, and sodium. The accuracies of both Optium ketone and glucose measurements were significantly influenced by varying levels of hematocrit and ascorbic acid. StatStrip ketone and glucose measurements were unaffected by the interferences tested with exception of ascorbic acid, which reduced the higher level ketone value. The accuracy of Accu-Chek glucose measurements was affected by hematocrit, by ascorbic acid, and significantly by galactose. The method correlation assessment indicated differences between the meters in compliance to ISO 15197 and CLSI 12-A3 performance criteria. Combined POC glucose/ketone methods are now available. The use of these devices in a hospital setting requires careful consideration with regard to the selection of instruments not sensitive to hematocrit variation and presence of interfering substances. PMID:25519295

  2. Comparative Performance Assessment of Point-of-Care Testing Devices for Measuring Glucose and Ketones at the Patient Bedside

    PubMed Central

    Ceriotti, Ferruccio; Kaczmarek, Ewa; Guerra, Elena; Mastrantonio, Fabrizio; Lucarelli, Fausto; Valgimigli, Francesco; Mosca, Andrea

    2014-01-01

    Background: Point-of-care (POC) testing devices for monitoring glucose and ketones can play a key role in the management of dysglycemia in hospitalized diabetes patients. The accuracy of glucose devices can be influenced by biochemical changes that commonly occur in critically ill hospital patients and by the medication prescribed. Little is known about the influence of these factors on ketone POC measurements. The aim of this study was to assess the analytical performance of POC hospital whole-blood glucose and ketone meters and the extent of glucose interference factors on the design and accuracy of ketone results. Methods: StatStrip glucose/ketone, Optium FreeStyle glucose/ketone, and Accu-Chek Performa glucose were also assessed and results compared to a central laboratory reference method. The analytical evaluation was performed according to Clinical and Laboratory Standards Institute (CLSI) protocols for precision, linearity, method comparison, and interference. Results: The interferences assessed included acetoacetate, acetaminophen, ascorbic acid, galactose, maltose, uric acid, and sodium. The accuracies of both Optium ketone and glucose measurements were significantly influenced by varying levels of hematocrit and ascorbic acid. StatStrip ketone and glucose measurements were unaffected by the interferences tested with exception of ascorbic acid, which reduced the higher level ketone value. The accuracy of Accu-Chek glucose measurements was affected by hematocrit, by ascorbic acid, and significantly by galactose. The method correlation assessment indicated differences between the meters in compliance to ISO 15197 and CLSI 12-A3 performance criteria. Conclusions: Combined POC glucose/ketone methods are now available. The use of these devices in a hospital setting requires careful consideration with regard to the selection of instruments not sensitive to hematocrit variation and presence of interfering substances. PMID:25519295

  3. Role of point of care - ST2, Galectin-3 and adrenomedullin in the evaluation and treatment of emergency patients

    PubMed Central

    Siler-Fisher, Angela; Tucci, Veronica; Kalra, Sarathi; Galwankar, Sagar C; Khose, Swapnil D; Sanjeevani, S; Goel, Ashish; Peacock, Frank W

    2014-01-01

    There have been many technological advances improving the work up and treatment of patients in the emergency department (ED). Point of care testing (POCT) is becoming more common, especially in the time compressed clinically high-pressured environment of the emergency department. In present times, emphasis of POCT has spurred search of novel biomarkers which promise earlier and more specific detection of disease. This article reviews the role of ST2, Galectin-3 and Adrenomedullin in the acute care setting addressing the screening, diagnostic, and prognostic role of each marker for stratification of patients. Use of these markers has shown a strong correlation with early identification and efficient management in the ED. PMID:25337491

  4. Role of point of care - ST2, Galectin-3 and adrenomedullin in the evaluation and treatment of emergency patients.

    PubMed

    Siler-Fisher, Angela; Tucci, Veronica; Kalra, Sarathi; Galwankar, Sagar C; Khose, Swapnil D; Sanjeevani, S; Goel, Ashish; Peacock, Frank W

    2014-07-01

    There have been many technological advances improving the work up and treatment of patients in the emergency department (ED). Point of care testing (POCT) is becoming more common, especially in the time compressed clinically high-pressured environment of the emergency department. In present times, emphasis of POCT has spurred search of novel biomarkers which promise earlier and more specific detection of disease. This article reviews the role of ST2, Galectin-3 and Adrenomedullin in the acute care setting addressing the screening, diagnostic, and prognostic role of each marker for stratification of patients. Use of these markers has shown a strong correlation with early identification and efficient management in the ED. PMID:25337491

  5. A simple 96 well microfluidic chip combined with visual and densitometry detection for resource-poor point of care testing

    PubMed Central

    Yang, Minghui; Sun, Steven; Kostov, Yordan

    2010-01-01

    There is a well-recognized need for low cost biodetection technologies for resource-poor settings with minimal medical infrastructure. Lab-on-a-chip (LOC) technology has the ability to perform biological assays in such settings. The aim of this work is to develop a low cost, high-throughput detection system for the analysis of 96 samples simultaneously outside the laboratory setting. To achieve this aim, several biosensing elements were combined: a syringe operated ELISA lab-on-a-chip (ELISA-LOC) which integrates fluid delivery system into a miniature 96-well plate; a simplified non-enzymatic reporter and detection approach using a gold nanoparticle-antibody conjugate as a secondary antibody and silver enhancement of the visual signal; and Carbon nanotubes (CNT) to increase primary antibody immobilization and improve assay sensitivity. Combined, these elements obviate the need for an ELISA washer, electrical power for operation and a sophisticated detector. We demonstrate the use of the device for detection of Staphylococcal enterotoxin B, a major foodborne toxin using three modes of detection, visual detection, CCD camera and document scanner. With visual detection or using a document scanner to measure the signal, the limit of detection (LOD) was 0.5ng/ml. In addition to visual detection, for precise quantitation of signal using densitometry and a CCD camera, the LOD was 0.1ng/ml for the CCD analysis and 0.5 ng/ml for the document scanner. The observed sensitivity is in the same range as laboratory-based ELISA testing. The point of care device can analyze 96 samples simultaneously, permitting high throughput diagnostics in the field and in resource poor areas without ready access to laboratory facilities or electricity. PMID:21503269

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

    PubMed Central

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

    2015-01-01

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

  7. 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

  8. Antenatal Syphilis Screening Using Point-of-Care Testing in Sub-Saharan African Countries: A Cost-Effectiveness Analysis

    PubMed Central

    Kuznik, Andreas; Lamorde, Mohammed; Nyabigambo, Agnes; Manabe, Yukari C.

    2013-01-01

    Background Untreated syphilis in pregnancy is associated with adverse clinical outcomes for the infant. Most syphilis infections occur in sub-Saharan Africa (SSA), where coverage of antenatal screening for syphilis is inadequate. Recently introduced point-of-care syphilis tests have high accuracy and demonstrate potential to increase coverage of antenatal screening. However, country-specific cost-effectiveness data for these tests are limited. The objective of this analysis was to evaluate the cost-effectiveness and budget impact of antenatal syphilis screening for 43 countries in SSA and estimate the impact of universal screening on stillbirths, neonatal deaths, congenital syphilis, and disability-adjusted life years (DALYs) averted. Methods and Findings The decision analytic model reflected the perspective of the national health care system and was based on the sensitivity (86%) and specificity (99%) reported for the immunochromatographic strip (ICS) test. Clinical outcomes of infants born to syphilis-infected mothers on the end points of stillbirth, neonatal death, and congenital syphilis were obtained from published sources. Treatment was assumed to consist of three injections of benzathine penicillin. Country-specific inputs included the antenatal prevalence of syphilis, annual number of live births, proportion of women with at least one antenatal care visit, per capita gross national income, and estimated hourly nurse wages. In all 43 sub-Saharan African countries analyzed, syphilis screening is highly cost-effective, with an average cost/DALY averted of US$11 (range: US$2–US$48). Screening remains highly cost-effective even if the average prevalence falls from the current rate of 3.1% (range: 0.6%–14.0%) to 0.038% (range: 0.002%–0.113%). Universal antenatal screening of pregnant women in clinics may reduce the annual number of stillbirths by up to 64,000, neonatal deaths by up to 25,000, and annual incidence of congenital syphilis by up to 32,000, and avert up to 2.6 million DALYs at an estimated annual direct medical cost of US$20.8 million. Conclusions Use of ICS tests for antenatal syphilis screening is highly cost-effective in SSA. Substantial reduction in DALYs can be achieved at a relatively modest budget impact. In SSA, antenatal programs should expand access to syphilis screening using the ICS test. Please see later in the article for the Editors' Summary PMID:24223524

  9. 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-chains. As validation of the assays was conducted in a third-level laboratory environment, field based evaluation trials are necessary to determine the clinical performance at peripheral health care level. PMID:26566026

  10. 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 and broad stake-holder engagement we developed a clinical DST for the non-pharmacologist. This tools affords our clinicians the ability to seamlessly transition from patient assessment, to pharmacokinetic modeling and simulation, and subsequent prescription order entry. PMID:27065859

  11. 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.

  12. Impact of emerging technologies and regulations on the role of POCT.

    PubMed

    Gouget, B; Barclay, J; Rakotoambinina, B

    2001-05-01

    Point-of-care testing (POCT) can be introduced by laboratory directors or clinicians in response to the need for rapid results to guide treatment. The professional responsibility for ensuring reliable and accurate results is well-defined in some countries such as France, but the role and responsibility of the laboratory is less clear in many other places. When point-of-care instrument technology and the intrinsic design of the device leads to device-specific parameters or analytical differences from laboratory-based equipment, there is a risk of misinterpretation and erroneous treatment decisions. Laboratory staffs are more often aware of the interaction of analytical technology and result interpretation than clinicians, making it more rational to involve the laboratory in the selection of point-of-care equipment, procedures, and therapeutic decisions based on the results. The design control and risk-analysis provisions of emerging regulations such as the EU in vitro diagnostic medical device (IVD) can be interpreted as engaging the manufacturer's responsibility, even when the equipment is functioning according to specification. This is especially true of device-specific parameters in which cross-calibration or traceability to a reference material or method is not possible. This is a further argument for involvement of the laboratory in the selection and implementation of point-of-care testing devices. PMID:11369363

  13. Effect of incorporating a 10 minute point of care test for salivary nicotine metabolites into a general practice based smoking cessation programme: randomised controlled trial

    PubMed Central

    Barnfather, Kristian D; Cope, Graham F; Chapple, Iain L

    2005-01-01

    Objective To investigate the effect of immediate feedback from a point of care test for salivary nicotine metabolites in promoting smoking cessation and reduction in tobacco use. Design Prospective, operator blinded, randomised controlled trial. Setting General dental practice, London. Participants 100 adult smokers. Interventions Participants completed a questionnaire on smoking, undertook a clinical examination, and received counselling in smoking cessation. Saliva samples were analysed at presentation and at eight weeks for salivary nicotine metabolites using a 10 minute semiquantitative point of care test. Main outcome measures Smoking cessation measured by salivary nicotine metabolite values (scale 0-6), patient feedback on the perceived value of the test (visual analogue scale) in quitting, and reduction in tobacco use. Results A higher smoking quit rate was achieved with the point of care test (23% cases v 7% controls; P < 0.039), and overall tobacco use also decreased (68% cases v 28% controls; P < 0.001). Baseline values for salivary nicotine metabolites did not differ between the groups (cases, mean 4.1, SD 1.3 and 4.3, 1.4; P = 0.51). 87 participants reattended at eight weeks (44 cases, 43 controls). Mean nicotine metabolite values at eight weeks were 2.58 (2.0) for cases and 4.29 (1.8) for controls (P < 0.001). Conclusion Incorporation of individualised personal feedback using a point of care test for salivary nicotine metabolites into a general practice based smoking cessation programme increased quit rates by 17% at eight weeks and reduced tobacco use. PMID:16210250

  14. Point of care blood gases with electrolytes and lactates in adult emergencies

    PubMed Central

    Kapoor, Dheeraj; Srivastava, Meghana; Singh, Pritam

    2014-01-01

    Point-of-care testing (POCT) is one of the formidable concept introduce in the field of critical care settings to deliver decentralized, patient-centric health care to the patients. Rapid provision of blood measurements, particularly blood gases and electrolytes, may translate into improved clinical outcomes. Studies shows that POCT carries advantages of providing reduced therapeutic turnaround time (TTAT), shorter door-to-clinical-decision time, rapid data availability, reduced preanalytic and postanalytic testing errors, self-contained user-friendly instruments, small sample volume requirements, and frequent serial whole-blood testing. However, still there is a noticeable debate that exists among the laboratorians, clinicians, and administrators over concerns regarding analyzer inaccuracy, imprecision and performance (interfering substances), poorly trained non-laboratorians, high cost of tests, operator-dependent quality of testing, and difficulty in integrating test results with hospital information system (HIS). On search of literature using Medline/Pubmed and Embase using the key phrases “ppoint-of-care test,” “central laboratory testing,” “electrolytes,” “blood gas analysis,” “lactate,” “emergency department,” “intensive care unit,” we found that POCT of blood gases and selected electrolytes may not entirely replace centralized laboratory testing but may transfigure the clinical practice paradigm of emergency and critical care physicians. We infer that further comprehensive, meaningful and rigorous evaluations are required to determine outcomes which are more quantifiable, closely related to testing events and are associated with effective cost benefits. PMID:25337483

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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; Jrgensen, Karsten Juhl; Hrbjartsson, Asbjrn; 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) impact on antibiotic use; ii) duration of and recovery from infection; iii) complications including the number of re-consultations, hospitalisations and mortality; iv) patient satisfaction. We assessed the risk of bias of all included trials and applied GRADE. We used random-effects meta-analyses when feasible. We further analysed results with a high level of heterogeneity in pre-specified subgroups of individually and cluster-RCTs.Main results The only point-of-care biomarker of infection currently available to primary care identified in this review was C-reactive protein. We included six trials (3284 participants; 139 children) that evaluated a C-reactive protein point-of-care test. The available information was from trials with a low to moderate risk of bias that address the main objectives of this review.Overall a reduction in the use of antibiotic treatments was found in the C-reactive protein group (631/1685) versus standard of care(785/1599). However, the high level of heterogeneity and the statistically significant test for subgroup differences between the three RCTs and three cluster-RCTs suggest that the results of the meta-analysis on antibiotic use should be interpreted with caution and the pooled effect estimate (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.66 to 0.92; I2 statistic = 68%) may not be meaningful.The observed heterogeneity disappeared in our pre planned subgroup analysis based on study design: RR 0.90, 95% CI 0.80 to 1.02; I2 statistic = 5% for RCTs and RR 0.68, 95% CI 0.61 to 0.75; I2 statistic = 0% for cluster-RCTs, suggesting that this was the cause of the observed heterogeneity.There was no difference between using a C-reactive protein point-of-care test and standard care in clinical recovery (defined as at least substantial improvement at day 7 and 28 or need for re-consultations day 28). However, we noted an increase in hospitalisations in the C-reactive protein group in one study, but this was based on few events and may be a chance finding. No deaths were reported in any of the included studies.We classified the quality of the evidence as moderate according to GRADE due to imprecision of the main effect estimate.Authors' conclusions A point-of-care biomarker (e.g. C-reactive protein) to guide antibiotic treatment of ARIs in primary care can reduce antibiotic use,although the degree of reduction remains uncertain. Used as an adjunct to a doctor's clinical examination this reduction in antibiotic use did not affect patient-reported outcomes, including recovery from and duration of illness.However, a possible increase in hospitalisations is of concern. A more precise effect estimate is needed to assess the costs of the intervention and compare the use of a point-of-care biomarker to other antibiotic-saving strategies. PMID:25374293

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

    PubMed

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

    2014-11-15

    In this paper, a pen-on-paper electrochemiluminescence (PoP-ECL) device was entirely hand drawn and written in commercially available crayon and pencil in turn for the first time, and a constant potential-triggered sandwich-type immunosensor was introduced into the PoP-ECL device to form a low-cost ECL immunodevice proof. Each PoP-ECL device contained a hydrophilic paper channel and two PoP electrodes, and the PoP-ECL device was produced as follows: crayon was firstly used to draw hydrophobic regions on pure cellulose paper to create the hydrophilic paper channels followed with a baking treatment, and then a 6B-type black pencil with low resistivity was applied for precision writing, as the PoP electrodes, across the hydrophilic paper channel. For further point-of-care testing, a portable, low-cost rechargeable battery was employed as the power source to provide constant potential to the PoP electrodes to trigger the ECL. Using Carbohydrate antigen 199 as model analyte, this PoP-ECL immunodevice showed a good linear response range from 0.01-200 U mL(-1) with a detection limit of 0.0055 U mL(-1), a high sensitivity and stability. The proposed PoP-ECL immunodevice could be used in point-of-care testing of other tumor markers for remote regions and developing countries. PMID:24841090

  3. Point-of-care monitoring of haemostasis.

    PubMed

    Mallett, S V; Armstrong, M

    2015-01-01

    Recent research in the management of haemorrhage has led to several changes in clinical practice. Evidence is accumulating that point-of-care testing results in fewer transfusions, improved patient outcomes, and reduced hospital costs. However, there is still insufficient high quality evidence to support transfusion guidelines and algorithms based on point-of-care tests alone, and more robust studies are needed. The implementation of point-of-care testing requires institutional support and senior clinical leadership to realise the benefits, with educational programmes, audit, and feedback regarding transfusion practice. A change in philosophy is required, from performing testing only when there is an obvious bleeding problem, towards the concept of routinely monitoring high-risk patients throughout the surgical procedure. This informs clinical practice, establishes normal ranges for that population, identifies patients at risk and allows early identification and treatment of evolving coagulopathy. PMID:25440399

  4. 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/specificity and higher cost than published values. In other resource-limited settings with fewer opportunities to access care, POC-CD4 has a greater impact on clinical outcomes and remains cost-effective compared to LAB-CD4. Limitations of the analysis include the uncertainty around input parameters, which is examined in sensitivity analyses. The potential added benefits due to decreased transmission are excluded; their inclusion would likely further increase the value of POC-CD4 compared to LAB-CD4. Conclusions POC-CD4 at the time of HIV diagnosis could improve survival and be cost-effective compared to LAB-CD4 in Mozambique, if it improves linkage to care. POC-CD4 could have the greatest impact on mortality in settings where resources for HIV testing and linkage are most limited. Please see later in the article for the Editors' Summary PMID:25225800

  5. Multi-Centre Evaluation of the Determine HIV Combo Assay when Used for Point of Care Testing in a High Risk Clinic-Based Population

    PubMed Central

    Conway, Damian P.; Holt, Martin; McNulty, Anna; Couldwell, Deborah L.; Smith, Don E.; Davies, Stephen C.; Cunningham, Philip; Keen, Phillip; Guy, Rebecca

    2014-01-01

    Background Determine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics. Methods We compared DHC performance (overall, by test component and in early infection) with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests) when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months. Results Of 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection) and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive) and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022). Specificity overall was 99.4% with the antigen component contributing to 33% of false positives. Conclusions The DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population. PMID:24714441

  6. Association between point-of-care CRP testing and antibiotic prescribing in respiratory tract infections: a systematic review and meta-analysis of primary care studies

    PubMed Central

    Huang, Yafang; Chen, Rui; Wu, Tao; Wei, Xiaoming; Guo, Aimin

    2013-01-01

    Background Most patients with respiratory tract infections (RTIs) are prescribed antibiotics in general practice. However, there is little evidence that antibiotics bring any value to the treatment of most RTIs. Point-of-care C-reactive protein testing may reduce antibiotic prescribing. Aim To systematically review studies that have examined the association between point-of-care (POC) C-reactive protein testing and antibiotic prescribing for RTIs in general practice. Design and setting Systematic review and meta-analysis of randomised controlled trials and observational studies. Method MEDLINE and Embase were systematically searched to identify relevant publications. All studies that examined the association between POC C-reactive protein testing and antibiotic prescribing for patients with RTIs were included. Two authors independently screened the search results and extracted data from eligible studies. Dichotomous measures of outcomes were combined using risk ratios (RRs) with 95% confidence intervals (CIs) either by fixed or random-effect models. Results Thirteen studies containing 10 005 patients met the inclusion criteria. POC C-reactive protein testing was associated with a significant reduction in antibiotic prescribing at the index consultation (RR 0.75, 95% CI = 0.67 to 0.83), but was not associated with antibiotic prescribing at any time during the 28-day follow-up period (RR 0.85, 95% CI = 0.70 to 1.01) or with patient satisfaction (RR 1.07, 95% CI = 0.98 to 1.17). Conclusion POC C-reactive protein testing significantly reduced antibiotic prescribing at the index consultation for patients with RTIs. Further studies are needed to analyse the confounders that lead to the heterogeneity. PMID:24267862

  7. 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’ perceptions about the INR testing device, the cost of device, trust in doctors/clinicians, and the age of the patient, which need to be considered prior to any intervention involving INR self-testing by patients. Manufacturers should focus on increasing the affordability of INR testing devices for patients’ self-testing and on the potential role of medical practitioners in supporting use of these medical devices as patients move from hospital to home testing. PMID:23300344

  8. 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

  9. 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

  10. 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

  11. Point-of-care method for total white cell count: an evaluation of the HemoCue WBC device

    PubMed Central

    OSEI-BIMPONG, A; JURY, C; McLEAN, R; LEWIS, S M

    2009-01-01

    Point-of-care testing (POCT) is becoming an important adjunct to haematology laboratory practice. An important component of the blood count is the total white cell count (WBC). Previously, this required laborious microscopic cell counting, but it can now be performed by means of automation; however, in many under-resourced countries, costly automated counters are only available in very few central hospitals. Moreover, neither method is practical in most POCT situations. The HemoCue WBC has been developed as a simplified alternative method, consisting of a reagent pre-loaded disposable cuvette together with basic image analysis technology. This report describes an assessment of its utility. The WBC of 500 routine blood samples from the hospital were tested in parallel by the HemoCue WBC and by a reference analyser to assess accuracy and utility of the former. The tests included precision, linearity, type of blood sample and anticoagulant and potential interfering substances in blood specimens. In the tests for accuracy, 192 of the 200 showed percentage difference from the NEQAS reference of <10% whilst the remaining eight samples differed by <12%, thus meeting the requirements of Clinical laboratory improvement amendments (CLIA)-88 regulations. Of the samples tested with potential interfering substances only those with >2% normoblasts or reticulocytosis showed significant differences from the reference measurements. The HemoCue WBC is reliable for WBC counts within the analytical range of 0.4–30.0 × 109/l, except in samples where there are significant numbers of normoblasts or reticulocytes. It is simple to use and provides a valuable advance in the facilities available for POCT in haematology. PMID:18759736

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

    PubMed Central

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

    2014-01-01

    Objective Despite the growing number of point-of-care (POC) tests available, little research has assessed primary care clinician need for such tests. We therefore aimed to determine which POC tests they actually use or would like to use (if not currently available in their practice). Design Cross-sectional survey. Setting Primary care in Australia, Belgium (Flanders region only), the Netherlands, the UK and the USA. Participants Primary care doctors (general practitioners, family physicians). Main measures We asked respondents to (1) identify conditions for which a POC test could help inform diagnosis, (2) from a list of tests provided: evaluate which POC tests they currently use (and how frequently) and (3) determine which tests (from that same list) they would like to use in the future (and how frequently). Results 2770 primary care clinicians across five countries responded. Respondents in all countries wanted POC tests to help them diagnose acute conditions (infections, acute cardiac disease, pulmonary embolism/deep vein thrombosis), and some chronic conditions (diabetes, anaemia). Based on the list of POC tests provided, the most common tests currently used were: urine pregnancy, urine leucocytes or nitrite and blood glucose. The most commonly reported tests respondents expressed a wish to use in the future were: D-dimer, troponin and chlamydia. The UK and the USA reported a higher actual and desired use for POC tests than Australia, Belgium and the Netherlands. Our limited data suggest (but do not confirm) representativeness. Conclusions Primary care clinicians in all five countries expressed a desire for POC tests to help them diagnose a range of acute and chronic conditions. Rates of current reported use and desired future use were generally high for a small selection of POC tests, but varied across countries. Future research is warranted to explore how specific POC tests might improve primary care. PMID:25107438

  13. 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

  14. 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

  15. Suitability of capillary blood for quantitative assessment of G6PD activity and performances of G6PD point-of-care tests.

    PubMed

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

    2015-04-01

    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

  16. 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

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

    PubMed

    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

  18. 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

  19. Mapping patient pathways and estimating resource use for point of care versus standard testing and treatment of chlamydia and gonorrhoea in genitourinary medicine clinics in the UK

    PubMed Central

    Adams, Elisabeth J; Ehrlich, Alice; Turner, Katherine M E; Shah, Kunj; Macleod, John; Goldenberg, Simon; Meray, Robin K; Pearce, Vikki; Horner, Patrick

    2014-01-01

    Objectives We aimed to explore patient pathways using a chlamydia/gonorrhoea point-of-care (POC) nucleic acid amplification test (NAAT), and estimate and compare the costs of the proposed POC pathways with the current pathways using standard laboratory-based NAAT testing. Design/participants Workshops were conducted with healthcare professionals at four sexual health clinics representing diverse models of care in the UK. They mapped out current pathways that used chlamydia/gonorrhoea tests, and constructed new pathways using a POC NAAT. Healthcare professionals' time was assessed in each pathway. Outcome measure The proposed POC pathways were then priced using a model built in Microsoft Excel, and compared to previously published costs for pathways using standard NAAT-based testing in an off-site laboratory. Results Pathways using a POC NAAT for asymptomatic and symptomatic patients and chlamydia/gonorrhoea-only tests were shorter and less expensive than most of the current pathways. Notably, we estimate that POC testing as part of a sexual health screen for symptomatic patients, or as stand-alone chlamydia/gonorrhoea testing, could reduce costs per patient by as much as £16 or £6, respectively. In both cases, healthcare professionals' time would be reduced by approximately 10 min per patient. Conclusions POC testing for chlamydia/gonorrhoea in a clinical setting may reduce costs and clinician time, and may lead to more appropriate and quicker care for patients. Further study is warranted on how to best implement POC testing in clinics, and on the broader clinical and cost implications of this technology. PMID:25056977

  20. 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

  1. 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

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

    PubMed

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

    2015-07-01

    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

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

    PubMed Central

    Dutta, Arindam; Kumar, Robins; Malhotra, Suruchi; Chugh, Sanjay; Banerjee, Alakananda; Dutta, Anirban

    2013-01-01

    The World Health Organization estimated that major depression is the fourth most significant cause of disability worldwide for people aged 65 and older, where depressed older adults reported decreased independence, poor health, poor quality of life, functional decline, disability, and increased chronic medical problems. Therefore, the objectives of this study were (1) to develop a low-cost point-of-care testing system for psychomotor symptoms of depression and (2) to evaluate the system in community dwelling elderly in India. The preliminary results from the cross-sectional study showed a significant negative linear correlation between balance and depression. Here, monitoring quantitative electroencephalography along with the center of pressure for cued response time during functional reach tasks may provide insights into the psychomotor symptoms of depression where average slope of the Theta-Alpha power ratio versus average slope of baseline-normalized response time may be a candidate biomarker, which remains to be evaluated in our future clinical studies. Once validated, the biomarker can be used for monitoring the outcome of a comprehensive therapy program in conjunction with pharmacological interventions. Furthermore, the frequency of falls can be monitored with a mobile phone-based application where the propensity of falls during the periods of psychomotor symptoms of depression can be investigated further. PMID:24205436

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

    PubMed

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

    2014-12-01

    It has been reported that detection of exhaled breath condensate (EBC) is available for studies of pulmonary diseases, especially lung disease. In order to detect lung cancer (LC) at early stage, a point-of-care testing system suitable for measurement of tumor markers in EBC is developed. The assay, based on gold nanoparticle sandwich immunoassay and subsequent gold staining, was performed on a Love-wave sensor packaged inside a chip cartridge. Benefit from high sensitivity of Love-wave sensor, oriented immobilization of coating antibodies and immunogold staining enhancement, the present immunosensor could provide a sensitive, specific and rapid measurement. Carcinoembryonic antigen (CEA), neuron specific enolase (NSE) and squamous cell carcinoma antigen (SCC) in EBC collected from 17 patients with LC and 13 healthy volunteers were detected by this system. Results were compared with commercial chemiluminescence immunoassay and showed high correlation between two methods. Additionally, it revealed significantly statistical differences existing between two groups of subjects. These results indicate that the present system is suitable for detection of tumor markers in EBC and could be used as assistant tools for early detection of LC. PMID:25158626

  5. A field evaluation of a new molecular-based point-of-care test for chlamydia and gonorrhoea in remote Aboriginal health services in Australia.

    PubMed

    Causer, Louise M; Hengel, Belinda; Natoli, Lisa; Tangey, Annie; Badman, Steven G; Tabrizi, Sepehr N; Whiley, David; Ward, James; Kaldor, John M; Guy, Rebecca J

    2014-11-27

    Background Point-of-care (POC) tests could be important public health tools in settings with treatment delays and high rates of sexually transmissible infections (STIs). Use is limited due to suboptimal performance. The performance and ease-of-use of a new molecular-based POC test for simultaneous detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) was assessed, alongside two single-organism immunochromatographic tests (ICT). Methods: The evaluation occurred between May 2012 and March 2013 during community STI screens in two remote Aboriginal health services. Urine was tested with the GeneXpert®CT/NG and if sufficient volume, also with Diaquick CT and Gonorrhoea Card. The gold standard comparison was laboratory nucleic acid amplification testing (NAAT). Operational characteristics were also assessed. Results: Among 198 samples, GeneXpert CT sensitivity and specificity was 100% [95% confidence intervals (CI): 75.9-100] and 99.5% (95% CI: 96.5-100), and NG was 100% (95% CI: 96.5-100) and 100% (95% CI: 97.5-100), respectively. Among a sample subset, Diaquick CT (n=104) sensitivity and specificity was 27.3% (95% CI: 7.3-60.7) and 66.7% (95% CI: 12.5-98.2), and Gonorrhoea Card (n=29), was 66.7% (95% CI: 12.5-98.2) and 76.9% (95% CI: 56.0-90.2), respectively. GeneXpert required 1mL of urine, four steps, 1min specimen preparation and 90min to result. ICTs required 15mL of urine, eight steps, 18min preparation and 10-15min to result. Conclusion: The accuracy and operational benefits of GeneXpert CT/NG make it very suitable in these settings where delays to treatment are encountered. PMID:25426655

  6. Comparison of three point-of-care testing devices to detect hemostatic changes in adult elective cardiac surgery: a prospective observational study

    PubMed Central

    2014-01-01

    Background Bleeding complications in cardiac surgery may lead to increased morbidity and mortality. Traditional blood coagulation tests are not always suitable to detect rapid changes in the patient's coagulation status. Point-of-care instruments such as the TEG (thromboelastograph) and RoTEM (thromboelastometer) have been shown to be useful as a guide for the clinician in the choice of blood products and they may lead to a reduction in the need for blood transfusion, contributing to better patient blood management. Methods The purpose of this study was to evaluate the ability of the TEG, RoTEM and Sonoclot instruments to detect changes in hemostasis in elective cardiac surgery with cardiopulmonary bypass and to investigate possible correlations between variables from these three instruments and routine hematological coagulation tests. Blood samples from thirty-five adult patients were drawn before and after surgery and analyzed in TEG, RoTEM, Sonoclot and routine coagulation tests. Data were compared using repeated measures analysis of variance and Pearson's test for linear correlation. Results We found significant changes for all TEG variables after surgery, for three of the RoTEM variables, and for one variable from the Sonoclot. There were significant correlations postoperatively between plasma fibrinogen levels and variables from the three instruments. Conclusions TEG and RoTEM may be used to detect changes in hemostasis following cardiac surgery with CPB. Sonoclot seems to be less suitable to detect such changes. Variables from the three instruments correlated with plasma fibrinogen and could be used to monitor treatment with fibrinogen concentrate. PMID:25276093

  7. 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

  8. 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

  9. A miniaturized self-contained single-use disposable quantitatitve test for hemoglobin A1c in blood at the point of care.

    PubMed

    Stivers, C R; Baddam, S R; Clark, A L; Ammirati, E B; Irvin, B R; Blatt, J M

    2000-01-01

    DRx HbA1c is a finger-stick (< or =10 microL) test for hemoglobin A1c (HbA1c) developed by Metrika, Inc., for rapid quantitative testing at the point of care. It incorporates microelectronics, optics, and dry reagent chemistry inside a self-contained, integrated, single-use device. Test results (%HbA1c) are displayed in numeric form on the device's liquid crystal display within 8 min after sample application. Having no switches or buttons, DRx HbA1c self-activates upon addition of sample. It contains two dry reagent lateral flow strips, each having an HbA1c immunoassay test zone and a total hemoglobin (Hb) test zone. An on-board microprocessor calculates %HbA1c from the reflectances of the test zones. The microprocessor also corrects for lot-specific reagent characteristics and optical variation, in addition to checking electrical functioning and proper sample volume. For testing accuracy, subjects both with and without diabetes were recruited in order to obtain samples with a wide range of HbA1c values. Whole blood samples were analyzed using both DRx HbA1c units and a laboratory method (Bio-Rad DiaSTATT). DRx HbA1c testing was performed by laboratory personnel and by subjects who received brief training. Repeatability, linearity, sample volume tolerance, diluted sample stability and hematocrit tolerance of the DRx HbA1c test were assessed by trained laboratory personnel as described in the text. The linear %HbA1c range of the assay extended from approximately 3% to 15%. Hb was measurable from 6.8 to 20.0 g/dL, encompassing over 99.8% of the normal population. DRx HbA1c clinical sample test results (n = 50) correlated linearly to the Bio-Rad DiaSTAT method (r = 0.935) with slope and intercept values of 0.994 and 0.003, respectively. The repeatability for %HbA1c was within 5-9% CV. We conclude that DRx HbA1c performance is closely equivalent to that of existing tests. PMID:11469613

  10. 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 pilot and national rollout settings, and highlighted important differences in costs that may be observed when moving from pilot to scale-up. PMID:25970443

  11. An innovative sample-to-answer polymer lab-on-a-chip with on-chip reservoirs for the POCT of thyroid stimulating hormone (TSH).

    PubMed

    Jung, Wooseok; Han, Jungyoup; Kai, Junhai; Lim, Ji-Youn; Sul, Donggeun; Ahn, Chong H

    2013-12-01

    A new sample-to-answer polymer lab-on-a-chip, which can perform immunoassay with minimum user intervention through on-chip reservoirs for reagents and single-channel assay system, has been designed, developed and successfully characterized as a point-of-care testing (POCT) cartridge for the detection of thyroid stimulating hormone (TSH). Test results were obtained within 30 minutes after a sample was dropped into the POCT cartridge. The analyzed results of TSH showed a linear range of up to 55 μIU mL(-1) with the limit of detection (LOD) of 1.9 μIU mL(-1) at the signal-to-noise ratio (SNR) of 3. The reagents stored in the on-chip reservoirs maintained more than 97% of their initial volume for 120 days of storage time while the detection antibody retained its activity above 98% for 120 days. The sample-to-answer polymer lab-on-a-chip developed in this work using the mass-producible and low-cost polymer is well suited for the point-of-care testing of rapid in vitro diagnostics (IVD) of TSH. PMID:24121997

  12. 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

  13. 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 limited settings with poor access to laboratories or screening for syphilis. PMID:23468842

  14. 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 low screening rates or continue national syphilis screening programs in countries with high rates. PMID:26010366

  15. Quantitative Influenza Follow-Up Testing (QIFT)—A Novel Biomarker for the Monitoring of Disease Activity at the Point-of-Care

    PubMed Central

    Chen, Xi; Pouran Yousef, Kaveh; Duwe, Susanne; Karsch, Katharina; Grover, Sandeep; Wählisch, Stephanie; Obermeier, Patrick; Tief, Franziska; Mühlhans, Susann; Seeber, Lea; von Kleist, Max; Schweiger, Brunhilde; Rath, Barbara

    2014-01-01

    Background Influenza infections induce considerable disease burden in young children. Biomarkers for the monitoring of disease activity at the point-of-care (POC) are currently lacking. Recent methodologies for fluorescence-based rapid testing have been developed to provide improved sensitivities with the initial diagnosis. The present study aims to explore the utility of second-generation rapid testing during longitudinal follow-up of influenza patients (Rapid Influenza Follow-up Testing = RIFT). Signal/control fluorescent readouts (Quantitative Influenza Follow-up Testing = QIFT) are evaluated as a potential biomarker for the monitoring of disease activity at the POC. Methods and Findings RIFT (SOFIA) and QIFT were performed at the POC and compared to blinded RT-PCR at the National Reference Centre for Influenza. From 10/2011-4/2013, a total of 2048 paediatric cases were studied prospectively; 273 cases were PCR-confirmed for influenza. During follow-up, RIFT results turned negative either prior to PCR (68%), or simultaneously (30%). The first negative RIFT occurred after a median of 8 days with a median virus load (VL) of 5.6×10∧3 copies/ml and cycle threshold of 37, with no evidence of viral rebound. Binning analysis revealed that QIFT differentiated accurately between patients with low, medium and high viral titres. QIFT increase/decrease showed 88% agreement (sensitivity = 52%, specificity = 95%) with VL increase/decrease, respectively. QIFT-based viral clearance estimates showed similar values compared to PCR-based estimates. Variations in viral clearance rates were lower in treated compared to untreated patients. The study was limited by use of non-invasive, semi-quantitative nasopharyngeal samples. VL measurements below the limit of detection could not be quantified reliably. Conclusions During follow-up, RIFT provides a first surrogate measure for influenza disease activity. A “switch” from positive to negative values may indicate a drop in viral load below a critical threshold, where rebound is no longer expected. QIFT may provide a useful tool for the monitoring of disease burden and viral clearance at the POC. PMID:24658130

  16. 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 implementation modeling is required. PMID:25740777

  17. 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 results indicate the potential for detrimental effects in some settings. Local context needs to be considered and services restructured to accommodate innovative technologies in order to improve service delivery to expectant mothers. PMID:26308345

  18. 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

  19. “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 found the GeneXpert highly acceptable. These findings have implications for use in other primary care settings around the world. PMID:26713441

  20. 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

  1. Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis.

