Sample records for point-of-care testing poct

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

    PubMed

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

    2012-01-01

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

  2. Inflammation markers in point-of-care testing (POCT).

    PubMed

    Pfäfflin, Albrecht; Schleicher, Erwin

    2009-03-01

    Inflammation is a central issue in medicine. Inflammatory processes may be local or systemic, acute or chronic, and they may be benign or fatal. In bacterial or viral infections fast and reliable diagnosis is essential for appropriate treatment, e.g. antimicrobial therapy. The time to diagnosis is critical because uncontrolled infections may lead to sepsis with a mortality rate close to 50%. Beside clinical signs, laboratory markers are important in detecting, differentiating, and monitoring inflammation, particularly acute infections. Currently several inflammation markers including leukocyte count and leukocyte differentiation, C-reactive protein (CRP), procalcitonin (PCT), and interleukins (IL) 6 and 8, is available, and potential future serum markers are under development. In this article the clinical use of these markers in routine laboratory and in point-of-care testing is described and the diagnostic value of the four groups of laboratory marker is compared. Current data show that leukocyte count or, better, neutrophil count, CRP, and PCT are well suited to support of rapid diagnosis of inflammation and infections in children and adults whereas measurement of IL-6 and 8 are preferable for detection of sepsis in neonates. PMID:19104782

  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 Control Issues in Point of Care Testing

    Microsoft Academic Search

    Cameron L Martin

    Summary • Quality Control (QC) in Point of Care Testing (PoCT) is often thought of as a complex issue; however intelligent system analysis can simplify matters and greatly increase the chances of a well controlled system. What we want to achieve is a QC program which adequately controls the PoCT system, but does not excessively contribute to the operating costs

  5. Guidelines for point-of-care testing: haematology.

    PubMed

    Briggs, Carol; Guthrie, David; Hyde, Keith; Mackie, Ian; Parker, Norman; Popek, Mary; Porter, Neil; Stephens, Clare

    2008-09-01

    This guideline provides a framework for the arrangement of point-of-care testing (POCT) services, previously known as near patient testing (patient self-testing not covered). POCT is defined as any analytical test performed outside the laboratory. Primary users are often non-laboratory healthcare workers. The guidance applies to units within hospitals as well as general practioner surgeries, community clinics and pharmacies. The head of the haematology laboratory or a point of care coordinator must take responsibility for all aspects of the POCT service, including quality and training. Depending on the size and nature of the POCT practice, a local POCT manager may also be required. Equipment selected should have received a successful independent performance evaluation. If an independent evaluation has not been performed the purchaser should assess the device according to the protocol in this document. POCT devices should generate results that are comparable to those of the local laboratory. An accredited external quality assessment programme and internal quality control system must be established. Manufacturers promoting POCT devices designed for non-laboratory sites, e.g. pharmacies, should undertake training and annual competency assessment, perhaps using a web-based system. A diagram to illustrate the stages for the implementation of a POCT service is illustrated. PMID:18671699

  6. Poised for growth. Point-of-care testing.

    PubMed

    Scalise, Dagmara

    2006-09-01

    The United States is the world's biggest market for diagnostic testing, and one of the most active segments within that is point-of-care testing, or POCT. As test devices become more compact and easier to use, as well as more accurate, tests can be more frequently performed at the point of care, whether that is the emergency department, intensive care unit or a patient's home. Among the most common tests are those for blood glucose, blood gases, cardiac markers and sepsis, as well as pregnancy and ovulation. The biggest advantage of POCT is speed. Although home-based point-of-care testing is common, 70 percent of POCT takes place in hospitals, doctor's offices and other provider locations, and experts predict this segment will grow an average of 15.5 percent each year, significantly outpacing home-based testing. This gatefold gives an overview of POCT, discusses the challenges, benefits for hospitals, and provides a glimpse of what experts believe point-of-care testing will look like in the future. PMID:17036771

  7. Does POCT reduce the risk of error in laboratory testing?

    PubMed

    Plebani, Mario

    2009-06-01

    Point-of-care testing (POCT), the fastest growing segment of the current clinical laboratory testing market, is a rapid means for providing test results in different clinical settings. In theory, this tool eliminates some of the more problematic steps in the testing process, including specimen transport and result distribution. However, POCT has created new challenges, and sources of potential errors; moreover, while the upsurge in its use has generated concerns regarding the quality of test results, few data are available in the literature on errors with POCT. Nor are data available for the evaluation of errors, and the risk of errors in POCT based on all steps in the entire testing process, including test requesting and result utilization. According to a modified Kost model, which takes into account all steps of the testing process and latent conditions for error, POCT reduces errors and the risk of error in only a few steps of the testing process. There is therefore an urgent need for an evaluation of errors and risks of error in POCT that is based on the entire testing process and uses well-designed studies aiming to improve clinical outcomes and increase patient safety. PMID:19298804

  8. ICSH Guideline for worldwide point-of-care testing in haematology with special reference to the complete blood count

    Microsoft Academic Search

    C. BRIGGS; J. CARTER; S.-H. LEE; L. SANDHAUS; R. SIMON-LOPEZ; J.-L. VIVES CORRONS

    2008-01-01

    SUMMARY These guidelines provide information on how to develop and manage a point-of-care (POCT) service so that reliable haematology results are produced regardless of where the test is performed. Many of the issues addressed here are relevant to POCT within hospitals or health centres; however, the principles are equally applicable to care in the commu- nity and doctors' offices. Other

  9. 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

  10. 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

  11. [Blood test results are available sooner if Point of Care testing is established in an emergency room].

    PubMed

    Aachmann-Andersen, Niels Jacob; Bjerrum, Poul Jannik; Rasmussen, Søren Wistisen; Schmidt, Thomas Andersen

    2012-01-16

    To determine patient priority and degree of urgency with an objective high-quality evaluation, general Point of Care testing (POCT) was established as a novel facility in the emergency department at Holbæk Hospital, a laboratory that provides faster results for common lab tests. When evaluating response time from arrival of the patient to the time at which the test results are available, POCT is not a significantly better test method than ordinary test methods. This indicates that in order to benefit from POCT the time before taking blood samples should be reduced to a minimum. Overcrowding needs to be controlled in order to accomplish this. PMID:22248847

  12. Lensless Imaging for Point-of-Care Testing

    PubMed Central

    Moon, SangJun; Keles, Hasan Onur; Kim, Yun-Gon; Kuritzkes, Daniel; Demirci, Utkan

    2013-01-01

    We show a platform that merges a microfluidic chip with lensless imaging for CD4+ T-lymphocyte counting at resource-limited settings. To capture CD4+ T lymphocytes, anti-CD4 antibody was immobilized on a microfluidic chip. The captured cells were detected by a charge coupled device (CCD) sensor using lensless shadow imaging techniques. Gray scale shadow images of captured cells on the chip (24 mm × 4 mm × 50 ?m) were enumerated in three seconds using an automatic cell counting software. The device 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). This integrated platform has potential for point-of-care testing (POCT) to rapidly capture, image and count specific cell types from unprocessed whole blood. PMID:19964416

  13. Cost consequences of point-of-care troponin T testing in a Swedish primary health care setting

    PubMed Central

    Andersson, Agneta; Janzon, Magnus; Karlsson, Jan-Erik; Levin, Lars-Åke

    2014-01-01

    Abstract Objective. To evaluate the safety and cost-effectiveness of point-of-care troponin T testing (POCT-TnT) for the management of patients with chest pain in primary care. Design. Prospective observational study with follow-up. Setting. Three primary health care (PHC) centres using POCT-TnT and four PHC centres not using POCT-TnT in south-east Sweden. Patients. All patients ? 35 years of age, contacting one of the PHC centres for chest pain, dyspnoea on exertion, unexplained weakness and/or fatigue, with no other probable cause than cardiac, were included. Symptoms must have commenced or worsened during the previous seven days. Main outcome measures. Emergency referral rates, diagnoses of acute myocardial infarction (AMI) or unstable angina (UA), and costs were collected for 30 days after the patient sought care at the PHC centre. Results. A total of 196 patients with chest pain were included: 128 in PHC centres with POCT-TnT and 68 in PHC centres without POCT-TnT. Fewer patients from the PHC centres with POCT-TnT (n = 32, 25%) were emergently referred to hospital than from centres without POCT-TnT (n = 29, 43%; p = 0.011). Eight patients (6.2%) from PHC centres with POCT-TnT were diagnosed with AMI or UA compared with six patients (8.8%) from centres without POCT-TnT (p = 0.565). Two patients with AMI or UA were classified as missed cases from PHC centres with POCT-TnT and there were no missed cases from PHC centres without POCT-TnT. SKr290 000 was saved per missed case of AMI or UA. Conclusion. The use of POCT-TnT in primary care may be cost saving but at the expense of missed cases. PMID:25434410

  14. Point-of-care testing, medical error, and patient safety: a 2007 assessment.

    PubMed

    Ehrmeyer, Sharon S; Laessig, Ronald H

    2007-01-01

    Point-of-care testing (POCT) is the fastest growing segment of a US$30 billion worldwide market. "Errors" in the testing process, as well as medical data interpretation and treatment associated with POCT, are recognized as leading to major compromises of patient safety. In today's environment, most testing errors (pre-analytical, analytical and post-analytical) can be virtually eliminated by proper design of testing systems. We cite examples of two systems that have made exceptional progress in this respect. It has been recently suggested that the basic errors associated with the testing process are amplified in the POC setting. Two of the amplifiers - incoherent regulations and failure of clinician/caregivers to respond appropriately to POCT results - lead us to recognize additional changes in today's POCT environment. The first is a willingness of manufacturers, not laboratories, to take responsibility for the quality of test results - an outgrowth of an industrial philosophy called autonomation. The second is a need to substantially modify the clinician/caregiver test utilization paradigm to take full advantage of POCT results, available on site in real time. Both have already begun to take place. PMID:17579530

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

    PubMed

    Rooney, Kevin D; Schilling, Ulf Martin

    2014-01-01

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

  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. Accuracy and precision of point-of-care testing for glucose and prothrombin time at the critical care units

    Microsoft Academic Search

    Cecilia Yuoh; M Tarek Elghetany; John R Petersen; Amin Mohammad; Anthony O Okorodudu

    2001-01-01

    The use of point-of-care testing (POCT) in critical care patient units has continued to increase since the 1980s. This increase is due to the need for prompt therapeutic interventions that may impact mortality and morbidity, and reduce the overall cost of healthcare for critically ill patients. The diagnostic manufacturing industry has risen to this challenge by introducing portable and\\/or handheld

  18. Bodily Fluid Analysis of Non-Serum Samples using Point-of-Care Testing with iSTAT and Piccolo Analyzers Versus a Fixed Hospital Chemistry Analytical Platform

    PubMed Central

    Davis, Konrad; Helman, Donald; Abadie, Jude

    2014-01-01

    Introduction: Forward deployed military medical units can provide sophisticated medical care with limited resources. Point-of-Care Testing (POCT) may facilitate care and expedite diagnosis. This study assessed the accuracy of results for POCT for non-serum samples (pleural, peritoneal, and cerebrospinal fluid) using iSTAT and Piccolo hand-held devices compared with results obtained using a hospital chemistry analyzer. Methods: Pleural, peritoneal, and cerebrospinal fluids obtained during routine care were simultaneously analyzed on a Vitros 5600 automated clinical chemistry hospital analyzer, iSTAT, and Piccolo POCT devices. Results: POCT results were highly correlated with the Vitros 5600 for pleural fluid LDH, glucose, and triglycerides (TG); for peritoneal fluid bilirubin, TG, glucose, albumin, and protein; and glucose for cerebrospinal fluid. Conclusion: POCT results for non-serum samples from pleural, peritoneal, and cerebrospinal fluid correlate with standard hospital chemistry analysis. The results of this study demonstrate potential for possible new diagnostic roles for POCT in resource-limited environments. PMID:25285247

  19. 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

  20. Review: progress in the diagnosis of dengue virus infections and importance of point of care test: a review.

    PubMed

    Fatima, Aneela; Wang, Jufang

    2015-01-01

    It is an urgent need of highly sensitive, specific and economical diagnostic tools for early and fast diagnosis of highly challenging dengue virus infections. Many laboratory methods including virus detection, genome detection, antigen detection and serological detection of such short-lived viremia were explored but promising outcomes for economical immunochromatographic tests have been reported in this review. With the trend of fast, easy operation, rapid diagnostic tests (RDT) based on immunochromatographic assays are of great importance due to point of care test (POCT) in the dengue endemic regions where it is short of laboratory equipments and cold storage conditions. Such kind of point of care diagnosis is more efficient, fast and user friendly. Moreover, the development of highly advance RDT is dependent on the use of anti-dengue monoclonal antibodies highly specific for particular analyte/antigen. PMID:25553705

  1. Integrating microfluidics and lensless imaging for point-of-care testing.

    PubMed

    Moon, Sangjun; Keles, Hasan Onur; Ozcan, Aydogan; Khademhosseini, Ali; Haeggstrom, Edward; Kuritzkes, Daniel; Demirci, Utkan

    2009-07-15

    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 x 4 mm x 50 microm microfluidic chip was obtained by the lensless imaging platform. The automatic cell counting software enumerated the captured cells in 3s. 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 min. 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

  2. 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 ?m 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

  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 of Hemostasis in Cardiac Surgery.

    PubMed

    Prisco, Domenico; Paniccia, Rita

    2003-05-01

    An excessive perioperative blood loss, that requires transfusion of blood products, sometimes occurs in patients undergoing cardiopulmonary bypass for cardiac surgery. Blood loss and transfusion requirements in these patients may be reduced with a better control of heparin treatment and its reversal. Blood component administration in patients with excessive post-cardiopulmonary bypass bleeding has been empiric for a long time due to turnaround times of laboratory coagulation tests. Devices are now available for rapid, point-of-care assessment of hemostasis alterations to allow an appropriate, targeted therapy. In particular, a quick evaluation of platelet and coagulation defects with new point-of-care devices can optimize the administration of pharmacological and transfusion-based therapy in patients with excessive bleeding after cardiopulmonary bypass. PMID:12904262

  5. Point-of-Care Testing of Hemostasis in Cardiac Surgery

    PubMed Central

    Prisco, Domenico; Paniccia, Rita

    2003-01-01

    An excessive perioperative blood loss, that requires transfusion of blood products, sometimes occurs in patients undergoing cardiopulmonary bypass for cardiac surgery. Blood loss and transfusion requirements in these patients may be reduced with a better control of heparin treatment and its reversal. Blood component administration in patients with excessive post-cardiopulmonary bypass bleeding has been empiric for a long time due to turnaround times of laboratory coagulation tests. Devices are now available for rapid, point-of-care assessment of hemostasis alterations to allow an appropriate, targeted therapy. In particular, a quick evaluation of platelet and coagulation defects with new point-of-care devices can optimize the administration of pharmacological and transfusion-based therapy in patients with excessive bleeding after cardiopulmonary bypass. PMID:12904262

  6. 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

  7. Economic Evidence and Point-of-Care Testing.

    PubMed

    St John, Andrew; Price, Christopher P

    2013-08-01

    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

  8. Point-of-care nucleic acid testing for infectious diseases

    PubMed Central

    Niemz, Angelika; Ferguson, Tanya M.; Boyle, David S.

    2013-01-01

    Nucleic acid testing for infectious diseases at the point of care is beginning to enter clinical practice in developed and developing countries; especially for applications requiring fast turnaround times, and in settings where a centralized laboratory approach faces limitations. Current systems for clinical diagnostic applications are mainly PCR-based, can only be used in hospitals, and are still relatively complex and expensive. Integrating sample preparation with nucleic acid amplification and detection in a cost-effective, robust, and user-friendly format remains challenging. This review describes recent technical advances that might be able to address these limitations, with a focus on isothermal nucleic acid amplification methods. It briefly discusses selected applications related to the diagnosis and management of tuberculosis, HIV, and perinatal and nosocomial infections. PMID:21377748

  9. 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

  10. 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

  11. Point-of-care testing in critically ill patients.

    PubMed

    Fries, Dietmar; Streif, Werner

    2015-02-01

    Point-of-care (POC) testing in hemostasis has experienced a significant increase in the spectrum of available tests and the number of tests performed. Short turn-around time and observation of rapid changes in test results are facilitated. The quality control process in POC testing must encompass a preanalytic (collection), analytic (measurement), and postanalytic (clinical response) phase. Erroneous interpretation of findings and difficult quality controls can outweigh the advantages of POC testing.Only a limited number of hemostatic POC tests have proven useful so far: prothrombin time POC-monitoring of oral vitamin K antagonists; activated clotting time POC-monitoring of high-dose heparin therapy; platelet function analyzer (PFA; Siemens, Marburg, Germany) closure time (CT)-detection of von Willebrand disease and severe platelet function defects; whole blood aggregometry (WBA) Multiplate (Roche Diagnostics, Rotkreuz, Switzerland), and the VerifyNow system (Accumetrics, San Diego, CA)-detection of platelet dysfunction due to antiplatelet drugs; thromboelastography-continuous observation of clot formation and fibrinolysis. The use of various agonists in WBA and thromboelastography (TEG) requires some expertise. In experienced hands the PFA CT and WBA and TEG are recommended combinations.Application of POC testing depends strictly on whether it improves medical care and patient outcome. More POC test systems are in the research pipeline, but only a few will resist the ravages of time. PMID:25611850

  12. Total internal reflection (TIRF)-based quantification of procalcitonin for sepsis diagnosis--a point-of-care testing application.

    PubMed

    Rascher, Daniela; Geerlof, Arie; Kremmer, Elisabeth; Krämer, Petra; Michael, Schmid; Hartmann, Anton; Rieger, Martin

    2014-09-15

    A new, highly sensitive fluorescence immunoassay for a TIRF (total internal reflection)-based point-of-care testing (POCT) device was developed for the detection of procalcitonin (PCT), a specific and early marker for sepsis and microbial infections. The immunoassay was performed on a bench-top system that fulfilled all the necessary characteristics of a POCT application, including a short measurement time (<9 min), no sample pre-treatment requirements and application directly near patients. New rat monoclonal antibodies targeting PCT were screened and characterized. The best combinations of antibodies were then integrated into single-use cartridges, and the reduction of nonspecific binding was achieved by supplying suitable additives. Moreover, human recombinant PCT (hrPCT) for use as a standard was developed in the native form of hPCT in plasma (PCT1-116, PCT3-116). The assay achieves the required sensitivity range in human plasma to allow reliable differentiation between healthy persons and varying stages of infection severity (LOD=0.04 ng/mL; LOQ=0.12 ng/mL). Furthermore, the developed PCT assay can be applied in whole human blood with an adequate sensitivity (LOD=0.02 ng/mL; LOQ=0.09 ng/mL). To the best of our knowledge, this is the first diagnostic test for sepsis to use whole blood, which is a crucial requirement for POCT. We were able to detect native PCT in patient samples and showed a good correlation (R(2)=0.988) with the results of the Kryptor(®) device from BRAHMS, a state of the art device for the detection of PCT. PMID:24732603

  13. 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

  14. 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

  15. 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

  16. Rapid Point-of-Care Testing for Detection of HIV and Clinical Monitoring

    PubMed Central

    Arora, D. R.; Maheshwari, Megha; Arora, B.

    2013-01-01

    Reversing and arresting the epidemic of HIV are a challenge for any country. Early diagnosis and rapid initiation of treatment remain a key strategy in the control of HIV. Technological advances in the form of low-cost rapid point-of-care tests have completely transformed the diagnosis and management of HIV, especially in resource limited settings, where health infrastructure is poor and timely access to medical care is a challenge. Point-of-care devices have proven to be easy to transport, operate, and maintain, and also lower-skilled staff is equally able to perform these tests as compared to trained laboratory technicians. Point-of-care tests allow rapid detection of HIV allowing for rapid initiation of therapy, monitoring of antiretroviral therapy and drug toxicity, and detection of opportunistic infections and associated illnesses. PMID:24052887

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

    PubMed Central

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

    2014-01-01

    Background Syphilis point-of-care tests may reduce morbidity and ongoing transmission by increasing the proportion of people rapidly treated. Syphilis stage and co-infection with HIV may influence test performance. We evaluated four commercially available syphilis point-of-care devices in a head-to-head comparison using sera from laboratories in Australia. Methods Point-of-care tests were evaluated using sera stored at Sydney and Melbourne laboratories. Sensitivity and specificity were calculated by standard methods, comparing point-of-care results to treponemal immunoassay (IA) reference test results. Additional analyses by clinical syphilis stage, HIV status, and non-treponemal antibody titre were performed. Non-overlapping 95% confidence intervals (CI) were considered statistically significant differences in estimates. Results In total 1203 specimens were tested (736 IA-reactive, 467 IA-nonreactive). Point-of-care test sensitivities were: Determine 97.3%(95%CI:95.8–98.3), Onsite 92.5%(90.3–94.3), DPP 89.8%(87.3–91.9) and Bioline 87.8%(85.1–90.0). Specificities were: Determine 96.4%(94.1–97.8), Onsite 92.5%(90.3–94.3), DPP 98.3%(96.5–99.2), and Bioline 98.5%(96.8–99.3). Sensitivity of the Determine test was 100% for primary and 100% for secondary syphilis. The three other tests had reduced sensitivity among primary (80.4–90.2%) compared to secondary syphilis (94.3–98.6%). No significant differences in sensitivity were observed by HIV status. Test sensitivities were significantly higher among high-RPR titre (RPR?8) (range: 94.6–99.5%) than RPR non-reactive infections (range: 76.3–92.9%). Conclusions The Determine test had the highest sensitivity overall. All tests were most sensitive among high-RPR titre infections. Point-of-care tests have a role in syphilis control programs however in developed countries with established laboratory infrastructures, the lower sensitivities of some tests observed in primary syphilis suggest these would need to be supplemented with additional tests among populations where syphilis incidence is high to avoid missing early syphilis cases. PMID:24618681

  18. Excluding venous thromboembolism using point of care D-dimer tests in outpatients: a diagnostic meta-analysis

    Microsoft Academic Search

    G. J. Geersing; K. J. M. Janssen; R. Oudega; L. Bax; A. W. Hoes; J. B. Reitsma; K. G. M. Moons

    2009-01-01

    Objective To review the evidence on the diagnostic accuracy of the currently available point of care D-dimer tests for excluding venous thromboembolism.Design Systematic review of research on the accuracy of point of care D-dimer tests, using bivariate regression to examine sources of variation and to estimate sensitivity and specificity.Data sources Studies on the diagnostic accuracy of point of care D-dimer

  19. Risk stratification with a point-of-care cardiac troponin T test in acute myocardial infarction

    Microsoft Academic Search

    E. Magnus Ohman; Paul W Armstrong; Harvey D White; Christopher B Granger; Robert G Wilcox; W. Douglas Weaver; W. Brian Gibler; Amanda L Stebbins; Cresha Cianciolo; Robert M Califf; Eric J Topol

    1999-01-01

    Troponin T has been used successfully to risk stratify patients with acute coronary syndromes, but the utility of this approach using a rapid bedside assay in patients undergoing thrombolysis for ST-segment elevation acute myocardial infarction has not been assessed in a large population. We assessed whether a point-of-care, qualitative troponin T test at enrollment could independently risk-stratify patients randomized to

  20. 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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

    Engel, Nora; Pant Pai, Nitika

    2015-01-01

    Point-of-care (POC) testing in communities, home settings and primary healthcare centers plays an important role in cutting delays in HIV diagnosis and in the uptake of voluntary testing and counseling. Qualitative research methods have important potential to overcome the current challenges in expanding HIV POC testing programs and strategies, by examining the diagnostic processes, complex inter-relationships and patterns involved in making POC diagnostics work in real-world settings. This article reviews existing qualitative studies on POC testing strategies and programs for HIV. Qualitative research on POC diagnostics around the uptake of POC tests, the actual diagnostic and testing processes involved, the influence of POC tests on clinical decision-making, communication of decisions and decisions exercised by patients are limited. Equally limited are studies that explore adaptation of POC programs to various socio-cultural contexts. More qualitative research is needed to inform test developers, funders and policymakers. PMID:25267607

  3. 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

  4. Evaluation of the Alere D-dimer test for point of care testing.

    PubMed

    Helmersson-Karlqvist, Johanna; Karlsson, Bo; Fredriksson, Annika; Larsson, Anders

    2014-01-01

    The primary care regularly sees patients that have symptoms that could be due to thromboembolic diseases. It would be valuable to be able to rule out deep venous thrombosis or pulmonary embolism using Wells score and a negative D-dimer testing already at the primary care unit. This requires a validated D-dimer assay suitable for primary care use. We compared D-dimer results obtained with the new point of care analyzer Alere Triage(®) and the central hospital laboratory STA-R Evolution analyzer from the same patient samples (n = 102). We also calculated the total coefficient of variation (CV) for the Alere method. The two methods showed a good linear correlation (R(2) = 0.977) and a slope of 0.975. CV for the Alere D-dimer method was well below 10%. The study shows that the Alere D-dimer assay and the central laboratory standard assay show similar results. We suggest that the Alere D-dimer assay could be used in primary care in combination with Wells score to reduce referrals to the emergency unit. PMID:24381121

  5. Diagnostic Accuracy of Point-of-Care Testing for Diabetic Ketoacidosis at Emergency-Department Triage

    PubMed Central

    Arora, Sanjay; Henderson, Sean O.; Long, Theodore; Menchine, Michael

    2011-01-01

    OBJECTIVE In the emergency department, hyperglycemic patients are screened for diabetic ketoacidosis (DKA) via a urine dipstick. In this prospective study, we compared the test characteristics of point-of-care ?-hydroxybutyrate (?-OHB) analysis with the urine dipstick. RESEARCH DESIGN AND METHODS Emergency-department patients with blood glucose ?250 mg/dL had urine dipstick, chemistry panel, venous blood gas, and capillary ?-OHB measurements. DKA was diagnosed according to American Diabetes Association criteria. RESULTS Of 516 hyperglycemic subjects, 54 had DKA. The urine dipstick had a sensitivity of 98.1% (95% CI 90.1–100), a specificity of 35.1% (30.7–39.6), a positive predictive value of 15% (11.5–19.2), and a negative predictive value of 99.4% (96.6–100) for DKA. Using the manufacturer-suggested cutoff of >1.5 mmol/L, ?-OHB had a sensitivity of 98.1% (90.1–100), a specificity of 78.6% (74.5–82.2), a positive predictive value of 34.9% (27.3–43), and a negative predictive value of 99.7% (98.5–100) for DKA. CONCLUSIONS Point-of-care ?-OHB and the urine dipstick are equally sensitive for detecting DKA (98.1%). However, ?-OHB is more specific (78.6 vs. 35.1%), offering the potential to significantly reduce unnecessary DKA work-ups among hyperglycemic patients in the emergency department. PMID:21307381

  6. Emerging Nucleic Acid–Based Tests for Point-of-Care Detection of Malaria

    PubMed Central

    Cordray, Michael S.; Richards-Kortum, Rebecca R.

    2012-01-01

    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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

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

    PubMed Central

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

    2014-01-01

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

  14. 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 2years of age with a test sensitivity of 81.8%. RSV sensitivities were highest (85%) in the first 2days 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

  15. 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

  16. 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

  17. 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

  18. Routine use of point-of-care tests: usefulness and application in clinical microbiology.

    PubMed

    Clerc, O; Greub, G

    2010-08-01

    Point-of-care (POC) tests offer potentially substantial benefits for the management of infectious diseases, mainly by shortening the time to result and by making the test available at the bedside or at remote care centres. Commercial POC tests are already widely available for the diagnosis of bacterial and viral infections and for parasitic diseases, including malaria. Infectious diseases specialists and clinical microbiologists should be aware of the indications and limitations of each rapid test, so that they can use them appropriately and correctly interpret their results. The clinical applications and performance of the most relevant and commonly used POC tests are reviewed. Some of these tests exhibit insufficient sensitivity, and should therefore be coupled to confirmatory tests when the results are negative (e.g. Streptococcus pyogenes rapid antigen detection test), whereas the results of others need to be confirmed when positive (e.g. malaria). New molecular-based tests exhibit better sensitivity and specificity than former immunochromatographic assays (e.g. Streptococcus agalactiae detection). In the coming years, further evolution of POC tests may lead to new diagnostic approaches, such as panel testing, targeting not just a single pathogen, but all possible agents suspected in a specific clinical setting. To reach this goal, the development of serology-based and/or molecular-based microarrays/multiplexed tests will be needed. The availability of modern technology and new microfluidic devices will provide clinical microbiologists with the opportunity to be back at the bedside, proposing a large variety of POC tests that will allow quicker diagnosis and improved patient care. PMID:20670287

  19. 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.

  20. 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

  1. 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

  2. Integration of clinical point-of-care requirements in a DNA microarray genotyping test.

    PubMed

    Van Dorst, Bieke; Cremers, Amelieke; Jans, Karolien; Van Domburg, Trees; Steegen, Kim; Huang, Chengjun; Dorrer, Christian; Lagae, Liesbet; Ferwerda, Gerben; Stuyver, Lieven J

    2014-11-15

    Various proof-of-concept studies have shown the potential of biosensors with a high multiplex detection capability for the readout of DNA microarrays in a lab-on-a-chip. This is particularly interesting for the development of point-of-care genotyping tests, to screen for multiple pathogens and/or antibiotic resistance patterns. In this paper, an assay workflow is presented, suited for the development of novel lab-on-a-chips with an integrated DNA microarray. Besides the description of the different assay steps (DNA purification, amplification and detection), a control strategy is presented according to recommendations of the US Food and Drug Administration (FDA). To use a lab-on-a-chip for diagnostic applications, the optimization and evaluation of the assay performance with clinical samples is very important. Therefore, appropriate quantification methods are described, which allow optimization and evaluation of the separate assay steps, as well as total assay performance. In order to demonstrate and evaluate the total workflow, blood samples spiked with Streptococcus pneumoniae were tested. All blood samples with ? 10(3)CFU S. pneumoniae per ml of human blood were successfully detected by this genotyping assay. PMID:24967749

  3. 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

  4. 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.

  5. 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

  6. 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

    2014-09-25

    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

  7. Point-of-care platelet function testing in patients undergoing PCI: between a rock and a hard place

    PubMed Central

    van Werkum, J.W.; Hackeng, C.M.; de Korte, F.I.; Verheugt, F.W.A.; ten Berg, J.M.

    2007-01-01

    Since recent studies have linked an impaired response to antiplatelet therapy with a higher incidence of atherothrombotic events, the monitoring of the efficacy of antiplatelet therapy in the individual patient has attracted much attention. In the present report, we demonstrate that platelet function testing with several point-of-care assays results in ambiguous and conflicting results: some assays indicated that the patient’s platelets were insufficiently inhibited by clopidogrel whereas other assays reported an adequate response. Therefore, platelet function assays should not be used solely to guide treatment decisions, and tailor-made antithrombotic treatment has to wait for the most predictive platelet function test to emerge for measuring the risk for thrombotic complications after stenting. Until then, daily clinical practice should not be guided by point-of-care platelet function testing. (Neth Heart J 2007;15:299-305.18030318). PMID:18030318

  8. 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

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

    PubMed Central

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

    2015-01-01

    Background Point-of-care tests provide a plausible diagnostic strategy for hepatitis C infection in economically impoverished areas. However, their utility depends upon the overall performance of individual tests. Methods A literature search was conducted using the metasearch engine Mett?, a query interface for retrieving articles from five leading medical databases. Studies were included if they employed point-of-care tests to detect antibodies of hepatitis C virus and compared the results with reference tests. Two reviewers performed a quality assessment of the studies and extracted data for estimating test accuracy. Findings Thirty studies that had evaluated 30 tests fulfilled the inclusion criteria. The overall pooled sensitivity, specificity, positive likelihood-ratio, negative likelihood-ratio and diagnostic odds ratio for all tests were 97.4% (95% CI: 95.9–98.4), 99.5% (99.2–99.7), 80.17 (55.35–116.14), 0.03 (0.02–0.04), and 3032.85 (1595.86–5763.78), respectively. This suggested a high pooled accuracy for all studies. We found substantial heterogeneity between studies, but none of the subgroups investigated could account for the heterogeneity. Genotype diversity of HCV had no or minimal influence on test performance. Of the seven tests evaluated in the meta-regression model, OraQuick had the highest test sensitivity and specificity and showed better performance than a third generation enzyme immunoassay in seroconversion panels. The next highest test sensitivities and specificities were from TriDot and SDBioline, followed by Genedia and Chembio. The Spot and Multiplo tests produced poor test sensitivities but high test specificities. Nine of the remaining 23 tests produced poor test sensitivities and specificities and/or showed poor performances in seroconversion panels, while 14 tests had high test performances with diagnostic odds ratios ranging from 590.70 to 28822.20. Conclusions Performances varied widely among individual point-of-care tests for diagnosis of hepatitis C virus infection. Physicians should consider this while using specific tests in clinical practice. PMID:25816332

  10. 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

  11. 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

  12. 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

  13. Multiplexed testing for HIV and related bacterial and viral co-infections at the point-of-care: quo vadis?

    PubMed

    Pant Pai, Nitika; Daher, Jana

    2015-04-01

    Recently, there has been a paradigm shift toward an understanding of the need to screen select sub-populations for several sexually transmitted and blood-borne infections simultaneously, at one time with various rapid point-of-care (POC) technologies, rather than one infection at a time. This is an encouraging and promising change, however many contextual factors need to be considered before implementing such technologies. In this editorial, we highlight some challenges, issues and concerns regarding implementation, integration, and uptake of these technologies across global settings. However, careful planning and well thought out implementation plan that include investments in training health care professionals, improving test and treat algorithms, rapid protocols on communicating actionable results to providers, and timely action, will bring about the desired impact in patient's lives. This is especially true in settings where they stand to achieve the maximum desired public health and social impact. PMID:25795042

  14. Microfluidics and point-of-care testing DOI: 10.1039/b817915h

    E-print Network

    Sia, Samuel K.

    to the development of dip stick devices, and these devices evolved to self-contained lateral flow tests (e near the patient without needing a clinical lab): low consumption of reagents and sample and were based on tablets containing the test reagents. Subsequent technological innovation led

  15. 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.

  16. 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

  17. Multisite evaluation of point of care CD4 testing in Papua New Guinea.

    PubMed

    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 (r(2) = 0.973, p<0.0001, n = 101) and PIMA -22.43 cells/µl (r(2)= 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 r(2) = 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

  18. 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

  19. 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

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

    PubMed Central

    Shuster, Sara M.; Davey, Cynthia S.

    2014-01-01

    Objective: Determine the percentage of subjects taking antipsychotics who meet criteria for metabolic syndrome based on point-of-care testing analyses. Evaluate pharmacist comprehensive medication management services using point-of-care tests to reduce the mean difference in number of metabolic syndrome risk parameters at 6 and 12 months. Method: This 12-month, prospective, multisite, randomized, controlled study included 120 subjects taking antipsychotics (mean [SD] age of 42.9 [11.3] years) recruited from 3 community mental health clinics in Minnesota. Subjects consented to receive either pharmacist (PCS; n = 60) or no pharmacist (NCS; n = 60) comprehensive medication management services. Data were collected from February 2010 to January 2012. Results: No statistical differences in metabolic syndrome based on point-of-care tests were observed between the 2 groups at baseline (PCS: 85.2%, n = 46 versus NCS: 71.2%, n = 42, P = .073) or at 12 months (PCS: 84.4%, n = 38 versus NCS: 70.2%, n = 33, P = .104). Subjects, overall, screened positive at baseline for dyslipidemia (85.8%, n = 106), hypertension (52.5%, n = 63), and diabetes (22.5%, n = 27) based on point-of-care testing for metabolic risk criteria. After 12 months, a nonsignificant (P = .099) higher adjusted mean number of metabolic syndrome parameters in PCS subjects compared to NCS subjects (mean difference [95% CI] = 0.41 [?0.08 to 0.90]) were found. Conclusions: A relatively high proportion of subjects met criteria for metabolic syndrome, although no significant improvement was observed between the groups after 12 months. Point-of-care test analyses identified a high proportion of subjects meeting criteria for dyslipidemia, hypertension, and diabetes. Utilizing point-of-care tests in mental health settings and fostering interprofessional partnerships with comprehensive medication management pharmacists may improve identification and long-term management of metabolic risks among patients prescribed antipsychotics. Trial Registration: ClinicalTrials.gov identifier: NCT02029989 PMID:25667811

  1. Disposable dry-reagent cotton thread-based point-of-care diagnosis devices for protein and nucleic acid test.

    PubMed

    Mao, Xun; Du, Ting-E; Wang, Yiyun; Meng, Lili

    2014-10-30

    We report here for the first time by using dry-reagent cotton thread-based point-of-care diagnosis devices for low-cost, sensitive and rapid detection of a lung cancer related biomarker, squamous cell carcinoma antigen (SCCA) and a human genetic disease, hereditary tyrosinemia type I related DNA sequences. A model system comprising SCCA as an analyte and a pair of monoclonal antibodies is used to demonstrate the proof-of-concept on the dry-reagent cotton thread based immunoassay device. An enhancement protocol was employed by using two kinds of gold nanoparticle labels for SCCA test which greatly improved the sensitivity of the device. The assay avoids the multiple incubation and washing steps performed in most conventional protein analyses, which is similar with the lateral flow strip technology. Under optimal conditions, the thread based immunoassay device was capable of measuring 1ng/mL SCCA in 20min which meet the requirement for clinical diagnosis. DNA detection was successfully realized by using a novel adenosine based molecular beacon probe as reporter probes in the cotton thread based device, the linear range is 75-3000fmol which is suitable for quantitative test. PMID:25461186

  2. 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

  3. 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

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

    PubMed

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

    2012-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2014-12-01

    Early identification of chronic hepatitis B is important for optimal disease management and prevention of transmission. Cost and lack of access to commercial hepatitis B surface antigen (HBsAg) immunoassays can compromise the effectiveness of HBV screening in resource-limited settings and among marginalized populations. High-quality point-of-care (POC) testing may improve HBV diagnosis in these situations. Currently available POC HBsAg assays are often limited in sensitivity. We evaluated the NanoSign(®) HBs POC chromatographic immunoassay for its ability to detect HBsAg of different genotypes and with substitutions in the 'a' determinant. Thirty-seven serum samples from patients with HBV infection, covering HBV genotypes A-G, were assessed for HBsAg titre with the Roche Elecsys HBsAg II quantification assay and with the POC assay. The POC assay reliably detected HBsAg at a concentration of at least 50 IU/mL for all genotypes, and at lower concentrations for some genotypes. Eight samples with substitutions in the HBV 'a' determinant were reliably detected after a 1/100 dilution. The POC strips were used to screen serum samples from 297 individuals at risk for HBV in local clinical settings (health fairs and outreach events) in parallel with commercial laboratory HBsAg testing (Quest Diagnostics EIA). POC testing was 73.7% sensitive and 97.8% specific for detection of HBsAg. Although the POC test demonstrated high sensitivity over a range of genotypes, false negatives were frequent in a clinical setting. Nevertheless, the POC assay offers advantages for testing in both developed and resource-limited countries due to its low cost (0.50$) and immediately available results. PMID:24779356

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

    PubMed

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

    2014-12-01

    We assessed the efficiency of point-of-care (POC) tests in the emergency department (ED) by comparing them with the international standard. We recorded the turnaround times (TATs) for processing laboratory biomarkers to assess laboratory efficiency from 17 EDs in national/regional hospitals. We also compared patient components between national and regional hospitals. Although the 17 enrolled hospitals expanded their EDs, they contained only five POC machines among them. The P50 (P25, P75) of the TATs for POC tests was 47 min (39, 55.5 min) for cardiac troponin T, which was much longer than the international standard (30 min). The TATs of other cardiac biomarkers were also longer than 30 min. The low efficiency of TATs for POC tests was a common feature in both regional and national hospitals (p > 0.05). Myocardial infarction was diagnosed in 61% of investigated ED patients who visited national hospitals, which is more frequently than those diagnosed at regional hospitals (46%, p < 0.05). Chronic heart failure was less frequent at national hospitals (28%) than at regional hospitals (41%, p < 0.05). The patient distribution in this study indicates that patients have the tendency to choose hospitals when they are affected with chest pain. However, the POC panel is rarely used in the ED, which delayed the TAT level and affected laboratory efficiency. This finding indicates a severe problem in the administrative management of EDs. This issue should be addressed in the next version of the medical reform policy. PMID:25092349

  8. 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

  9. SAMBA HIV Semiquantitative Test, a New Point-of-Care Viral-Load-Monitoring Assay for Resource-Limited Settings

    PubMed Central

    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

    2014-01-01

    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

  10. 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

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

    Microsoft Academic Search

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

    2011-01-01

    BackgroundThe clinical signs of active trachoma are often present in the absence of ocular Chlamydia trachomatis infection in low prevalence and mass treated settings. Treatment decisions are currently based on the prevalence of clinical signs, and this may result in the unnecessary distribution of mass antibiotic treatment. We aimed to evaluate the diagnostic accuracy of a prototype point-of-care (POC) test,

  13. 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

    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; Lemoine, Maud

    2015-04-01

    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

  14. Evaluation of a point-of-care influenza antigen test for the detection of highly pathogenic avian influenza H5N1 virus in cats.

    PubMed

    Marschall, J; Schulz, B; Hartmann, K

    2008-09-01

    Quick diagnosis of H5N1 infection in cats is important because of the zoonotic and pandemic potential of this virus. Human rapid influenza antigen tests are also sold commercially to veterinarians for use in cats. The point-of-care test actim(trade mark) Influenza A&B (Medix Biochemica, Kauniainen, Finland) was evaluated for the diagnosis of H5N1 infection in cats. The test showed a very low sensitivity and did not detect virus in samples of experimentally infected cats, so that its application cannot be recommended for the diagnosis of H5N1 infection in cats. PMID:18774992

  15. Evaluation of the TAS Analyzer and the Low-Range Heparin Management Test in Patients Undergoing Extracorporeal Membrane Oxygenation

    Microsoft Academic Search

    Theresa M. Ambrose; Curtis A. Parvin; Eric Mendeloff; Lori Luchtman-Jones

    Background: The new Low-Range Heparin Manage- ment Test (LHMT), a method for point-of-care testing (POCT) of heparinization, has been designed to func- tion at the low to moderate heparin concentrations typically found in patients undergoing extracorporeal membrane oxygenation (ECMO). In this study, the new method is compared with two POCT methods and a laboratory-based anti-Xa assay. Methods: We obtained 760

  16. Comparative evaluation of a point-of-care immunochromatographic test SNAP 4Dx with molecular detection tests for vector-borne canine pathogens in Hong Kong.

    PubMed

    Wong, Samson S Y; Teng, Jade L L; Poon, Rosana W S; Choi, Garnet K Y; Chan, Kwok-Hung; Yeung, Michelle L; Hui, Janet J Y; Yuen, Kwok-Yung

    2011-09-01

    There are no comprehensive studies on the performance of commonly used point-of-care diagnostic enzyme immunoassay for common arthropod-borne canine pathogens. A comparative evaluation of an immunochromatographic test for these infections with a comprehensive polymerase chain reaction (PCR) test panel was performed on 100 pet dogs and 100 stray dogs without obvious clinical symptoms. Of the 162 positive test results from both immunochromatographic test and PCR, there was 85.2% concordance. The 24 discordant results between serology and PCR occurred in tests involving Ehrlichia canis (14) and Anaplasma platys (10), which may be related to the time of infection. No positive cases of borreliosis or rickettsiosis were detected. One important limitation of the immunochromatographic test was its lack of testing for babesiosis and hepatozoonosis. The former is the most prevalent arthropod-borne canine infection in our cohort (41%). Coinfections were found in 19% stray dogs and 6% of pet dogs with both tests (p < 0.01). Seventeen and 8 samples from stray and pet dogs, respectively, were initially positive in the PCR test for Ehrlichia. However, on sequencing of the PCR amplicon, 10 from stray and 2 from pet dogs were found to be Wolbachia sequences instead, with 100% nucleotide identity to the 16S rRNA sequence of Wolbachia endosymbiont of Dirofilaria immitis. The presence of Wolbachia DNAemia (6%) correlated well with the molecular test and immunochromatographic antigen test for D. immitis. PMID:21612526

  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. 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

  19. Accuracy of Rapid Point-of-Care Diagnostic Tests for Hepatitis B Surface Antigen—A Systematic Review and Meta-analysis

    PubMed Central

    Khuroo, Mehnaaz S.; Khuroo, Naira S.; Khuroo, Mohammad S.

    2014-01-01

    Background Rapid point-of-care tests provide plausible diagnostic strategy for hepatitis B surface antigen (HBsAg) in low resource areas. However, their utility depends upon their overall performance. Our objective was to meta-analyze the diagnostic accuracy of rapid point-of-care tests for HBsAg. Methods Literature search was done with the help of a metasearch engine Mett?, a query interface for retrieving articles from five leading medical databases. Studies that employed rapid point-of-care tests for detection of HBsAg and compared the results with reference test were included. Two reviewers performed quality assessment of the studies and extracted data for estimating test accuracy. Twenty-seven studies were meta-analyzed and stratified by multiple parameters. Results Twenty-seven studies had evaluated 49 test brands and generated 76 data points. Sensitivity of individual tests varied widely and were heterogeneous (range 43.5%–99.8%); while specificity estimates were more robust and close to 100% (range 90%–100%). Overall pooled sensitivity, specificity, positive likelihood ratio (LR), negative LR and diagnostic odds ratio for all tests were 97.1% (95% CI, 96.1%–97.9%), 99.9% (CI, 99.8%–100%), 118.4 (CI, 84.7–165.5), 0.032 (CI, 0.023–0.045) and 4094.7 (CI, 2504.1–6600.8) respectively. This suggested high pooled accuracy for all studies. We found substantial heterogeneity between studies. Three factors (study location, reference standard and study score) appeared most strongly associated with test estimates and observed heterogeneity. The Determine test showed consistency in performance in studies done across developed and developing countries and the Determine and the BinaxNOW tests had significantly higher estimates than pooled estimates of remaining tests. Tests revealed analytical sensitivity of 4 IU/ml against manufacturer's claim of 0.5 IU/ml; reduced sensitivity with HBsAg mutants and poor performance in seroconversion panels. Conclusions Tests with better analytical sensitivity need to be developed and their feasibility and outcomes in various clinical settings need to be addressed. PMID:25755565

  20. 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

  1. 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

  2. Performance evaluation of the Pima™ point-of-care CD4 analyser using capillary blood sampling in field tests in South Africa

    PubMed Central

    2012-01-01

    Background Point-of-care CD4 testing can provide immediate CD4 reporting at HIV-testing sites. This study evaluated performance of capillary blood sampling using the point-of-care Pima™ CD4 device in representative primary health care clinics doing HIV testing. Methods Prior to testing, prescribed capillary-sampling and instrument training was undertaken by suppliers across all sites. Matching venous EDTA samples were drawn throughout for comparison to laboratory predicate methodology (PLG/CD4). In Phase I, Pima™ cartridges were pipette-filled with EDTA venous blood in the laboratory (N = 100). In Phase II (N = 77), Pima™ CD4 with capillary sampling was performed by a single operator in a hospital-based antenatal clinic. During subsequent field testing, Pima™ CD4 with capillary sampling was performed in primary health care clinics on HIV-positive patients by multiple attending nursing personnel in a rural clinic (Phase-IIIA, N = 96) and an inner-city clinic (Phase-IIIB, N = 139). Results Pima™ CD4 compared favourably to predicate/CD4 when cartridges were pipette-filled with venous blood (bias -17.3 ± STDev = 36.7 cells/mm3; precision-to-predicate %CV < 6%). Decreased precision of Pima™ CD4 to predicate/CD4 (varying from 17.6 to 28.8%SIM CV; mean bias = 37.9 ± STDev = 179.5 cells/mm3) was noted during field testing in the hospital antenatal clinic. In the rural clinic field-studies, unacceptable precision-to-predicate and positive bias was noted (mean 28.4%SIM CV; mean bias = +105.7 ± STDev = 225.4 cells/mm3). With additional proactive manufacturer support, reliable performance was noted in the subsequent inner-city clinic field study where acceptable precision-to-predicate (11%SIM CV) and less bias of Pima™ to predicate was shown (BA bias ~11 ± STDev = 69 cells/mm3). Conclusions Variable precision of Pima™ to predicate CD4 across study sites was attributable to variable capillary sampling. Poor precision was noted in the outlying primary health care clinic where the system is most likely to be used. Stringent attention to capillary blood collection technique is therefore imperative if technologies like Pima™ are used with capillary sampling at the POC. Pima™ CD4 analysis with venous blood was shown to be reproducible, but testing at the point of care exposes operators to biohazard risk related to uncapping vacutainer samples and pipetting of blood, and is best placed in smaller laboratories using established principles of Good Clinical Laboratory Practice. The development of capillary sampling quality control methods that assure reliable CD4 counts at the point of care are awaited. PMID:22284546

  3. A multi?centre evaluation of nine rapid, point?of?care syphilis tests using archived sera

    PubMed Central

    Herring, A J; Ballard, R C; Pope, V; Adegbola, R A; Changalucha, J; Fitzgerald, D W; Hook, E W; Kubanova, A; Mananwatte, S; Pape, J W; Sturm, A W; West, B; Yin, Y P; Peeling, R W

    2006-01-01

    Objectives To evaluate nine rapid syphilis tests at eight geographically diverse laboratory sites for their performance and operational characteristics. Methods Tests were compared “head to head” using locally assembled panels of 100 archived (50 positive and 50 negative) sera at each site using as reference standards the Treponema pallidum haemagglutination or the T pallidum particle agglutination test. In addition inter?site variation, result stability, test reproducibility and test operational characteristics were assessed. Results All nine tests gave good performance relative to the reference standard with sensitivities ranging from 84.5–97.7% and specificities from 84.5–98%. Result stability was variable if result reading was delayed past the recommended period. All the tests were found to be easy to use, especially the lateral flow tests. Conclusions All the tests evaluated have acceptable performance characteristics and could make an impact on the control of syphilis. Tests that can use whole blood and do not require refrigeration were selected for further evaluation in field settings. PMID:17118953

  4. Comparison of point-of-care tests for the rapid diagnosis of visceral leishmaniasis in East African patients.

    PubMed

    Bezuneh, Asrat; Mukhtar, Maowia; Abdoun, Asim; Teferi, Tedla; Takele, Yegnasew; Diro, Ermias; Jemaneh, Asfaw; Shiferaw, Welelta; Wondimu, Hirut; Bhatia, Ajay; Howard, Randall F; Ghalib, Hashim; Ireton, Gregory C; Hailu, Asrat; Reed, Steven G

    2014-12-01

    The development of rK39-based rapid diagnostic tests (RDTs) has greatly aided the diagnosis of visceral leishmaniasis, especially in the Indian subcontinent and Brazil, by offering high sensitivity and specificity. However, these tests have been less sensitive and less specific in sub-Saharan Africa. To improve upon the performance of rK39 in Africa, we engineered the fusion molecule rK28, which retained some of the rK39 repeats and combined them with repeat sequences from two additional Leishmania genes. This polyprotein was used in the development of several prototype RDTs by different commercial manufacturers with the goal of assessing relative performance in inexpensive formats. Here, we report field studies showing that the rK28 antigen could be readily adapted to a variety of RDT formats to achieve high sensitivity, generally > 90%, and adequate specificity to aid in the diagnosis of human visceral leishmaniasis in East Africa, Asia, and South America. PMID:25311696

  5. 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

  6. 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

  7. 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, François 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

  8. 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

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

    PubMed Central

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

    2014-01-01

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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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: $26). We modeled South African PMTCT guidelines during the study period (WHO “Option A”): antenatal zidovudine (CD4 ?350/?L) or ART (CD4>350/?L). Outcomes included MTCT risk at weaning (age 6 months), maternal and pediatric life expectancy (LE), maternal and pediatric lifetime healthcare costs (2013 USD), and cost-effectiveness ($/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

  16. Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed hiv-infected adults: a prospective, clinic-based study

    PubMed Central

    2014-01-01

    Background A rapid diagnostic test for active tuberculosis (TB) at the clinical point-of-care could expedite case detection and accelerate TB treatment initiation. We assessed the diagnostic accuracy of a rapid urine lipoarabinomannan (LAM) test for TB screening among HIV-infected adults in a TB-endemic setting. Methods We prospectively enrolled newly-diagnosed HIV-infected adults (?18 years) at 4 outpatient clinics in Durban from Oct 2011-May 2012, excluding those on TB therapy. A physician evaluated all participants and offered CD4 cell count testing. Trained study nurses collected a sputum sample for acid-fast bacilli smear microscopy (AFB) and mycobacterial culture, and performed urine LAM testing using Determine™ TB LAM in the clinic. The presence of a band regardless of intensity on the urine LAM test was considered positive. We defined as the gold standard for active pulmonary TB a positive sputum culture for Mycobacterium tuberculosis. Diagnostic accuracy of urine LAM was assessed, alone and in combination with smear microscopy, and stratified by CD4 cell count. Results Among 342 newly-diagnosed HIV-infected participants, 190 (56%) were male, mean age was 35.6 years, and median CD4 was 182/mm3. Sixty participants had culture-positive pulmonary TB, resulting in an estimated prevalence of 17.5% (95% CI 13.7-22.0%). Forty-five (13.2%) participants were urine LAM positive. Mean time from urine specimen collection to LAM test result was 40 minutes (95% CI 34–46 minutes). Urine LAM test sensitivity was 28.3% (95% CI 17.5-41.4) overall, and 37.5% (95% CI 21.1-56.3) for those with CD4 count <100/mm3, while specificity was 90.1% (95% CI 86.0-93.3) overall, and 86.9% (95% CI 75.8-94.2) for those with CD4?test positive), sensitivity increased to 38.3% (95% CI 26.0-51.8), but specificity decreased to 85.8% (95% CI 81.1-89.7). Conclusions In this prospective, clinic-based study with trained nurses, a rapid urine LAM test had low sensitivity for TB screening among newly-diagnosed HIV-infected adults, but improved sensitivity when combined with sputum smear microscopy. PMID:24571362

  17. 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

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

    PubMed

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

    2011-01-01

    Development of reliable, easy-to-use, rapid diagnostic tests (RDTs) to detect glucose-6-phosphate dehydrogenase (G6PD) deficiency at point of care is essential to deploying primaquine therapies as part of malaria elimination strategies. We assessed a kit under research and development called CareStart™ G6PD deficiency screening test (Access Bio, New Jersey, USA) by comparing its performance to quantitative G6PD enzyme activity using a standardized spectrophotometric method ('gold standard'). Blood samples (n?=?903) were collected from Cambodian adults living in Pailin province, western Cambodia. G6PD enzyme activities ranged from 0 to 20.5 U/g Hb (median 12.0 U/g Hg). Based on a normal haemoglobin concentration and wild-type G6PD gene, the normal values of G6PD enzymatic activity for this population was 3.6 to 20.5 U/g Hg (95(th) percentiles from 5.5 to 17.2 U/g Hg). Ninety-seven subjects (10.7%) had <3.6 U/g Hg and were classified as G6PD deficient. Prevalence of deficiency was 15.0% (64/425) among men and 6.9% (33/478) among women. Genotype was analyzed in 66 G6PD-deficient subjects and 63 of these exhibited findings consistent with Viangchang genotype. The sensitivity and specificity of the CareStart™ G6PD deficiency screening test was 0.68 and 1.0, respectively. Its detection threshold was <2.7 U/g Hg, well within the range of moderate and severe enzyme deficiencies. Thirteen subjects (1.4%, 12 males and 1 female) with G6PD enzyme activities <2 U/g Hg were falsely classified as "normal" by RDT. This experimental RDT test here evaluated outside of the laboratory for the first time shows real promise, but safe application of it will require lower rates of falsely "normal" results. PMID:22164279

  19. [Guidelines for the management of point-of care testing pre-examination, examination and post-examination phases according to the EN ISO 22870 standard].

    PubMed

    Vassault, A; Annaix, V; Houlbert, C; Berkane, Z; Vaubourdolle, M; Goudable, J; Guimont, M C; Pernet, P

    2012-02-01

    Quality of point-of-care examinations depends on the quality assurance system settled. This paper describes the different tools used to control the pre-examination, examination and post-examination procedures taking part in the quality of patient care according to the requirements of the standard EN ISO 22870 and EN ISO 15189 as well. They include mainly: For the pre-examination phase, the sample traceability and for the analytical phase, the practice of internal quality control and the participation in external quality assessment programme. PMID:22736706

  20. Anesthesiology Point of Care project.

    PubMed

    McDonald, John S; Noback, Carl R; Cheng, Drew; Lee, T K; Nenov, Val

    2002-01-01

    We are developing a dynamic prototype visual communication system for the operating room environs. This has classically been viewed as an isolated and impenetrable workplace. All medical experiences and all teaching remain in a one to one closed loop with no recall or subsequent sharing for the training and education of other colleagues. The "Anesthesia Point of Care" (APOC) concept embraces the sharing of, recording of, and presentation of various physiological and pharmacological events so that real time memory can be shared at a later time for the edification of other colleagues who were not present at the time of the primary learning event. In addition it also provides a remarkably rapid tool for fellow faculty to respond to obvious stress and crisis events that can be broadcast instantly at the time of happening. Finally, it also serves as an efficient and effective means of paging and general communication throughout the daily routines among various healthcare providers in anesthesiology who work as a team unit; these include the staff, residents, CRNAs, physician assistants, and technicians. This system offers a unique opportunity to eventually develop future advanced ideas that can include training exercises, presurgical evaluations, surgical scheduling and improvements in efficiency based upon earlier than expected case completion or conversely later than expected case completion and even as a unique window to development of improved billing itemization and coordination. PMID:15458103

  1. 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.

  2. [Analysis of the Cochrane review: biomarkers as point-of-care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care. Cochrane Database Syst Rev. 2014,11:CD10130].

    PubMed

    Azevedo, Pedro; Costa, João; Vaz-Carneiro, António

    2014-01-01

    Acute respiratory infections are the most frequent reason for prescribing antibiotics in primary health care. Since most acute respiratory infections are of viral or non-severe bacterial etiology, the use of antibiotics is not beneficial and exposes patients to side effects. In addition, the undifferentiated prescription of this drug group increases antibiotic resistance and promotes: 1. increased costs for health systems; 2. failure to future treatments, increased morbidity and mortality from infectious diseases. In the appropriate clinical setting, the use of biomarkers as point-of-care tests to assess the acute phase response to injury of tissue / organ, is a strategy in the therapeutic management of patients with acute respiratory infections in outpatient context. This Cochrane review compared the prescription of antibiotics to acute respiratory infections based: 1. exclusively in the clinic; 2. Iinn the use of biomarkers as point-of-care tests (eg C-reactive protein). The C-reactive protein in quick test seems to be associated with reduced use of antibiotics, however, there has not been a reduction in the lenght of treatment or the perception of recovery by the patient. There may be an increase of hospitalizations compared with the group of patients without the biomarker use; no mortality was register in either group. PMID:25641279

  3. 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

  4. Results of an innovative education, training and quality assurance program for point-of-care HbA1c testing using the Bayer DCA 2000 in Australian Aboriginal Community Controlled Health Services.

    PubMed

    Shephard, Mark D; Gill, Janice P

    2003-11-01

    This study describes the development, implementation and management of a multi-faceted quality assurance program called Quality Assurance for Aboriginal Medical Services (QAAMS) to support point-of-care HbA(1c) testing on the Bayer DCA 2000 in Aboriginal people with diabetes from 45 Australian Aboriginal Community Controlled Health Services. The quality assurance program comprised four elements: production of culturally appropriate education resources, formal training for Aboriginal Health Workers conducting HbA(1c) testing, an external quality assurance program and on-going quality management support services including a help hotline and an annual workshop. Aboriginal Health Workers were required to test two quality assurance (QAAMS) samples in a blind sense every month since July 1999. Samples were linearly related and comprised six paired levels of HbA(1c). The short and long term performance of each service's DCA 2000 was reviewed monthly and at the end of each six month testing cycle. The average participation rate over 7 six-monthly QAAMS testing cycles was 88%. 84% of 3100 quality assurance tests performed were within preset limits of acceptability. The median precision (CV%) for HbA(1c) testing has averaged 3.8% across the past 5 cycles (range 3.4 to 4.0%) and is continuing to improve. The introduction of a medical rebate for HbA(1c) testing has ensured the program's sustainability. Through continuing education and training, Aboriginal Health Workers have achieved consistent analytical performance for HbA(1c) testing on the DCA 2000, equivalent to that of laboratory scientists using the same instrument. This unique quality assurance model can be readily adapted to other Indigenous health settings and other point-of-care tests and instruments. PMID:18568052

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

    PubMed

    Barbosa, Catia; Tao Dong

    2014-08-01

    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

  6. 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

  7. 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

    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

    2015-04-01

    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

  8. 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

  9. Can Point-of-Care Urine LAM Strip Testing for Tuberculosis Add Value to Clinical Decision Making in Hospitalised HIV-Infected Persons?

    PubMed Central

    Peter, Jonathan G.; Theron, Grant; Dheda, Keertan

    2013-01-01

    Background The urine lipoarabinomannan (LAM) strip-test (Determine®-TB) can rapidly rule-in TB in HIV-infected persons with advanced immunosuppression. However, given high rates of empiric treatment amongst hospitalised patients in high-burden settings (?50%) it is unclear whether LAM can add any value to clinical decision making, or identify a subset of patients with unfavourable outcomes that would otherwise have been missed by empiric treatment. Methods 281 HIV-infected hospitalised patients with suspected TB received urine LAM strip testing, and were categorised as definite (culture-positive), probable-, or non-TB. Both the proportion and morbidity of TB cases identified by LAM testing, early empiric treatment (initiated prior to test result availability) and a set of clinical predictors were compared across groups. Results 187/281 patients had either definite- (n?=?116) or probable-TB (n?=?71). As a rule-in test for definite and probable-TB, LAM identified a similar proportion of TB cases compared to early empiric treatment (85/187 vs. 93/187, p?=?0.4), but a greater proportion than classified by a set of clinical predictors alone (19/187; p<0.001). Thirty-nine of the 187 (21%) LAM-positive patients who had either definite- or probable-TB were missed by early empiric treatment, and of these 25/39 (64%) would also have been missed by smear microscopy. Thus, 25/187 (8%) of definite- or probable-TB patients with otherwise delayed initiation of TB treatment could be detected by the LAM strip test. LAM-positive patients missed by early empiric treatment had a lower median CD4 count (p?=?0.008), a higher median illness severity score (p?=?0.001) and increased urea levels (p?=?0.002) compared to LAM-negative patients given early empiric treatment. Conclusions LAM strip testing outperformed TB diagnosis based on clinical criteria but in day-to-day practice identified a similar proportion of patients compared to early empiric treatment. However, compared to empiric treatment, LAM identified a different subset of patients with more advanced immunosuppression and greater disease severity. PMID:23390504

  10. 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

  11. Utility of point-of-care testing of natriuretic peptides (brain natriuretic peptide and n-terminal pro-brain natriuretic peptide) in the emergency department

    PubMed Central

    Nayer, Jamshed; Aggarwal, Praveen; Galwankar, Sagar

    2014-01-01

    Rapid and accurate diagnosis of a patient with an acute disease is a challenge for emergency physicians. Natriuretic peptides have emerged as important tools for diagnosis, risk stratification and therapeutic decision making for some categories of emergency patients. Brain natriuretic peptide (BNP) is a member of a four natriuretic peptides family that shares a common 17-peptide ring structure. Atrial natriuretic peptide, C-natriuretic peptide (CNP), and D-type natriuretic peptide are the other natriuretic peptide, which share the same common 17-peptide ring structure. The N-terminal fragment of pro-BNP, N-terminal pro-brain natriuretic peptide (NT-proBNP) consists of 76 amino acids, which is biologically inert, while the active component BNP contains 32 amino acids. BNP and NT-proBNP are secreted in the plasma in equimolar quantities and are frequently used in the diagnosis of congestive heart failure, and distinguishing between patients with dyspnea of cardiac or pulmonary origin. Both natriuretic peptides have also been evaluated for use in the assessment and management of several other conditions including sepsis, cirrhosis of liver and renal failure. However, one should remember that the values of natriuretic peptides are affected by age and weight of the patients, and presence of several comorbidities such as chronic renal failure, type 2 diabetes mellitus, anemia, pulmonary embolism, and acute coronary syndrome. Values of these peptides also vary depending on the type of test used. The performance characteristics of these natriuretic peptides vary depending on the patients on whom they are used. Therefore determination of reference values for these peptides represents a challenge. PMID:25337482

  12. 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

  13. Single-use lancet and capillary loading mechanism for complete blood count point of care device

    E-print Network

    Zimmerman, Julia C

    2011-01-01

    As part of the development of a point of care complete blood count device, I designed a single use lancet integrated with a blood collection mechanism and interface and successfully tested a prototype. High speed video was ...

  14. 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

  15. 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…

  16. 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 1990s. 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

  17. Point-of-Care Ultrasonography by Pediatric Emergency Medicine Physicians.

    PubMed

    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 medicine (PEM) 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. PEM 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 PEM physicians. PMID:25825531

  18. The Senior Assessment Coupler: point-of-care decision support and data acquisition tool.

    PubMed Central

    McGowan, J. J.; Johnson-Lamarche, H.

    1999-01-01

    In an effort to provide more effective, point-of-care management of the elderly population in the state of Vermont and to begin to collect data on health care outcomes across this population, the Vermont Department of Aging and Disabilities partnered with the PKC Corporation to pilot test the Senior Assessment Coupler. Results of this pilot have shown that the Coupler is an effective tool for collecting health status information, providing decision support at the point of care, facilitating reporting to various state and federal agencies, and empowering elderly Vermonters to make informed decisions about their health care and quality of life. PMID:10566484

  19. Point-of-Care Ultrasound Detection of Acute Scaphoid Fracture.

    PubMed

    Tessaro, Mark O; McGovern, Terrance R; Dickman, Eitan; Haines, Lawrence E

    2015-03-01

    In cases of traumatic wrist pain, emergency physicians must maintain a high index of suspicion for scaphoid fractures due to their potential for serious complications. A growing body of literature supports the use of point-of-care ultrasonography by emergency physicians in the evaluation of potential fractures. We report a case of a pediatric scaphoid fracture that was initially not visualized on x-ray and was subsequently detected using point-of-care ultrasound in the ED. PMID:25738245

  20. 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.

  1. Microfluidic point-of-care diagnostics for resource-poor environments

    Microsoft Academic Search

    Tassaneewan Laksanasopin; Curtis D. Chin; H. Moore; J. Wang; Yuk Kee Cheung; S. K. Sia

    2009-01-01

    Point-of-care (POC) diagnostics have tremendous potential to improve human health in remote and resource-poor settings. However, the design criteria for diagnostic tests appropriate in settings with limited infrastructure are unique and challenging. Here we present a custom optical reader which quantifies silver absorbance from heterogeneous immunoassays. The reader is simple, low-cost and suited for POC diagnostics.

  2. 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

  3. A Handheld Point-of-Care Genomic Diagnostic System

    PubMed Central

    Myers, Frank B.; Henrikson, Richard H.; 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

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

    PubMed

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

    2004-01-01

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

  5. Handheld tools assess medical necessity at the point of care.

    PubMed

    Pollard, Dan

    2002-01-01

    An emerging strategy to manage financial risk in clinical practice is to involve the physician at the point of care. Using handheld technology, encounter-specific information along with medical necessity policy can be presented to physicians allowing them to integrate it into their medical decision-making process. Three different strategies are discussed: reference books or paper encounter forms, electronic reference tools, and integrated process tools. The electronic reference tool strategy was evaluated and showed a return on investment exceeding 1200% due to reduced overhead costs associated with rework of claim errors. PMID:12389325

  6. 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

    ...Accuracy Requirements for Point of Care Blood Glucose Meters; Public Meeting; Request...Accuracy Requirements for Point of Care Blood Glucose Meters. The purpose of the public...discuss the clinical accuracy requirements of blood glucose meters and other topics...

  7. Point-of-care pathology with miniature microscopes

    PubMed Central

    Liu, Jonathan T.C.; Loewke, Nathan O.; Mandella, Michael J.; Levenson, Richard M.; Crawford, James M.; Contag, Christopher H.

    2011-01-01

    Advances in optical designs are enabling the development of miniature microscopes that can examine tissue in situ for early anatomic and molecular indicators of disease, in real time, and at cellular resolution. These new devices will lead to major changes in how diseases are detected and managed, driving a shift from today’s diagnostic paradigm of biopsy followed by histopathology and recommended therapy, to non-invasive point-of-care diagnosis with possible same-session definitive treatment. This shift may have major implications for the training requirements of future physicians to enable them to interpret real-time in vivo microscopic data, and will also shape the emerging fields of telepathology and telemedicine. Implementation of new technologies into clinical practice is a complex process that requires bridging gaps between clinicians, engineers and scientists. This article provides a forward-looking discussion of these issues, with a focus on malignant and pre-malignant lesions, by first highlighting some of the clinical areas where point-of-care in vivo microscopy could address unmet needs, and then by reviewing the technological challenges that are being addressed, or need to be addressed, for in vivo microscopy to become a standard clinical tool. PMID:21673433

  8. Lensless imaging for point-of-care testing

    E-print Network

    Moon, SangJun

    We show a platform that merges a microfluidic chip with lensless imaging for CD4[superscript +] T-lymphocyte counting at resource-limited settings. To capture CD4[superscript +] T lymphocytes, anti-CD4[superscript +] ...

  9. 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

  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. Change in Intraocular Pressure During Point-of-Care Ultrasound

    PubMed Central

    Berg, Cameron; Doniger, Stephanie J.; Zaia, Brita; Williams, Sarah R.

    2015-01-01

    Introduction Point-of-care ocular ultrasound (US) is a valuable tool for the evaluation of traumatic ocular injuries. Conventionally, any maneuver that may increase intraocular pressure (IOP) is relatively contraindicated in the setting of globe rupture. Some authors have cautioned against the use of US in these scenarios because of a theoretical concern that an US examination may cause or exacerbate the extrusion of intraocular contents. This study set out to investigate whether ocular US affects IOP. The secondary objective was to validate the intraocular pressure measurements obtained with the Diaton® as compared with standard applanation techniques (the Tono-Pen®). Methods We enrolled a convenience sample of healthy adult volunteers. We obtained the baseline IOP for each patient by using a transpalpebral tonometer. Ocular US was then performed on each subject using a high-frequency linear array transducer, and a second IOP was obtained during the US examination. A third IOP measurement was obtained following the completion of the US examination. To validate transpalpebral measurement, a subset of subjects also underwent traditional transcorneal applanation tonometry prior to the US examination as a baseline measurement. In a subset of 10 patients, we obtained baseline pre-ultrasound IOP measurements with the Diaton® and Tono-Pen®, and then compared them. Results The study included 40 subjects. IOP values during ocular US examination were slightly greater than baseline (average +1.8mmHg, p=0.01). Post-US examination IOP values were not significantly different than baseline (average ?0.15mmHg, p=0.42). In a subset of 10 subjects, IOP values were not significantly different between transpalpebral and transcorneal tonometry (average +0.03mmHg, p=0.07). Conclusion In healthy volunteer subjects, point-of-care ocular US causes a small and transient increase in IOP. We also showed no difference between the Diaton® and Tono-Pen® methods of IOP measurement. Overall, the resulting change in IOP with US transducer placement is considerably less than the mean diurnal variation in healthy subjects, or pressure generated by physical examination, and is therefore unlikely to be clinically significant. However, it is important to take caution when performing ocular ultrasound, since it is unclear what the change in IOP would be in patients with ocular trauma. PMID:25834668

  12. 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

  13. 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

  14. 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

  15. Dielectrophoresis: applications and future outlook in point of care.

    PubMed

    Demircan, Ya?mur; Özgür, Ebru; Külah, Haluk

    2013-04-01

    Dielectrophoresis (DEP) is a label free, noninvasive, stand alone, rapid, and sensitive particle manipulation and characterization technique. Improvements in micro-electro-mechanical systems technology have enabled the biomedical applications of DEP over the past decades. By this way, integration of DEP into lab-on-a-chip systems has become achievable, creating a potential tool for point-of-care (POC) systems. DEP can be utilized in many different POC applications including early detection and prognosis of various cancer types, diagnosis of infectious diseases, blood cell analysis, and stem cell therapy. However, there are still some challenges to be resolved to have DEP-based devices available in POC market. Today, researchers have focused on these challenges to have this powerful theory as a solution for many POC applications. Here, DEP theory, cell modeling, and most common device structures are introduced briefly. Next, POC applications of DEP theory, such as cell (blood, cancer, stem, and fetal) and microorganism separation, manipulation, and enrichment for diagnosis and prognosis, are explained. Integration of DEP with other detection techniques to have more sensitive systems is summarized. Finally, future outlook for DEP-based systems are discussed with some challenges, which are currently preventing these systems to be a common tool for POC applications, and possible solutions. PMID:23348714

  16. 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 (?PADs), 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

  17. Rapid optical heating of blood for clinical point-of-care diagnostics

    NASA Astrophysics Data System (ADS)

    Catanzaro, Brian E.; Hill, Ted; Hankins, Steve; Gandola, Kent

    2010-02-01

    Clinical testing of human blood requires adherence to a number of regulatory standards, including maintaining a temperature that is representative of the human body (e.g. 37 C). The economics of private and public healthcare drives blood assays to be conducted using low cost, disposable assay devices that also eliminate the possibility of cross contamination. Unfortunately, the materials that meet the economic and disposable constraints of the marketplace are thermal insulators, not ideal for rapid heating. We present a novel means of optically heating blood samples in plastic assay devices within a time period suitable for point-of-care use. The novel approach uses LED's in the red portion of the visible spectrum. The lower absorption of optical radiation in the visible spectrum enables the absorption of energy deep into the assay device. This produces even heating, avoiding the gradients that can occur by surface heating (conduction) or surface absorption (highly absorbing wavelengths). Analytical and computational models will be discussed. A specific application to a point-of-care blood assay instrument will be reviewed. In this application, optical heating was achieved using a small array of high brightness LED's. Experimental results will be discussed. The experimental results with this instrument validated the predictions.

  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. Emerging technologies in point-of-care molecular diagnostics for resource-limited settings.

    PubMed

    Peeling, Rosanna W; McNerney, Ruth

    2014-06-01

    Emerging molecular technologies to diagnose infectious diseases at the point at which care is delivered have the potential to save many lives in developing countries where access to laboratories is poor. Molecular tests are needed to improve the specificity of syndromic management, monitor progress towards disease elimination and screen for asymptomatic infections with the goal of interrupting disease transmission and preventing long-term sequelae. In simplifying laboratory-based molecular assays for use at point-of-care, there are inevitable compromises between cost, ease of use and test performance. Despite significant technological advances, many challenges remain for the development of molecular diagnostics for resource-limited settings. There needs to be more advocacy for these technologies to be applied to infectious diseases, increased efforts to lower the barriers to market entry through streamlined and harmonized regulatory approaches, faster policy development for adoption of new technologies and novel financing mechanisms to enable countries to scale up implementation. PMID:24784765

  20. 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.

  1. Research review paper Point-of-care assays for tuberculosis: Role of nanotechnology/microfluidics

    E-print Network

    Demirci, Utkan

    Research review paper Point-of-care assays for tuberculosis: Role of nanotechnology/microfluidics Keywords: Tuberculosis Point-of-care Nanotechnology Microfluidics Tuberculosis (TB) remains one of the most for TB diagnosis, and highlight the recent advances in nanotechnology and microfluidics that potentially

  2. 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

  3. 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

  4. 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

  5. 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

  6. Creating a mobile subject guide to improve access to point-of-care resources for medical students: a case study

    PubMed Central

    Boruff, Jill T; Bilodeau, Edward

    2012-01-01

    Question: Can a mobile optimized subject guide facilitate medical student access to mobile point-of-care tools? Setting: The guide was created at a library at a research-intensive university with six teaching hospital sites. Objectives: The team created a guide facilitating medical student access to point-of-care tools directly on mobile devices to provide information allowing them to access and set up resources with little assistance. Methods: Two librarians designed a mobile optimized subject guide for medicine and conducted a survey to test its usefulness. Results: Web analytics and survey results demonstrate that the guide is used and the students are satisfied. Conclusion: The library will continue to use the subject guide as its primary means of supporting mobile devices. It remains to be seen if the mobile guide facilitates access for those who do not need assistance and want direct access to the resources. Internet access in the hospitals remains an issue. PMID:22272160

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

    NASA Astrophysics Data System (ADS)

    Vaitkuviene, A.; G?gžna, 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.

  8. 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 ?-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

  9. Development of a microchip Europium nanoparticle immunoassay for sensitive point-of-care HIV detection.

    PubMed

    Liu, Jikun; Du, Bingchen; Zhang, Panhe; Haleyurgirisetty, Mohan; Zhao, Jiangqin; Ragupathy, Viswanath; Lee, Sherwin; DeVoe, Don L; Hewlett, Indira K

    2014-11-15

    Rapid, sensitive and specific diagnostic assays play an indispensable role in determination of HIV infection stages and evaluation of efficacy of antiretroviral therapy. Recently, our laboratory developed a sensitive Europium nanoparticle-based microtiter-plate immunoassay capable of detecting target analytes at subpicogram per milliliter levels without the use of catalytic enzymes and signal amplification processes. Encouraged by its sensitivity and simplicity, we continued to miniaturize this assay to a microchip platform for the purpose of converting the benchtop assay technique to a point-of-care test. It was found that detection capability of the microchip platform could be readily improved using Europium nanoparticle probes. We were able to routinely detect 5 pg/mL (4.6 attomoles) of HIV-1 p24 antigen at a signal-to-blank ratio of 1.5, a sensitivity level reasonably close to that of microtiter-plate Europium nanoparticle assay. Meanwhile, use of the microchip platform effectively reduced sample/reagent consumption 4.5 fold and shortened total assay time 2 fold in comparison with microtiter plate assays. Complex matrix substance in plasma negatively affected the microchip assays and the effects could be minimized by diluting the samples before loading. With further improvements in sensitivity, reproducibility, usability, assay process simplification, and incorporation of portable time-resolved fluorescence reader, Europium nanoparticle immunoassay technology could be adapted to meet the challenges of point-of-care diagnosis of HIV or other health-threatening pathogens at bedside or in resource-limited settings. PMID:24880655

  10. Point-of-care screenings at the University of Minnesota: mechanism for civic engagement.

    PubMed

    Palombi, Laura C; Bastianelli, Karen; Stratton, Timothy

    2014-01-01

    OBJECTIVES To describe Wellness Initiative of the Northland (WIN) screening events; present participant results from those events; discuss the benefits of pharmacist-conducted, community-based point-of-care (POC) testing to medically underserved patients and to the profession of pharmacy; and describe logistical considerations in launching disease screening services. SETTING Pharmacist-led community health fairs in a variety of settings, including shopping malls, churches, community pharmacies, senior residence facilities, critical-access hospitals, and clinics. PRACTICE DESCRIPTION Disease screenings for economically disadvantaged residents of northeastern Minnesota and northwest Wisconsin, held between 2005 and 2012, through WIN. PRACTICE INNOVATION Mobile POC screenings for dyslipidemia, diabetes, hypertension, and osteoporosis. MAIN OUTCOME MEASURE Percentage of screenings with out-of-range readings. RESULTS Since 2005, WIN screenings have served more than 2,000 individuals, providing 4,152 POC screenings. Out-of-range readings were obtained for 40.3% of fingerstick cholesterol tests, 24.8% of fingerstick blood glucose tests, 24.3% of blood pressure tests, and 38.7% of quantitative ultrasound heel bone density readings. CONCLUSION Community-conducted POC testing functions both as an important public health service and a mechanism by which pharmacists and student pharmacists can become involved in civic engagement. PMID:24407741

  11. Revolutionizing Clinical Microbiology Laboratory Organization in Hospitals with In Situ Point-of-Care

    E-print Network

    Stéphan Cohen-bacrie; Laetitia Ninove; Antoine Nougairède; Rémi Charrel; Hervé Richet; Sékéné Badiaga; Guilhem Noël; Bernard La Scola; Xavier De Lamballerie; Michel Drancourt; Didier Raoult

    Background: Clinical microbiology may direct decisions regarding hospitalization, isolation and anti-infective therapy, but it is not effective at the time of early care. Point-of-care (POC) tests have been developed for this purpose. Methods and Findings: One pilot POC-lab was located close to the core laboratory and emergency ward to test the proof of concept. A second POC-lab was located inside the emergency ward of a distant hospital without a microbiology laboratory. Twenty-three molecular and immuno-detection tests, which were technically undemanding, were progressively implemented, with results obtained in less than four hours. From 2008 to 2010, 51,179 tests yielded 6,244 diagnoses. The second POC-lab detected contagious pathogens in 982 patients who benefited from targeted isolation measures, including those undertaken during the influenza outbreak. POC tests prevented unnecessary treatment of patients with non-streptococcal tonsillitis (n = 1,844) and pregnant women negative for Streptococcus agalactiae carriage (n = 763). The cerebrospinal fluid culture remained sterile in 50 % of the 49 patients with bacterial meningitis, therefore antibiotic

  12. 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

    ...2007D-0290] Draft Guidance for Industry: Cell Selection Devices for Point of Care Production...Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance AGENCY...entitled ``Draft Guidance for Industry: Cell Selection Devices for Point of Care...

  13. 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

  14. 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

  15. Improving Healthcare Accessibility through Point-of-Care Technologies

    Microsoft Academic Search

    Christopher P. Price; Larry J. Kricka

    Results: Many testing procedures were considered to be valuable in the clinical settings discussed. Technologi- cal solutions were proposed to meet these needs, as well as the practical requirements around clinical process change and regulation. From these considerations, a series of recommendations was formulated for develop- ment of POC technologies based on input from the symposium attendees. Conclusion: NIBIB has

  16. Isothermal Amplification Using a Chemical Heating Device for Point-of-Care Detection of HIV-1

    PubMed Central

    Curtis, Kelly A.; Rudolph, Donna L.; Nejad, Irene; Singleton, Jered; Beddoe, Andy; Weigl, Bernhard; LaBarre, Paul; Owen, S. Michele

    2012-01-01

    Background To date, the use of traditional nucleic acid amplification tests (NAAT) for detection of HIV-1 DNA or RNA has been restricted to laboratory settings due to time, equipment, and technical expertise requirements. The availability of a rapid NAAT with applicability for resource-limited or point-of-care (POC) settings would fill a great need in HIV diagnostics, allowing for timely diagnosis or confirmation of infection status, as well as facilitating the diagnosis of acute infection, screening and evaluation of infants born to HIV-infected mothers. Isothermal amplification methods, such as reverse-transcription, loop-mediated isothermal amplification (RT-LAMP), exhibit characteristics that are ideal for POC settings, since they are typically quicker, easier to perform, and allow for integration into low-tech, portable heating devices. Methodology/Significant Findings In this study, we evaluated the HIV-1 RT-LAMP assay using portable, non-instrumented nucleic acid amplification (NINA) heating devices that generate heat from the exothermic reaction of calcium oxide and water. The NINA heating devices exhibited stable temperatures throughout the amplification reaction and consistent amplification results between three separate devices and a thermalcycler. The performance of the NINA heaters was validated using whole blood specimens from HIV-1 infected patients. Conclusion The RT-LAMP isothermal amplification method used in conjunction with a chemical heating device provides a portable, rapid and robust NAAT platform that has the potential to facilitate HIV-1 testing in resource-limited settings and POC. PMID:22384022

  17. Revolutionizing Clinical Microbiology Laboratory Organization in Hospitals with In Situ Point-of-Care

    PubMed Central

    Cohen-Bacrie, Stéphan; Ninove, Laetitia; Nougairède, Antoine; Charrel, Rémi; Richet, Hervé; Minodier, Philippe; Badiaga, Sékéné; Noël, Guilhem; La Scola, Bernard; de Lamballerie, Xavier; Drancourt, Michel; Raoult, Didier

    2011-01-01

    Background Clinical microbiology may direct decisions regarding hospitalization, isolation and anti-infective therapy, but it is not effective at the time of early care. Point-of-care (POC) tests have been developed for this purpose. Methods and Findings One pilot POC-lab was located close to the core laboratory and emergency ward to test the proof of concept. A second POC-lab was located inside the emergency ward of a distant hospital without a microbiology laboratory. Twenty-three molecular and immuno-detection tests, which were technically undemanding, were progressively implemented, with results obtained in less than four hours. From 2008 to 2010, 51,179 tests yielded 6,244 diagnoses. The second POC-lab detected contagious pathogens in 982 patients who benefited from targeted isolation measures, including those undertaken during the influenza outbreak. POC tests prevented unnecessary treatment of patients with non-streptococcal tonsillitis (n?=?1,844) and pregnant women negative for Streptococcus agalactiae carriage (n?=?763). The cerebrospinal fluid culture remained sterile in 50% of the 49 patients with bacterial meningitis, therefore antibiotic treatment was guided by the molecular tests performed in the POC-labs. With regard to enterovirus meningitis, the mean length-of-stay of infected patients over 15 years old significantly decreased from 2008 to 2010 compared with 2005 when the POC was not in place (1.43±1.09 versus 2.91±2.31 days; p?=?0.0009). Altogether, patients who received POC tests were immediately discharged nearly thrice as often as patients who underwent a conventional diagnostic procedure. Conclusions The on-site POC-lab met physicians' needs and influenced the management of 8% of the patients that presented to emergency wards. This strategy might represent a major evolution of decision-making regarding the management of infectious diseases and patient care. PMID:21811599

  18. 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

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

    PubMed

    Walia, Kamini

    2013-07-01

    The good quality laboratory services in developing countries are often limited to major urban centers. As a result, many commercially available high-quality diagnostic tests for infectious diseases are neither accessible nor affordable to patients in the rural areas. Health facilities in rural areas are compromised and this limits the usability and performance of the best medical diagnostic technologies in rural areas as they are designed for air-conditioned laboratories, refrigerated storage of chemicals, a constant supply of calibrators and reagents, stable electrical power, highly trained personnel and rapid transportation of samples. The advent of new technologies have allowed miniaturization and integration of complex functions, which has made it possible for sophisticated diagnostic tools to move out of the developed-world laboratory in the form of a "point of care"(POC) tests. Many diagnostic tests are being developed using these platforms. However, the challenge is to develop diagnostics which are inexpensive, rugged and well suited to the medical and social contexts of the developing world and do not compromise on accuracy and reliability. The already available POC tests which are reliable and affordable, like for HIV infection, malaria, syphilis, and some neglected tropical diseases, and POC tests being developed for other diseases if correctly used and effectively regulated after rigorous evaluation, have the potential to make a difference in clinical management and improve surveillance. In order to use these tests effectively they would need to be supported by technically competent manpower, availability of good-quality reagents, and healthcare providers who value and are able to interpret laboratory results to guide treatment; and a system for timely communication between the laboratory and the healthcare provider. Strengthening the laboratories at the rural level can enable utilization of these diagnostics for improving the diagnosis and management of infectious diseases among children which require prompt treatment and thus, considerably reduce morbidity and mortality among the pediatric age group. PMID:23564518

  20. Point-of-care diagnostics for noncommunicable diseases using synthetic urinary biomarkers and paper microfluidics

    PubMed Central

    Warren, Andrew D.; Kwong, Gabriel A.; Wood, David K.; Lin, Kevin Y.; Bhatia, Sangeeta N.

    2014-01-01

    With noncommunicable diseases (NCDs) now constituting the majority of global mortality, there is a growing need for low-cost, noninvasive methods to diagnose and treat this class of diseases, especially in resource-limited settings. Molecular biomarkers combined with low-cost point-of-care assays constitute a potential solution for diagnosing NCDs, but the dearth of naturally occurring, predictive markers limits this approach. Here, we describe the design of exogenous agents that serve as synthetic biomarkers for NCDs by producing urinary signals that can be quantified by a companion paper test. These synthetic biomarkers are composed of nanoparticles conjugated to ligand-encoded reporters via protease-sensitive peptide substrates. Upon delivery, the nanoparticles passively target diseased sites, such as solid tumors or blood clots, where up-regulated proteases cleave the peptide substrates and release reporters that are cleared into urine. The reporters are engineered for detection by sandwich immunoassays, and we demonstrate their quantification directly from unmodified urine; furthermore, capture antibody specificity allows the probes to be multiplexed in vivo and quantified simultaneously by ELISA or paper lateral flow assay (LFA). We tailor synthetic biomarkers specific to colorectal cancer, a representative solid tumor, and thrombosis, a common cardiovascular disorder, and demonstrate urinary detection of these diseases in mouse models by paper diagnostic. Together, the LFA and injectable synthetic biomarkers, which could be tailored for multiple diseases, form a generalized diagnostic platform for NCDs that can be applied in almost any setting without expensive equipment or trained medical personnel. PMID:24567404

  1. Point of Care Perioperative Coagulation Management in Liver Transplantation and Complete Portal Vein Thrombosis

    PubMed Central

    Piangatelli, Cristiano; Faloia, Lucia; Valentini, Ilaria; Vivarelli, Marco

    2014-01-01

    Liver transplantation (LT) is a serious hemostatic challenge in patients with portal vein thrombosis (PVT). Advances in monitoring systems have improved surgery in this setting. We report the successful application of a point-of-care (POC) rotational viscoelastic thromboelastometry-guided (TEM) testing system (ROTEM) which allowed management of coagulation during LT in a 64-year-old cirrhotic patient with a model for end-stage liver disease (MELD) score of 16. Perioperatively, the patient showed complete PVT, hepatomegaly, splenomegaly, recanalization of the umbilical vein, and portosystemic shunt. Macroscopic liver and spleen adherences with collateral circulation were evident. Coagulation factors and fibrinolysis were assessed preoperatively and at graft reperfusion to evaluate the need of hemostatic therapy. Based on ROTEM findings, the patient received 16?g of human fibrinogen concentrate, half preoperatively (with prothrombin complex concentrate 2000?IU, tranexamic acid 1?g, and platelets 2?IU), and two doses of 4?g before and after graft reperfusion; we achieved normalization of all monitored parameters. No ischemia-reperfusion syndrome was present. Postoperatively portal vein flux at Color-Doppler ultrasonography was normal. After a 3-day ICU stay, the patient was moved to the Department of Surgery and discharged on day 14. The postoperative course was uneventful and did not require any further haemostatic therapy. PMID:24653855

  2. Miniaturized protein microarray with internal calibration as point-of-care device for diagnosis of neonatal sepsis.

    PubMed

    Buchegger, Patricia; Sauer, Ursula; Toth-Székély, Hedvig; Preininger, Claudia

    2012-01-01

    Neonatal sepsis is still a leading cause of death among newborns. Therefore a protein-microarray for point-of-care testing that simultaneously quantifies the sepsis associated serum proteins IL-6, IL-8, IL-10, TNF alpha, S-100, PCT, E-Selectin, CRP and Neopterin has been developed. The chip works with only a 4 ?L patient serum sample and hence minimizes excessive blood withdrawal from newborns. The 4 ?L patient samples are diluted with 36 ?L assay buffer and distributed to four slides for repetitive measurements. Streptavidin coated magnetic particles that act as distinct stirring detection components are added, not only to stir the sample, but also to detect antibody antigen binding events. We demonstrate that the test is complete within 2.5 h using a single step assay. S-100 conjugated to BSA is spotted in increasing concentrations to create an internal calibration. The presented low volume protein-chip fulfills the requirements of point-of-care testing for accurate and repeatable (CV < 14%) quantification of serum proteins for the diagnosis of neonatal sepsis. PMID:22438722

  3. 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.