    PubMed Central

    Whiting, Penny; Al, Maiwenn; Westwood, Marie; Ramos, Isaac Corro; Ryder, Steve; Armstrong, Nigel; Misso, Kate; Ross, Janine; Severens, Johan; Kleijnen, Jos

    2015-01-01

    BACKGROUND Patients with substantive bleeding usually require transfusion and/or (re-)operation. Red blood cell (RBC) transfusion is independently associated with a greater risk of infection, morbidity, increased hospital stay and mortality. ROTEM (ROTEM® Delta, TEM International GmbH, Munich, Germany; www.rotem.de), TEG (TEG® 5000 analyser, Haemonetics Corporation, Niles, IL, USA; www.haemonetics.com) and Sonoclot (Sonoclot® coagulation and platelet function analyser, Sienco Inc., Arvada, CO) are point-of-care viscoelastic (VE) devices that use thromboelastometry to test for haemostasis in whole blood. They have a number of proposed advantages over standard laboratory tests (SLTs): they provide a result much quicker, are able to identify what part of the clotting process is disrupted, and provide information on clot formation over time and fibrinolysis. OBJECTIVES This assessment aimed to assess the clinical effectiveness and cost-effectiveness of VE devices to assist with the diagnosis, management and monitoring of haemostasis disorders during and after cardiac surgery, trauma-induced coagulopathy and post-partum haemorrhage (PPH). METHODS Sixteen databases were searched to December 2013: MEDLINE (OvidSP), MEDLINE In-Process and Other Non-Indexed Citations and Daily Update (OvidSP), EMBASE (OvidSP), BIOSIS Previews (Web of Knowledge), Science Citation Index (SCI) (Web of Science), Conference Proceedings Citation Index (CPCI-S) (Web of Science), Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA) database, Latin American and Caribbean Health Sciences Literature (LILACS), International Network of Agencies for Health Technology Assessment (INAHTA), National Institute for Health Research (NIHR) HTA programme, Aggressive Research Intelligence Facility (ARIF), Medion, and the International Prospective Register of Systematic Reviews (PROSPERO). Randomised controlled trials (RCTs) were assessed for quality using the Cochrane Risk of Bias tool. Prediction studies were assessed using QUADAS-2. For RCTs, summary relative risks (RRs) were estimated using random-effects models. Continuous data were summarised narratively. For prediction studies, the odds ratio (OR) was selected as the primary effect estimate. The health-economic analysis considered the costs and quality-adjusted life-years of ROTEM, TEG and Sonoclot compared with SLTs in cardiac surgery and trauma patients. A decision tree was used to take into account short-term complications and longer-term side effects from transfusion. The model assumed a 1-year time horizon. RESULTS Thirty-one studies (39 publications) were included in the clinical effectiveness review. Eleven RCTs (n=1089) assessed VE devices in patients undergoing cardiac surgery; six assessed thromboelastography (TEG) and five assessed ROTEM. There was a significant reduction in RBC transfusion [RR 0.88, 95% confidence interval (CI) 0.80 to 0.96; six studies], platelet transfusion (RR 0.72, 95% CI 0.58 to 0.89; six studies) and fresh frozen plasma to transfusion (RR 0.47, 95% CI 0.35 to 0.65; five studies) in VE testing groups compared with control. There were no significant differences between groups in terms of other blood products transfused. Continuous data on blood product use supported these findings. Clinical outcomes did not differ significantly between groups. There were no apparent differences between ROTEM or TEG; none of the RCTs evaluated Sonoclot. There were no data on the clinical effectiveness of VE devices in trauma patients or women with PPH. VE testing was cost-saving and more effective than SLTs. For the cardiac surgery model, the cost-saving was £43 for ROTEM, £79 for TEG and £132 for Sonoclot. For the trauma population, the cost-savings owing to VE testing were more substantial, amounting to per-patient savings of £688 for ROTEM compared with SLTs, £721 for TEG, and £818 for Sonoclot. This finding was entirely dependent on material costs, which are slightly higher for ROTEM. VE testing remained cost-saving following various scenario analyses. CONCLUSIONS VE testing is cost-saving and more effective than SLTs, in both patients undergoing cardiac surgery and trauma patients. However, there were no data on the clinical effectiveness of Sonoclot or of VE devices in trauma patients. STUDY REGISTRATION This study is registered as PROSPERO CRD42013005623. FUNDING The NIHR Health Technology Assessment programme. PMID:26215747

  2. 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 was bench tested on 15 healthy subjects that showed a statistically significant (p < 0.01) difference in the signal-to-noise ratio (SNR) between the ON- and OFF-states of anodal tDCS where the mean SNR of the NIRS device was found to be 42.33 ± 1.33 dB in the ON-state and 40.67 ± 1.23 dB in the OFF-state. Moreover, the clinical study conducted on 14 stroke survivors revealed that the lesioned hemisphere with impaired circulation showed significantly (p < 0.01) less change in \\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} than the nonlesioned side in response to anodal tDCS. The EEG study on healthy subjects showed a statistically significant (p < 0.05) decrease around individual alpha frequency in the alpha band (8−13 Hz) following anodal tDCS. Moreover, the joint EEG-NIRS imaging on 4 stroke survivors showed an immediate increase in the theta band (4−8 Hz) EEG activity after the start of anodal tDCS at the nonlesioned hemisphere. Furthermore, cross-correlation function revealed a significant (95% confidence interval) negative cross correlation only at the nonlesioned hemisphere during anodal tDCS, where the log-transformed mean-power of EEG within 0.5−11.25 Hz lagged \\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} response in one of the stroke survivors with white matter lesions. Therefore, it was concluded that the anodal tDCS can perturb the local neural and the vascular activity (via NVC) which can be used for assessing regional NVC functionality where confirmatory clinical studies are required.

  3. 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

  4. Canadian Public Health Laboratory Network laboratory guidelines for the use of serological tests (excluding point-of-care tests) for the diagnosis of syphilis in Canada.

    PubMed

    Levett, Paul N; Fonseca, Kevin; Tsang, Raymond Sw; Kadkhoda, Kamran; Serhir, Bouchra; Radons, Sandra M; Morshed, Muhammad

    2015-01-01

    Syphilis, caused by the bacterium Treponema pallidum subsp. pallidum, is an infection recognized since antiquity. It was first reported at the end of the 15th century in Europe. Infections may be sexually transmitted as well as spread from an infected mother to her fetus or through blood transfusions. The laboratory diagnosis of syphilis infection is complex. Because this organism cannot be cultured, serology is used as the principal diagnostic method. Some of the issues related to serological diagnoses are that antibodies take time to appear after infection, and serology screening tests require several secondary confirmatory tests that can produce complex results needing interpretation by experts in the field. Traditionally, syphilis screening was performed using either rapid plasma reagin or Venereal Disease Research Laboratory tests, and confirmed by treponemal tests such as MHA-TP, TPPA or FTA-Abs. Currently, that trend is reversed, ie, most of the laboratories in Canada now screen for syphilis using treponemal enzyme immunoassays and confirm the status of infection using rapid plasma reagin or Venereal Disease Research Laboratory tests; this approach is often referred to as the reverse algorithm. This chapter reviews guidelines for specimen types and sample collection, treponemal and non-treponemal tests utilized in Canada, the current status of serological tests for syphilis in Canada, the complexity of serological diagnosis of syphilis infection and serological testing algorithms. Both traditional and reverse sequence algorithms are recommended and the algorithm used should be based on a combination of local disease epidemiology, test volumes, performance of the proposed assays and available resources. PMID:25798165

  5. Canadian Public Health Laboratory Network laboratory guidelines for the use of serological tests (excluding point-of-care tests) for the diagnosis of syphilis in Canada

    PubMed Central

    Levett, Paul N; Fonseca, Kevin; Tsang, Raymond SW; Kadkhoda, Kamran; Serhir, Bouchra; Radons, Sandra M; Morshed, Muhammad

    2015-01-01

    Syphilis, caused by the bacterium Treponema pallidum subsp. pallidum, is an infection recognized since antiquity. It was first reported at the end of the 15th century in Europe. Infections may be sexually transmitted as well as spread from an infected mother to her fetus or through blood transfusions. The laboratory diagnosis of syphilis infection is complex. Because this organism cannot be cultured, serology is used as the principal diagnostic method. Some of the issues related to serological diagnoses are that antibodies take time to appear after infection, and serology screening tests require several secondary confirmatory tests that can produce complex results needing interpretation by experts in the field. Traditionally, syphilis screening was performed using either rapid plasma reagin or Venereal Disease Research Laboratory tests, and confirmed by treponemal tests such as MHA-TP, TPPA or FTA-Abs. Currently, that trend is reversed, ie, most of the laboratories in Canada now screen for syphilis using treponemal enzyme immunoassays and confirm the status of infection using rapid plasma reagin or Venereal Disease Research Laboratory tests; this approach is often referred to as the reverse algorithm. This chapter reviews guidelines for specimen types and sample collection, treponemal and non-treponemal tests utilized in Canada, the current status of serological tests for syphilis in Canada, the complexity of serological diagnosis of syphilis infection and serological testing algorithms. Both traditional and reverse sequence algorithms are recommended and the algorithm used should be based on a combination of local disease epidemiology, test volumes, performance of the proposed assays and available resources. PMID:25798165

  6. Noninferiority of glucose-6-phosphate dehydrogenase deficiency diagnosis by a point-of-care rapid test vs the laboratory fluorescent spot test demonstrated by copper inhibition in normal human red blood cells

    PubMed Central

    Baird, J. Kevin; Dewi, Mewahyu; Subekti, Decy; Elyazar, Iqbal; Satyagraha, Ari W.

    2015-01-01

    Tens of millions of patients diagnosed with vivax malaria cannot safely receive primaquine therapy against repeated attacks caused by activation of dormant liver stages called hypnozoites. Most of these patients lack access to screening for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a highly prevalent disorder causing serious acute hemolytic anemia with primaquine therapy. We optimized CuCl inhibition of G6PD in normal red blood cells (RBCs) to assess G6PD diagnostic technologies suited to point of care in the impoverished rural tropics. The most widely applied technology for G6PD screening—the fluorescent spot test (FST)—is impractical in that setting. We evaluated a new point-of-care G6PD screening kit (CareStart G6PD, CSG) against FST using graded CuCl treatments to simulate variable hemizygous states, and varying proportions of CuCl-treated RBC suspensions to simulate variable heterozygous states of G6PD deficiency. In experiments double-blinded to CuCl treatment, technicians reading FST and CSG test (n = 269) classified results as positive or negative for deficiency. At G6PD activity ≤40% of normal (n = 112), CSG test was not inferior to FST in detecting G6PD deficiency (P = 0.003), with 96% vs 90% (P = 0.19) sensitivity and 75% and 87% (P = 0.01) specificity, respectively. The CSG test costs less, requires no specialized equipment, laboratory skills, or cold chain for successful application, and performs as well as the FST standard of care for G6PD screening. Such a device may vastly expand access to primaquine therapy and aid in mitigating the very substantial burden of morbidity and mortality imposed by the hypnozoite reservoir of vivax malaria. PMID:25312015

  7. Noninferiority of glucose-6-phosphate dehydrogenase deficiency diagnosis by a point-of-care rapid test vs the laboratory fluorescent spot test demonstrated by copper inhibition in normal human red blood cells.

    PubMed

    Baird, J Kevin; Dewi, Mewahyu; Subekti, Decy; Elyazar, Iqbal; Satyagraha, Ari W

    2015-06-01

    Tens of millions of patients diagnosed with vivax malaria cannot safely receive primaquine therapy against repeated attacks caused by activation of dormant liver stages called hypnozoites. Most of these patients lack access to screening for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a highly prevalent disorder causing serious acute hemolytic anemia with primaquine therapy. We optimized CuCl inhibition of G6PD in normal red blood cells (RBCs) to assess G6PD diagnostic technologies suited to point of care in the impoverished rural tropics. The most widely applied technology for G6PD screening-the fluorescent spot test (FST)-is impractical in that setting. We evaluated a new point-of-care G6PD screening kit (CareStart G6PD, CSG) against FST using graded CuCl treatments to simulate variable hemizygous states, and varying proportions of CuCl-treated RBC suspensions to simulate variable heterozygous states of G6PD deficiency. In experiments double-blinded to CuCl treatment, technicians reading FST and CSG test (n=269) classified results as positive or negative for deficiency. At G6PD activity ?40% of normal (n=112), CSG test was not inferior to FST in detecting G6PD deficiency (P=0.003), with 96% vs 90% (P=0.19) sensitivity and 75% and 87% (P=0.01) specificity, respectively. The CSG test costs less, requires no specialized equipment, laboratory skills, or cold chain for successful application, and performs as well as the FST standard of care for G6PD screening. Such a device may vastly expand access to primaquine therapy and aid in mitigating the very substantial burden of morbidity and mortality imposed by the hypnozoite reservoir of vivax malaria. PMID:25312015

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Should Malaria Treatment Be Guided by a Point of Care Rapid Test? A Threshold Approach to Malaria Management in Rural Burkina Faso

    PubMed Central

    Bisoffi, Zeno; Tinto, Halidou; Sirima, Bienvenu Sodiomon; Gobbi, Federico; Angheben, Andrea; Buonfrate, Dora; Van den Ende, Jef

    2013-01-01

    Background In Burkina Faso, rapid diagnostic tests for malaria have been made recently available. Previously, malaria was managed clinically. This study aims at assessing which is the best management option of a febrile patient in a hyperendemic setting. Three alternatives are: treating presumptively, testing, or refraining from both test and treatment. The test threshold is the tradeoff between refraining and testing, the test-treatment threshold is the tradeoff between testing and treating. Only if the disease probability lies between the two should the test be used. Methods and Findings Data for this analysis was obtained from previous studies on malaria rapid tests, involving 5220 patients. The thresholds were calculated, based on disease risk, treatment risk and cost, test accuracy and cost. The thresholds were then matched against the disease probability. For a febrile child under 5 in the dry season, the pre-test probability of clinical malaria (3.2%), was just above the test/treatment threshold. In the rainy season, that probability was 63%, largely above the test/treatment threshold. For febrile children >5 years and adults in the dry season, the probability was 1.7%, below the test threshold, while in the rainy season it was higher (25.1%), and situated between the two thresholds (3% and 60.9%), only if costs were not considered. If they were, neither testing nor treating with artemisinin combination treatments (ACT) would be recommended. Conclusions A febrile child under 5 should be treated presumptively. In the dry season, the probability of clinical malaria in adults is so low, that neither testing nor treating with any regimen should be recommended. In the rainy season, if costs are considered, a febrile adult should not be tested, nor treated with ACT, but a possible alternative would be a presumptive treatment with amodiaquine plus sulfadoxine-pyrimethamine. If costs were not considered, testing would be recommended. PMID:23472129

  15. A novel point-of-care system for high-speed real-time polymerase chain reaction testing for epidermal growth factor receptor mutations in bronchial lavage fluids after transbronchial biopsy in patients with non-small cell lung cancer

    PubMed Central

    SAKAMOTO, TOMOHIRO; KODANI, MASAHIRO; TAKATA, MIYAKO; CHIKUMI, HIROKI; NAKAMOTO, MASAKI; NISHII-ITO, SHIZUKA; UEDA, YASUTO; IZUMI, HIROKI; MAKINO, HARUHIKO; TOUGE, HIROKAZU; TAKEDA, KENICHI; YAMASAKI, AKIRA; YANAI, MASAAKI; TANAKA, NATSUMI; IGISHI, TADASHI; SHIMIZU, EIJI

    2015-01-01

    Epidermal growth factor receptor (EGFR) gene mutation testing is essential for choosing appropriate treatment options in patients with advanced non-small cell lung cancer (NSCLC). However, a time delay occurs between histological diagnosis and molecular diagnosis in clinical situations. To minimize this delay, we developed a novel point-of-care test for EGFR mutations, based on a high-speed real-time polymerase chain reaction (PCR) system designated here as ultrarapid PCR combined with highly accurate bronchoscopic sampling. We investigated whether our system for detecting EGFR mutations was valid by comparing test results with those obtained using a commercialized EGFR mutation test. We obtained small amounts of bronchial lavage fluids after transbronchial biopsies (TBBs) were performed on enrolled patients (n=168) who underwent endobronchial ultrasonography using a guide sheath (EBUS-GS). EGFR mutation analysis was performed by ultrarapid PCR immediately after EBUS-GS-TBBs were obtained (on the same day). After pathological diagnoses of NSCLC, EGFR mutation status in formalin-fixed, paraffin- embedded samples was confirmed by the PCR-invader method, and the concordance rates between the PCR methods were compared. The total diagnostic yield of EBUS-GS-TBB was 91.0%. The positive concordance rates for detecting 19del and L858R with the ultrarapid PCR and PCR-invader methods were both 100%. Negative concordance rates were 97.2 and 98.1%, respectively. We also demonstrated a dramatic effect of early erlotinib administration, based on ultrarapid PCR results, for a 52-year-old woman suffering from respiratory failure due to severe intrapulmonary metastases with poor performance status. In conclusion, ultrarapid PCR combined with EBUS-GS-TBB enabled rapid and reliable point-of-care testing for EGFR mutations. PMID:25651992

  16. Modelling and design of a capacitive touch sensor for urinary tract infection detection at the point-of-care.

    PubMed

    Barbosa, Cátia; Dong, Tao

    2014-01-01

    Due to great use of touchscreens in mobile telephones and other electronic devices, there has been great evolution in this technology. Its wide applicability makes the touch sensor technology suitable for detection of specific components in urine, responsible for urinary tract infection (UTI). Integration of a touch sensor in a disposable probe tip to be used in UTI detection represents a powerful tool to develop new point-of-care testing (POCT) devices. The simplified structure of an electrodes array touch screen was simulated using the software COMSOL Multiphysics to prove that capacitive based touch screens can be used for detection of UTI. Besides we assumed presence of E.coli, one of the major causes of UTI urine. Results show that global capacitance increases if an E.coli sphere is present near the active electrodes, remaining approximately constant when further apart electrodes are excited. The output simulated voltage varies according to the capacitance value, decreasing when the capacitance is increased. PMID:25571114

  17. 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

  18. 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 health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues. PMID:26030741

  19. 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 health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues. PMID:26030741

  20. A Systematic Review and Meta-Analysis of the Performance of Two Point of Care Typhoid Fever Tests, Tubex TF and Typhidot, in Endemic Countries

    PubMed Central

    Thriemer, Kamala; Ley, Benedikt; Menten, Joris; Jacobs, Jan; van den Ende, Jef

    2013-01-01

    Background In the absence of well-equipped laboratory infrastructure in many developing countries the accurate diagnosis of typhoid fever is challenging. Rapid diagnostic tests (RDT) with good performance indicators would be helpful to improve clinical management of suspected cases. We performed a systematic literature review and meta- analysis to determine the performance of TUBEX TF and Typhidot for the diagnosis of typhoid fever using PRISMA guidelines. Methods Titles and abstracts were reviewed for relevance. Articles were screened for language, reference method and completeness. Studies were categorized according to control groups used. Meta-analysis was performed only for categories where enough data was available to combine sensitivity and specificity estimates. Sub-analysis was performed for the Typhidot test to determine the influence of indeterminate results on test performance. Results A total of seven studies per test were included. The sensitivity of TUBEX TF ranged between 56% and 95%, Specificity between 72% and 95%. Meta-analysis showed an average sensitivity of 69% (95%CI: 45–85) and an average specificity of 88% (CI95%:83–91). A formal meta-analysis for Typhidot was not possible due to limited data available. Across the extracted studies, sensitivity and specificity estimates ranged from 56% to 84% and 31% to 97% respectively. Conclusion The observed performance does not support the use of either rapid diagnostic test exclusively as the basis for diagnosis and treatment. There is a need to develop an RDT for typhoid fever that has a performance level comparable to malaria RDTs. PMID:24358109

  1. 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 quality assurance, and lack of staff capacity deter the use of more rapid tests at POC. Further research into the practices and choices of these providers is necessary to aid the development of new POC tests. PMID:26509894

  2. 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

  3. Point-of-care oral-based diagnostics

    PubMed Central

    Hart, RW; Mauk, MG; Liu, C; Qiu, X; Thompson, JA; Chen, D; Malamud, D; Abrams, WR; Bau, HH

    2014-01-01

    Many of the target molecules that reside in blood are also present in oral fluids, albeit at lower concentrations. Oral fluids are, however, relatively easy and safe to collect without the need for specialized equipment and training. Thus, oral fluids provide convenient samples for medical diagnostics. Recent advances in lab-on-a-chip technologies have made minute, fully integrated diagnostic systems practical for an assortment of point-of-care tests. Such systems can perform either immunoassays or molecular diagnostics outside centralized laboratories within time periods ranging from minutes to an hour. The article briefly reviews recent advances in devices for point-of-care testing with a focus on work that has been carried out by the authors as part of a NIH program. PMID:21521419

  4. 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

  5. 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

  6. 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

  7. 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 device itself, study quality, also impacts the performance of the test. These factors must be kept in mind in future evaluations of an improved device, relevant for global scale up and implementation. PMID:26891218

  8. 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

  9. 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

  10. 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…

  11. 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

  12. Point-of-care diagnostics for ricin exposure.

    PubMed

    Diakite, Mohamed Lemine Youba; Rollin, Jérôme; Jary, Dorothée; Berthier, Jean; Mourton-Gilles, Chantal; Sauvaire, Didier; Philippe, Cathy; Delapierre, Guillaume; Gidrol, Xavier

    2015-05-21

    A long-sought milestone in the defense against bioterrorism is the development of rapid, simple, and near-patient assays for diagnostic and theranostic purposes. Here, we present a powerful test based on a host response to a biological weapon agent, namely the ricin toxin. A signature for exposure to ricin was extracted and characterized in mice and then integrated into a plastic microfluidic cartridge. This enabled early diagnosis of exposure to ricin in mice using a drop of whole blood in less than 1 h and 30 min. The cartridge stores the reagents and implements all of the steps of the analysis, including mRNA extraction from a drop of blood, followed by tens of parallel RT-qPCR reactions. The simple and low-cost microfluidic cartridge developed here may find other applications in point-of-care diagnostics. PMID:25892365

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. Point-of-care diagnostics: will the hurdles be overcome this time?

    PubMed

    Huckle, David

    2006-07-01

    Point-of-care diagnostics have been proposed as the latest development in clinical diagnostics several times in the last 30 years; however, they have not yet fully developed into a business sector to match the projections. This perspective examines the reasons for past failures and the failure of technology to meet user needs. Advances have taken place in the last few years that effectively remove technology as a barrier to the development of point-of-care testing. Even regulatory issues regarding how products are developed and claims supported have been absorbed, understood and now accepted. The emphasis here is on the possible favorable aspects that are novel this time around. These changes have arisen as a result of the situation with global healthcare economics and the pressure from patients to be treated more like customers. The final hurdles relate to the conflict between diagnosis with the patient present and treated as soon as the point-of-care result is available and the entrenched positions of the central laboratory, the suppliers and their established distribution chains, and the way in which healthcare budgets are allocated. The ultimate hurdle that encapsulates all of these issues is reimbursement, which is the final barrier to a significant point-of-care diagnostics market--without reimbursement there will be no market. PMID:16866639

  19. [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 pulmonary thromboembolism to search for potential embolic sources. PMID:26548235

  20. 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, and source code for the µBAR instrument with the goal of spurring further innovation toward low-cost genetic diagnostics. PMID:23936402

  1. ClinicalKey: a point-of-care search engine.

    PubMed

    Vardell, Emily

    2013-01-01

    ClinicalKey is a new point-of-care resource for health care professionals. Through controlled vocabulary, ClinicalKey offers a cross section of resources on diseases and procedures, from journals to e-books and practice guidelines to patient education. A sample search was conducted to demonstrate the features of the database, and a comparison with similar tools is presented. PMID:23394422

  2. Nursing Reference Center: a point-of-care resource.

    PubMed

    Vardell, Emily; Paulaitis, Gediminas Geddy

    2012-01-01

    Nursing Reference Center is a point-of-care resource designed for the practicing nurse, as well as nursing administrators, nursing faculty, and librarians. Users can search across multiple resources, including topical Quick Lessons, evidence-based care sheets, patient education materials, practice guidelines, and more. Additional features include continuing education modules, e-books, and a new iPhone application. A sample search and comparison with similar databases were conducted. PMID:22559182

  3. 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 was crucial. PMID:26643196

  4. Miniature magnetic resonance system for point-of-care diagnostics†

    PubMed Central

    Issadore, David; Min, Changwook; Liong, Monty; Chung, Jaehoon; Weissleder, Ralph; Lee, Hakho

    2011-01-01

    We have developed a next generation, miniaturized platform to diagnose disease at the point-of-care using diagnostic magnetic resonance (DMR-3). Utilizing a rapidly growing library of functionalized magnetic nanoparticles, DMR has previously been demonstrated as a versatile tool to quantitatively and rapidly detect disease biomarkers in unprocessed biological samples. A major hurdle for bringing DMR to the point-of-care has been its sensitivity to temperature variation. As an alternative to costly and bulky mechanisms to control temperature, we have implemented an automated feedback system to track and compensate for the temperature drift, which enables reliable and robust DMR measurements in realistic clinical environments (4–50 °C). Furthermore, the new system interfaces with a mobile device to facilitate system control and data sharing over wireless networks. With such features, the DMR-3 platform can function as a self-contained laboratory even in resource-limited, remote settings. The clinical potential of the new system is demonstrated by detecting trace amounts of proteins and as few as 10 bacteria (Staphylococcus aureus) in a short time frame (<30 min). PMID:21547317

  5. Point-of-care Arkansas method for measuring adherence to treatment with isoniazid

    PubMed Central

    Guerra, Renata L.; Conde, Marcus B.; Efron, Anne; Loredo, Carla; Bastos, Gisele; Chaisson, Richard E.; Golub, Jonathan E.

    2010-01-01

    Summary We evaluated the accuracy of a point-of-care test designed to measure adherence to isoniazid (INH) preventive therapy in a hospital setting in Rio de Janeiro, Brazil. Patients on treatment with daily INH and patients not receiving INH were included. Sensitivity and specificity of the test were 84%/98% at the first minute, and 95%/98% at the fifth minute, respectively. Among smokers, sensitivity and specificity was reduced (80%/89% at the fifth minute, respectively), but only 17% smoked. This test accurately detected INH metabolites 24 hours following directly observed INH intake, though sensitivity and specificity may be compromised by tobacco smoke exposure. PMID:20202806

  6. Present technology and future trends in point-of-care microfluidic diagnostics.

    PubMed

    Kulinsky, Lawrence; Noroozi, Zahra; Madou, Marc

    2013-01-01

    This work reviews present technologies and developing trends in Point-of-Care (POC) microfluidic diagnostics platforms. First, various fluidics technologies such as pressure-driven flows, capillary flows, electromagnetically driven flows, centrifugal fluidics, acoustically driven flows, and droplet fluidics are categorized. Then three broad categories of POC microfluidic testing devices are considered: lateral flow devices, desktop and handheld POC diagnostic platforms, and emergent molecular diagnostic POC systems. Such evolving trends as miniaturization, multiplexing, networking, new more sensitive detection schemes, and the importance of sample processing are discussed. It is concluded that POC microfluidic diagnostics has a potential to improve patient treatment outcome and bring substantial savings in overall healthcare costs. PMID:23329432

  7. Towards Point-of-Care Diagnostic and Staging Tools for Human African Trypanosomiaisis

    PubMed Central

    Matovu, Enock; Kazibwe, Anne Juliet; Mugasa, Claire Mack; Ndungu, Joseph Mathu; Njiru, Zablon Kithingi

    2012-01-01

    Human African trypanosomiasis is a debilitating disease prevalent in rural sub-Saharan Africa. Control of this disease almost exclusively relies on chemotherapy that should be driven by accurate diagnosis, given the unacceptable toxicity of the few available drugs. Unfortunately, the available diagnostics are characterised by low sensitivities due to the inherent low parasitaemia in natural infections. Demonstration of the trypanosomes in body fluids, which is a prerequisite before treatment, often follows complex algorithms. In this paper, we review the available diagnostics and explore recent advances towards development of novel point-of-care diagnostic tests. PMID:22545057

  8. Point-of-Care Blood Glucose Meter Accuracy in the Hospital Setting

    PubMed Central

    Klonoff, David C.

    2014-01-01

    In Brief Point-of-care (POC) tests provide analytical information that can be used to make decisions at patients' bedside, as opposed to laboratory tests that must be run at a central laboratory. POC testing is a widely used tool to enable immediate determination of glucose levels in hospitalized patients and facilitate rapid treatment decisions in response to fluctuations in glycemia. Accurate POC glucose testing requires attention to various factors before, during, and after performance of tests. These include 1) proper preparation of test sites to avoid preanalytical errors, 2) proper identification of tested patients whose physiological status permits sampled capillary specimens to correlate with central venous blood glucose levels to avoid analytical errors, and 3) proper documentation of the fidelity of meter results with the medical record to avoid postanalytical errors. PMID:26246776

  9. A microfluidic anti-Factor Xa assay device for point of care monitoring of anticoagulation therapy.

    PubMed

    Harris, Leanne F; Rainey, Paul; Castro-Lpez, Vanessa; O'Donnell, James S; Killard, Anthony J

    2013-09-01

    The development of new point of care coagulation assay devices is necessary due to the increasing number of patients requiring long-term anticoagulation in addition to the desire for appropriate, targeted anticoagulant therapy and a more rapid response to optimization of treatment. The majority of point of care devices currently available for hemostasis testing rely on clot-based endpoints which are variable, unreliable and limited to measuring only certain portions of the coagulation pathway. Here we present a novel fluorescence-based anti-Factor Xa (FXa) microfluidic assay device for monitoring the effect of anticoagulant therapy at the point of care. The device is a disposable, laminated polymer microfluidic strip fabricated from a combination of hydrophobic and hydrophilic cyclic polyolefins to allow reagent deposition in addition to effective capillary fill. Zeonor was the polymer of choice resulting in low background fluorescence (208.5 AU), suitable contact angles (17.5 0.9) and capillary fill times (20.3 2.1 s). The device was capable of measuring unfractionated heparin and tinzaparin from 0-0.8 U ml(-1) and enoxaparin from 0-0.6 U ml(-1) with average CVs < 10%. A linear correlation was observed between the device and the fluorescent assay in the plate for plasma samples spiked with UFH, with an R(2) value of 0.99, while correlations with tinzaparin and enoxaparin resulted in sigmoidal responses (R(2) = 0.99). Plasma samples containing UFH resulted in a linear correlation between the device and a standard chromogenic assay with an R(2) value of 0.98, with both LMWHs resulting in sigmoidal relationships (R(2) = 0.99). PMID:23666610

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

    PubMed

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

    2011-01-01

    Electronic health records (EHRs) provide clinical learning opportunities through quick and contextual linkage of patient signalment, symptom, and diagnosis data with knowledge resources covering tests, drugs, conditions, procedures, and client instructions. This paper introduces the EHR standards for linkage and the partners-practitioners, content publishers, and software developers-necessary to leverage this possibility in veterinary medicine. The efforts of the American Animal Hospital Association (AAHA) Electronic Health Records Task Force to partner with veterinary practice management systems to improve the use of controlled vocabulary is a first step in the development of standards for sharing knowledge at the point of care. The Veterinary Medical Libraries Section (VMLS) of the Medical Library Association's Task Force on Connecting the Veterinary Health Record to Information Resources compiled a list of resources of potential use at point of care. Resource details were drawn from product Web sites and organized by a metric used to evaluate medical point-of-care resources. Additional information was gathered from questions sent by e-mail and follow-up interviews with two practitioners, a hospital network, two software developers, and three publishers. Veterinarians with electronic records use a variety of information resources that are not linked to their software. Systems lack the infrastructure to use the Infobutton standard that has been gaining popularity in human EHRs. While some veterinary knowledge resources are digital, publisher sites and responses do not indicate a Web-based linkage of veterinary resources with EHRs. In order to facilitate lifelong learning and evidence-based practice, veterinarians and educators of future practitioners must demonstrate to veterinary practice software developers and publishers a clinically-based need to connect knowledge resources to veterinary EHRs. PMID:22023919

  11. Point-of-Care Rare Cell Cancer Diagnostics

    PubMed Central

    Issadore, David

    2015-01-01

    The sparse cells that are shed from tumors into peripheral circulation are an increasingly promising resource for noninvasive monitoring of cancer progression, early diagnosis of disease, and serve as a tool for improving our understanding of cancer metastasis. However, the extremely sparse concentration of circulating tumor cells (CTCs) in blood (~1–100 CTC in 7.5 mL of blood) as well as their heterogeneous biomarker expression has limited their detection using conventional laboratory techniques. To overcome these challenges, we have developed a microfluidic chip-based micro-Hall detector (μHD), which can directly measure single, immunomagnetically tagged cells in whole blood. The μHD can detect individual cells even in the presence of vast numbers of blood cells and unbound reactants, and does not require any washing or purification steps. Furthermore, this cost-effective, single-cell analytical technique is well suited for miniaturization into a mobile platform for low-cost point-of-care use. In this chapter, we describe the methodology used to design, fabricate, and apply these chips to cancer diagnostics. PMID:25626536

  12. Point of Care and Factor Concentrate-Based Coagulation Algorithms

    PubMed Central

    Theusinger, Oliver M.; Stein, Philipp; Levy, Jerrold H.

    2015-01-01

    In the last years it has become evident that the use of blood products should be reduced whenever possible. There is increasing evidence regarding serious adverse events, including higher mortality and morbidity, related to transfusions. The use of point of care (POC) devices integrated in algorithms is one of the important mechanisms to limit blood product exposure. Any type of algorithm, especially the POC-based ones, allows goal-directed transfusions of blood products and even better targeted factor concentrate substitutions. Different types of algorithms in different surgical settings (cardiac surgery, trauma, liver surgery etc.) have been established with growing interest in their use as they offer objective therapy for management and reduction of blood product use. The use of POC devices with evidence-based algorithms is important in the bleeding patient independent of its origin (traumatic vs. surgical). The use of factor concentrates compared to the classical blood products can be cost-saving, beneficial for the patient, and in agreement with the WHO-requested standard of care. The empiric and uncontrolled use of blood products such as fresh frozen plasma, red blood cells, and platelets without POC monitoring should no longer be followed with regard to actual evidence in literature. Furthermore, the use of factor concentrates may provide better outcomes and potential for cost saving. PMID:26019707

  13. Wireless Integrated Biosensors for Point-of-Care Diagnostic Applications

    PubMed Central

    Ghafar-Zadeh, Ebrahim

    2015-01-01

    Recent advances in integrated biosensors, wireless communication and power harvesting techniques are enticing researchers into spawning a new breed of point-of-care (POC) diagnostic devices that have attracted significant interest from industry. Among these, it is the ones equipped with wireless capabilities that drew our attention in this review paper. Indeed, wireless POC devices offer a great advantage, that of the possibility of exerting continuous monitoring of biologically relevant parameters, metabolites and other bio-molecules, relevant to the management of various morbid diseases such as diabetes, brain cancer, ischemia, and Alzheimer’s. In this review paper, we examine three major categories of miniaturized integrated devices, namely; the implantable Wireless Bio-Sensors (WBSs), the wearable WBSs and the handheld WBSs. In practice, despite the aforesaid progress made in developing wireless platforms, early detection of health imbalances remains a grand challenge from both the technological and the medical points of view. This paper addresses such challenges and reports the state-of-the-art in this interdisciplinary field. PMID:25648709

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

    PubMed

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

    2014-04-15

    Advanced diagnostic technologies, such as polymerase chain reaction (PCR) and enzyme-linked immunosorbent assay (ELISA), have been widely used in well-equipped laboratories. However, they are not affordable or accessible in resource-limited settings due to the lack of basic infrastructure and/or trained operators. Paper-based diagnostic technologies are affordable, user-friendly, rapid, robust, and scalable for manufacturing, thus holding great potential to deliver point-of-care (POC) diagnostics to resource-limited settings. In this review, we present the working principles and reaction mechanism of paper-based diagnostics, including dipstick assays, lateral flow assays (LFAs), and microfluidic paper-based analytical devices (μPADs), as well as the selection of substrates and fabrication methods. Further, we report the advances in improving detection sensitivity, quantification readout, procedure simplification and multi-functionalization of paper-based diagnostics, and discuss the disadvantages of paper-based diagnostics. We envision that miniaturized and integrated paper-based diagnostic devices with the sample-in-answer-out capability will meet the diverse requirements for diagnosis and treatment monitoring at the POC. PMID:24333570

  15. Wireless integrated biosensors for point-of-care diagnostic applications.

    PubMed

    Ghafar-Zadeh, Ebrahim

    2015-01-01

    Recent advances in integrated biosensors, wireless communication and power harvesting techniques are enticing researchers into spawning a new breed of point-of-care (POC) diagnostic devices that have attracted significant interest from industry. Among these, it is the ones equipped with wireless capabilities that drew our attention in this review paper. Indeed, wireless POC devices offer a great advantage, that of the possibility of exerting continuous monitoring of biologically relevant parameters, metabolites and other bio-molecules, relevant to the management of various morbid diseases such as diabetes, brain cancer, ischemia, and Alzheimer's. In this review paper, we examine three major categories of miniaturized integrated devices, namely; the implantable Wireless Bio-Sensors (WBSs), the wearable WBSs and the handheld WBSs. In practice, despite the aforesaid progress made in developing wireless platforms, early detection of health imbalances remains a grand challenge from both the technological and the medical points of view. This paper addresses such challenges and reports the state-of-the-art in this interdisciplinary field. PMID:25648709

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

    PubMed Central

    Bissonnette, Luc; Bergeron, Michel G.

    2012-01-01

    Infectious disease management essentially consists in identifying the microbial cause(s) of an infection, initiating if necessary antimicrobial therapy against microbes, and controlling host reactions to infection. In clinical microbiology, the turnaround time of the diagnostic cycle (>24 hours) often leads to unnecessary suffering and deaths; approaches to relieve this burden include rapid diagnostic procedures and more efficient transmission or interpretation of molecular microbiology results. Although rapid nucleic acid-based diagnostic testing has demonstrated that it can impact on the transmission of hospital-acquired infections, we believe that such life-saving procedures should be performed closer to the patient, in dedicated 24/7 laboratories of healthcare institutions, or ideally at point of care. While personalized medicine generally aims at interrogating the genomic information of a patient, drug metabolism polymorphisms, for example, to guide drug choice and dosage, personalized medicine concepts are applicable in infectious diseases for the (rapid) identification of a disease-causing microbe and determination of its antimicrobial resistance profile, to guide an appropriate antimicrobial treatment for the proper management of the patient. The implementation of point-of-care testing for infectious diseases will require acceptance by medical authorities, new technological and communication platforms, as well as reimbursement practices such that time- and life-saving procedures become available to the largest number of patients. PMID:25562799

  17. Assessing Point-of-Care Device Specifications and Needs for Pathogen Detection in Emergencies and Disasters

    PubMed Central

    Kost, Gerald J.; Mecozzi, Daniel M.; Brock, T. Keith; Curtis, Corbin M.

    2012-01-01

    Background We assessed point-of-care device specifications and needs for pathogen detection in urgent care, emergencies, and disasters. Methods We surveyed American Association for Clinical Chemistry members and compared responses to those of disaster experts. Online SurveyMonkey questions covered performance characteristics, device design, pathogen targets, and other specifications. Results For disasters, respondents preferred direct sample collection with a disposable test cassette that stores biohazardous material (P<0.001). They identified methicillin-resistant Staphylococcus aureus, Salmonella typhi, Vibrio cholerae, Escherichia coli, Staphylococcus aureus, and Streptococcus pneumoniae as high priority pathogens. First responders were deemed the professional group who should perform POC testing in disasters (P<0.001). Conclusions Needs assessment now is requisite for competitive funding, so the results in this report will be useful to investigators preparing grant applications. Point-of-care devices used in disasters should address the needs of first responders, who give high priority to contamination-free whole-blood sampling, superior performance pathogen detection, and HIV-1/2 blood donor screening. There was surprising concordance of preferences among different professional groups, which presages formulation of global consensus guidelines to assist high impact preparedness. PMID:23049471

  18. Point-of-care, portable microfluidic blood analyzer system

    NASA Astrophysics Data System (ADS)

    Maleki, Teimour; Fricke, Todd; Quesenberry, J. T.; Todd, Paul W.; Leary, James F.