  4. Clinical evaluation of the ABL-77 for point-of-care analysis in the cardiovascular operating room.

    PubMed

    Prichard, Jack S; French, John S; Alvar, Nestor

    2006-06-01

    As a small portable instrument, which can be dedicated to the perfusionist, the Radiometer model ABL-77 point-of-care blood gas, electrolyte, and hematocrit analyzer has come to provide an alternative to in-line monitoring of such parameters. This is not to say that it can necessarily replace the utility of in-line monitoring. However, point of care instruments, such as the ABL-77, can provide faster results than a more remote lab. This study was done as part of an ongoing quality assurance program in conjunction with the main lab department to maintain accreditation. The hypothesis being tested is that during cardiopulmonary bypass (CPB) the ABL-77 is in agreement with alternative instruments used outside the cardiovascular operating room. With the appropriate institutional approval, a total of 20 blood samples were randomly gathered among five patients after initiation of CPB. This was done over a five-day period for pH, pCO2, pO2, potassium, sodium, and hematocrit determinations. Analysis results from the ABL-77 were compared to those made by three other bench top models. These included a Radiometer model ABL-720 analyzer, a Dale Dimension model RxL analyzer, and a Beckerman model LH 750 Coulter Counter. A statistically significant difference is demonstrated for all parameters when each of these instruments is compared to the ABL-77. However, the observed mean differences are only judged to be clinically significant in the case of hematocrit. The ABL-77 is found to demonstrate a negative bias with respect to the different methodologies used by the ABL-720 and the Coulter Counter. This bias may be due to the hemodilution of plasma with crystalloid solution during CPB. This causes error in hematocrit results as the methodology of many point of care instruments is based on the electrical conductivity of whole blood. This may be corrected by using a relationship determined from linear regression analysis. This error adjustment has been implemented as part of a concerted blood conservation effort. Otherwise, the ABL-77 has been found to be reliable and consistent for point of care blood analysis. PMID:16921685

  5. 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

  6. 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

  7. 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 <0.5°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

  8. Evaluation of PIMA™® point of care technology for CD4 T cell enumeration in Kenya.

    PubMed

    Mwau, Matilu; Adungo, Ferdinard; Kadima, Silvia; Njagi, Ephantus; Kirwaye, Carolyne; Abubakr, Najma Salim; Okubi, Lucy Atsieno; Waihenya, Mary; Lusike, Judi; Hungu, Jackson

    2013-01-01

    CD4+ T cell enumeration is used to determine eligibility for antiretroviral therapy (ART) and to monitor the immune status of HIV-positive patients; however, many patients do not have access to this essential diagnostic test. Introducing point of care (POC) testing may improve access. We have evaluated Alere's PIMA™, one such POC device, against conventional CD4+ testing platforms to determine its performance and validity for use in Kenya. In our hands, Alere PIMA™ had a coefficient of variability of 10.3% and of repeatability of 175.6 cells/µl. It differed from both the BD FACSCalibur™ (r(2)?=?0.762, mean bias -64.8 cells/µl), and the BD FACSCount™ (r(2)?=?0.874, mean bias 7.8 cells/µl). When compared to the FACSCalibur™ at a cutoff of 350 cells/µl, it had a sensitivity of 89.6% and a specificity of 86.7% in those aged 5 years and over (Kw?=?0.7566). With the BD FACSCount™, it had a sensitivity of 79.4% and a specificity of 83.4% in those aged 5 years and over (Kw?=?0.7790). The device also differed from PARTEC Cyflow™ (r(2)?=?0.781, mean bias -24.2 cells/µl) and GUAVA™ (r(2)?=?0.658, mean bias -0.3 cells/µl) platforms, which are used in some facilities in Kenya. We conclude that with refinement, Alere PIMA™ technology has potential benefits for HIV-positive patients. This study highlights the difficulty in selecting the most appropriate reference technology for technical evaluations. PMID:23825674

  9. 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 ?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

  10. 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

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

    PubMed

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

    2013-11-01

    Often, high-sensitivity, point-of-care (POC) clinical tests, such as HIV viral load, require large volumes of plasma. Although centrifuges are ubiquitously used in clinical laboratories to separate plasma from whole blood, centrifugation is generally inappropriate for on-site testing. Suitable alternatives are not readily available to separate the relatively large volumes of plasma from milliliters of blood that may be needed to meet stringent limit-of-detection specifications for low-abundance target molecules. We report on a simple-to-use, low-cost, pump-free, membrane-based, sedimentation-assisted plasma separator capable of separating a relatively large volume of plasma from undiluted whole blood within minutes. This plasma separator consists of an asymmetric, porous, polysulfone membrane housed in a disposable chamber. The separation process takes advantage of both gravitational sedimentation of blood cells and size exclusion-based filtration. The plasma separator demonstrated a "blood in-plasma out" capability, consistently extracting 275 ± 33.5 ?L of plasma from 1.8 mL of undiluted whole blood within less than 7 min. The device was used to separate plasma laden with HIV viruses from HIV virus-spiked whole blood with recovery efficiencies of 95.5% ± 3.5%, 88.0% ± 9.5%, and 81.5% ± 12.1% for viral loads of 35,000, 3500, and 350 copies/mL, respectively. The separation process is self-terminating to prevent excessive hemolysis. The HIV-laden plasma was then injected into our custom-made microfluidic chip for nucleic acid testing and was successfully subjected to reverse-transcriptase loop-mediated isothermal amplification (RT-LAMP), demonstrating that the plasma is sufficiently pure to support high-efficiency nucleic acid amplification. PMID:24099566

  12. 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

  13. 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

  14. Botfly larva masquerading as periorbital cellulitis: identification by point-of-care ultrasonography.

    PubMed

    Minakova, Elena; Doniger, Stephanie J

    2014-06-01

    Myiasis, or the infiltration of the botfly larvae, is a relatively frequent problem encountered by travelers to parts of Latin America. This is a novel case report that documents a Dermatobia hominis infestation of the left facial region with secondary periorbital cellulitis diagnosed by point-of-care ultrasonography. PMID:24892687

  15. Actuation of elastomeric microvalves in point-of-care settings using handheld, battery-powered instrumentation

    E-print Network

    Sia, Samuel K.

    Actuation of elastomeric microvalves in point-of-care settings using handheld, battery liquid-filled control channels, can be actuated using only a handheld instrument powered by a 9 V battery Microfluidic chamber and control layer fabrication The microfluidic flow and control layers were fabricated

  16. A Wearable Ultrasonic Assembly for Point-of-Care Autonomous Diagnostics of Malignant Growth

    E-print Network

    Bhunia, Swarup

    encompassing transducer design parameters, power and memory requirements. Next, we study the effectivenessA Wearable Ultrasonic Assembly for Point-of-Care Autonomous Diagnostics of Malignant Growth allowing the malignancy to reach an advanced stage. Automated high-resolution monitoring of body parts

  17. Deployment of Freestanding Polyacrylamide Gel Electrophoresis Platform for Point-of-Care Diagnostic Applications

    E-print Network

    Sekhon, Jasjeet S.

    Deployment of Freestanding Polyacrylamide Gel Electrophoresis Platform for Point-of-Care Diagnostic polyacrylamide gel (fsPAG) electrophoresis is proposed as a cheap and robust platform for the diagnosis of preserving reagents within the gels; and the conditions under which the gels are dehydrated and rehydrated

  18. TR-IIS-07-004 Point-of-Care Support for

    E-print Network

    Chen, Sheng-Wei

    TR-IIS-07-004 Point-of-Care Support for Error-Free Medication Process J. W. S. Liu, C. S. Shih, P for prevention and reduction of medication errors. The focus of this paper is on devices and tools that support errors, as well as missing standards that will enable their integration in medication process tool chains

  19. A PDA based Point of Care E-Health Solution for Ambulatory Care

    Microsoft Academic Search

    Daniel Walsh; Carole Alcock; Lois Burgess; Joan Cooper

    2005-01-01

    The adoption of PDAs and mobile communication is expected to provide a solution to the use of computer technology by healthcare workers at the point-of-care. The Australian National Health Information Strategy, Health Online, is providing national leadership for approaches to address the quality and availability of information to assist in the planning and delivery of care. One area for potential

  20. 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.

  1. 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

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

    PubMed

    Manias, Elizabeth; Hughes, Carmel

    2014-10-13

    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

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

    PubMed

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

    2013-04-01

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

  5. 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

  6. Diagnosis of traumatic iliopsoas hematoma using point-of-care ultrasound

    Microsoft Academic Search

    Toru Kameda; Masato Fujita; Isao Takahashi

    2011-01-01

    Case 1 involved a 24-year-old man who complained of severe right groin pain and difficulty of walking after falling to the\\u000a ground while snowboarding. The patient manifested flexion hip contracture on the right side. Abdominal examination detected\\u000a tenderness in the right lower quadrant. Point-of-care ultrasound identified swelling of the right psoas major, compressing\\u000a the right kidney. Case 2 involved a

  7. 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

  8. Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia.

    PubMed

    Lal, Ashutosh; Patterson, Lasandra; Goldrich, Alisa; Marsh, Anne

    2015-05-01

    Carbon monoxide (CO) production from heme catabolism is increased with hemolysis. A portable end-tidal CO (ETCO) monitor was used to analyze breath samples in 16 children with sickle cell anemia (SCA, 5-14 years). Median (range) ETCO for SCA was 4.35?ppm (1.8-9.7) versus 0.80?ppm (0.2-2.3) for controls (P?2.1?ppm provided sensitivity and specificity of 93.8% (69.8-99.8%) for detecting SCA. ETCO correlated with reticulocytosis (P?=?0.015) and bilirubin (P?=?0.009), and was 32% lower in children receiving hydroxyurea (P?=?0.09). Point-of-care ETCO analysis may prove useful for non-invasive monitoring of hemolysis and as a screening test for SCA. Pediatr Blood Cancer 2015;62:912-914. © 2015 Wiley Periodicals, Inc. PMID:25683629

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

    PubMed Central

    2009-01-01

    Background Bleeding is a frequent complication during surgery. The intraoperative administration of blood products, including packed red blood cells, platelets and fresh frozen plasma (FFP), is often live saving. Complications of blood transfusions contribute considerably to perioperative costs and blood product resources are limited. Consequently, strategies to optimize the decision to transfuse are needed. Bleeding during surgery is a dynamic process and may result in major blood loss and coagulopathy due to dilution and consumption. The indication for transfusion should be based on reliable coagulation studies. While hemoglobin levels and platelet counts are available within 15 minutes, standard coagulation studies require one hour. Therefore, the decision to administer FFP has to be made in the absence of any data. Point of care testing of prothrombin time ensures that one major parameter of coagulation is available in the operation theatre within minutes. It is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP. Methods/Design The objective of the POC-OP trial is to determine the effectiveness of point of care prothrombin time testing to reduce the administration of FFP. It is a patient and assessor blind, single center randomized controlled parallel group trial in 220 patients aged between 18 and 90 years undergoing major surgery (any type, except cardiac surgery and liver transplantation) with an estimated blood loss during surgery exceeding 20% of the calculated total blood volume or a requirement of FFP according to the judgment of the physicians in charge. Patients are randomized to usual care plus point of care prothrombin time testing or usual care alone without point of care testing. The primary outcome is the relative risk to receive any FFP perioperatively. The inclusion of 110 patients per group will yield more than 80% power to detect a clinically relevant relative risk of 0.60 to receive FFP of the experimental as compared with the control group. Discussion Point of care prothrombin time testing in the operation theatre may reduce the administration of FFP considerably, which in turn may decrease costs and complications usually associated with the administration of blood products. Trial registration NCT00656396 PMID:19930626

  10. 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

  11. 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.

  12. Utility of point-of-care biliary ultrasound in the evaluation of emergency patients with isolated acute non-traumatic epigastric pain.

    PubMed

    Adhikari, Srikar; Morrison, Daniel; Lyon, Matthew; Zeger, Wes; Krueger, Anthony

    2014-08-01

    To determine the utility of emergency physician-performed point-of-care biliary ultrasound in the evaluation of emergency department (ED) patients with isolated acute non-traumatic epigastric pain. This was a multi-center prospective observational study of adult patients presenting to the ED with isolated acute non-traumatic epigastric pain. Patients with abdominal tenderness at any site other than the epigastric region, or with a history of gall stones, cholecystectomy, gastrointestinal bleeding, chronic abdominal pain, trauma, or altered mental status were excluded. Emergency physician investigators performed point-of-care biliary ultrasound after clinical assessment. Demographic information, history, physical examination findings, laboratory results, additional diagnostic tests, and disposition data were collected. A total of 51 patients (39 women, 12 men) were enrolled. The mean age of the patients was 36.4 years ± 13.6 (SD). All subjects had isolated epigastric tenderness. Gallstones were found in 20/51 (39%, 95% CI 26-52%) on point-of-care biliary ultrasound. Of the 20 patients who had gallstones, eight had sonographic signs of chloecystitis. The treating emergency physicians' initial evaluation did not plan to include an ultrasound in 17/20 patients with gallstones. 19/20 patients were initially given a GI cocktail by the treating emergency physicians. Point-of-care biliary ultrasound detected gall stones in more than one-third of ED patients with isolated acute non-traumatic epigastric pain. All patients presenting to the ED with non-traumatic epigastric pain should be evaluated for biliary disease with an ultrasound imaging study. Bedside ultrasound can avoid misdiagnosis and expedite management in these patients. PMID:24442493

  13. 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

  14. 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

  15. 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 ?l 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

  16. 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.

  17. Identification of Optic Disc Elevation and the Crescent Sign Using Point-of-Care Ocular Ultrasound in Children.

    PubMed

    Marchese, Ronald F; Mistry, Rakesh D; Scarfone, Richard J; Chen, Aaron E

    2015-04-01

    Point-of-care ocular ultrasound has been used to detect papilledema. In previous studies, investigators have evaluated only optic nerve sheath diameter as a screen for increased intracranial pressure. In this series of 4 children, we demonstrate 2 additional optic nerve abnormalities using point-of-care ocular ultrasound: optic disc elevation and the crescent sign. Assessing the optic nerve for each of these 3 findings may assist the examiner in detecting papilledema. PMID:25831036

  18. 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

  19. 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

  20. 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

  1. Measurement of biomarker proteins for point-of-care early detection and monitoring of cancer

    PubMed Central

    Kumar, Challa V.; Gutkind, J. Silvio; Patel, Vyomesh

    2010-01-01

    This critical review evaluates progress toward viable point-of-care protein biomarker measurements for cancer detection and diagnostics. The ability to measure panels of specific, selective cancer biomarker proteins in physicians’ surgeries and clinics has the potential to revolutionize cancer detection, monitoring, and therapy. The dream envisions reliable, cheap, automated, technically undemanding devices that can analyze a patient’s serum or saliva in a clinical setting, allowing on-the-spot diagnosis. Existing commercial products for protein assays are reliable in laboratory settings, but have limitations for point-of-care applications. A number of ultrasensitive immunosensors and some arrays have been developed, many based on nanotechnology. Multilabel detection coupled with high capture molecule density in immunosensors and arrays seems to be capable of detecting a wide range of protein concentrations with sensitivity ranging into the sub pg mL?1 level. Multilabel arrays can be designed to detect both high and ultralow abundance proteins in the same sample. However, only a few of the newer ultrasensitive methods have been evaluated with real patient samples, which is key to establishing clinical sensitivity and selectivity. PMID:20614087

  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. Integrated electrochemical microsystems for genetic detection of pathogens at the point of care.

    PubMed

    Hsieh, Kuangwen; Ferguson, B Scott; Eisenstein, Michael; Plaxco, Kevin W; Soh, H Tom

    2015-04-21

    The capacity to achieve rapid, sensitive, specific, quantitative, and multiplexed genetic detection of pathogens via a robust, portable, point-of-care platform could transform many diagnostic applications. And while contemporary technologies have yet to effectively achieve this goal, the advent of microfluidics provides a potentially viable approach to this end by enabling the integration of sophisticated multistep biochemical assays (e.g., sample preparation, genetic amplification, and quantitative detection) in a monolithic, portable device from relatively small biological samples. Integrated electrochemical sensors offer a particularly promising solution to genetic detection because they do not require optical instrumentation and are readily compatible with both integrated circuit and microfluidic technologies. Nevertheless, the development of generalizable microfluidic electrochemical platforms that integrate sample preparation and amplification as well as quantitative and multiplexed detection remains a challenging and unsolved technical problem. Recognizing this unmet need, we have developed a series of microfluidic electrochemical DNA sensors that have progressively evolved to encompass each of these critical functionalities. For DNA detection, our platforms employ label-free, single-step, and sequence-specific electrochemical DNA (E-DNA) sensors, in which an electrode-bound, redox-reporter-modified DNA "probe" generates a current change after undergoing a hybridization-induced conformational change. After successfully integrating E-DNA sensors into a microfluidic chip format, we subsequently incorporated on-chip genetic amplification techniques including polymerase chain reaction (PCR) and loop-mediated isothermal amplification (LAMP) to enable genetic detection at clinically relevant target concentrations. To maximize the potential point-of-care utility of our platforms, we have further integrated sample preparation via immunomagnetic separation, which allowed the detection of influenza virus directly from throat swabs and developed strategies for the multiplexed detection of related bacterial strains from the blood of septic mice. Finally, we developed an alternative electrochemical detection platform based on real-time LAMP, which not is only capable of detecting across a broad dynamic range of target concentrations, but also greatly simplifies quantitative measurement of nucleic acids. These efforts represent considerable progress toward the development of a true sample-in-answer-out platform for genetic detection of pathogens at the point of care. Given the many advantages of these systems, and the growing interest and innovative contributions from researchers in this field, we are optimistic that iterations of these systems will arrive in clinical settings in the foreseeable future. PMID:25785632

  4. 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/?L 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.

  5. Rapid and quantitative detection of C-reactive protein using quantum dots and immunochromatographic test strips

    PubMed Central

    Cheng, Xianglin; Pu, Xu; Jun, Pen; Zhu, XiaoBo; Zhu, Di; Chen, Ming

    2014-01-01

    Background Rapid immunochromatographic tests can detect disease markers in 10–15 minutes, which facilitates clinical diagnosis and treatment programs. However, most immunochromatographic tests employ gold nanoparticles as reporters, and these have only moderate sensitivity and act as qualitative methods for analyzing high biomarker concentrations. Methods In this study, we introduce quantum dots (QDs) as fluorescent probes and immunochromatographic strips to develop quantitative fluorescence point-of-care tests (QF-POCT) to analyze C-reactive protein (CRP) levels. Goat anti-rabbit IgG and rabbit IgG were used as control antibodies, and mouse monoclonal CRP antibody pairs were used for disease marker detection. One monoclonal CRP antibody was conjugated with QDs and served as a signal antibody, and the other monoclonal CRP antibody was dispensed onto the nitrocellulose membrane and served as a capturing antibody. In the presence of CRP, the fluorescence intensity of the monoclonal antibody-CRP-monoclonal antibody sandwich complex captured on the nitrocellulose membrane was determined using the fluorescence strip reader. Results QF-POCT assays could quantitatively analyze the concentration of CRP in 15 minutes had a detection limit of 0.25 mg/L, and had a wide detection linearity range (0.5–300 mg/L). The intra-assay and interassay coefficients of variation were 8.95% and 9.86% at 0.5 mg/L, 6.47% and 8.66% at 10 mg/L, and 6.81% and 9.10% at 60 mg/L, respectively. In a comparison between clinical samples, the results of this QD-based assay of CRP levels were significantly correlated with those of an Immulite 2000 assay (R=0.993, P<0.001). Conclusion Our results demonstrated that the QD-based immunochromatographic test is a rapid, sensitive, accurate, and quantitative method for the detection of disease biomarkers. PMID:25506215

  6. 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

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

    PubMed Central

    Borecki, Micha?; 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

  8. 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

  9. 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

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

    PubMed

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

    2014-01-01

    This article reviews the current technology, literature, teaching models, and methods associated with simulation-based point-of-care ultrasound training. Patient simulation appears particularly well suited for learning point-of-care ultrasound, which is a required core competency for emergency medicine and other specialties. Work hour limitations have reduced the opportunities for clinical practice, and simulation enables practicing a skill multiple times before it may be used on patients. Ultrasound simulators can be categorized into 2 groups: low and high fidelity. Low-fidelity simulators are usually static simulators, meaning that they have nonchanging anatomic examples for sonographic practice. Advantages are that the model may be reused over time, and some simulators can be homemade. High-fidelity simulators are usually high-tech and frequently consist of many computer-generated cases of virtual sonographic anatomy that can be scanned with a mock probe. This type of equipment is produced commercially and is more expensive. High-fidelity simulators provide students with an active and safe learning environment and make a reproducible standardized assessment of many different ultrasound cases possible. The advantages and disadvantages of using low- versus high-fidelity simulators are reviewed. An additional concept used in simulation-based ultrasound training is blended learning. Blended learning may include face-to-face or online learning often in combination with a learning management system. Increasingly, with simulation and Web-based learning technologies, tools are now available to medical educators for the standardization of both ultrasound skills training and competency assessment. PMID:24371095

  11. Evaluation of "point of care" devices in the measurement of low blood glucose in neonatal practice

    PubMed Central

    Ho, H; Yeung, W; Young, B

    2004-01-01

    Background: Low blood glucose in newborns is difficult to detect clinically. Hence a reliable "point of care" device (glucometer) for early detection and treatment of low glucose is needed. Objective: To evaluate the performance of five readily available glucometers for the detection of low blood glucose in newborn infants. Method: Glucostix measurements were taken for newborns with risk factors using a Reflolux S (Boehringer) glucometer. If the initial reading was low (< 2.6 mmol/l), further measurements were taken with two other glucometers (phase I, Advantage and Glucotrend (Roche); phase II, Elite XL (Bayer) and Precision (Abbott)), and plasma glucose was measured in the laboratory (Aeroset; Abbott). Results: Over 10 months, 101 specimens were collected from 71 newborns (57 in phase I; 44 in phase II). The Advantage glucometer usually overestimated blood glucose with a mean difference of 1.07 mmol/l (p < 0.01) at all low glucose ranges. The Glucotrend, Precision, and Elite XL glucometers performed better; the mean differences were not significantly different from the laboratory measured value (0.17 mmol/l (p  =  0.37); –0.12 mmol/l (p  =  0.13), and 0.24 mmol/l (p  =  0.13) respectively). For detection of glucose concentrations < 2.6 mmol/l, the Precision glucometer had the highest sensitivity (96.4%) and negative predictive value (90%). For lower glucose concentrations (< 2.0 mmol/l), the Glucotrend glucometer performed even better (sensitivity 92.3%, negative predictive value 96.3%). Conclusion: Point of care devices should have good precision in the low glucose concentration range, sensitivity, and accuracy for early detection of neonatal hypoglycaemia. None of the five glucometers was satisfactory as the sole measuring device. The Glucotrend and Precision glucometers have the greatest sensitivity and negative predictive value. However, confirmation with laboratory measurements of plasma glucose and clinical assessment are still of the utmost importance. PMID:15210675

  12. Immediate versus delayed integrated point-of-care-ultrasonography to manage acute dyspnea in the emergency department

    PubMed Central

    2014-01-01

    Background Dyspnea is one of the most frequent complaints in the Emergency Department. Thoracic ultrasound should help to differentiate cardiogenic from non-cardiogenic causes of dyspnea. We evaluated whether the diagnostic accuracy can be improved by adding a point-of-care-ultrasonography (POC-US) to routine exams and if an early use of this technique produces any advantage. Methods One hundred sixty-eight patients were enrolled and randomized in two groups: Group 1 received an immediate POC-US in addition to routine laboratory and instrumental tests; group 2 received an ultrasound scan within 1 h from the admission to the Emergency Department. The concordance between initial and final diagnosis and the percentage of wrong diagnosis in the two groups were evaluated. Mortality, days of hospitalization in Emergency Medicine department and transfers to other wards were compared. Sensitivity and specificity of the routine protocol and the one including ultrasonography for the diagnosis of the causes of dyspnea were also analyzed. Results Eighty-eight patients were randomized in group 1 and 80 in group 2. The concordance rate between initial and final diagnoses was significantly different (0.94 in group 1 vs. 0.22 in group 2, p?

  13. An isothermal amplification reactor with an integrated isolation membrane for point-of-care detection of infectious diseases

    PubMed Central

    Liu, Changchun; Geva, Eran; Mauk, Michael; Qiu, Xianbo; Abrams, William R.; Malamud, Daniel; Curtis, Kelly; Owen, S. Michele; Bau, Haim H.

    2015-01-01

    A simple, point of care, inexpensive, disposable cassette for the detection of nucleic acids extracted from pathogens was designed, constructed, and tested. The cassette utilizes a single reaction chamber for isothermal amplification of nucleic acids. The chamber is equipped with an integrated, flow-through, Flinders Technology Associates (Whatman FTA®) membrane for the isolation, concentration, and purification of DNA and/or RNA. The nucleic acids captured by the membrane are used directly as templates for amplification without elution, thus simplifying the cassette’s flow control. The FTA membrane also serves another critical role—enabling the removal of inhibitors that dramatically reduce detection sensitivity. Thermal control is provided with a thin film heater external to the cassette. The amplification process was monitored in real time with a portable, compact fluorescent reader. The utility of the integrated, single-chamber cassette was demonstrated by detecting the presence of HIV-1 in oral fluids. The HIV RNA was reverse transcribed and subjected to loop-mediated, isothermal amplification (LAMP). A detection limit of less than 10 HIV particles was demonstrated. The cassette is particularly suitable for resource poor regions, where funds and trained personnel are in short supply. The cassette can be readily modified to detect nucleic acids associated with other pathogens borne in saliva, urine, and other body fluids as well as in water and food. PMID:21455542

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

    E-print Network

    Pollock, Nira R.

    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 ...

  15. 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.

  16. 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.

  17. Impact of telavancin on prothrombin time and activated partial thromboplastin time as determined using point-of-care coagulometers.

    PubMed

    Ero, Michael P; Harvey, Nathaniel R; Harbert, Jack L; Janc, James W; Chin, Kay H; Barriere, Steven L

    2014-01-01

    Telavancin is approved in the United States, Canada, and Europe (At the time of submission, the telavancin European marketing authorization for nosocomial pneumonia was suspended until Theravance provides evidence of a new European Medicines Agency approved supplier) as an antibiotic to treat certain Gram-positive bacterial skin infections. Telavancin has been shown to prolong plasmatic prothrombin (PT) and activated partial thromboplastin (aPTT) clotting times in clinical diagnostic lab-based assays. In this study, we evaluated the potential for telavancin to prolong whole blood PT/International Normalized Ratio (INR) and aPTT tests on point-of-care (POC) instruments. Whole blood collected from 8 healthy subjects was supplemented with telavancin to final concentrations of 0, 10, 20, and 100 ?g/ml. Final concentrations were selected to match trough, twice trough, and peak plasma levels following the approved 10 mg/kg dose. Four widely employed POC coagulation instruments were chosen to be representative of the POC platforms currently in use.. These systems were the Roche Coaguchek XS, the Abbott iSTAT, the ITC Hemochron SIG+, and the Alere INRatio2 POC devices. The PT/INR measured by the Coaguchek XS showed the greatest sensitivity to the presence of telavancin. The PT/INR measured by the Hemochron SIG+ and iSTAT were sensitive to telavancin but to a lesser extent. The INRatio2 was the least sensitive to the presence of telavancin when testing the whole blood PT/INR. Only the Hemochron SIG+ device was capable of measuring aPTT and showed a concentration-dependent increase in aPTT. This study supports the current recommendation that PT and aPTT monitoring be conducted immediately to the next dose of telavancin when coagulation parameters are tested using POC instrumentation. PMID:24132401

  18. Identifying barriers to hypertension guideline adherence using clinician feedback at the point of care.

    PubMed

    Lin, N D; Martins, S B; Chan, A S; Coleman, R W; Bosworth, H B; Oddone, E Z; Shankar, R D; Musen, M A; Hoffman, B B; Goldstein, M K

    2006-01-01

    Factors contributing to low adherence to clinical guidelines by clinicians are not well understood. The user interface of ATHENA-HTN, a guideline-based decision support system (DSS) for hypertension, presents a novel opportunity to collect clinician feedback on recommendations displayed at the point of care. We analyzed feedback from 46 clinicians who received ATHENA advisories as part of a 15-month randomized trial to identify potential reasons clinicians may not intensify hypertension therapy when it is recommended. Among the 368 visits for which feedback was provided, clinicians commonly reported they did not follow recommendations because: recorded blood pressure was not representative of the patient's typical blood pressure; hypertension was not a clinical priority for the visit; or patients were nonadherent to medications. For many visits, current quality-assurance algorithms may incorrectly identify clinically appropriate decisions as guideline nonadherent due to incomplete capture of relevant information. We present recommendations for how automated DSSs may help identify "apparent" barriers and better target decision support. PMID:17238390

  19. 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

  20. 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

  1. Coagulation Abnormalities in the Trauma Patient: The Role of Point-of-Care Thromboelastography

    PubMed Central

    Gonzalez, Eduardo; Pieracci, Fredric M.; Moore, Ernest E.; Kashuk, Jeffry L.

    2015-01-01

    Current recommendations for resuscitation of the critically injured patient are limited by a lack of point-of-care (POC) assessment of coagulation status. Accordingly, the potential exists for indiscriminant blood component administration. Furthermore, although thromboembolic events have been described shortly after injury, the time sequence of post-injury coagulation changes is unknown. Our current understanding of hemostasis has shifted from a classic view, in which coagulation was considered a chain of catalytic enzyme reactions, to the cell-based model (CBM), representing the interplay between the cellular and plasma components of clot formation. Thromboelastography (TEG), a time-sensitive dynamic assay of the viscoelastic properties of blood, closely parallels the CBM, permitting timely, goal-directed restoration of hemostasis via POC monitoring of coagulation status. TEG-based therapy allows for goal-directed blood product administration in trauma, with potential avoidance of the complications resulting from overzealous component administration, as well as the ability to monitor post-injury coagulation status and thromboprophylaxis. This overview addresses coagulation status and thromboprophylaxis management in the trauma patient and the emerging role of POC TEG. PMID:20978993

  2. 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

  3. 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

  4. Nucleic acid aptamers: ideal reagents for point-of-care diagnostics?

    PubMed

    Cass, Anthony E G; Zhang, Yangyang

    2011-01-01

    Nucleic acid aptamers have many of the properties that make for effective reagents in point-of-care diagnostic devices and whilst superficially similar to antibodies as affinity reagents the scope for engineering them to fit this role is considerable. Synthesis of aptamers allows for the incorporation of functionality for both immobilisation and electrochemical signalling in a way that is compatible with the 'strip' type sensors familiar in enzyme sensors, such as those for glucose. Control of the structure of DNA aptamers through Watson-Crick base pairing allows for different electrochemical assay formats, whilst ferrocenes provide a versatile redox label and insights into the interactions between the aptamer and its target are obtained through both cyclic and square-wave voltammetries. Square-wave voltammetry in particular demonstrates good analytical utility. Two different approaches were used to assemble aptamer/redox probe structures on the surface of gold electrodes and both showed "signal on" behaviour (i.e. the current increases in the presence of analyte) although the two different methods appear to give quite distinct surface coatings. PMID:21413174

  5. BioPen: direct writing of functional materials at the point of care

    NASA Astrophysics Data System (ADS)

    Han, Yu Long; Hu, Jie; Genin, Guy M.; Lu, Tian Jian; Xu, Feng

    2014-05-01

    Rapid and precise patterning of functional biomaterials is desirable for point-of-care (POC) tissue engineering and diagnostics. However, existing technologies such as dip-pen nanolithography and inkjet printing are currently unsuitable for POC applications due to issues of cost and portability. Here, we report the development of `BioPen', a portable tool for continuous, defined and scalable deposition of functional materials with micrometer spatial resolution and nanolitre volumetric resolution. BioPen is based upon the ballpoint pen but with multiple ``ink sources'' (functional material solutions) and with an apparatus that can be optimized for writing living cells, proteins, nucleic acids, etc. We demonstrate POC detection of human immunodeficiency virus type 1 (HIV-1) nucleic acid by writing on paper with BioPen using ``ink'' consisting of nucleic acid probes and nucleic acid-modified gold nanoparticles. We also demonstrate POC tissue engineering by writing a continuous pattern of living, functional, interconnected cells with a defined extracellular environment. Because it is simple, accurate, inexpensive and portable, BioPen has broad potential for POC detection of diagnostic biomarkers, and for POC engineering of tissues for a range of healing applications.

  6. Emerging technologies for monitoring drug-resistant tuberculosis at the point-of-care.

    PubMed

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

    2014-11-30

    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 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

  7. 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

  8. 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.

  9. 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

  10. 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…

  11. The rapid, automated, point-of-care system (RapiDx) developed by Sandia National Laboratories is redefining

    E-print Network

    Singh, Anup

    Dx Protein signatures of infection, disease, or exposure to tox- ic substances circulate in blood and saliva or saliva can be collected and analyzed at the point of care (e.g., in a doctor's or dentist's office of blood or saliva in a doctor's office, enabling low-cost, rapid diagnoses during an office visit

  12. 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.

  13. 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

  14. Rapid point of care analyzer for the measurement of cyanide in blood.

    PubMed

    Ma, Jian; Ohira, Shin-Ichi; Mishra, Santosh K; Puanngam, Mahitti; Dasgupta, Purnendu K; Mahon, Sari B; Brenner, Matthew; Blackledge, William; Boss, Gerry R

    2011-06-01

    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% H(3)PO(4) 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 (?(max) = 510 nm) to violet (?(max) = 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 10 times 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 improves the limit of detection by 4 times to ~0.5 ?M for a 1 mL blood sample. Blood cyanide levels of imminent concern (?10 ?M) 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 ?M 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, r(2) 0.9257); independent calibration standards were used. PMID:21553921

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

    PubMed Central

    Stolz, Lori; O’Brien, Kathleen M.; Miller, Marc L.; Winters-Brown, Nicole D.; Blaivas, Michael; Adhikari, Srikar

    2015-01-01

    Introduction New medical technology brings the potential of lawsuits related to the usage of that new technology. In recent years the use of point-of-care (POC) ultrasound has increased rapidly in the emergency department (ED). POC ultrasound creates potential legal risk to an emergency physician (EP) either using or not using this tool. The aim of this study was to quantify and characterize reported decisions in lawsuits related to EPs performing POC ultrasound. Methods We conducted a retrospective review of all United States reported state and federal cases in the Westlaw database. We assessed the full text of reported cases between January 2008 and December 2012. EPs with emergency ultrasound fellowship training reviewed the full text of each case. Cases were included if an EP was named, the patient encounter was in the emergency department, the interpretation or failure to perform an ultrasound was a central issue and the application was within the American College of Emergency Physician (ACEP) ultrasound core applications. In order to assess deferred risk, cases that involved ultrasound examinations that could have been performed by an EP but were deferred to radiology were included. Results We identified five cases. All reported decisions alleged a failure to perform an ultrasound study or a failure to perform it in a timely manner. All studies were within the scope of emergency medicine and were ACEP emergency ultrasound core applications. A majority of cases (n=4) resulted in a patient death. There were no reported cases of failure to interpret or misdiagnoses. Conclusion In a five-year period from January 2008 through December 2012, five malpractice cases involving EPs and ultrasound examinations that are ACEP core emergency ultrasound applications were documented in the Westlaw database. All cases were related to failure to perform an ultrasound study or failure to perform a study in a timely manner and none involved failure to interpret or misdiagnosis when using of POC ultrasound. PMID:25671000

  16. 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

  17. 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 (?max = 510 nm) to violet (?max = 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 ?M for a 1 mL blood sample. Blood cyanide levels of imminent concern (? 10 ?M) 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 ?M 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

  18. Phaseguide-assisted blood separation microfluidic device for point-of-care applications.

    PubMed

    Xu, Linfeng; Lee, Hun; Brasil Pinheiro, Mariana Vanderlei; Schneider, Phil; Jetta, Deekshitha; 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 ?l of whole blood but yielding approximately 0.38??l 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

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

    PubMed

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

    2014-09-01

    A widely used method in monitoring glycemic status of ICU patients is point-of-care (POC) monitoring devices. A possible limitation to this method is altered peripheral blood flow in patients in shock, which may result in over/underestimations of their true glycemic status. This study aims to determine the accuracy of blood glucose measurements with a POC meter compared to laboratory methods in critically ill patients in shock. POC blood glucose was measured with a glucose-1-dehydrogenase-based reflectometric meter. The reference method was venous plasma glucose measured by a clinical chemistry analyzer (glucose oxidase-based). Outcomes assessed were concordance to ISO 15197:2003 minimum accuracy criteria for glucose meters, bias in glucose measurements obtained by the 2 methods using Bland-Altman analysis, and clinical accuracy through modified error grid analysis. A total of 186 paired glucose measurements were obtained. ISO 2003 accuracy criteria were met in 95.7% and 79.8% of POC glucose values in the normotensive and hypotensive group, respectively. Mean bias for the normotensive group was -12.4 mg/dL, while mean bias in the hypotensive group was -34.9 mg/dL. POC glucose measurements within the target zone for clinical accuracy were 90.2% and 79.8% for the normotensive and hypotensive group, respectively. POC blood glucose measurements were significantly less accurate in the hypotensive subgroup of ICU patients compared to the normotensive group. We recommend a lower threshold in confirming POC blood glucose with a central laboratory method if clinically incompatible. In light of recently updated accuracy standards, we also recommend alternative methods of glucose monitoring for the ICU population as a whole regardless of blood pressure status. PMID:25172876

  20. 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

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

    PubMed Central

    Cawley, Michael J.; Pacitti, Richard; Warning, William

    Objective To assess value-added service of a pharmacist-driven point-of-care spirometry clinic to quantify respiratory disease abnormalities within a primary care physicians office Methods This retrospective, cohort study was an analysis of physician referred patients who attended our spirometry clinic during 2008-2010 due to pulmonary symptoms or disease. After spirometry testing, data was collected retrospectively to include patient demographics, spirometry results, and pulmonary pharmaceutical interventions. Abnormal spirometry was identified as an obstructive and/or restrictive defect. Results Sixty-five patients with a primary diagnosis of cough, shortness of breath, or diagnosis of asthma or chronic obstructive pulmonary disease were referred to the spirometry clinic for evaluation. A total of 51 (32 patients with normal spirometry, 19 abnormal spirometry) completed their scheduled appointment. Calculated lung age was lower in normal spirometry (58.1; SD=20 yrs) than abnormal spirometry (78.2; SD=7.5 yrs, p<0.001). Smoking pack years was also lower in normal spirometry (14.4; SD=10.7 yrs) than abnormal spirometry (32.7; SD=19.5 yrs, p=0.004). Resting oxygen saturation of the arterial blood (SaO2) was higher in normal spirometry than abnormal spirometry (98.1% vs 96.5%, p=0.016). Mean change in the forced expiratory volume in one second (FEV1) after administration of bronchodilator was greater in patients with abnormal spirometry compared with normal spirometry (10.9% vs 4.1%, p<0.001). Spirometry testing assisted in addition, discontinuation or altering pulmonary drug regimens in 41/51 patients (80%) and the need for further diagnostic testing or physician referral in 14/51 patients (27.4%). Conclusions Implementation of a pharmacist-driven spirometry clinic is a value-added service that can be integrated with other clinical pharmacy services within the ambulatory care setting. Further studies are needed to determine the role of pharmacists in performing spirometry testing and measuring performance outcomes of the pulmonary patient. PMID:24198860

  2. An Integrated Tiered Service Delivery Model (ITSDM) Based on Local CD4 Testing Demands Can Improve Turn-Around Times and Save Costs whilst Ensuring Accessible and Scalable CD4 Services across a National Programme

    PubMed Central

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

    2014-01-01

    Background The South African National Health Laboratory Service (NHLS) responded to HIV treatment initiatives with two-tiered CD4 laboratory services in 2004. Increasing programmatic burden, as more patients access anti-retroviral therapy (ART), has demanded extending CD4 services to meet increasing clinical needs. The aim of this study was to review existing services and develop a service-model that integrated laboratory-based and point-of-care testing (POCT), to extend national coverage, improve local turn-around/(TAT) and contain programmatic costs. Methods NHLS Corporate Data Warehouse CD4 data, from 60–70 laboratories and 4756 referring health facilities was reviewed for referral laboratory workload, respective referring facility volumes and related TAT, from 2009–2012. Results An integrated tiered service delivery model (ITSDM) is proposed. Tier-1/POCT delivers CD4 testing at single health-clinics providing ART in hard-to-reach areas (<5 samples/day). Laboratory-based testing is extended with Tier-2/POC-Hubs (processing ?30–40 CD4 samples/day), consolidating POCT across 8–10 health-clinics with other HIV-related testing and Tier-3/‘community’ laboratories, serving ?40 health-clinics, processing ?150 samples/day. Existing Tier-4/‘regional’ laboratories serve ?100 facilities and process <350 samples/day; Tier-5 are high-volume ‘metro’/centralized laboratories (>350–1500 tests/day, serving ?200 health-clinics). Tier-6 provides national support for standardisation, harmonization and quality across the organization. Conclusion The ITSDM offers improved local TAT by extending CD4 services into rural/remote areas with new Tier-3 or Tier-2/POC-Hub services installed in existing community laboratories, most with developed infrastructure. The advantage of lower laboratory CD4 costs and use of existing infrastructure enables subsidization of delivery of more expensive POC services, into hard-to-reach districts without reasonable access to a local CD4 laboratory. Full ITSDM implementation across 5 service tiers (as opposed to widespread implementation of POC testing to extend service) can facilitate sustainable ‘full service coverage’ across South Africa, and save>than R125 million in HIV/AIDS programmatic costs. ITSDM hierarchical parental-support also assures laboratory/POC management, equipment maintenance, quality control and on-going training between tiers. PMID:25490718

  3. Type of Evidence Behind Point-of-Care Clinical Information Products: A Bibliometric Analysis

    PubMed Central

    2011-01-01

    Background Point-of-care (POC) products are widely used as information reference tools in the clinical setting. Although usability, scope of coverage, ability to answer clinical questions, and impact on health outcomes have been studied, no comparative analysis of the characteristics of the references, the evidence for the content, in POC products is available. Objective The objective of this study was to compare the type of evidence behind five POC clinical information products. Methods This study is a comparative bibliometric analysis of references cited in monographs in POC products. Five commonly used products served as subjects for the study: ACP PIER, Clinical Evidence, DynaMed, FirstCONSULT, and UpToDate. The four clinical topics examined to identify content in the products were asthma, hypertension, hyperlipidemia, and carbon monoxide poisoning. Four indicators were measured: distribution of citations, type of evidence, product currency, and citation overlap. The type of evidence was determined based primarily on the publication type found in the MEDLINE bibliographic record, as well as the Medical Subject Headings (MeSH), both assigned by the US National Library of Medicine. MeSH is the controlled vocabulary used for indexing articles in MEDLINE/PubMed. Results FirstCONSULT had the greatest proportion of references with higher levels of evidence publication types such as systematic review and randomized controlled trial (137/153, 89.5%), although it contained the lowest total number of references (153/2330, 6.6%). DynaMed had the largest total number of references (1131/2330, 48.5%) and the largest proportion of current (2007-2009) references (170/1131, 15%). The distribution of references cited for each topic varied between products. For example, asthma had the most references listed in DynaMed, Clinical Evidence, and FirstCONSULT, while hypertension had the most references in UpToDate and ACP PIER. An unexpected finding was that the rate of citation overlap was less than 1% for each topic across all five products. Conclusions Differences between POC products are revealed by examining the references cited in the monographs themselves. Citation analysis extended to include key content indicators can be used to compare the evidence levels of the literature supporting the content found in POC products. PMID:21335319

  4. 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.

  5. 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.

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

    PubMed Central

    Moja, Lorenzo; Kwag, Koren Hyogene

    2015-01-01

    The structure and aim of continuing medical education (CME) is shifting from the passive transmission of knowledge to a competency-based model focused on professional development. Self-directed learning is emerging as the foremost educational method for advancing competency-based CME. In a field marked by the constant expansion of knowledge, self-directed learning allows physicians to tailor their learning strategy to meet the information needs of practice. Point of care information services are innovative tools that provide health professionals with digested evidence at the front line to guide decision making. By mobilising self-directing learning to meet the information needs of clinicians at the bedside, point of care information services represent a promising platform for competency-based CME. Several points, however, must be considered to enhance the accessibility and development of these tools to improve competency-based CME and the quality of care. PMID:25655251

  7. Diagnosis of metacarpal fracture with equivocal x-ray by point-of-care ultrasound: a case report.

    PubMed

    Ruskis, Jennifer; Kummer, Tobias

    2014-07-01

    Metacarpal fractures represent a very common injury among patients presenting to the emergency department. Diagnosis is of utmost importance given the high morbidity associated with lack of full hand function. We report a case of a 37-year-old man who sustained extremity trauma after a mechanical fall. He presented with an examination that revealed diffuse tenderness over the wrist and hand. X-ray of the hand was equivocal for a metacarpal fracture; however, point-of-care ultrasound revealed disruption of the bony cortex confirming the diagnosis. The patient was splinted and referred for follow-up with a hand specialist. Point-of-care ultrasound may be useful for the diagnosis of hand fractures, which may reduce health care costs and radiation exposure in the future. PMID:24630805

  8. Point-of-care ultrasonography for the identification of 2 children with optic disc drusen mimicking papilledema.

    PubMed

    Braun, Alanna; Doniger, Stephanie J

    2014-07-01

    We present 2 cases of asymptomatic patients who were found to have raised and blurred optic discs on physical examination, suggestive of papilledema. Evaluation in the emergency department revealed 2 well-appearing children with normal vital signs and neurologic evaluation results, without symptoms of increased intracranial pressure. Point-of-care ocular ultrasonography was performed on both children, demonstrating calcification at the optic nerve, which is diagnostic of optic disc drusen. Optic disc drusen is caused by the deposition of calcified axonal debris and is often buried within the optic disc in pediatric patients. It can cause some changes in visual acuity and visual fields, but patients who are otherwise asymptomatic can be easily diagnosed through point-of-care ultrasound, thereby sparing patients an aggressive workup if their clinical picture is otherwise reassuring. PMID:24987997

  9. An Evaluation of the Point-of-Care Analyzer, i-Smart 30, for Measurement of Electrolytes.

    PubMed

    Arya, Subhash C; Agarwal, Nirmala; Michael, Beena

    2014-10-01

    Analytical functioning of a point-of-care analyzer, i-Smart 30 (i-sens: Seoul, South Korea), for electrolyte quantification was investigated at Sant Parmanand Hospital, a tertiary-care hospital in Delhi, India. Samples that were received for electrolyte assay were assayed, double-blinded for their Na and K level using the arterial blood gas analyzer, the ABL 555 (Radiometer, Copenhagen) and the i-Smart 30 electrolyte analyzer. There was satisfactory correlation between the results obtained with the two analyzers with an encouraging bias, standard deviation and the 95 % limits of agreement between the data generated for Na and K levels. The performance of the i-Smart 30 would be satisfactory during the point-of-care measurements of Na and K levels in emergency rooms and clinical laboratories with inadequate infrastructure only if its day-to-day performance was monitored to ensure reliability of the generated reports. PMID:25298635

  10. Accuracy of clinician-performed point-of-care ultrasound for the diagnosis of fractures in children and young adults

    Microsoft Academic Search

    Eric R. Weinberg; Michael G. Tunik; James W. Tsung

    2010-01-01

    IntroductionInjury is a major cause of death and disability in children and young adults worldwide. X-rays are routinely performed to evaluate injuries with suspected fractures. However, the World Health Organisation estimates that up to 75% of the world population has no access to any diagnostic imaging services. Use of clinician-performed point-of-care ultrasound to diagnose fractures is not only feasible in

  11. Integrated optical detection of autonomous capillary microfluidic immunoassays:a hand-held point-of-care prototype.

    PubMed

    Novo, P; Chu, V; Conde, J P

    2014-07-15

    The miniaturization of biosensors using microfluidics has potential in enabling the development of point-of-care devices, with the added advantages of reduced time and cost of analysis with limits-of-detection comparable to those obtained through traditional laboratory techniques. Interfacing microfluidic devices with the external world can be difficult especially in aspects involving fluid handling and the need for simple sample insertion that avoids special equipment or trained personnel. In this work we present a point-of-care prototype system by integrating capillary microfluidics with a microfabricated photodiode array and electronic instrumentation into a hand-held unit. The capillary microfluidic device is capable of autonomous and sequential fluid flow, including control of the average fluid velocity at any given point of the analysis. To demonstrate the functionality of the prototype, a model chemiluminescence ELISA was performed. The performance of the integrated optical detection in the point-of-care prototype is equal to that obtained with traditional bench-top instrumentation. The photodiode signals were acquired, displayed and processed by a simple graphical user interface using a computer connected to the microcontroller through USB. The prototype performed integrated chemiluminescence ELISA detection in about 15 min with a limit-of-detection of ?2 nM with an antibody-antigen affinity constant of ?2×10(7) M(-1). PMID:24607579

  12. EBMPracticeNet: A Bilingual National Electronic Point-Of-Care Project for Retrieval of Evidence-Based Clinical Guideline Information and Decision Support

    PubMed Central

    2013-01-01

    Background In Belgium, the construction of a national electronic point-of-care information service, EBMPracticeNet, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The collaboration of the government, health care providers, evidence-based medicine (EBM) partners, and vendors of electronic health records (EHR) is unique to this project. All Belgian health care professionals get free access to an up-to-date database of validated Belgian and nearly 1000 international guidelines, incorporated in a portal that also provides EBM information from other sources than guidelines, including computerized clinical decision support that is integrated in the EHRs. Objective The objective of this paper was to describe the development strategy, the overall content, and the management of EBMPracticeNet which may be of relevance to other health organizations creating national or regional electronic point-of-care information services. Methods Several candidate providers of comprehensive guideline solutions were evaluated and one database was selected. Translation of the guidelines to Dutch and French was done with translation software, post-editing by translators and medical proofreading. A strategy is determined to adapt the guideline content to the Belgian context. Acceptance of the computerized clinical decision support tool has been tested and a randomized controlled trial is planned to evaluate the effect on process and patient outcomes. Results Currently, EBMPracticeNet is in "work in progress" state. Reference is made to the results of a pilot study and to further planned research including a randomized controlled trial. Conclusions The collaboration of government, health care providers, EBM partners, and vendors of EHRs is unique. The potential value of the project is great. The link between all the EHRs from different vendors and a national database held on a single platform that is controlled by all EBM organizations in Belgium are the strengths of EBMPracticeNet. PMID:23842038

  13. Repurposed Automated Handheld Counter as a Point-of-Care Tool to Identify Individuals ‘At Risk’ of Serious Post-Ivermectin Encephalopathy

    PubMed Central

    Bennuru, Sasisekhar; Pion, Sébastien D. S.; Kamgno, Joseph; Wanji, Samuel; Nutman, Thomas B.

    2014-01-01

    Introduction Administration of ivermectin (IVM) as part of mass drug administration (MDA) campaigns for onchocerciasis and/or lymphatic filariasis (LF) has been suspended in areas co-endemic for Loa loa due to severe post-treatment adverse events (SAEs) associated with high-burden of infection (>30,000 mf/ml). One simple approach for preventing SAEs is to identify and exclude individuals at risk from MDA. Here, we describe a repurposed hand-held automated cell counter (Scepter 2.0; HHAC) as a rapid, point-of-care method for quantifying microfilariae (mf) in the blood of infected individuals. Methodology/Principal Findings The quantification of microfilarial levels in blood of naturally infected humans, experimentally infected baboons, or mf-spiked human blood was tested using a microfluidic-based automated counter and compared to traditional calibrated thick-smears. We demonstrate that mf can be quantified in 20 µl of whole blood following lysis with 10% saponin within a minute of obtaining blood. There was a highly significant concordance between the counts obtained by the HHAC and those by microscopy for mf densities of >5,000 (p<0.0001, rc?=?0.97) or >30,000 per ml (p<0.0001, rc?=?0.90). Preliminary proof of concept field studies in Cameroon with 20 µl of blood from L. loa infected humans (n?=?22) and baboons (n?=?4) also demonstrated a significantly high concordance (p<0.0001, rc?=?0.89) with calibrated thick blood smears counts. Conclusions/Significance A repurposed HHAC is a portable, sensitive, rapid, point-of-care and quantitative tool to identify individuals with high levels of L. loa mf that put them at risk for SAEs following MDA. In addition, it provides ease of data storage and accessibility. PMID:25232954

  14. Highly Sensitive and Novel Point-of-Care System, aQcare Chlamydia TRF Kit for Detecting Chlamydia trachomatis by Using Europium (Eu) (III) Chelated Nanoparticles

    PubMed Central

    Ham, Ji Yeon; Jung, Jaean; Hwang, Byung-Gap; Kim, Won-Jung; Kim, Young-Seop; Kim, Eun-Ju; Cho, Mi-Yeon; Hwang, Mi-Sun; Won, Dong Il

    2015-01-01

    Background The bacterium Chlamydia trachomatis is one of the leading causes of sexually transmitted diseases worldwide. Since no simple and effective tool exists to diagnose C. trachomatis infections, we evaluated a novel point-of-care (POC) test, aQcare Chlamydia TRF kit, which uses europium-chelated nanoparticles and a time-resolved fluorescence reader. Methods The test performance was evaluated by comparing the results obtained using the novel POC testing kit with those obtained using a nucleic acid amplification test (NAAT), using 114 NAAT-positive and 327 NAAT-negative samples. Results The cut-off value of the novel test was 20.8 with a detection limit of 0.27 ng/mL. No interference or cross-reactivity was observed. Diagnostic accuracy showed an overall sensitivity of 93.0% (106/114), specificity of 96.3% (315/327), positive predictive value (PPV) of 89.8% (106/118), and negative predictive value (NPV) of 97.5% (315/323). The sensitivity of the novel test was much higher than that of currently available POC tests. Furthermore, the relative ease and short turnaround time (30 min) of this assay enables C. trachomatis-infected individuals to be treated without a diagnostic delay. Conclusions This simple and novel test is a potential tool to screen a larger population, especially those in areas with limited resources. PMID:25553280

  15. RAPID METHOD FOR ESTIMATING OCTANOL-WATER PARTITION COEFFICIENT (LOG POCT) FROM ISOCRATIC RP-HPLC AND A HYDROGEN BOND ACIDITY TERM (A)

    Microsoft Academic Search

    Chau My Du; Klara Valko; Chris Bevan; Derek Reynolds; Michael H. Abraham

    2001-01-01

    The linear solvation equation approach has been used to describe the octanol\\/water lipophilicity scale (logPoct) and the isocratic retention factors (log k) obtained using reversed phase HPLC with acetonitrile. Both the octanol\\/water partition coefficients and the RP-HPLC retention data obtained from the literature, showed good correlation with the molecular descriptors such as size, excess molar refractivity, H-bond acidity\\/basicity, and polarity\\/dipolarity.

  16. Treating Severe Hypoglycemia: Rapid Mixing of Lyophilized Glucagon and Diluent at Point of Care With the Enject GlucaPen.

    PubMed

    Rylander, Dick

    2015-01-01

    Severe hypoglycemia (SH) is a common problem in type 1 diabetes (T1D). Annually, nearly 1 of 5 persons with long-standing T1D will have SH. Though injections of glucagon are effective in treating SH, liquid formulations of glucagon are biochemically very unstable. For this reason, available preparations of glucagon are lyophilized; the powder and the diluent must be mixed at the point of care prior to administration and any remaining drug must be discarded. The process of mixing and delivery is complex. Coupled with the emotional stress of the caregiver, errors in glucagon delivery are very common. For these reasons, workers at Enject, Inc are in the process of developing a device that addresses the shortcomings of this currently approved method of glucagon delivery. The Enject device will store the glucagon powder and the diluent in separate compartments and will rapidly mix and inject the components only upon activation of the pen at the point of care. PMID:25182147

  17. A smartphone dongle for diagnosis of infectious diseases at the point of care.

    PubMed

    Laksanasopin, Tassaneewan; Guo, Tiffany W; Nayak, Samiksha; Sridhara, Archana A; Xie, Shi; Olowookere, Owolabi O; Cadinu, Paolo; Meng, Fanxing; Chee, Natalie H; Kim, Jiyoon; Chin, Curtis D; Munyazesa, Elisaphane; Mugwaneza, Placidie; Rai, Alex J; Mugisha, Veronicah; Castro, Arnold R; Steinmiller, David; Linder, Vincent; Justman, Jessica E; Nsanzimana, Sabin; Sia, Samuel K

    2015-02-01

    This work demonstrates that a full laboratory-quality immunoassay can be run on a smartphone accessory. This low-cost dongle replicates all mechanical, optical, and electronic functions of a laboratory-based enzyme-linked immunosorbent assay (ELISA) without requiring any stored energy; all necessary power is drawn from a smartphone. Rwandan health care workers used the dongle to test whole blood obtained via fingerprick from 96 patients enrolling into care at prevention of mother-to-child transmission clinics or voluntary counseling and testing centers. The dongle performed a triplexed immunoassay not currently available in a single test format: HIV antibody, treponemal-specific antibody for syphilis, and nontreponemal antibody for active syphilis infection. In a blinded experiment, health care workers obtained diagnostic results in 15 min from our triplex test that rivaled the gold standard of laboratory-based HIV ELISA and rapid plasma reagin (a screening test for syphilis), with sensitivity of 92 to 100% and specificity of 79 to 100%, consistent with needs of current clinical algorithms. Patient preference for the dongle was 97% compared to laboratory-based tests, with most pointing to the convenience of obtaining quick results with a single fingerprick. This work suggests that coupling microfluidics with recent advances in consumer electronics can make certain laboratory-based diagnostics accessible to almost any population with access to smartphones. PMID:25653222

  18. Bedside point of care toxicology screens in the ED: Utility and pitfalls

    PubMed Central

    Bhalla, Ashish

    2014-01-01

    Exposure to drugs and toxins is a major cause for patients’ visits to the emergency department (ED). For most drugs-of-abuse intoxication, ED physicians are skeptical to rely on results of urine drug testing for emergent management decisions. This is partially because immunoassays, although rapid, have limitations in sensitivity and specificity and chromatographic assays, which are more definitive, are more labor intensive. Testing for toxic alcohols is needed, but rapid commercial assays are not available. ED physicians need stat assays for acetaminophen, salicylates, co-oximetry, cholinesterase, iron, and some therapeutic drugs that could be used as agents of self-harm. In this review, we look at the potential limitations of these screening tests and suggest improvements and innovations needed for better clinical utilization. New drugs of abuse should be sought and assays should be developed to meet changing abuse patterns. PMID:25337490

  19. Performance of point-of-care diagnostics for glucose, lactate, and hemoglobin in the management of severe malaria in a resource-constrained hospital in Uganda.

    PubMed

    Hawkes, Michael; Conroy, Andrea L; Opoka, Robert O; Namasopo, Sophie; Liles, W Conrad; John, Chandy C; Kain, Kevin C

    2014-04-01

    Severe malaria is frequently managed without access to laboratory testing. We report on the performance of point-of-care tests used to guide the management of a cohort of 179 children with severe malaria in a resource-limited Ugandan hospital. Correlation coefficients between paired measurements for glucose (i-STAT and One Touch Ultra), lactate (i-STAT and Lactate Scout), and hemoglobin (Hb; laboratory and i-STAT) were 0.86, 0.85, and 0.73, respectively. The OneTouch Ultra glucometer readings deviated systematically from the i-STAT values by +1.7 mmol/L. Lactate Scout values were systematically higher than i-STAT by +0.86 mmol/L. Lactate measurements from either device predicted subsequent mortality. Hb estimation by the i-STAT instrument was unbiased, with upper and lower limits of agreement of -34 and +34 g/L, and it was 91% sensitive and 89% specific for the diagnosis of severe anemia (Hb < 50 g/L). New commercially available bedside diagnostic tools, although imperfect, may expedite clinical decision-making in the management of critically ill children in resource-constrained settings. PMID:24591431

  20. Health care sensor--based systems for point of care monitoring and diagnostic applications: a brief survey.

    PubMed

    Tsakalakis, Michail; Bourbakis, Nicolaos G

    2014-01-01

    Continuous, real-time remote monitoring through medical point--of--care (POC) systems appears to draw the interest of the scientific community for healthcare monitoring and diagnostic applications the last decades. Towards this direction a significant merit has been due to the advancements in several scientific fields. Portable, wearable and implantable apparatus may contribute to the betterment of today's healthcare system which suffers from fundamental hindrances. The number and heterogeneity of such devices and systems regarding both software and hardware components, i.e sensors, antennas, acquisition circuits, as well as the medical applications that are designed for, is impressive. Objective of the current study is to present the major technological advancements that are considered to be the driving forces in the design of such systems, to briefly state the new aspects they can deliver in healthcare and finally, the identification, categorization and a first level evaluation of them. PMID:25571429

  1. The opioid manager: a point-of-care tool to facilitate the use of the Canadian Opioid Guideline.

    PubMed

    Furlan, Andrea D; Reardon, Rhoda; Salach, Lena

    2012-01-01

    The Opioid Manager is designed to be used as a point-of-care tool for providers prescribing opioids for chronic noncancer pain. It condenses the key elements from the Canadian Opioid Guideline and can be used as a chart insert. The Opioid Manager has been validated and is available for download from the Guideline's Web site http://nationalpaincentre.mcmaster.ca/opioidmanager/. The Opioid Manager is divided into the following four parts: A) before you write the first script, B) initiation trial, C) maintenance and monitoring, and D) when is it time to decrease the dose or stop the opioid completely? The Opioid Manager has been downloaded by 1,432 users: 47 percent family physicians, 18 percent pharmacists, 13 percent other physicians, and 22 percent miscellaneous. To show how to use the Opioid Manager, the authors created a 10-minute video that is available on the Internet. The Opioid Manager is being translated to French, Spanish, Portuguese, and Farsi. PMID:22479886

  2. Point-of-care and point-of-procedure optical imaging technologies for primary care and global health.

    PubMed

    Boppart, Stephen A; Richards-Kortum, Rebecca

    2014-09-10

    Leveraging advances in consumer electronics and wireless telecommunications, low-cost, portable optical imaging devices have the potential to improve screening and detection of disease at the point of care in primary health care settings in both low- and high-resource countries. Similarly, real-time optical imaging technologies can improve diagnosis and treatment at the point of procedure by circumventing the need for biopsy and analysis by expert pathologists, who are scarce in developing countries. Although many optical imaging technologies have been translated from bench to bedside, industry support is needed to commercialize and broadly disseminate these from the patient level to the population level to transform the standard of care. This review provides an overview of promising optical imaging technologies, the infrastructure needed to integrate them into widespread clinical use, and the challenges that must be addressed to harness the potential of these technologies to improve health care systems around the world. PMID:25210062

  3. ClinicalTrials.gov as a Data Source for Semi-Automated Point-Of-Care Trial Eligibility Screening

    PubMed Central

    Pfiffner, Pascal B.; Oh, JiWon; Miller, Timothy A.; Mandl, Kenneth D.

    2014-01-01

    Background Implementing semi-automated processes to efficiently match patients to clinical trials at the point of care requires both detailed patient data and authoritative information about open studies. Objective To evaluate the utility of the ClinicalTrials.gov registry as a data source for semi-automated trial eligibility screening. Methods Eligibility criteria and metadata for 437 trials open for recruitment in four different clinical domains were identified in ClinicalTrials.gov. Trials were evaluated for up to date recruitment status and eligibility criteria were evaluated for obstacles to automated interpretation. Finally, phone or email outreach to coordinators at a subset of the trials was made to assess the accuracy of contact details and recruitment status. Results 24% (104 of 437) of trials declaring on open recruitment status list a study completion date in the past, indicating out of date records. Substantial barriers to automated eligibility interpretation in free form text are present in 81% to up to 94% of all trials. We were unable to contact coordinators at 31% (45 of 146) of the trials in the subset, either by phone or by email. Only 53% (74 of 146) would confirm that they were still recruiting patients. Conclusion Because ClinicalTrials.gov has entries on most US and many international trials, the registry could be repurposed as a comprehensive trial matching data source. Semi-automated point of care recruitment would be facilitated by matching the registry's eligibility criteria against clinical data from electronic health records. But the current entries fall short. Ultimately, improved techniques in natural language processing will facilitate semi-automated complex matching. As immediate next steps, we recommend augmenting ClinicalTrials.gov data entry forms to capture key eligibility criteria in a simple, structured format. PMID:25334031

  4. Towards a modular, robust, and portable sensing platform for biological and point of care diagnostics

    NASA Astrophysics Data System (ADS)

    Finch, Amethist S.; Bickford, Justin R.; Conn, Marvin A.; Coppock, Matthew B.; Sarkes, Deborah A.; Stratis-Cullum, Dimitra N.

    2013-05-01

    The ability to conveniently and immediately test and diagnose in a diverse and rapidly changing environment is critical for field diagnostics. Smart biomedical sensors employ many different diagnostic/therapeutic methodologies; however, an ideal system would include the ability for results to be shared instantaneously with all members of the team through a software interface. We discuss our efforts towards the development and use of a robust, mobile platform (Android-based smart phone) that incorporates stable molecular recognition elements in sensor development. The inexpensive, compact, robust, archival, and portable design is ideal for rapid field diagnostics.

  5. Emerging technologies for point-of-care management of HIV infection.

    PubMed

    Shafiee, Hadi; Wang, ShuQi; Inci, Fatih; Toy, Mehlika; Henrich, Timothy J; Kuritzkes, Daniel R; Demirci, Utkan

    2015-01-01

    The global HIV/AIDS pandemic has resulted in 39 million deaths to date, and there are currently more than 35 million people living with HIV worldwide. Prevention, screening, and treatment strategies have led to major progress in addressing this disease globally. Diagnostics is critical for HIV prevention, screening and disease staging, and monitoring antiretroviral therapy (ART). Currently available diagnostic assays, which include polymerase chain reaction (PCR), enzyme-linked immunosorbent assay (ELISA), and western blot (WB), are complex, expensive, and time consuming. These diagnostic technologies are ill suited for use in low- and middle-income countries, where the challenge of the HIV/AIDS pandemic is most severe. Therefore, innovative, inexpensive, disposable, and rapid diagnostic platform technologies are urgently needed. In this review, we discuss challenges associated with HIV management in resource-constrained settings and review the state-of-the-art HIV diagnostic technologies for CD4(+) T lymphocyte count, viral load measurement, and drug resistance testing. PMID:25423597

  6. Expanding Cancer Detection Using Molecular Imprinting for a Novel Point-of-Care Diagnostic Device

    NASA Astrophysics Data System (ADS)

    Yu, Yingjie; Rafailovich, Miriam; Wang, Yantian; Ranjbaran, Alina; Wang, Tom; Nam, David

    2012-02-01

    We propose the use of a potentiometric biosensor that incorporates the efficient and specific molecular imprinting (MI) method with a self-assembled monolayer (SAM). We first tested the biosensor using carcinoembryonic antigen, CEA, a biomarker associated with pancreatic cancer. No change in detection efficiency was observed when detection was performed in the presence of 100% serum albumin, indicating that the sensor is able to discriminate for the template analyte even in concentrated solution of similar substances. Computer simulations of the protein structure were performed in order to estimate the changes in morphology and determine the sensitivity of the biosensor to conformational changes in the proteins. We found that even small changes in PH can generate rotation of the surface functional groups, without significant change in the morphology. Yet, the results show that only when the detection and imprinting conditions are similar, robust signals occurs. Hence we concluded that both morphology and surface chemistry play a role in the recognition.

  7. Point-of-Care Laboratory of Pathogen Diagnosis in Rural Senegal

    PubMed Central

    Fenollar, Florence; Bassene, Hubert; Diatta, Georges; Tall, Adama; Trape, Jean-François; Drancourt, Michel; Raoult, Didier

    2013-01-01

    Background In tropical Africa, where the spectrum of the bacterial pathogens that cause fevers is poorly understood and molecular-based diagnostic laboratories are rare, the time lag between test results and patient care is a critical point for treatment of disease. Methodology/Principal Findings We implemented POC laboratory in rural Senegal to resolve the time lag between test results and patient care. During the first year of the study (February 2011 to January 2012), 440 blood specimens from febrile patients were collected in Dielmo and Ndiop villages. All samples were screened for malaria, dengue fever, Borrelia spp., Coxiella burnetii, Tropheryma whipplei, Rickettsia conorii, R. africae, R. felis, and Bartonella spp. Conclusions/Significance We identified DNA from at least one pathogenic bacterium in 80/440 (18.2%) of the samples from febrile patients. B. crocidurae was identified in 35 cases (9.5%), and R. felis DNA was found in 30 cases (6.8%). The DNA of Bartonella spp. was identified in 23/440 cases (4.3%), and DNA of C. burnetii was identified in 2 cases (0.5%). T. whipplei (0.2%) was diagnosed in one patient. No DNA of R. africae or R. conorii was identified. Among the 7 patients co-infected by two different bacteria, we found R. felis and B. crocidurae in 4 cases, B. crocidurae and Bartonella spp. in 2 cases, and B. crocidurae and C. burnetii in 1 case. Malaria was diagnosed in 54 cases. In total, at least one pathogen (bacterium or protozoa) was identified in 127/440 (28.9%) of studied samples. Here, the authors report the proof of concept of POC in rural tropical Africa. Discovering that 18.2% of acute infections can be successfully treated with doxycycline should change the treatment strategy for acute fevers in West Africa. PMID:23350001

  8. Optical enhanced luminescent measurements and sequential reagent mixing on a centrifugal microfluidic device for multi-analyte point-of-care applications

    NASA Astrophysics Data System (ADS)

    Bartholomeusz, Daniel A.; Davies, Rupert H.; Andrade, Joseph D.

    2006-02-01

    A centrifugal-based microfluidic device1 was built with lyophilized bioluminescent reagents for measuring multiple metabolites from a sample of less than 15 ?L. Microfluidic channels, reaction wells, and valves were cut in adhesive vinyl film using a knife plotter with features down to 30 ?m and transferred to metalized polycarbonate compact disks (CDs). The fabrication method was simple enough to test over 100 prototypes within a few months. It also allowed enzymes to be packaged in microchannels without exposure to heat or chemicals. The valves were rendered hydrophobic using liquid phase deposition. Microchannels were patterned using soft lithography to make them hydrophilic. Reagents and calibration standards were deposited and lyophilized in different wells before being covered with another adhesive film. Sample delivery was controlled by a modified CD ROM. The CD was capable of distributing 200 nL sample aliquots to 36 channels, each with a different set of reagents that mixed with the sample before initiating the luminescent reactions. Reflection of light from the metalized layer and lens configuration allowed for 20% of the available light to be collected from each channel. ATP was detected down to 0.1 ?M. Creatinine, glucose, and galactose were also measured in micro and milliMolar ranges. Other optical-based analytical assays can easily be incorporated into the device design. The minimal sample size needed and expandability of the device make it easier to simultaneously measure a variety of clinically relevant analytes in point-of-care settings.

  9. Integration of Cell Phone Imaging with Microchip ELISA to Detect Ovarian Cancer HE4 Biomarker in Urine at the Point-of-Care

    PubMed Central

    Wang, ShuQi; Zhao, Xiaohu; Khimji, Imran; Akbas, Ragip; Qiu, Weiliang; Edwards, Dale; Cramer, Daniel W.; Ye, Bin; Demirci, Utkan

    2013-01-01

    Ovarian cancer is asymptomatic at early stages and most patients present with advanced levels of disease. Lack of cost-effective methods that can achieve frequent, simple and non-invasive testing hinders early detection and causes high mortality in ovarian cancer patients. Here, we report a simple and inexpensive microchip ELISA-based detection module that employs a portable detection system, i.e., a cell phone/charge-coupled device (CCD) to quantify an ovarian cancer biomarker, HE4, in urine. Integration of a mobile application with a cell phone enabled immediate processing of microchip ELISA results, which eliminated the need for a bulky, expensive spectrophotometer. The HE4 level detected by a cell phone or a lensless CCD system was significantly elevated in urine samples from cancer patients (n = 19) than normal healthy controls (n = 20) (p < 0.001). Receiver operating characteristic (ROC) analyses showed that the microchip ELISA coupled with a cell phone running an automated analysis application had a sensitivity of 89.5% at a specificity of 90%. Under the same specificity, the microchip ELISA coupled with a CCD had a sensitivity of 84.2%. In conclusion, integration of microchip ELISA with cell phone/CCD-based colorimetric measurement technology can be used to detect HE4 biomarker at the point-of-care (POC), paving the way to create bedside technologies for diagnostics and treatment monitoring. PMID:21881677

  10. Integration of cell phone imaging with microchip ELISA to detect ovarian cancer HE4 biomarker in urine at the point-of-care.

    PubMed

    Wang, Shuqi; Zhao, Xiaohu; Khimji, Imran; Akbas, Ragip; Qiu, Weiliang; Edwards, Dale; Cramer, Daniel W; Ye, Bin; Demirci, Utkan

    2011-10-21

    Ovarian cancer is asymptomatic in the early stages and most patients present with advanced levels of disease. The lack of cost-effective methods that can achieve frequent, simple and non-invasive testing hinders early detection and causes high mortality in ovarian cancer patients. Here, we report a simple and inexpensive microchip ELISA-based detection module that employs a portable detection system, i.e., a cell phone/charge-coupled device (CCD) to quantify an ovarian cancer biomarker, HE4, in urine. Integration of a mobile application with a cell phone enabled immediate processing of microchip ELISA results, which eliminated the need for a bulky, expensive spectrophotometer. The HE4 level detected by a cell phone or a lensless CCD system was significantly elevated in urine samples from cancer patients (n = 19) than healthy controls (n = 20) (p < 0.001). Receiver operating characteristic (ROC) analyses showed that the microchip ELISA coupled with a cell phone running an automated analysis mobile application had a sensitivity of 89.5% at a specificity of 90%. Under the same specificity, the microchip ELISA coupled with a CCD had a sensitivity of 84.2%. In conclusion, integration of microchip ELISA with cell phone/CCD-based colorimetric measurement technology can be used to detect HE4 biomarker at the point-of-care (POC), paving the way to create bedside technologies for diagnostics and treatment monitoring. PMID:21881677

  11. Critical role of the sample matrix in a point-of-care protein chip for sepsis.

    PubMed

    Sauer, Ursula; Pultar, Johanna; Preininger, Claudia

    2012-04-30

    Both highly specific antibodies and appropriate assay buffers are key elements in the development of sensitive multi-analyte diagnostic tests and essential assay components to minimize interferences from the sample matrix. Herein, we investigate the influence of 0.1 M Tris (pH 7.4)/0.1 M NaCl/10 mM CaCl(2)/0.1% Tween-20 used as assay buffer and diluent for serum, plasma and saliva samples in a protein biomarker chip for the diagnosis of sepsis. In detail, on-chip sandwich assays for detection of IL-6 and PCT are established using pure assay buffer and serum, plasma, and saliva, each diluted by a factor of 10 and 100 with assay buffer. The dilution linearity as well as the cross-reactivity to immobilized IL-8, IL-10 and TNF-? antibodies (<1.8% in plasma and serum) is investigated; furthermore the influence of immunoglobulin G, fibrinogen and lysozyme, highly abundant proteins in serum, plasma and saliva. This effect is two times more pronounced in serum than in plasma and saliva and strongly decreases with increasing analyte concentration. Though the matrix proteins bind unspecifically to the immobilized receptors, they do not prevent the analyte binding; on the contrary, the analyte is reliably detected with high sensitivity, featuring limits of detection of 16 ng/L and 0.31 ?g/L, and coefficients of variation of 18% and 29% for IL-6 and PCT in 10% serum. PMID:22342572

  12. Expanding Cancer Detection Using Molecular Imprinting for a Novel Point-of-Care Diagnostic Device

    NASA Astrophysics Data System (ADS)

    Yu, Yingjie; Rafailovich, Miriam; Wang, Yantian; Kang, Yeona; Zhang, Lingxi; Rigas, Basil

    2013-03-01

    We propose the use of a potentiometric biosensor that incorporates the efficient and specific molecular imprinting (MI) method with a self-assembled monolayer (SAM). We first tested the biosensor using carcinoembryonic antigen, CEA, a biomarker associated with pancreatic cancer. No change in detection efficiency was observed, indicating that the sensor is able to discriminate for the template analyte even in concentrated solution of similar substances. In addition, we use biosensor to discriminate normal fibrinogen and damaged fibrinogen, which is critical for the detection of bleeding disorder. Computer simulations of the protein structure were performed in order to estimate the changes in morphology and determine the sensitivity of the biosensor to conformational changes in the proteins. We found that even small changes in PH can generate rotation of the surface functional groups. Yet, the results show that only when the detection and imprinting conditions are similar, robust signals occurs. Hence we concluded that both morphology and surface chemistry play a role in the recognition.

  13. A comprehensive information technology system to support physician learning at the point of care.

    PubMed

    Cook, David A; Sorensen, Kristi J; Nishimura, Rick A; Ommen, Steve R; Lloyd, Farrell J

    2015-01-01

    MayoExpert is a multifaceted information system integrated with the electronic medical record (EMR) across Mayo Clinic's multisite health system. It was developed as a technology-based solution to manage information, standardize clinical practice, and promote and document learning in clinical contexts. Features include urgent test result notifications; models illustrating expert-approved care processes; concise, expert-approved answers to frequently asked questions (FAQs); a directory of topic-specific experts; and a portfolio for provider licensure and credentialing. The authors evaluate MayoExpert's reach, effectiveness, adoption, implementation, and maintenance. Evaluation data sources included usage statistics, user surveys, and pilot studies.As of October 2013, MayoExpert was available at 94 clinical sites in 12 states and contained 1,368 clinical topics, answers to 7,640 FAQs, and 92 care process models. In 2012, MayoExpert was accessed at least once by 2,578/3,643 (71%) staff physicians, 900/1,374 (66%) midlevel providers, and 1,728/2,291 (75%) residents and fellows. In a 2013 survey of MayoExpert users with 536 respondents, all features were highly rated (?67% favorable). More providers reported using MayoExpert to answer questions before/after than during patient visits (68% versus 36%). During November 2012 to April 2013, MayoExpert sent 1,660 notifications of new-onset atrial fibrillation and 1,590 notifications of prolonged QT. MayoExpert has become part of routine clinical and educational operations, and its care process models now define Mayo Clinic best practices. MayoExpert's infrastructure and content will continue to expand with improved templates and content organization, new care process models, additional notifications, better EMR integration, and improved support for credentialing activities. PMID:25374037

  14. Point of care platelet activity measurement in primary PCI [PINPOINT-PPCI]: a protocol paper

    PubMed Central

    2014-01-01

    Background Optimal treatment of acute ST-elevation myocardial infarction (STEMI) involves rapid diagnosis, and transfer to a cardiac centre capable of percutaneous coronary intervention (PCI) for immediate mechanical revascularisation. Successful treatment requires rapid return of perfusion to the myocardium achieved by thromboaspiration, passivation of the culprit lesion with stent scaffolding and systemic inhibition of thrombosis and platelet activation. A delicate balance exists between thrombosis and bleeding and consequently anti-thrombotic and antiplatelet treatment regimens continue to evolve. The desire to achieve reperfusion as soon as possible, in the setting of high platelet reactivity, requires potent and fast-acting anti-thrombotic/anti-platelet therapies. The associated bleeding risk may be minimised by use of short-acting anti-thrombotic intravenous agents. However, effective oral platelet inhibition is required to prevent recurrent thrombosis. The interaction between baseline platelet reactivity, timing of revascularisation and effective inhibition of thrombosis is yet to be formally investigated. Methods/Design We present a protocol for a prospective observational study in patients presenting with acute STEMI treated with primary PCI (PPCI) and receiving bolus/infusion bivalirudin and prasugrel therapy. The objective of this study is to describe variation in platelet reactivity, as measured by the multiplate platelet function analyser, at presentation, the end of the PPCI procedure and 1, 2, & 24 hours post-procedure. We intend to assess the prevalence of high residual platelet reactivity within 24 hours of PPCI in acute STEMI patients receiving prasugrel and bivalirudin. Additionally, we will investigate the association between high platelet reactivity before and after PPCI and the door-to-procedure completion time. This is a single centre study with a target sample size of 108 participants. Discussion The baseline platelet reactivity on presentation with a STEMI may impact on the effect of acute anti-thrombotic and anti-platelet therapy and expose patients to a heightened risk of bleeding or ongoing thrombosis. This study will define the baseline variation in platelet reactivity in a population of patients experiencing acute STEMI and assess the pharmacodynamic response to combined treatment with bivalirudin and prasugrel. The data obtained from this trial will be hypothesis generating for future trials testing alternative pharmacotherapies in the acute phase of treatment for STEMI. Trial registration This study has approval from Wiltshire research ethics committee (10/H0106/87) and is registered with current controlled trials (http://www.controlled-trials.com/ISRCTN82257414). PMID:24708700

  15. Can medical learners achieve point-of-care ultrasound competency using a high-fidelity ultrasound simulator?: a pilot study

    PubMed Central

    2013-01-01

    Background Point-of-care ultrasound (PoCUS) is currently not a universal component of curricula for medical undergraduate and postgraduate training. We designed and assessed a simulation-based PoCUS training program for medical learners, incorporating image acquisition and image interpretation for simulated emergency medical pathologies. We wished to see if learners could achieve competency in simulated ultrasound following focused training in a PoCUS protocol. Methods Twelve learners (clerks and residents) received standardized training consisting of online preparation materials, didactic teaching, and an interactive hands-on workshop using a high-fidelity ultrasound simulator (CAE Vimedix). We used the Abdominal and Cardiothoracic Evaluation by Sonography (ACES) protocol as the curriculum for PoCUS training. Participants were assessed during 72 simulated emergency cardiorespiratory scenarios. Their ability to complete an ACES scan independently was assessed. Data was analyzed using R software. Results Participants independently generated 574 (99.7%) of the 576 expected ultrasound windows during the 72 simulated scenarios and correctly interpreted 67 (93%) of the 72 goal-directed PoCUS scans. Conclusions Following a focused training process using medical simulation, medical learners demonstrated an ability to achieve a degree of competency to both acquire and correctly interpret cardiorespiratory PoCUS findings using a high-fidelity ultrasound simulator. PMID:24245514

  16. Long-term dry storage of an enzyme-based reagent system for ELISA in point-of-care devices.

    PubMed

    Ramachandran, Sujatha; Fu, Elain; Lutz, Barry; Yager, Paul

    2014-03-21

    Lateral flow devices are commonly used for many point-of-care (POC) applications in low-resource settings. However, they lack the sensitivity needed for many analytes relevant in the diagnosis of diseases. One approach to achieve higher sensitivity is signal amplification, which is commonly used in laboratory assays, but uses reagents that require refrigeration and inherently requires multiple assay steps not normally compatible with POC settings. Enzyme-based signal amplification, such as the one used in ELISA, could greatly improve the limit of detection if it were translated to a format compatible with POC requirements. A signal-amplified POC device not only requires the reagents to be stored in a stable form, but also requires automation of the multiple sequential steps of signal amplification protocols. Here, we describe a method for the long-term dry storage of ELISA reagents: horseradish peroxidase (HRP) conjugated antibody label and its colorimetric substrate diaminobenzidine (DAB). The HRP conjugate retained ?80% enzymatic activity after dry storage at 45 °C for over 5 months. The DAB substrate was also stable at 45 °C and exhibited no detectable loss of activity over 3 months. These reagents were incorporated into a two-dimensional paper network (2DPN) device that automated the steps of ELISA for the detection of a malarial biomarker. These results demonstrate the potential of enzyme-based signal amplification for enhanced sensitivity in POC devices for low resource settings. PMID:24496140

  17. A simple cassette as point-of-care diagnostic device for naked-eye colorimetric bacteria detection.

    PubMed

    Safavieh, Mohammadali; Ahmed, Minhaz Uddin; Sokullu, Esen; Ng, Andy; Braescu, Liliana; Zourob, Mohammed

    2014-01-21

    Effective pathogen detection is necessary for treatment of infectious diseases. Point of care (POC) devices have tremendously improved the global human heath. However, design criteria for sample processing POC devices for pathogen detection in limited infrastructure are challenging and can make a significant contribution to global health by providing rapid and sensitive detection of bacteria in food, water, and patient samples. In this paper, we demonstrate a novel portable POC diagnostic device that is simple to assemble for genetic detection of bacterial pathogens by isothermal DNA amplification. The device is fabricated with very low production cost, using simple methods and easy-to-access materials on a flexible ribbon polyethylene substrate. We showed that the device is capable of detection of 30 CFU mL(-1) of E. coli and 200 CFU mL(-1) of S. aureus in less than 1 hour. Through numerical simulations, we estimated that the device can be extended to high-throughput detection simultaneously performing a minimum of 36 analyses. This robust and sensitive detection device can be assembled and operated by non-specialist personnel, particularly for multiple bacterial pathogen detections in low-resource settings. PMID:24300967

  18. Integrated optical microfluidic biosensor using a polycarbazole photodetector for point-of-care detection of hormonal compounds.

    PubMed

    Pires, Nuno Miguel Matos; Dong, Tao; Hanke, Ulrik; Hoivik, Nils

    2013-09-01

    A picogram-sensitive optical microfluidic biosensor using an integrated polycarbazole photodiode is developed. The photodetector is mainly composed of the blend heterojunction of poly [N-9'-heptadecanyl-2,7-carbazole-alt-5,5-(4',7'-di-2-thienyl-2',1',3'-benzothiadiazole)] (PCDTBT) and [6,6]-phenyl C71-butyric acid methyl ester (PC70BM) and the poly(3,4-ethylenedioxythiophene):polystyrene sulfonate (PEDOT:PSS) as the hole transport layer. Analyte detection is accomplished via a chemiluminescent immunoassay performed in a poly(dimethylsiloxane)-gold-glass hybrid microchip, on which antibodies were immobilized and chemiluminescent horseradish peroxidase-luminol-peroxide reactions were generated. Enhanced sensor response to the chemiluminescent light is achieved by optimizing the thickness of PCDTBT:??PC70BM and PEDOT:PSS. Using the optimized polycarbazole photodiode for detecting the human thyroid-stimulating hormone as the model target, the integrated biosensor demonstrates an excellent linearity in the range of 0.03 to 10??ng/ml with an analytical sensitivity of 68??pg/ml. The sensor response shows high specificity and reproducibility. Hormone detection in clinical samples is further demonstrated and compared with a commercial enzyme-linked immunosorbent assay. The integrated device reported here has potential to detect other hormonal compounds or protein targets. Moreover, the presented concept enables the development of miniaturized, low-cost but highly sensitive optical microfluidic biosensors based on integrated polymer photodetectors with high potential for point-of-care diagnostics. PMID:24002194

  19. Rapid point-of-care detection of the tuberculosis pathogen using a BlaC-specific fluorogenic probe

    NASA Astrophysics Data System (ADS)

    Xie, Hexin; Mire, Joseph; Kong, Ying; Chang, Mihee; Hassounah, Hany A.; Thornton, Chris N.; Sacchettini, James C.; Cirillo, Jeffrey D.; Rao, Jianghong

    2012-10-01

    Early diagnosis of tuberculosis can dramatically reduce both its transmission and the associated death rate. The extremely slow growth rate of the causative pathogen, Mycobacterium tuberculosis (Mtb), however, makes this challenging at the point of care, particularly in resource-limited settings. Here we report the use of BlaC (an enzyme naturally expressed/secreted by tubercle bacilli) as a marker and the design of BlaC-specific fluorogenic substrates as probes for Mtb detection. These probes showed an enhancement by 100-200 times in fluorescence emission on BlaC activation and a greater than 1,000-fold selectivity for BlaC over TEM-1 ?-lactamase, an important factor in reducing false-positive diagnoses. Insight into the BlaC specificity was revealed by successful co-crystallization of the probe/enzyme mutant complex. A refined green fluorescent probe (CDG-OMe) enabled the successful detection of live pathogen in less than ten minutes, even in unprocessed human sputum. This system offers the opportunity for the rapid, accurate detection of very low numbers of Mtb for the clinical diagnosis of tuberculosis in sputum and other specimens.