    2012-03-01

    Recent advances in MEMS technology have provided an opportunity to develop microfluidic devices with enormous potential for portable, point-of-care, low-cost medical diagnostic tools. Hand-held flow cytometers will soon be used in disease diagnosis and monitoring. Despite much interest in miniaturizing commercially available cytometers, they remain costly, bulky, and require expert operation. In this article, we report progress on the development of a battery-powered handheld blood analyzer that will quickly and automatically process a drop of whole human blood by real-time, on-chip magnetic separation of white blood cells (WBCs), fluorescence analysis of labeled WBC subsets, and counting a reproducible fraction of the red blood cells (RBCs) by light scattering. The whole blood (WB) analyzer is composed of a micro-mixer, a special branching/separation system, an optical detection system, and electronic readout circuitry. A droplet of un-processed blood is mixed with the reagents, i.e. magnetic beads and fluorescent stain in the micro-mixer. Valve-less sorting is achieved by magnetic deflection of magnetic microparticle-labeled WBC. LED excitation in combination with an avalanche photodiode (APD) detection system is used for counting fluorescent WBC subsets using several colors of immune-Qdots, while counting a reproducible fraction of red blood cells (RBC) is performed using a laser light scatting measurement with a photodiode. Optimized branching/channel width is achieved using Comsol Multi-Physics™ simulation. To accommodate full portability, all required power supplies (40v, +/-10V, and +3V) are provided via step-up voltage converters from one battery. A simple onboard lock-in amplifier is used to increase the sensitivity/resolution of the pulse counting circuitry.

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

    PubMed

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

    2015-03-01

    To meet a critical and growing need for a standardized approach to emergency point of care ultrasound (PoCUS) worldwide, emergency physicians must be trained to deliver and teach this skill in an accepted and reliable format. Currently, there is no globally recognized, standard PoCUS curriculum that defines the accepted applications, as well as standards for training and practice of PoCUS by specialists and trainees in emergency medicine. To address this deficit, the International Federation for Emergency Medicine (IFEM) convened a sub-committee of international experts in PoCUS to outline a curriculum for training of specialists in emergency PoCUS. This curriculum document represents the consensus of recommendations by this sub-committee. The curriculum is designed to provide a framework for PoCUS education in emergency medicine. The focus is on the processes required to select core and enhanced applications, as well as the key elements required for the delivery of PoCUS training from introduction through to continuing professional development and skill maintenance. It is designed not to be prescriptive but to assist educators and emergency medicine leadership to advance PoCUS education in emergency medicine no matter the training venue. The content of this curriculum is relevant not just for communities with mature emergency medicine systems but in particular for developing nations or for nations seeking to develop PoCUS training programs within the current educational structure. We anticipate that there will be wide variability in how this curriculum is implemented and taught, reflecting the existing educational environment, resources and goals of educational programs. PMID:26052968

  20. An Automated Point-of-Care System for Immunodetection of Staphylococcal Enterotoxin B

    PubMed Central

    Yang, Minghui; Sun, Steven; Kostov, Yordan; Rasooly, Avraham

    2011-01-01

    An automated point-of-care (POC) immunodetection system for immunological detection of Staphylococcal enterotoxin B (SEB) was designed, fabricated, and tested. The system combines several elements: (1) ELISA-Lab-on-a-chip (ELISA-LOC) with fluidics, (2) a CCD camera detector, (3) pumps and valves for fluid delivery to the ELISA-LOC, (4) a computer interface board, and (5) a computer for controlling the fluidics, logging and data analysis of the CCD data. The ELISA-LOC integrates a simple microfluidics system into a miniature ninety-six well sample plate, allowing the user to carry out immunological assays without a laboratory. The analyte is measured in a sandwich ELISA assay format combined with a sensitive Electrochemiluminescence (ECL) detection method. Using the POC system, SEB, a major foodborne toxin, was detected at concentrations as low as 0.1 ng/ml. This is similar to the reported sensitivity of conventional ELISA. The open platform with simple modular fluid delivery automation design described here is interchangeable between detection systems and because of its versatility it can be also used to automate many other LOC systems, simplifying LOC development. This new point-of-care system is useful for carrying out various immunological and other complex medical assays without a laboratory and can easily be adapted for high throughput biological screening in remote and resource poor areas. PMID:21640067

  1. Xpert Flu for point-of-care diagnosis of human influenza in industrialized countries.

    PubMed

    Salez, Nicolas; Nougairede, Antoine; Ninove, Laetitia; Zandotti, Christine; de Lamballerie, Xavier; Charrel, Rémi N

    2014-05-01

    Respiratory infections, particularly those caused by influenza viruses, represent the third-most important cause of death in the world due to infectious diseases. Nevertheless, despite the enormous publicity attracted by epidemics due to these viruses, laboratory diagnosis, documentation and recording of respiratory diseases is still unsatisfactory. Available diagnostic tests capable of providing results rapidly are either limited and insufficiently sensitive or highly sensitive and specific but insufficiently rapid. Considerable investment and research efforts have been made towards the development of new diagnostics for influenza A and B viruses and the Xpert(®) Flu assay (Cepheid(®), CA, USA) has emerged as one of the most promising. In this article, we review current knowledge of the Xpert Flu test, discuss its potential value as a point-of-care test and outline the potential leads for future development. PMID:24707995

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

    NASA Astrophysics Data System (ADS)

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

    2013-06-01

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

  3. Emerging technologies for point-of-care CD4 T-lymphocyte counting

    PubMed Central

    Boyle, David S.; Hawkins, Kenneth R.; Steele, Matthew S.; Singhal, Mitra; Cheng, Xuanhong

    2012-01-01

    A CD4 T-lymphocyte count determines eligibility for antiretroviral therapy (ART) with patients recently diagnosed with HIV and also monitors the efficacy of ART treatment thereafter. ART slows the progression of HIV to AIDS. In the developing world, CD4 tests are often performed in centralized laboratories, typically in urban areas. The expansion of ART programs into rural areas has created a need for rapid CD4 counting as logistical barriers can delay the timely dissemination of test results and affect patient care through delay in intervention or loss of follow-up care. CD4 measurement at the point-of-care (POC) in rural areas could help facilitating ART and monitoring of treatment. This review highlights recent technology developments with applications towards determining CD4 counts at the POC. PMID:21798607

  4. Strategic Point-of-Care Requirements of Hospitals and Public Health for Preparedness in Regions At Risk.

    PubMed

    Kost, Gerald J; Katip, Pratheep; Curtis, Corbin M

    2012-06-01

    OBJECTIVES: To study health resources and point-of-care (POC) testing requirements for urgent, emergency, and disaster care in Phang Nga Province, Thailand; to determine instrument design specifications through a direct needs assessment survey; to describe POC test menus useful in the small-world network; and to assess strategies for preparedness following the 2004 Tsunami. METHODS: We surveyed medical professionals in community hospitals, a regional hospital, and the Naval Base Hospital; and officials at the offices of Provincial Public Health and Disaster Prevention and Mitigation. Questions covered: a) demographics and test requirements, b) POC needs, c) device design specifications, and d) pathogen detection options. Respondents scored choices. Scores determined priorities. RESULTS: Respondents selected complete blood count, electrolytes/chemistry, blood type, oxygen saturation (by pulse oximeter), hematocrit, and microbiology as top priorities, and preferred direct blood sampling with cassettes. Cardiac biomarkers were important in alternate care facilities. Staphylococcus aureus, SARS, Streptococcus pneumoniae, and hepatitis B were top infectious disease problems. Temperature, vibration, humidity, and impact shock were four important environmental conditions during extreme conditions. CONCLUSIONS: Point-of-care testing can be used on a daily basis for competency and efficiency. Familiarity improves preparedness. Instrument designs must anticipate user preferences and environment stresses. The results show how a region at risk can adapt its small-world network. Point-of-care testing has become an important risk-reducing modality for crises and works equally well in low-resource settings to speed the delivery of routine and urgent care. PMID:23049470

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

    NASA Astrophysics Data System (ADS)

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

    2015-03-01

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

  6. Rapid DNA detection of Mycobacterium tuberculosis-towards single cell sensitivity in point-of-care diagnosis

    PubMed Central

    Ng, Benjamin Y.C.; Wee, Eugene J.H.; West, Nicholas P.; Trau, Matt

    2015-01-01

    Although there have been many recent advances in Tuberculosis (TB) detection technologies, there still remains a major need to develop simpler point-of-care techniques. In an effort towards such a diagnostic test for resource-poor settings, we have designed a bioassay based on detecting amplified DNA via bridging flocculation. The assay is cheap, with a sensitivity approaching a single cell of Mycobacterium tuberculosis and the potential for translation into broader applications.

  7. The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: systematic review and economic evaluation.

    PubMed Central

    Sharma, Pawana; Scotland, Graham; Cruickshank, Moira; Tassie, Emma; Fraser, Cynthia; Burton, Chris; Croal, Bernard; Ramsay, Craig R; Brazzelli, Miriam

    2015-01-01

    BACKGROUND Self-monitoring (self-testing and self-management) could be a valid option for oral anticoagulation therapy monitoring in the NHS, but current evidence on its clinical effectiveness or cost-effectiveness is limited. OBJECTIVES We investigated the clinical effectiveness and cost-effectiveness of point-of-care coagulometers for the self-monitoring of coagulation status in people receiving long-term vitamin K antagonist therapy, compared with standard clinic monitoring. DATA SOURCES We searched major electronic databases (e.g. MEDLINE, MEDLINE In Process & Other Non-Indexed Citations, EMBASE, Bioscience Information Service, Science Citation Index and Cochrane Central Register of Controlled Trials) from 2007 to May 2013. Reports published before 2007 were identified from the existing Cochrane review (major databases searched from inception to 2007). The economic model parameters were derived from the clinical effectiveness review, other relevant reviews, routine sources of cost data and clinical experts' advice. REVIEW METHODS We assessed randomised controlled trials (RCTs) evaluating self-monitoring in people with atrial fibrillation or heart valve disease requiring long-term anticoagulation therapy. CoaguChek(®) XS and S models (Roche Diagnostics, Basel, Switzerland), INRatio2(®) PT/INR monitor (Alere Inc., San Diego, CA USA), and ProTime Microcoagulation system(®) (International Technidyne Corporation, Nexus Dx, Edison, NJ, USA) coagulometers were compared with standard monitoring. Where possible, we combined data from included trials using standard inverse variance methods. Risk of bias assessment was performed using the Cochrane risk of bias tool. A de novo economic model was developed to assess the cost-effectiveness over a 10-year period. RESULTS We identified 26 RCTs (published in 45 papers) with a total of 8763 participants. CoaguChek was used in 85% of the trials. Primary analyses were based on data from 21 out of 26 trials. Only four trials were at low risk of bias. Major clinical events: self-monitoring was significantly better than standard monitoring in preventing thromboembolic events [relative risk (RR) 0.58, 95% confidence interval (CI) 0.40 to 0.84; p = 0.004]. In people with artificial heart valves (AHVs), self-monitoring almost halved the risk of thromboembolic events (RR 0.56, 95% CI 0.38 to 0.82; p = 0.003) and all-cause mortality (RR 0.54, 95% CI 0.32 to 0.92; p = 0.02). There was greater reduction in thromboembolic events and all-cause mortality through self-management but not through self-testing. Intermediate outcomes: self-testing, but not self-management, showed a modest but significantly higher percentage of time in therapeutic range, compared with standard care (weighted mean difference 4.44, 95% CI 1.71 to 7.18; p = 0.02). Patient-reported outcomes: improvements in patients' quality of life related to self-monitoring were observed in six out of nine trials. High preference rates were reported for self-monitoring (77% to 98% in four trials). Net health and social care costs over 10 years were £7295 (self-monitoring with INRatio2); £7324 (standard care monitoring); £7333 (self-monitoring with CoaguChek XS) and £8609 (self-monitoring with ProTime). The estimated quality-adjusted life-year (QALY) gain associated with self-monitoring was 0.03. Self-monitoring with INRatio2 or CoaguChek XS was found to have ≈ 80% chance of being cost-effective, compared with standard monitoring at a willingness-to-pay threshold of £20,000 per QALY gained. CONCLUSIONS Compared with standard monitoring, self-monitoring appears to be safe and effective, especially for people with AHVs. Self-monitoring, and in particular self-management, of anticoagulation status appeared cost-effective when pooled estimates of clinical effectiveness were applied. However, if self-monitoring does not result in significant reductions in thromboembolic events, it is unlikely to be cost-effective, based on a comparison of annual monitoring costs alone. Trials investigating the longer-term outcomes of self-management are needed, as well as direct comparisons of the various point-of-care coagulometers. STUDY REGISTRATION This study is registered as PROSPERO CRD42013004944. FUNDING The National Institute for Health Research Health Technology Assessment programme. PMID:26138549

  8. Point of care diagnostics for sexually transmitted infections: perspectives and advances

    PubMed Central

    Gaydos, Charlotte; Hardick, Justin

    2014-01-01

    Accurate and inexpensive point-of-care (POC) tests are urgently needed to control sexually transmitted infection (STI) epidemics, so that patients can receive immediate diagnoses and treatment. Current POC assays for Chlamydia trachomatis and Neisseria gonorrhoeae perform inadequately and require better assays. Diagnostics for Trichomonas vaginalis rely on wet preparation, with some notable advances. Serological POC assays for syphilis can impact resource-poor settings, with many assays available, but only one available in the U.S. HIV POC diagnostics demonstrate the best performance, with excellent assays available. There is a rapid assay for HSV lesion detection; but no POC serological assays are available. Despite the inadequacy of POC assays for treatable bacterial infections, application of technological advances offers the promise of advancing POC diagnostics for all STIs. PMID:24484215

  9. Point-of-Care assays for Tuberculosis: Role of Nanotechnology/Microfluidics

    PubMed Central

    Wang, ShuQi; Inci, Fatih; De Libero, Gennaro; Singhal, Amit; Demirci, Utkan

    2013-01-01

    Tuberculosis (TB) remains one of the most devastating infectious diseases and its eradication is still unattainable given the limitations of current technologies for diagnosis, treatment and prevention. The World Health Organization’s goal to eliminate TB globally by 2050 remains an ongoing challenge as delayed diagnosis and misdiagnosis of TB continues to fuel the worldwide epidemic. Despite considerable improvements in diagnostics for the last few decades, a simple and effective point-of-care TB diagnostic test is yet not available. Here, we review the current assays used for TB diagnosis, and highlight the recent advances in nanotechnology and microfluidics that potentially enable new approaches for TB diagnosis in resource-constrained settings. PMID:23357365

  10. Point-of-Care Diagnostics in Low Resource Settings: Present Status and Future Role of Microfluidics

    PubMed Central

    Sharma, Shikha; Zapatero-Rodríguez, Julia; Estrela, Pedro; O’Kennedy, Richard

    2015-01-01

    The inability to diagnose numerous diseases rapidly is a significant cause of the disparity of deaths resulting from both communicable and non-communicable diseases in the developing world in comparison to the developed world. Existing diagnostic instrumentation usually requires sophisticated infrastructure, stable electrical power, expensive reagents, long assay times, and highly trained personnel which is not often available in limited resource settings. This review will critically survey and analyse the current lateral flow-based point-of-care (POC) technologies, which have made a major impact on diagnostic testing in developing countries over the last 50 years. The future of POC technologies including the applications of microfluidics, which allows miniaturisation and integration of complex functions that facilitate their usage in limited resource settings, is discussed The advantages offered by such systems, including low cost, ruggedness and the capacity to generate accurate and reliable results rapidly, are well suited to the clinical and social settings of the developing world. PMID:26287254

  11. Point-of-care assays for tuberculosis: role of nanotechnology/microfluidics.

    PubMed

    Wang, ShuQi; Inci, Fatih; De Libero, Gennaro; Singhal, Amit; Demirci, Utkan

    2013-01-01

    Tuberculosis (TB) remains one of the most devastating infectious diseases and its eradication is still unattainable given the limitations of current technologies for diagnosis, treatment and prevention. The World Health Organization's goal to eliminate TB globally by 2050 remains an ongoing challenge as delayed diagnosis and misdiagnosis of TB continue to fuel the worldwide epidemic. Despite considerable improvements in diagnostics for the last few decades, a simple and effective point-of-care TB diagnostic test is yet not available. Here, we review the current assays used for TB diagnosis, and highlight the recent advances in nanotechnology and microfluidics that potentially enable new approaches for TB diagnosis in resource-constrained settings. PMID:23357365

  12. Self-priming compartmentalization digital LAMP for point-of-care.

    PubMed

    Zhu, Qiangyuan; Gao, Yibo; Yu, Bingwen; Ren, Hao; Qiu, Lin; Han, Sihai; Jin, Wei; Jin, Qinhan; Mu, Ying

    2012-11-21

    Digital nucleic acid amplification provides unprecedented opportunities for absolute nucleic acid quantification by counting of single molecules. This technique is useful for molecular genetic analysis in cancer, stem cell, bacterial, non-invasive prenatal diagnosis in which many biologists are interested. This paper describes a self-priming compartmentalization (SPC) microfluidic chip platform for performing digital loop-mediated amplification (LAMP). The energy for the pumping is pre-stored in the degassed bulk PDMS by exploiting the high gas solubility of PDMS; therefore, no additional structures other than channels and reservoirs are required. The sample and oil are sequentially sucked into the channels, and the pressure difference of gas dissolved in PDMS allows sample self-compartmentalization without the need for further chip manipulation such as with pneumatic microvalves and control systems, and so on. The SPC digital LAMP chip can be used like a 384-well plate, so, the world-to-chip fluidic interconnections are avoided. The microfluidic chip contains 4 separate panels, each panel contains 1200 independent 6 nL chambers and can be used to detect 4 samples simultaneously. Digital LAMP on the microfluidic chip was tested quantitatively by using β-actin DNA from humans. The self-priming compartmentalization behavior is roughly predictable using a two-dimensional model. The uniformity of compartmentalization was analyzed by fluorescent intensity and fraction of volume. The results showed that the feasibility and flexibility of the microfluidic chip platform for amplifying single nucleic acid molecules in different chambers made by diluting and distributing sample solutions. The SPC chip has the potential to meet the requirements of a general laboratory: power-free, valve-free, operating at isothermal temperature, inexpensive, sensitive, economizing labour time and reagents. The disposable analytical devices with appropriate air-tight packaging should be useful for point-of-care, and enabling it to become one of the common tools for biology research, especially, in point-of-care testing. PMID:22986619

  13. Point-of-care quantification of blood-borne filarial parasites with a mobile phone microscope.

    PubMed

    D'Ambrosio, Michael V; Bakalar, Matthew; Bennuru, Sasisekhar; Reber, Clay; Skandarajah, Arunan; Nilsson, Lina; Switz, Neil; Kamgno, Joseph; Pion, Sébastien; Boussinesq, Michel; Nutman, Thomas B; Fletcher, Daniel A

    2015-05-01

    Parasitic helminths cause debilitating diseases that affect millions of people in primarily low-resource settings. Efforts to eliminate onchocerciasis and lymphatic filariasis in Central Africa through mass drug administration have been suspended because of ivermectin-associated serious adverse events, including death, in patients infected with the filarial parasite Loa loa. To safely administer ivermectin for onchocerciasis or lymphatic filariasis in regions co-endemic with L. loa, a strategy termed "test and (not) treat" has been proposed whereby those with high levels of L. loa microfilariae (>30,000/ml) that put them at risk for life-threatening serious adverse events are identified and excluded from mass drug administration. To enable this, we developed a mobile phone-based video microscope that automatically quantifies L. loa microfilariae in whole blood loaded directly into a small glass capillary from a fingerprick without the need for conventional sample preparation or staining. This point-of-care device automatically captures and analyzes videos of microfilarial motion in whole blood using motorized sample scanning and onboard motion detection, minimizing input from health care workers and providing a quantification of microfilariae per milliliter of whole blood in under 2 min. To validate performance and usability of the mobile phone microscope, we tested 33 potentially Loa-infected patients in Cameroon and confirmed that automated counts correlated with manual thick smear counts (94% specificity; 100% sensitivity). Use of this technology to exclude patients from ivermectin-based treatment at the point of care in Loa-endemic regions would allow resumption/expansion of mass drug administration programs for onchocerciasis and lymphatic filariasis in Central Africa. PMID:25947164

  14. Progress in the development of paper-based diagnostics for low-resource point-of-care settings

    PubMed Central

    Byrnes, Samantha; Thiessen, Gregory; Fu, Elain

    2014-01-01

    This Review focuses on recent work in the field of paper microfluidics that specifically addresses the goal of translating the multistep processes that are characteristic of gold-standard laboratory tests to low-resource point-of-care settings. A major challenge is to implement multistep processes with the robust fluid control required to achieve the necessary sensitivity and specificity of a given application in a user-friendly package that minimizes equipment. We review key work in the areas of fluidic controls for automation in paper-based devices, readout methods that minimize dedicated equipment, and power and heating methods that are compatible with low-resource point-of-care settings. We also highlight a focused set of recent applications and discuss future challenges. PMID:24256361

  15. Current Status and Future Prospects for Electronic Point-of-Care Clinical Decision Support in Diabetes Care

    PubMed Central

    O’Connor, Patrick J.; Desai, Jay; Butler, John; Kharbanda, Elyse; Sperl-Hillen, JoAnn M.

    2013-01-01

    Early efforts to use point-of-care clinical decision support (CDS) were limited to the use of prompts and reminders, which improved test ordering but not intermediate outcomes of care such as glucose, blood pressure, or lipid levels. More sophisticated diabetes CDS tools are now available that use electronic medical record data to provide patient-specific advice on medication use based on previous treatment, distance from goal, and other clinical data. These tools have shown modest but significant improvement in glucose and blood pressure control. Promising next-generation developments will include prioritizing clinical actions that have maximum benefit to a given patient at the point of care and developing effective methods to communicate CDS information to patients to better incorporate patient preferences in care decisions. PMID:23225213

  16. Point-of-Care Ultrasonography for Appendicitis Uncovers Two Alternate Diagnoses.

    PubMed

    Marin, Jennifer R; Kornblith, Aaron E; Doniger, Stephanie J

    2016-04-01

    We present two cases of pediatric patients initially presenting with a clinical suspicion of acute appendicitis. In these cases, point-of-care ultrasonography was performed early in the patient's emergency department course, leading to alternate diagnoses. This article highlights a role for point-of-care ultrasound in the diagnoses of two alternate conditions that clinically mimic appendicitis: Meckel diverticulitis and acute ileocecitis. We offer a brief overview of terminology, relevant literature, and ultrasound scanning technique for the right-lower-quadrant point-of-care ultrasound evaluation. PMID:26785100

  17. Platelet function tests: a comparative review

    PubMed Central

    Paniccia, Rita; Priora, Raffaella; Alessandrello Liotta, Agatina; Abbate, Rosanna

    2015-01-01

    In physiological hemostasis a prompt recruitment of platelets on the vessel damage prevents the bleeding by the rapid formation of a platelet plug. Qualitative and/or quantitative platelet defects promote bleeding, whereas the high residual reactivity of platelets in patients on antiplatelet therapies moves forward thromboembolic complications. The biochemical mechanisms of the different phases of platelet activation – adhesion, shape change, release reaction, and aggregation – have been well delineated, whereas their complete translation into laboratory assays has not been so fulfilled. Laboratory tests of platelet function, such as bleeding time, light transmission platelet aggregation, lumiaggregometry, impedance aggregometry on whole blood, and platelet activation investigated by flow cytometry, are traditionally utilized for diagnosing hemostatic disorders and managing patients with platelet and hemostatic defects, but their use is still limited to specialized laboratories. To date, a point-of-care testing (POCT) dedicated to platelet function, using pertinent devices much simpler to use, has now become available (ie, PFA-100, VerifyNow System, Multiplate Electrode Aggregometry [MEA]). POCT includes new methodologies which may be used in critical clinical settings and also in general laboratories because they are rapid and easy to use, employing whole blood without the necessity of sample processing. Actually, these different platelet methodologies for the evaluation of inherited and acquired bleeding disorders and/or for monitoring antiplatelet therapies are spreading and the study of platelet function is strengthening. In this review, well-tried and innovative platelet function tests and their methodological features and clinical applications are considered. PMID:25733843

  18. Point-of-care ultrasonography by pediatric emergency physicians. Policy statement.

    PubMed

    Marin, Jennifer R; Lewiss, Resa E

    2015-04-01

    Point-of-care ultrasonography is increasingly being used to facilitate accurate and timely diagnoses and to guide procedures. It is important for pediatric emergency physicians caring for patients in the emergency department to receive adequate and continued point-of-care ultrasonography training for those indications used in their practice setting. Emergency departments should have credentialing and quality assurance programs. Pediatric emergency medicine fellowships should provide appropriate training to physician trainees. Hospitals should provide privileges to physicians who demonstrate competency in point-of-care ultrasonography. Ongoing research will provide the necessary measures to define the optimal training and competency assessment standards. Requirements for credentialing and hospital privileges will vary and will be specific to individual departments and hospitals. As more physicians are trained and more research is completed, there should be one national standard for credentialing and privileging in point-of-care ultrasonography for pediatric emergency physicians. PMID:25805037

  19. ClinicalKey 2.0: Upgrades in a Point-of-Care Search Engine.

    PubMed

    Huslig, Mary Ann; Vardell, Emily

    2015-01-01

    ClinicalKey 2.0, launched September 23, 2014, offers a mobile-friendly design with a search history feature for targeting point-of-care resources for health care professionals. Browsing is improved with searchable, filterable listings of sources highlighting new resources. ClinicalKey 2.0 improvements include more than 1,400 new Topic Pages for quick access to point-of-care content. A sample search details some of the upgrades and content options. PMID:26211794

  20. An Interferometric Reflectance Imaging Sensor for Point of Care Viral Diagnostics

    PubMed Central

    Reddington, Alexander P.; Trueb, Jacob T.; Freedman, David S.; Tuysuzoglu, Ahmet; Daaboul, George G.; Lopez, Carlos A.; Karl, W. Clem; Connor, John H.; Fawcett, Helen; Ünlü, M. Selim

    2014-01-01

    The use of in vitro diagnostic devices is transitioning from the laboratory to the primary care setting to address early disease detection needs. Time critical viral diagnoses are often made without support due to the experimental time required in today’s standard tests. Available rapid point of care (POC) viral tests are less reliable, requiring a follow-on confirmatory test before conclusions can be drawn. The development of a reliable POC viral test for the primary care setting would decrease the time for diagnosis leading to a lower chance of transmission and improve recovery. The single particle interferometric reflectance imaging sensor (SP-IRIS) has been shown to be a sensitive and specific-detection platform in serum and whole blood. This paper presents a step towards a POC viral assay through a SP-IRIS prototype with automated data acquisition and analysis and a simple, easy-to-use software interface. Decreasing operation complexity highlights the potential of SP-IRIS as a sensitive and specific POC diagnostic tool. With the integration of a microfluidic cartridge, this automated instrument will allow an untrained user to run a sample-to-answer viral assay in the POC setting. PMID:24271115

  1. Biosensor for total antinuclear antibody determination at the point-of-care.

    PubMed

    Rubin, Robert L; Konstantinov, Konstantin N

    2016-09-15

    Antinuclear antibodies (ANA) are important in diagnosis and follow-up of patients with autoimmune conditions. The current increase in ANA requests is driven by broadening the use of ANA from a test for lupus to a test for diverse autoimmune diseases, but the standard method is protracted, cumbersome and prone to error. We describe an electrochemical method for quantifying total ANA for use as a point-of-care diagnostic aid. In this technology the target autoantigens are derived from a protein/nucleoprotein mixture prepared from an inexpensive source and adsorbed to a porous membrane with high protein binding capacity. Serum is slowly drawn through the membrane comprising the high density autoantigen mixture to induce rapid binding of patient autoantibodies. After rinsing, peroxidase-conjugated anti-IgG is drawn through the membrane followed by rinsing, insertion of an electrode assembly, and addition of the enzyme substrate. Substrate peroxidation is measured by microamperage-level current accompanying electrochemical reduction of the intermediate product. Values are comparable to a standard ANA test but require a total processing time of ~20min. This method has the promise to greatly expand ANA testing in clinical settings for initial patient assessment of autoimmune disease. PMID:27132005

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

    PubMed Central

    Kang, Tarina Lee; Berona, Kristin; Elkhunovich, Marsha A; Medero-Colon, Roberto; Seif, Dina; Chilstrom, Mikaela L; Mailhot, Tom

    2015-01-01

    Objectives To evaluate two educational methods for point-of-care ultrasound (POC US) in order to: 1) determine participant test performance and attitudes in using POC US and 2) compare cost and preparation time to run the courses. Methods This was a pilot study conducted at a county teaching hospital. Subjects were assigned to participate in either a large group course with live classroom lectures (Group A) or a group asked to watch 4.5 hours of online prerecorded lectures (Group B). Both groups participated in small-group hands-on training after watching the lectures. Both groups took a pre- and post-course exam, and completed course surveys. Cost and time spent running the courses were also compared. Results Forty-seven physicians participated in the study. The pre-test and post-test scores between the two groups did not differ significantly. Of those with prior ultrasound experience, the majority of both groups preferred to continue classroom-based teaching for future courses. Interestingly, in the groups who had no ultrasound experience prior to their course participation, there was a higher percentage who preferred web-based teaching. Lastly, Group B was shown to have the potential to take less preparatory time when compared to Group A. Conclusion A web-based curriculum in POC US appears to be a promising and potentially time saving alternative to live classroom lectures and seems to offer similar educational benefits for the postgraduate learner. PMID:25792863

  3. Point-of-care diagnosis of periodontitis using saliva: technically feasible but still a challenge

    PubMed Central

    Ji, Suk; Choi, Youngnim

    2015-01-01

    Periodontitis is a chronic inflammation of the periodontium caused by persistent bacterial infection that leads to the breakdown of connective tissue and bone. Because the ability to reconstruct the periodontium is limited after alveolar bone loss, early diagnosis and intervention should be the primary goals of periodontal treatment. However, periodontitis often progresses without noticeable symptoms, and many patients do not seek professional dental care until the periodontal destruction progresses to the point of no return. Furthermore, the current diagnosis of periodontitis depends on time-consuming clinical measurements. Therefore, there is an unmet need for near-patient testing to diagnose periodontitis. Saliva is an optimal biological fluid to serve as a near-patient diagnostic tool for periodontitis. Recent developments in point-of-care (POC) testing indicate that a diagnostic test for periodontitis using saliva is now technically feasible. A number of promising salivary biomarkers associated with periodontitis have been reported. A panel of optimal biomarkers must be carefully selected based on the pathogenesis of periodontitis. The biggest hurdle for the POC diagnosis of periodontitis using saliva may be the process of validation in a large, diverse patient population. Therefore, we propose the organization of an International Consortium for Biomarkers of Periodontitis, which will gather efforts to identify, select, and validate salivary biomarkers for the diagnosis of periodontitis. PMID:26389079

  4. Potential impact of co-payment at point of care to influence emergency department utilization

    PubMed Central

    Baum, Zachary; Simmons, Michael R.; Guardiola, Jose H.; Smith, Cynthia; Carrasco, Lynn; Ha, Joann

    2016-01-01

    Background. Many proponents for healthcare reform suggest increased cost-sharing by patients as a method to reduce overall expenditures. Prior studies on the effects of co-payments for ED visits have generally not been directed toward understanding patient attitudes/behavior at point of care. Objectives. We conducted a survey at point of care to test our hypothesis that a significant number of patients with urgent chief complaints might have avoided the ED if asked to provide a co-payment. Methods. Cross-sectional study design. Stable, oriented, consenting patients at an inner-city, academic ED were consecutively enrolled at hours in which trained research associates were available to assist with data collection. Enrolled patients completed a written survey providing demographic/chief complaint information, and then were asked whether 13 interval amounts of co-payment ranging from 0 to >500 would have impacted their decision to visit the ED. Categorical data are presented as frequency of occurrence and analyzed by chi-square; continuous data presented as means ± standard deviation, analyzed by t-tests. ORs and 95% confidence intervals provided. Primary outcome parameter was the % of patients who would have avoided the ED if asked to pay any co-payment for several urgent chief complaints: chest pain, SOB, and abdominal pain. Results. A total of 581 patients were enrolled; 63.1% female, mean age 42.4 ± 15.1 years, 65% Hispanic, 71.2% income less than 20,000, 28.6% less than high school graduate, 81.3% had primary care physician, 57.6% had 2 or more ED visits/past year. Overall, 30.2% of patients chose 0 as the maximum they would have been willing to pay if it was required to be seen in the ED. 16/58 (28%; 95% CI [18–40%]) of chest pain patients, 9/43 (20.9%; 95% CI [11–35%]) of SOB patients, and 24/127 (26.8%; 95% CI [13–27%]) of abdominal pain patients would have been unwilling to pay a co-pay. Patients with income >20,000 were more willing to pay a co-payment (OR = 2.55; 95% CI [1.59–4.10]). No significant relationship was identified between willingness to pay for: gender, race, education, established primary care provider, and frequency of ED visits. Conclusion. Overall, 30.2% of our patients would not have accepted a co-pay in order to be seen, including more than 20% of the patients with chest pain, shortness of breath, and abdominal pain respectively. PMID:26819839

  5. Accurate Point-of-Care Detection of Ruptured Fetal Membranes: Improved Diagnostic Performance Characteristics with a Monoclonal/Polyclonal Immunoassay

    PubMed Central

    Rogers, Linda C.; Scott, Laurie; Block, Jon E.

    2016-01-01

    OBJECTIVE Accurate and timely diagnosis of rupture of membranes (ROM) is imperative to allow for gestational age-specific interventions. This study compared the diagnostic performance characteristics between two methods used for the detection of ROM as measured in the same patient. METHODS Vaginal secretions were evaluated using the conventional fern test as well as a point-of-care monoclonal/polyclonal immunoassay test (ROM Plus®) in 75 pregnant patients who presented to labor and delivery with complaints of leaking amniotic fluid. Both tests were compared to analytical confirmation of ROM using three external laboratory tests. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. RESULTS Diagnostic performance characteristics uniformly favored ROM detection using the immunoassay test compared to the fern test: sensitivity (100% vs. 77.8%), specificity (94.8% vs. 79.3%), PPV (75% vs. 36.8%), NPV (100% vs. 95.8%), and accuracy (95.5% vs. 79.1%). CONCLUSIONS The point-of-care immunoassay test provides improved diagnostic accuracy for the detection of ROM compared to fern testing. It has the potential of improving patient management decisions, thereby minimizing serious complications and perinatal morbidity. PMID:27199579

  6. Microfluidic point-of-care blood panel based on a novel technique: Reversible electroosmotic flow.

    PubMed

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

    2015-09-01

    A wide range of diseases and conditions are monitored or diagnosed from blood plasma, but the ability to analyze a whole blood sample with the requirements for a point-of-care device, such as robustness, user-friendliness, and simple handling, remains unmet. Microfluidics technology offers the possibility not only to work fresh thumb-pricked whole blood but also to maximize the amount of the obtained plasma from the initial sample and therefore the possibility to implement multiple tests in a single cartridge. The microfluidic design presented in this paper is a combination of cross-flow filtration with a reversible electroosmotic flow that prevents clogging at the filter entrance and maximizes the amount of separated plasma. The main advantage of this design is its efficiency, since from a small amount of sample (a single droplet [Formula: see text]10 μl) almost 10% of this (approx 1 μl) is extracted and collected with high purity (more than 99%) in a reasonable time (5-8 min). To validate the quality and quantity of the separated plasma and to show its potential as a clinical tool, the microfluidic chip has been combined with lateral flow immunochromatography technology to perform a qualitative detection of the thyroid-stimulating hormone and a blood panel for measuring cardiac Troponin and Creatine Kinase MB. The results from the microfluidic system are comparable to previous commercial lateral flow assays that required more sample for implementing fewer tests. PMID:26396660

  7. Simultaneous Quantitative Detection of Helicobacter Pylori Based on a Rapid and Sensitive Testing Platform using Quantum Dots-Labeled Immunochromatiographic Test Strips

    NASA Astrophysics Data System (ADS)

    Zheng, Yu; Wang, Kan; Zhang, Jingjing; Qin, Weijian; Yan, Xinyu; Shen, Guangxia; Gao, Guo; Pan, Fei; Cui, Daxiang

    2016-02-01

    Quantum dots-labeled urea-enzyme antibody-based rapid immunochromatographic test strips have been developed as quantitative fluorescence point-of-care tests (POCTs) to detect helicobacter pylori. Presented in this study is a new test strip reader designed to run on tablet personal computers (PCs), which is portable for outdoor detection even without an alternating current (AC) power supply. A Wi-Fi module was integrated into the reader to improve its portability. Patient information was loaded by a barcode scanner, and an application designed to run on tablet PCs was developed to handle the acquired images. A vision algorithm called Kmeans was used for picture processing. Different concentrations of various human blood samples were tested to evaluate the stability and accuracy of the fabricated device. Results demonstrate that the reader can provide an easy, rapid, simultaneous, quantitative detection for helicobacter pylori. The proposed test strip reader has a lighter weight than existing detection readers, and it can run for long durations without an AC power supply, thus verifying that it possesses advantages for outdoor detection. Given its fast detection speed and high accuracy, the proposed reader combined with quantum dots-labeled test strips is suitable for POCTs and owns great potential in applications such as screening patients with infection of helicobacter pylori, etc. in near future.

  8. Simultaneous Quantitative Detection of Helicobacter Pylori Based on a Rapid and Sensitive Testing Platform using Quantum Dots-Labeled Immunochromatiographic Test Strips.