  20. An Ontology-Based, Mobile-Optimized System for Pharmacogenomic Decision Support at the Point-of-Care

    PubMed Central

    Miñarro-Giménez, Jose Antonio; Blagec, Kathrin; Boyce, Richard D.; Adlassnig, Klaus-Peter; Samwald, Matthias

    2014-01-01

    Background The development of genotyping and genetic sequencing techniques and their evolution towards low costs and quick turnaround have encouraged a wide range of applications. One of the most promising applications is pharmacogenomics, where genetic profiles are used to predict the most suitable drugs and drug dosages for the individual patient. This approach aims to ensure appropriate medical treatment and avoid, or properly manage, undesired side effects. Results We developed the Medicine Safety Code (MSC) service, a novel pharmacogenomics decision support system, to provide physicians and patients with the ability to represent pharmacogenomic data in computable form and to provide pharmacogenomic guidance at the point-of-care. Pharmacogenomic data of individual patients are encoded as Quick Response (QR) codes and can be decoded and interpreted with common mobile devices without requiring a centralized repository for storing genetic patient data. In this paper, we present the first fully functional release of this system and describe its architecture, which utilizes Web Ontology Language 2 (OWL 2) ontologies to formalize pharmacogenomic knowledge and to provide clinical decision support functionalities. Conclusions The MSC system provides a novel approach for enabling the implementation of personalized medicine in clinical routine. PMID:24787444

  1. A portable fiberoptic ratiometric fluorescence analyzer provides rapid point-of-care determination of glomerular filtration rate in large animals.

    PubMed

    Wang, Exing; Meier, Daniel J; Sandoval, Ruben M; Von Hendy-Willson, Vanessa E; Pressler, Barrak M; Bunch, Robert M; Alloosh, Mouhamad; Sturek, Michael S; Schwartz, George J; Molitoris, Bruce A

    2012-01-01

    Measurement of the glomerular filtration rate (GFR) is the gold standard for precise assessment of kidney function. A rapid, point-of-care determination of the GFR may provide advantages in the clinical setting over currently available assays. Here we demonstrate a proof of principle for such an approach in a pig and dogs, two species that approximate the vascular access and GFR results expected in humans. In both animal models, a sub-millimeter optical fiber that delivered excitation light and collected fluorescent emissions was inserted into a peripheral vein (dog) or central venous access (pig) by means of commercial intravenous catheters. A mixture of fluorescent chimeras of a small freely filterable reporter and large non-filterable plasma volume marker were infused as a bolus, excited by light-emitting diodes, and the in vivo signals detected and quantified by photomultiplier tubes in both species in less than 60 min. Concurrent standardized 6-h iohexol plasma kidney clearances validated the accuracy of our results for both physiologic and a chronic kidney disease setting. Thus, our ratiometric technique allows for both measurement of plasma vascular volume and highly accurate real-time GFR determinations, enabling clinical decision making in real time. PMID:21881552

  2. Point of care monitoring of hemodialysis patients with a breath ammonia measurement device based on printed polyaniline nanoparticle sensors.

    PubMed

    Hibbard, Troy; Crowley, Karl; Kelly, Frank; Ward, Frank; Holian, John; Watson, Alan; Killard, Anthony J

    2013-12-17

    A device for measuring human breath ammonia was developed based on a single use, disposable, inkjet printed ammonia sensor fabricated using polyaniline nanoparticles. The device was optimized for sampling ammonia in human breath samples by addressing issues such as variations in breath sample volume, flow rate, sources of oral ammonia, temperature and humidity. The resulting system was capable of measuring ammonia in breath from 40 to 2993 ppbv (r(2 )= 0.99, n = 3) as correlated with photoacoustic laser spectroscopy and correlation in normal human breath samples yielded a slope of 0.93 and a Pearson correlation coefficient of 0.9705 (p < 0.05, n = 11). Measurement of ammonia in the breath of patients with end-stage kidney disease demonstrated its significant reduction following dialysis, while also correlating well with blood urea nitrogen (BUN) (r = 0.61, p < 0.01, n = 96). Excellent intraindividual correlations were demonstrated between breath ammonia and BUN (0.86 to 0.96), which demonstrates the possibility of using low cost point of care breath ammonia systems as a noninvasive means of monitoring kidney dysfunction and treatment. PMID:24299143

  3. Access denied; care impaired: the benefits of having online medical information available at the point-of-care.

    PubMed

    Finegan, Barry A

    2004-11-01

    The availability of Internet-enabled computers in the operating room (OR) facilitates unparalleled physician access to current peer reviewed research, either in abstract or full text format, a development that provides physicians with an exciting opportunity to incorporate such findings into clinical practice at the point-of-care. In this report I describe how the availability of online peer reviewed medical literature altered, in one case a planned surgical procedure and, in the other, the interpretation by the anesthesiologist of the clinical significance of an intraoperative echocardiographic finding. In case one, a free, rather than an intact, internal mammary (IM) artery graft was placed to the left anterior descending coronary artery of a patient with renal failure and an ipsilateral upper extremity arteriovenous fistula. The change occurred after the full text results of a study indicating that steal could well occur during the initiation of dialysis if an intact IM was used were made available to the surgeon. In case two, the occurrence of mild central mitral regurgitation in a Carpentier-Edwards Perimount prosthetic mitral valve was confirmed to be a benign finding after a study detailing the long term performance characteristics of this valve was accessed online in the OR. The benefits and potential pitfalls of searching and interpreting online medical information are discussed. PMID:15502047

  4. Developing electrochemical sensor for point-of-care diagnostics of oxidative stress marker using imprinted bimetallic Fe/Pd nanoparticle.

    PubMed

    Roy, Ekta; Patra, Santanu; Madhuri, Rashmi; Sharma, Prashant K

    2015-01-01

    A novel electrochemical-sensing platform based on imprinted bimetallic Fe/Pd (BI-Fe/Pd) nanoparticle has been fabricated for point-of-care diagnostics of oxidative stress marker (3-nitrotyrosine) in biological fluids. Herein, BI-Fe/Pd nanoparticles are used as a platform on which 3-nitrotyrosine imprinted cavities are created using acrylamide as monomer and N-N'-methylene bisacrylamide as cross-linker. The performance of the obtained imprinted sensor is investigated by cyclic, differential pulse, and square wave voltammetry in stripping mode. The imprinted sensor exhibits high recognition ability and affinity for 3-nitrotyrosine in comparison with the non-imprinted one. In addition, the proposed sensor is capable of measuring 3-nitrotyrosine in aqueous as well as in human blood serum, plasma, and urine samples within the range of 4.90-867.57 µg L(-1) and 9.90-867.57 µg L(-1) with detection limit of 1.20 µg L(-1) and 3.25 µg L(-1) by square wave and differential pulse stripping voltammetry, respectively. Imprinted BI-Fe/Pd nanoparticle modified sensor shows high affinity and no interference from blood or urine components. Modified sensor was stored for 45 days at room temperature without any detrimental effects to their binding properties. The high affinity of proposed sensor and the lack of requirement for cold chain logistics make them an attractive alternative to the enzyme-linked immunosorbent assay (ELISA) technique. PMID:25476325

  5. The accuracy of renal point of care ultrasound to detect hydronephrosis in children with a urinary tract infection.

    PubMed

    Guedj, Romain; Escoda, Simon; Blakime, Philippe; Patteau, Géraldine; Brunelle, Francis; Cheron, Gérard

    2015-04-01

    The objective of this study was to investigate the accuracy of renal point of care ultrasound (POCUS) for the detection of hydronephrosis in children with a urinary tract infection (UTI). We prospectively included all patients with a final diagnosis of UTI who visited our pediatric emergency department between November 2009 and April 2011. Emergency physicians were encouraged to perform a renal POCUS during these visits, and a follow-up renal ultrasonography was performed by a radiologist who was blinded to the results of POCUS. We calculated the accuracy of POCUS to detect hydronephrosis (renal pelvis enlargement ?10?mm). We included 433 UTI visits, and 382 (88.2%) POCUS were performed. The sensitivity and the specificity were 76.5% (95% confidence interval: 58.1-94.6%) and 97.2% (95.2-99.2%), respectively. The positive and the negative predictive values were 59.1% (36.4-79.3%) and 98.8% (97.7-99.9%), respectively. Renal POCUS might be used to rule out hydronephrosis in pediatric UTI. PMID:24858915

  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

    ...Detection of Colon and Rectal Cancer, Breast Cancer, and Lung Cancer AGENCY: National...state recognition, detection, diagnosis, monitoring, association and...risk-stratification of colon and rectal cancer, breast cancer, and lung cancer....

  7. Risk of cross transmission with point-of-care ultrasound system: effect of a glass-sealed control panel on microbial contamination.

    PubMed

    Mekontso Dessap, Armand; Jansen, Chloe; Boissier, Florence; Razazi, Keyvan; de Prost, Nicolas; Michaud, Gaël; Cizeau, Florence; Ducellier, David; Abid, Shariq; Decousser, Jean-Winoc; Brun-Buisson, Christian

    2014-12-01

    Contamination of a point-of-care ultrasound system (POCUS) mainly involved electrocardiography accessories and included pathogenic microorganisms. The use of a glass-sealed control panel significantly facilitated its cleaning and reduced its bacterial contamination compared with a standard control panel. Overall hand hygiene compliance during examinations with POCUS was poor. PMID:25419778

  8. Microfluidic Tool Box as Technology Platform for Hand-Held Diagnostics

    Microsoft Academic Search

    Michael J. Pugia; Gert Blankenstein; Ralf-Peter Peters; Lames A. Profitt; Klaus Kadel; Thomas Willms; Ronald Sommer; Hai Hang Kuo; Lloyd S. Schulman

    2005-01-01

    Background: Use of microfluidics in point-of-care test- ing (POCT) will require on-board fluidics, self-con- tained reagents, and multistep reactions, all at a low cost. Disposable microchips were studied as a potential POCT platform. Methods: Micron sized structures and capillaries were embedded in disposable plastics with mechanisms for fluidic control, metering, specimen application, separa- tion, and mixing of nanoliter to microliter

  9. Assessment of Diabetic Neuropathy Using a Point-of-Care Nerve Conduction Device Shows Significant Associations With the LDIFLARE Method and Clinical Neuropathy Scoring.

    PubMed

    Sharma, Sanjeev; Vas, Prashanth Rj; Rayman, Gerry

    2015-01-01

    Accurate assessment of diabetes polyneuropathy (DPN) is important in the prevention of foot ulcerations and amputations. Simple screening methods including the 10 g monofilament and the 128-Hz tuning fork are not sensitive enough nor intended for detection of early neuropathy, while more confirmatory tests such as nerve conduction studies are not universally available. We evaluated a rapid, low-cost, point-of-care nerve conduction device (POCD; NC-stat®|DPNCheck™) for the assessment of DPN and compared it with the LDIFLARE technique-an established method for early detection of small fibre dysfunction. A total of 162 patients with diabetes (DM) and 80 healthy controls (HC) were recruited. Based on the 10-point Neuropathy Disability Score (NDS), DPN was categorized into none (<2), mild (3-5) moderate (6-7), and severe (8-10). The LDIFLARE was performed in all patients according to previously described methodology. The associations between POCD outcomes and the LDIFLARE within the NDS categories were evaluated using regression analysis. In HC and DM, SNCV measured with the POCD correlated significantly with the LDIFLARE technique (r < 0.90 and r = 0.78, respectively) as did SNAP (r = 0.88 and r = 0.73, respectively); in addition, significance was found in all categories of DPN (r = 0.64 to 0.84; p= ? 0.03). ROC curves within each category of DPN showed that the POCD was sensitive in the assessment of DPN. We report highly significant linear relationships between the POCD with both comparators-the LDIFLARE technique and clinical neuropathy scores. Thus, the NC-stat|DPNCheck™ system appears to be an excellent adjunctive diagnostic tool for diagnosing DPN in the clinical setting. PMID:25231114

  10. DNA-Aptamer optical biosensors based on a LPG-SPR optical fiber platform for point-of-care diagnostic

    NASA Astrophysics Data System (ADS)

    Coelho, L.; Queirós, R. B.; Santos, J. L.; Martins, M. Cristina L.; Viegas, D.; Jorge, P. A. S.

    2014-03-01

    Surface Plasmon Resonance (SPR) is the base for some of the most sensitive label free optical fiber biosensors. However, most solutions presented to date require the use of fragile fiber optic structure such as adiabatic tapers or side polished fibers. On the other hand, long-period fiber gratings (LPG) present themselves as an interesting solution to attain an evanescent wave refractive index sensor platform while preserving the optical fiber integrity. The combination of these two approaches constitute a powerful platform that can potentially reach the highest sensitivities as it was recently demonstrated by detailed theoretical study [1, 2]. In this work, a LPG-SPR platform is explored in different configurations (metal coating between two LPG - symmetric and asymmetric) operating in the telecom band (around 1550 nm). For this purpose LPGs with period of 396 ?m are combined with tailor made metallic thin films. In particular, the sensing regions were coated with 2 nm of chromium to improve the adhesion to the fiber and 16 nm of gold followed by a 100 nm thick layer of TiO2 dielectric material strategically chosen to attain plasmon resonance in the desired wavelength range. The obtained refractometric platforms were then validated as a biosensor. For this purpose the detection of thrombin using an aptamer based probe was used as a model system for protein detection. The surface of the sensing fibers were cleaned with isopropanol and dried with N2 and then the aminated thrombin aptamer (5'-[NH2]- GGTTGGTGTGGTTGG-3') was immobilized by physisorption using Poly-L-Lysine (PLL) as cationic polymer. Preliminary results indicate the viability of the LPFG-SPR-APTAMER as a flexible platforms point of care diagnostic biosensors.

  11. Model Point-of-Care Ultrasound Curriculum in an Intensive Care Unit Fellowship Program and Its Impact on Patient Management

    PubMed Central

    Killu, Keith; Coba, Victor; Mendez, Michael; Reddy, Subhash; Adrzejewski, Tanja; Huang, Yung; Ede, Jessica; Horst, Mathilda

    2014-01-01

    Objectives. This study was designed to assess the clinical applicability of a Point-of-Care (POC) ultrasound curriculum into an intensive care unit (ICU) fellowship program and its impact on patient care. Methods. A POC ultrasound curriculum for the surgical ICU (SICU) fellowship was designed and implemented in an urban, academic tertiary care center. It included 30 hours of didactics and hands-on training on models. Minimum requirement for each ICU fellow was to perform 25–50 exams on respective systems or organs for a total not less than 125 studies on ICU. The ICU fellows implemented the POC ultrasound curriculum into their daily practice in managing ICU patients, under supervision from ICU staff physicians, who were instructors in POC ultrasound. Impact on patient care including finding a new diagnosis or change in patient management was reviewed over a period of one academic year. Results. 873 POC ultrasound studies in 203 patients admitted to the surgical ICU were reviewed for analysis. All studies included were done through the POC ultrasound curriculum training. The most common exams performed were 379 lung/pleural exams, 239 focused echocardiography and hemodynamic exams, and 237 abdominal exams. New diagnosis was found in 65.52% of cases (95% CI 0.590, 0.720). Changes in patient management were found in 36.95% of cases (95% CI 0.303, 0.435). Conclusions. Implementation of POC ultrasound in the ICU with a structured fellowship curriculum was associated with an increase in new diagnosis in about 2/3 and change in management in over 1/3 of ICU patients studied. PMID:25478217

  12. Evaluation of generic medical information accessed via mobile phones at the point of care in resource-limited settings

    PubMed Central

    Goldbach, Hayley; Chang, Aileen Y; Kyer, Andrea; Ketshogileng, Dineo; Taylor, Lynne; Chandra, Amit; Dacso, Matthew; Kung, Shiang-Ju; Rijken, Taatske; Fontelo, Paul; Littman-Quinn, Ryan; Seymour, Anne K; Kovarik, Carrie L

    2014-01-01

    Objective Many mobile phone resources have been developed to increase access to health education in the developing world, yet few studies have compared these resources or quantified their performance in a resource-limited setting. This study aims to compare the performance of resident physicians in answering clinical scenarios using PubMed abstracts accessed via the PubMed for Handhelds (PubMed4Hh) website versus medical/drug reference applications (Medical Apps) accessed via software on the mobile phone. Methods A two-arm comparative study with crossover design was conducted. Subjects, who were resident physicians at the University of Botswana, completed eight scenarios, each with multi-part questions. The primary outcome was a grade for each question. The primary independent variable was the intervention arm and other independent variables included residency and question. Results Within each question type there were significant differences in ‘percentage correct’ between Medical Apps and PubMed4Hh for three of the six types of questions: drug-related, diagnosis/definitions, and treatment/management. Within each of these question types, Medical Apps had a higher percentage of fully correct responses than PubMed4Hh (63% vs 13%, 33% vs 12%, and 41% vs 13%, respectively). PubMed4Hh performed better for epidemiologic questions. Conclusions While mobile access to primary literature remains important and serves an information niche, mobile applications with condensed content may be more appropriate for point-of-care information needs. Further research is required to examine the specific information needs of clinicians in resource-limited settings and to evaluate the appropriateness of current resources in bridging location- and context-specific information gaps. PMID:23535665

  13. Model Point-of-Care Ultrasound Curriculum in an Intensive Care Unit Fellowship Program and Its Impact on Patient Management.

    PubMed

    Killu, Keith; Coba, Victor; Mendez, Michael; Reddy, Subhash; Adrzejewski, Tanja; Huang, Yung; Ede, Jessica; Horst, Mathilda

    2014-01-01

    Objectives. This study was designed to assess the clinical applicability of a Point-of-Care (POC) ultrasound curriculum into an intensive care unit (ICU) fellowship program and its impact on patient care. Methods. A POC ultrasound curriculum for the surgical ICU (SICU) fellowship was designed and implemented in an urban, academic tertiary care center. It included 30 hours of didactics and hands-on training on models. Minimum requirement for each ICU fellow was to perform 25-50 exams on respective systems or organs for a total not less than 125 studies on ICU. The ICU fellows implemented the POC ultrasound curriculum into their daily practice in managing ICU patients, under supervision from ICU staff physicians, who were instructors in POC ultrasound. Impact on patient care including finding a new diagnosis or change in patient management was reviewed over a period of one academic year. Results. 873 POC ultrasound studies in 203 patients admitted to the surgical ICU were reviewed for analysis. All studies included were done through the POC ultrasound curriculum training. The most common exams performed were 379 lung/pleural exams, 239 focused echocardiography and hemodynamic exams, and 237 abdominal exams. New diagnosis was found in 65.52% of cases (95% CI 0.590, 0.720). Changes in patient management were found in 36.95% of cases (95% CI 0.303, 0.435). Conclusions. Implementation of POC ultrasound in the ICU with a structured fellowship curriculum was associated with an increase in new diagnosis in about 2/3 and change in management in over 1/3 of ICU patients studied. PMID:25478217

  14. Reliability and Validity of a Point-of-Care Sural Nerve Conduction Device for Identification of Diabetic Neuropathy

    PubMed Central

    Lee, Justin A.; Halpern, Elise M.; Lovblom, Leif E.; Yeung, Emily; Bril, Vera; Perkins, Bruce A.

    2014-01-01

    Background Confirmation of diabetic sensorimotor polyneuropathy (DSP) relies on standard nerve conduction studies (NCS) performed in specialized clinics. We explored the utility of a point-of-care device (POCD) for DSP detection by nontechnical personnel and a validation of diagnostic thresholds with those observed in a normative database. Research Design and Methods 44 subjects with type 1 and type 2 diabetes underwent standard NCS (reference method). Two nontechnical examiners measured sural nerve amplitude potential (SNAP) and conduction velocity (SNCV) using the POCD. Reliability was determined by intraclass correlation coefficients (ICC [2], [1]). Validity was determined by Bland-Altman analysis and receiver operating characteristic curves. Results The 44 subjects (50% female) with mean age 56±18 years had mean SNAP and SNCV of 8.0±8.6 µV and 41.5±8.2 m/s using standard NCS and 8.0±8.2 µV and 49.9±11.1 m/s using the POCD. Intrarater reproducibility ICC values were 0.97 for SNAP and 0.94 for SNCV while interrater reproducibility values were 0.83 and 0.79, respectively. Mean bias of the POCD was ?0.1±3.6 µV for SNAP and +8.4±6.4 m/s for SNCV. A SNAP of ?6 µV had 88% sensitivity and 94% specificity for identifying age-and height-standardized reference NCS values, while a SNCV of ?48 m/s had 94% specificity and 82% sensitivity. Abnormality in one or more of these thresholds was associated with 95% sensitivity and 71% specificity for identification of DSP according to electrophysiological criteria. Conclusions The POCD demonstrated excellent reliability and acceptable accuracy. Threshold values for DSP identification validated those of published POCD normative values. We emphasize the presence of measurement bias – particularly for SNCV – that requires adjustment of threshold values to reflect those of standard NCS. PMID:24466129

  15. Creating a Web-accessible, point-of-care, team-based information system (PointTIS): the librarian as publisher.

    PubMed

    Burrows, S C; Moore, K M; Lemkau, H L

    2001-04-01

    The Internet has created new opportunities for librarians to develop information systems that are readily accessible at the point of care. This paper describes the multiyear process used to justify, fund, design, develop, promote, and evaluate a rehabilitation prototype of a point-of-care, team-based information system (PoinTIS) and train health care providers to use this prototype for their spinal cord injury and traumatic brain injury patient care and education activities. PoinTIS is a successful model for librarians in the twenty-first century to serve as publishers of information created or used by their parent organizations and to respond to the opportunities for information dissemination provided by recent technological advances. PMID:11337946

  16. Detection of protective antibody titers against feline panleukopenia virus, feline herpesvirus-1, and feline calicivirus in shelter cats using a point-of-care ELISA

    Microsoft Academic Search

    Brian A DiGangi; Lauren K Gray; Julie K Levy; Edward J Dubovi; Sylvia J Tucker

    2011-01-01

    Serum antibody titers are a useful measurement of protection against infection (feline panleukopenia virus [FPV]) or clinical disease (feline herpesvirus-1 [FHV] and feline calicivirus [FCV]), and their determination has been recommended as part of disease outbreak management in animal shelters. The objective of this study was to determine the sensitivity, specificity, and inter-observer and inter-assay agreement of two semi-quantitative point-of-care

  17. PDAs and Effective Community Healthcare Delivery: a Mobile Technology Solution to Point-of-Care Health Services Delivery for Ambulatory Care

    Microsoft Academic Search

    Daniel Walsh; Carole Alcock; Lois Burgess; Joan Cooper

    Improvements in the delivery of community-based healthcare are expectedthrough the adoption of PDAs and mobile communication at the point-of-care. The Australian National Health Information Strategy, Health Online, is providing national leadership for approaches to address the quality and availability of information to assist in the planning and delivery of care. One area for potential growth is the availability and capture

  18. Cross-sectional comparison of point-of-care with laboratory HbA1c in detecting diabetes in real-world remote Aboriginal settings

    PubMed Central

    Marley, Julia V; Oh, May S; Hadgraft, Nyssa; Singleton, Sally; Isaacs, Kim; Atkinson, David

    2015-01-01

    Objectives To determine if point-of-care (POC) glycated haemoglobin (HbA1c) is sufficiently accurate in real-world remote settings to predict or exclude the diagnosis of diabetes based on laboratory HbA1c measurements. Design Cross-sectional study comparing POC capillary HbA1c results with corresponding venous HbA1c levels measured in a reference laboratory. Participants Aboriginal patients ?15?years old who were due for diabetes screening at the participating clinics were invited to participate. Two hundred and fifty-five Aboriginal participants were enrolled and 241 were included in the analysis. Setting 6 primary healthcare sites in the remote Kimberley region of Western Australia from September 2011 to November 2013. Main outcome measures Concordance and mean differences between POC capillary blood HbA1c measurement and laboratory measurement of venous blood HbA1c level; POC capillary blood HbA1c equivalence value for screening for diabetes or a high risk of developing diabetes; sensitivity, specificity and positive-predictive value for diagnosing and screening for diabetes; barriers to conducting POC testing. Results Concordance between POC and laboratory results was good (?=0.88, p<0.001). The mean difference was ?0.15% (95% limits of agreement, ?0.67% to 0.36%). POC HbA1c measurements ?6.5%, 48?mmol/mol had a specificity of 98.2% and sensitivity of 73.7% for laboratory measurements ?6.5%. The POC equivalence value for screening for diabetes or a high risk of developing diabetes was ?5.7%, 39?mmol/mol (sensitivity, 91%; specificity, 76.7% for laboratory measurements ?6.0%, 42?mmol/mol). Staff trained by other clinic staff ‘on the job’ performed as well as people with formal accredited training. Staff reported difficulty in maintaining formal accreditation. Conclusions POC HbA1c testing is sufficiently accurate to be a useful component in screening for, and diagnosing, diabetes in remote communities. Limited local training is adequate to produce results comparable to laboratory results and accreditation processes need to reflect this. PMID:25765020

  19. Detection of protective antibody titers against feline panleukopenia virus, feline herpesvirus-1, and feline calicivirus in shelter cats using a point-of-care ELISA.

    PubMed

    Digangi, Brian A; Gray, Lauren K; Levy, Julie K; Dubovi, Edward J; Tucker, Sylvia J

    2011-12-01

    Serum antibody titers are a useful measurement of protection against infection (feline panleukopenia virus [FPV]) or clinical disease (feline herpesvirus-1 [FHV] and feline calicivirus [FCV]), and their determination has been recommended as part of disease outbreak management in animal shelters. The objective of this study was to determine the sensitivity, specificity, and inter-observer and inter-assay agreement of two semi-quantitative point-of-care assays for the detection of protective antibody titers (PAT) against FPV, FHV and FCV in shelter cats. Low sensitivity for FPV antibodies (28%) rendered a canine point-of-care assay inappropriate for use in cats. The feline point-of-care assay also had low sensitivity (49%) and low negative predictive value (74%) for FPV PAT detection, but was highly accurate in the assessment of FHV and FCV PAT. Improvements in accuracy and repeatability of FPV PAT determination could make this tool a valuable component of a disease outbreak response in animal shelters. PMID:21885311

  20. Master project: Ebola point-of-care diagnostics development for low-resource settings A padlock probe is a linear oligonucleotide with two target-specific arms and an auxiliary linker

    E-print Network

    Uppsala Universitet

    Master project: Ebola point-of-care diagnostics development for low-resource settings A padlock methods that are sensitive, cheap and simple to perform are desirable. The current situation of the Ebola

  1. Duplex Molecular Assay Intended for Point-of-Care Diagnosis of Influenza A/B Virus Infection

    PubMed Central

    Wu, Liang-Ta; Thomas, Isabelle; Curran, Martin D.; Ellis, Joanna S.; Parmar, Surendra; Goel, Neha; Sharma, Pia I.; Allain, Jean-Pierre

    2013-01-01

    Early diagnosis and management of influenza virus infection directly correlates with the effectiveness in disease control. Current molecular influenza virus tests were designed for use in diagnostic testing facilities, where sophisticated equipment and highly trained technicians are available. A longer turnaround time for the centralized testing than when testing near the sample source could delay the initiation of medical intervention, thereby reducing the efficacy of antiviral treatment. The new assay, the SAMBA (simple amplification-based assay) Flu duplex test, is a dipstick-based molecular assay developed to provide a simple, accurate, and cost-effective solution for the diagnosis of influenza A/B viruses intended for near-patient testing. The test presents an alternative format of influenza virus molecular testing that utilizes isothermal amplification and visual detection of nucleic acid on a test strip. The entire test procedure (extraction, amplification, and detection) is integrated into an enclosed semiautomated system. Analytically, the SAMBA Flu duplex test detects 95 and 85 copies of viral genomes for influenza A and B viruses, respectively, with no cross-reactivity observed against other common respiratory pathogens. The clinical performance was established by blind testing of 328 nasal/throat and nasopharyngeal swab specimens from the United Kingdom and Belgium and comparing the results with the quantitative reverse transcription-PCR method routinely used in two public health laboratories. The SAMBA Flu duplex test showed a clinical sensitivity and specificity of 100% and 97.9% for influenza virus A and 100% and 100% for influenza virus B. The test provides a new technology that could facilitate simple and timely identification of influenza virus infection, potentially resulting in more efficient control measures. PMID:23850955

  2. Genetic Analysis of H1N1 Influenza Virus from Throat Swab Samples in a Microfluidic System for Point-of-Care Diagnostics

    PubMed Central

    Ferguson, B. Scott; Buchsbaum, Steven F.; Wu, Ting-Ting; Hsieh, Kuangwen; Xiao, Yi; Sun, Ren; Soh, H. Tom

    2011-01-01

    The ability to obtain sequence-specific genetic information about rare target organisms directly from complex biological samples at the point of care would transform many areas of biotechnology. Microfluidics technology offers compelling tools for integrating multiple biochemical processes in a single device, but despite significant progress, only limited examples have shown specific, genetic analysis of clinical samples within the context of a fully integrated, portable platform. Herein we present the Magnetic Integrated Microfluidic Electrochemical Detector (MIMED) that integrates sample preparation and electrochemical sensors in a monolithic disposable device to detect RNA-based virus directly from patient samples. By combining immunomagnetic target capture, concentration and purification, reverse-transcriptase polymerase chain reaction (RT-PCR) and single-stranded DNA (ssDNA) generation in the sample preparation chamber, as well as sequence specific electrochemical DNA detection in the electrochemical cell, we demonstrate the detection of influenza H1N1 in throat swab samples at loads as low as 10 TCID50 - 4 orders of magnitude below the clinical titer for this virus. Given the availability of affinity reagents for a broad range of pathogens, our system offers a general approach for multi-target diagnostics at the point-of-care. PMID:21561070

  3. Development and examination of a rubric for evaluating point-of-care medical applications for mobile devices.

    PubMed

    Butcher, Robyn; MacKinnon, Martin; Gadd, Kathleen; LeBlanc-Duchin, Denise

    2015-01-01

    The rapid development and updates of mobile medical resource applications (apps) highlight the need for an evaluation tool to assess the content of these resources. The purpose of the study was to develop and test a new evaluation rubric for medical resource apps. The evaluation rubric was designed using existing literature and through a collaborative effort between a hospital and an academic librarian. Testing found scores ranging from 23% to 88% for the apps. The evaluation rubric proved able to distinguish levels of quality within each content component of the apps, demonstrating potential for standardization of medical resource app evaluations. PMID:25611442

  4. Performance of BinaxNOW G6PD Deficiency Point-of-Care Diagnostic in P. vivax-Infected Subjects

    PubMed Central

    Osorio, Lyda; Carter, Nick; Arthur, Preetam; Bancone, Germana; Gopalan, Sowmya; Gupta, Sandeep K.; Noedl, Harald; Kochar, Sanjay K.; Kochar, Dhanpat K.; Krudsood, Srivicha; Lacerda, Marcus V.; Llanos-Cuentas, Alejandro; Rueangweerayut, Ronnatrai; Srinivasan, Ramadurai; Treiber, Moritz; Möhrle, Jörg J.; Green, Justin

    2015-01-01

    Accurate diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency is required to avoid the risk of acute hemolysis associated with 8-aminoquinoline treatment. The performance of the BinaxNOW G6PD test compared with the quantitative spectrophotometric analysis of G6PD activity was assessed in 356 Plasmodium vivax-infected subjects in Brazil, Peru, Thailand, and India. In the quantitative assay, the median G6PD activity was 8.81 U/g hemoglobin (range = 0.05–20.19), with 11 (3%) subjects identified as deficient. Sensitivity of the BinaxNOW G6PD to detect deficient subjects was 54.5% (6 of 11), and specificity was 100% (345 of 345). Room temperatures inadvertently falling outside the range required to perform the rapid test (18–25°C) together with subtlety of color change and insufficient training could partially explain the low sensitivity found. Ensuring safe use of 8-aminoquinolines depends on additional development of simple, highly sensitive G6PD deficiency diagnostic tests suitable for routine use in malaria-endemic areas. PMID:25385861

  5. Performance of BinaxNOW G6PD deficiency point-of-care diagnostic in P. vivax-infected subjects.

    PubMed

    Osorio, Lyda; Carter, Nick; Arthur, Preetam; Bancone, Germana; Gopalan, Sowmya; Gupta, Sandeep K; Noedl, Harald; Kochar, Sanjay K; Kochar, Dhanpat K; Krudsood, Srivicha; Lacerda, Marcus V; Llanos-Cuentas, Alejandro; Rueangweerayut, Ronnatrai; Srinivasan, Ramadurai; Treiber, Moritz; Möhrle, Jörg J; Green, Justin

    2015-01-01

    Accurate diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency is required to avoid the risk of acute hemolysis associated with 8-aminoquinoline treatment. The performance of the BinaxNOW G6PD test compared with the quantitative spectrophotometric analysis of G6PD activity was assessed in 356 Plasmodium vivax-infected subjects in Brazil, Peru, Thailand, and India. In the quantitative assay, the median G6PD activity was 8.81 U/g hemoglobin (range = 0.05-20.19), with 11 (3%) subjects identified as deficient. Sensitivity of the BinaxNOW G6PD to detect deficient subjects was 54.5% (6 of 11), and specificity was 100% (345 of 345). Room temperatures inadvertently falling outside the range required to perform the rapid test (18-25°C) together with subtlety of color change and insufficient training could partially explain the low sensitivity found. Ensuring safe use of 8-aminoquinolines depends on additional development of simple, highly sensitive G6PD deficiency diagnostic tests suitable for routine use in malaria-endemic areas. PMID:25385861

  6. Evaluation of optical detection platforms for multiplexed detection of proteins and the need for point-of-care biosensors for clinical use.

    PubMed

    Spindel, Samantha; Sapsford, Kim E

    2014-01-01

    This review investigates optical sensor platforms for protein multiplexing, the ability to analyze multiple analytes simultaneously. Multiplexing is becoming increasingly important for clinical needs because disease and therapeutic response often involve the interplay between a variety of complex biological networks encompassing multiple, rather than single, proteins. Multiplexing is generally achieved through one of two routes, either through spatial separation on a surface (different wells or spots) or with the use of unique identifiers/labels (such as spectral separation-different colored dyes, or unique beads-size or color). The strengths and weaknesses of conventional platforms such as immunoassays and new platforms involving protein arrays and lab-on-a-chip technology, including commercially-available devices, are discussed. Three major public health concerns are identified whereby detecting medically-relevant markers using Point-of-Care (POC) multiplex assays could potentially allow for a more efficient diagnosis and treatment of diseases. PMID:25429414

  7. Evaluation of Optical Detection Platforms for Multiplexed Detection of Proteins and the Need for Point-of-Care Biosensors for Clinical Use

    PubMed Central

    Spindel, Samantha; Sapsford, Kim E.

    2014-01-01

    This review investigates optical sensor platforms for protein multiplexing, the ability to analyze multiple analytes simultaneously. Multiplexing is becoming increasingly important for clinical needs because disease and therapeutic response often involve the interplay between a variety of complex biological networks encompassing multiple, rather than single, proteins. Multiplexing is generally achieved through one of two routes, either through spatial separation on a surface (different wells or spots) or with the use of unique identifiers/labels (such as spectral separation—different colored dyes, or unique beads—size or color). The strengths and weaknesses of conventional platforms such as immunoassays and new platforms involving protein arrays and lab-on-a-chip technology, including commercially-available devices, are discussed. Three major public health concerns are identified whereby detecting medically-relevant markers using Point-of-Care (POC) multiplex assays could potentially allow for a more efficient diagnosis and treatment of diseases. PMID:25429414

  8. Using integrated bio-physiotherapy informatics in home health-care settings: A qualitative analysis of a point-of-care decision support system.

    PubMed

    Canally, Culum; Doherty, Sean; Doran, Diane M; Goubran, Rafik A

    2014-05-16

    The growing need to gain efficiencies within a home care setting has prompted home care practitioners to focus on health informatics to address the needs of an aging clientele. The remote and heterogeneous nature of the home care environment necessitates the use of non-intrusive client monitoring and a portable, point-of-care graphical user interface. Using a grounded theory approach, this article examines the simulated use of a graphical user interface by practitioners in a home care setting to explore the salient features of monitoring the activity of home care clients. The results demonstrate the need for simple, interactive displays that can provide large amounts of geographical and temporal data relating to patient activity. Additional emerging themes from interviews indicate that home care professionals would use a graphical user interface of this type for patient education and goal setting as well as to assist in the decision-making process of home care practitioners. PMID:24835146

  9. Open-source point-of-care electronic medical records for use in resource-limited settings: systematic review and questionnaire surveys

    PubMed Central

    Bru, Juan; Berger, Christopher A

    2012-01-01

    Background Point-of-care electronic medical records (EMRs) are a key tool to manage chronic illness. Several EMRs have been developed for use in treating HIV and tuberculosis, but their applicability to primary care, technical requirements and clinical functionalities are largely unknown. Objectives This study aimed to address the needs of clinicians from resource-limited settings without reliable internet access who are considering adopting an open-source EMR. Study eligibility criteria Open-source point-of-care EMRs suitable for use in areas without reliable internet access. Study appraisal and synthesis methods The authors conducted a comprehensive search of all open-source EMRs suitable for sites without reliable internet access. The authors surveyed clinician users and technical implementers from a single site and technical developers of each software product. The authors evaluated availability, cost and technical requirements. Results The hardware and software for all six systems is easily available, but they vary considerably in proprietary components, installation requirements and customisability. Limitations This study relied solely on self-report from informants who developed and who actively use the included products. Conclusions and implications of key findings Clinical functionalities vary greatly among the systems, and none of the systems yet meet minimum requirements for effective implementation in a primary care resource-limited setting. The safe prescribing of medications is a particular concern with current tools. The dearth of fully functional EMR systems indicates a need for a greater emphasis by global funding agencies to move beyond disease-specific EMR systems and develop a universal open-source health informatics platform. PMID:22763661

  10. A multiplexed reverse transcriptase PCR assay for identification of viral respiratory pathogens at point-of-care

    SciTech Connect

    Letant, S E; .Ortiz, J I; Tammero, L; Birch, J M; Derlet, R W; Cohen, S; Manning, D; McBride, M T

    2007-04-11

    We have developed a nucleic acid-based assay that is rapid, sensitive, specific, and can be used for the simultaneous detection of 5 common human respiratory pathogens including influenza A, influenza B, parainfluenza type 1 and 3, respiratory syncytial virus, and adenovirus group B, C, and E. Typically, diagnosis on an un-extracted clinical sample can be provided in less than 3 hours, including sample collection, preparation, and processing, as well as data analysis. Such a multiplexed panel would enable rapid broad-spectrum pathogen testing on nasal swabs, and therefore allow implementation of infection control measures, and timely administration of antiviral therapies. This article presents a summary of the assay performance in terms of sensitivity and specificity. Limits of detection are provided for each targeted respiratory pathogen, and result comparisons are performed on clinical samples, our goal being to compare the sensitivity and specificity of the multiplexed assay to the combination of immunofluorescence and shell vial culture currently implemented at the UCDMC hospital. Overall, the use of the multiplexed RT-PCR assay reduced the rate of false negatives by 4% and reduced the rate of false positives by up to 10%. The assay correctly identified 99.3% of the clinical negatives, 97% of adenovirus, 95% of RSV, 92% of influenza B, and 77% of influenza A without any extraction performed on the clinical samples. The data also showed that extraction will be needed for parainfluenza virus, which was only identified correctly 24% of the time on un-extracted samples.

  11. A Portable, Pressure Driven, Room Temperature Nucleic Acid Extraction and Storage System for Point of Care Molecular Diagnostics.

    PubMed

    Byrnes, Samantha; Fan, Andy; Trueb, Jacob; Jareczek, Francis; Mazzochette, Mark; Sharon, Andre; Sauer-Budge, Alexis F; Klapperich, Catherine M

    2013-07-01

    Many new and exciting portable HIV viral load testing technologies are emerging for use in global medicine. While the potential to provide fast, isothermal, and quantitative molecular diagnostic information to clinicians in the field will soon be a reality, many of these technologies lack a robust front end for sample clean up and nucleic acid preparation. Such a technology would enable many different downstream molecular assays. Here, we present a portable system for centrifuge-free room temperature nucleic acid extraction from small volumes of whole blood (70 µL), using only thermally stable reagents compatible with storage and transport in low resource settings. Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) analysis of simulated samples demonstrate a lower limit of detection of 1000 copies/ml, with the ability to detect differences in viral load across four orders of magnitude. The system can also be used to store extracted RNA on detachable cartridges for up to one week at ambient temperature, and can be operated using only hand generated air pressure. PMID:23914255

  12. Recent advances in the use of laser-induced breakdown spectroscopy (LIBS) as a rapid point-of-care pathogen diagnostic

    NASA Astrophysics Data System (ADS)

    Rehse, Steven J.; Miziolek, Andrzej W.

    2012-06-01

    Laser-induced breakdown spectroscopy (LIBS) has made tremendous progress in becoming a viable technology for rapid bacterial pathogen detection and identification. The significant advantages of LIBS include speed (< 1 sec analysis), portability, robustness, lack of consumables, little to no need for sample preparation, lack of genetic amplification, and the ability to identify all bacterial pathogens without bias (including spore-forms and viable but nonculturable specimens). In this manuscript, we present the latest advances achieved in LIBS-based bacterial sensing including the ability to uniquely identify species from more than five bacterial genera with high-sensitivity and specificity. Bacterial identifications are completely unaffected by environment, nutrition media, or state of growth and accurate diagnoses can be made on autoclaved or UV-irradiated specimens. Efficient discrimination of bacteria at the strain level has been demonstrated. A rapid urinary tract infection diagnosis has been simulated with no sample preparation and a one second diagnosis of a pathogen surrogate has been demonstrated using advanced chemometric analysis with a simple "stop-light" user interface. Stand-off bacterial identification at a 20-m distance has been demonstrated on a field-portable instrument. This technology could be implemented in doctors' offices, clinics, or hospital laboratories for point-of-care medical specimen analysis; mounted on military medical robotic platforms for in-the- field diagnostics; or used in stand-off configuration for remote sensing and detection.

  13. Detection of cardiac biomarkers exploiting surface enhanced Raman scattering (SERS) using a nanofluidic channel based biosensor towards coronary point-of-care diagnostics

    NASA Astrophysics Data System (ADS)

    Benford, Melodie E.; Wang, Miao; Kameoka, Jun; Coté, Gerard L.

    2009-02-01

    According to the World Health Organization, cardiovascular disease is the most common cause of death in the world. In the US, over 115 million people visit the emergency department (ED), 5 million of which may have acute coronary syndrome (ACS). Cardiac biomarkers can provide early identification and diagnosis of ACS, and can provide information on the prognosis of the patient by assessing the risk of death. In addition, the biomarkers can serve as criteria for admission, indicate possibility of re-infarction, or eliminate ACS as a diagnosis altogether. We propose a SERSbased multi-marker approach towards a point-of-care diagnostic system for ACS. Using a nanofluidic device consisting of a microchannel leading into a nanochannel, we formed SERS active sites by mechanically aggregating gold particles (60 nm) at the entrance to the nanochannel (40nm×1?m). The induced capillary flow produces a high density of aggregated nanoparticles at this precise region, creating areas with enhanced electromagnetic fields within the aggregates, shifting the plasmon resonance to the near infrared region, in resonance with incident laser wavelength. With this robust sensing platform, we were able to obtain qualitative information of brain natriuretic peptide (biomarker of ventricular dysfunction or pulmonary stress), troponin I (biomarker of myocardial necrosis), and C-reactive protein (biomarker of inflammation potentially caused by atherosclerosis).

  14. Cardiac troponin assays: a review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction.

    PubMed

    Amundson, Beret E; Apple, Fred S

    2015-04-01

    Cardiac troponin (cTn) I and T are released from myocardial cells following necrosis, i.e., cell death. An accurate measure of cTn concentrations in a patient's blood following ischemia/chest pain can enable providers to determine whether or not a myocardial infarction (MI) has occurred. Point-of-care (POC) devices that measure blood cTn concentrations in under 30 min may help to significantly reduce hospital costs by managing and triaging patients out of the emergency department as quickly as possible. The use of POC devices that measure cTnI and cTnT with a coefficient of variation (CV) ?20% at the 99th percentile upper reference limit (URL) limits both false positive and negative results and provides clinically acceptable findings to assist in appropriate diagnoses. This article reviews nine POC devices that measure cTn in terms of their clinical sensitivity and specificity, analytical imprecision, sample type and preparation, and each assay's principle of analysis. PMID:25324453

  15. Optimal Management of the Critically Ill: Anaesthesia, Monitoring, Data Capture, and Point-of-Care Technological Practices in Ovine Models of Critical Care

    PubMed Central

    Shekar, Kiran; Tung, John-Paul; Dunster, Kimble R.; Platts, David; Watts, Ryan P.; Gregory, Shaun D.; Simonova, Gabriela; McDonald, Charles; Hayes, Rylan; Bellpart, Judith; Timms, Daniel; Fung, Yoke L.; Toon, Michael; Maybauer, Marc O.; Fraser, John F.

    2014-01-01

    Animal models of critical illness are vital in biomedical research. They provide possibilities for the investigation of pathophysiological processes that may not otherwise be possible in humans. In order to be clinically applicable, the model should simulate the critical care situation realistically, including anaesthesia, monitoring, sampling, utilising appropriate personnel skill mix, and therapeutic interventions. There are limited data documenting the constitution of ideal technologically advanced large animal critical care practices and all the processes of the animal model. In this paper, we describe the procedure of animal preparation, anaesthesia induction and maintenance, physiologic monitoring, data capture, point-of-care technology, and animal aftercare that has been successfully used to study several novel ovine models of critical illness. The relevant investigations are on respiratory failure due to smoke inhalation, transfusion related acute lung injury, endotoxin-induced proteogenomic alterations, haemorrhagic shock, septic shock, brain death, cerebral microcirculation, and artificial heart studies. We have demonstrated the functionality of monitoring practices during anaesthesia required to provide a platform for undertaking systematic investigations in complex ovine models of critical illness. PMID:24783206

  16. A low cost point-of-care viscous sample preparation device for molecular diagnosis in the developing world; an example of microfluidic origami.

    PubMed

    Govindarajan, A V; Ramachandran, S; Vigil, G D; Yager, P; Böhringer, K F

    2012-01-01

    The lab-on-a-chip concept has led to several point-of-care (POC) diagnostic microfluidic platforms. However, few of these can process raw samples for molecular diagnosis and fewer yet are suited for use in a resource-limited setting without permanent electrical infrastructure. We present here a very low cost paper microfluidic device for POC extraction of bacterial DNA from raw viscous samples--a challenge for conventional microfluidic platforms. This is an example of "microfluidic origami" in that the system is activated by folding; demonstrated here is room temperature cell lysis and DNA extraction from pig mucin (simulating sputum) spiked with E. coli without the use of external power. The microfluidic origami device features dry reagent storage and rehydration of the lysis buffer. We demonstrate DNA extraction from samples with a bacterial load as low as 33 CFU ml(-1). Extraction times, starting from the raw sample, have been optimized to about 1.5 h without the use of external power, or to within 1 h using an oven or a heater block. The fabrication of this paper microfluidic device can be translated into high volume production in the developing world without the need for a semiconductor clean room or a microfabrication facility. The sample preparation can be performed with the addition of just the sample, water, ethanol and elute buffer to the device, thus reducing chemical hazards during transport and handling. PMID:22068336

  17. TLC-Asthma: An Integrated Information System for Patient-centered Monitoring, Case Management, and Point-of-Care Decision Support

    PubMed Central

    Adams, William G.; Fuhlbrigge, Anne L.; Miller, Charles W.; Panek, Celeste G.; Gi, Yangsoon; Loane, Kathleen C.; Madden, Nancy E.; Plunkett, Anne M.; Friedman, Robert H.

    2003-01-01

    A great deal of successful work has been done in the area of EMR development, implementation, and evaluation. Less work has been done in the area of automated systems for patients. Efforts to link data at multiple levels – the patient, the case manager, and the clinician have been rudimentary to-date. In this paper we present a model information system that integrates patient health information across multiple domains to support the monitoring and care of children with persistent asthma. The system has been developed for use in a multi-specialty group practice and includes three primary components: 1) a patient-centered telephone-linked communication system; 2) a web-based alert reporting and nurse case-management system; and 3) EMR-based provider communication to support clinical decision making at the point-of-care. The system offers a model for a new level of connectivity for health information that supports customized monitoring, IT-enabled nurse case-managers, and the delivery of longitudinal data to clinicians to support the care of children with persistent asthma. Systems like the one described are well -suited, perhaps essential, technologies for the care of children and adults with chronic conditions such as asthma. PMID:14728122

  18. Use of autologous blood-derived endothelial progenitor cells at point-of-care to protect against implant thrombosis in a large animal model

    PubMed Central

    Jantzen, Alexandra E.; Lane, Whitney O.; Gage, Shawn M.; Jamiolkowski, Ryan M.; Haseltine, Justin M.; Galinat, Lauren J.; Lin, Fu-Hsiung; Lawson, Jeffrey H.; Truskey, George A.; Achneck, Hardean E.

    2011-01-01

    Titanium (Ti) is commonly utilized in many cardiovascular devices, e.g. as a component of Nitinol stents, intra- and extracorporeal mechanical circulatory assist devices, but is associated with the risk of thromboemboli formation. We propose to solve this problem by lining the Ti blood-contacting surfaces with autologous peripheral blood-derived late outgrowth endothelial progenitor cells (EPCs) after having previously demonstrated that these EPCs adhere to and grow on Ti under physiological shear stresses and functionally adapt to their environment under flow conditions ex vivo. Autologous fluorescently-labeled porcine EPCs were seeded at the point-of-care in the operating room onto Ti tubes for 30 minutes and implanted into the pro-thrombotic environment of the inferior vena cava of swine (n = 8). After 3 days, Ti tubes were explanted, disassembled, and the blood-contacting surface was imaged. A blinded analysis found all 4 cell-seeded implants to be free of clot, whereas 4 controls without EPCs were either entirely occluded or partially thrombosed. Pre-labeled EPCs had spread and were present on all 4 cell-seeded implants while no endothelial cells were observed on control implants. These results suggest that late outgrowth autologous EPCs represent a promising source of lining Ti implants to reduce thrombosis in vivo. PMID:21840592

  19. A comparison of measurements of sodium, potassium, haemoglobin and creatinine between an Emergency Department-based point-of-care machine and the hospital laboratory.

    PubMed

    Bloom, Benjamin M; Connor, Hilary; Benton, Sally; Harris, Tim

    2014-08-01

    Blood gas analysers provide electrolyte and metabolic data. In the author's institution, these values were not used clinically because of the risk of inaccuracy. To discover whether this approach was warranted, we compared values from our Radiometer point-of-care (POC) analyser and the laboratory. A total of 207 patients from an urban Emergency Department received venepuncture for sodium, potassium, creatinine and haemoglobin. Two samples were drawn; one analysed in the laboratory, the other on the POC machine. The results were: sodium: n=182, mean difference (MD) (lab-POC) 3.36, 95% limits of agreement (LOA) 0.18-6.54; potassium: n=171, MD 0.46, 95% LOA -0.12 to 1.03; creatinine: n=183, MD 1.6, 95% LOA -16.2 to 18.7; haemoglobin: n=191, MD -0.29, 95% LOA -1.71 to 1.12. Thus, sodium and potassium showed negative bias on the Radiometer compared with the laboratory. Creatinine and haemoglobin agreed well. We advocate the clinical use of POC values when taken in clinical context. PMID:23982441

  20. The Impact of Continuous Glucose Monitoring on Low Interstitial Glucose Values and Low Blood Glucose Values Assessed by Point-of-care Blood Glucose Meters: Results of a Crossover Trial.

    PubMed

    Hermanns, Norbert; Schumann, Beatrix; Kulzer, Bernhard; Haak, Thomas

    2014-05-01

    In a randomized crossover trial the impact of continuous glucose monitoring (CGM) was tested on the occurrence of low blood glucose values measured by point of care (POC) measurement and on low glucose values measured by CGM in the interstitial fluid. A total of 41 type 1 diabetic patients (age 42.0 ± 11.4 years, diabetes duration 15.3 ± 10.1 years, A1c 8.2 ± 1.4%) used a CGM system (Dexcom SEVEN PLUS system) twice. In first study phase (CGM blind), patients were blind regarding the CGM current glucose levels and were not alerted when critical glucose values were reached. In the second phase (CGM real time), patients had access to current glucose levels and were alerted if critical glucose values were reached. During CGM real time the proportion of hypoglycemic POC blood glucose values were significantly reduced (7.5 ± 5.6% vs 10.1 ± 7.5%; P = .04), whereas the proportion of euglycemic blood glucose values were significantly enhanced (73.7 ± 18.3% vs 68.3 ± 12.1%; P = .01). The duration of low glucose periods in the interstitial fluid was significantly lower in the CGM real time phase (125 ± 89 vs 181 ± 125 minutes per day; P = .005). The time until a low blood glucose was detected by POC measurement was shortened by 33.2 ± 76.1 minutes (P = .03). The study demonstrated that CGM is able to not only reduce duration of hypoglycemia measured by CGM in interstitial fluid, but also reduce the proportion of low POC blood glucose measurements. In addition, hypoglycemia can be detected earlier. PMID:24876615

  1. Fast and highly sensitive fiber-enhanced Raman spectroscopic monitoring of molecular H2 and CH4 for point-of-care diagnosis of malabsorption disorders in exhaled human breath.

    PubMed

    Hanf, Stefan; Bögözi, Timea; Keiner, Robert; Frosch, Torsten; Popp, Jürgen

    2015-01-20

    Breath gas analysis is a novel powerful technique for noninvasive, early-stage diagnosis of metabolic disorders or diseases. Molecular hydrogen and methane are biomarkers for colonic fermentation, because of malabsorption of oligosaccharides (e.g., lactose or fructose) and for small intestinal bacterial overgrowth. Recently, the presence of these gases in exhaled breath was also correlated with obesity. Here, we report on the highly selective and sensitive detection of molecular hydrogen and methane within a complex gas mixture (consisting of H2, CH4, N2, O2, and CO2) by means of fiber-enhanced Raman spectroscopy (FERS). An elaborate FERS setup with a microstructured hollow core photonic crystal fiber (HCPCF) provided a highly improved analytical sensitivity. The simultaneous monitoring of H2 with all other gases was achieved by a combination of rotational (H2) and vibrational (other gases) Raman spectroscopy within the limited spectral transmission range of the HCPCF. The HCPCF was combined with an adjustable image-plane aperture pinhole, in order to separate the H2 rotational Raman bands from the silica background signal and improve the sensitivity down to a limit of detection (LOD) of 4.7 ppm (for only 26 fmol H2). The ability to monitor the levels of H2 and CH4 in a positive hydrogen breath test (HBT) was demonstrated. The FERS sensor possesses a high dynamic range (?5 orders of magnitude) with a fast response time of few seconds and provides great potential for miniaturization. We foresee that this technique will pave the way for fast, noninvasive, and painless point-of-care diagnosis of metabolic diseases in exhaled human breath. PMID:25545503

  2. Point-of-care detection and real-time monitoring of intravenously delivered drugs via tubing with an integrated SERS sensor

    NASA Astrophysics Data System (ADS)

    Wu, Hsin-Yu; Cunningham, Brian T.

    2014-04-01

    We demonstrate an approach for detection, identification, and kinetic monitoring of drugs flowing within tubing, through the use of a plasmonic nanodome array (PNA) surface. The PNA structures are fabricated using a low-cost nanoreplica molding process upon a flexible plastic substrate that is subsequently integrated with a flow cell that connects in series with ordinary intravenous (IV) drug delivery tubing. To investigate the potential clinical applications for point-of-care detection and real-time monitoring, we perform SERS detection of ten pharmaceutical compounds (hydrocodone, levorphanol, morphine, oxycodone, methadone, phenobarbital, dopamine, diltiazem, promethazine, and mitoxantrone). We demonstrate dose-dependent SERS signal magnitude, resulting in detection limits (ng ml-1) well below typical administered dosages (mg ml-1). Further, we show that the detected drugs are not permanently attached to the PNA surface, and thus our approach is capable of performing continuous monitoring of drug delivery as materials flow through IV tubing that is connected in series with the sensor. Finally, we demonstrate the potential co-detection of multiple drugs when they are mixed together, and show excellent reproducibility and stability of SERS measurements for periods extending at least five days. The capabilities reported here demonstrate the potential to use PNA SERS surfaces for enhancing the safety of IV drug delivery.We demonstrate an approach for detection, identification, and kinetic monitoring of drugs flowing within tubing, through the use of a plasmonic nanodome array (PNA) surface. The PNA structures are fabricated using a low-cost nanoreplica molding process upon a flexible plastic substrate that is subsequently integrated with a flow cell that connects in series with ordinary intravenous (IV) drug delivery tubing. To investigate the potential clinical applications for point-of-care detection and real-time monitoring, we perform SERS detection of ten pharmaceutical compounds (hydrocodone, levorphanol, morphine, oxycodone, methadone, phenobarbital, dopamine, diltiazem, promethazine, and mitoxantrone). We demonstrate dose-dependent SERS signal magnitude, resulting in detection limits (ng ml-1) well below typical administered dosages (mg ml-1). Further, we show that the detected drugs are not permanently attached to the PNA surface, and thus our approach is capable of performing continuous monitoring of drug delivery as materials flow through IV tubing that is connected in series with the sensor. Finally, we demonstrate the potential co-detection of multiple drugs when they are mixed together, and show excellent reproducibility and stability of SERS measurements for periods extending at least five days. The capabilities reported here demonstrate the potential to use PNA SERS surfaces for enhancing the safety of IV drug delivery. Electronic supplementary information (ESI) available: Fabrication of PNA substrates, fabrication details of the flow cell, details of FDTD simulation, characterization of the scattering volume, and detection of diltiazem diluted in DI water and PBS. See DOI: 10.1039/c4nr00027g

  3. Reduction of Fresh Frozen Plasma Requirements by Perioperative Point-of-Care Coagulation Management with Early Calculated Goal-Directed Therapy

    PubMed Central

    Görlinger, Klaus; Fries, Dietmar; Dirkmann, Daniel; Weber, Christian F.; Hanke, Alexander A.; Schöchl, Herbert

    2012-01-01

    Background Massive bleeding and transfusion of packed red blood cells (PRBC), fresh frozen plasma (FFP) and platelets are associated with increased morbidity, mortality and costs. Patients and Methods We analysed the transfusion requirements after implementation of point-of-care (POC) coagulation management algorithms based on early, calculated, goal-directed therapy with fibrinogen concentrate and prothrombin complex concentrate (PCC) in different perioperative settings (trauma surgery, visceral and transplant surgery (VTS), cardiovascular surgery (CVS) and general and surgical intensive care medicine) at 3 different hospitals (AUVA Trauma Centre Salzburg, University Hospital Innsbruck and University Hospital Essen) in 2 different countries (Austria and Germany). Results In all institutions, the implementation of POC coagulation management algorithms was associated with a reduction in the transfusion requirements for FFP by about 90% (Salzburg 94%, Innsbruck 88% and Essen 93%). Furthermore, PRBC transfusion was reduced by 8.4–62%. The incidence of intraoperative massive transfusion (?10 U PRBC) could be more than halved in VTS and CVS (2.56 vs. 0.88%; p < 0.0001 and 2.50 vs. 1.06%; p = 0.0007, respectively). Platelet transfusion could be reduced by 21–72%, except in CVS where it increased by 115% due to a 5-fold increase in patients with dual antiplatelet therapy (2.7 vs. 13.7%; p < 0.0001). Conclusions The implementation of perioperative POC coagulation management algorithms based on early, calculated, goal-directed therapy with fibrinogen concentrate and PCC is associated with a reduction in the transfusion requirements for FFP, PRBC and platelets as well as with a reduced incidence of massive transfusion. Thus, the limited blood resources can be used more efficiently. PMID:22670128

  4. Programmable Bio-Nano-Chip Systems for Serum CA125 Quantification: Towards Ovarian Cancer Diagnostics at the Point-of-Care

    PubMed Central

    Raamanathan, Archana; Simmons, Glennon W.; Christodoulides, Nicolaos; Floriano, Pierre N.; Furmaga, Wieslaw B.; Redding, Spencer W.; Lu, Karen H.; Bast, Robert C.; McDevitt, John T.

    2013-01-01

    Point-of-care (POC) implementation of early detection and screening methodologies for ovarian cancer may enable improved survival rates through early intervention. Current laboratory-confined immunoanalyzers have long turnaround times and are often incompatible with multiplexing and POC implementation. Rapid, sensitive and multiplexable POC diagnostic platforms compatible with promising early detection approaches for ovarian cancer are needed. To this end, we report the adaptation of the programmable bio-nano-chip (p-BNC), an integrated, microfluidic, modular (Programmable) platform for CA125 serum quantitation, a biomarker prominently implicated in multi-modal and multi-marker screening approaches. In the p-BNC, CA125 from diseased sera (Bio) is sequestered and assessed with a fluorescence-based sandwich immunoassay, completed in the nano-nets (Nano) of sensitized agarose microbeads localized in individually addressable wells (Chip), housed in a microfluidic module, capable of integrating multiple sample, reagent and biowaste processing and handling steps. Antibody pairs that bind to distinct epitopes on CA125 were screened. To permit efficient biomarker sequestration in a 3-D microfluidic environment, the p-BNC operating variables (incubation times, flow rates and reagent concentrations) were tuned to deliver optimal analytical performance under 45 minutes. With short analysis times, competitive analytical performance (Inter- and intra-assay precision of 1.2% and 1.9% and LODs of 1.0 U/mL) was achieved on this mini-sensor ensemble. Further validation with sera of ovarian cancer patients (n=20) demonstrated excellent correlation (R2 = 0.97) with gold-standard ELISA. Building on the integration capabilities of novel microfluidic systems programmed for ovarian cancer, the rapid, precise and sensitive miniaturized p-BNC system shows strong promise for ovarian cancer diagnostics. PMID:22490510

  5. A multiplexable, microfluidic platform for the rapid quantitation of a biomarker panel for early ovarian cancer detection at the point-of-care.

    PubMed

    Shadfan, Basil H; Simmons, Archana R; Simmons, Glennon W; Ho, Andy; Wong, Jorge; Lu, Karen H; Bast, Robert C; McDevitt, John T

    2015-01-01

    Point-of-care (POC) diagnostic platforms have the potential to enable low-cost, large-scale screening. As no single biomarker is shed by all ovarian cancers, multiplexed biomarker panels promise improved sensitivity and specificity to address the unmet need for early detection of ovarian cancer. We have configured the programmable bio-nano-chip (p-BNC)-a multiplexable, microfluidic, modular platform-to quantify a novel multi-marker panel comprising CA125, HE4, MMP-7, and CA72-4. The p-BNC is a bead-based immunoanalyzer system with a credit-card-sized footprint that integrates automated sample metering, bubble and debris removal, reagent storage and waste disposal, permitting POC analysis. Multiplexed p-BNC immunoassays demonstrated high specificity, low cross-reactivity, low limits of detection suitable for early detection, and a short analysis time of 43 minutes. Day-to-day variability, a critical factor for longitudinally monitoring biomarkers, ranged between 5.4% and 10.5%, well below the biologic variation for all four markers. Biomarker concentrations for 31 late-stage sera correlated well (R(2) = 0.71 to 0.93 for various biomarkers) with values obtained on the Luminex platform. In a 31 patient cohort encompassing early- and late-stage ovarian cancers along with benign and healthy controls, the multiplexed p-BNC panel was able to distinguish cases from controls with 68.7% sensitivity at 80% specificity. Utility for longitudinal biomarker monitoring was demonstrated with prediagnostic plasma from 2 cases and 4 controls. Taken together, the p-BNC shows strong promise as a diagnostic tool for large-scale screening that takes advantage of faster results and lower costs while leveraging possible improvement in sensitivity and specificity from biomarker panels. PMID:25388014

  6. Point-of-Care Autofluorescence Imaging for Real-Time Sampling and Treatment Guidance of Bioburden in Chronic Wounds: First-in-Human Results

    PubMed Central

    DaCosta, Ralph S.; Kulbatski, Iris; Lindvere-Teene, Liis; Starr, Danielle; Blackmore, Kristina; Silver, Jason I.; Opoku, Julie; Wu, Yichao Charlie; Medeiros, Philip J.; Xu, Wei; Xu, Lizhen; Wilson, Brian C.; Rosen, Cheryl; Linden, Ron

    2015-01-01

    Background Traditionally, chronic wound infection is diagnosed by visual inspection under white light and microbiological sampling, which are subjective and suboptimal, respectively, thereby delaying diagnosis and treatment. To address this, we developed a novel handheld, fluorescence imaging device (PRODIGI) that enables non-contact, real-time, high-resolution visualization and differentiation of key pathogenic bacteria through their endogenous autofluorescence, as well as connective tissues in wounds. Methods and Findings This was a two-part Phase I, single center, non-randomized trial of chronic wound patients (male and female, ?18 years; UHN REB #09-0015-A for part 1; UHN REB #12-5003 for part 2; clinicaltrials.gov Identifier: NCT01378728 for part 1 and NCT01651845 for part 2). Part 1 (28 patients; 54% diabetic foot ulcers, 46% non-diabetic wounds) established the feasibility of autofluorescence imaging to accurately guide wound sampling, validated against blinded, gold standard swab-based microbiology. Part 2 (12 patients; 83.3% diabetic foot ulcers, 16.7% non-diabetic wounds) established the feasibility of autofluorescence imaging to guide wound treatment and quantitatively assess treatment response. We showed that PRODIGI can be used to guide and improve microbiological sampling and debridement of wounds in situ, enabling diagnosis, treatment guidance and response assessment in patients with chronic wounds. PRODIGI is safe, easy to use and integrates into the clinical workflow. Clinically significant bacterial burden can be detected in seconds, quantitatively tracked over days-to-months and their biodistribution mapped within the wound bed, periphery, and other remote areas. Conclusions PRODIGI represents a technological advancement in wound sampling and treatment guidance for clinical wound care at the point-of-care. Trial Registration ClinicalTrials.gov NCT01651845; ClinicalTrials.gov NCT01378728 PMID:25790480

  7. Turning Knowledge Into Action at the Point-of-Care: The Collective Experience of Nurses Facilitating the Implementation of Evidence-Based Practice

    PubMed Central

    Dogherty, Elizabeth J; Harrison, Margaret B; Graham, Ian D; Vandyk, Amanda Digel; Keeping-Burke, Lisa

    2013-01-01

    Background: Facilitation is considered a way of enabling clinicians to implement evidence into practice by problem solving and providing support. Practice development is a well-established movement in the United Kingdom that incorporates the use of facilitators, but in Canada, the role is more obtuse. Few investigations have observed the process of facilitation as described by individuals experienced in guideline implementation in North America. AimTo describe the tacit knowledge regarding facilitation embedded in the experiences of nurses implementing evidence into practice. Methods: Twenty nurses from across Canada were purposively selected to attend an interactive knowledge translation symposium to examine what has worked and what has not in implementing evidence in practice. This study is an additional in-depth analysis of data collected at the symposium that focuses on facilitation as an intervention to enhance evidence uptake. Critical incident technique was used to elicit examples to examine the nurses’ facilitation experiences. Participants shared their experiences with one another and completed initial data analysis and coding collaboratively. The data were further thematically analyzed using the qualitative inductive approach of constant comparison. Results: A number of factors emerged at various levels associated with the successes and failures of participants’ efforts to facilitate evidence-based practice. Successful implementation related to: (a) focus on a priority issue, (b) relevant evidence, (c) development of strategic partnerships, (d) the use of multiple strategies to effect change, and (e) facilitator characteristics and approach. Negative factors influencing the process were: (a) poor engagement or ownership, (b) resource deficits, (c) conflict, (d) contextual issues, and (e) lack of evaluation and sustainability. Conclusions: Factors at the individual, environmental, organizational, and cultural level influence facilitation of evidence-based practice in real situations at the point-of-care. With a greater understanding of factors contributing to successful or unsuccessful facilitation, future research should focus on analyzing facilitation interventions tailored to address barriers and enhance facilitators of evidence uptake. PMID:23796066

  8. Preparation of a portable point-of-care in vitro diagnostic system, for quantification of canine C-reactive protein, based on a magnetic two-site immunoassay.

    PubMed

    Ibraimi, Filiz; Ekberg, Björn; Kriz, Dario; Danielsson, Gertrud; Bülow, Leif

    2013-07-01

    In this study, characterization of the binding kinetics and optimization of a magnetic permeability based point-of-care (POC) immunoassay system for quantification of canine C-reactive protein (cCRP) is described. The reagent is based on a two-site heterogeneous immunoassay system utilizing conjugated superparamagnetic nanoparticles (SPION) and silica particles, both particles carrying covalently linked antibodies directed to the cCRP analyte. Detection is carried out using a magnetic permeability-based small instrument, adjusted in order to apply it in a POC setting near the patients. The kinetic parameters are characterized and applied in the final design of the assay system. In the cCRP system studied, 90% of the binding between immobilized solid-phase silica antibody and cCRP is complete after only 15 s, and 30 s for the binding between the antibody on the SPION and the bound cCRP on the silica particle. Additionally, the binding rate constants are determined to be 149 and 30 M(-1)s(-1), respectively. The analytical sensitivity, clinical sensitivity, and imprecision verifies the clinical usefulness of the system. Also, quantification of cCRP, using the system described, in dog clinical samples from mixed breeds shows a high correlation to a commercially available comparative cCRP ELISA system (y?=?0.98?×?+3.2, R(2)?=?0.98, n?=?47). The immunoassay system described can thus provide the veterinarian a valuable tool for rapid diagnosis and monitoring of inflammatory diseases in dogs in a setting near the patients. PMID:23660695

  9. Programmable bio-nano-chip systems for serum CA125 quantification: toward ovarian cancer diagnostics at the point-of-care.

    PubMed

    Raamanathan, Archana; Simmons, Glennon W; Christodoulides, Nicolaos; Floriano, Pierre N; Furmaga, Wieslaw B; Redding, Spencer W; Lu, Karen H; Bast, Robert C; McDevitt, John T

    2012-05-01

    Point-of-care (POC) implementation of early detection and screening methodologies for ovarian cancer may enable improved survival rates through early intervention. Current laboratory-confined immunoanalyzers have long turnaround times and are often incompatible with multiplexing and POC implementation. Rapid, sensitive, and multiplexable POC diagnostic platforms compatible with promising early detection approaches for ovarian cancer are needed. To this end, we report the adaptation of the programmable bio-nano-chip (p-BNC), an integrated, microfluidic, and modular (programmable) platform for CA125 serum quantitation, a biomarker prominently implicated in multimodal and multimarker screening approaches. In the p-BNCs, CA125 from diseased sera (Bio) is sequestered and assessed with a fluorescence-based sandwich immunoassay, completed in the nano-nets (Nano) of sensitized agarose microbeads localized in individually addressable wells (Chip), housed in a microfluidic module, capable of integrating multiple sample, reagent and biowaste processing, and handling steps. Antibody pairs that bind to distinct epitopes on CA125 were screened. To permit efficient biomarker sequestration in a three-dimensional microfluidic environment, the p-BNC operating variables (incubation times, flow rates, and reagent concentrations) were tuned to deliver optimal analytical performance under 45 minutes. With short analysis times, competitive analytical performance (inter- and intra-assay precision of 1.2% and 1.9% and limit of detection of 1.0 U/mL) was achieved on this minisensor ensemble. Furthermore, validation with sera of patients with ovarian cancer (n = 20) showed excellent correlation (R(2) = 0.97) with gold-standard ELISA. Building on the integration capabilities of novel microfluidic systems programmed for ovarian cancer, the rapid, precise, and sensitive miniaturized p-BNC system shows strong promise for ovarian cancer diagnostics. PMID:22490510

  10. Comparison of methods for monitoring residual platelet reactivity after clopidogrel by point-of-care tests on whole blood in high-risk patients.

    PubMed

    Paniccia, Rita; Antonucci, Emilia; Maggini, Niccolò; Miranda, Marco; Gori, Anna Maria; Marcucci, Rossella; Giusti, Betti; Balzi, Daniela; Prisco, Domenico; Abbate, Rosanna

    2010-08-01

    Cardiovascular events are more frequent in high-risk coronary artery disease (CAD) patients on dual antiplatelet therapy with a residual platelet reactivity (RPR) than in those showing inhibition of ADP-inducible platelet activation. It is known that post-interventional RPR is a clinically important entity confirming it as a risk factor for thrombo-ischaemic events. Multiple electrode platelet aggregometry (MEA) on whole blood has been recently proposed as a rapid tool to evaluate RPR in high-risk CAD patients on clopidogrel therapy. It was the aim of this study to detect RPR in 801 high-risk CAD patients on dual antiplatelet therapy comparing MEA with the VerifyNow P2Y12 assay on whole blood and classical light transmission aggregation (LTA) on platelet-rich plasma. ADP (10 microM) was employed as agonist for MEA and LTA. The prevalence of RPR was 20.6% by MEA, 16.1% by LTA and 30.8% by VerifyNow. MEA showed a significant correlation (rho=0.62, p<0.0001) with VerifyNow and a moderate agreement (k=0.52, p<0.001) with 81.5% of concordant values. A significant correlation was found between MEA and LTA (rho=0.71, p<0.001) with a good agreement (k=0.63, p<0.001) and 88.8% of concordant values. MEA in relation to LTA showed a sensitivity of 80% and a specificity of 91%. MEA might represent a reliable method and valid alternative in comparison with other available platelet function assays. It might help to guide antiplatelet therapy and thus improve clinical outcome of high-risk CAD patients. PMID:20458439

  11. Testing bio-chips

    Microsoft Academic Search

    K. Chakrabarty

    2009-01-01

    Dependability is an essential attribute for microfluidic biochips that are being developed for safety-critical applications such as point-of-care health assessment, air-quality monitoring, and food-safety testing. Therefore, these devices must be adequately tested after manufacture and during bioassay operations. This paper describes testing and diagnosis techniques for droplet-based \\

  12. Polymeric LabChip Real-Time PCR as a Point-of-Care-Potential Diagnostic Tool for Rapid Detection of Influenza A/H1N1 Virus in Human Clinical Specimens

    PubMed Central

    Song, Hyun-Ok; Kim, Je-Hyoung; Ryu, Ho-Sun; Lee, Dong-Hoon; Kim, Sun-Jin; Kim, Deog-Joong; Suh, In Bum; Choi, Du Young; In, Kwang-Ho; Kim, Sung-Woo; Park, Hyun

    2012-01-01

    It is clinically important to be able to detect influenza A/H1N1 virus using a fast, portable, and accurate system that has high specificity and sensitivity. To achieve this goal, it is necessary to develop a highly specific primer set that recognizes only influenza A viral genes and a rapid real-time PCR system that can detect even a single copy of the viral gene. In this study, we developed and validated a novel fluidic chip-type real-time PCR (LabChip real-time PCR) system that is sensitive and specific for the detection of influenza A/H1N1, including the pandemic influenza strain A/H1N1 of 2009. This LabChip real-time PCR system has several remarkable features: (1) It allows rapid quantitative analysis, requiring only 15 min to perform 30 cycles of real-time PCR. (2) It is portable, with a weight of only 5.5 kg. (3) The reaction cost is low, since it uses disposable plastic chips. (4) Its high efficiency is equivalent to that of commercially available tube-type real-time PCR systems. The developed disposable LabChip is an economic, heat-transferable, light-transparent, and easy-to-fabricate polymeric chip compared to conventional silicon- or glass-based labchip. In addition, our LabChip has large surface-to-volume ratios in micro channels that are required for overcoming time consumed for temperature control during real-time PCR. The efficiency of the LabChip real-time PCR system was confirmed using novel primer sets specifically targeted to the hemagglutinin (HA) gene of influenza A/H1N1 and clinical specimens. Eighty-five human clinical swab samples were tested using the LabChip real-time PCR. The results demonstrated 100% sensitivity and specificity, showing 72 positive and 13 negative cases. These results were identical to those from a tube-type real-time PCR system. This indicates that the novel LabChip real-time PCR may be an ultra-fast, quantitative, point-of-care-potential diagnostic tool for influenza A/H1N1 with a high sensitivity and specificity. PMID:23285281

  13. Accuracy of point-of-care ultrasound for identifying fractures in patients with orthopaedic trauma presenting to emergency department of the All India Institute of Medical Sciences, level 1 trauma centre

    Microsoft Academic Search

    Tej Prakash Sinha; Sudeep Kumar; Sanjeev Bhoi; Ankur Goswami; Amit Bhasin; Radhakrishna Ramchandani; Mahaveer Singh Rodha; Vinay Gulati

    Background  Radiography is the standard observation tool for examining orthopaedic injuries. Point-of-care ultrasonography may thus be\\u000a a faster, non-invasive alternative to effectively identify bone fractures in the emergency department (ED) setting. The study\\u000a compares the diagnostic utilities of BUS and radiography for identifying long bone fractures.\\u000a \\u000a \\u000a \\u000a \\u000a Methods  Prospective observation study with convenience sampling was conducted in ED in patients above 5 years, with

  14. Academic College of Emergency Experts in India's INDO-US Joint Working Group and OPUS12 Foundation Consensus Statement on Creating A Coordinated, Multi-Disciplinary, Patient-Centered, Global Point-of-Care Biomarker Discovery Network

    PubMed Central

    Stawicki, Stanislaw P.; Stoltzfus, Jill C.; Aggarwal, Praveen; Bhoi, Sanjeev; Bhatt, Shashi; Kalra, O. P.; Bhalla, Ashish; Hoey, Brian A.; Galwankar, Sagar C.; Paladino, Lorenzo; Papadimos, Thomas J.

    2014-01-01

    Biomarker science brings great promise to clinical medicine. This is especially true in the era of technology miniaturization, rapid dissemination of knowledge, and point-of-care (POC) implementation of novel diagnostics. Despite this tremendous progress, the journey from a candidate biomarker to a scientifically validated biomarker continues to be an arduous one. In addition to substantial financial resources, biomarker research requires considerable expertise and a multidisciplinary approach. Investigational designs must also be taken into account, with the randomized controlled trial remaining the “gold standard”. The authors present a condensed overview of biomarker science and associated investigational methods, followed by specific examples from clinical areas where biomarker development and/or implementation resulted in tangible enhancements in patient care. This manuscript also serves as a call to arms for the establishment of a truly global, well-coordinated infrastructure dedicated to biomarker research and development, with focus on delivery of the latest discoveries directly to the patient via point-of-care technology. PMID:25337481

  15. Disparities in CD4+ T-Lymphocyte Monitoring Among Human Immunodeficiency Virus-Positive Medicaid Beneficiaries: Evidence of Differential Treatment at the Point of Care

    PubMed Central

    Davis, Anna C.; Watson, Greg; Pourat, Nadereh; Kominski, Gerald F.; Roby, Dylan H.

    2014-01-01

    Background ?Monitoring of immune function, measured by CD4+ T-lymphocyte (CD4) cell count, is an essential service for people with human immunodeficiency virus (HIV). Prescription of antiretroviral (ARV) medications is contingent on CD4 cell count; patients without regular CD4 monitoring are unlikely to receive ARVs when indicated. This study assesses disparities in CD4 monitoring among HIV-positive Medicaid beneficiaries. Methods ?In this retrospective observational study, we examined 24 months of administrative data on 2250 HIV-positive, continuously enrolled, fee-for-service, Medicaid beneficiaries with at least 2 outpatient healthcare encounters. We used logistic regression to evaluate the association of patient demographics (age, gender, race or ethnicity, and language) with receipt of at least 1 CD4 test per year, controlling for other potentially confounding variables. Results ?Having a history of ARV therapy was positively associated with receipt of CD4 tests. We found racial or ethnic, gender, and age disparities in CD4 testing. Among individuals with a history of ARV use, all racial or ethnic groups were significantly less likely to have CD4 tests than White non-Latinos (African Americans, odds ratio [OR] = 0.35, P < .0001; Asian or Pacific Islanders, OR = 0.31, P = .0047; and Latinos, OR = 0.42, P < .0001). Conclusions ?We identified disparities in receipt of CD4 tests, a finding that may elucidate one potential pathway for previously reported disparities in ARV treatment. Further qualitative and quantitative research is needed to identify the specific factors that account for these disparities, so that appropriate interventions can be implemented. PMID:25401120

  16. Epidemiological characteristics, clinical presentation and diagnosis at point-of-care during the first wave of the H1N1 influenza pandemic in Cambodia.

    PubMed

    Yasuda, Chadwick; Sovann, Ly; Kasper, Matthew; Williams, Maya; Wierzba, Thomas F

    2012-01-01

    We conducted clinic-based surveillance for influenza virus among cases with acute febrile illness at 9 medical clinics in south-central Cambodia during 2006-2009. Patients greater than or equal to 24 months old presenting with acute fever (> 38 degrees C) were enrolled. In late July 2009, the study identified its first case of pandemic H1N1 (pH1N1) influenza virus infection. The prevalence of pH1N1 infections increased rapidly during August and September and by October, pH1N1 infections had peaked replacing H3N2 as the dominant subtype. The incidence of pH1N1 subsequently decreased, with only one case identified in late December. From late July through December 2009, 42.4% of all influenza cases were caused by pH1N1. Except for headache, less frequently reported among pH1N1-infected patients, patients infected with the pH1N1 reported symptoms (eg, cough, diarrhea, vomiting and nausea) similar to seasonal H3N2 and B virus infections. Among children 6 to 12 years old, there was a higher number of hospitalizations campared to other age groups. Identification of influenza virus types A and B using the QuickVue rapid diagnostic test was found to be equally sensitive for pH1N1 (50.4%), H3N2 (51.7%) and influenza B (53.9%) viruses, although the sensitivity was low among all subtypes. The pH1N1 virus rapidly became the dominant virus subtype in 2009 in Cambodia, but no symptoms consistently distinguished the pandemic strain from other influenza virus subtypes. The QuickVue test was as sensitive for detecting pH1N1 viral as well as other circulating seasonal influenza viruses. PMID:23082556

  17. Holographic Point-of-Care Diagnostic Devices

    E-print Network

    Yetisen, Ali Kemal

    2014-11-29

    Glucose Sensor Readouts. . . . . . . . . . . . 110 5.5.2 Holographic Glucose Sensor Readouts in Artificial Urine . . . . . . . . . . . . . . . . . . . . . . . . . . 112 5.5.3 Lactate and Fructose Interference . . . . . . . . . . . . . . . 115 5... . . . . . . . . . . . . . . . . . . . . . . . . . . 118 xii Contents 5.6 Kinetic Theory for Hydrogel Swelling . . . . . . . . . . . . . . . . . . 120 5.7 Quantification of Glucose Concentration in Urine . . . . . . . . . . 122 5.8 Lactate and Fructose Interference...

  18. Point of care ultrasound strikes again.

    PubMed

    Ockerse, P; Mallin, M

    2014-11-01

    The article by Vohra and colleagues, "Sonographic Signs of Snakebites", is reviewed and offers a novel use of ultrasound to assess the severity of soft tissue injury due to crotaline envenomation. The authors have shown the feasibility and potential utility of this modality. Further studies are needed to determine the true value of these sonographic findings and how to apply them to patient care. PMID:25345434

  19. To Test or to Treat? An Analysis of Influenza Testing and Antiviral Treatment Strategies Using Economic Computer Modeling

    PubMed Central

    Lee, Bruce Y.; McGlone, Sarah M.; Bailey, Rachel R.; Wiringa, Ann E.; Zimmer, Shanta M.; Smith, Kenneth J.; Zimmerman, Richard K.

    2010-01-01

    Background Due to the unpredictable burden of pandemic influenza, the best strategy to manage testing, such as rapid or polymerase chain reaction (PCR), and antiviral medications for patients who present with influenza-like illness (ILI) is unknown. Methodology/Principal Findings We developed a set of computer simulation models to evaluate the potential economic value of seven strategies under seasonal and pandemic influenza conditions: (1) using clinical judgment alone to guide antiviral use, (2) using PCR to determine whether to initiate antivirals, (3) using a rapid (point-of-care) test to determine antiviral use, (4) using a combination of a point-of-care test and clinical judgment, (5) using clinical judgment and confirming the diagnosis with PCR testing, (6) treating all with antivirals, and (7) not treating anyone with antivirals. For healthy younger adults (<65 years old) presenting with ILI in a seasonal influenza scenario, strategies were only cost-effective from the societal perspective. Clinical judgment, followed by PCR and point-of-care testing, was found to be cost-effective given a high influenza probability. Doubling hospitalization risk and mortality (representing either higher risk individuals or more virulent strains) made using clinical judgment to guide antiviral decision-making cost-effective, as well as PCR testing, point-of-care testing, and point-of-care testing used in conjunction with clinical judgment. For older adults (?65 years old), in both seasonal and pandemic influenza scenarios, employing PCR was the most cost-effective option, with the closest competitor being clinical judgment (when judgment accuracy ?50%). Point-of-care testing plus clinical judgment was cost-effective with higher probabilities of influenza. Treating all symptomatic ILI patients with antivirals was cost-effective only in older adults. Conclusions/Significance Our study delineated the conditions under which different testing and antiviral strategies may be cost-effective, showing the importance of accuracy, as seen with PCR or highly sensitive clinical judgment. PMID:20585642

  20. Bedside ultrasonography (US), Echoscopy and US point of care as a new kind of stethoscope for Internal Medicine Departments: the training program of the Italian Internal Medicine Society (SIMI).

    PubMed

    Arienti, Vincenzo; Di Giulio, Rosella; Cogliati, Chiara; Accogli, Esterita; Aluigi, Leonardo; Corazza, Gino Roberto

    2014-10-01

    In recent years, thanks to the development of miniaturized ultrasound devices, comparable to personal computers, tablets and even to smart phones, we have seen an increasing use of bedside ultrasound in internal medicine departments as a novel kind of ultrasound stethoscope. The clinical ultrasound-assisted approach has proved to be particularly useful in assessing patients with nodules of the neck, dyspnoea, abdominal pain, and with limb edema. In several cases, it has allowed a simple, rapid and precise diagnosis. Since 2005, the Italian Society of Internal Medicine and its Ultrasound Study Group has been holding a Summer School and training courses in ultrasound for residents in internal medicine. A national network of schools in bedside ultrasound was then organized for internal medicine specialists who want to learn this technique. Because bedside ultrasound is a user-dependent diagnostic method, it is important to define the limits and advantages of different new ultrasound devices, to classify them (i.e. Echoscopy and Point of Care Ultrasound), to establish appropriate different levels of competence and to ensure their specific training. In this review, we describe the point of view of the Italian Internal Medicine Society on these topics. PMID:25145290

  1. Functional testing of digital microfluidic biochips

    Microsoft Academic Search

    Tao Xu; Krishnendu Chakrabarty

    2007-01-01

    Dependability is an important attribute for microfluidic biochips that are used for safety-critical applications such as point-of-care health assessment, air-quality monitoring, and food-safety testing. Therefore, these devices must be adequately tested after manufacture and during bioassay operations. Known techniques for biochip testing are all function-oblivious, i.e., while they can detect and locate defect sites on a microfluidic array, they cannot

  2. A portable instrument for the optical interrogation of a novel biochip

    NASA Astrophysics Data System (ADS)

    Baldini, F.; Bolzoni, L.; Giannetti, A.; Porro, G.; Trono, C.

    2010-09-01

    In the present paper a novel optical system for the monitoring and measurements of different analytes in Point of Care Testing (POCT) is presented. It is based on an optical biochip constituted by a two-piece polymethylmetacrylate (PMMA) chip, with 13 microchannels through which the analysed sample flows, and the sensing layer, where the immunochemical reaction takes place, is located on the bottom side of the upper piece of the PMMA chip. All the electronics, optoelectronics and fluidics components are embedded in a portable instrument is totally controlled by software. Preliminary tests on C-reactive protein (CRP) and procalcitonin (PCT) immunoassay are reported.

  3. System-on-fluidics immunoassay device integrating wireless radio-frequency-identification sensor chips.

    PubMed

    Yazawa, Yoshiaki; Oonishi, Tadashi; Watanabe, Kazuki; Shiratori, Akiko; Funaoka, Sohei; Fukushima, Masao

    2014-09-01

    A simple and sensitive point-of-care-test (POCT) device for chemiluminescence (CL) immunoassay was devised and tested. The device consists of a plastic flow-channel reactor and two wireless-communication sensor chips, namely, a photo-sensor chip and a temperature-sensor chip. In the flow-channel reactor, a target antigen is captured by an antibody immobilized on the inner wall of the flow-channel and detected with enzyme labeled antibody by using CL substrate. The CL signal corresponding to the amount of antigen is measured by a newly developed radio-frequency-identification (RFID) sensor, which enables batteryless operation and wireless data communication with an external reader. As for the POCT device, its usage environment, especially temperature, varies for each measurement. Hence, temperature compensation is a key issue in regard to eliminating dark-signal fluctuation, which is a major factor in deterioration of the precision of the POCT device. A two-stage temperature-compensation scheme was adopted. As for the first stage, the signals of two photodiodes, one with an open window and one with a sealed window, integrated on the photo-sensor chip are differentiated to delete the dark signal. As for the second stage, the differentiated signal fluctuation caused by a temperature variation is compensated by using the other sensor chip (equipped with a temperature sensor). The dark-level fluctuation caused by temperature was reduced from 0.24 to 0.02 pA/°C. The POCT device was evaluated as a CL immunoassay of thyroid-stimulating hormone (TSH). The flow rate of the CL reagent in the flow channel was optimized. As a result, the detection limit of the POCT device was 0.08 ng/ml (i.e., 0.4 ?IU/ml). PMID:24735652

  4. Immunoassay in healthcare testing applications.

    PubMed

    DePriest, Anne Z; Black, David L; Robert, Timothy A

    2015-01-01

    Immunoassay is used extensively for drug testing in pain management. Drug testing for the purpose of compliance monitoring is fundamentally different from forensic applications, which may rely on immunoassay screening to rapidly identify "negative" samples. In clinical settings, focus is shifted from identification of select drugs of abuse with low positivity rates to detection of a wide variety of licit and illicit compounds with expected high positivity rates. The primary drug classes of interest in this population, opioids and benzodiazepines, require special testing considerations when immunoassay is used. This review highlights the performance characteristics of immunoassay, with special emphasis on prescription drug classes and testing at the point-of-care. PMID:25750161

  5. Fault Modeling and Functional Test Methods for Digital Microfluidic Biochips

    Microsoft Academic Search

    Tao Xu; Krishnendu Chakrabarty

    2009-01-01

    Dependability is an important attribute for microfluidic biochips that are used for safety-critical applications, such as point-of-care health assessment, air-quality monitoring, and food-safety testing. Therefore, these devices must be adequately tested after manufacture and during bioassay operations. Known techniques for biochip testing are all function oblivious (i.e., while they can detect and locate defect sites on a microfluidic array, they

  6. Clinical Evaluation of the OneStep Gonorrhea RapiCard InstaTest for Detection of Neisseria gonorrhoeae in Symptomatic Patients from KwaZulu-Natal, South Africa.