    PubMed

    Zheng, Yu; Wang, Kan; Zhang, Jingjing; Qin, Weijian; Yan, Xinyu; Shen, Guangxia; Gao, Guo; Pan, Fei; Cui, Daxiang

    2016-12-01

    Quantum dots-labeled urea-enzyme antibody-based rapid immunochromatographic test strips have been developed as quantitative fluorescence point-of-care tests (POCTs) to detect helicobacter pylori. Presented in this study is a new test strip reader designed to run on tablet personal computers (PCs), which is portable for outdoor detection even without an alternating current (AC) power supply. A Wi-Fi module was integrated into the reader to improve its portability. Patient information was loaded by a barcode scanner, and an application designed to run on tablet PCs was developed to handle the acquired images. A vision algorithm called Kmeans was used for picture processing. Different concentrations of various human blood samples were tested to evaluate the stability and accuracy of the fabricated device. Results demonstrate that the reader can provide an easy, rapid, simultaneous, quantitative detection for helicobacter pylori. The proposed test strip reader has a lighter weight than existing detection readers, and it can run for long durations without an AC power supply, thus verifying that it possesses advantages for outdoor detection. Given its fast detection speed and high accuracy, the proposed reader combined with quantum dots-labeled test strips is suitable for POCTs and owns great potential in applications such as screening patients with infection of helicobacter pylori, etc. in near future. PMID:26842795

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

    PubMed

    Huckle, David

    2008-11-01

    The particular reasons for the relative lack in development of point-of-care (PoC) diagnostics in a business context were discussed in our sister journal, Expert Review of Medical Devices, over 2 years ago. At that time, it could be seen that the concept of PoC testing was being revisited for at least the fifth time in the last 20 years. There had been important advances in technology but, with changes in global healthcare structures and funding, the overall in vitro diagnostics sector has had sluggish growth. Only molecular diagnostics and PoC testing are growing strongly. PoC testing is now a quarter of the total global in vitro diagnostics market, but largely due to use in diabetes monitoring. An increased focus on areas other than glucose self-testing has created a disturbance in the market. An implementation issue from this disturbance is that of control between central laboratories and the proposed sites for PoC testing. Evidence is presented to show that the first step is likely to be increased use in clinics and outpatient facilities closely linked with the laboratory. The aim will be to control the quality of the test, maintenance of equipment and provide support for the clinician in interpretation. The major problem for effective PoC implementation will be the significant changes to patient pathways that are required. The changes will benefit the patient and clinical outcomes but will require healthcare professionals to change their work patterns. This will be an uphill task! PMID:18999920

  10. Identification of high-risk patients with acute coronary syndrome using point-of-care echocardiography in the ED.

    PubMed

    Frenkel, Oron; Riguzzi, Christine; Nagdev, Arun

    2014-06-01

    Stratifying risk of patients with acute coronary syndrome (ACS) in the emergency department (ED) remains a frequent challenge. When ST-elevation criteria are absent, current recommendations rely upon insensitive and time-intensive methods such as the electrocardiogram and cardiac enzyme testing. Here, we report on a series of cases, where emergency physicians used a simplified model for identifying regional wall motion abnormalities by point-of-care echocardiography in patients presenting with chest pain to the ED. With the use of a simplified model described herein, high-risk patients with ACS were identified rapidly in a cohort usually difficult to risk stratify. PMID:24745875

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

    PubMed

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

    2015-12-15

    Nucleic acid testing (NAT), as a molecular diagnostic technique, including nucleic acid extraction, amplification and detection, plays a fundamental role in medical diagnosis for timely medical treatment. However, current NAT technologies require relatively high-end instrumentation, skilled personnel, and are time-consuming. These drawbacks mean conventional NAT becomes impractical in many resource-limited disease-endemic settings, leading to an urgent need to develop a fast and portable NAT diagnostic tool. Paper-based devices are typically robust, cost-effective and user-friendly, holding a great potential for NAT at the point of care. In view of the escalating demand for the low cost diagnostic devices, we highlight the beneficial use of paper as a platform for NAT, the current state of its development, and the existing challenges preventing its widespread use. We suggest a strategy involving integrating all three steps of NAT into one single paper-based sample-to-answer diagnostic device for rapid medical diagnostics in the near future. PMID:26164488

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

    PubMed

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

    2015-10-01

    This study challenges the commonly held view that the feline immunodeficiency virus (FIV) infection status of FIV-vaccinated cats cannot be determined using point-of-care antibody test kits due to indistinguishable antibody production in FIV-vaccinated and naturally FIV-infected cats. The performance of three commercially available point-of-care antibody test kits was compared in a mixed population of FIV-vaccinated (n=119) and FIV-unvaccinated (n=239) cats in Australia. FIV infection status was assigned by considering the results of all antibody kits in concert with results from a commercially available PCR assay (FIV RealPCR™). Two lateral flow immunochromatography test kits (Witness FeLV/FIV; Anigen Rapid FIV/FeLV) had excellent overall sensitivity (100%; 100%) and specificity (98%; 100%) and could discern the true FIV infection status of cats, irrespective of FIV vaccination history. The lateral flow ELISA test kit (SNAP FIV/FeLV Combo) could not determine if antibodies detected were due to previous FIV vaccination, natural FIV infection, or both. The sensitivity and specificity of FIV RealPCR™ for detection of viral and proviral nucleic acid was 92% and 99%, respectively. These results will potentially change the way veterinary practitioners screen for FIV in jurisdictions where FIV vaccination is practiced, especially in shelter scenarios where the feasibility of mass screening is impacted by the cost of testing. PMID:26459979

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

    PubMed

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

    2015-01-01

    Scientific literature is one of the popular resources for providing decision support at point of care. It is highly desirable to bring the most relevant literature to support the evidence-based clinical decision making process. Motivated by the recent advance in semantically enhanced information retrieval, we have developed a system, which aims to bring semantically enriched literature, Semantic Medline, to meet the information needs at point of care. This study reports our work towards operationalizing the system for real time use. We demonstrate that the migration of a relational database implementation to a NoSQL (Not only SQL) implementation significantly improves the performance and makes the use of Semantic Medline at point of care decision support possible. PMID:26306259

  14. Update on point of care ultrasound in the care of the critically ill patient

    PubMed Central

    Blaivas, Michael

    2012-01-01

    One of the most exciting developments to come to the aid of the critically ill patient in recent years is not new at all, but rather has been repackaged and evolved to a level where point-of-care use by critical care physicians has been made possible. Critical care or point-of-care ultrasound dates back more than twenty years, but has come to prominence in the last 5 years and is spreading quickly. Multiple critical care societies have taken up ultrasound policy and training and one organization has been formed that concentrates only on point-of-care ultrasound in critical settings and interventions. The amount of literature generated on the topic is increasing rapidly and hardly a major clinical journal exists that has not published ultrasound related topics. PMID:24701407

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

    PubMed Central

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

    2015-01-01

    Scientific literature is one of the popular resources for providing decision support at point of care. It is highly desirable to bring the most relevant literature to support the evidence-based clinical decision making process. Motivated by the recent advance in semantically enhanced information retrieval, we have developed a system, which aims to bring semantically enriched literature, Semantic Medline, to meet the information needs at point of care. This study reports our work towards operationalizing the system for real time use. We demonstrate that the migration of a relational database implementation to a NoSQL (Not only SQL) implementation significantly improves the performance and makes the use of Semantic Medline at point of care decision support possible. PMID:26306259

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

    SciTech Connect

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

    2008-02-04

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

  17. [Fast diagnostics in the emergency department: Laboratory testing - what we need and what we don't].

    PubMed

    Möckel, Martin; Müller, Christian; Lindner, Tobias; Searle, Julia

    2016-03-01

    Laboratory parameters in emergency medicine can be divided into 3 categories. Urgent obligatory parameters are necessary for immediate therapeutic decisions and must be available within 60 minutes. For these, testing in the emergency department (ED) as point-of-care-testing (POCT) should be considered. The second category are obligatory parameters which require diagnostic / therapeutic consequences in the emergency department, but are not necessary for immediate life-saving actions. Due to international consensus of a 4-hour length of stay target for ED, results should be available within this time. The third category are parameters which do not lead to immediate diagnostic or therapeutic consequences, but are important for process management and patient flow in the ED. They should therefore be available as emergency tests. POC-testing should be used for a limited number of very urgent parameters and should be organized as a satellite laboratory in cooperation with the central laboratory. PMID:26939101

  18. Optical systems for point-of-care diagnostic instrumentation: analysis of imaging performance and cost

    PubMed Central

    Pierce, Mark C.; Weigum, Shannon E.; Jaslove, Jacob M.; Richards-Kortum, Rebecca; Tkaczyk, Tomasz S.

    2013-01-01

    One of the key elements in point-of-care (POC) diagnostic test instrumentation is the optical system required for signal detection and / or imaging. Many tests which use fluorescence, absorbance, or colorimetric optical signals are under development for management of infectious diseases in resource limited settings, where the overall size and cost of the device is of critical importance. At present, high-performance lenses are expensive to fabricate and difficult to obtain commercially, presenting barriers for developers of in vitro POC tests or microscopic image-based diagnostics. We recently described a compact “hybrid” objective lens incorporating both glass and plastic optical elements, with a numerical aperture of 1.0 and field-of-view of 250 m. This design concept may potentially enable mass-production of high-performance, low-cost optical systems which can be easily incorporated in the readout path of existing and emerging POC diagnostic assays. In this paper, we evaluate the biological imaging performance of these lens systems in three broad POC diagnostic application areas; (1) bright field microscopy of histopathology slides, (2) cytologic examination of blood smears, and (3) immunofluorescence imaging. We also break down the fabrication costs and draw comparisons with other miniature optical systems. The hybrid lenses provided images with quality comparable to conventional microscopy, enabling examination of neoplastic pathology and infectious parasites including malaria and cryptosporidium. We describe how these components can be produced at below $10 per unit in full-scale production quantities, making these systems well suited for use within POC diagnostic instrumentation. PMID:24097204

  19. Optical systems for point-of-care diagnostic instrumentation: analysis of imaging performance and cost.

    PubMed

    Pierce, Mark C; Weigum, Shannon E; Jaslove, Jacob M; Richards-Kortum, Rebecca; Tkaczyk, Tomasz S

    2014-01-01

    One of the key elements in point-of-care (POC) diagnostic test instrumentation is the optical system required for signal detection and/or imaging. Many tests which use fluorescence, absorbance, or colorimetric optical signals are under development for management of infectious diseases in resource limited settings, where the overall size and cost of the device is of critical importance. At present, high-performance lenses are expensive to fabricate and difficult to obtain commercially, presenting barriers for developers of in vitro POC tests or microscopic image-based diagnostics. We recently described a compact "hybrid" objective lens incorporating both glass and plastic optical elements, with a numerical aperture of 1.0 and field-of-view of 250 μm. This design concept may potentially enable mass-production of high-performance, low-cost optical systems which can be easily incorporated in the readout path of existing and emerging POC diagnostic assays. In this paper, we evaluate the biological imaging performance of these lens systems in three broad POC diagnostic application areas; (1) bright field microscopy of histopathology slides, (2) cytologic examination of blood smears, and (3) immunofluorescence imaging. We also break down the fabrication costs and draw comparisons with other miniature optical systems. The hybrid lenses provided images with quality comparable to conventional microscopy, enabling examination of neoplastic pathology and infectious parasites including malaria and cryptosporidium. We describe how these components can be produced at below $10 per unit in full-scale production quantities, making these systems well suited for use within POC diagnostic instrumentation. PMID:24097204

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

    PubMed Central

    Liang, Jun; Duan, Song; Ma, Yan-Ling; Wang, Ji-Bao; Su, Ying-Zhen; Zhang, Hui; Ou, Chin-Yih; Hao, Ling; Qi, Ming-Shan; Bulterys, Marc; Westerman, Larry; Jiang, Yan; Xiao, Yao

    2015-01-01

    Background: CD4 count is used to determine antiretroviral therapy (ART) eligibility. In China, flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas. In an attempt to address this issue, we conducted a study to validate the performance of Alere PIMA point-of-care CD4 analyzer. Methods: Venous and finger-prick blood specimens were collected from HIV-positive participants from two voluntary counseling and testing sites in Yunnan Province. Both venous and finger-prick blood specimens were tested with the PIMA analyzer. Venous blood specimens tested with the Becton Dickinson FACSCalibur were used as a reference. Results: Venous specimens from 396 and finger-prick specimens from 387 persons were available for analysis. CD4 counts by PIMA correlated well with those from FACSCalibur with an R2 of 0.91 for venous blood and 0.81 for finger-prick blood. Compared to FACSCalibur, the PIMA analyzer yielded lower counts with a mean bias of − 47.0 cells/μl (limit of agreement, [LOA]: −204–110 cells/μl) for venous blood and −71.0 cells/μl (LOA: −295–153 cells/μl) for finger-prick blood. For a CD4 threshold of 350 cells/μl, the positive predictive value (PPV) of PIMA was 84.2% and 75.7% and the negative predictive value (NPV) was 97.6% and 95.8% for venous and finger-prick blood, respectively. For an ART threshold of 500 cells/μl, the corresponding PPV was 90.3% and 84.0% and NPV was 94.3% and 93.4%, respectively. Conclusions: CD4 counting using venous blood with PIMA analyzers is a feasible alternative to a large flow cytometer to determine ART eligibility. PMID:25836608

  1. Electricity-free amplification and detection for molecular point-of-care diagnosis of HIV-1.

    PubMed

    Singleton, Jered; Osborn, Jennifer L; Lillis, Lorraine; Hawkins, Kenneth; Guelig, Dylan; Price, Will; Johns, Rachel; Ebels, Kelly; Boyle, David; Weigl, Bernhard; LaBarre, Paul

    2014-01-01

    In resource-limited settings, the lack of decentralized molecular diagnostic testing and sparse access to centralized medical facilities can present a critical barrier to timely diagnosis, treatment, and subsequent control and elimination of infectious diseases. Isothermal nucleic acid amplification methods, including reverse transcription loop-mediated isothermal amplification (RT-LAMP), are well-suited for decentralized point-of-care molecular testing in minimal infrastructure laboratories since they significantly reduce the complexity of equipment and power requirements. Despite reduced complexity, however, there is still a need for a constant heat source to enable isothermal nucleic acid amplification. This requirement poses significant challenges for laboratories in developing countries where electricity is often unreliable or unavailable. To address this need, we previously developed a low-cost, electricity-free heater using an exothermic reaction thermally coupled with a phase change material. This heater achieved acceptable performance, but exhibited considerable variability. Furthermore, as an enabling technology, the heater was an incomplete diagnostic solution. Here we describe a more precise, affordable, and robust heater design with thermal standard deviation <0.5C at operating temperature, a cost of approximately US$.06 per test for heater reaction materials, and an ambient temperature operating range from 16C to 30C. We also pair the heater with nucleic acid lateral flow (NALF)-detection for a visual readout. To further illustrate the utility of the electricity-free heater and NALF-detection platform, we demonstrate sensitive and repeatable detection of HIV-1 with a -actin positive internal amplification control from processed sample to result in less than 80 minutes. Together, these elements are building blocks for an electricity-free platform capable of isothermal amplification and detection of a variety of pathogens. PMID:25426953

  2. Membrane-based, sedimentation-assisted plasma separator for point-of-care applications

    PubMed Central

    Liu, Changchun; Mauk, Michael; Gross, Robert; Bushman, Frederic D.; Edelstein, Paul H.; Collman, Ronald G.; Bau, Haim H.

    2014-01-01

    Often, high sensitivity, point of care, clinical tests, such as HIV viral load, require large volumes of plasma. Although centrifuges are ubiquitously used in clinical laboratories to separate plasma from whole blood, centrifugation is generally inappropriate for on-site testing. Suitable alternatives are not readily available to separate the relatively large volumes of plasma from milliliters of blood that may be needed to meet stringent limit-of-detection specifications for low abundance target molecules. We report on a simple to use, low-cost, pump-free, membrane-based, sedimentation-assisted plasma separator capable of separating a relatively large volume of plasma from undiluted whole blood within minutes. This plasma separator consists of an asymmetric, porous, polysulfone membrane housed in a disposable chamber. The separation process takes advantage of both gravitational sedimentation of blood cells and size exclusion-based filtration. The plasma separator demonstrated a blood in-plasma out capability, consistently extracting 275 33.5 ?L of plasma from 1.8 mL of undiluted whole blood in less than 7 min. The device was used to separate plasma laden with HIV viruses from HIV virus-spiked whole blood with recovery efficiencies of 95.5% 3.5%, 88.0% 9.5%, and 81.5% 12.1% for viral loads of 35,000, 3,500 and 350 copies/mL, respectively. The separation process is self-terminating to prevent excessive hemolysis. The HIV-laden plasma was then injected into our custom-made microfluidic chip for nucleic acid Testing And Was Successfully Subjected To Reverse Transcriptase Loop mediated isothermal amplification (RT-LAMP), demonstrating that the plasma is sufficiently pure to support high efficiency nucleic acid amplification. PMID:24099566

  3. Electricity-Free Amplification and Detection for Molecular Point-of-Care Diagnosis of HIV-1

    PubMed Central

    Singleton, Jered; Osborn, Jennifer L.; Lillis, Lorraine; Hawkins, Kenneth; Guelig, Dylan; Price, Will; Johns, Rachel; Ebels, Kelly; Boyle, David; Weigl, Bernhard; LaBarre, Paul

    2014-01-01

    In resource-limited settings, the lack of decentralized molecular diagnostic testing and sparse access to centralized medical facilities can present a critical barrier to timely diagnosis, treatment, and subsequent control and elimination of infectious diseases. Isothermal nucleic acid amplification methods, including reverse transcription loop-mediated isothermal amplification (RT-LAMP), are well-suited for decentralized point-of-care molecular testing in minimal infrastructure laboratories since they significantly reduce the complexity of equipment and power requirements. Despite reduced complexity, however, there is still a need for a constant heat source to enable isothermal nucleic acid amplification. This requirement poses significant challenges for laboratories in developing countries where electricity is often unreliable or unavailable. To address this need, we previously developed a low-cost, electricity-free heater using an exothermic reaction thermally coupled with a phase change material. This heater achieved acceptable performance, but exhibited considerable variability. Furthermore, as an enabling technology, the heater was an incomplete diagnostic solution. Here we describe a more precise, affordable, and robust heater design with thermal standard deviation <0.5°C at operating temperature, a cost of approximately US$.06 per test for heater reaction materials, and an ambient temperature operating range from 16°C to 30°C. We also pair the heater with nucleic acid lateral flow (NALF)-detection for a visual readout. To further illustrate the utility of the electricity-free heater and NALF-detection platform, we demonstrate sensitive and repeatable detection of HIV-1 with a ß-actin positive internal amplification control from processed sample to result in less than 80 minutes. Together, these elements are building blocks for an electricity-free platform capable of isothermal amplification and detection of a variety of pathogens. PMID:25426953

  4. Influence of CRP testing and clinical findings on antibiotic prescribing in adults presenting with acute cough in primary care

    PubMed Central

    Jakobsen, Kristin Alise; Melbye, Hasse; Kelly, Mark J.; Ceynowa, Christina; Mlstad, Sigvard; Hood, Kerenza; Butler, Christopher C.

    2010-01-01

    Objective Respiratory tract infections are the most common indication for antibiotic prescribing in primary care. The value of clinical findings in lower respiratory tract infection (LRTI) is known to be overrated. This study aimed to determine the independent influence of a point of care test (POCT) for C-reactive protein (CRP) on the prescription of antibiotics in patients with acute cough or symptoms suggestive of LRTI, and how symptoms and chest findings influence the decision to prescribe when the test is and is not used. Design Prospective observational study of presentation and management of acute cough/LRTI in adults. Setting Primary care research networks in Norway, Sweden, and Wales. Subjects Adult patients contacting their GP with symptoms of acute cough/LRTI. Main outcome measures Predictors of antibiotic prescribing were evaluated in those tested and those not tested with a POCT for CRP using logistic regression and receiver operating characteristic (ROC) curve analysis. Results A total of 803 patients were recruited in the three networks. Among the 372 patients tested with a POCT for CRP, the CRP value was the strongest independent predictor of antibiotic prescribing, with an odds ratio (OR) of CRP ? 50 mg/L of 98.1. Crackles on auscultation and a patient preference for antibiotics perceived by the GP were the strongest predictors of antibiotic prescribing when the CRP test was not used. Conclusions The CRP result is a major influence in the decision whether or not to prescribe antibiotics for acute cough. Clinicians attach less weight to discoloured sputum and abnormal lung sounds when a CRP value is available. CRP testing could prevent undue reliance on clinical features that poorly predict benefit from antibiotic treatment. PMID:20704523

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

    NASA Astrophysics Data System (ADS)

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

    2011-09-01

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

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

    PubMed

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

    2016-01-15

    Ebola outbreak-2014 (mainly Zaire strain related Ebola virus) has been declared most widely spread deadly persistent epidemic due to unavailability of rapid diagnostic, detection, and therapeutics. Ebola virus disease (EVD), a severe viral hemorrhagic fever syndrome caused by Ebola virus (EBOV) is transmitted by direct contact with the body fluids of infected person and objects contaminated with virus or infected animals. World Health Organization (WHO) has declared EVD epidemic as public health emergency of international concern with severe global economic burden. At fatal EBOV infection stage, patients usually die before the antibody response. Currently, rapid blood tests to diagnose EBOV infection include the antigen or antibodies capture using ELISA and RNA detection using RT/Q-PCR within 3-10 days after the onset of symptoms. Moreover, few nanotechnology-based colorimetric and paper-based immunoassay methods have been recently reported to detect Ebola virus. Unfortunately, these methods are limited to laboratory only. As state-of-the art (SoA) diagnostics time to confirm Ebola infection, varies from 6h to about 3 days, it causes delay in therapeutic approaches. Thus developing a cost-effective, rapid, sensitive, and selective sensor to detect EVD at point-of-care (POC) is certainly worth exploring to establish rapid diagnostics to decide therapeutics. This review highlights SoA of Ebola diagnostics and also a call to develop rapid, selective and sensitive POC detection of EBOV for global health care. We propose that adopting miniaturized electrochemical EBOV immunosensing can detect virus level at pM concentration within ∼40min compared to 3 days of ELISA test at nM levels. PMID:26319169

  7. A microfluidic biochip for complete blood cell counts at the point-of-care

    PubMed Central

    Hassan, U.; Reddy, B.; Damhorst, G.; Sonoiki, O.; Ghonge, T.; Yang, C.; Bashir, R.

    2016-01-01

    Complete blood cell counts (CBCs) are one of the most commonly ordered and informative blood tests in hospitals. The results from a CBC, which typically include white blood cell (WBC) counts with differentials, red blood cell (RBC) counts, platelet counts and hemoglobin measurements, can have implications for the diagnosis and screening of hundreds of diseases and treatments. Bulky and expensive hematology analyzers are currently used as a gold standard for acquiring CBCs. For nearly all CBCs performed today, the patient must travel to either a hospital with a large laboratory or to a centralized lab testing facility. There is a tremendous need for an automated, portable point-of-care blood cell counter that could yield results in a matter of minutes from a drop of blood without any trained professionals to operate the instrument. We have developed microfluidic biochips capable of a partial CBC using only a drop of whole blood. Total leukocyte and their 3-part differential count are obtained from 10 μL of blood after on-chip lysing of the RBCs and counting of the leukocytes electrically using microfabricated platinum electrodes. For RBCs and platelets, 1 μL of whole blood is diluted with PBS on-chip and the cells are counted electrically. The total time for measurement is under 20 minutes. We demonstrate a high correlation of blood cell counts compared to results acquired with a commercial hematology analyzer. This technology could potentially have tremendous applications in hospitals at the bedside, private clinics, retail clinics and the developing world. PMID:26909365

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

    PubMed

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

    2016-04-01

    Point-of-care detection is a widely studied area that attracts effort and interest from a large number of fields and companies. However, there is also increased interest from the general public in this type of device, which has driven enormous changes in the design and conception of these developments and the way data is handled. Therefore, future point-of-care detection has to include communication with front-end technology, such as smartphones and networks, automation of manufacture, and the incorporation of concepts like the Internet of Things (IoT) and cloud computing. Three key examples, based on different sensing technology, are analyzed in detail on the basis of these items to highlight a route for the future design and development of point-of-care detection devices and their data capture and handling. Graphical Abstract The future Point-of-care device key elements: recognition element, end user device and integration to other technological platforms and manufacture processes. PMID:26780711

  9. 75 FR 2549 - Clinical Accuracy Requirements for Point of Care Blood Glucose Meters; Public Meeting; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-15

    ... Glucose Meters; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION... public meeting entitled: Clinical Accuracy Requirements for Point of Care Blood Glucose Meters. The purpose of the public meeting is to discuss the clinical accuracy requirements of blood glucose meters...

  10. Femur Fracture Diagnosis and Management Aided by Point-of-Care Ultrasonography.

    PubMed

    Ali, Afrah A W; Solomon, David M; Hoffman, Robert J

    2016-03-01

    We describe a point-of-care ultrasonography to facilitate diagnosis of a femur fracture in a 13-year-old adolescent boy. Rapid detection of the fracture, which was not possible by physical examination alone, permitted immediate stabilization of the leg with traction, rapid communication with orthopedic surgeons, and facilitated analgesic therapy before transport and movement to obtain radiographs. PMID:26928101

  11. Laboratory Evaluation of the Alere q Point-of-Care System for Early Infant HIV Diagnosis

    PubMed Central

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

    2016-01-01

    Introduction Early infant diagnosis (EID) and prompt linkage to care are critical to minimise the high morbidity and mortality associated with infant HIV infection. Attrition in the “EID cascade” is common; however, point-of-care (POC) EID assays with same-day result could facilitate prompt linkage of HIV-infected infant to treatment. Despite a number of POC EID assays in development, few have been independently evaluated and data on new technologies are urgently needed to inform policy. Methods We compared Alere q 1/2 Detect POC system laboratory test characteristics with the local standard of care (SOC), Roche CAP/CTM HIV-1 qualitative PCR in an independent laboratory-based evaluation in Cape Town, South Africa. Routinely EID samples collected between November 2013 and September 2014 were each tested by both SOC and POC systems. Repeat testing was done to troubleshoot any discrepancy between POC and SOC results. Results Overall, 1098 children with a median age of 47 days (IQR, 42–117) were included. Birth PCR (age <7 days) comprised of 8% (n = 92) tests while 56% (n = 620) of children tested as part of routine EID (ages 6–14 weeks). In the overall direct comparison, Alere q Detect achieved sensitivity of 95.5% (95% CI, 91.7–97.9%) and a specificity of 99.8% (95% CI, 99.1–100%). Following repeat testing of discordant samples and exclusion of any inconclusive results, the POC assay sensitivity and specificity were 96.9% (95% CI 93.4–98.9%) and 100% (lower 95% CI 98%) respectively. Among birth PCR tests the POC assay had slightly lower sensitivity (93.3% vs 96.5% in routine EID) and higher assay error rate (10% vs 5% in samples of older children, p = 0.04). Conclusion Our results indicate this POC assay performs well for EID in the laboratory. The high specificity and thus high positive predictive value would suggest a positive POC result may be adequate for immediate infant ART initiation. While POC testing for EID may have particular utility for birth testing at delivery facilities, the lower sensitivity and error rate requires further attention, as does field implementation of POC EID technologies in other clinical care settings. PMID:27032094

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

    PubMed

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

    2016-06-15

    Access to appropriate diagnostic tools is an essential component in the evaluation and improvement of global health. Additionally, timely detection of infectious agents is critical in early diagnosis and treatment of infectious diseases. Conventional pathogen detection methods such as culturing, enzyme linked immunosorbent assay (ELISA) or polymerase chain reaction (PCR) require long assay times, and complex and expensive instruments making them not adaptable to point-of-care (PoC) needs at resource-constrained places and primary care settings. Therefore, there is an unmet need to develop portable, simple, rapid, and accurate methods for PoC detection of infections. Here, we present the development and validation of a portable, robust and inexpensive electrochemical magnetic microbeads-based biosensor (EMBIA) platform for PoC serodiagnosis of infectious diseases caused by different types of microorganisms (parasitic protozoa, bacteria and viruses). We demonstrate the potential use of the EMBIA platform for in situ diagnosis of human (Chagas disease and human brucellosis) and animal (bovine brucellosis and foot-and-mouth disease) infections clearly differentiating infected from non-infected individuals or animals. For Chagas disease, a more extensive validation of the test was performed showing that the EMBIA platform displayed an excellent diagnostic performance almost indistinguishable, in terms of specificity and sensitivity, from a fluorescent immunomagnetic assay and the conventional ELISA using the same combination of antigens. This platform technology could potentially be applicable to diagnose other infectious and non-infectious diseases as well as detection and/or quantification of biomarkers at the POC and primary care settings. PMID:26802749

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

    PubMed

    Lindner, T; Conze, M; Albers, C E; Leidel, B A; Levy, P; Kleber, C; De Moya, M; Exadaktylos, A; Stoupis, C

    2013-01-01

    Background. A nonrecognized pneumothorax (PTX) may become a life-threatening tension PTX. A reliable point-of-care diagnostic tool could help in reduce this risk. For this purpose, we investigated the feasibility of the use of the PneumoScan, an innovative device based on micropower impulse radar (MIR). Patients and Methods. addition to a standard diagnostic protocol including clinical examination, chest X-ray (CXR), and computed tomography (CT), 24 consecutive patients with chest trauma underwent PneumoScan testing in the shock trauma room to exclude a PTX. Results. The application of the PneumoScan was simple, quick, and reliable without functional disorder. Clinical examination and CXR each revealed one and PneumoScan three out of altogether four PTXs (sensitivity 75%, specificity 100%, positive predictive value 100%, and negative predictive value 95%). The undetected PTX did not require intervention. Conclusion. The PneumoScan as a point-of-care device offers additional diagnostic value in patient management following chest trauma. Further studies with more patients have to be performed to evaluate the diagnostic accuracy of the device. PMID:24187624

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

    PubMed Central

    Lindner, T.; Conze, M.; Albers, C. E.; Leidel, B. A.; Levy, P.; Kleber, C.; De Moya, M.; Exadaktylos, A.; Stoupis, C.

    2013-01-01

    Background. A nonrecognized pneumothorax (PTX) may become a life-threatening tension PTX. A reliable point-of-care diagnostic tool could help in reduce this risk. For this purpose, we investigated the feasibility of the use of the PneumoScan, an innovative device based on micropower impulse radar (MIR). Patients and Methods. addition to a standard diagnostic protocol including clinical examination, chest X-ray (CXR), and computed tomography (CT), 24 consecutive patients with chest trauma underwent PneumoScan testing in the shock trauma room to exclude a PTX. Results. The application of the PneumoScan was simple, quick, and reliable without functional disorder. Clinical examination and CXR each revealed one and PneumoScan three out of altogether four PTXs (sensitivity 75%, specificity 100%, positive predictive value 100%, and negative predictive value 95%). The undetected PTX did not require intervention. Conclusion. The PneumoScan as a point-of-care device offers additional diagnostic value in patient management following chest trauma. Further studies with more patients have to be performed to evaluate the diagnostic accuracy of the device. PMID:24187624

  15. Multivalent nanoparticle networks enable point-of-care detection of human phospholipase-A2 in serum.

    PubMed

    Chapman, Robert; Lin, Yiyang; Burnapp, Mark; Bentham, Andrew; Hillier, David; Zabron, Abigail; Khan, Shahid; Tyreman, Matthew; Stevens, Molly M

    2015-03-24

    A rapid and highly sensitive point-of-care (PoC) lateral flow assay for phospholipase A2 (PLA2) is demonstrated in serum through the enzyme-triggered release of a new class of biotinylated multiarmed polymers from a liposome substrate. Signal from the enzyme activity is generated by the adhesion of polystreptavidin-coated gold nanoparticle networks to the lateral flow device, which leads to the appearance of a red test line due to the localized surface plasmon resonance effect of the gold. The use of a liposome as the enzyme substrate and multivalent linkers to link the nanoparticles leads to amplification of the signal, as the cleavage of a small amount of lipids is able to release a large amount of polymer linker and adhesion of an even larger amount of gold nanoparticles. By optimizing the molecular weight and multivalency of these biotinylated polymer linkers, the sensitivity of the device can be tuned to enable naked-eye detection of 1 nM human PLA2 in serum within 10 min. This high sensitivity enabled the correct diagnosis of pancreatitis in diseased clinical samples against a set of healthy controls using PLA2 activity in a point-of-care device for the first time. PMID:25756526

  16. Basic capillary microfluidic chip and highly sensitive optical detector for point of care application

    NASA Astrophysics Data System (ADS)

    Yao, Mingjin

    A cost-effective and highly sensitive portable diagnostic device is needed to enable much more widespread monitoring of health conditions in disease prevention, detection, and control. Miniaturized and easy-to-operate devices can reduce the inherent costs and inefficiencies associated with healthcare testing in central laboratories. Hence, clinicians are beginning to use point of care (POC) testing and flexible clinical chemistry testing devices which are beneficial for the patient. In our work, a low-cost and simple autonomous microfluidic device for biochemical detection was developed. The pumpless capillary system with capillary stop valves and trigger valves is fabricated on a silicon (Si) wafer and then bonded with the modified polydimethylsiloxane (PDMS) cover. The key point of this study is the change of the surface contact angle of the PDMS to achieve the functionalities such as timing features (capillary-driven stop valve) and basic logical functions (trigger valves). The polydimethylsiloxane-ethylene oxide polymer (PDMS-b-PEO) is utilized as a surfactant additive to make the PDMS hydrophilic. The contact angle of the modified PDMS can be adjusted from 80.9° to 21.5° with different mixing ratios. The contact angles of PEO-PDMS accepted in this work are from 80.9° to 58.5° to bring the capillary channel and valve into effect. This autonomous capillary-driven device with good microfluidic flow manipulation can be widely applied to a number of microfluidic devices and pumpless fluidic actuation mechanisms, which is suitable for cost-effective diagnostic tools in the biomedical analysis and POC testing applications. Another obstacle for miniaturization of the bio-detection system is the optical detector. We developed a novel, highly sensitive and miniaturized detector. It integrates a light source--light emitting diode (LED), all necessary optical components, and a photodiode with preamplifier into one package about 2 cm x 2 cm x 2 cm, especially for the applications of lab-on-a-chip (LOC), portable bio-detection system and POC diagnostic system. The size of this detector is smaller than the existing miniaturized detector of the size 5 cm x 5 cm x 5 cm. The fluorescence dye 5-Carboxyfluorescein (5-FAM) dissolved into the solvent DMSO (Dimethyl Sulfoxide) and diluted with DI water was used as the testing solution samples. The prototype has been tested to prove a remarkable sensitivity at pico-scale molar, around 1.08 pM, which is the highest sensitivity by now. It is higher than the current limit of detection at 1.96 nm, which will be presented in detail in the latter section.

  17. Diagnostic Accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 Point-of-Care Hemoglobin Meters in a Central Laboratory and a Community Based Clinic in Durban, South Africa

    PubMed Central

    Jaggernath, Manjeetha; Naicker, Rumallen; Madurai, Savathree; Brockman, Mark A.; Ndung’u, Thumbi; Gelderblom, Huub C.

    2016-01-01

    In South Africa, various point-of-care hemoglobin meters are used. However, the regulatory framework for approval, implementation and oversight of use of point-of-care hemoglobin meters is suboptimal. We assessed the diagnostic accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 point-of-care hemoglobin meters, compared to a central laboratory based reference assay, in a central laboratory and a community based clinic in Durban, South Africa. Differences in performance of the point-of-care assays, compared to the reference assay, were more pronounced in the community based clinic. Results were reasonable for the HemoCue Hb 301, but poor for the STAT-Site MHgb and the URIT-12. Poor test performance of point-of-care hemoglobin meters, and inadequate evaluations and oversight in South Africa, leads to suboptimal clinical care and clinical research, and increased costs. There is a need for proper evaluation and quality assurance of point-of-care tests, the results of which should be made widely available to key stakeholders. PMID:27046200

  18. Introduction of point of care analysis for prescribing warfarin at a Swedish primary care centre

    PubMed Central

    Fernholm, Rita; Hermansson, Jonas

    2015-01-01

    Boo Health Centre in Nacka, Sweden, manages approximately 240 patients on warfarin treatment. A risk analysis showed that testing and prescribing of warfarin involved 28 different steps and nine parties, leading to a high risk of errors. The aim of the study was to shorten and simplify the process flow for the testing and prescription of warfarin by introducing point of care analysis (POC). The aim was also to evaluate changes in time expenditure and cost related to the new processes well as the quality in form of time in therapeutic range (TTR) and number of adverse events. A study with POC was performed during six months in 2014. Time expenditure, cost, TTR, and adverse events related to warfarin treatment were recorded. An evaluation was also conducted in the form of surveys to patients and staff regarding satisfaction with the new process. The process was shortened from 28 steps and nine parties involved to nine steps and four parties involved. The patient got their test result and met with the prescribing doctor, all within the same visit, meaning that the feedback time for patients was shortened from one to three days by mail to less than 10 minutes at the medical centre. TTR did not change and the incidence of adverse events was not affected. The surveys showed that the overwhelming proportion of patients, doctors, assistant nurses, and laboratory staff were pleased with the changes and the patients would recommend others to monitor their treatment at Boo Health Centre. There was a reduction in time expenditure for the staff. The costs decreased from approximately 8 000 €/month to about 7 000 €/month. The introduction of the POC method enabled a shorter process flow with reduced time expenditure for both patients and staff and reduced costs. TTR did not change. Patients and staff were satisfied with the changes and the patients could take a more active role in their treatment. It is possible that POC analysis may have implications on improved compliance to warfarin treatment, if so, it will increase patient safety. PMID:26734421

  19. Ultrasound in athletes: emerging techniques in point-of-care practice.

    PubMed

    Yim, Eugene S; Corrado, Gianmichel

    2012-01-01

    Ultrasound offers sports medicine clinicians the potential to diagnose, treat, and manage a broad spectrum of conditions afflicting athletes. This review article highlights applications of ultrasound that hold promise as point-of-care diagnostics and therapeutic tools that can be used directly by clinicians to direct real-time management of athletes. Point-of-care ultrasound has been examined most in the context of musculoskeletal disorders in athletes, with attention given to Achilles tendinopathy, patellar tendinopathy, hip and thigh pathology, elbow tendinopathy, wrist pathology, and shoulder pain. More research has focused on therapeutic applications than diagnostic, but initial evidence has been generated in both. Preliminary evidence has been published also on abdominal ultrasound for splenic enlargement in mononucleosis, cardiopulmonary processes and hydration status, deep vein thrombosis, and bone mineral density. Further research will be required to validate these applications and to explore further applications of portable ultrasound that can be used in the care of athletes. PMID:23147017

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

    PubMed

    Manias, Elizabeth; Hughes, Carmel

    2015-01-01

    In clinical practice, pharmacists play a very important role in identifying and correcting medication discrepancies as older patients move across transition points of care. With increasing complexity of health care needs of older people, these discrepancies are likely to increase. The major concern with identifying and correcting medication discrepancies is that medication reconciliation is considered a retrospective problem--that is, dealing with medication discrepancies after they have occurred. It is argued here that a more proactive stance should be taken where doctors, nurses and pharmacists collectively work together to prevent medication discrepancies from happening in the first place. Improved involvement of patients and family members will help to facilitate better management of medications across transition points of care. Efficient use of information technology aids, such as electronic medication reconciliation tools, should also assist with organizational systems problems associated with the working culture, heavy workloads, and staff and skill mix of health professionals. PMID:25455760

  1. Rapid Detection of Ebola Virus with a Reagent-Free, Point-of-Care Biosensor

    PubMed Central

    Baca, Justin T.; Severns, Virginia; Lovato, Debbie; Branch, Darren W.; Larson, Richard S.

    2015-01-01

    Surface acoustic wave (SAW) sensors can rapidly detect Ebola antigens at the point-of-care without the need for added reagents, sample processing, or specialized personnel. This preliminary study demonstrates SAW biosensor detection of the Ebola virus in a concentration-dependent manner. The detection limit with this methodology is below the average level of viremia detected on the first day of symptoms by PCR. We observe a log-linear sensor response for highly fragmented Ebola viral particles, with a detection limit corresponding to 1.9 × 104 PFU/mL prior to virus inactivation. We predict greatly improved sensitivity for intact, infectious Ebola virus. This point-of-care methodology has the potential to detect Ebola viremia prior to symptom onset, greatly enabling infection control and rapid treatment. This biosensor platform is powered by disposable AA batteries and can be rapidly adapted to detect other emerging diseases in austere conditions. PMID:25875186

  2. Rapid detection of Ebola virus with a reagent-free, point-of-care biosensor.

    PubMed

    Baca, Justin T; Severns, Virginia; Lovato, Debbie; Branch, Darren W; Larson, Richard S

    2015-01-01

    Surface acoustic wave (SAW) sensors can rapidly detect Ebola antigens at the point-of-care without the need for added reagents, sample processing, or specialized personnel. This preliminary study demonstrates SAW biosensor detection of the Ebola virus in a concentration-dependent manner. The detection limit with this methodology is below the average level of viremia detected on the first day of symptoms by PCR. We observe a log-linear sensor response for highly fragmented Ebola viral particles, with a detection limit corresponding to 1.9 104 PFU/mL prior to virus inactivation. We predict greatly improved sensitivity for intact, infectious Ebola virus. This point-of-care methodology has the potential to detect Ebola viremia prior to symptom onset, greatly enabling infection control and rapid treatment. This biosensor platform is powered by disposable AA batteries and can be rapidly adapted to detect other emerging diseases in austere conditions. PMID:25875186

  3. Promoting Evidence-Based Practice Through a Research Training Program for Point-of-Care Clinicians

    PubMed Central

    Black, Agnes T.; Balneaves, Lynda G.; Garossino, Candy; Puyat, Joseph H.; Qian, Hong

    2015-01-01

    OBJECTIVES: The purpose of this study was to evaluate the effect of a research training program on clinicians’ knowledge, attitudes, and practices related to research and evidence-based practice (EBP). BACKGROUND: EBP has been shown to improve patient care and outcomes. Innovative approaches are needed to overcome individual and organizational barriers to EBP. METHODS: Mixed-methods design was used to evaluate a research training intervention with point-of-care clinicians in a Canadian urban health organization. Participants completed the Knowledge, Attitudes, and Practice Survey over 3 timepoints. Focus groups and interviews were also conducted. RESULTS: Statistically significant improvement in research knowledge and ability was demonstrated. Participants and administrators identified benefits of the training program, including the impact on EBP. CONCLUSIONS: Providing research training opportunities to point-of-care clinicians is a promising strategy for healthcare organizations seeking to promote EBP, empower clinicians, and showcase excellence in clinical research. PMID:25390076

  4. Rapid detection of Ebola virus with a reagent-free, point-of-care biosensor

    SciTech Connect

    Baca, Justin T.; Severns, Virginia; Lovato, Debbie; Branch, Darren W.; Larson, Richard S.

    2015-04-14

    Surface acoustic wave (SAW) sensors can rapidly detect Ebola antigens at the point-of-care without the need for added reagents, sample processing, or specialized personnel. This preliminary study demonstrates SAW biosensor detection of the Ebola virus in a concentration-dependent manner. The detection limit with this methodology is below the average level of viremia detected on the first day of symptoms by PCR. We observe a log-linear sensor response for highly fragmented Ebola viral particles, with a detection limit corresponding to 1.9 × 10⁴ PFU/mL prior to virus inactivation. We predict greatly improved sensitivity for intact, infectious Ebola virus. This point-of-care methodology has the potential to detect Ebola viremia prior to symptom onset, greatly enabling infection control and rapid treatment. This biosensor platform is powered by disposable AA batteries and can be rapidly adapted to detect other emerging diseases in austere conditions.

  5. Rapid detection of Ebola virus with a reagent-free, point-of-care biosensor

    DOE PAGESBeta

    Baca, Justin T.; Severns, Virginia; Lovato, Debbie; Branch, Darren W.; Larson, Richard S.

    2015-04-14

    Surface acoustic wave (SAW) sensors can rapidly detect Ebola antigens at the point-of-care without the need for added reagents, sample processing, or specialized personnel. This preliminary study demonstrates SAW biosensor detection of the Ebola virus in a concentration-dependent manner. The detection limit with this methodology is below the average level of viremia detected on the first day of symptoms by PCR. We observe a log-linear sensor response for highly fragmented Ebola viral particles, with a detection limit corresponding to 1.9 × 10⁴ PFU/mL prior to virus inactivation. We predict greatly improved sensitivity for intact, infectious Ebola virus. This point-of-care methodologymore » has the potential to detect Ebola viremia prior to symptom onset, greatly enabling infection control and rapid treatment. This biosensor platform is powered by disposable AA batteries and can be rapidly adapted to detect other emerging diseases in austere conditions.« less

  6. Smart biosensors for multiplexed and fully integrated point-of-care diagnostics.

    PubMed

    Romeo, A; Leung, T S; Sánchez, S

    2016-05-24

    Point-of-care diagnostics (PoC) and personalised medicine are highly valuable for the improvement of world health. Smartphone PoC platforms which precisely diagnose diseases and track their development through the detection of several bioanalytes represent one of the newest and most exciting advancements towards mass-screening applications. Here we focus on recent advances in both multiplexed and smartphone integrated PoC sensors. PMID:27149012

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

    PubMed

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

    2015-12-01

    Microelectromechanical systems (MEMS) have become an invaluable technology to advance the development of point-of-care (POC) devices for diagnostics and sample analyses. MEMS can transform sophisticated methods into compact and cost-effective microdevices that offer numerous advantages at many levels. Such devices include microchannels, microsensors, etc., that have been applied to various miniaturized POC products. Here we discuss some of the recent advances made in the use of MEMS devices for POC applications. PMID:26459443

  8. Point of care ultrasonography use and training among trauma providers across Canada

    PubMed Central

    AlEassa, Essa M.; Ziesmann, Markus T.; Kirkpatrick, Andrew W.; Wurster, Charles L.; Gillman, Lawrence M.

    2016-01-01

    Summary Point of care ultrasonography (POCUS) is revolutionizing care of critically ill patients. However, training in POCUS is extremely variable, with no accepted curriculum or certification process. We aimed to delineate the training experience and use of POCUS among trauma providers across Canada via a secure e-questionnaire sent to members of the Trauma Association of Canada. This commentary discusses our survey results and argues for the standardization of POCUS training and certification in Canada. PMID:26574705

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

    PubMed Central

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

    2014-01-01

    This study aims to develop a wireless EEG system to provide critical point-of-care information about brain electrical activity. A novel dry electrode, which can be installed rapidly, is used to acquire EEG from the scalp. A wireless data link between the electrode and a data port (i.e., a smartphone) is established based on the Bluetooth technology. A prototype of this system has been implemented and its performance in acquiring EEG has been evaluated. PMID:25419099

  10. Theme-based teaching of point-of-care ultrasound in undergraduate medical education.

    PubMed

    Amini, Richard; Stolz, Lori Ann; Gross, Austin; O'Brien, Kathleen; Panchal, Ashish Raman; Reilly, Kevin; Chan, Lisa; Drummond, Brian Scott; Sanders, Arthur; Adhikari, Srikar

    2015-08-01

    A handful of medical schools have developed formal curricula to teach medical students point-of-care ultrasound; however, no ideal method has been proposed. The purpose of this study was to assess an innovative theme-based ultrasound educational model for undergraduate medical education. This was a single-center cross-sectional study conducted at an academic medical center. The study participants were 95 medical students with minimal or no ultrasound experience during their third year of training. The educational theme for the ultrasound session was "The evaluation of patients involved in motor vehicle collisions." This educational theme was carried out during all components of the 1-day event called SonoCamp: asynchronous learning, the didactic lecture, the skills stations, the team case challenge and the individual challenge stations. Assessment consisted of a questionnaire, team case challenge, and individual challenges. A total of 89 of 95 (94 %) students who participated in SonoCamp responded, and 92 % (87 of 95) completed the entire questionnaire before and after the completion of SonoCamp. Ninety-nine percent (95 % CI, 97-100 %) agreed that training at skill stations helped solidify understanding of point-of-care ultrasound. Ninety-two percent (95 % CI, 86-98 %) agreed that theme-based learning is an engaging learning style for point-of-care ultrasound. All students agreed that having a team exercise is an engaging way to learn point-of-care ultrasound; and of the 16 groups, the average score on the case-based questions was 82 % (SD + 28). The 1-day, theme-based ultrasound educational event was an engaging learning technique at our institution which lacks undergraduate medical education ultrasound curriculum. PMID:25764053

  11. Point-of-care ultrasound detection of tracheal wall thickening caused by smoke inhalation

    PubMed Central

    2014-01-01

    Smoke inhalation is the leading cause of death due to fires. When a patient presents with smoke inhalation, prompt assessment of the airway and breathing is necessary. Point-of-care ultrasonography (US) is used for the rapid assessment of critically ill or injured patients. We herein present a case report of a 54-year-old male who was transferred to the emergency department with shortness of breath, coughing, carbonaceous sputa, and rhinorrhea after inhaling smoke caused by a fire in his locked bedroom. He had no surface burns on the face and no edema or erosion in the oral cavity. He had hoarseness without stridor. His breath sounds were positive for expiratory wheezes. Laryngoscopy showed light edema and erosive findings on the supraglottic region. Bedside point-of-care US revealed hypoechoic thickening of the tracheal wall. The thickening was confirmed by a computed tomographic scan. The patient was carefully monitored with preparation for emergency airway management and was treated with supplemental oxygen and an aerosolized beta-2 adrenergic agonist in the intensive care unit. The symptoms were subsequently relieved, and reexamination by US after 2 days showed remission of the wall thickening. Point-of-care US may therefore be a useful modality for the rapid diagnosis and effective follow-up of tracheal wall thickening caused by smoke inhalation. PMID:25097745

  12. Rapid point-of-care multiplex immunodetection using two-dimensional microarray technology

    NASA Astrophysics Data System (ADS)

    Chuang, Frank Y. S.; Gutierrez, Dora M.; Nguyen, Christine P.; Johnson, David C.; Palmer, Richard A.; Richards, James B.; Chang, John T.; Visuri, Steven R.; Colston, Bill W., Jr.

    2003-07-01

    In response to a broad-based need for point-of-care multiplex diagnostic capability, we have developed a novel hybrid platform to analyze optically encoded microspheres arranged on a 2-dimensional planar array. The microspheres which we have initially selected are developed by Luminex Inc. as substrates for sandwich-type fluorescent immunoassays and are typically used in conjunction with a customized flow analyzer. CCD-based optics are the essential feature which enables the development of a rugged diagnostic instrument which can be scaled for point-of-care applications. We have characterized the Multiplex Immunoassay Diagnostic System (MIDS) using a benchtop prototype built around a conventional 12-bit CCD. This system is capable of resolving up to 6 discrete classes of fluorescent microbeads, and measuring their corresponding reporter signal. The MIDS sensitivity to the phycoerythrin (PE) reporter compared favorably to that of the reference Luminex flow system, and is capable of identifying viral, bacterial, and protein simulants in laboratory samples, at concentrations less than 1μg/ml. The ability to resolve small differences in the average PE fluorescence is a direct function of CCD performance, and may be a necessary trade-off for developing a portable and economical detection system. However, we are confident that the MIDS platform can easily be scaled to meet the nominal requirements of any given point-of-care or screening application, and furthermore provide much-needed diagnostic functionality in this particular environment.

  13. A research protocol for developing a Point-Of-Care Key Evidence Tool ‘POCKET’: a checklist for multidimensional evidence reporting on point-of-care in vitro diagnostics

    PubMed Central

    Huddy, Jeremy R; Ni, Melody; Mavroveli, Stella; Barlow, James; Williams, Doris-Ann; Hanna, George B

    2015-01-01

    Introduction Point-of-care in vitro diagnostics (POC-IVD) are increasingly becoming widespread as an acceptable means of providing rapid diagnostic results to facilitate decision-making in many clinical pathways. Evidence in utility, usability and cost-effectiveness is currently provided in a fragmented and detached manner that is fraught with methodological challenges given the disruptive nature these tests have on the clinical pathway. The Point-of-care Key Evidence Tool (POCKET) checklist aims to provide an integrated evidence-based framework that incorporates all required evidence to guide the evaluation of POC-IVD to meet the needs of policy and decisionmakers in the National Health Service (NHS). Methods and analysis A multimethod approach will be applied in order to develop the POCKET. A thorough literature review has formed the basis of a robust Delphi process and validation study. Semistructured interviews are being undertaken with POC-IVD stakeholders, including industry, regulators, commissioners, clinicians and patients to understand what evidence is required to facilitate decision-making. Emergent themes will be translated into a series of statements to form a survey questionnaire that aims to reach a consensus in each stakeholder group to what needs to be included in the tool. Results will be presented to a workshop to discuss the statements brought forward and the optimal format for the tool. Once assembled, the tool will be field-tested through case studies to ensure validity and usability and inform refinement, if required. The final version will be published online with a call for comments. Limitations include unpredictable sample representation, development of compromise position rather than consensus, and absence of blinding in validation exercise. Ethics and dissemination The Imperial College Joint Research Compliance Office and the Imperial College Hospitals NHS Trust R&D department have approved the protocol. The checklist tool will be disseminated through a PhD thesis, a website, peer-reviewed publication, academic conferences and formal presentations. PMID:26163033

  14. Seroprevalence of equine granulocytic anaplasmosis and lyme borreliosis in Canada as determined by a point-of-care enzyme-linked immunosorbent assay (ELISA)

    PubMed Central

    Schvartz, Gili; Epp, Tasha; Burgess, Hilary J.; Chilton, Neil B.; Pearl, David L.; Lohmann, Katharina L.

    2015-01-01

    Equine granulocytic anaplasmosis (EGA) and Lyme borreliosis (LB) are an emerging concern in Canada. We estimated the seroprevalence of EGA and equine LB by testing 376 convenience serum samples from 3 provinces using a point-of-care SNAP® 4Dx® ELISA (IDEXX Laboratories, Westbrook, Maine, USA), and investigated the agreement between the point-of-care ELISA and laboratory-based serologic tests. The estimated seroprevalence for EGA was 0.53% overall (0.49% in Saskatchewan, 0.71% in Manitoba), while the estimated seroprevalence for LB was 1.6% overall (0.49% in Saskatchewan, 2.86% in Manitoba). There was limited agreement between the point-of-care ELISA and an indirect fluorescent antibody test for EGA (kappa 0.1, PABAK 0.47) and an ELISA/Western blot combination for LB (kappa 0.23, PABAK 0.71). While the SNAP® 4Dx® ELISA yielded expected seroprevalence estimates, further evaluation of serologic tests for the purposes of disease exposure recognition may be needed. PMID:26028677

  15. Programmable Bio-Nano-Chip Technology for the Diagnosis of Cardiovascular Disease at the Point-of-Care

    PubMed Central

    Pierre, Floriano N.; Sanchez, Ximena; Li, Luanyi; Hocquard, Kyle; Patton, Aaron; Muldoon, Rachna; Miller, Craig S.; Ebersole, Jeffrey L.; Redding, Spencer; Yeh, Chih-Ko; Furmaga, Wieslaw B.; Wampler, David A.; Bozkurt, Biykem; Ballantyne, Christie M.; McDevitt, John T.

    2012-01-01

    Cardiovascular disease remains the leading cause of death in the world and continues to serve as the major contributor to healthcare costs. Likewise, there is an ever-increasing need and demand for novel and more efficient diagnostic tools for the early detection of cardiovascular disease, especially at the point-of-care (POC). This article reviews the programmable bio-nanochip (P-BNC) system, a new medical microdevice approach with the capacity to deliver both high performance and reduced cost. This fully integrated, total analysis system leverages microelectronic components, microfabrication techniques, and nanotechnology to noninvasively measure multiple cardiac biomarkers in complex fluids, such as saliva, while offering diagnostic accuracy equal to laboratory-confined reference methods. This article profiles the P-BNC approach, describes its performance in real-world testing of clinical samples, and summarizes new opportunities for medical microdevices in the field of cardiac diagnostics. PMID:22891104

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-03-01

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

  18. A novel microfluidic anti-factor Xa assay device for monitoring anticoagulant therapy at the point-of-care

    NASA Astrophysics Data System (ADS)

    Harris, Leanne F.; Rainey, Paul; Castro-López, Vanessa; O'Donnell, James S.; Killard, Anthony J.

    2013-05-01

    Millions of patients worldwide are receiving anticoagulant therapy to treat hypercoagulable diseases. While standard testing is still performed in the central laboratory, point-of-care (POC) diagnostics are being developed due to the increasing number of patients requiring long-term anticoagulation and with a need for more personalized and targeted therapy. Many POC devices on the market focus on clot measurement, a technique which is limited in terms of variability, highlighting the need for more reliable assays of anticoagulant status. The anti-Xa assay, a factor specific optical assay, was developed to measure the extent to which exogenous factor Xa (FXa) is inhibited by heparinantithrombin complexes. We have developed a novel microfluidic device and assay for monitoring the effect of heparin anticoagulant therapy at the point-of-care. The assay which was also developed in our institute is based on the anti-Xa assay principle but uses fluorescence as the method of detection. Our device is a disposable laminate microfluidic strip, fabricated from the cyclic polyolefin (COP), Zeonor®, which is extremely suitable for application to fluorescent device platforms. We present data on the execution of the anti-Xa assay in this microfluidic format, demonstrating that the assay can be used to measure heparin in human plasma samples from 0 to 0.8 U/ml, with average assay reproducibility of 8% and a rapid result obtained within 60 seconds. Results indicate that with further development, the fluorogenic anti-Xa assay and device could become a successful method for monitoring anticoagulant therapy.

  19. Evaluation of the Nova StatSensor® XpressTM Creatinine Point-Of-Care Handheld Analyzer

    PubMed Central

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

    2015-01-01

    Creatinine is a parameter that is required to monitor renal function and is important to follow in patients under treatment with potentially toxic renal drugs, such as the anti-HIV drug Tenofovir. A point of care instrument to measure creatinine would be useful for patients monitoring in resource-limited settings, where more instruments that are sophisticated are not available. The StatSensor Xpress Creatinine (Nova Biomedical Cooperation, Waltham, MA, USA) point of care analyzer was evaluated for its diagnostic performance in indicating drug therapy change. Creatinine was measured in parallel using the Nova StatSensor Xpress Creatinine analyzer and the Vitros 5,1FS (Ortho Clinical Diagnostics, Inc, Rochester, USA), which served as reference standard. The precision (i.e., repeatability and reproducibility) and accuracy of the StatSensor Xpress Creatinine analyzer were calculated using a panel of specimens with normal, low pathological and high pathological values. Two different Nova StatSensor Xpress Creatinine analyzers were used for the assessment of accuracy using repeated measurements. The coefficient of variation of the StatSensor Xpress Creatinine analyzers ranged from 2.3 to 5.9% for repeatability and from 4.2 to 9.0% for between-run reproducibility. The concordance correlation agreement was good except for high values (>600 µmol/L). The Bland-Altman analysis in high pathological specimens suggests that the Nova StatSensor Xpress Creatinine test tends to underestimate high creatinine values (i.e., >600 µmol/L). The Nova StatSensor Xpress Creatinine analyzers showed acceptable to good results in terms of repeatability, inter-device reproducibility and between-run reproducibility over time using quality control reagents. The analyzer was found sufficiently accurate for detecting pathological values in patients (age >10 year) and can be used with a moderate risk of misclassification. PMID:25886375

  20. The effects of on-screen, point of care computer reminders on processes and outcomes of care

    PubMed Central

    Shojania, Kaveh G; Jennings, Alison; Mayhew, Alain; Ramsay, Craig R; Eccles, Martin P; Grimshaw, Jeremy

    2014-01-01

    Background The opportunity to improve care by delivering decision support to clinicians at the point of care represents one of the main incentives for implementing sophisticated clinical information systems. Previous reviews of computer reminder and decision support systems have reported mixed effects, possibly because they did not distinguish point of care computer reminders from e-mail alerts, computer-generated paper reminders, and other modes of delivering ‘computer reminders’. Objectives To evaluate the effects on processes and outcomes of care attributable to on-screen computer reminders delivered to clinicians at the point of care. Search methods We searched the Cochrane EPOC Group Trials register, MEDLINE, EMBASE and CINAHL and CENTRAL to July 2008, and scanned bibliographies from key articles. Selection criteria Studies of a reminder delivered via a computer system routinely used by clinicians, with a randomised or quasi-randomised design and reporting at least one outcome involving a clinical endpoint or adherence to a recommended process of care. Data collection and analysis Two authors independently screened studies for eligibility and abstracted data. For each study, we calculated the median improvement in adherence to target processes of care and also identified the outcome with the largest such improvement. We then calculated the median absolute improvement in process adherence across all studies using both the median outcome from each study and the best outcome. Main results Twenty-eight studies (reporting a total of thirty-two comparisons) were included. Computer reminders achieved a median improvement in process adherence of 4.2% (interquartile range (IQR): 0.8% to 18.8%) across all reported process outcomes, 3.3% (IQR: 0.5% to 10.6%) for medication ordering, 3.8% (IQR: 0.5% to 6.6%) for vaccinations, and 3.8% (IQR: 0.4% to 16.3%) for test ordering. In a sensitivity analysis using the best outcome from each study, the median improvement was 5.6% (IQR: 2.0% to 19.2%) across all process measures and 6.2% (IQR: 3.0% to 28.0%) across measures of medication ordering. In the eight comparisons that reported dichotomous clinical endpoints, intervention patients experienced a median absolute improvement of 2.5% (IQR: 1.3% to 4.2%). Blood pressure was the most commonly reported clinical endpoint, with intervention patients experiencing a median reduction in their systolic blood pressure of 1.0 mmHg (IQR: 2.3 mmHg reduction to 2.0 mmHg increase). Authors’ conclusions Point of care computer reminders generally achieve small to modest improvements in provider behaviour. A minority of interventions showed larger effects, but no specific reminder or contextual features were significantly associated with effect magnitude. Further research must identify design features and contextual factors consistently associated with larger improvements in provider behaviour if computer reminders are to succeed on more than a trial and error basis. PMID:19588323

  1. [Effective IT-Based Quality Management of Clinical Laboratories--Using POCT Apparatus].

    PubMed

    Goto, Shinichi

    2015-02-01

    Clinical laboratories are beneficial for users with difficulty in participating in a regular health examination to conveniently undergo it and directly and promptly receive the results. As some users possibly make their own judgments on such results, and submit them to clinics or hospitals, it is necessary for clinical laboratories analyzing patients' samples to provide accurate results based on quality management. For rapid result-reporting, POCT apparatus and kits may be more appropriate examination devices, rather than those for analysis, which are large and used in general examination rooms. Effective IT-based data management systems combined with such devices may enable users to obtain reliable examination results. PMID:26529975

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

    PubMed

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

    2015-03-01

    Effective vein visualization is clinically important for various point-of-care applications, such as needle insertion. It can be achieved by utilizing ultrasound imaging or by applying infrared laser excitation and monitoring its absorption. However, while these approaches can be used for vein visualization, they are not suitable for point-of-care applications because of their cost, time, and accessibility. In this paper, a new vein visualization method based on multispectral Wiener estimation is proposed and its real-time implementation on a smart phone is presented. In the proposed method, a conventional RGB camera on a commercial smart phone (i.e., Galaxy Note 2, Samsung Electronics Inc., Suwon, Korea) is used to acquire reflectance information from veins. Wiener estimation is then applied to extract the multispectral information from the veins. To evaluate the performance of the proposed method, an experiment was conducted using a color calibration chart (ColorChecker Classic, X-rite, Grand Rapids, MI, USA) and an average root-mean-square error of 12.0% was obtained. In addition, an in vivo subcutaneous vein imaging experiment was performed to explore the clinical performance of the smart phone-based Wiener estimation. From the in vivo experiment, the veins at various sites were successfully localized using the reconstructed multispectral images and these results were confirmed by ultrasound B-mode and color Doppler images. These results indicate that the presented multispectral Wiener estimation method can be used for visualizing veins using a commercial smart phone for point-of-care applications (e.g., vein puncture guidance). PMID:24691170

  3. Development of Advanced Electrochemical Sensors for DNA Detection at the Point of Care

    NASA Astrophysics Data System (ADS)

    Hsieh, Kuangwen

    In the post-genomic era, ever-advancing capabilities in DNA detection and analysis have become vital to the detection of infectious diseases and the diagnosis of genetic abnormalities and inheritable diseases. The benefit of such capabilities, however, has yet to reach patients outside of centralized facilities. There thus exists an increasing need to decentralize DNA detection methods and to administer such diagnostics at the "point of care." Electrochemical-based DNA sensors present a compelling approach, but have yet to deliver satisfactory sensitivity, specificity, miniaturization, and real-time monitoring capability to meet the demand of point-of-care diagnostics. Motivated by their potential and their current limitations, in this dissertation, we present a series of strategies that we have undertaken in order to address the key shortcomings of electrochemical DNA sensors and advance them toward point-of-care applications. First, we report a single-step, single reagent, label-free, isothermal electrochemical DNA sensor based on the phenomenon of enzyme catalyzed target recycling amplification. Using this technique, we achieve improved detection limit in comparison to hybridization-based sensors without amplification. We also demonstrate greater than 16-fold amplification of signal at low target concentrations. Next, we present a novel electrochemical DNA sensor that detects single-nucleotide mismatched targets with unprecedented "polarity-switching" responses. This "bipolar" sensor employs a surface-bound and redox-modified (methylene blue) DNA probe architecture, and outputs a decreased Faradaic current when hybridized to a perfectly matched (PM) target, but conversely reports an increased Faradaic current when hybridized to a single-base mismatched (SM) target. Third, we describe the microfluidic electrochemical dynamic allele specific hybridization (microE-DASH) platform for versatile and rapid detection of single-nucleotide polymorphisms. Implementing electrochemical-based melting curve analysis within the microfluidic device, this platform directly detects PCR amplicon-like targets and distinguishes perfectly matched target from single-base mismatched target and heterozygote combination of both targets in 20 minutes. Finally, we present the microfluidic electrochemical quantitative loop-mediated isothermal amplification (MEQ-LAMP) platform for rapid, sensitive, and quantitative detection of pathogen genomic DNA at the point of care. DNA amplification is electrochemically monitored in real time within a monolithic microfluidic device, enabling the detection of as few as 16 copies of Salmonella genomic DNA via a single-step process in under an hour.

  4. Point-of-care Ultrasound to Identify Distal Ulnar Artery Thrombosis: Case of Hypothenar Hammer Syndrome

    PubMed Central

    Ken, Jonathan; Khangura, Darshan; Stickles, Sean P.

    2015-01-01

    Hypothenar hammer syndrome (HHS) is a rare condition of distal ulnar artery injury and thrombosis secondary to repetitive blunt trauma to the hypothenar area. We present a case of HHS for which point-of-care ultrasound (POCUS) was used as the initial means of imaging, prompting management and disposition without further imaging studies ordered in the emergency department (ED). This case demonstrates the utility of POCUS to aid the Emergency Physician in the diagnosis and management of patients with extremity vascular issues in the ED, and details a rarely seen clinical entity in the ED. PMID:26265969

  5. An Acoustothermal Heater for Paper Microfluidics towards Point-of-care Glucose Detection

    NASA Astrophysics Data System (ADS)

    Park, Jinsoo; Ha, Byung Hang; Destgeer, Ghulam; Jung, Jin Ho; Sung, Hyung Jin

    We report the first observation of acoustothermal heating of wet papers under high frequency vibrations. The proposed heating method utilizes acoustic absorption of cellulose fiber, which exhibits viscoelastic properties. The surface acoustic waves propagate on the piezoelectric substrate and refract into a wet paper strip on the substrate. The refracted longitudinal waves deliver acoustic energy into the wet paper by vibration damping in the form of heat. Acoustothermal heating was discovered to be frequency-dependent and to reach local maxima at certain frequencies. Based on this finding, we developed a paper-based microfluidic heating system for point-of-care glucose detection.

  6. Magnetic droplet manipulation platforms for nucleic acid detection at the point of care.

    PubMed

    Shin, Dong Jin; Wang, Tza-Huei

    2014-11-01

    This review summarizes recent developments in the use of magnetically actuated droplets in point-of-care molecular diagnostic platforms. We discuss the fundamentals of magnetic droplet manipulation and the various modes of actuation. The balance of forces acting on a droplet during transport and particle extraction, as well as the devices and instrumentation developed to perform these operations will be presented and discussed. Furthermore, we review some of the recent advances on the diagnostic applications of platforms utilizing magnetic manipulation for genetic assessment of biological samples. PMID:25008142

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

    NASA Astrophysics Data System (ADS)

    Schotter, Joerg; Shoshi, Astrit; Brueckl, Hubert

    2009-05-01

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

  8. Wearable Ultrasound Array for Point-of-Care Imaging and Patient Monitoring.

    PubMed

    Mierzwa, Andrzej P; Huang, Sean P; Nguyen, Kristen T; Culjat, Martin O; Singh, Rahul S

    2016-01-01

    A versatile, flexible piezoceramic array has been developed for a variety of ultrasound applications. The transducer can be configured as a linear or curvilinear transducer array, or mounted directly onto the body as a patch or wearable device. Results using a prototype 16-element array demonstrated equivalence to commercial linear array probes in accuracy of vessel diameter measurements in vascular phantoms. The ability to view needle insertion for peripherally inserted central catheter (PICC) procedures was also demonstrated. Opportunities for wearable ultrasound devices include point-of-care imaging, combat casualty care, ultrasound therapy, patient monitoring, and personal health. PMID:27046585

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

    PubMed

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

    2016-03-01

    Interprofessional point of care or in situ simulation is used as a training tool in our operating theatre directorate with the aim of improving crisis behaviours. This study aimed to assess the impact of interprofessional point of care simulation on the safety culture of operating theatres. A validated Safety Attitude Questionnaire was administered to staff members before each simulation scenario and then re-administered to the same staff members after 6-12 months. Pre- and post-training Safety Attitude Questionnaire-Operating Room (SAQ-OR) scores were compared using paired sample t-tests. Analysis revealed a statistically significant perceived improvement in both safety (p < 0.001) and teamwork (p = 0.013) climate scores (components of safety culture) 6-12 months after interprofessional simulation training. A growing body of literature suggests that a positive safety culture is associated with improved patient outcomes. Our study supports the implementation of point of care simulation as a useful intervention to improve safety culture in theatres. PMID:26854195

  10. Opportunities and Challenges for Cost-Efficient Implementation of New Point-of-Care Diagnostics for HIV and Tuberculosis

    PubMed Central

    Peter, Trevor F.; Cavanaugh, Sean; Piatek, Amy S.; Young, Gloria J.; Alexander, Heather; Coggin, William; Domingo, Gonzalo J.; Ellenberger, Dennis; Ermantraut, Eugen; Jani, Ilesh V.; Katamba, Achilles; Palamountain, Kara M.; Essajee, Shaffiq; Dowdy, David W.

    2012-01-01

    Stakeholders agree that supporting high-quality diagnostics is essential if we are to continue to make strides in the fight against human immunodeficiency virus (HIV) and tuberculosis. Despite the need to strengthen existing laboratory infrastructure, which includes expanding and developing new laboratories, there are clear diagnostic needs where conventional laboratory support is insufficient. Regarding HIV, rapid point-of-care (POC) testing for initial HIV diagnosis has been successful, but several needs remain. For tuberculosis, several new diagnostic tests have recently been endorsed by the World Health Organization, but a POC test remains elusive. Human immunodeficiency virus and tuberculosis are coendemic in many high prevalence locations, making parallel diagnosis of these conditions an important consideration. Despite its clear advantages, POC testing has important limitations, and laboratory-based testing will continue to be an important component of future diagnostic networks. Ideally, a strategic deployment plan should be used to define where and how POC technologies can be most efficiently and cost effectively integrated into diagnostic algorithms and existing test networks prior to widespread scale-up. In this fashion, the global community can best harness the tremendous capacity of novel diagnostics in fighting these 2 scourges. PMID:22457286

  11. Opportunities and challenges for cost-efficient implementation of new point-of-care diagnostics for HIV and tuberculosis.

    PubMed

    Schito, Marco; Peter, Trevor F; Cavanaugh, Sean; Piatek, Amy S; Young, Gloria J; Alexander, Heather; Coggin, William; Domingo, Gonzalo J; Ellenberger, Dennis; Ermantraut, Eugen; Jani, Ilesh V; Katamba, Achilles; Palamountain, Kara M; Essajee, Shaffiq; Dowdy, David W

    2012-05-15

    Stakeholders agree that supporting high-quality diagnostics is essential if we are to continue to make strides in the fight against human immunodeficiency virus (HIV) and tuberculosis. Despite the need to strengthen existing laboratory infrastructure, which includes expanding and developing new laboratories, there are clear diagnostic needs where conventional laboratory support is insufficient. Regarding HIV, rapid point-of-care (POC) testing for initial HIV diagnosis has been successful, but several needs remain. For tuberculosis, several new diagnostic tests have recently been endorsed by the World Health Organization, but a POC test remains elusive. Human immunodeficiency virus and tuberculosis are coendemic in many high prevalence locations, making parallel diagnosis of these conditions an important consideration. Despite its clear advantages, POC testing has important limitations, and laboratory-based testing will continue to be an important component of future diagnostic networks. Ideally, a strategic deployment plan should be used to define where and how POC technologies can be most efficiently and cost effectively integrated into diagnostic algorithms and existing test networks prior to widespread scale-up. In this fashion, the global community can best harness the tremendous capacity of novel diagnostics in fighting these 2 scourges. PMID:22457286

  12. Leukodepletion as a point-of-care method for monitoring HIV-1 viral load in whole blood.

    PubMed

    Titchmarsh, Logan; Zeh, Clement; Verpoort, Thierry; Allain, Jean-Pierre; Lee, Helen

    2015-04-01

    In order to limit the interference of HIV-1 cellular nucleic acids in estimating viral load (VL), the feasibility of leukodepletion of a small whole-blood (WB) volume to eliminate only leukocyte cell content was investigated, using a selection of filters. The efficacy of leukocyte filtration was evaluated by counting, CD45 quantitative PCR, and HIV-1 DNA quantification. Plasma HIV-1 was tested by real-time reverse transcription (RT)-PCR. A specific, miniaturized filter was developed and tested for leukocyte and plasma virus retention, WB sample dilution, and filtration parameters in HIV-1-spiked WB samples. This device proved effective to retain >99.9% of white blood cells in 100 μl of WB without affecting plasma VL. The Samba sample preparation chemistry was adapted to use a leukodepleted WB sample for VL monitoring using the point-of-care Samba-1 semiautomated system. The clinical performance of the assay was evaluated by testing 207 consecutive venous EDTA WB samples from HIV-1-infected patients attending a CD4 testing clinic. Most patients were on antiretroviral treatment (ART), but their VL status was unknown. Compared to the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test, the new Samba assay had a concordance of 96.5%. The use of the Samba system with a VL test for WB might contribute to HIV-1 ART management and reduce loss-to-follow-up rates in resource-limited settings. PMID:25428162

  13. Efficacy of adrenal venous sampling is increased by point of care cortisol analysis

    PubMed Central

    Viste, Kristin; Grytaas, Marianne A; Jørstad, Melissa D; Jøssang, Dag E; Høyden, Eivind N; Fotland, Solveig S; Jensen, Dag K; Løvås, Kristian; Thordarson, Hrafnkell; Almås, Bjørg; Mellgren, Gunnar

    2013-01-01

    Primary aldosteronism (PA) is a common cause of secondary hypertension and is caused by unilateral or bilateral adrenal disease. Treatment options depend on whether the disease is lateralized or not, which is preferably evaluated with selective adrenal venous sampling (AVS). This procedure is technically challenging, and obtaining representative samples from the adrenal veins can prove difficult. Unsuccessful AVS procedures often require reexamination. Analysis of cortisol during the procedure may enhance the success rate. We invited 21 consecutive patients to participate in a study with intra-procedural point of care cortisol analysis. When this assay showed nonrepresentative sampling, new samples were drawn after redirection of the catheter. The study patients were compared using the 21 previous procedures. The intra-procedural cortisol assay increased the success rate from 10/21 patients in the historical cohort to 17/21 patients in the study group. In four of the 17 successful procedures, repeated samples needed to be drawn. Successful sampling at first attempt improved from the first seven to the last seven study patients. Point of care cortisol analysis during AVS improves success rate and reduces the need for reexaminations, in accordance with previous studies. Successful AVS is crucial when deciding which patients with PA will benefit from surgical treatment. PMID:24169597

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

    PubMed

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

    2014-08-01

    Point-of-care evidence-based medicine websites allow physicians to answer clinical queries using recent evidence at the bedside. Despite significant research into the function, usability and effectiveness of these programmes, little attention has been paid to their ethical issues. As many of these sites summarise the literature and provide recommendations, we sought to assess the role of conflicts of interest in two widely used websites: UpToDate and Dynamed. We recorded all conflicts of interest for six articles detailing treatment for the following conditions: erectile dysfunction, fibromyalgia, hypogonadism, psoriasis, rheumatoid arthritis and Crohn's disease. These diseases were chosen as their medical management is either controversial, or they are treated using biological drugs which are mostly available by brand name only. Thus, we hypothesised that the role of conflict of interest would be more significant in these conditions than in an illness treated with generic medications or by strict guidelines. All articles from the UpToDate articles demonstrated a conflict of interest. At times, the editor and author would have a financial relationship with a company whose drug was mentioned within the article. This is in contrast with articles on the Dynamed website, in which no author or editor had a documented conflict. We offer recommendations regarding the role of conflict of interest disclosure in these point-of-care evidence-based medicine websites. PMID:24493079

  15. Multiplexed volumetric bar-chart chip for point-of-care diagnostics

    PubMed Central

    Song, Yujun; Zhang, Yuanqing; Bernard, Paul E.; Reuben, James M.; Ueno, Naoto T.; Arlinghaus, Ralph B.; Zu, Youli; Qin, Lidong

    2012-01-01

    Microfluidics have become an enabling technology for point-of-care and personalized diagnostics. Desirable capabilities of microfluidics-based diagnostic devices include simplicity, portability, low cost and the performance of multiplexed and quantitative measurements, ideally in a high-throughput format. Here we present the multiplexed volumetric bar-chart chip (V-Chip), which integrates all these capabilities in one device. A key feature of the V-Chip is that quantitative results are displayed as bar charts directly on the device—without the need for optical instruments or any data processing or plotting steps. This is achieved by directly linking oxygen production by catalase, which is proportional to the concentration of the analyte, with the displacement of ink along channels on the device. We demonstrate the rapid quantification of protein biomarkers in diverse clinical samples with the V-Chip. The development of the V-Chip thus opens up the possibility of greatly simplified point-of-care and personalized diagnostics. PMID:23250413

  16. An instantaneous low-cost point-of-care anemia detection device.

    PubMed

    Punter-Villagrasa, Jaime; Cid, Joan; Páez-Avilés, Cristina; Rodríguez-Villarreal, Ivón; Juanola-Feliu, Esteve; Colomer-Farrarons, Jordi; Miribel-Català, Pere Ll

    2015-01-01

    We present a small, compact and portable device for point-of-care instantaneous early detection of anemia. The method used is based on direct hematocrit measurement from whole blood samples by means of impedance analysis. This device consists of a custom electronic instrumentation and a plug-and-play disposable sensor. The designed electronics rely on straightforward standards for low power consumption, resulting in a robust and low consumption device making it completely mobile with a long battery life. Another approach could be powering the system based on other solutions like indoor solar cells, or applying energy-harvesting solutions in order to remove the batteries. The sensing system is based on a disposable low-cost label-free three gold electrode commercial sensor for 50 µL blood samples. The device capability for anemia detection has been validated through 24 blood samples, obtained from four hospitalized patients at Hospital Clínic. As a result, the response, effectiveness and robustness of the portable point-of-care device to detect anemia has been proved with an accuracy error of 2.83% and a mean coefficient of variation of 2.57% without any particular case above 5%. PMID:25690552

  17. Toward Microfluidic Reactors for Cell-Free Protein Synthesis at the Point-of-Care.

    PubMed

    Timm, Andrea C; Shankles, Peter G; Foster, Carmen M; Doktycz, Mitchel J; Retterer, Scott T

    2016-02-01

    Cell-free protein synthesis (CFPS) is a powerful technology that allows for optimization of protein production without maintenance of a living system. Integrated within micro and nanofluidic architectures, CFPS can be optimized for point-of-care use. Here, the development of a microfluidic bioreactor designed to facilitate the production of a single-dose of a therapeutic protein, in a small footprint device at the point-of-care, is described. This new design builds on the use of a long, serpentine channel bioreactor and is enhanced by integrating a nanofabricated membrane to allow exchange of materials between parallel "reactor" and "feeder" channels. This engineered membrane facilitates the exchange of metabolites, energy, and inhibitory species, and can be altered by plasma-enhanced chemical vapor deposition and atomic layer deposition to tune the exchange rate of small molecules. This allows for extended reaction times and improved yields. Further, the reaction product and higher molecular weight components of the transcription/translation machinery in the reactor channel can be retained. It has been shown that the microscale bioreactor design produces higher protein yields than conventional tube-based batch formats, and that product yields can be dramatically improved by facilitating small molecule exchange within the dual-channel bioreactor. PMID:26690885

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

    PubMed

    Li, Jia; Macdonald, Joanne

    2016-09-15

    Lateral flow biosensors are a leading technology in point-of-care diagnostics due to their simplicity, rapidness and low cost. Their primacy in this arena continues through technological breakthroughs such as multiplexing: the detection of more than one biomarker in a single assay. Multiplexing capacity is critical for improving diagnostic efficiency, enhancing the diagnostic precision for specific diseases and reducing diagnostic cost. Here we review, for the first time, the various types and strategies employed for creating multiplexed lateral flow biosensors. These are classified into four main categories in terms of specific application or multiplexing level, namely linear, parameter, spatial and conceptual. We describe the practical applications and implications for each approach and compare their advantages and disadvantages. Importantly, multiplexing is still subject to limitations of the traditional lateral flow biosensor, such as sensitivity and specificity. However, by pushing the limitations of the traditional medium into the multiplex arena, several technological breakthroughs are emerging with novel solutions that further expand the utility of lateral flow biosensing for point-of-care applications. PMID:27125840

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

    PubMed

    Obermeier, Patrick; Muehlhans, Susann; Hoppe, Christian; Karsch, Katharina; Tief, Franziska; Seeber, Lea; Chen, Xi; Conrad, Tim; Boettcher, Sindy; Diedrich, Sabine; Rath, Barbara

    2016-02-01

    Infectious and inflammatory diseases of the central nervous system are difficult to identify early. Case definitions for aseptic meningitis, encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM) are available, but rarely put to use. The VACC-Tool (Vienna Vaccine Safety Initiative Automated Case Classification-Tool) is a mobile application enabling immediate case ascertainment based on consensus criteria at the point-of-care. The VACC-Tool was validated in a quality management program in collaboration with the Robert-Koch-Institute. Results were compared to ICD-10 coding and retrospective analysis of electronic health records using the same case criteria. Of 68,921 patients attending the emergency room in 10/2010-06/2013, 11,575 were hospitalized, with 521 eligible patients (mean age: 7.6 years) entering the quality management program. Using the VACC-Tool at the point-of-care, 180/521 cases were classified successfully and 194/521 ruled out with certainty. Of the 180 confirmed cases, 116 had been missed by ICD-10 coding, 38 misclassified. By retrospective application of the same case criteria, 33 cases were missed. Encephalitis and ADEM cases were most likely missed or misclassified. The VACC-Tool enables physicians to ask the right questions at the right time, thereby classifying cases consistently and accurately, facilitating translational research. Future applications will alert physicians when additional diagnostic procedures are required. PMID:26981582

  20. Towards microfluidic reactors for cell-free protein synthesis at the point-of-care

    DOE PAGESBeta

    Timm, Andrea C.; Shankles, Peter G.; Foster, Carmen M.; Doktycz, Mitchel John; Retterer, Scott T.