    PubMed

    Abbai, N S; Moodley, P; Reddy, T; Zondi, T G; Rambaran, S; Naidoo, K; Ramjee, G

    2015-04-01

    We evaluated a point-of-care test for the detection of Neisseria gonorrhoeae in patients attending a public health clinic in KwaZulu-Natal, South Africa. The test showed a low sensitivity against PCR and culture (<40%); however, a higher specificity was observed (>95%). This test is unsuitable as a screening tool for gonorrhea. PMID:25609726

  7. Escherichia coli counting using lens-free imaging for sepsis diagnosis

    NASA Astrophysics Data System (ADS)

    Moon, Sangjun; Manzur, Fahim; Manzur, Tariq; Klapperich, Catherine; Demirci, Utkan

    2009-09-01

    Sepsis causes 9.3% of overall deaths in United States. To diagnose sepsis, cell/bacteria capture and culturing methods have been widely investigated in the medical field. Escherichia Coli (E. Coli) is used as a model organism for sepsis in blood stream since wide variety of antibodies are established and the genetic modification process is well documented for fluorescent tagging. In point-of-care testing applications, the sepsis diagnostics require fast monitoring, inexpensive testing, and reliable results at resource limited settings, i.e. battle field, home care for dialysis. However, the cell/E.coli are hard to directly capture and see at the POCT because of the small size, 2 ?m long and 0.5 ?m in diameter, and the bacteria are rare in the blood stream in sepsis. Here, we propose a novel POCT platform to image and enumerate cell/E.coli on a microfluidic surface to diagnose sepsis at resource limited conditions. We demonstrate that target cells are captured from 5 ?l of whole blood using specific antibodies and E.coli are imaged using a lens-free imaging platform, 2.2 ?m pixel CMOS based imaging sensor. This POCT cell/bacteria capture and enumeration approach can further be used for medical diagnostics of sepsis. We also show approaches to rapidly quantify white blood cell counts from blood which can be used to monitor immune response.

  8. Significant roadblocks exist in developing sputum sample libraries for clinical validation of novel in vitro diagnostics.

    PubMed

    Dollow, Joshua M; Green, Justin A

    2014-01-01

    With the continuing rise of multiresistant pathogens, reliable, cost-effective, and novel diagnostics are urgently required by clinicians and clinical trialists to diagnose conditions such as respiratory tract infections to enable rational antimicrobial choice and enhance clinical outcomes. However, during product development, validation of these in vitro diagnostic devices, a key regulatory hurdle, requires sputum samples in large numbers. The Rapid Point-of-Care test Platform for Infectious Diseases (RAPP-ID) consortium is tasked with producing point of care test (POCT) platforms for rapid diagnosis of lower respiratory tract infections, including tuberculosis and blood stream infections. Validation of diagnostic platforms would ideally use well-characterized samples in a sputum library taken from a range of clinical settings to allow for a wide panel of pathogens to be assessed. These samples would be stored in specific stable conditions (monitored temperature, specific medium) until required for validation. Therefore we reviewed the current literature for details of storage conditions of sputum samples and for previous validation studies of other diagnostic tests using this methodology. However, we conclude that little data exists, and thus the acquisition and successful storage of good quality clinical samples are major roadblocks in the validation of novel POCT platforms, and that while not without limitations, spiked sputum samples appear the best solution until sputum library laboratory techniques allowing careful preservation of pathogens are improved. PMID:24489460

  9. The benefits of a rapid, point-of-care "TnI-Only" zero and 2-hour protocol for the evaluation of chest pain patients in the Emergency Department.

    PubMed

    Blick, Kenneth E

    2014-03-01

    Delays in diagnosis and treatment of cardiac patients presenting in the Emergency Department with symptoms of acute coronary syndromes are associated with poorer patient outcomes; hence, the timely and accurate diagnosis in the Emergency Department now requires the 24/7 availability of real-time, rapid testing for cardiac markers. Cardiac troponin (cTnI) has emerged as the biomarker of choice to aid physicians in the diagnosis of acute myocardial infarction and moreover current guidelines call for cTnI results to be available to clinicians within 60 minutes of blood draw each and every time a cTnI is ordered. PMID:24507788

  10. Towards a “Sample-In, Answer-Out” Point-of-Care Platform for Nucleic Acid Extraction and Amplification: Using an HPV E6/E7 mRNA Model System

    PubMed Central

    Gulliksen, Anja; Keegan, Helen; Martin, Cara; O'Leary, John; Solli, Lars A.; Falang, Inger Marie; Grønn, Petter; Karlgård, Aina; Mielnik, Michal M.; Johansen, Ib-Rune; Tofteberg, Terje R.; Baier, Tobias; Gransee, Rainer; Drese, Klaus; Hansen-Hagge, Thomas; Riegger, Lutz; Koltay, Peter; Zengerle, Roland; Karlsen, Frank; Ausen, Dag; Furuberg, Liv

    2012-01-01

    The paper presents the development of a “proof-of-principle” hands-free and self-contained diagnostic platform for detection of human papillomavirus (HPV) E6/E7 mRNA in clinical specimens. The automated platform performs chip-based sample preconcentration, nucleic acid extraction, amplification, and real-time fluorescent detection with minimal user interfacing. It consists of two modular prototypes, one for sample preparation and one for amplification and detection; however, a common interface is available to facilitate later integration into one single module. Nucleic acid extracts (n = 28) from cervical cytology specimens extracted on the sample preparation chip were tested using the PreTect HPV-Proofer and achieved an overall detection rate for HPV across all dilutions of 50%–85.7%. A subset of 6 clinical samples extracted on the sample preparation chip module was chosen for complete validation on the NASBA chip module. For 4 of the samples, a 100% amplification for HPV 16 or 33 was obtained at the 1?:?10 dilution for microfluidic channels that filled correctly. The modules of a “sample-in, answer-out” diagnostic platform have been demonstrated from clinical sample input through sample preparation, amplification and final detection. PMID:22235204

  11. GeneXpert Testing: Applications for Clinical Microbiology, Part II

    Microsoft Academic Search

    Elizabeth M. Marlowe; Donna M. Wolk

    2008-01-01

    The impact of rapid polymerase chain reaction (PCR) technology on infectious-disease testing is continuing to evolve outside the realm of a centralized laboratory. The GeneXpert Dx system is the first unit dose, near-point-of-care, molecular device commercially available. Part I of this two-part article addressed the use of the GeneXpert system for the detection of group B Streptococcus, enterovirus, and methicillin-resistant

  12. GeneXpert Testing: Applications for Clinical Microbiology, Part I

    Microsoft Academic Search

    Elizabeth M. Marlowe; Donna M. Wolk

    2008-01-01

    The impact of rapid polymerase chain reaction (PCR) technology on infectious disease testing is continuing to evolve outside the realm of a centralized laboratory. The GeneXpert Dx system is the first unit dose, near-point-of-care molecular device commercially available. To date, there are five FDA-cleared assays available for the GeneXpert System: group B Streptococcus (GBS) from vaginal-rectal swabs, enterovirus from cerebrospinal

  13. Point-of-care technology: a new perspective.

    PubMed

    Simpson, R L

    1997-08-01

    Technology advances transform the staff nurses' work processes. Most importantly, however, they provide the potential to help nurses do what they've always wanted to do--spend more time with the patient, delivering nursing care. The nurse who has the tablet personal computer or "cart" computer right at hand can capture all the information that needs to be captured. Thus, the nurse executive has a greater body of automated information and data upon which to make managerial decisions. PMID:9325943

  14. Point-of-care colorimetric detection with a smartphone.

    PubMed

    Shen, Li; Hagen, Joshua A; Papautsky, Ian

    2012-11-01

    Paper-based immunoassays are becoming powerful and low-cost diagnostic tools, especially in resource-limited settings. Inexpensive methods for quantifying these assays have been shown using desktop scanners, which lack portability, and cameras, which suffer from the ever changing ambient light conditions. In this work, we introduce a novel approach of quantifying colors of colorimetric diagnostic assays with a smartphone that allows high accuracy measurements in a wide range of ambient conditions, making it a truly portable system. Instead of directly using the red, green, and blue (RGB) intensities of the color images taken by a smartphone camera, we use chromaticity values to construct calibration curves of analyte concentrations. We demonstrate the high accuracy of this approach in pH measurements with linear response ranges of 1-12. These results are comparable to those reported using a desktop scanner or silicon photodetectors. To make the approach adoptable under different lighting conditions, we developed a calibration technique to compensate for measurement errors due to variability in ambient light. This technique is applicable to a number of common light sources, such as sun light, fluorescent light, or smartphone LED light. Ultimately, the entire approach can be integrated in an "app" to enable one-click reading, making our smartphone based approach operable without any professional training or complex instrumentation. PMID:22996728

  15. Modular microfluidics for point-of-care protein purifications.

    PubMed

    Millet, L J; Lucheon, J D; Standaert, R F; Retterer, S T; Doktycz, M J

    2015-03-31

    Biochemical separations are the heart of diagnostic assays and purification methods for biologics. On-chip miniaturization and modularization of separation procedures will enable the development of customized, portable devices for personalized health-care diagnostics and point-of-use production of treatments. In this report, we describe the design and fabrication of miniature ion exchange, size exclusion and affinity chromatography modules for on-chip clean-up of recombinantly-produced proteins. Our results demonstrate that these common separations techniques can be implemented in microfluidic modules with performance comparable to conventional approaches. We introduce embedded 3-D microfluidic interconnects for integrating micro-scale separation modules that can be arranged and reconfigured to suit a variety of fluidic operations or biochemical processes. We demonstrate the utility of the modular approach with a platform for the enrichment of enhanced green fluorescent protein (eGFP) from Escherichia coli lysate through integrated affinity and size-exclusion chromatography modules. PMID:25740172

  16. Point-of-Care Diagnostics for the Developing World

    NSDL National Science Digital Library

    The University of Washington's "UWTV" website is an archive of talks by visitors to the University as well as professors, librarians, and others who have a formal association with the institution. The talks cover a myriad of topics from urban planning to zoology, and this specific talk looks into the world of health care provisioning in the developing world. The talk is by Professor Paul Yager of the bioengineering department at the UW, and he offers information and findings about a new technology for manipulating small volumes of fluids. This technology will help health care professionals as they work to create a small portable and inexpensive system for detecting pathogens far from any centralized laboratory. It's an engaging hour-long talk, and one that will be of interest to persons in the health care and public health fields.

  17. Point of Care Diagnostics for the Developing World Video

    NSDL National Science Digital Library

    Nancy Maizels (University of Washington; University of Washington Molecular Medicine Trainging program)

    2010-05-28

    This hour-long video from the University of Washingtonâ??s Molecular Medicine Training Program explains microfluidicsâ??a technology for manipulating small volumes of fluid that could have a major impact on global health by enabling the development of a portable and inexpensive system for detecting pathogens.

  18. Mother-Child Conflict and Sibling Relatedness: A Test of Hypotheses from Parent-Offspring Conflict Theory

    ERIC Educational Resources Information Center

    Schlomer, Gabriel L.; Ellis, Bruce J.; Garber, Judy

    2010-01-01

    Parent-offspring conflict theory (POCT) has been underutilized in studies of human family dynamics. An implication of POCT is that the presence of siblings will increase conflict in biological parent-child dyads, and that half siblings will increase that conflict more than full siblings. Evidence consistent with this prediction was found in a…

  19. In vitro comparison of the effect of heparin, enoxaparin and fondaparinux on tests of coagulation

    Microsoft Academic Search

    Lori-Ann Linkins; Jim A Julian; Janice Rischke; Jack Hirsh; Jeffrey I Weitz

    2002-01-01

    Low-molecular weight heparin (LMWH) is increasingly used in place of unfractionated heparin (UFH) in patients with unstable angina, and phase II clinical trials using fondaparinux for this indication are underway. Because unstable angina patients often require urgent percutaneous coronary interventions (PCI) or aortocoronary bypass surgery, a point-of-care test is needed to monitor the anticoagulant effect of these agents. The activated

  20. Handheld and portable test systems for decentralized testing: from lab to marketplace

    NASA Astrophysics Data System (ADS)

    Faulstich, Konrad; Haberstroh, Klaus

    2009-05-01

    Emergency Diagnostics, Homeland Security, Epidemiological Preparedness and the high cost of the Health Care Systems have increased demand for affordable and mobile point of care (POC) devices with highest sensitivity, specificity and rapid time to result. We have developed pocket and brief case sized systems for point of care and field based tests based on fluorescence read-out. The core consists of battery operated, 90 gram electro-optical units with optional wireless data transfer, which have been optimized to achieve highest accuracy and sensitivity combined with simplicity of use. The robust systems have been applied to molecular diagnostics such as DNA based testing, immunodiagnostics as well as environmental monitoring and agricultural testing. Starting with the current bottlenecks of in-vitro diagnostics testing and a brief market overview, we will show commercially available portable test systems for molecular diagnostics and how we solve the current bottlenecks. We will further show battery operated handheld prototypes for DNA testing. ESE's handheld and portable testing platforms have been shown to provide sensitive, accurate, and specific results, as well as rapid turnaround. The stand-alone devices demonstrate operational and physical robustness, and they can be manufactured to be affordable.

  1. [In Process Citation].

    PubMed

    Risch, Lorenz; Senn, Oliver

    2015-02-01

    Point of care testing (POCT) allows, among others, for efficient care of patients presenting with acute problems to primary care physicians. A combination of clinical information and laboratory results enables physicians to obtain posttest probabilities for the presence or absence of a specific disease. In order to rule in or rule out a disease, the physician has to know both the pretest probability for a disease in a patient as well as the analytical and diagnostic characteristics of the employed test. Pretest probability can be assessed by scores or by personal judgment of the experienced clinician. This article presents the basics of the Bayes theorem together with its clinical applications in acute scenarios in primary health care. These scenarios comprise the use of D-Dimer testing in ruling out venous thromboembolism, rapid testing of group A streptococci in the setting of acute pharyngitis, troponin testing in patients with thoracic pain, c-reactive protein (CRP) testing in patients presenting with acute cough and fever, as well as urine dipstick testing in suspected urinary tract infection. These examples illustrate, that risk stratification before conducting laboratory analysis is of utmost importance in order to obtain valid results for ruling in or ruling out diseases in POCT-settings. PMID:25630292

  2. Meeting the challenges of globalisation and miniaturisation in laboratory services.

    PubMed

    Melo, Murilo R; Rosenfeld, Luiz Gastão

    2007-12-01

    In the recent years, two trends emerged in the clinical laboratory: the miniaturisation of equipments to provide point-of-care testing (POCT) and a concentration of laboratories through mergers and acquisitions. New technology has expanded both opportunities. POCT provides the benefit of a convenient test where it is needed, i.e. near the patient. For companies, it is easier and cheaper to develop such tests, since technical requirements are somewhat less stringent, being an interesting area for start-ups. Nanotechnology is one of the most fascinating technical advances, with some advocating a US$1 trillion market-size for it by 2015. Laboratory tests and biomaterials will probably be greatly influenced by it, with new approaches for molecular diagnosis, with tests that can target both DNA and proteins in a process that eliminates PCR and allows multiplex analysis. On the other hand, there is a strong trend towards the globalisation of clinical laboratories and that occurs in four areas: a) Consumption of health services abroad; b) Movement of Health Personnel; c) Cross-Border delivery of trade; and d) Commercial presence. Each of these areas presents new challenges and opportunities for clinical laboratories, what will certainly shape the way we work today and in the future. PMID:19108396

  3. Express Testing Makes for More Effective Vet Visit

    NASA Technical Reports Server (NTRS)

    2003-01-01

    This paper presents a discussion on Vetscan, a system designed to provide veterinarians with instant diagnostic information needed for rapid treatment decisions. VetScan is designed for point-of-care testing in any treatment setting, including mobile environments, where veterinarians can operate the analyzer from a car-lighter adapter. A full range of tests is available for almost every species normally treated by veterinarians, including cats, dogs, birds, reptiles, and large animals, such as those in the equine and bovine families.

  4. HIV testing in developing countries: what is required?

    PubMed

    Alemnji, George; Nkengasong, John N; Parekh, Bharat S

    2011-12-01

    HIV diagnostic and follow up testing are usually done in laboratory settings. However, in developing countries there is a need to decentralize testing as the majority of the population lives in rural settings. In developing countries stringent quality assurance (QA) practices, which include appropriate training, development of standard operating procedures, maintenance of operator proficiency, routine use of quality control (QC) specimens, standardized data management, equipment calibration and maintenance, and biohazard safety with proper disinfection/disposal procedures are not routinely followed to ensure reliability of results and a safe work environment. The introduction of point-of-care testing technologies involving the use of non-laboratorians in routine testing has further increased the complexity of QA. Therefore, a careful approach towards improvement of laboratories that encourages best practices, coupled with incentives, and review of government policies in point-of-care testing is needed to improve quality of testing as decentralization takes place. Development of a functional laboratory tiered network that facilitates communication, referral, training and problem solving could further enhance confidence in laboratory testing. There is also a need for special considerations in implementing a step-wise approach towards quality improvement, strengthening of the supply chain management, human capacity development, infrastructure upgrade, and strong public private partnerships to ensure long term sustainability of these efforts. PMID:22310813

  5. Evaluation of up-converting phosphor technology-based lateral flow strips for rapid detection of Bacillus anthracis Spore, Brucella spp., and Yersinia pestis.

    PubMed

    Zhang, Pingping; Liu, Xiao; Wang, Chengbin; Zhao, Yong; Hua, Fei; Li, Chunfeng; Yang, Ruifu; Zhou, Lei

    2014-01-01

    Bacillus anthracis, Brucella spp., and Yersinia pestis are zoonotic pathogens and biowarfare- or bioterrorism-associated agents that must be detected rapidly on-site from various samples (e.g., viscera and powders). An up-converting phosphor technology-based lateral flow (UPT-LF) strip was developed as a point-of-care testing (POCT) to satisfy the requirements of first-level emergency response. We developed UPT-LF POCT to quantitatively detect the three pathogens within 15 min. Sample and operation-error tolerances of the assay were comprehensively evaluated. The sensitivity of UPT-LF assay to bacterial detection reached 10(4) cfu · mL(-1) (100 cfu/test), with a linear quantitative range of 4 to 6 orders of magnitude. Results revealed that the UPT-LF assay exhibited a high specificity with the absence of false-positive results even at 10(9) cfu · mL(-1) of non-specific bacterial contamination. The assay could tolerate samples with a wide pH range (2 to 12), high ion strengths (? 4 mol · L(-1) of NaCl), high viscosities (? 25 mg · mL(-1) of PEG20000 or ? 20% of glycerol), and high concentrations of bio-macromolecule (? 200 mg · mL(-1) of bovine serum albumin or ? 80 mg · mL(-1) of casein). The influence of various types of powders and viscera (fresh and decomposed) on the performance of UPT-LF assay was determined. The operational error of liquid measurement exhibited few effects on sensitivity and specificity. The developed UPT-LF POCT assay is applicable under field conditions with excellent tolerance to sample complexity and operational error. PMID:25144726

  6. Evaluation of Up-Converting Phosphor Technology-Based Lateral Flow Strips for Rapid Detection of Bacillus anthracis Spore, Brucella spp., and Yersinia pestis

    PubMed Central

    Zhao, Yong; Hua, Fei; Li, Chunfeng; Yang, Ruifu; Zhou, Lei

    2014-01-01

    Bacillus anthracis, Brucella spp., and Yersinia pestis are zoonotic pathogens and biowarfare- or bioterrorism-associated agents that must be detected rapidly on-site from various samples (e.g., viscera and powders). An up-converting phosphor technology-based lateral flow (UPT–LF) strip was developed as a point-of-care testing (POCT) to satisfy the requirements of first-level emergency response. We developed UPT–LF POCT to quantitatively detect the three pathogens within 15 min. Sample and operation-error tolerances of the assay were comprehensively evaluated. The sensitivity of UPT–LF assay to bacterial detection reached 104 cfu·mL?1 (100 cfu/test), with a linear quantitative range of 4 to 6 orders of magnitude. Results revealed that the UPT–LF assay exhibited a high specificity with the absence of false-positive results even at 109 cfu·mL?1 of non-specific bacterial contamination. The assay could tolerate samples with a wide pH range (2 to 12), high ion strengths (?4 mol·L?1 of NaCl), high viscosities (?25 mg·mL?1 of PEG20000 or ?20% of glycerol), and high concentrations of bio-macromolecule (?200 mg·mL?1 of bovine serum albumin or ?80 mg·mL?1 of casein). The influence of various types of powders and viscera (fresh and decomposed) on the performance of UPT–LF assay was determined. The operational error of liquid measurement exhibited few effects on sensitivity and specificity. The developed UPT–LF POCT assay is applicable under field conditions with excellent tolerance to sample complexity and operational error. PMID:25144726

  7. Label-free impedimetric biosensor for thrombin using the thrombin-binding aptamer as receptor

    NASA Astrophysics Data System (ADS)

    Frense, D.; Kang, S.; Schieke, K.; Reich, P.; Barthel, A.; Pliquett, U.; Nacke, T.; Brian, C.; Beckmann, D.

    2013-04-01

    This study presents the further establishment of impedimetric biosensors with aptamers as receptors. Aptamers are short single-stranded oligonucleotides which bind analytes with a specific region of their 3D structure. Electrical impedance spectroscopy is a sensitive method for analyzing changes on the electrode surface, e.g. caused by receptor-ligand-interactions. Fast and inexpensive prototyping of electrodes on the basis of commercially available compact discs having a 24 carat gold reflective layer was investigated. Electrode structures (CDtrodes [1]) in the range from few millimetres down to 100 microns were realized. The well-studied thrombin-binding aptamer (TBA) was used as receptor for characterizing these micro- and macro-electrodes. The impedance signal showed a linear correlation for concentrations of thrombin between 1.0 nM to 100 nM. This range corresponds well with most of the references and may be useful for the point-of-care testing (POCT).

  8. Image Decoding of Photonic Crystal Beads Array in the Microfluidic Chip for Multiplex Assays

    PubMed Central

    Yuan, Junjie; Zhao, Xiangwei; Wang, Xiaoxia; Gu, Zhongze

    2014-01-01

    Along with the miniaturization and intellectualization of biomedical instruments, the increasing demand of health monitoring at anywhere and anytime elevates the need for the development of point of care testing (POCT). Photonic crystal beads (PCBs) as one kind of good encoded microcarriers can be integrated with microfluidic chips in order to realize cost-effective and high sensitive multiplex bioassays. However, there are difficulties in analyzing them towards automated analysis due to the characters of the PCBs and the unique detection manner. In this paper, we propose a strategy to take advantage of automated image processing for the color decoding of the PCBs array in the microfluidic chip for multiplex assays. By processing and alignment of two modal images of epi-fluorescence and epi-white light, every intact bead in the image is accurately extracted and decoded by PC colors, which stand for the target species. This method, which shows high robustness and accuracy under various configurations, eliminates the high hardware requirement of spectroscopy analysis and user-interaction software, and provides adequate supports for the general automated analysis of POCT based on PCBs array. PMID:25341876

  9. Image Decoding of Photonic Crystal Beads Array in the Microfluidic Chip for Multiplex Assays

    NASA Astrophysics Data System (ADS)

    Yuan, Junjie; Zhao, Xiangwei; Wang, Xiaoxia; Gu, Zhongze

    2014-10-01

    Along with the miniaturization and intellectualization of biomedical instruments, the increasing demand of health monitoring at anywhere and anytime elevates the need for the development of point of care testing (POCT). Photonic crystal beads (PCBs) as one kind of good encoded microcarriers can be integrated with microfluidic chips in order to realize cost-effective and high sensitive multiplex bioassays. However, there are difficulties in analyzing them towards automated analysis due to the characters of the PCBs and the unique detection manner. In this paper, we propose a strategy to take advantage of automated image processing for the color decoding of the PCBs array in the microfluidic chip for multiplex assays. By processing and alignment of two modal images of epi-fluorescence and epi-white light, every intact bead in the image is accurately extracted and decoded by PC colors, which stand for the target species. This method, which shows high robustness and accuracy under various configurations, eliminates the high hardware requirement of spectroscopy analysis and user-interaction software, and provides adequate supports for the general automated analysis of POCT based on PCBs array.

  10. Reduced Serum Butyrylcholinesterase Activity Indicates Severe Systemic Inflammation in Critically Ill Patients

    PubMed Central

    Zivkovic, Aleksandar R.; Schmidt, Karsten; Sigl, Annette; Decker, Sebastian O.; Brenner, Thorsten; Hofer, Stefan

    2015-01-01

    Systemic inflammation is an immune response to a nonspecific insult of either infectious or noninfectious origin and remains a challenge in the intensive care units with high mortality rate. Cholinergic neurotransmission plays an important role in the regulation of the immune response during inflammation. We hypothesized that the activity of butyrylcholinesterase (BChE) might serve as a marker to identify and prognose systemic inflammation. By using a point-of-care-testing (POCT) approach we measured BChE activity in patients with severe systemic inflammation and healthy volunteers. We observed a decreased BChE activity in patients with systemic inflammation, as compared to that of healthy individuals. Furthermore, BChE activity showed an inverse correlation with the severity of the disease. Although hepatic function has previously been found essential for BChE production, we show here that the reduced BChE activity associated with systemic inflammation occurs independently of and is thus not caused by any deficit in liver function in these patients. A POCT approach, used to assess butyrylcholinesterase activity, might further improve the therapy of the critically ill patients by minimizing time delays between the clinical assessment and treatment of the inflammatory process. Hence, assessing butyrylcholinesterase activity might help in early detection of inflammation. PMID:25762852

  11. Reliability of rapid testing for hepatitis B in a region of high HIV endemicity.

    PubMed

    Davies, J; van Oosterhout, J J G; Nyirenda, M; Bowden, J; Moore, E; Hart, I J; Zijlstra, E E; Chaponda, M; Faragher, B; Beeching, N J; Beadsworth, M B J

    2010-02-01

    Hepatitis B (HBV) and HIV co-infection is common in resource-poor settings. A recent study from Malawi revealed poor correlation between hepatitis B surface antigen (HBsAg) point-of-care tests and reference tests in patients co-infected with HIV. We studied a cohort of 300 Malawian adults entering a treatment programme for HIV. Sera were tested for HBsAg first using the Determine rapid test and re-tested using a commercial enzyme immunoassay (EIA). All tests were done under optimal conditions in Liverpool, UK. Sera from all 25 patients positive for HBsAg using the rapid test and from 50 who were negative, were re-tested using the EIA, with complete concordance of results. The kappa correlation was 1, specificity 100% (93-100%) and sensitivity 100% (86-100%) compared to the reference test. Patients had advanced immune suppression (mean CD4=175 cells x 10(6)/l). In a non-field setting, the results of point-of-care Determine rapid hepatitis B tests appear reliable in patients with HIV-1 co-infection. PMID:19931107

  12. Handheld and portable test systems for immunodiagnostics, nucleic acid detection and more

    NASA Astrophysics Data System (ADS)

    Faulstich, Konrad; Haberstroh, Klaus; Gruler, Roman; Eberhard, Michael; Wiest, Thomas; Lentzsch, Dirk

    2008-04-01

    Emergency Diagnostics, Homeland Security, Epidemiological Preparedness and the high cost of the Health Care Systems have increased demand for affordable and mobile point of care (POC) devices with highest sensitivity, specificity and rapid time to result. We have developed pocket sized systems for point of care and field based tests based on fluorescence read-out. The core consists of battery operated, 90 gram electro-optical units with optional wireless data transfer, which have been optimized to achieve highest accuracy and sensitivity paired with simplicity of use. The robust systems have been applied to molecular diagnostics such as DNA based testing, immunodiagnostics as well as environmental monitoring and agricultural testing. We will show examples of DNA testing, testing of drugs and toxins, cell based assays and water monitoring. We will discuss drivers and rationale for mobile testing platforms and address critical points such as sample preparation and sampling problems e.g. target delivery in small volumes. ESE's battery-operated handheld and mobile testing platforms have been shown to provide sensitive, accurate, and specific results, as well as rapid turnaround. The stand-alone devices demonstrate operational and physical robustness, and they can be manufactured to be affordable. Some underlying assays work directly from clinical samples such as urine or blood.

  13. Rapid non-invasive tests for diagnostics of infectious diseases

    NASA Astrophysics Data System (ADS)

    Malamud, Daniel

    2014-06-01

    A rapid test for an infectious disease that can be used at point-of-care at a physician's office, a pharmacy, or in the field is critical for the prompt and appropriate therapeutic intervention. Ultimately by treating infections early on will decrease transmission of the pathogen. In contrast to metabolic diseases or cancer where multiple biomarkers are required, infectious disease targets (e.g. antigen, antibody, nucleic acid) are simple and specific for the pathogen causing the disease. Our laboratory has focused on three major infectious disease; HIV, Tuberculosis, and Malaria. These diseases are pandemic in much of the world thus putting natives, tourists and military personnel at risk for becoming infected, and upon returning to the U.S., transmitting these diseases to their contacts. Our devices are designed to detect antigens, antibodies or nucleic acids in blood or saliva samples in less than 30 minutes. An overview describing the current status of each of the three diagnostic platforms is presented. These microfluidic point-of-care devices will be relatively inexpensive, disposable, and user friendly.

  14. Comparison of Delivery Strategies for Pharmacogenetic Testing Services

    PubMed Central

    Moaddeb, Jivan

    2013-01-01

    The number and use of pharmacogenetic tests to assess a patient’s likelihood of response or risk of an adverse event is expanding across medical specialties and becoming more prevalent. During this period of development and translation, different approaches are being investigated to optimize delivery of pharmacogenetic services. In this paper, we review preemptive and point-of-care delivery approaches currently implemented or being investigated and discuss the advantages and disadvantages of each approach. The continued growth in knowledge about the genetic basis of drug response combined with development of new and cheaper testing technologies and electronic medical records will impact future delivery systems. Regardless of delivery approach, the currently limited knowledge of health professionals about genetics generally or PGx specifically will remain a major obstacle to utilization. PMID:24384556

  15. Arguments for and against HIV self-testing

    PubMed Central

    Wood, Brian R; Ballenger, Carl; Stekler, Joanne D

    2014-01-01

    Approximately 60% of human immunodeficiency virus (HIV)-infected individuals are unaware of their infection, and stigma and discrimination continue to threaten acceptance of HIV testing services worldwide. Self-testing for HIV has garnered controversy for years and the debate reignited with the approval of a point-of-care test for over-the-counter sale in the US in 2012. Here, we present arguments for and against HIV self-testing. The case in support of HIV self-testing contends that: the modality is highly acceptable, especially among the most at-risk individuals; self-testing empowers users, thus helping to normalize testing; and mutual partner testing has the potential to increase awareness of risk and avert condomless sex between discordant partners. Arguments against HIV self-testing include: cost limits access to those who need testing most; false-negative results, especially during the window period, may lead to false reassurance and could promote sex between discordant partners at the time of highest infectivity; opportunities for counseling, linkage to care, and diagnosis of other sexually transmitted infections may be missed; and self-testing leads to potential for coercion between partners. Research is needed to better define the risks of self-testing, especially as performance of the assays improves, and to delineate the benefits of programs designed to improve access to self-test kits, because this testing modality has numerous potential advantages and drawbacks. PMID:25114592

  16. Streamlining HIV testing for HIV preexposure prophylaxis.

    PubMed

    Guanira, Juan V; Leigler, Teri; Kallas, Esper; Schechter, Mauro; Sharma, Usha; Glidden, David; Grant, Robert M

    2015-01-01

    HIV-testing algorithms for preexposure prophylaxis (PrEP) should be optimized to minimize the risk of drug resistance, the time off PrEP required to evaluate false-positive screening results, and costs and to expedite the start of therapy for those confirmed to be infected. HIV rapid tests (RTs) for anti-HIV antibodies provide results in less than 1 h and can be conducted by nonlicensed staff at the point of care. In many regions, Western blot (WB) testing is required to confirm reactive RT results. WB testing, however, causes delays in diagnosis and adds expense. The iPrEx study evaluated the safety and efficacy of daily oral emtricitabine-tenofovir disoproxil fumarate among HIV-seronegative men and transgender women who have sex with men: HIV infection was assessed with two RTs plus WB confirmation, followed by HIV-1 plasma viral load testing. During the iPrEx study, there were 51,260 HIV status evaluations among 2,499 volunteers using RTs: 142 (0.28%) had concordant positive results (100% were eventually confirmed) and 19 (0.04%) had discordant results among 14 participants; 11 were eventually determined to be HIV infected. A streamlined approach using only one RT to screen and a second RT to confirm (without WB) would have had nearly the same accuracy. Discrepant RT results are best evaluated with nucleic acid testing, which would also increase sensitivity. PMID:25378570

  17. Point-of-care optical tool to detect early stage of hemorrhage and shock

    NASA Astrophysics Data System (ADS)

    Gurjar, Rajan S.; Riccardi, Suzannah L.; Johnson, Blair D.; Johnson, Christopher P.; Paradis, Norman A.; Joyner, Michael J.; Wolf, David E.

    2014-02-01

    There is a critical unmet clinical need for a device that can monitor and predict the onset of shock: hemorrhagic shock or bleeding to death, septic shock or systemic infection, and cardiogenic shock or blood flow and tissue oxygenation impairment due to heart attack. Together these represent 141 M patients per year. We have developed a monitor for shock based on measuring blood flow in peripheral (skin) capillary beds using diffuse correlation spectroscopy, a form of dynamic light scattering, and have demonstrated proof-of-principle both in pigs and humans. Our results show that skin blood flow measurement, either alone or in conjunction with other hemodynamic properties such as heart rate variability, pulse pressure variability, and tissue oxygenation, can meet this unmet need in a small self-contained patch-like device in conjunction with a hand-held processing unit. In this paper we describe and discuss the experimental work and the multivariate statistical analysis performed to demonstrate proof-of-principle of the concept.

  18. Point of care cutaneous imaging technology in melanoma screening and mole mapping.

    PubMed

    Higgins, H William; Lee, Kachiu C; Leffell, David J

    2014-01-01

    Melanoma is a malignancy of melanocytes or pigment-producing cells located predominantly in the skin. It is less common than other skin cancers but causes the greatest number of skin cancer-related deaths worldwide. The incidence of melanoma continues to increase and early detection is the most promising means of decreasing morbidity and mortality. Currently, physicians perform routine skin cancer screenings for melanoma without the benefit of imaging devices more advanced than handheld magnifiers or dermatoscopes. However, it is possible that the diagnosis of melanoma may be improved with technology that provides diagnostic discrimination beyond what is possible on routine inspection. This article reviews current and emerging technologies to aid in the diagnosis of melanoma. Ultimately, these advances may enhance the early diagnosis of melanoma. PMID:24860656

  19. Integrated fluorescence correlation spectroscopy device for point-of-care clinical applications

    PubMed Central

    Olson, Eben; Torres, Richard; Levene, Michael J.

    2013-01-01

    We describe an optical system which reduces the cost and complexity of fluorescence correlation spectroscopy (FCS), intended to increase the suitability of the technique for clinical use. Integration of the focusing optics and sample chamber into a plastic component produces a design which is simple to align and operate. We validate the system by measurements on fluorescent dye, and compare the results to a commercial instrument. In addition, we demonstrate its application to measurements of concentration and multimerization of the clinically relevant protein von Willebrand factor (vWF) in human plasma. PMID:23847733

  20. Evidence-based medicine: medical librarians providing evidence at the point of care.

    PubMed

    Yaeger, Lauren H; Kelly, Betsy

    2014-01-01

    Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. .. by best available external clinical evidence we mean clinically relevant research.' Health care reform authorized by the Affordable Care Act is based on the belief that evidence-based practice (EBP) generates cost savings due to the delivery of more effective care.2 Medical librarians, skilled in identifying appropriate resources and working with multiple complex interfaces, can support clinicians' efforts to practice evidence based medicine by providing time and expertise in articulating the clinical question and identifying the best evidence. PMID:25438362

  1. Evidence-based medicine: medical librarians providing evidence at the point of care.

    PubMed

    Yaeger, Lauren H; Kelly, Betsy

    2014-01-01

    Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. .. by best available external clinical evidence we mean clinically relevant research.' Health care reform authorized by the Affordable Care Act is based on the belief that evidence-based practice (EBP) generates cost savings due to the delivery of more effective care.2 Medical librarians, skilled in identifying appropriate resources and working with multiple complex interfaces, can support clinicians' efforts to practice evidence based medicine by providing time and expertise in articulating the clinical question and identifying the best evidence. PMID:25507879

  2. Integrating knowledge resources at the point of care: opportunities for librarians.

    PubMed

    Fuller, S S; Ketchell, D S; Tarczy-Hornoch, P; Masuda, D

    1999-10-01

    Health sciences librarians at the University of Washington (UW) are partners in the evolution of Internet-based clinical information systems for two medical centers, University of Washington Medical Center and Harborview Medical Center, as well as the UW Primary Care Network clinics. Librarians lead information resource and systems development projects and play a variety of roles including facilitator, publisher, integrator, and educator. These efforts have been coordinated with parallel development efforts by the Integrated Advanced Information Management Systems (IAIMS) clinical informatics group in developing electronic medical record systems and clinical decision support tools. The outcome is MINDscape, a very heavily used Web view of the patient medical record with tightly integrated knowledge resources as well as numerous Web-accessible information resources and tools. The goal of this article is to provide a case study of librarian involvement in institutional information systems development at UW and to illustrate the variety of roles that librarians can assume in hospital settings. PMID:10550024

  3. Towards a quality and safety framework for point of care decision support systems

    Microsoft Academic Search

    J. Bury; J. Fox

    2000-01-01

    The development of new paradigms for the electronic dissemination and consultation of clinical knowledge must be accompanied by new methods for ensuring the quality of the information available. This paper sets out a possible framework for ensuring the quality, reliability and safety of machine-enactable electronic guidelines. This addresses the quality of the clinical content and the integrity of the software

  4. Teaching and Evaluating Point of Care Learning with an Internet-Based Clinical-Question Portfolio

    ERIC Educational Resources Information Center

    Green, Michael L.; Reddy, Siddharta G.; Holmboe, Eric

    2009-01-01

    Introduction: Diplomates in the American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) program satisfy the self-evaluation of medical knowledge requirement by completing open-book multiple-choice exams. However, this method remains unlikely to affect practice change and often covers content areas not relevant to diplomates'…

  5. Nursing Reference Center: A Point-of-Care Resource from EBSCO

    Microsoft Academic Search

    Christee King

    2008-01-01

    Nursing Reference Center (NRC) is a new database offering from EBSCO Industries, Inc. The intended audience is nurses at all levels of the profession: students, hospital nurses, nurse educators, administrators, and faculty. Content is derived from a number of resources ranging from legal cases to research instruments. It is a big product with lots of ways to approach the information.

  6. Mobile Point-of-Care Systems in Hospitals: Designing for the

    E-print Network

    of stationary computers can have a negative impact on doctor-patient communication. There is, however, little for the degree of Philosophiae Doctor Trondheim, November 2011 Norwegian University of Science and Technology Faculty of Information Technology, Mathematics and Electrical Engineering Department of Computer

  7. Point-of-care diagnostics for noncommunicable diseases using synthetic urinary biomarkers and paper microfluidics

    E-print Network

    Warren, Andrew David

    With noncommunicable diseases (NCDs) now constituting the majority of global mortality, there is a growing need for low-cost, noninvasive methods to diagnose and treat this class of diseases, especially in resource-limited ...

  8. An integrated approach to computer-based decision support at the point of care.

    PubMed

    Cimino, James J

    2007-01-01

    Information needs that arise when clinicians use clinical information systems often go unresolved, forcing clinicians to defer decisions or make them with incomplete knowledge. My research characterizes these needs in order to build information systems that can help clinicians get timely answers to their questions. My colleagues and I have developed "Infobuttons", which are links between clinical information systems and on-line knowledge resources, and have developed an "Infobutton Manager" (IM) that attempts to determine the information need based on the context of what the user is doing. The IM presents users with a set of questions, each of which is a link to an online information resource that will answer the question. The Infobutton Manager has been successfully deployed in five systems at four institutions and provides users with over 1,000 accesses to on-line health information each month, with a positive impact on patient care. PMID:18528510

  9. A total patient monitoring system for point-of-care applications

    NASA Astrophysics Data System (ADS)

    Whitchurch, Ashwin K.; Abraham, Jose K.; Varadan, Vijay K.

    2007-04-01

    Traditionally, home care for chronically ill patients and the elderly requires periodic visits to the patient's home by doctors or healthcare personnel. During these visits, the visiting person usually records the patient's vital signs and takes decisions as to any change in treatment and address any issues that the patient may have. Patient monitoring systems have since changed this scenario by significantly reducing the number of home visits while not compromising on continuous monitoring. This paper describes the design and development of a patient monitoring systems capable of concurrent remote monitoring of 8 patient-worn sensors: Electroencephalogram (EEG), Electrocardiogram (ECG), temperature, airflow pressure, movement and chest expansion. These sensors provide vital signs useful for monitoring the health of chronically ill patients and alerts can be raised if certain specified signal levels fall above or below a preset threshold value. The data from all eight sensors are digitally transmitted to a PC or to a standalone network appliance which relays the data through an available internet connection to the remote monitoring client. Thus it provides a real-time rendering of the patient's health at a remote location.

  10. Versatile electrophoresis-based self-test platform.

    PubMed

    Guijt, Rosanne M

    2015-03-01

    Lab on a Chip technology offers the possibility to extract chemical information from a complex sample in a simple, automated way without the need for a laboratory setting. In the health care sector, this chemical information could be used as a diagnostic tool for example to inform dosing. In this issue, the research underpinning a family of electrophoresis-based point-of-care devices for self-testing of ionic analytes in various sample matrices is described [Electrophoresis 2015, 36, 712-721.]. Hardware, software, and methodological chances made to improve the overall analytical performance in terms of accuracy, precision, detection limit, and reliability are discussed. In addition to the main focus of lithium monitoring, new applications including the use of the platform for veterinary purposes, sodium, and for creatinine measurements are included. PMID:25655425

  11. Scaling up syphilis testing in China: implementation beyond the clinic

    PubMed Central

    Hawkes, Sarah J; Yin, Yue-Pin; Peeling, Rosanna W; Cohen, Myron S; Chen, Xiang-Sheng

    2010-01-01

    Abstract China is experiencing a syphilis epidemic of enormous proportions. The regions most heavily affected by syphilis correspond to regions where sexually transmitted HIV infection is also a major public health threat. Many high-risk patients in China fail to receive routine syphilis screening. This missed public health opportunity stems from both a failure of many high-risk individuals to seek clinical care and a disconnect between policy and practice. New point-of-care syphilis testing enables screening in non-traditional settings such as community organizations or sex venues. This paper describes the current Chinese syphilis policies, suggests a spatiotemporal framework (based on targeting high-risk times and places) to improve screening and care practices, and emphasizes a syphilis control policy extending beyond the clinical setting. PMID:20539859

  12. A Biosensor Platform for Rapid Antimicrobial Susceptibility Testing Directly From Clinical Samples

    PubMed Central

    Mach, Kathleen E.; Mohan, Ruchika; Baron, Ellen Jo; Shih, Mei-Chiung; Gau, Vincent; Wong, Pak Kin; Liao, Joseph C.

    2014-01-01

    Purpose A significant barrier to efficient antibiotic management of infection is that the standard diagnostic methodologies do not provide results at the point of care. The delays between sample collection and bacterial culture and antibiotic susceptibility reporting have led to empirical use of antibiotics, contributing to the emergence of drug resistant pathogens. As a key step toward the development of a point of care device for determining the antibiotic susceptibility of urinary tract pathogens, we report on a biosensor based antimicrobial susceptibility test. Materials and Methods For assay development bacteria were cultured with or without antibiotics, and growth was quantitated by determining viable counts and electrochemical biosensor measurement of bacterial 16S rRNA. To determine antibiotic susceptibility directly from patient samples, urine was cultured on antibiotic plates for 2.5 hours and growth was determined by electrochemical measurement of bacterial 16S rRNA. For assay validation 252 urine samples were collected from patients at the Spinal Cord Injury Service at Veterans Affairs Palo Alto Health Care System. The biosensor based antimicrobial susceptibility test was completed for samples containing gram-negative organisms. Pathogen identification and antibiotic susceptibility results were compared between our assay and standard microbiological analysis. Results A direct biosensor quantitation of bacterial 16S rRNA can be used to monitor bacterial growth for a biosensor based antimicrobial susceptibility test. Clinical validation of a biosensor based antimicrobial susceptibility test with patient urine samples demonstrated that this test was 94% accurate in 368 pathogen-antibiotic tests compared to standard microbiological analysis. Conclusions This biosensor based antimicrobial susceptibility test, in concert with our previously described pathogen identification assay, can provide culture and susceptibility information directly from a urine sample within 3.5 hours. PMID:21074208

  13. In Vitro and In Vivo Studies of a Rapid and Selective Breath Test for Tuberculosis Based upon Mycobacterial CO Dehydrogenase

    PubMed Central

    Maiga, Mamoudou; Choi, Seong Won; Atudorei, Viorel; Maiga, Mariama C.; Sharp, Zachary D.; Bishai, William R.; Timmins, Graham S.