    2015-12-22

    Cell-free protein synthesis (CFPS) is a powerful technology that allows for optimization of protein production without maintenance of a living system. Integrated within micro- and nano-fluidic architectures, CFPS can be optimized for point-of care use. Here, we describe the development of a microfluidic bioreactor designed to facilitate the production of a single-dose of a therapeutic protein, in a small footprint device at the point-of-care. This new design builds on the use of a long, serpentine channel bioreactor and is enhanced by integrating a nanofabricated membrane to allow exchange of materials between parallel reactor and feeder channels. This engineered membrane facilitatesmore » the exchange of metabolites, energy, and inhibitory species, prolonging the CFPS reaction and increasing protein yield. Membrane permeability can be altered by plasma-enhanced chemical vapor deposition and atomic layer deposition to tune the exchange rate of small molecules. This allows for extended reaction times and improved yields. Further, the reaction product and higher molecular weight components of the transcription/translation machinery in the reactor channel can be retained. As a result, we show that the microscale bioreactor design produces higher protein yields than conventional tube-based batch formats, and that product yields can be dramatically improved by facilitating small molecule exchange within the dual-channel bioreactor.« less

  1. Raman Spectroscopy as a Promising Tool for Noninvasive Point-of-Care Glucose Monitoring

    PubMed Central

    Bijlsma, Sabina; Fokkert, Marion J.; Slingerland, Robbert; van Veen, Sjaak J. F.

    2014-01-01

    Self-monitoring of glucose is important for managing diabetes. Noninvasive glucose monitors are not yet available, but patients would benefit highly from such a device. We present results that may lead to a novel, point-of-care noninvasive system to measure blood glucose based on Raman spectroscopy. A hospitalized cohort of 111 subjects was measured using a custom-made Raman spectrometer system. Blood glucose reference samples were used to correlate Raman data to glucose levels, using advanced preprocessing and analysis algorithms. A correlation coefficient (R 2) of .83 was found correlating independent Raman-based predictions on reference blood glucose for the full cohort. Stratification of the cohort in gender-specific groups raised correlation levels to .88 (females) and .94 (males). Glucose could be measured noninvasively with average errors as low as 0.9 mM. We conclude that this novel system shows promising results for the advance of noninvasive, point-of-care glucose monitoring. PMID:25037192

  2. Depression Treatment for Impoverished Mothers by Point-of-Care Providers: A Randomized Controlled Trial

    PubMed Central

    Segre, Lisa S.; Brock, Rebecca L.; O’Hara, Michael W.

    2015-01-01

    Objective Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial evaluated the effectiveness of LV delivered at a woman’s usual point-of-care, including home-visits or an ob-gyn office. Method Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician’s assistant), all of whom had low levels of prior counseling experience. Three quarters of the study’s participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from four study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Results Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared to women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. Conclusions In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. PMID:25486371

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

    PubMed Central

    Punter-Villagrasa, Jaime; Cid, Joan; Páez-Avilés, Cristina; Rodríguez-Villarreal, Ivón; Juanola-Feliu, Esteve; Colomer-Farrarons, Jordi; Miribel-Català, Pere Ll.

    2015-01-01

    We present a small, compact and portable device for point-of-care instantaneous early detection of anemia. The method used is based on direct hematocrit measurement from whole blood samples by means of impedance analysis. This device consists of a custom electronic instrumentation and a plug-and-play disposable sensor. The designed electronics rely on straightforward standards for low power consumption, resulting in a robust and low consumption device making it completely mobile with a long battery life. Another approach could be powering the system based on other solutions like indoor solar cells, or applying energy-harvesting solutions in order to remove the batteries. The sensing system is based on a disposable low-cost label-free three gold electrode commercial sensor for 50 μL blood samples. The device capability for anemia detection has been validated through 24 blood samples, obtained from four hospitalized patients at Hospital Clínic. As a result, the response, effectiveness and robustness of the portable point-of-care device to detect anemia has been proved with an accuracy error of 2.83% and a mean coefficient of variation of 2.57% without any particular case above 5%. PMID:25690552

  4. Towards microfluidic reactors for cell-free protein synthesis at the point-of-care

    SciTech Connect

    Timm, Andrea C.; Shankles, Peter G.; Foster, Carmen M.; Doktycz, Mitchel John; Retterer, Scott T.

    2015-12-22

    Cell-free protein synthesis (CFPS) is a powerful technology that allows for optimization of protein production without maintenance of a living system. Integrated within micro- and nano-fluidic architectures, CFPS can be optimized for point-of care use. Here, we describe the development of a microfluidic bioreactor designed to facilitate the production of a single-dose of a therapeutic protein, in a small footprint device at the point-of-care. This new design builds on the use of a long, serpentine channel bioreactor and is enhanced by integrating a nanofabricated membrane to allow exchange of materials between parallel reactor and feeder channels. This engineered membrane facilitates the exchange of metabolites, energy, and inhibitory species, prolonging the CFPS reaction and increasing protein yield. Membrane permeability can be altered by plasma-enhanced chemical vapor deposition and atomic layer deposition to tune the exchange rate of small molecules. This allows for extended reaction times and improved yields. Further, the reaction product and higher molecular weight components of the transcription/translation machinery in the reactor channel can be retained. As a result, we show that the microscale bioreactor design produces higher protein yields than conventional tube-based batch formats, and that product yields can be dramatically improved by facilitating small molecule exchange within the dual-channel bioreactor.

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

    PubMed Central

    Wanigasuriya, Kamani; Jayawardene, Innocent; Lee, Kyungheon; Lee, Hakho; Vaidya, Vishal S.; Weissleder, Ralph

    2015-01-01

    The high incidence of acute and chronic kidney injury due to various environmental factors such as heavy metals or chemicals has been a major problem in developing countries. However, the diagnosis of kidney injury in these areas can be more challenging due to the lack of highly sensitive and specific techniques that can be applied in point-of-care settings. To address this, we have developed a technique called ‘micro-urine nanoparticle detection (μUNPD)’, that allows the detection of trace amounts of molecular markers in urine. Specifically, this technique utilizes an automated on-chip assay followed by detection with a hand-held device for the read-out. Using the μUNPD technology, the kidney injury markers KIM-1 and Cystatin C were detected down to concentrations of 0.1 ng/ml and 20 ng/ml respectively, which meets the cut-off range required to identify patients with acute or chronic kidney injury. Thus, we show that the μUNPD technology enables point of care and non-invasive detection of kidney injury, and has potential for applications in diagnosing kidney injury with high sensitivity in resource-limited settings. PMID:26186708

  6. Point-of-Care Echocardiography Improves Assessment of Volume Status in Cirrhosis and Hepatorenal Syndrome.

    PubMed

    Huggins, John Terrill; Doelken, Peter; Walters, Chet; Rockey, Don C

    2016-05-01

    The management of patients with cirrhosis along with acute kidney injury is complex and depends in large part on accurate assessment of intravascular volume status. Assessment of intravascular volume status by point-of-care echocardiography often relies solely on inferior vena cava size and variability evaluation; however, this parameter should be interpretated with an understanding of right ventricular function integrated with stroke volume and flow. Attempts to optimize intra-abdominal hemodynamics favorably are clearly problematic when physical examination findings or rudimentary assessments of central venous pressure or change in central venous pressure are used. Here, we have demonstrated the potential utility of point-of-care echocardiography to optimize the hemodynamic state in patients with decompensated cirrhosis along with acute kidney injury. This case is very unique and describes how this technique may have great promise in optimizing the intra-abdominal hemodynamics and predict the timing of large-volume paracentesis in patients with decompensated cirrhosis, which in turn can aid in promoting favorable renal recovery. PMID:27140719

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

    PubMed

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

    2014-07-01

    Since its initial introduction into the bedside assessment of the trauma patient via the Focused Assessment with Sonography for Trauma (FAST) exam, the use of point-of-care ultrasound has expanded rapidly. A growing body of literature demonstrates ultrasound can be used by nonradiologists as an extension of the physical exam to accurately diagnose or exclude a variety of conditions. These conditions include, but are not limited to, hemoperitoneum, pneumothorax, pulmonary edema, long-bone fracture, deep vein thrombosis, and elevated intracranial pressure. As ultrasound machines have become more compact and portable, their use has extended outside of hospitals to places where the physical exam and diagnostic capabilities may be limited, including the aviation environment. A number of studies using focused sonography have been performed to meet the diagnostic challenges of space medicine. The following article reviews the available literature on portable ultrasound use in aerospace medicine and highlights both known and potential applications of point-of-care ultrasound for the aeromedical clinician. PMID:25022161

  8. Polyelectrolyte-coated gold magnetic nanoparticles for immunoassay development: toward point of care diagnostics for syphilis screening.

    PubMed

    Yang, Dong; Ma, Jianzhong; Zhang, Qinlu; Li, Ningning; Yang, Jiangcun; Raju, Paul Ananda; Peng, Mingli; Luo, Yanling; Hui, Wenli; Chen, Chao; Cui, Yali

    2013-07-16

    Immediate response for disease control relies on simple, inexpensive, and sensitive diagnostic tests, highly sought after for timely and accurate test of various diseases, including infectious diseases. Composite Fe3O4/Au nanoparticles have attracted considerable interest in diagnostic applications due to their unique physical and chemical properties. Here, we developed a simple coating procedure for gold magnetic nanoparticles (GMNs) with poly(acrylic acid) (PAA). PAA-coated GMNs (PGMNs) were stable and monodispersed and characterized by Fourier transform-infrared spectroscopy (FT-IR), transmission electron microscopy, UV-visible scanning spectrophotometry, thermogravimetric analysis, and Zetasizer methodologies. For diagnostic application, we established a novel lateral flow immunoassay (LFIA) strip test system where recombinant Treponema pallidum antigens (r-Tp) were conjugated with PGMNs to construct a particle probe for detection of anti-Tp antibodies. Intriguingly, the particle probes specifically identified Tp antibodies with a detection limitation as low as 1 national clinical unit/mL (NCU/mL). An ample pool of 1020 sera samples from three independent hospitals were obtained to assess our PGMNs-based LFIA strips, which exhibited substantially high values of sensitivity and specificity for all clinical tests (higher than 97%) and, therefore, proved to be a suitable approach for syphilis screening at a point-of-care test manner. PMID:23735054

  9. Barriers to HIV testing and characteristics associated with never testing among gay and bisexual men attending sexual health clinics in Sydney

    PubMed Central

    Conway, Damian P; Holt, Martin; Couldwell, Deborah L; Smith, Don E; Davies, Stephen C; McNulty, Anna; Keen, Phillip; Cunningham, Philip; Guy, Rebecca

    2015-01-01

    Introduction HIV diagnoses among gay and bisexual men have increased over the past decade in Australia. HIV point-of-care testing (POCT) was introduced in Australia in 2011 as a strategy to increase HIV testing by making the testing process more convenient. We surveyed gay and bisexual men undergoing POCT to assess barriers to HIV testing and characteristics associated with not having previously tested for HIV (never testing). Methods During 2011 and 2012, gay and bisexual men who were undergoing POCT at four Sydney sexual health clinics self-completed questionnaires assessing testing history and psychological and structural barriers to HIV testing. Bivariate and multivariate logistic regression was used to assess associations between patient characteristics and never testing. Results Of 1093 participants, 981 (89.9%) reported ever testing for HIV and 110 (10.1%) never testing. At least one barrier to testing was reported by 1046 men (95.7%), with only 47 men (4.3%) not reporting any barrier to testing. The most commonly reported barriers to testing were annoyance at having to return for results (30.2%), not having done anything risky (29.6%), stress in waiting for results (28.4%), being afraid of testing positive (27.5%) and having tested recently (23.2%). Never testing was independently associated with being non-gay-identified (adjusted odds ratio [AOR]: 1.9; 95% confidence interval [CI]: 1.1–3.2), being aged less than 25 years (AOR: 2.4; 95% CI: 1.6–3.8), living in a suburb with few gay couples (AOR: 1.9; 95% CI: 1.2–3.0), being afraid of testing HIV-positive (AOR: 1.6; 95% CI: 1.0–2.4), not knowing where to test (AOR: 3.8; 95% CI: 1.3–11.2) and reporting one or no sexual partners in the last six months (AOR: 2.7; 95% CI: 1.2–6.2). Conclusions Barriers to HIV testing were commonly reported among the clinic-based gay and bisexual men in this study. Our findings suggest further health promotion and prevention strategies are needed to address the knowledge, attitudes and behavioural factors associated with never testing. PMID:26318960

  10. Flexible opto-electronics enabled microfluidics systems with cloud connectivity for point-of-care micronutrient analysis.

    PubMed

    Lee, Stephen; Aranyosi, A J; Wong, Michelle D; Hong, Ji Hyung; Lowe, Jared; Chan, Carol; Garlock, David; Shaw, Scott; Beattie, Patrick D; Kratochvil, Zachary; Kubasti, Nick; Seagers, Kirsten; Ghaffari, Roozbeh; Swanson, Christina D

    2016-04-15

    In developing countries, the deployment of medical diagnostic technologies remains a challenge because of infrastructural limitations (e.g. refrigeration, electricity), and paucity of health professionals, distribution centers and transportation systems. Here we demonstrate the technical development and clinical testing of a novel electronics enabled microfluidic paper-based analytical device (EE-μPAD) for quantitative measurement of micronutrient concentrations in decentralized, resource-limited settings. The system performs immune-detection using paper-based microfluidics, instrumented with flexible electronics and optoelectronic sensors in a mechanically robust, ultrathin format comparable in size to a credit card. Autonomous self-calibration, plasma separation, flow monitoring, timing and data storage enable multiple devices to be run simultaneously. Measurements are wirelessly transferred to a mobile phone application that geo-tags the data and transmits it to a remote server for real time tracking of micronutrient deficiencies. Clinical tests of micronutrient levels from whole blood samples (n=95) show comparable sensitivity and specificity to ELISA-based tests. These results demonstrate instantaneous acquisition and global aggregation of diagnostics data using a fully integrated point of care system that will enable rapid and distributed surveillance of disease prevalence and geographical progression. PMID:26630284

  11. Metacognitive factors that impact student nurse use of point of care technology in clinical settings.

    PubMed

    Kuiper, RuthAnne

    2010-01-01

    The utility of personal digital assistants (PDA) as a point of care resource in health care practice and education presents new challenges for nursing faculty. While there is a plethora of PDA resources available, little is known about the variables that effect student learning and technology adoption. In this study nursing students used PDA software programs which included a drug guide, medical dictionary, laboratory manual and nursing diagnosis manual during acute care clinical experiences. Analysis of student journals comparative reflective statements about the PDA as an adjunct to other available resources in clinical practice are presented. The benefits of having a PDA included readily available data, validation of thinking processes, and facilitation of care plan re-evaluation. Students reported increased frequency of use and independence. Significant correlations between user perceptions and computer self-efficacy suggested greater confidence in abilities with technology resulting in increased self-awareness and achievement of learning outcomes. PMID:20196764

  12. Immunofluorescence microtip sensor for point-of-care tuberculosis (TB) diagnosis.

    PubMed

    Kim, Jong-Hoon; Lee, Kyong-Hoon; Cangelosi, Gerard A; Chung, Jae-Hyun

    2015-01-01

    A immunofluorescence microtip sensor was developed for specific detection of Mycobacterium cells in sputum samples by the combination of electric field, streaming flow, and immuno-affinity binding. The detection limit was 200 CFU/mL in human sputum, which was comparable to PCR but without requiring bacteriological culture, centrifugation, or nucleic acid amplification. In spite of the complex nature of physical, chemical, and biological mechanisms, the simple operation of "dipping and withdrawal" of tips will allow for screening by minimally trained personnel within 30 min. In addition, the minimal power requirement (5 W) combined with low assay cost is ideal for point-of-care (POC) screening in resource-limited settings. PMID:25626531

  13. The use of personal information webs: convergence of enterprise information sources at the point of care

    PubMed

    Culp; Myers; Miller

    2000-01-01

    Scott and White is the largest integrated healthcare delivery system in the Southwest. The rapid and continual expansion of readily available patient-related computerized information from multiple sources and systems within our enterprise over the last ten years has now enabled our development of a user-friendly, yet secure, access module to meet our clinicians' point-of-care information needs. We have developed and begun implementation of these individualized "Personal Information Webs". Each clinician is provided, with rigorous security and confidentiality measures built in, a personal web portal to our enterprise intranet. This page has predetermined navigational parameters and functionalities that are based on a rigorous role-based user security profile model. The portal provides its owner bi-directional communication with our back-end enterprise business and clinical information resources by communicating with them at a "virtual XML document" level, using a personal information broker/server as an intermediary. PMID:11080029

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

    PubMed Central

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

    2010-01-01

    This paper presents a review, based on the published literature and on the authors’ own research, of the current state of the art of fiber-optic capillary sensors and related instrumentation as well as their applications, with special emphasis on point-of-care chemical and biochemical sensors, systematizing the various types of sensors from the point of view of the principles of their construction and operation. Unlike classical fiber-optic sensors which rely on changes in light propagation inside the fiber as affected by outside conditions, optical capillary sensors rely on changes of light transmission in capillaries filled with the analyzed liquid, which opens the possibility of interesting new applications, while raising specific issues relating to the construction, materials and instrumentation of those sensors. PMID:22319325

  15. Miniature swept source for point of care optical frequency domain imaging.

    PubMed

    Goldberg, Brian D; Motaghian Nezam, S M R; Jillella, Priyanka; Bouma, Brett E; Tearney, Guillermo J

    2009-03-01

    Point of care (POC) medical technologies require portable, small, robust instrumentation for practical implementation. In their current embodiment, optical frequency domain imaging (OFDI) systems employ large form-factor wavelength-swept lasers, making them impractical in the POC environment. Here, we describe a first step toward a POC OFDI system by demonstrating a miniaturized swept-wavelength source. The laser is based on a tunable optical filter using a reflection grating and a miniature resonant scanning mirror. The laser achieves 75 nm of bandwidth centered at 1340 nm, a 0.24 nm instantaneous line width, a 15.3 kHz repetition rate with 12 mW peak output power, and a 30.4 kHz A-line rate when utilizing forward and backward sweeps. The entire laser system is approximately the size of a deck of cards and can operate on battery power for at least one hour. PMID:19259202

  16. Advances in addressing technical challenges of point-of-care diagnostics in resource-limited settings.

    PubMed

    Wang, ShuQi; Lifson, Mark A; Inci, Fatih; Liang, Li-Guo; Sheng, Ye-Feng; Demirci, Utkan

    2016-04-01

    The striking prevalence of HIV, TB and malaria, as well as outbreaks of emerging infectious diseases, such as influenza A (H7N9), Ebola and MERS, poses great challenges for patient care in resource-limited settings (RLS). However, advanced diagnostic technologies cannot be implemented in RLS largely due to economic constraints. Simple and inexpensive point-of-care (POC) diagnostics, which rely less on environmental context and operator training, have thus been extensively studied to achieve early diagnosis and treatment monitoring in non-laboratory settings. Despite great input from material science, biomedical engineering and nanotechnology for developing POC diagnostics, significant technical challenges are yet to be overcome. Summarized here are the technical challenges associated with POC diagnostics from a RLS perspective and the latest advances in addressing these challenges are reviewed. PMID:26777725

  17. Point-of-care temperature and respiration monitoring sensors for smart fabric applications

    NASA Astrophysics Data System (ADS)

    Jung, Soyoun; Ji, Taeksoo; Varadan, Vijay K.

    2006-12-01

    Advances in smart sensors, miniaturization, and related technologies leading to the emergence of smart fabrics are prerequisites to the construction of a point-of-care (POC) system for continuous health monitoring and illness prevention. Low manufacturing cost, light weight, portability and flexibility are among the requirements for smart sensors when embedded into smart fabrics. Organic semiconductor technology has recently been envisioned to meet these requirements, and to encourage the development of organic semiconductor based sensors because of its low process temperature and potential for very low cost manufacturing. In this paper, we present flexible sensors based on an organic semiconductor capable of measuring physiological parameters such as strain and temperature, adopting pentacene thin film transistors (TFTs) and Wheatstone bridge structures. It is expected that these sensors, integrated into textile structures, will enable real time POC monitoring of a patient's respiration rate, skin temperature, body heat flow and body temperature at an early stage.

  18. Advances in Microfluidic PCR for Point-of-Care Infectious Disease Diagnostics

    PubMed Central

    Park, Seungkyung; Zhang, Yi; Lin, Shin; Wang, Tza-Huei; Yang, Samuel

    2011-01-01

    Global burdens from existing or emerging infectious diseases emphasize the need for point-of-care (POC) diagnostics to enhance timely recognition and intervention. Molecular approaches based on PCR methods have made significant inroads by improving detection time and accuracy but are still largely hampered by resource-intensive processing in centralized laboratories, thereby precluding their routine bedside- or field-use. Microfluidic technologies have enabled miniaturization of PCR processes onto a chip device with potential benefits including speed, cost, portability, throughput, and automation. In this review, we provide an overview of recent advances in microfluidic PCR technologies and discuss practical issues and perspectives related to implementing them into infectious disease diagnostics. PMID:21741465

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

    PubMed

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

    2014-12-15

    This paper presents a novel approach of using a miniaturized potentiostat (M-P) chip (LMP91000) to perform full range cyclic voltammetry (CV) measurements for the detection of biomarkers. The LMP91000 evaluation board was reconfigured to perform three-electrode CV measurements in order to achieve electrochemical cortisol immunosensing. The microelectrodes for cortisol estimation were fabricated by immobilizing monoclonal anti-cortisol antibody (Anti-M-Cab) onto self-assembled monolayer (SAM) modified Au microelectrodes. The results obtained using the M-P were compared to those obtained using a conventional potentiostat. The M-P was successful in measuring cortisol levels in the range of pM. The outcomes of the studies suggest that M-P can effectively perform biochemical measurements on three electrode systems, enabling the development of miniature systems for point-of-care (POC) diagnosis. PMID:25016332

  20. Palm-Sized Device for Point-of-Care Ebola Detection.

    PubMed

    Ahrberg, Christian D; Manz, Andreas; Neužil, Pavel

    2016-05-01

    We show the utilization of a recently developed cellphone-sized real-time polymerase chain reaction (PCR) device to detect Ebola virus RNA using single-step reverse transcription PCR (RT-PCR). The device was shown to concurrently perform four PCRs, each with a sample volume of 100 nL: one positive control with both Ebola and GAPDH RNA and one negative control. The last two positions were used to measure the GAPDH and the Ebola content of a sample. A comparison of threshold cycles (CT) from the two samples provided relative quantification. The entire process, which consisted of reverse transcription, PCR amplification, and melting curve analysis (MCA), was conducted in less than 37 min. The next step will be integration with a sample preparation unit to form an integrated sample-to-answer system for point-of-care infectious disease diagnostics. PMID:27064314

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

    NASA Astrophysics Data System (ADS)

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

    2015-05-01

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

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

    NASA Astrophysics Data System (ADS)

    Liu, Hongxing; Xing, Da; Zhou, Xiaoming

    2014-09-01

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

  3. Smartphone spectroscopy: three unique modalities for point-of-care testing

    NASA Astrophysics Data System (ADS)

    Long, Kenneth D.; Yu, Hojeong; Cunningham, Brian T.

    2015-06-01

    Here we demonstrate three principle modalities for a smartphone-based spectrometer: absorption, fluorescence, and photonic crystal (PC)-based label-free detection. When combined with some simple optical components, the rear-facing CMOS camera in a mobile device can provide spectrometric data that rivals that of laboratory instruments, but at a fraction of the cost. The use of a smartphone-based platform poses significant advantages based upon the rise of smartphone apps, which allow for user-interface and data-processing algorithms to be packaged and distributed within environments that are externally maintained with potential for integration with services such as cloud storage, GIS-tagging, and remote expert analysis. We demonstrate the absorption modality of our device by performing an enzyme-linked immunosorbent assay (ELISA) on both a cancer biomarker and a peanut allergen, demonstrating clinically relevant limits of detection (LOD). Second, we demonstrate the success of a molecular beacon (MB)-based assay on the smartphone platform, achieving an LOD of 1.3 pM for a specific RNA sequence, less than that of a commercial benchtop instrument. Finally, we use a PC biosensor to perform label-free detection of a representative biological interaction: Protein A and human immunoglobulin G (IgG) in the nanomolar regime. Our work represents the first demonstration of smartphone-based spectroscopy for biological assays, and the first mobile-device-enabled detection instrument that serves to measure three distinct sensing modalities (label-free biosensing, absorption spectroscopy, and fluorescence spectroscopy). The smartphone platform has the potential to expand the use of spectrometric analysis to environments assay from the laboratory, which may include rural or remote locations, low-resource settings, and consumer markets.

  4. Prehospital point of care testing of blood gases and electrolytes — an evaluation of IRMA

    PubMed Central

    Prause, Gerhard; Ratzenhofer-Komenda, Beatrice; Offner, Anton; Lauda, Peter; Voit, Henrika; Pojer, Horst

    1997-01-01

    Background: This study evaluated the feasibility of blood gas analysis and electrolyte measurements during emergency transport prior to hospital admission. Results: A portable, battery-powered blood analyzer was used on patients in life threatening conditions to determine pH, pCO2, pO2, sodium, potassium and ionized calcium. Arterial blood was used for blood gas analysis and electrolyte measurements. Venous blood was used for electrolyte measurement alone. During the observation period of 4 months, 32 analyses were attempted on 25 patients. Eleven measurements (34%) could not be performed due to technical failure. Overall, 25 samples taken from 21 patients were evaluated. The emergency physicians (all anesthesiologists) considered the knowledge of blood gases and/or electrolytes to be helpful in 72% of cases. This knowledge led to immediate therapeutic consequences in 52% of all cases. After a short training and familiarization session the handling of the device was found to be problem free. Conclusions: We concluded that knowledge of the patients' pH, pCO2 and pO2 in life threatening situations yields more objective information about oxygenation, carbon dioxide and acid-base regulation than pulse oximetry and/or capnometry alone. Additionally, it enables physicians to correct severe hypokalemia or hypocalcemia in cases of cardiac failure or malignant arrhythmia. PMID:11056700

  5. Portable guided-mode resonance biosensor platform for point-of-care testing

    NASA Astrophysics Data System (ADS)

    Sung, Gun Yong; Kim, Wan-Joong; Ko, Hyunsung; Kim, Bong K.; Kim, Kyung-Hyun; Huh, Chul; Hong, Jongcheol

    2012-10-01

    It represents a viable solution for the realization of a portable biosensor platform that could screen/diagnose acute myocardial infarction by measuring cardiac marker concentrations such as cardiac troponin I (cTnI), creatine kinase MB (CK-MB), and myoglobin (MYO) for application to u-health monitoring system. The portable biosensor platform introduced in this presentation has a more compact structure and a much higher measuring resolution than a conventional spectrometer system. Portable guided-mode resonance (GMR) biosensor platform was composed of a biosensor chip stage, an optical pick-up module, and a data display panel. Disposable plastic GMR biosensor chips with nano-grating patterns were fabricated by injection-molding. Whole blood filtration and label-free immunoassay were performed on these single chips, automatically. Optical pick-up module was fabricated by using the miniaturized bulk optics and the interconnecting optical fibers and a tunable VCSEL (vertical cavity surface emitting laser). The reflectance spectrum from the GMR biosensor was measured by the optical pick-up module. Cardiac markers in human serum with concentrations less than 0.1ng/mL were analyzed using a GMR biosensor. Analysis time was 30min, which is short enough to meet clinical requirements. Our results show that the GMR biosensor will be very useful in developing lowcost portable biosensors that can screen for cardiac diseases.

  6. Nucleic acid testing for tuberculosis at the point-of-care in high-burden countries

    PubMed Central

    Niemz, Angelika; Boyle, David S

    2013-01-01

    Early diagnosis of tuberculosis (TB) facilitates appropriate treatment initiation and can limit the spread of this highly contagious disease. However, commonly used TB diagnostic methods are slow, often insensitive, cumbersome and inaccessible to most patients in TB endemic countries that lack necessary resources. This review discusses nucleic acid amplification technologies, which are being developed for rapid near patient TB diagnosis, that are in the market or undergoing clinical evaluation. They are based on PCR or isothermal methods and are implemented as manual assays or partially/fully integrated instrument systems, with associated tradeoffs between clinical performance, cost, robustness, quality assurance and usability in remote settings by minimally trained personnel. Unmet needs prevail for the identification of drug-resistant TB and for TB diagnosis in HIV-positive and pediatric patients. PMID:23153237

  7. Surface plasmon enhanced-field fluorescence biosensor for point-of-care testing using fluorescent nanoparticles

    NASA Astrophysics Data System (ADS)

    Horii, Kazuyoshi; Kimura, Toshihito; Ohtsuka, Hisashi; Kasagi, Noriyuki; Oohara, Tomoya; Matsuno, Tadahiro; Hakamata, Masashi; Komatsu, Akihiro; Sendai, Tomonari

    2012-03-01

    An optical biosensor system using surface-plasmon field-enhanced fluorescence has been developed, which allows high sensitivity and fast measurement available. Intensity of fluorophores in SPFS is highly dependent upon the distance from metal surface. The resonant evanescent electric field excites fluorophores within the penetration area. On the other hand, fluorescence quenching in close proximity to a metal surface interfere with the excitation. We have developed a new technology for fluorescent nanoparticles that could receive the energy from metal surface effectively. This enables technology of detecting strong and stable SPFS signals, as well as homogeneous assay method that allows us to eliminate binding/free separation process for unreacted fluorescent particles. A rate assay method has also been employed, which resolves affect from diffusion-limited access, in order to realize a fast surface immunoreaction in a microchannel. Taking advantage of these two developments, as eliminating an enzyme response process such as CLEIA, our system reaches much faster reaction time of 2 minutes to detect thyroid stimulating hormone (TSH) of canine serum sample at 0.1ng/mL. We believe our system with these new technologies is a powerful tool for in-vitro diagnosis which meets various clinical requirements.

  8. CD4 Count Outperforms World Health Organization Clinical Algorithm for Point-of Care HIV Diagnosis among Hospitalized HIV-exposed Malawian Infants

    PubMed Central

    Maliwichi, Madalitso; Rosenberg, Nora E.; Macfie, Rebekah; Olson, Dan; Hoffman, Irving; van der Horst, Charles M.; Kazembe, Peter N.; Hosseinipour, Mina C.; McCollum, Eric D.

    2014-01-01

    Objective To determine, for the WHO algorithm for point-of-care diagnosis of HIV infection, the agreement levels between pediatricians and non-physician clinicians, and to compare sensitivity and specificity profiles of the WHO algorithm and different CD4 thresholds against HIV PCR testing in hospitalized Malawian infants. Methods In 2011, hospitalized HIV-exposed infants <12 months in Lilongwe, Malawi were evaluated independently with the WHO algorithm by both a pediatrician and clinical officer. Blood was collected for CD4 and molecular HIV testing (DNA or RNA PCR). Using molecular testing as the reference, sensitivity, specificity, and positive predictive value (PPV) were determined for the WHO algorithm and CD4 count thresholds of 1500 and 2000 cells/mm3 by pediatricians and clinical officers. Results We enrolled 166 infants (50% female, 34% <2 months, 37% HIV-infected). Sensitivity was higher using CD4 thresholds (<1500, 80%; <2000, 95%) than with the algorithm (physicians, 57%; clinical officers, 71%). Specificity was comparable for CD4 thresholds (<1500, 68%, <2000, 50%) and the algorithm (pediatricians, 55%, clinical officers, 50%). The positive predictive values were slightly better using CD4 thresholds (<1500, 59%, <2000, 52%) than the algorithm (pediatricians, 43%, clinical officers 45%) at this prevalence. Conclusion Performance by the WHO algorithm and CD4 thresholds resulted in many misclassifications. Point-of-care CD4 thresholds of <1500 cells/mm3 or <2000 cells/mm3 could identify more HIV-infected infants with fewer false positives than the algorithm. However, a point-of-care option with better performance characteristics is needed for accurate, timely HIV diagnosis. PMID:24754543

  9. The patient impact of point-of-care vs. laboratory placement of Xpert® MTB/RIF

    PubMed Central

    Hanrahan, C. F.; Clouse, K.; Bassett, J.; Mutunga, L.; Selibas, K.; Stevens, W.; Scott, L.; Sanne, I.; Van Rie, A.

    2015-01-01

    SUMMARY BACKGROUND The Xpert® MTB/RIF assay can diagnose tuberculosis (TB) rapidly and with great accuracy. The effect of Xpert placement at point of care (POC) vs. at an off-site laboratory on patient management remains unknown. DESIGN At a primary care clinic in Johannesburg, South Africa, we compared TB diagnosis and treatment initiation among 1861 individuals evaluated for pulmonary TB using Xpert performed either at POC or offsite. RESULTS When Xpert was performed at POC, a higher proportion of Xpert-positive individuals started treatment (95% vs. 87%, P = 0.047) and time to treatment initiation was shorter (median 0 vs. 5 days, P < 0.001). In contrast, among Xpert-negative TB cases, a higher proportion (87% vs. 72%, P =0.001) started treatment when the sample was sent to the laboratory, with a shorter time to treatment (median 9 vs. 13 days, P = 0.056). While the overall proportion of presumed TB patients starting treatment was independent of Xpert placement, the proportion started based on a bacteriologically confirmed diagnosis was higher when Xpert was performed at POC (73% vs. 58%, P = 0.006). CONCLUSIONS Placement of Xpert at POC resulted in more Xpert-positive patients receiving treatment, but did not increase the total number of presumed TB patients starting treatment. When samples were sent to a laboratory for Xpert testing, empiric decision making increased. PMID:26056107

  10. Portable microfluidic and smartphone-based devices for monitoring of cardiovascular diseases at the point of care.

    PubMed

    Hu, Jie; Cui, Xingye; Gong, Yan; Xu, Xiayu; Gao, Bin; Wen, Ting; Lu, Tian Jian; Xu, Feng

    2016-01-01

    Cardiovascular diseases (CVDs) are the main causes of morbidity and mortality in the world where about 4 in every 5 CVD deaths happen in low- and middle-income countries (LMICs). Most CVDs are preventable and curable, which is largely dependent on timely and effective interventions, including diagnosis, prognosis and therapeutic monitoring. However, these interventions are high-cost in high income countries and are usually lacking in LMICs. Thanks to the rapid development of microfluidics and nanotechnology, lots of portable analytical devices are developed for detection of CVDs at the point-of-care (POC). In the meantime, smartphone, as a versatile and powerful handheld tool, has been employed not only as a reader for microfluidic assays, but also as an analyzer for physiological indexes. In this review, we present a comprehensive introduction of the current status and potential development direction on POC diagnostics for CVDs. First of all, we introduce some main facts about CVDs and their standard diagnostic procedures and methods. Second, we discuss about both commercially available POC devices and developed prototypes for detection of CVDs via immunoassays. Subsequently, we report the advances in smartphone-based readout for microfluidic assays. Finally, we present some examples using smartphone, individually or combined with other components or devices, for CVD monitoring. We envision an integrated smartphone-based system capable of functioning blood tests, disease examination, and imaging will come in the future. PMID:26898179

  11. Cellphone camera imaging of a periodically patterned chip as a potential method for point-of-care diagnostics.

    PubMed

    Gupta, Ritu; Reifenberger, Ronald G; Kulkarni, Giridhar U

    2014-03-26

    In this study, we demonstrate that a disposable chip periodically patterned with suitable ligands, an ordinary cellphone camera, and a simple pattern recognition software, can potentially be used for quantitative diagnostics. A key factor in this demonstration is the design of a calibration grid around the chip that, through a contrast transfer process, enables reliable analysis of the images collected under variable ambient lighting conditions. After exposure to a dispersion of amine terminated silica beads used as analyte mimicking pathogens, an epoxy-terminated glass substrate microcontact printed with octadecyltrichlorosilane (250 ?m periodicity) developed a characteristic pattern of beads which could be easily imaged with a cellphone camera of 3.2 MP pixels. A simple pattern recognition algorithm using fast Fourier transform produced a quantitative estimate of the analyte concentration present in the test solution. In this method importantly, neither the chip fabrication process nor the fill-factor of the periodic pattern need be perfect to arrive at a conclusive diagnosis. The method suggests a viable platform that may potentially find use in fault-tolerant and robust point-of-care diagnostic applications. PMID:24564576

  12. Robust ultrasensitive tunneling-FET biosensor for point-of-care diagnostics.

    PubMed

    Gao, Anran; Lu, Na; Wang, Yuelin; Li, Tie

    2016-01-01

    For point-of-care (POC) applications, robust, ultrasensitive, small, rapid, low-power, and low-cost sensors are highly desirable. Here, we present a novel biosensor based on a complementary metal oxide semiconductor (CMOS)-compatible silicon nanowire tunneling field-effect transistor (SiNW-TFET). They were fabricated "top-down" with a low-cost anisotropic self-stop etching technique. Notably, the SiNW-TFET device provided strong anti-interference capacity by applying the inherent ambipolarity via both pH and CYFRA21-1 sensing. This offered a more robust and portable general protocol. The specific label-free detection of CYFRA21-1 down to 0.5 fgml(-1) or ~12.5 aM was achieved using a highly responsive SiNW-TFET device with a minimum sub-threshold slope (SS) of 37 mVdec(-1). Furthermore, real-time measurements highlighted the ability to use clinically relevant samples such as serum. The developed high performance diagnostic system is expected to provide a generic platform for numerous POC applications. PMID:26932158

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

    PubMed

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

    2010-08-01

    Evidence-based medicine relies on repositories of empirical research evidence that can be used to support clinical decision making for improved patient care. However, retrieving evidence from such repositories at local sites presents many challenges. This paper describes a methodological framework for automatically indexing and retrieving empirical research evidence in the form of the systematic reviews and associated studies from The Cochrane Library, where retrieved documents are specific to a patient-physician encounter and thus can be used to support evidence-based decision making at the point of care. Such an encounter is defined by three pertinent groups of concepts - diagnosis, treatment, and patient, and the framework relies on these three groups to steer indexing and retrieval of reviews and associated studies. An evaluation of the indexing and retrieval components of the proposed framework was performed using documents relevant for the pediatric asthma domain. Precision and recall values for automatic indexing of systematic reviews and associated studies were 0.93 and 0.87, and 0.81 and 0.56, respectively. Moreover, precision and recall for the retrieval of relevant systematic reviews and associated studies were 0.89 and 0.81, and 0.92 and 0.89, respectively. With minor modifications, the proposed methodological framework can be customized for other evidence repositories. PMID:20230908

  14. Concise gene signature for point-of-care classification of tuberculosis.

    PubMed

    Maertzdorf, Jeroen; McEwen, Gayle; Weiner, January; Tian, Song; Lader, Eric; Schriek, Ulrich; Mayanja-Kizza, Harriet; Ota, Martin; Kenneth, John; Kaufmann, Stefan He

    2015-01-01

    There is an urgent need for new tools to combat the ongoing tuberculosis (TB) pandemic. Gene expression profiles based on blood signatures have proved useful in identifying genes that enable classification of TB patients, but have thus far been complex. Using real-time PCR analysis, we evaluated the expression profiles from a large panel of genes in TB patients and healthy individuals in an Indian cohort. Classification models were built and validated for their capacity to discriminate samples from TB patients and controls within this cohort and on external independent gene expression datasets. A combination of only four genes distinguished TB patients from healthy individuals in both cross-validations and on separate validation datasets with very high accuracy. An external validation on two distinct cohorts using a real-time PCR setting confirmed the predictive power of this 4-gene tool reaching sensitivity scores of 88% with a specificity of around 75%. Moreover, this gene signature demonstrated good classification power in HIV(+) populations and also between TB and several other pulmonary diseases. Here we present proof of concept that our 4-gene signature and the top classifier genes from our models provide excellent candidates for the development of molecular point-of-care TB diagnosis in endemic areas. PMID:26682570

  15. Xurography as a Rapid Fabrication Alternative for Point-of-Care Devices: Assessment of Passive Micromixers

    PubMed Central

    Martínez-López, J. Israel; Mojica, Mauricio; Rodríguez, Ciro A.; Siller, Héctor R.

    2016-01-01

    Despite the copious amount of research on the design and operation of micromixers, there are few works regarding manufacture technology aimed at implementation beyond academic environments. This work evaluates the viability of xurography as a rapid fabrication tool for the development of ultra-low cost microfluidic technology for extreme Point-of-Care (POC) micromixing devices. By eschewing photolithographic processes and the bulkiness of pumping and enclosure systems for rapid fabrication and passively driven operation, xurography is introduced as a manufacturing alternative for asymmetric split and recombine (ASAR) micromixers. A T-micromixer design was used as a reference to assess the effects of different cutting conditions and materials on the geometric features of the resulting microdevices. Inspection by stereographic and confocal microscopy showed that it is possible to manufacture devices with less than 8% absolute dimensional error. Implementation of the manufacturing methodology in modified circular shape- based SAR microdevices (balanced and unbalanced configurations) showed that, despite the precision limitations of the xurographic process, it is possible to implement this methodology to produce functional micromixing devices. Mixing efficiency was evaluated numerically and experimentally at the outlet of the microdevices with performances up to 40%. Overall, the assessment encourages further research of xurography for the development of POC micromixers. PMID:27196904

  16. Programmable nano-bio-chips: multifunctional clinical tools for use at the point-of-care

    PubMed Central

    Jokerst, Jesse V

    2011-01-01

    A new generation of programmable diagnostic devices is needed to take advantage of information generated from the study of genomics, proteomics, metabolomics and glycomics. This report describes the ‘programmable nano-bio-chip’ with potential to bridge the significant scientific, technology and clinical gaps through the creation of a diagnostic platform to measure the molecules of life. This approach, with results at the point-of-care, possesses capabilities for measuring such diverse analyte classes as cells, proteins, DNA and small molecules in the same compact device. Applications such as disease diagnosis and prognosis for areas including cancer, heart disease and HIV are described. New diagnostic panels are inserted as ‘plug and play’ elements into the modular platform with universal assay operating systems and standard read out sequences. The nano-bio-chip ensemble exhibits excellent analytical performance and cost-effectiveness with extensive validation versus standard reference methods (R2 = 0.95–0.99). This report describes the construction and use of two major classes of nano-bio-chip designs that serve as cellular and chemical processing units, and provides perspective on future growth in this newly emerging field of programmable nano-bio-chip sensor systems. PMID:20025471

  17. Simultaneous Point-of-Care Detection of Enterovirus 71 and Coxsackievirus B3.

    PubMed

    Wang, Jia-Jia; Jiang, Yong-Zhong; Lin, Yi; Wen, Li; Lv, Cheng; Zhang, Zhi-Ling; Chen, Gang; Pang, Dai-Wen

    2015-11-01

    Human enterovirus 71 (EV71) is one of the pathogens that causes hand, foot, and mouth disease (HFMD), which generally leads to neurological diseases and fatal complications among children. Since the early clinical symptoms from EV71 infection are very similar to those from Coxsackievirus B3 (CVB3) infection, a robust and sensitive detection method that can be used to distinguish EV71 and CVB3 is urgently needed for prompting medical treatment of related diseases. Herein, based on immunomagnetic nanobeads and fluorescent semiconductor CdSe quantum dots (QDs), a method for simultaneous point-of-care detection of EV71 and CVB3 is proposed. The synchronous detection of EV71 and CVB3 virions was achieved within 45 min with high specificity and repeatability. The limits of detection are 858 copies/500 μL for EV71 and 809 copies/500 μL for CVB3.This proposed method was further validated with 20 human throat swab samples obtained from EV71 or CVB3 positive cases, with results 93.3% consistent with those by the real-time PCR method, demonstrating the potential of this method for clinical quantification of EV71 and CVB3. The method may also facilitate the prevention and treatment of the diseases. PMID:26461918

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

    PubMed

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

    2012-06-01

    Most entrepreneurial ventures fail long before the core technology can be brought to the marketplace because of disconnects in performance and usability measures such as accuracy, cost, complexity, assay stability, and time requirements between technology developers' specifications and needs of the end-users. By going through a clinical needs assessment (CNA) process, developers will gain vital information and a clear focus that will help minimize the risks associated with the development of new technologies available for use within the health care system. This article summarizes best practices of the principal investigators of the National Institute of Biomedical Imaging and Bioengineering point-of-care (POC) centers within the National Institute of Biomedical Imaging and Bioengineering POC Technologies Research Network. Clinical needs assessments are particularly important for product development areas that do not sufficiently benefit from traditional market research, such as grant-funded research and development, new product lines using cutting-edge technologies developed in start-up companies, and products developed through product development partnerships for low-resource settings. The objectives of this article were to (1) highlight the importance of CNAs for development of POC devices, (2) discuss methods applied by POC Technologies Research Network for assessing clinical needs, and (3) provide a road map for future CNAs. PMID:23935405

  19. Retrospective Review of Ocular Point-of-Care Ultrasound for Detection of Retinal Detachment

    PubMed Central

    Jacobsen, Bradley; Lahham, Sari; Lahham, Shadi; Patel, Amy; Spann, Sophia; Fox, John C.

    2016-01-01

    Introduction Retinal detachment is an ocular emergency that commonly presents to the emergency department (ED). Ophthalmologists are able to accurately make this diagnosis with a dilated fundoscopic exam, scleral depression or ophthalmic ultrasound when a view to the retina is obstructed. Emergency physicians (EPs) are not trained to examine the peripheral retina, and thus ophthalmic ultrasound can be used to aid in diagnosis. We assessed the accuracy of ocular point-of-care ultrasound (POCUS) in diagnosing retinal detachment. Methods We retrospectively reviewed charts of ED patients with suspected retinal detachment who underwent ocular POCUS between July 2012 and May 2015. Charts were reviewed for patients presenting to the ED with ocular complaints and clinical concern for retinal detachment. We compared ocular POCUS performed by EPs against the criterion reference of the consulting ophthalmologist’s diagnosis. Results We enrolled a total of 109 patients. Of the 34 patients diagnosed with retinal detachment by the ophthalmologists, 31 were correctly identified as having retinal detachment by the EP using ocular POCUS. Of the 75 patients who did not have retinal detachment, 72 were ruled out by ocular POCUS by the EP. This resulted in a POCUS sensitivity of 91% (95% CI [76–98]) and specificity of 96% (95% CI [89–99]). Conclusion This retrospective study suggests that ocular POCUS performed by EPs can aid in the diagnosis of retinal detachment in ED. PMID:26973752

  20. Robust ultrasensitive tunneling-FET biosensor for point-of-care diagnostics

    PubMed Central

    Gao, Anran; Lu, Na; Wang, Yuelin; Li, Tie

    2016-01-01

    For point-of-care (POC) applications, robust, ultrasensitive, small, rapid, low-power, and low-cost sensors are highly desirable. Here, we present a novel biosensor based on a complementary metal oxide semiconductor (CMOS)-compatible silicon nanowire tunneling field-effect transistor (SiNW-TFET). They were fabricated “top-down” with a low-cost anisotropic self-stop etching technique. Notably, the SiNW-TFET device provided strong anti-interference capacity by applying the inherent ambipolarity via both pH and CYFRA21-1 sensing. This offered a more robust and portable general protocol. The specific label-free detection of CYFRA21-1 down to 0.5 fgml−1 or ~12.5 aM was achieved using a highly responsive SiNW-TFET device with a minimum sub-threshold slope (SS) of 37 mVdec−1. Furthermore, real-time measurements highlighted the ability to use clinically relevant samples such as serum. The developed high performance diagnostic system is expected to provide a generic platform for numerous POC applications. PMID:26932158

  1. Emerging Technologies for Monitoring Drug-Resistant Tuberculosis at the Point-of-Care

    PubMed Central

    Mani, Vigneshwaran; Wang, ShuQi; Inci, Fatih; De Libero, Gennaro; Singhal, Amit; Demirci, Utkan

    2014-01-01

    Infectious diseases are the leading cause of death worldwide. Among them, tuberculosis (TB) remains a major threat to public health, exacerbated by the emergence of multiple drug-resistant (MDR) and extensively drug-resistant (XDR) Mycobacterium tuberculosis (Mtb). MDR-Mtb strains are resistant to first-line anti-TB drugs such as isoniazid and rifampicin; whereas XDR-Mtb strains are resistant to additional drugs including at least to any fluoroquinolone and at least one of the second-line anti-TB injectable drugs such as kanamycin, capreomycin, or amikacin. Clinically, these strains have significantly impacted the management of TB in high-incidence developing countries, where systemic surveillance of TB drug resistance is lacking. For effective management of TB on-site, early detection of drug resistance is critical to initiate treatment, to reduce mortality, and to thwart drug-resistant TB transmission. In this review, we discuss the diagnostic challenges to detect drug-resistant TB at the point-of-care (POC). Moreover, we present the latest advances in nano/microscale technologies that can potentially detect TB drug resistance to improve on-site patient care. PMID:24882226

  2. Combined impedance and dielectrophoresis portable device for point-of-care analysis

    NASA Astrophysics Data System (ADS)

    del Moral Zamora, B.; Colomer-Farrarons, J.; Mir-Llorente, M.; Homs-Corbera, A.; Miribel-Català, P.; Samitier-Martí, J.

    2011-05-01

    In the 90s, efforts arise in the scientific world to automate and integrate one or several laboratory applications in tinny devices by using microfluidic principles and fabrication technologies used mainly in the microelectronics field. It showed to be a valid method to obtain better reactions efficiency, shorter analysis times, and lower reagents consumption over existing analytical techniques. Traditionally, these fluidic microsystems able to realize laboratory essays are known as Lab-On-a-Chip (LOC) devices. The capability to transport cells, bacteria or biomolecules in an aqueous medium has significant potential for these microdevices, also known as micro-Total-Analysis Systems (uTAS) when their application is of analytical nature. In particular, the technique of dielectrophoresis (DEP) opened the possibility to manipulate, actuate or transport such biological particles being of great potential in medical diagnostics, environmental control or food processing. This technique consists on applying amplitude and frequency controlled AC signal to a given microsystem in order to manipulate or sort cells. Furthermore, the combination of this technique with electrical impedance measurements, at a single or multiple frequencies, is of great importance to achieve novel reliable diagnostic devices. This is because the sorting and manipulating mechanism can be easily combined with a fully characterizing method able to discriminate cells. The paper is focused in the electronics design of the quadrature DEP generator and the four-electrode impedance measurement modules. These together with the lab-on-a-chip device define a full conception of an envisaged Point-of-Care (POC) device.

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

    PubMed Central

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

    2013-01-01

    Most entrepreneurial ventures fail long before the core technology can be brought to the marketplace because of disconnects in performance and usability measures such as accuracy, cost, complexity, assay stability, and time requirements between technology developers’ specifications and needs of the end-users. By going through a clinical needs assessment (CNA) process, developers will gain vital information and a clear focus that will help minimize the risks associated with the development of new technologies available for use within the health care system. This article summarizes best practices of the principal investigators of the National Institute of Biomedical Imaging and Bioengineering point-of-care (POC) centers within the National Institute of Biomedical Imaging and Bioengineering POC Technologies Research Network. Clinical needs assessments are particularly important for product development areas that do not sufficiently benefit from traditional market research, such as grant-funded research and development, new product lines using cutting-edge technologies developed in start-up companies, and products developed through product development partnerships for low-resource settings. The objectives of this article were to (1) highlight the importance of CNAs for development of POC devices, (2) discuss methods applied by POC Technologies Research Network for assessing clinical needs, and (3) provide a road map for future CNAs. PMID:23935405

  4. Advanced Yellow Fever Virus Genome Detection in Point-of-Care Facilities and Reference Laboratories

    PubMed Central

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

    2012-01-01

    Reported methods for the detection of the yellow fever viral genome are beset by limitations in sensitivity, specificity, strain detection spectra, and suitability to laboratories with simple infrastructure in areas of endemicity. We describe the development of two different approaches affording sensitive and specific detection of the yellow fever genome: a real-time reverse transcription-quantitative PCR (RT-qPCR) and an isothermal protocol employing the same primer-probe set but based on helicase-dependent amplification technology (RT-tHDA). Both assays were evaluated using yellow fever cell culture supernatants as well as spiked and clinical samples. We demonstrate reliable detection by both assays of different strains of yellow fever virus with improved sensitivity and specificity. The RT-qPCR assay is a powerful tool for reference or diagnostic laboratories with real-time PCR capability, while the isothermal RT-tHDA assay represents a useful alternative to earlier amplification techniques for the molecular diagnosis of yellow fever by field or point-of-care laboratories. PMID:23052311

  5. Programmable nano-bio-chips: multifunctional clinical tools for use at the point-of-care.

    PubMed

    Jokerst, Jesse V; McDevitt, John T

    2010-01-01

    A new generation of programmable diagnostic devices is needed to take advantage of information generated from the study of genomics, proteomics, metabolomics and glycomics. This report describes the 'programmable nano-bio-chip' with potential to bridge the significant scientific, technology and clinical gaps through the creation of a diagnostic platform to measure the molecules of life. This approach, with results at the point-of-care, possesses capabilities for measuring such diverse analyte classes as cells, proteins, DNA and small molecules in the same compact device. Applications such as disease diagnosis and prognosis for areas including cancer, heart disease and HIV are described. New diagnostic panels are inserted as 'plug and play' elements into the modular platform with universal assay operating systems and standard read out sequences. The nano-bio-chip ensemble exhibits excellent analytical performance and cost-effectiveness with extensive validation versus standard reference methods (R(2) = 0.95-0.99). This report describes the construction and use of two major classes of nano-bio-chip designs that serve as cellular and chemical processing units, and provides perspective on future growth in this newly emerging field of programmable nano-bio-chip sensor systems. PMID:20025471

  6. On the Slow Diffusion of Point-of-Care Systems in Therapeutic Drug Monitoring

    PubMed Central

    Sanavio, Barbara; Krol, Silke

    2015-01-01

    Recent advancements in point-of-care (PoC) technologies show great transformative promises for personalized preventative and predictive medicine. However, fields like therapeutic drug monitoring (TDM), that first allowed for personalized treatment of patients’ disease, still lag behind in the widespread application of PoC devices for monitoring of patients. Surprisingly, very few applications in commonly monitored drugs, such as anti-epileptics, are paving the way for a PoC approach to patient therapy monitoring compared to other fields like intensive care cardiac markers monitoring, glycemic controls in diabetes, or bench-top hematological parameters analysis at the local drug store. Such delay in the development of portable fast clinically effective drug monitoring devices is in our opinion due more to an inertial drag on the pervasiveness of these new devices into the clinical field than a lack of technical capability. At the same time, some very promising technologies failed in the clinical practice for inadequate understanding of the outcome parameters necessary for a relevant technological breakthrough that has superior clinical performance. We hope, by over-viewing both TDM practice and its yet unmet needs and latest advancement in micro- and nanotechnology applications to PoC clinical devices, to help bridging the two communities, the one exploiting analytical technologies and the one mastering the most advanced techniques, into translating existing and forthcoming technologies in effective devices. PMID:25767794

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

    PubMed

    Dutta, Satarupa; Mandal, Nilanjan; Bandyopadhyay, Dipankar

    2016-04-15

    We report the fabrication of a paper-sensor for quantitative detection of α-amylase activity in human blood serum. Pieces of filter papers were coated with starch-iodine solution leading to an intense blue coloration on the surface. Dispensing α-amylase solution on the starch-iodine coated paper reduced the intensity of the color because of starch-hydrolysis catalyzed by amylase. The variation in the intensity of the color with the concentration of amylase was estimated in three stages: (i) initially, the paper-surface was illuminated with a light emitting diode, (ii) then, the transmitted (reflected) rays emitted through (from) the paper were collected on a photoresistor, and (iii) the variations in the electrical resistance of the photoresistor were correlated with the amylase concentration in analyte. The resistance of photoresistor decreased monotonically with an increase in amylase concentration because the intensity of the reflected (transmitted) rays collected from (through) the paper increased with reduction in the color intensity on the paper surface. Since a specific bio-reaction was employed to detect the activity of amylase, the sensor was found to be equally efficient in detecting unknown quantities of amylase in human blood serum. The reported sensor has shown the potential to graduate into a point-of-care detection tool for α-amylase. PMID:26655186

  8. Mentoring frontline managers: the vital force in stimulating innovation at the point of care.

    PubMed

    Shiparski, Laurie; Authier, Philip

    2013-01-01

    Frontline managers in health care are the keepers of culture, the gateway to evoking a grass roots intelligence network, and they hold a pivotal role in advancing innovation at the point of care. Their roles are ever expanding and include knowledge and skills in managing the business, leading the people, and advancing their own leadership development. In all 3 areas, the impact of their leadership exponentially increases if they maximize innovative thinking and action. Health care executives need to establish the expectations for an innovative culture and the role of frontline managers. They must model the behaviors they promote and take the time to develop these frontline managers who are the hub for innovative success in the organization. This article offers insights and practical applications while exploring the innovation keystones of the following: creating an organizational culture of innovation, igniting collaboration that fuels diverse thinking and creativity, utilizing meaningful data to drive innovative decisions, and assessing and monitoring the ongoing climate and outcomes of innovation. PMID:23222751

  9. Mapping Out Point-of-Care Review Screens for Omaha System Data.

    PubMed

    Lee, Seonah

    2016-02-01

    Omaha System data are text data that consist of standardized terminology and customized descriptions. The customized descriptions related to patient care reveal changes in a client's status over time. These data help public health nurses to understand the patient's progress and to plan future care. However, most electronic health records do not provide clinicians with efficient displays of stored text data. The purpose of this study is to develop point-of-care review screens for Omaha System data on an individual patient level and examine nurse perceptions of the usefulness of the displayed data in improving patient care. Individual patients' data were organized on a Web-based overview page to present all of the health problems that a client had and on detailed pages to present all records of Omaha System data regarding each health problem. Nurse survey results indicated the usefulness of at-a-glance displays of text data on patient care and nurses' decision making. The meaningful review of patient data using a health information system supports patient-data-driven, evidence-based practice and decision making. PMID:26765656

  10. Point-of-care Diagnostic Tools to Detect Circulating MicroRNAS as Biomarkers of Disease

    PubMed Central

    Vaca, Luis

    2014-01-01

    MicroRNAs or miRNAs are a form of small non-coding RNAs (ncRNAs) of 19–22 nucleotides in length in their mature form. miRNAs are transcribed in the nucleus of all cells from large precursors, many of which have several kilobases in length. Originally identified as intracellular modulators of protein synthesis via posttranscriptional gene silencing, more recently it has been found that miRNAs can travel in extracellular human fluids inside specialized vesicles known as exosomes. We will be referring to this miRNAs as circulating microRNAs. More interestingly, the miRNA content inside exosomes changes during pathological events. In the present review we analyze the literature about circulating miRNAs and their possible use as biomarkers. Furthermore, we explore their future in point-of-care (POC) diagnostics and provide an example of a portable POC apparatus useful in the detection of circulating miRNAs. PMID:24858962

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

    PubMed

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

    2012-07-01

    We present a cost-effective portable ultrasound system based on a single field-programmable gate array (FPGA) for point-of-care applications. In the portable ultrasound system developed, all the ultrasound signal and image processing modules, including an effective 32-channel receive beamformer with pseudo-dynamic focusing, are embedded in an FPGA chip. For overall system control, a mobile processor running Linux at 667 MHz is used. The scan-converted ultrasound image data from the FPGA are directly transferred to the system controller via external direct memory access without a video processing unit. The potable ultrasound system developed can provide real-time B-mode imaging with a maximum frame rate of 30, and it has a battery life of approximately 1.5 h. These results indicate that the single FPGA-based portable ultrasound system developed is able to meet the processing requirements in medical ultrasound imaging while providing improved flexibility for adapting to emerging POC applications. PMID:22828834

  12. Robust ultrasensitive tunneling-FET biosensor for point-of-care diagnostics

    NASA Astrophysics Data System (ADS)

    Gao, Anran; Lu, Na; Wang, Yuelin; Li, Tie

    2016-03-01

    For point-of-care (POC) applications, robust, ultrasensitive, small, rapid, low-power, and low-cost sensors are highly desirable. Here, we present a novel biosensor based on a complementary metal oxide semiconductor (CMOS)-compatible silicon nanowire tunneling field-effect transistor (SiNW-TFET). They were fabricated “top-down” with a low-cost anisotropic self-stop etching technique. Notably, the SiNW-TFET device provided strong anti-interference capacity by applying the inherent ambipolarity via both pH and CYFRA21-1 sensing. This offered a more robust and portable general protocol. The specific label-free detection of CYFRA21-1 down to 0.5 fgml-1 or ~12.5 aM was achieved using a highly responsive SiNW-TFET device with a minimum sub-threshold slope (SS) of 37 mVdec-1. Furthermore, real-time measurements highlighted the ability to use clinically relevant samples such as serum. The developed high performance diagnostic system is expected to provide a generic platform for numerous POC applications.

  13. Smart point-of-care systems for molecular diagnostics based on nanotechnology: whole blood glucose analysis

    NASA Astrophysics Data System (ADS)

    Devadhasan, Jasmine P.; Kim, Sanghyo

    2015-07-01

    Complementary metal oxide semiconductor (CMOS) image sensors are received great attention for their high efficiency in biological applications. The present work describes a CMOS image sensor-based whole blood glucose monitoring system through a point-of-care (POC) approach. A simple poly-ethylene terephthalate (PET) film chip was developed to carry out the enzyme kinetic reaction at various concentrations of blood glucose. In this technique, assay reagent was adsorbed onto amine functionalized silica (AFSiO2) nanoparticles in order to achieve glucose oxidation on the PET film chip. The AFSiO2 nanoparticles can immobilize the assay reagent with an electrostatic attraction and eased to develop the opaque platform which was technically suitable chip to analyze by the camera module. The oxidized glucose then produces a green color according to the glucose concentration and is analyzed by the camera module as a photon detection technique. The photon number decreases with increasing glucose concentration. The simple sensing approach, utilizing enzyme immobilized AFSiO2 nanoparticle chip and assay detection method was developed for quantitative glucose measurement.

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

    PubMed

    Ibaida, Ayman; Khalil, Ibrahim

    2013-12-01

    With the growing number of aging population and a significant portion of that suffering from cardiac diseases, it is conceivable that remote ECG patient monitoring systems are expected to be widely used as point-of-care (PoC) applications in hospitals around the world. Therefore, huge amount of ECG signal collected by body sensor networks from remote patients at homes will be transmitted along with other physiological readings such as blood pressure, temperature, glucose level, etc., and diagnosed by those remote patient monitoring systems. It is utterly important that patient confidentiality is protected while data are being transmitted over the public network as well as when they are stored in hospital servers used by remote monitoring systems. In this paper, a wavelet-based steganography technique has been introduced which combines encryption and scrambling technique to protect patient confidential data. The proposed method allows ECG signal to hide its corresponding patient confidential data and other physiological information thus guaranteeing the integration between ECG and the rest. To evaluate the effectiveness of the proposed technique on the ECG signal, two distortion measurement metrics have been used: the percentage residual difference and the wavelet weighted PRD. It is found that the proposed technique provides high-security protection for patients data with low (less than 1%) distortion and ECG data remain diagnosable after watermarking (i.e., hiding patient confidential data) and as well as after watermarks (i.e., hidden data) are removed from the watermarked data. PMID:23708767

  15. Low-cost fluorescence microscopy for point-of-care cell imaging

    NASA Astrophysics Data System (ADS)

    Lochhead, Michael J.; Ives, Jeff; Givens, Monique; Delaney, Marie; Moll, Kevin; Myatt, Christopher J.

    2010-02-01

    Fluorescence microscopy has long been a standard tool in laboratory medicine. Implementation of fluorescence microscopy for near-patient diagnostics, however, has been limited due to cost and complexity associated with traditional fluorescence microscopy techniques. There is a particular need for robust, low-cost imaging in high disease burden areas in the developing world, where access to central laboratory facilities and trained staff is limited. Here we describe a point-of-care assay that combines a disposable plastic cartridge with an extremely low cost fluorescence imaging instrument. Based on a novel, multi-mode planar waveguide configuration, the system capitalizes on advances in volume-manufactured consumer electronic components to deliver an imaging system with minimal moving parts and low power requirements. A two-color cell imager is presented, with magnification optimized for enumeration of immunostained human T cells. To demonstrate the system, peripheral blood mononuclear cells were stained with fluorescently labeled anti-human-CD4 and anti-human-CD3 antibodies. Registered images were used to generate fractional CD4+ and CD3+ staining and enumeration results that show excellent correlation with flow cytometry. The cell imager is under development as a very low cost CD4+ T cell counter for HIV disease management in limited resource settings.

  16. Venous-to-arterial CO2 differences and the quest for bedside point-of-care monitoring to assess the microcirculation during shock

    PubMed Central

    Midwinter, Mark J.; Hutchings, Sam

    2016-01-01

    The microcirculation is the anatomical location of perfusion and substrate exchange, and its functional impairment is of paramount importance during the state of shock. The difference in venous-to-arterial carbon dioxide partial pressures (Pv-aCO2) has recently been reported to correlate with microcirculatory dysfunction during early septic shock with greater fidelity than global hemodynamic parameters. This makes it a potential candidate as a point-of-care test in goal directed therapy that aims to restore microcirculatory function in an emergency clinical context. This early work needs to be explored further, and a better understanding of Pv-aCO2 during the resuscitation and subsequent patient progression is required. The quest for an ideal bedside point-of-care test for microcirculatory behavior is ongoing, and is likely to consist of a combination of non-invasive sublingual microcirculatory monitoring and biochemical tests that reflect tissue perfusion. These tools have the potential to provide more accurate and clinically relevant data with regards to the microcirculation that more conventional resuscitative monitoring such as blood pressure, cardiac output, and serum lactate. PMID:26889490

  17. Swab Sample Transfer for Point-Of-Care Diagnostics: Characterization of Swab Types and Manual Agitation Methods

    PubMed Central

    Panpradist, Nuttada; Toley, Bhushan J.; Zhang, Xiaohong; Byrnes, Samantha; Buser, Joshua R.; Englund, Janet A.; Lutz, Barry R.

    2014-01-01

    Background The global need for disease detection and control has increased effort to engineer point-of-care (POC) tests that are simple, robust, affordable, and non-instrumented. In many POC tests, sample collection involves swabbing the site (e.g., nose, skin), agitating the swab in a fluid to release the sample, and transferring the fluid to a device for analysis. Poor performance in sample transfer can reduce sensitivity and reproducibility. Methods In this study, we compared bacterial release efficiency of seven swab types using manual-agitation methods typical of POC devices. Transfer efficiency was measured using quantitative PCR (qPCR) for Staphylococcus aureus under conditions representing a range of sampling scenarios: 1) spiking low-volume samples onto the swab, 2) submerging the swab in excess-volume samples, and 3) swabbing dried sample from a surface. Results Excess-volume samples gave the expected recovery for most swabs (based on tip fluid capacity); a polyurethane swab showed enhanced recovery, suggesting an ability to accumulate organisms during sampling. Dry samples led to recovery of ∼20–30% for all swabs tested, suggesting that swab structure and volume is less important when organisms are applied to the outer swab surface. Low-volume samples led to the widest range of transfer efficiencies between swab types. Rayon swabs (63 µL capacity) performed well for excess-volume samples, but showed poor recovery for low-volume samples. Nylon (100 µL) and polyester swabs (27 µL) showed intermediate recovery for low-volume and excess-volume samples. Polyurethane swabs (16 µL) showed excellent recovery for all sample types. This work demonstrates that swab transfer efficiency can be affected by swab material, structure, and fluid capacity and details of the sample. Results and quantitative analysis methods from this study will assist POC assay developers in selecting appropriate swab types and transfer methods. PMID:25181250

  18. Point-of-care and visual detection of P. aeruginosa and its toxin genes by multiple LAMP and lateral flow nucleic acid biosensor.

    PubMed

    Chen, Yuting; Cheng, Nan; Xu, Yuancong; Huang, Kunlun; Luo, Yunbo; Xu, Wentao

    2016-07-15

    This study describes a simple and sensitive approach for visual and point-of-care detection of P. aeruginosa and its toxin genes based on multiple loop-mediated isothermal amplification (mLAMP) and lateral flow nucleic acid biosensor (LFNAB). Differentiation of the internal standard gene ecfX and toxin genes (ExoS and ExoU) in P. aeruginosa was determined using FITC-, hex-and digoxin-modified primers in the mLAMP process. In the presence of biotin-and FITC- (hex-, digoxin-) modified primers and Bst DNA polymerase large fragments, the mLAMP produced numerous biotin- and FITC- (hex-, digoxin-) attached duplex DNA products. The products were detected by LFNAB through dual immunoreactions (anti-biotin antibodies on the gold nanoparticle (Au-NP) and biotin on the duplex, anti-FITC (hex, digoxin) antibodies on the LFNAB test line and FITC (hex, digoxin) on the duplex). The accumulation of Au-NPs produced a characteristic red band, enabling visual detection of P. aeruginosa and its toxin genes without instrumentation. After systematic optimization of LFNAB preparation and detecting conditions, the current approach was capable of detecting concentrations as low as 20 CFU/mL P. aeruginosa or its toxin genes within 50min without complicated instrument, which is more sensitive than PCR. Therefore, this approach provides a simple, pollution free, sensitive, and low-cost point-of-care test for the detection of P. aeruginosa and its toxin genes. PMID:26985584

  19. High performance multichannel photonic biochip sensors for future point of care diagnostics: an overview on two EU-sponsored projects

    NASA Astrophysics Data System (ADS)

    Giannone, Domenico; Kazmierczak, Andrzej; Dortu, Fabian; Vivien, Laurent; Sohlström, Hans

    2010-04-01

    We present here research work on two optical biosensors which have been developed within two separate European projects (6th and 7th EU Framework Programmes). The biosensors are based on the idea of a disposable biochip, integrating photonics and microfluidics, optically interrogated by a multichannel interrogation platform. The objective is to develop versatile tools, suitable for performing screening tests at Point of Care or for example, at schools or in the field. The two projects explore different options in terms of optical design and different materials. While SABIO used Si3N4/SiO2 ring resonators structures, P3SENS aims at the use of photonic crystal devices based on polymers, potentially a much more economical option. We discuss both approaches to show how they enable high sensitivity and multiple channel detection. The medium term objective is to develop a new detection system that has low cost and is portable but at the same time offering high sensitivity, selectivity and multiparametric detection from a sample containing various components (e.g. blood, serum, saliva, etc.). Most biological sensing devices already present on the market suffer from limitations in multichannel operation capability (either the detection of multiple analytes indicating a given pathology or the simultaneous detection of multiple pathologies). In other words, the number of different analytes that can be detected on a single chip is very limited. This limitation is a main issue addressed by the two projects. The excessive cost per test of conventional bio sensing devices is a second issue that is addressed.

  20. Competitive volumetric bar-chart chip with real-time internal control for point-of-care diagnostics.

    PubMed

    Li, Ying; Xuan, Jie; Xia, Tom; Han, Xin; Song, Yujun; Cao, Zheng; Jiang, Xin; Guo, Yi; Wang, Ping; Qin, Lidong

    2015-04-01

    Point-of-care (POC) testing has become widely used in clinical analysis because of its speed and portability; however, POC tools, such as lateral flow assays, suffer from low specificity, unclear readouts, and susceptibility to environmental and user errors. Herein, we report an ELISA-based competitive volumetric bar-chart chip (CV-chip) that eliminates these limitations. The CV-chip displays the readout in the form of ink bar charts based on direct competition between gases generated by the sample and the internal control. By employing a "competition mode", this platform decreases the potential influence of background resulting from environmental factors and provides visually clear positive or negative results without the requirement of calibration. In addition, the on-chip comparison enables the device to distinguish imperceptible differences (less than 1.3-fold) in human chorionic gonadotropin (hCG) concentrations that are near the cutoff value for pregnancy (∼1.4 ng/mL). We also utilized the ELISA-based CV-chip to successfully detect biomarkers from cancer cells. As a proof-of-concept application in a clinical setting, the CV-chip was employed to evaluate the status of drugs of abuse in 18 patients. For six different drugs, zero false-positive and very few false-negative (<2%) results were reported in more than 100 tests. This new ELISA platform offers a clinical diagnostics tool that is portable and easy to use, and provides improved clarity and sensitivity due to the inclusion of a real-time internal control. PMID:25751686

  1. Home point-of-care international normalised ratio monitoring sustained by a non-selective educational program in children.

    PubMed

    Bajolle, Fanny; Lasne, Dominique; Elie, Caroline; Cheurfi, Radhia; Grazioli, Aurélie; Traore, Maladon; Souillard, Patrick; Boudjemline, Younes; Jourdain, Patrick; Bonnet, Damien

    2012-10-01

    Adverse events related to vitamin K antagonist (VKA) therapy might be reduced by point-of-care international normalised ratio (POC INR) monitoring supported by an education program (EP). Our aim was to evaluate the efficacy of a non-selective VKA paediatric EP (regardless of the social, economic, educational or linguistic levels) by analysing the time spent in the therapeutic range (TTR), VKA adverse events and compliance to treatment, and INR control prescriptions. The EP was modified from the pediatric EP previously described but improved by a specifically devised child-focused game. One hundred four consecutive children (median age 8 years) receiving VKA were included in a standardised EP. Patients were in self-testing, and dose adjustments were made by a single physician for three tolerance ranges according to the underlying disease: [2.5-4], [1.8-3.2], and [1.5-2.5]. The median follow-up was 481 days [70-1,001]. The overall TTR was 81.4% [36-100]. The TTR were 74%, 85.6% and 89% for the ranges [2.5-4], [1.8-3.2], and [1.5-2.5], respectively. These results were sustainable during the study period. Only one serious VKA adverse event was recorded. The median number of POC INR tests was 2.5 [1.6-5.7] INR per patient and month. Patients/families performed POC INR when requested in 86.9% of the cases. More than 90% of the families found the EP supportive and wished to follow a long-term reinforcement program. In conclusion, this non-selective child-focused EP for VKA therapy, strongly supported by our dedicated game, is useful in maintaining efficacy, safety and compliance to anticoagulation and its monitoring. PMID:22955724

  2. Competitive Volumetric Bar-Chart Chip with Real-Time Internal Control for Point-of-Care Diagnostics

    PubMed Central

    Li, Ying; Xuan, Jie; Xia, Tom; Han, Xin; Song, Yujun; Cao, Zheng; Jiang, Xin; Guo, Yi; Wang, Ping; Qin, Lidong

    2015-01-01

    Point-of-care (POC) testing has become widely used in clinical analysis because of its speed and portability; however, POC tools, such as lateral flow assays, suffer from low specificity, unclear readouts, and susceptibility to environmental and user errors. Herein, we report an ELISA-based competitive volumetric bar-chart chip (CV-chip) that eliminates these limitations. The CV-chip displays the readout in the form of ink bar charts based on direct competition between gases generated by the sample and the internal control. By employing a “competition mode”, this platform decreases the potential influence of background resulting from environmental factors and provides visually clear positive or negative results without the requirement of calibration. In addition, the on-chip comparison enables the device to distinguish imperceptible differences (less than 1.3-fold) in human chorionic gonadotropin (hCG) concentrations that are near the cutoff value for pregnancy (~1.4 ng/mL). We also utilized the ELISA-based CV-chip to successfully detect biomarkers from cancer cells. As a proof-of-concept application in a clinical setting, the CV-chip was employed to evaluate the status of drugs of abuse in 18 patients. For six different drugs, zero false-positive and very few false-negative (<2%) results were reported in more than 100 tests. This new ELISA platform offers a clinical diagnostics tool that is portable and easy to use, and provides improved clarity and sensitivity due to the inclusion of a real-time internal control. PMID:25751686

  3. Swellable polymer films containing Au nanoparticles for point-of-care therapeutic drug monitoring using surface-enhanced Raman spectroscopy.

    PubMed

    Lee, Wendy W Y; McCoy, Colin P; Donnelly, Ryan F; Bell, Steven E J

    2016-03-17

    Large (10 × 10 cm) sheets of surface-enhanced Raman spectroscopy (SERS) active polymer have been prepared by stabilising metal nanoparticle aggregates within dry hydroxyethylcellulose (HEC) films. In these films the aggregates are protected by the polymer matrix during storage but in use they are released when aqueous analyte droplets cause the films to swell to their gel form. The fact that these "Poly-SERS" films can be prepared in bulk but then cut to size and stored in air before use means that they provide a cost effective and convenient method for routine SERS analysis. Here we have tested both Ag and Au Poly-SERS films for use in point-of-care monitoring of therapeutic drugs, using phenytoin as the test compound. Phenytoin in water could readily be detected using Ag Poly-SERS films but dissolving the compound in phosphate buffered saline (PBS) to mimic body fluid samples caused loss of the drug signal due to competition for metal surface sites from Cl(-) ions in the buffer solution. However, with Au Poly-SERS films there was no detectable interference from Cl(-) and these materials allowed phenytoin to be detected at 1.8 mg L(-1), even in PBS. The target range of detection of phenytoin in therapeutic drug monitoring is 10-20 mg L(-1). With the Au Poly-SERS films, the absolute signal generated by a given concentration of phenytoin was lower for the films than for the parent colloid but the SERS signals were still high enough to be used for therapeutic monitoring, so the cost in sensitivity for moving from simple aqueous colloids to films is not so large that it outweighs the advantages which the films bring for practical applications, in particular their ease of use and long shelf life. PMID:26920779

  4. 76 FR 51038 - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... INFORMATION: In a notice published in the Federal Register of July 26, 2007 (72 FR 41080), FDA announced the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal...

  5. A Novice User of Pediatric Emergency Point-of-Care Ultrasonography Avoids Misdiagnosis in a Case of Chronic Abdominal Distention.

    PubMed

    Pe, Marybelle; Dickman, Eitan; Tessaro, Mark

    2016-02-01

    A 13-year-old adolescent girl with chronic abdominal distention was referred to the pediatric emergency department after the outpatient workup suggested moderate ascites. Point-of-care ultrasonography performed by the emergency physicians ruled out ascites, instead demonstrating a well-circumscribed cystic mass subsequently identified as an ovarian mucinous cystadenoma. PMID:26835571

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

  8. Rapid diagnostic imaging and pathologic evaluation of whole core biopsies at the point-of-care using structured illumination microscopy

    NASA Astrophysics Data System (ADS)

    Wang, Mei; Sholl, Andrew B.; Kimbrell, Hillary; Tulman, David B.; Elfer, Katherine N.; Brown, J. Quincy

    2015-07-01

    Video-rate structured illumination microscopy (VR-SIM) of fluorescently stained prostate biopsies is demonstrated as a potential tool for rapid diagnosis of prostate biopsies at the point of care. Images of entire biopsies at 1.3 micron lateral resolution are rendered in seconds, and pathologist review of the resulting images achieves 90% accuracy as compared to gold standard histopathology.

  9. Phaseguide-assisted blood separation microfluidic device for point-of-care applications

    PubMed Central

    Lee, Hun; Oh, Kwang W.

    2015-01-01

    We propose a blood separation microfluidic device suitable for point-of-care (POC) applications. By utilizing the high gas permeability of polydimethylsiloxane (PDMS) and phaseguide structures, a simple blood separation device is presented. The device consists of two main parts. A separation chamber with the phaseguide structures, where a sample inlet, a tape-sealed outlet, and a dead-end ring channel are connected, and pneumatic chambers, in which manually operating syringes are plugged. The separation chamber and pneumatic chambers are isolated by a thin PDMS wall. By manually pulling out the plunger of the syringe, a negative pressure is instantaneously generated inside the pneumatic chamber. Due to the gas diffusion from the separation chamber to the neighboring pneumatic chamber through the thin permeable PDMS wall, low pressure can be generated, and then the whole blood at the sample inlets starts to be drawn into the separation chamber and separated through the phaseguide structures. Reversely, after removing the tape at the outlet and manually pushing in the plunger of the syringe, a positive pressure will be created which will cause the air to diffuse back into the ring channel, and therefore allow the separated plasma to be recovered at the outlet on demand. In this paper, we focused on the study of the plasma separation and associated design parameters, such as the PDMS wall thickness, the air permeable overlap area between the separation and pneumatic chambers, and the geometry of the phaseguides. The device required only 2 μl of whole blood but yielding approximately 0.38 μl of separated plasma within 12 min. Without any of the requirements of sophisticated equipment or dilution techniques, we can not only separate the plasma from the whole blood for on-chip analysis but also can push out only the separated plasma to the outlet for off-chip analysis. PMID:25713688

  10. Accuracy of Point-of-Care Blood Glucose Measurements in Critically Ill Patients in Shock

    PubMed Central

    Buenaluz-Sedurante, Myrna; Jimeno, Cecilia Alegado

    2014-01-01

    A widely used method in monitoring glycemic status of ICU patients is point-of-care (POC) monitoring devices. A possible limitation to this method is altered peripheral blood flow in patients in shock, which may result in over/underestimations of their true glycemic status. This study aims to determine the accuracy of blood glucose measurements with a POC meter compared to laboratory methods in critically ill patients in shock. POC blood glucose was measured with a glucose-1-dehydrogenase-based reflectometric meter. The reference method was venous plasma glucose measured by a clinical chemistry analyzer (glucose oxidase-based). Outcomes assessed were concordance to ISO 15197:2003 minimum accuracy criteria for glucose meters, bias in glucose measurements obtained by the 2 methods using Bland–Altman analysis, and clinical accuracy through modified error grid analysis. A total of 186 paired glucose measurements were obtained. ISO 2003 accuracy criteria were met in 95.7% and 79.8% of POC glucose values in the normotensive and hypotensive group, respectively. Mean bias for the normotensive group was –12.4 mg/dL, while mean bias in the hypotensive group was –34.9 mg/dL. POC glucose measurements within the target zone for clinical accuracy were 90.2% and 79.8% for the normotensive and hypotensive group, respectively. POC blood glucose measurements were significantly less accurate in the hypotensive subgroup of ICU patients compared to the normotensive group. We recommend a lower threshold in confirming POC blood glucose with a central laboratory method if clinically incompatible. In light of recently updated accuracy standards, we also recommend alternative methods of glucose monitoring for the ICU population as a whole regardless of blood pressure status. PMID:25172876

  11. Physicians' reported needs of drug information at point of care in Sweden

    PubMed Central

    Rahmner, Pia Bastholm; Eiermann, Birgit; Korkmaz, Seher; Gustafsson, Lars L; Gruvén, Magnus; Maxwell, Simon; Eichle, Hans-Georg; Vég, Anikó

    2012-01-01

    AIMS Relevant and easily accessible drug information at point-of-care is essential for physicians' decision making when prescribing. However, the information available by using Clinical Decision Support Systems (CDSSs) often does not meet physicians' requirements. The Summary of Product Characteristics (SmPC) is statutory information about drugs. However, the current structure, content and format of SmPCs make it difficult to incorporate them into CDSSs and link them to relevant patient information from the Electronic Health Records. The aim of the study was to evaluate the perceived needs for drug information among physicians in Sweden. METHODS We recruited three focus group discussions with 18 physicians covering different specialities. The information from the groups was combined with a questionnaire administered at the beginning of the group discussions. RESULTS Physicians reported their needs for knowledge databases at the point of drug prescribing. This included more consistent information about existing and new drugs. They also wished to receive automatically generated alerts for severe drug–drug interactions and adverse effects, and to have functions for calculating glomerular filtration rate to enable appropriate dose adjustments to be made for elderly patients and those with impaired renal function. Additionally, features enhancing electronic communication with colleagues and making drug information more searchable were suggested. CONCLUSIONS The results from the current study showed the need for knowledge databases which provide consistent information about new and existing drugs. Most of the required information from physicians appeared to be possible to transfer from current SmPCs to CDSSs. However, inconsistencies in the SmPC information have to be reduced to enhance their utility. PMID:21714807

  12. Rapid Point of Care Analyzer for the Measurement of Cyanide in Blood

    PubMed Central

    Ma, Jian; Ohira, Shin-Ichi; Mishra, Santosh K.; Puanngam, Mahitti; Dasgupta, Purnendu K.; Mahon, Sari B.; Brenner, Matthew; Blackledge, William; Boss, Gerry R.

    2011-01-01

    A simple, sensitive optical analyzer for the rapid determination of cyanide in blood in point of care applications is described. HCN is liberated by the addition of 20% H3PO4 and is absorbed by a paper filter impregnated with borate-buffered (pH 9.0) hydroxoaquocobinamide Hereinafter called cobinamide). Cobinamide on the filter changes color from orange (λmax = 510 nm) to violet (λmax = 583 nm) upon reaction with cyanide. This color change is monitored in the transmission mode by a light emitting diode (LED) with a 583 nm emission maximum and a photodiode detector. The observed rate of color change increases 10x when the cobinamide solution for filter impregnation is prepared in borate-buffer rather than in water. The use of a second LED emitting at 653 nm and alternate pulsing of the LEDs improve the limit of detection by 4x to ~ 0.5 μM for a 1 mL blood sample. Blood cyanide levels of imminent concern (≥ 10 μM) can be accurately measured in ~ 2 min. The response is proportional to the mass of cyanide in the sample – smaller sample volumes can be successfully used with proportionate change in the concentration LODs. Bubbling air through the blood-acid mixture was found effective for mixing of the acid with the sample and the liberation of HCN. A small amount of ethanol added to the top of the blood was found to be the most effective means to prevent frothing during aeration. The relative standard deviation (RSD) for repetitive determination of blood samples containing 9 μM CN was 1.09% (n=5). The technique was compared blind with a standard microdiffusion-spectrophotometric method used for the determination of cyanide in rabbit blood. The results showed good correlation (slope 1.05, r2 0.9257); independent calibration standards were used. PMID:21553921

  13. AC electrokinetics-enhanced capacitive immunosensor for point-of-care serodiagnosis of infectious diseases.

    PubMed

    Li, Shanshan; Cui, Haochen; Yuan, Quan; Wu, Jie; Wadhwa, Ashutosh; Eda, Shigetoshi; Jiang, Hongyuan

    2014-01-15

    The current serological diagnostic method can be time consuming and labor intensive, which is not practical for on-site diagnosis and screening of infectious diseases. Capacitive bioaffinity detection using microelectrodes is considered as a promising label-free method for point-of-care diagnosis, though with challenges in sensitivity and the time "from sample to result." With recent development in AC electrokinetics (ACEK), especially in dielectrophoresis (DEP), we are able to develop an ACEK enhanced capacitive bioaffinity sensing method to realize simple, fast and sensitive diagnosis from serum samples. The capacitive immunosensor presented here employs elevated AC potentials at a fixed frequency for impedimetric interrogation of the microelectrodes. According to prior work, such an AC signal is capable of inducing dielectrophoresis and other ACEK effects, so as to realize in-situ enrichment of macromolecules at microelectrodes and hence accelerated detection. Experimental study of the ACEK-enhanced capacitive sensing method was conducted, and the results corroborate our hypothesis. The capacitive sensing responses showed clear frequency dependence and voltage-level dependency, which supports the hypothesis that ACEK aids the antigen-antibody binding, and these dependencies were used to optimize our detection protocol. Our capacitive sensing method was shown to work with bovine sera to differentiate disease-positive samples from negative samples within 2 min, while conventional immunoassay would require multiple processing steps and take hours to complete. The results showed high accuracy and sensitivity. The detection limit is found to reach 10 ng/ml in 2 min. The ACEK-enhanced capacitive immunosensor is a platform technology, and can be employed to detect any combination of probe (e.g. antigen) and analyte (e.g. serum antibody) in a small volume of bodily fluids. PMID:24007749

  14. Point-of-Care Child Psychiatry Expertise: The Massachusetts Child Psychiatry Access Project

    PubMed Central

    Le, Thuy-Tien; Perrin, James M.

    2015-01-01

    OBJECTIVE: Since 2005, after a pilot program, the Massachusetts Child Psychiatry Access Project (MCPAP) has provided point-of-care psychiatry expertise and referral assistance by telephone to primary care providers. We examined its adoption and use and the practice characteristics associated with different adoption timelines and use patterns. METHODS: We merged data on calls to MCPAP in 2005 to 2011 with practice data (enrollment year, panel size, regional team assignment). We categorized practices’ days from enrollment to first call (adoption) (0–100, 101–365, >365 days) and quartile of call frequency (use) (annual highest, middle, and lowest quartiles of number of calls per 1000 empanelled patients). We determined associations between adoption and use and practice characteristics using multivariate models. RESULTS: Among 285 practices, adoption and use varied: 55% called 0 to 100 days from enrollment and 16% called >365 days from enrollment. Practices in the highest quartile of use made a mean 15.5 calls/year per 1000 patients, whereas the lowest quartile made 0.4 calls/year per 1000 patients. Adoption within 100 days was associated with enrollment during or after 2007 (odds ratio [OR] 4.09, 95% confidence interval [CI] 2.23–7.49) and assignment to the team at the pilot site (OR 4.42, 95% CI 2.16–9.04 for central Massachusetts). Highest-quartile use was associated with team assignment (OR 3.58, 95% CI 1.86–6.87 for central Massachusetts) and panel size (OR 0.10, 95% CI 0.03–0.31 for ≥10 000 vs <2000 patients). CONCLUSIONS: Adoption and use of MCPAP varied widely. Timing of enrollment, assignment to the team from the program’s pilot site, and panel size were associated with patterns of adoption and use. Findings may help other programs design effective implementation strategies. PMID:25896844

  15. Access to and Use of Point-of-Care Ultrasound in the Emergency Department

    PubMed Central

    Sanders, Jason L.; Noble, Vicki E.; Raja, Ali S.; Sullivan, Ashley F.; Camargo, Carlos A.

    2015-01-01

    Introduction Growing evidence supports emergency physician (EP)-performed point-of-care ultrasound (PoC US). However, there is a utilization gap between academic emergency departments (ED) and other emergency settings. We elucidated barriers to PoC US use in a multistate sample of predominantly non-academic EDs to inform future strategies to increase PoC US utilization, particularly in non-academic centers. Methods In 2010, we surveyed ED directors in five states (Arkansas, Hawaii, Minnesota, Vermont, and Wyoming; n=242 EDs) about general ED characteristics. In four states we determined barriers to PoC US use, proportion of EPs using PoC US, use privileges, and whether EPs can bill for PoC US. Results Response rates were >80% in each state. Overall, 47% of EDs reported PoC US availability. Availability varied by state, from 34% of EDs in Arkansas to 85% in Vermont. Availability was associated with higher ED visit volume, and percent of EPs who were board certified/board eligible in emergency medicine. The greatest barriers to use were limited training (70%), expense (39%), and limited need (perceived or real) (32%). When PoC US was used by EPs, 50% used it daily, 44% had privileges not requiring radiology confirmation, and 34% could bill separately for PoC US. Only 12% of EPs used it ≥80% of the time when placing central venous lines. Conclusion Only 47% of EDs in our five-state sample of predominantly non-academic EDs had PoC US immediately available. When available, the greatest barriers to use were limited training, expense, and limited need. Recent educational and technical advancements may help overcome these barriers. PMID:26587101

  16. Characteristics of a rapid, point-of-care lateral flow immunoassay for the diagnosis of sickle cell disease.

    PubMed

    McGann, Patrick T; Schaefer, Beverly A; Paniagua, Mary; Howard, Thad A; Ware, Russell E

    2016-02-01

    Sickle cell disease (SCD) is a common and life-threatening hematological disorder, affecting approximately 400,000 newborns annually worldwide. Most SCD births occur in low-resource countries, particularly in sub-Saharan Africa, where limited access to accurate diagnostics results in early mortality. We evaluated a prototype immunoassay as a novel, rapid, and low-cost point-of-care (POC) diagnostic device (Sickle SCAN™) designed to identify HbA, HbS, and HbC. A total of 139 blood samples were scored by three masked observers and compared to results using capillary zone electrophoresis. The sensitivity (98.3-100%) and specificity (92.5-100%) to detect the presence of HbA, HbS, and HbS were excellent. The test demonstrated 98.4% sensitivity and 98.6% specificity for the diagnosis of HbSS disease and 100% sensitivity and specificity for the diagnosis of HbSC disease. Most variant hemoglobins, including samples with high concentrations of HbF, did not interfere with the ability to detect HbS or HbC. Additionally, HbS and HbC were accurately detected at concentrations as low as 1-2%. Dried blood spot samples yielded clear positive bands, without loss of sensitivity or specificity, and devices stored at 37°C gave reliable results. These analyses indicate that the Sickle SCAN POC device is simple, rapid, and robust with high sensitivity and specificity for the detection of HbA, HbS, and HbC. The ability to obtain rapid and accurate results with both liquid blood and dried blood spots, including those with newborn high-HbF phenotypes, suggests that this POC device is suitable for large-scale screening and potentially for accurate diagnosis of SCD in limited resource settings. Am. J. Hematol. 91:205-210, 2016. © 2015 Wiley Periodicals, Inc. PMID:26537622

  17. A novel all-fiber optic flow cytometer technology for Point-of Care and Remote Environments

    NASA Astrophysics Data System (ADS)

    Mermut, Ozzy

    Traditional flow cytometry designs tend to be bulky systems with a complex optical-fluidic sub-system and often require trained personnel for operation. This makes them difficult to readily translate to remote site testing applications. A new compact and portable fiber-optic flow cell (FOFC) technology has been developed at INO. We designed and engineered a specialty optical fiber through which a square hole is transversally bored by laser micromachining. A capillary is fitted into that hole to flow analyte within the fiber square cross-section for detection and counting. With demonstrated performance benchmarks potentially comparable to commercial flow cytometers, our FOFC provides several advantages compared to classic free-space con-figurations, e.g., sheathless flow, low cost, reduced number of optical components, no need for alignment (occurring in the fabrication process only), ease-of-use, miniaturization, portability, and robustness. This sheathless configuration, based on a fiber optic flow module, renders this cytometer amenable to space-grade microgravity environments. We present our recent results for an all-fiber approach to achieve a miniature FOFC to translate flow cytometry from bench to a portable, point-of-care device for deployment in remote settings. Our unique fiber approach provides the capability to illuminate a large surface with a uniform intensity distri-bution, independently of the initial shape originating from the light source, and without loss of optical power. The CVs and sensitivities are measured and compared to industry benchmarks. Finally, integration of LEDs enable several advantages in cost, compactness, and wavelength availability.

  18. Biomarkers for diagnosis of neonatal infections: A systematic analysis of their potential as a point-of-care diagnostics

    PubMed Central

    Meem, Mahbuba; Modak, Joyanta K.; Mortuza, Roman; Morshed, Mahboob; Islam, Mohammad Shahidul; Saha, Samir K.

    2011-01-01

    Background Neonatal infections annually claim lives of 1.4 million neonates worldwide. Until now, there is no ideal diagnostic test for detecting sepsis and thus management of possible sepsis cases often depends on clinical algorithm leading to empirical treatment. This often results in unnecessary antibiotic use, which may lead to emergence of antibiotic resistance. Biomarkers have shown great promise in diagnosis of sepsis and guiding appropriate treatment of neonates. In this study, we conducted a literature review of existing biomarkers to analyze their status for use as a point-of-care diagnostic in developing countries. Methods PubMed and EMBASE database were searched with keywords, ‘infections’, ‘neonates’, and ‘biomarkers’ to retrieve potentially relevant papers from the period 1980 to 2010. Leading hospitals and manufacturers were communicated to inquire about the cost, laboratory requirements and current standing of biomarkers in clinical use. Results The search returned 6407 papers on biomarkers; 65 were selected after applying inclusion and exclusion criteria. Among the studies, C-reactive protein (CRP), procalcitonin (PCT) and interleukin 6 (IL-6) were the most widely studied biomarkers and were considered to be most promising for diagnosing neonatal infections. About 90% of the studies were from developed countries; more than 50% were from Europe. Conclusions Extensive work is being performed to find the diagnostic and prognostic value of biomarkers. However, the methodologies and study design are highly variable. Despite numerous research papers on biomarkers, their use in clinical setting is limited to CRP. The methods for detection of biomarkers are far too advanced to be used at the community level where most of the babies are dying. It is important that a harmonized multi-site study is initiated to find a battery of biomarkers for diagnosis of neonatal infections. PMID:23198119

  19. Pregnancy diabetes: A comparison of diagnostic protocols based on point-of-care, routine and optimized laboratory conditions

    PubMed Central

    van den Berg, Sjoerd A. A.; de Groot, Monique J. M.; Salden, Lorenzo P. W.; Draad, Patrick J. G. J.; Dijkstra, Ineke M.; Lunshof, Simone; van Thiel, Sjoerd W.; Boonen, Kristel J. M.; Thelen, Marc H. M.

    2015-01-01

    In vitro glycolysis poses a problem during diabetes screening, especially in remote laboratories. Point-of-care analysis (POC) may provide an alternative. We compared POC, routine and STAT analysis and a feasible protocol during glucose tolerance test (GTT) for pregnancy diabetes (GDM) screening. In the routine protocol, heparin tubes were used and turn-around-time (TAT) was unsupervised. In the STAT protocol, tubes were processed immediately. The feasible protocol comprised of citrated tubes with a TAT of 1 hour. Outcome was defined as glucose concentration and clinical diagnosis. Glucose measured by POC was higher compared to routine analysis at t = 0 (0.25 mM) and t = 120 (1.17 mM) resulting in 17% more GDM diagnoses. Compared to STAT analysis, POC glucose was also higher, although less pronounced (0.06 and 0.9 mM at t = 0 and t = 120 minutes, respectively) and misclassification was only 2%. Glucose levels and clinical diagnosis were similar using the feasible protocol and STAT analysis (0.03 mM and −0.07 mM at t = 0 and t = 120, 100% identical diagnoses). POC is an viable alternative for STAT glucose analysis in GDM screening (sensitivity: 100%, specificity: 98%). A feasible protocol (citrated phlebotomy tubes with a TAT of 60 minutes) resulted in 100% identical outcome and provides the best alternative. PMID:26542612

  20. Randomised controlled trial and health economic evaluation of the impact of diagnostic testing for influenza, respiratory syncytial virus and Streptococcus pneumoniae infection on the management of acute admissions in the elderly and high-risk 18- to 64-year-olds.

    PubMed Central

    Nicholson, Karl G; Abrams, Keith R; Batham, Sally; Medina, Marie Jo; Warren, Fiona C; Barer, Mike; Bermingham, Alison; Clark, Tristan W; Latimer, Nicholas; Fraser, Maria; Perera, Nelun; Rajakumar, K; Zambon, Maria

    2014-01-01

    BACKGROUND Western industrialised nations face a large increase in the number of older people. People over the age of 60 years account for almost half of the 16.8 million hospital admissions in England from 2009 to 2010. During 2009-10, respiratory infections accounted for approximately 1 in 30 hospital admissions and 1 in 20 of the 51.5 million bed-days. OBJECTIVE To determine the diagnostic accuracy and clinical effectiveness and cost-effectiveness of rapid molecular and near-patient diagnostic tests for influenza, respiratory syncytial virus (RSV) and Streptococcus pneumoniae infections in comparison with traditional laboratory culture. METHODS We carried out a randomised controlled trial (RCT) to evaluate impact on prescribing and clinical outcomes of point-of-care tests (POCTs) for influenza A and B and pneumococcal infection, reverse transcriptase-polymerase chain reaction (RT-PCR) tests for influenza A and B and RSV A and B, and conventional culture for these pathogens. We evaluated diagnostic accuracy of POCTs for influenza and pneumococcal infection, RT-PCR for influenza and sputum culture for S. pneumoniae using samples collected during the RCT. We did a systematic review and meta-analysis of POCTs for influenza A and B. We evaluated ease and speed of use of each test, process outcomes and cost-effectiveness. RESULTS There was no evidence of association between diagnostic group and prescribing or clinical outcomes. Using PCR as 'gold standard', Quidel Influenza A + B POCT detected 24.4% [95% confidence interval (CI) 16.0% to 34.6%] of influenza infections (specificity 99.7%, 95% CI 99.2% to 99.9%); viral culture detected 21.6% (95% CI 13.5% to 31.6%; specificity 99.8%, 95% CI 99.4% to 100%). Using blood culture as 'gold standard', BinaxNOW pneumococcal POCT detected 57.1% (95% CI 18.4% to 90.1%) of pneumococcal infections (specificity 92.5%; 95% CI 90.6% to 94.1%); sputum culture detected 100% (95% CI 2.5% to 100%; specificity 97.2%, 95% CI 94.3% to 98.9%). Overall, pooled estimates of sensitivity and specificity of POCTs for influenza from the literature were 74% (95% CI 67% to 80%) and 99% (95% CI 98% to 99%), respectively. Median intervals from specimen collection to test result were 15 minutes [interquartile range (IQR) 10-23 minutes) for Quidel Influenza A + B POCT, 20 minutes (IQR 15-30 minutes) for BinaxNOW pneumococcal POCT, 50.8 hours (IQR 44.3-92.6 hours) for semi-nested conventional PCR, 29.2 hours (IQR 26-46.9 hours) for real-time PCR, 629.6 hours (IQR 262.5-846.7 hours) for culture of influenza and 84.4 hours (IQR 70.7-137.8 hours) and 71.4 hours (IQR 69.15-84.0 hours) for culture of S. pneumoniae in blood and sputum, respectively. Both POCTs were rated straightforward and undemanding; blood culture was moderately complex and all other tests were complex. Costs and quality-adjusted life-years (QALYs) of each diagnostic strategy were similar. Incrementally, PCR was most cost-effective (78.3% probability at a willingness to pay of £20,000/QALY). Few patients were admitted within a timescale conducive to treatment with a neuraminidase inhibitor according to National Institute for Health and Care Excellence guidance. LIMITATIONS The accuracy study was limited by inadequate gold standards. CONCLUSIONS All tests had limitations. We found no evidence that POCTs for influenza or S. pneumoniae, or PCR for influenza or RSV influenced antimicrobial prescribing or clinical outcomes. The total costs and QALYs of each diagnostic strategy were similar, although, incrementally, PCR was the most cost-effective strategy. The analysis does not support routine use of POCTs for either influenza or pneumococcal antigen for adults presenting with acute cardiopulmonary conditions, but suggests that conventional viral culture for clinical diagnosis should be replaced by PCR. TRIAL REGISTRATION Current Controlled Trials ISRCTN21521552. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 36. See the NIHR Journals Library website for further project information. PMID:24875092

  1. Why you need to include human factors in clinical and empirical studies of in vitro point of care devices? Review and future perspectives.

    PubMed

    Borsci, Simone; Buckle, Peter; Hanna, George B

    2016-04-01

    Use of in-vitro point of care devices - intended as tests performed out of laboratories and near patient - is increasing in clinical environments. International standards indicate that interaction assessment should not end after the product release, yet human factors methods are frequently not included in clinical and empirical studies of these devices. Whilst the literature confirms some advantages of bed-side tests compared to those in laboratories there is a lack of knowledge of the risks associated with their use. This article provides a review of approaches applied by clinical researchers to model the use of in-vitro testing. Results suggest that only a few studies have explored human factor approaches. Furthermore, when researchers investigated people-device interaction these were predominantly limited to qualitative and not standardised approaches. The methodological failings and limitations of these studies, identified by us, demonstrate the growing need to integrate human factors methods in the medical field. PMID:26878393

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

    PubMed Central

    Shott, Joseph P.; Galiwango, Ronald M.; Reynolds, Steven J.

    2012-01-01

    Technology advances in rapid diagnosis and clinical monitoring of human immunodeficiency virus (HIV) infection have been made in recent years, greatly benefiting those at risk of HIV infection, those needing care and treatment, and those on antiretroviral (ART) therapy in sub-Saharan Africa. However, resource-limited, geographically remote, and harsh climate regions lack uniform access to these technologies. HIV rapid diagnostic tests (RDTs) and monitoring tools, such as those for CD4 counts, as well as tests for coinfections, are being developed and have great promise in these settings to aid in patient care. Here we explore the advances in point-of-care (POC) technology in the era where portable devices are bringing the laboratory to the patient. Quality management approaches will be imperative for the successful implementation of POC testing in endemic settings to improve patient care. PMID:22287974

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

    PubMed

    Sandhu, Adarsh; Handa, Hiroshi; Abe, Masanori

    2010-11-01

    Functionalized magnetic nanoparticles are important components in biorecognition and medical diagnostics. Here, we present a review of our contribution to this interdisciplinary research field. We start by describing a simple one-step process for the synthesis of highly uniform ferrite nanoparticles (d = 20-200 nm) and their functionalization with amino acids via carboxyl groups. For real-world applications, we used admicellar polymerization to produce 200 nm diameter 'FG beads', consisting of several 40 nm diameter ferrite nanoparticles encapsulated in a co-polymer of styrene and glycidyl methacrylate for high throughput molecular screening. The highly dispersive FG beads were functionalized with an ethylene glycol diglycidyl ether spacer and used for affinity purification of methotrexate-an anti-cancer agent. We synthesized sub-100 nm diameter magnetic nanocapsules by exploiting the self-assembly of viral capsid protein pentamers, where single 8, 20, and 27 nm nanoparticles were encapsulated with VP1 pentamers for applications including MRI contrast agents. The FG beads are now commercially available for use in fully automated bio-screening systems. We also incorporated europium complexes inside a polymer matrix to produce 140 nm diameter fluorescent-ferrite beads (FF beads), which emit at 618 nm. These FF beads were used for immunofluorescent staining for diagnosis of cancer metastases to lymph nodes during cancer resection surgery by labeling tumor cell epidermal growth factor receptor (EGFRs), and for the detection of brain natriuretic peptide (BNP)-a hormone secreted in excess amounts by the heart when stressed-to a level of 2.0 pg ml(-1). We also describe our work on Hall biosensors made using InSb and GaAs/InGaAs/AlGaAs 2DEG heterostructures integrated with gold current strips to reduce measurement times. Our approach for the detection of sub-200 nm magnetic bead is also described: we exploit the magnetically induced capture of micrometer sized 'probe beads' by nanometer sized 'target beads', enabling the detection of small concentrations of beads as small as 8 nm in 'pumpless' microcapillary systems. Finally, we describe a 'label-less homogeneous' procedure referred to as 'magneto-optical transmission (MT) sensing', where the optical transmission of a solution containing rotating linear chains of magnetic nanobeads was used to detect biomolecules with pM-level sensitivity with a dynamic range of more than four orders of magnitude. Our research on the synthesis and applications of nanoparticles is particularly suitable for point of care diagnostics. PMID:20935358

  4. Surface enhanced Raman spectroscopy based nanoparticle assays for rapid, point-of-care diagnostics

    NASA Astrophysics Data System (ADS)

    Driscoll, Ashley J.

    Nucleotide and immunoassays are important tools for disease diagnostics. Many of the current laboratory-based analytical diagnostic techniques require multiple assay steps and long incubation times before results are acquired. In the development of bioassays designed for detecting the emergence and spread of diseases in point-of-care (POC) and remote settings, more rapid and portable analytical methods are necessary. Nanoparticles provide simple and reproducible synthetic methods for the preparation of substrates that can be applied in colloidal assays, providing gains in kinetics due to miniaturization and plasmonic substrates for surface enhanced spectroscopies. Specifically, surface enhanced Raman spectroscopy (SERS) is finding broad application as a signal transduction method in immunological and nucleotide assays due to the production of narrow spectral peaks from the scattering molecules and the potential for simultaneous multiple analyte detection. The application of SERS to a no-wash, magnetic capture assay for the detection of West Nile Virus Envelope and Rift Valley Fever Virus N antigens is described. The platform utilizes colloid based capture of the target antigen in solution, magnetic collection of the immunocomplexes and acquisition of SERS spectra by a handheld Raman spectrometer. The reagents for a core-shell nanoparticle, SERS based assay designed for the capture of target microRNA implicated in acute myocardial infarction are also characterized. Several new, small molecule Raman scatterers are introduced and used to analyze the enhancing properties of the synthesized gold coated-magnetic nanoparticles. Nucleotide and immunoassay platforms have shown improvements in speed and analyte capture through the miniaturization of the capture surface and particle-based capture systems can provide a route to further surface miniaturization. A reaction-diffusion model of the colloidal assay platform is presented to understand the interplay of system parameters such as particle diameter, initial analyte concentration and dissociation constants. The projected sensitivities over a broad range of assay conditions are examined and the governing regime of particle systems reported. The results provide metrics in the design of more robust analytics that are of particular interest for POC diagnostics.

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

    NASA Astrophysics Data System (ADS)

    Sandhu, Adarsh; Handa, Hiroshi; Abe, Masanori

    2010-11-01

    Functionalized magnetic nanoparticles are important components in biorecognition and medical diagnostics. Here, we present a review of our contribution to this interdisciplinary research field. We start by describing a simple one-step process for the synthesis of highly uniform ferrite nanoparticles (d = 20-200 nm) and their functionalization with amino acids via carboxyl groups. For real-world applications, we used admicellar polymerization to produce 200 nm diameter 'FG beads', consisting of several 40 nm diameter ferrite nanoparticles encapsulated in a co-polymer of styrene and glycidyl methacrylate for high throughput molecular screening. The highly dispersive FG beads were functionalized with an ethylene glycol diglycidyl ether spacer and used for affinity purification of methotrexate—an anti-cancer agent. We synthesized sub-100 nm diameter magnetic nanocapsules by exploiting the self-assembly of viral capsid protein pentamers, where single 8, 20, and 27 nm nanoparticles were encapsulated with VP1 pentamers for applications including MRI contrast agents. The FG beads are now commercially available for use in fully automated bio-screening systems. We also incorporated europium complexes inside a polymer matrix to produce 140 nm diameter fluorescent-ferrite beads (FF beads), which emit at 618 nm. These FF beads were used for immunofluorescent staining for diagnosis of cancer metastases to lymph nodes during cancer resection surgery by labeling tumor cell epidermal growth factor receptor (EGFRs), and for the detection of brain natriuretic peptide (BNP)—a hormone secreted in excess amounts by the heart when stressed—to a level of 2.0 pg ml - 1. We also describe our work on Hall biosensors made using InSb and GaAs/InGaAs/AlGaAs 2DEG heterostructures integrated with gold current strips to reduce measurement times. Our approach for the detection of sub-200 nm magnetic bead is also described: we exploit the magnetically induced capture of micrometer sized 'probe beads' by nanometer sized 'target beads', enabling the detection of small concentrations of beads as small as 8 nm in 'pumpless' microcapillary systems. Finally, we describe a 'label-less homogeneous' procedure referred to as 'magneto-optical transmission (MT) sensing', where the optical transmission of a solution containing rotating linear chains of magnetic nanobeads was used to detect biomolecules with pM-level sensitivity with a dynamic range of more than four orders of magnitude. Our research on the synthesis and applications of nanoparticles is particularly suitable for point of care diagnostics.

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

    PubMed Central

    Satyagraha, Ari W.; Sadhewa, Arkasha; Elvira, Rosalie; Elyazar, Iqbal; Feriandika, Denny; Antonjaya, Ungke; Oyong, Damian; Subekti, Decy; Rozi, Ismail E.; Domingo, Gonzalo J.; Harahap, Alida R.; Baird, J. Kevin

    2016-01-01

    Background Patients infected by Plasmodium vivax or Plasmodium ovale suffer repeated clinical attacks without primaquine therapy against latent stages in liver. Primaquine causes seriously threatening acute hemolytic anemia in patients having inherited glucose-6-phosphate dehydrogenase (G6PD) deficiency. Access to safe primaquine therapy hinges upon the ability to confirm G6PD normal status. CareStart G6PD, a qualitative G6PD rapid diagnostic test (G6PD RDT) intended for use at point-of-care in impoverished rural settings where most malaria patients live, was evaluated. Methodology/Principal Findings This device and the standard qualitative fluorescent spot test (FST) were each compared against the quantitative spectrophotometric assay for G6PD activity as the diagnostic gold standard. The assessment occurred at meso-endemic Panenggo Ede in western Sumba Island in eastern Indonesia, where 610 residents provided venous blood. The G6PD RDT and FST qualitative assessments were performed in the field, whereas the quantitative assay was performed in a research laboratory at Jakarta. The median G6PD activity ≥5 U/gHb