    2014-01-01

    ABSTRACT One of the major hurdles in treating tuberculosis (TB) is the time-consuming and difficult methodology for diagnosis. Stable-isotope breath tests hold great potential for rapidly diagnosing an infectious disease, monitoring therapy, and determining a bacterial phenotype in a rapid, point-of-care manner that does not require invasive sampling. Here we describe the preclinical development of a potentially highly selective TB diagnostic breath test based upon the organism’s CO dehydrogenase activity. After development of the test in vitro, we were able to use the breath test to discriminate between infected and control rabbits, demonstrating that a diagnosis can potentially be made and also that a complex bacterial phenotype can be noninvasively and rapidly studied in the host. PMID:24736224

  14. Design of time-resolved fluorometer based on immunochromatography

    NASA Astrophysics Data System (ADS)

    Ren, Bingqiang; Huang, Lihua; Huang, Huijie

    2008-12-01

    This paper introduces the design of a novel time-resolved fluorometer based on immunochromatograghy. Different from the other time-resolved fluorometers, it tests the immunochromatographic strip which is labeled with lanthanide ions and their chelates. This instrument can provide a rapid, quantitative measurement of analytes present in samples without any washing steps and it can be used to carry out point-of-care test (POCT). The immunochromatograghy-based timeresolved fluorometer is composed of a specific optical sensor, a scanning stage, a signal processing system and a computer control system. The light from UV LED is focused on the test strip by a condense lens group in the optical sensor. If the labels are present in samples, the fluorescence at 613nm will be exited (when Eu3+chelate is used for marking substance). After a delay of some microseconds, the fluorescence will be collected by the optical sensor and converted into electronic signal by a photomultiplier tube (PMT). The concentration of the sample can be calculated through the standard working curve of this instrument. By testing, the sensitivity is several ng/ml level (when Eu3+chelate is used for marking substance), test linear range is from several ng/ml to 103 ng/ml, in which correlation coefficient is 99.97%.

  15. Institutional practices and policies in acid-base testing: a self reported Croatian survey study on behalf of the Croatian society of medical biochemistry and laboratory medicine Working Group for acid-base balance

    PubMed Central

    Duki?, Lora; Šimundi?, Ana-Maria

    2014-01-01

    Introduction: The aim of this survey study was to assess the current practices and policies in use related to the various steps in the blood gas testing process, across hospital laboratories in Croatia. Materials and methods: First questionnaire was sent by email to all medical biochemistry laboratories (N = 104) within general, specialized and clinical hospitals and university hospital centres to identify laboratories which perform blood gas analysis. Second questionnaire with detailed questions about sample collection, analysis and quality control procedures, was sent only to 47 laboratories identified by the first survey. Questionnaire was designed as combination of questions and statements with Likert scale. Third questionnaire was sent to all participating laboratories (N=47) for additional clarification for either indeterminate or unclear answers. Results: Blood gas analysis is performed in 47/104 hospital laboratories in Croatia. In 25/41 (0.61) of the laboratories capillary blood gas sampling is the preferred sample type for adult patient population, whereas arterial blood sample is preferentially used in only 5/44 laboratories (0.11). Blood sampling and sample processing for capillary samples is done almost always by laboratory technicians (36/41 and 37/44, respectively), whereas arterial blood sampling is almost always done by the physician (24/29) and only rarely by a nurse (5/28). Sample acceptance criteria and sample analysis are in accordance with international recommendations for majority of laboratories. 43/44 laboratories participate in the national EQA program. POCT analyzers are installed outside of the laboratory in 20/47 (0.43) institutions. Laboratory staff is responsible for education and training of ward personnel, quality control and instrument maintenance in only 12/22, 11/20 and 9/20 institutions, respectively. Conclusions: Practices related to collection and analysis for blood gases in Croatia are not standardised and vary substantially between laboratories. POCT analyzers are not under the direct supervision by laboratory personnel in a large proportion of surveyed institutions. Collective efforts should be made to harmonize and improve policies and procedures related to blood gas testing in Croatian laboratories. PMID:24969922

  16. Evaluation of the Accuracy of the EasyTest™ Malaria Pf/Pan Ag, a Rapid Diagnostic Test, in Uganda

    PubMed Central

    Chong, Chom-Kyu; Cho, Pyo Yun; Na, Byoung-Kuk; Ahn, Seong Kyu; Kim, Jin Su; Lee, Jin-Soo; Lee, Sung-Keun; Han, Eun-Taek; Kim, Hak-Yong; Park, Yun-Kyu; Cha, Seok Ho

    2014-01-01

    In recent years, rapid diagnostic tests (RDTs) have been widely used for malaria detection, primarily because of their simple operation, fast results, and straightforward interpretation. The Asan EasyTest™ Malaria Pf/Pan Ag is one of the most commonly used malaria RDTs in several countries, including Korea and India. In this study, we tested the diagnostic performance of this RDT in Uganda to evaluate its usefulness for field diagnosis of malaria in this country. Microscopic and PCR analyses, and the Asan EasyTest™ Malaria Pf/Pan Ag rapid diagnostic test, were performed on blood samples from 185 individuals with suspected malaria in several villages in Uganda. Compared to the microscopic analysis, the sensitivity of the RDT to detect malaria infection was 95.8% and 83.3% for Plasmodium falciparum and non-P. falciparum, respectively. Although the diagnostic sensitivity of the RDT decreased when parasitemia was ?500 parasites/µl, it showed 96.8% sensitivity (98.4% for P. falciparum and 93.8% for non-P. falciparum) in blood samples with parasitemia ?100 parasites/µl. The specificity of the RDT was 97.3% for P. falciparum and 97.3% for non-P. falciparum. These results collectively suggest that the accuracy of the Asan EasyTest™ Malaria Pf/Pan Ag makes it an effective point-of-care diagnostic tool for malaria in Uganda. PMID:25352698

  17. Evaluation of the Accuracy of the EasyTest™ malaria Pf/Pan Ag, a rapid diagnostic test, in Uganda.

    PubMed

    Chong, Chom-Kyu; Cho, Pyo Yun; Na, Byoung-Kuk; Ahn, Seong Kyu; Kim, Jin Su; Lee, Jin-Soo; Lee, Sung-Keun; Han, Eun-Taek; Kim, Hak-Yong; Park, Yun-Kyu; Cha, Seok Ho; Kim, Tong-Soo

    2014-10-01

    In recent years, rapid diagnostic tests (RDTs) have been widely used for malaria detection, primarily because of their simple operation, fast results, and straightforward interpretation. The Asan EasyTest™ Malaria Pf/Pan Ag is one of the most commonly used malaria RDTs in several countries, including Korea and India. In this study, we tested the diagnostic performance of this RDT in Uganda to evaluate its usefulness for field diagnosis of malaria in this country. Microscopic and PCR analyses, and the Asan EasyTest™ Malaria Pf/Pan Ag rapid diagnostic test, were performed on blood samples from 185 individuals with suspected malaria in several villages in Uganda. Compared to the microscopic analysis, the sensitivity of the RDT to detect malaria infection was 95.8% and 83.3% for Plasmodium falciparum and non-P. falciparum, respectively. Although the diagnostic sensitivity of the RDT decreased when parasitemia was ?500 parasites/µl, it showed 96.8% sensitivity (98.4% for P. falciparum and 93.8% for non-P. falciparum) in blood samples with parasitemia ?100 parasites/µl. The specificity of the RDT was 97.3% for P. falciparum and 97.3% for non-P. falciparum. These results collectively suggest that the accuracy of the Asan EasyTest™ Malaria Pf/Pan Ag makes it an effective point-of-care diagnostic tool for malaria in Uganda. PMID:25352698

  18. Laboratory testing under managed care dominance in the USA

    PubMed Central

    Takemura, Y; Beck, J

    2001-01-01

    The uncontrolled escalation of total health care expenditure despite the government's endeavours during the past decades in the USA had led to the rapid infiltration of managed care organisations (MCOs). Traditional hospital based laboratories have been placed in a crucial situation with the advent of the managed care era. A massive reduction of in house testing urged them to develop strategies against financial difficulty. Consolidation and networking, participation in the outreach testing market, and emphasis on point of care/satellite laboratory testing in non-traditional, ambulatory settings are major strategies for the survival of hospital laboratories. Several physicians' office laboratories (POLS) have closed their doors in response both to regulatory restrictions imposed by the Clinical Laboratory Improvement Amendments of 1988 and to managed care infiltration. It seems likely that POLs and hospital laboratories will continue to reduce test volumes, whereas commercial reference laboratories will thrive through contracting with MCOs. In the current climate of managed care dominance in the USA, clinical laboratories are changing their basic operation focus and mission in response to the aggressively changing landscape. Key Words: laboratory testing • managed care organisations • survival strategies PMID:11215291

  19. Microfluidic LIPS for serum antibody detection: Demonstration of a rapid test for HSV-2 infection

    PubMed Central

    Zubair, Adnan; Burbelo, Peter D.; Vincent, Ludovic G.; Iadarola, Michael J.; Smith, Paul D.; Morgan, Nicole Y.

    2012-01-01

    There is great interest in point-of-care antibody testing for the diagnosis of infectious and autoimmune diseases. As a first step in the development of self-contained and miniaturized devices for highly quantitative antibody detection, we demonstrate the application of Luciferase Immunoprecipitation Systems (LIPS) technology in a microfluidic format. Protein A/G was immobilized on the walls of PDMS-glass microchannels of 500 nL volume. The assay proceeds with the simultaneous introduction of plasma and Renilla luciferase–tagged antigens. Following washing, coelenterazine substrate was added and bound antigen-luciferase measured by chemiluminescence. Total assay time, including rinsing and detection, is under ten minutes. Using these stable microfluidic devices, high diagnostic performance (100% sensitivity and 100% specificity) was achieved for the diagnosis of HSV-2 infection. Based on these findings, the LIPS microfluidic format should readily lend itself to automation and the transfer to portable instrumentation. PMID:21826483

  20. Microfluidic LIPS for serum antibody detection: demonstration of a rapid test for HSV-2 infection.

    PubMed

    Zubair, Adnan; Burbelo, Peter D; Vincent, Ludovic G; Iadarola, Michael J; Smith, Paul D; Morgan, Nicole Y

    2011-12-01

    There is great interest in point-of-care antibody testing for the diagnosis of infectious and autoimmune diseases. As a first step in the development of self-contained and miniaturized devices for highly quantitative antibody detection, we demonstrate the application of Luciferase Immunoprecipitation Systems (LIPS) technology in a microfluidic format. Protein A/G was immobilized on the walls of PDMS-glass microchannels of 500 nL volume. The assay proceeds with the simultaneous introduction of plasma and Renilla luciferase-tagged antigens. Following washing, coelenterazine substrate was added and bound antigen-luciferase measured by chemiluminescence. Total assay time, including rinsing and detection, is under 10 min. Using these stable microfluidic devices, high diagnostic performance (100% sensitivity and 100% specificity) was achieved for the diagnosis of HSV-2 infection. Based on these findings, the LIPS microfluidic format should readily lend itself to automation and the transfer to portable instrumentation. PMID:21826483

  1. ?2GFP10, a High-Intensity Fluorophage, Enables Detection and Rapid Drug Susceptibility Testing of Mycobacterium tuberculosis Directly from Sputum Samples

    PubMed Central

    Jain, Paras; Hartman, Travis E.; Eisenberg, Nell; O'Donnell, Max R.; Kriakov, Jordan; Govender, Karnishree; Makume, Mantha; Thaler, David S.; Hatfull, Graham F.; Sturm, A. Willem; Larsen, Michelle H.; Moodley, Preshnie

    2012-01-01

    The difficulty of diagnosing active tuberculosis (TB) and lack of rapid drug susceptibility testing (DST) at the point of care remain critical obstacles to TB control. This report describes a high-intensity mycobacterium-specific-fluorophage (?2GFP10) that for the first time allows direct visualization of Mycobacterium tuberculosis in clinical sputum samples. Engineered features distinguishing ?2GFP10 from previous reporter phages include an improved vector backbone with increased cloning capacity and superior expression of fluorescent reporter genes through use of an efficient phage promoter. ?2GFP10 produces a 100-fold increase in fluorescence per cell compared to existing reporter phages. DST for isoniazid and oxofloxacin, carried out in cultured samples, was complete within 36 h. Use of ?2GFP10 detected M. tuberculosis in clinical sputum samples collected from TB patients. DST for rifampin and kanamycin from sputum samples yielded results after 12 h of incubation with ?2GFP10. Fluorophage ?2GFP10 has potential for clinical development as a rapid, sensitive, and inexpensive point-of-care diagnostic tool for M. tuberculosis infection and for rapid DST. PMID:22278833

  2. Rapid Detection of the Varicella Zoster Virus

    NASA Technical Reports Server (NTRS)

    Lewis, Michelle P.; Harding, Robert

    2011-01-01

    1.Technology Description-Researchers discovered that when the Varicella Zoster Virus (VZV) reactivates from latency in the body, the virus is consistently present in saliva before the appearance of skin lesions. A small saliva sample is mixed with a specialized reagent in a test kit. If the virus is present in the saliva sample, the mixture turns a red color. The sensitivity and specificity emanates from an antibody-antigen reaction. This technology is a rapid, non-invasive, point of-of-care testing kit for detecting the virus from a saliva sample. The device is easy to use and can be used in clinics and in remote locations to quickly detect VZV and begin treatment with antiviral drugs. 2.Market Opportunity- RST Bioscience will be the first and only company to market a rapid, same day test kit for the detection of VZV in saliva. The RST detection test kit will have several advantages over existing, competitive technology. The test kit is self contained and laboratory equipment is not required for analysis of the sample. Only a single saliva sample is required to be taken instead of blood or cerebral spinal fluid. The test kit is portable, sterile and disposable after use. RST detection test kits require no electrical power or expensive storage equipment and can be used in remote locations. 3.Market Analysis- According to the CDC, it is estimated that 1 million cases of shingles occur each year in the U.S. with more than half over the age of sixty. There is a high demand for rapid diagnostics by the public. The point-of-care testing (POCT) market is growing faster than other segments of in vitro diagnostics. According to a July 2007 InteLab Corporation industry report the overall market for POCT was forecast to increase from $10.3 billion in 2005 to $18.7 billion by 2011. The market value of this test kit has not been determined. 4.Competition- The VZV vaccine prevents 50% of cases and reduces neuralgia by 66%. The most popular test detects VZV-specific IgM antibody in blood. Other tests include running a sample in a polymerase chain reaction analyzer, enzyme immunoassay, latex agglutination, indirect fluorescent antibody and fluorescent antibody to membrane antigen assay. These existing tests require laboratory analysis by trained personnel, expensive equipment, invasive procedures and a longer period of time to obtain test results.

  3. [Near-patient testing devices to monitor vitamin K antagonists].

    PubMed

    Brionne-Francois, Marie; Le Querrec, Agnès; Lasne, Dominique

    2013-11-01

    Monitoring of the anticoagulant effect with the International normalized ratio (INR) is essential for patients receiving vitamin K antagonists (VKAs). The majority of point of care (POC) devices for INR monitoring has shown a good precision and accuracy with results similar to those obtained in a laboratory. In many countries, INR POC devices are widely used at home by the patients for self-testing. Their use in the hospital by the clinical staff (doctor or nurses) for bedside measurement is also growing. The INR POC testing is performed using fully automated devices. Capillary blood samples are easy to obtain. In the emergency room, POC INR devices are commonly used. This improves the quality of care for patient with suspicion of VKAs overdosage. INR measurement using bedside monitors is also of great interest in care units for specific populations of patients like paediatrics or geriatrics. Moreover, bedside INR monitoring may be useful in anticoagulant clinics or when the care unit is far from a laboratory. Although the bedside INR monitors are easy to use, their implementation requires adequate training and intermittent re-evaluation of any person performing the tests to ensure reliability of results. Such equipment must comply with EN ISO 22870 standard for POC testing accreditation, under the supervision of a biologist. In order to achieve these targets, connect the instrument to the laboratory's data management system is essential. PMID:24235329

  4. A cost-effective Z-folding controlled liquid handling microfluidic paper analysis device for pathogen detection via ATP quantification.

    PubMed

    Jin, Sheng-Quan; Guo, Su-Miao; Zuo, Peng; Ye, Bang-Ce

    2015-01-15

    A cost-effective microfluidic paper analysis device (?PAD) was developed with a special Z-folding design for controlling the fluidic flowing and substrate transportation. This presented ?PAD can be easily fabricated through wax printing by using a solid ink printer which deposits wax onto the surface of a chromatographic paper, and then baked on a hotplate by penetrating the molten wax into the paper to create a hydrophobic barrier. After ?PAD fabrication, liquid control and substrate transportation can be easily carried out by twice folding the ?PAD following Z shape. The Z folding made two separated reagent holding zone connected while the detection reaction occurred with the connection. In this paper, a pathogens detection indicated by ATP quantification was took as a proof-in-principle application of using this presented ?PAD, the limit of detection (LOD) was 1 ?M for ATP detection and 2.6×10(7) CFU/mL for Salmonella live cell detection, which showed a great potential for Point-of-Care Testing (POCT) applications. PMID:25127472

  5. An electrochemical one-step system for assaying methyltransferase activity based on transport of a quantum dot signaling tracer.

    PubMed

    Baek, Songyi; Won, Byoung Yeon; Park, Ki Soo; Park, Hyun Gyu

    2013-11-15

    A one-step, electrochemical method for assaying methyltransferase (MTase) activity, based on the convective transport of a quantum dot (QD) signaling tracer, has been developed. The assay chip used in this system was prepared by modifying a gold matrix with CdSe/ZnS QD-tagged dsDNA, which contains a specific methylation site (5'-GATC-3') recognized by MTase. Treatment of the chip with DNA adenine methylation (Dam) MTase, generates a methylated sequence (5'-GAmTC-3') within the dsDNA. The methylated dsDNA is then subjected to a cleavage reaction, induced by DpnI, which leads to release from the gold matrix of a DNA fragment tethered to a QD. Detection of the released QD, using square wave anodic stripping voltammetry (SWASV) on a glassy carbon (GC) electrode, enables the reliable quantitation of the methylated DNA. Because it is accomplished in a simple and convenient one step and does not require any complicated secondary or tedious washing steps, the new assay method holds great promise for epigenetic analysis in facility-limited environments or point-of-care testing (POCT) applications. PMID:23777705

  6. Molecular diagnosis of ?-thalassemias by the colorimetric nanogold.

    PubMed

    Chomean, Sirinart; Wangmaung, Nantawan; Sritongkham, Pornpimol; Promptmas, Chamras; Mas-Oodi, Sumana; Tanyong, Dalina; Ittarat, Wanida

    2014-02-21

    A new application of gold nanoparticles (AuNPs) as a colorimetric method for gene detection of ?-thalassemia 1 (SEA deletion) is reported here for the first time. This technique is based on color changes from salt-induced aggregation of un-hybridized nanogold probes after hybridization with the target DNA. Specific DNA probes were synthesized, thiol modified and conjugated on the surface of AuNPs. The target DNA was amplified and hybridized with the AuNPs-immobilized probe. Salt solution (NaCl) was added to induce aggregation of the un-hybridized nanogold probes. The color changes were visualized either by the naked eye or by UV-vis spectrophotometry at 520 nm. By this nanogold colorimetric method samples carrying normal ?-globin genes could be successfully identified from samples carrying ?-globin genes causing ?-thalassemia 1 (SEA deletion), either as a carrier or disease form. Results demonstrated that the new colorimetric nanogold method is a definite gene diagnosis of ?-thalassemia. It is accurate, simple, rapid, specific, sensitive, and cost effective. It is also a promising point-of-care testing (POCT) method for thalassemias and other genetic disorders. The new colorimetric nanogold is a method of choice for areas where access to sophisticated molecular diagnosis is limited. PMID:24383063

  7. DNA Nanostructure-based Interfacial engineering for PCR-free ultrasensitive electrochemical analysis of microRNA

    NASA Astrophysics Data System (ADS)

    Wen, Yanli; Pei, Hao; Shen, Ye; Xi, Junjie; Lin, Meihua; Lu, Na; Shen, Xizhong; Li, Jiong; Fan, Chunhai

    2012-11-01

    MicroRNAs (miRNAs) have been identified as promising cancer biomarkers due to their stable presence in serum. As an alternative to PCR-based homogenous assays, surface-based electrochemical biosensors offer great opportunities for low-cost, point-of-care tests (POCTs) of disease-associated miRNAs. Nevertheless, the sensitivity of miRNA sensors is often limited by mass transport and crowding effects at the water-electrode interface. To address such challenges, we herein report a DNA nanostructure-based interfacial engineering approach to enhance binding recognition at the gold electrode surface and drastically improve the detection sensitivity. By employing this novel strategy, we can directly detect as few as attomolar (<1, 000 copies) miRNAs with high single-base discrimination ability. Given that this ultrasensitive electrochemical miRNA sensor (EMRS) is highly reproducible and essentially free of prior target labeling and PCR amplification, we also demonstrate its application by analyzing miRNA expression levels in clinical samples from esophageal squamous cell carcinoma (ESCC) patients.

  8. DNA nanostructure-based ultrasensitive electrochemical microRNA biosensor.

    PubMed

    Wen, Yanli; Liu, Gang; Pei, Hao; Li, Lanying; Xu, Qin; Liang, Wen; Li, Yan; Xu, Li; Ren, Suzhen; Fan, Chunhai

    2013-12-15

    MicroRNAs (miRNAs) are key regulators of a wide range of cellular processes, and have been identified as promising cancer biomarkers due to their stable presence in serum. As an surface-based electrochemical biosensors which offer great opportunities for low-cost, point-of-care tests (POCTs) of disease-associated miRNAs. Nevertheless, the sensitivity of miRNA sensors is often limited by mass transport and the surface crowding effect at the water-electrode interface. Here, we present a protocol as well as guidelines for ultrasensitive detection of miRNA with DNA nanostructure-based electrochemical miRNA biosensor. By employing the three-dimensional DNA nanostructure-based interfacial engineering approach, we can directly detect as few as attomolar (<1000 copies) miRNAs with high single-base discrimination ability. Since this ultrasensitive electrochemical miRNA sensor (EMRS) is highly reproducible and essentially free of prior target labeling and PCR amplification, it can conveniently and reliably analyze miRNA expression levels in clinical samples from esophageal squamous cell carcinoma (ESCC) patients. PMID:23911620

  9. Recent Developments in Antibody-Based Assays for the Detection of Bacterial Toxins

    PubMed Central

    Zhu, Kui; Dietrich, Richard; Didier, Andrea; Doyscher, Dominik; Märtlbauer, Erwin

    2014-01-01

    Considering the urgent demand for rapid and accurate determination of bacterial toxins and the recent promising developments in nanotechnology and microfluidics, this review summarizes new achievements of the past five years. Firstly, bacterial toxins will be categorized according to their antibody binding properties into low and high molecular weight compounds. Secondly, the types of antibodies and new techniques for producing antibodies are discussed, including poly- and mono-clonal antibodies, single-chain variable fragments (scFv), as well as heavy-chain and recombinant antibodies. Thirdly, the use of different nanomaterials, such as gold nanoparticles (AuNPs), magnetic nanoparticles (MNPs), quantum dots (QDs) and carbon nanomaterials (graphene and carbon nanotube), for labeling antibodies and toxins or for readout techniques will be summarized. Fourthly, microscale analysis or minimized devices, for example microfluidics or lab-on-a-chip (LOC), which have attracted increasing attention in combination with immunoassays for the robust detection or point-of-care testing (POCT), will be reviewed. Finally, some new materials and analytical strategies, which might be promising for analyzing toxins in the near future, will be shortly introduced. PMID:24732203

  10. Prospective, multi?centre clinic?based evaluation of four rapid diagnostic tests for syphilis

    PubMed Central

    Mabey, D; Peeling, R W; Ballard, R; Benzaken, A S; Galbán, E; Changalucha, J; Everett, D; Balira, R; Fitzgerald, D; Joseph, P; Nerette, S; Li, J; Zheng, H

    2006-01-01

    Objectives To evaluate prospectively four rapid, point?of?care serological tests for syphilis in prenatal or high risk populations in four countries. Methods Tests were performed on consecutive clinic attenders, using whole blood in the clinic, and whole blood and serum in the laboratory. The sensitivity and specificity of each test was evaluated, using a standard treponemal test (Treponema pallidum haemagglutination assay (TPHA) or fluorescent treponemal antibody, absorbed (FTA?ABS) as gold standard. Non?treponemal tests (rapid plasma reagin (RPR) or venereal diseases research laboratory (VDRL) tests) were also performed on all subjects at three sites. Results The specificity of each rapid test was >95% at each site. Sensitivities varied from 64–100% and, in most cases, were lower when whole blood was used rather than serum. Conclusions Rapid serological tests for syphilis are an acceptable alternative to conventional laboratory tests. Since they do not require equipment or electricity, they could increase coverage of syphilis screening, and enable treatment to be given at the first clinic visit. PMID:17215274

  11. Evaluation of a novel stool native catalase antigen test for Helicobacter pylori infection in asymptomatic North American children.

    PubMed

    Cardenas, Victor M; Dominguez, Delfina C; Puentes, Flor A; Aragaki, Corinne C; Goodman, Karen J; Graham, David Y; Fukuda, Yoshihiro

    2008-04-01

    Rapid immunochromatographic tests for Helicobacter pylori infection have been developed to allow "near-patient" testing. We therefore performed a pilot study to test a rapid immunochromatographic stool antigen test for the diagnosis of H. pylori infection in asymptomatic children. We tested stool specimens collected from children participating in a cohort study in the United States and Mexico. H. pylori-positive status was defined by positivity on at least 2 tests: a commercial H. pylori stool antigen enzyme immunoassay, an immunoglobulin G antibody enzyme immunoassay, and the C-urea breath test. Negative H. pylori status was defined by negative findings of all of these tests. Of 52 children (22 girls, 30 boys) 25 were H. pylori-positive, 19 H. pylori-negative, and 8 uncertain (eg, presumably negative; positive findings on 1 of the 3 noninvasive tests). The sensitivity and specificity of the new stool antigen test for those with definite H. pylori status were 100% (exact 95% CI 86.3%-100% and 82.4%-100%, respectively). This rapid stool antigen test may prove useful for point-of-care testing and epidemiological field studies. Larger prospective studies are needed in symptomatic and asymptomatic children for more precise estimates. PMID:18367951

  12. Performance of the molecular Alere I influenza A&B test compared to that of the xpert flu A/B assay.

    PubMed

    Chapin, Kimberle C; Flores-Cortez, Estefany J

    2015-02-01

    Data on the performance of rapid molecular point-of-care use platforms for diagnosis of influenza are lacking. We validated nasopharyngeal (NP) flocked specimens in universal transport medium (UTM) and evaluated the clinical sensitivity and specificity of the Alere i influenza A&B test compared to those of the Xpert flu A/B assay. The Alere i influenza A&B test had an overall sensitivity and specificity of 93.8% and 62.5% for influenza A, respectively, and of 91.8% and 53.6% for influenza B, respectively. The poor specificity was due to influenza virus samples determined positive for both type A and B. PMID:25502527

  13. Diagnosis of Cryptococcosis and Prevention of Cryptococcal Meningitis Using a Novel Point-of-Care Lateral Flow Assay

    PubMed Central

    2013-01-01

    Despite access to antiretroviral therapy, mortality from cryptococcal meningitis (CM) is high among persons with advanced HIV infection in sub-Saharan Africa. Cryptococcal antigen (CrAg) is present several weeks to months before the onset of symptoms of meningitis and can be screened to prevent life threatening meningitis. Recently, the World Health Organisation recommended that a new rapid CrAg lateral flow ‘‘dipstick” assay (LFA) is to be used to screen HIV-infected persons with CD4 counts of less than 100?cells/µL. In this paper, we describe two cases of cryptococcosis with differing outcomes. In the first case, the new CrAg LFA was used as part of a screen and preemptive treatment strategy to prevent CM. In the second case, our patient had no access to the CrAg LFA and subsequently developed life threatening meningitis. To the best of our knowledge, this is the first case report of cryptococcosis diagnosed using this novel assay. PMID:24319464

  14. Microfluidic CD4+ and CD8+ T lymphocyte counters for point-of-care HIV diagnostics using whole blood.

    PubMed

    Watkins, Nicholas N; Hassan, Umer; Damhorst, Gregory; Ni, Hengkan; Vaid, Awais; Rodriguez, William; Bashir, Rashid

    2013-12-01

    Roughly 33 million people worldwide are infected with HIV; disease burden is highest in resource-limited settings. One important diagnostic in HIV disease management is the absolute count of lymphocytes expressing the CD4(+) and CD8(+) receptors. The current diagnostic instruments and procedures require expensive equipment and trained technicians. In response, we have developed microfluidic biochips that count CD4(+) and CD8(+) lymphocytes in whole blood samples, without the need for off-chip sample preparation. The device is based on differential electrical counting and relies on five on-chip modules that, in sequence, chemically lyses erythrocytes, quenches lysis to preserve leukocytes, enumerates cells electrically, depletes the target cells (CD4 or CD8) with antibodies, and enumerates the remaining cells electrically. We demonstrate application of this chip using blood from healthy and HIV-infected subjects. Erythrocyte lysis and quenching durations were optimized to create pure leukocyte populations in less than 1 min. Target cell depletion was accomplished through shear stress-based immunocapture, using antibody-coated microposts to increase the contact surface area and enhance depletion efficiency. With the differential electrical counting method, device-based CD4(+) and CD8(+) T cell counts closely matched control counts obtained from flow cytometry, over a dynamic range of 40 to 1000 cells/?l. By providing accurate cell counts in less than 20 min, from samples obtained from one drop of whole blood, this approach has the potential to be realized as a handheld, battery-powered instrument that would deliver simple HIV diagnostics to patients anywhere in the world, regardless of geography or socioeconomic status. PMID:24307694

  15. Category Capstone Project Title Student Names Bioengineering & Medical Devices A Point-of-Care Platform for Neonatal Complete Blood Counts

    E-print Network

    Sekhon, Jasjeet S.

    Project Peter Florin, Byron Pakter, Eric Scott, Brian Mick Product Design Concussion Terminator : Football of Things" Jonathan Chinen, Lee Hamstra, Oscar Segovia, Billy Frese, Daniel Lim Product Design Interactive of Valet Parking Ben Freudberg, Jonathan Steck, Sinan Liu, Sean Sheng, Ian Liu, Software & Hardware Design

  16. Classification and diagnosis of myeloproliferative neoplasms: The 2008 World Health Organization criteria and point-of-care diagnostic algorithms

    Microsoft Academic Search

    A Tefferi; J W Vardiman; A Tefferi

    2008-01-01

    The 2001 World Health Organization (WHO) treatise on the classification of hematopoietic tumors lists chronic myeloproliferative diseases (CMPDs) as a subdivision of myeloid neoplasms that includes the four classic myeloproliferative disorders (MPDs)—chronic myelogenous leukemia, polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF)—as well as chronic neutrophilic leukemia (CNL), chronic eosinophilic leukemia\\/hypereosinophilic syndrome (CEL\\/HES) and ‘CMPD, unclassifiable’. In the

  17. Micro-a-fluidics ELISA for Rapid CD4 Cell Count at the Point-of-Care

    E-print Network

    Wang, ShuQi

    HIV has become one of the most devastating pathogens in human history. Despite fast progress in HIV-related basic research, antiretroviral therapy (ART) remains the most effective method to save AIDS patients' lives. ...

  18. Micro-a-fluidics ELISA for Rapid CD4 Cell Count at the Point-of-Care

    PubMed Central

    Wang, ShuQi; Tasoglu, Savas; Chen, Paul Z.; Chen, Michael; Akbas, Ragip; Wach, Sonya; Ozdemir, Cenk Ibrahim; Gurkan, Umut Atakan; Giguel, Francoise F.; Kuritzkes, Daniel R.; Demirci, Utkan

    2014-01-01

    HIV has become one of the most devastating pathogens in human history. Despite fast progress in HIV-related basic research, antiretroviral therapy (ART) remains the most effective method to save AIDS patients' lives. Unfortunately, ART cannot be universally accessed, especially in developing countries, due to the lack of effective treatment monitoring diagnostics. Here, we present an inexpensive, rapid and portable micro-a-fluidic platform, which can streamline the process of an enzyme-linked immunosorbent assay (ELISA) in a fully automated manner for CD4 cell count. The micro-a-fluidic CD4 cell count is achieved by eliminating operational fluid flow via “moving the substrate”, as opposed to “flowing liquid” in traditional ELISA or microfluidic methods. This is the first demonstration of capturing and detecting cells from unprocessed whole blood using the enzyme-linked immunosorbent assay (ELISA) in a microfluidic channel. Combined with cell phone imaging, the presented micro-a-fluidic ELISA platform holds great promise for offering rapid CD4 cell count to scale up much needed ART in resource-constrained settings. The developed system can be extended to multiple areas for ELISA-related assays. PMID:24448112

  19. From cellular lysis to microarray detection, an integrated thermoplastic elastomer (TPE) point of care Lab on a Disc.

    PubMed

    Roy, Emmanuel; Stewart, Gale; Mounier, Maxence; Malic, Lidija; Peytavi, Régis; Clime, Liviu; Madou, Marc; Bossinot, Maurice; Bergeron, Michel G; Veres, Teodor

    2015-01-21

    We present an all-thermoplastic integrated sample-to-answer centrifugal microfluidic Lab-on-Disc system (LoD) for nucleic acid analysis. The proposed CD system and engineered platform were employed for analysis of Bacillus atrophaeus subsp. globigii spores. The complete assay comprised cellular lysis, polymerase chain reaction (PCR) amplification, amplicon digestion, and microarray hybridization on a plastic support. The fluidic robustness and operating efficiency of the assay were ensured through analytical optimization of microfluidic tools enabling beneficial implementation of capillary valves and accurate control of all flow timing procedures. The assay reliability was further improved through the development of two novel microfluidic strategies for reagents mixing and flow delay on the CD platform. In order to bridge the gap between the proof-of-concept LoD and production prototype demonstration, low-cost thermoplastic elastomer (TPE) was selected as the material for CD fabrication and assembly, allowing the use of both, high quality hot-embossing and injection molding processes. Additionally, the low-temperature and pressure-free assembly and bonding properties of TPE material offer a pertinent solution for simple and efficient loading and storage of reagents and other on-board components. This feature was demonstrated through integration and conditioning of microbeads, magnetic discs, dried DNA buffer reagents and spotted DNA array inserts. Furthermore, all microfluidic functions and plastic parts were designed according to the current injection mold-making knowledge for industrialization purposes. Therefore, the current work highlights a seamless strategy that promotes a feasible path for the transfer from prototype toward realistic industrialization. This work aims to establish the full potential for TPE-based centrifugal system as a mainstream microfluidic diagnostic platform for clinical diagnosis, water and food safety, and other molecular diagnostic applications. PMID:25385141

  20. Point-of-care detection and real-time monitoring of intravenously delivered drugs via tubing with an

    E-print Network

    Cunningham, Brian

    days. The capabilities reported here demonstrate the potential to use PNA SERS surfaces for enhancing. Infrared absorption spectroscopy and Raman scattering are label-free detection methods, and thus do the possibility for using Raman spectroscopy. Raman scattering provides several advantages over infrared abso

  1. Micro-a-fluidics ELISA for Rapid CD4 Cell Count at the Point-of-Care

    E-print Network

    Demirci, Utkan

    research, antiretroviral therapy (ART) remains the most effective method to save AIDS patients' lives worldwide1 . Although antiretroviral therapy (ART) is effective in saving AIDS patients' lives. Unfortunately, ART cannot be universally accessed, especially in developing countries, due to the lack

  2. Outdoor adventure program builds confidence and competence to help new graduate RNs become "everyday" leaders at the point of care.

    PubMed

    Greer-Day, Susan; Medland, Jackie; Watson, Lynn; Bojak, Sarah

    2015-01-01

    A nontraditional approach to leadership development promoted successful transition of new graduate RN residents to professional nurses. Utilizing an outdoor adventure program increased nurses' feelings of competence by boosting their confidence, facilitating an environment where leadership at the bedside became an ingrained part of their nursing practice. RN residents at a Midwestern medical center represented only 17% of the nursing population but reshaped the culture of the entire organization by becoming dynamic "everyday" leaders. PMID:25608096

  3. Component and system evaluation for the development of a handheld point-of-care spatial frequency domain imaging (SFDI) device

    NASA Astrophysics Data System (ADS)

    Nadeau, K. P.; Khoury, P.; Mazhar, A.; Cuccia, D.; Durkin, A. J.

    2013-03-01

    Recently, digital photography has become an efficient and economic method to assist dermatologists in monitoring skin characteristics. Although this technology has advanced a great deal in resolution and costs, conventional digital cameras continue to only provide qualitative recording of color information. To address this issue, we are developing a compact, quantitative skin imaging camera by employing spatial frequency domain imaging (SFDI), a non-contact approach for determining tissue optical properties over a wide field-of-view. SFDI uses knowledge of optical properties at multiple wavelengths to recover concentrations of tissue constituents such as oxy/deoxy-hemoglobin, water, and melanin. This method has been well researched and presented in laboratory and research settings. The next step in the development of SFDI systems is to make typical systems compact and cheaper using commercial components. We present our findings by performing a component-by-component analysis of key SFDI system components including light sources, projectors, and cameras.

  4. Point-of-care concerns in developing countries: Integration of infrastructure-appropriate technologies for global healthcare solutions

    Microsoft Academic Search

    T. J. Law; A. C. Abel; J. Lee; Y. Pun; R. S. Fashho

    2011-01-01

    For a number of reasons, medical standards often taken for granted in developed countries are difficult to implement in developing areas of the world. In particular, our team investigated the needs of community clinics in rural Ghana and identified reliable sterilization of everyday medical supplies as a critical need. Our resultant goal was to design an economically and technologically sustainable

  5. Platelet concentrates transfusion in cardiac surgery in relation to preoperative point-of-care assessment of platelet adhesion and aggregation.

    PubMed

    Solomon, Cristina; Hartmann, Jennifer; Osthaus, Alexander; Schöchl, Herbert; Raymondos, Kostas; Koppert, Wolfgang; Rahe-Meyer, Niels

    2010-01-01

    Platelet dysfunction is an important cause of bleeding early after cardiac surgery. Whole-blood multiple electrode aggregometry (MEA), investigating the adhesion and aggregation of activated platelets onto metal electrodes, has shown correlations with platelet concentrates transfusion in this setting. Platelet activity in vivo is dependent on shear stress, an aspect that cannot be investigated with MEA, but with the cone and plate(let) analyzer (CPA) Impact-R that measures the interaction of platelets and von Willebrand factor (vWF) in whole blood under shear. We hypothesized that preoperative CPA may show better correlation with platelet concentrates transfusion post-cardiac surgery than MEA, since it is dependent on both platelet activity and platelet interaction with vWF multimers. Blood was obtained preoperatively from 30 patients undergoing aorto-coronary bypass (ACB) and 20 patients with aortic valve (AV) surgery. MEA was performed in hirudin-anticoagulated blood. The Impact-R analyses were performed in blood anticoagulated with hirudin, heparin or the standard anticoagulant citrate. For the light microscopy images obtained, the parameter surface coverage (SC) was calculated. Preoperative Impact-R results were abnormally decreased in AV patients and significantly lower than in ACB patients. For the Impact-R analysis performed in citrated blood, no correlation with platelet concentrates transfusion was observed. In contrast, MEA was comparable between the groups and correlated significantly with intraoperative platelet concentrates transfusion in both groups (rho between -0.47 and -0.62, p < 0.05). Multiple electrode aggregometry appeared more useful and easier to apply than CPA for preoperatively identifying patients with platelet concentrates transfusion in cardiac surgery. PMID:20158381

  6. An optical smart needle : point-of-care technologies for integrated needle guidance using optical frequency domain ranging

    E-print Network

    Goldberg, Brian, 1979-

    2009-01-01

    Obtaining accurate needle placement is of critical importance in many medical scenarios. In the setting of fine needle aspiration biopsy (FNAB), manual palpation is often the only cue for determining the optimal position ...

  7. Electrochemical sensing method for point-of-care cortisol detection in human immunodeficiency virus-infected patients

    PubMed Central

    Kaushik, Ajeet; Yndart, Adriana; Jayant, Rahul Dev; Sagar, Vidya; Atluri, Venkata; Bhansali, Shekhar; Nair, Madhavan

    2015-01-01

    A novel electrochemical sensing method was devised for the first time to detect plasma cortisol, a potential psychological stress biomarker, in human immunodeficiency virus (HIV)-positive subjects. A miniaturized potentiostat (reconfigured LMP91000 chip) interfaced with a microfluidic manifold containing a cortisol immunosensor was employed to demonstrate electrochemical cortisol sensing. This fully integrated and optimized electrochemical sensing device exhibited a wide cortisol-detection range from 10 pg/mL to 500 ng/mL, a low detection limit of 10 pg/mL, and sensitivity of 5.8 ?A (pg mL)?1, with a regression coefficient of 0.995. This cortisol-selective sensing system was employed to estimate plasma cortisol in ten samples from HIV patients. The electrochemical cortisol-sensing performance was validated using an enzyme-linked immunosorbent assay technique. The results obtained using both methodologies were comparable within 2%–5% variation. The information related to psychological stress of HIV patients can be correlated with disease-progression parameters to optimize diagnosis, therapeutic, and personalized health monitoring. PMID:25632229

  8. Micro-a-fluidics ELISA for rapid CD4 cell count at the point-of-care.

    PubMed

    Wang, ShuQi; Tasoglu, Savas; Chen, Paul Z; Chen, Michael; Akbas, Ragip; Wach, Sonya; Ozdemir, Cenk Ibrahim; Gurkan, Umut Atakan; Giguel, Francoise F; Kuritzkes, Daniel R; Demirci, Utkan

    2014-01-01

    HIV has become one of the most devastating pathogens in human history. Despite fast progress in HIV-related basic research, antiretroviral therapy (ART) remains the most effective method to save AIDS patients' lives. Unfortunately, ART cannot be universally accessed, especially in developing countries, due to the lack of effective treatment monitoring diagnostics. Here, we present an inexpensive, rapid and portable micro-a-fluidic platform, which can streamline the process of an enzyme-linked immunosorbent assay (ELISA) in a fully automated manner for CD4 cell count. The micro-a-fluidic CD4 cell count is achieved by eliminating operational fluid flow via "moving the substrate", as opposed to "flowing liquid" in traditional ELISA or microfluidic methods. This is the first demonstration of capturing and detecting cells from unprocessed whole blood using the enzyme-linked immunosorbent assay (ELISA) in a microfluidic channel. Combined with cell phone imaging, the presented micro-a-fluidic ELISA platform holds great promise for offering rapid CD4 cell count to scale up much needed ART in resource-constrained settings. The developed system can be extended to multiple areas for ELISA-related assays. PMID:24448112

  9. Electromechanical cell lysis using a portable audio device: enabling challenging sample preparation at the point-of-care.

    PubMed

    Buser, J R; Wollen, A; Heiniger, E K; Byrnes, S A; Kauffman, P C; Ladd, P D; Yager, P

    2015-04-21

    Audio sources are ubiquitously available on portable electronic devices, including cell phones. Here we demonstrate lysis of Mycobacterium marinum and Staphylococcus epidermidis bacteria utilizing a portable audio device coupled with a simple and inexpensive electromagnetic coil. The resulting alternating magnetic field rotates a magnet in a tube with the sample and glass beads, lysing the cells and enabling sample preparation for these bacteria anywhere there is a cell phone, mp3 player, laptop, or other device with a headphone jack. PMID:25797443

  10. The Utility of Platelet and Coagulation Testing of Antithrombotics: Fusing Science with Patient Care

    PubMed Central

    Jennings, Lisa K; Kotha, Jayaprakash

    2013-01-01

    Strategy, Management and Health PolicyEnabling Technology, Genomics, ProteomicsPreclinical ResearchPreclinical Development Toxicology, Formulation Drug Delivery, PharmacokineticsClinical Development Phases I-III Regulatory, Quality, ManufacturingPostmarketing Phase IV There is an increasing need for the standardization of platelet function and coagulation testing for the assessment of antithrombotic therapies. Investigators continue to strive to identify ideal laboratory testing and monitoring procedures for acquired and inherited platelet function defects as well as for evaluating patient status when treated with existing or emerging antithrombotics. These therapies are used primarily in the treatment of ischemic complications. In patients receiving antithrombotic therapy, the balance between hemostasis and thrombosis is a challenge as there is an ongoing risk for bleeding when patients are receiving antiplatelet agents or anticoagulants to lessen their risk for secondary thrombotic events. There are several diverse tests for monitoring anticoagulant therapy; however, as new agents are developed, more specific tests will be required to directly assess these agents in relationship to overall coagulation status. Research in the platelet biology field is ongoing to provide point-of-care methodologies for the assessment of platelet reactivity in terms of both bleeding and thrombosis risk. Currently there are no instruments that reliably assess the risk of bleeding. The challenges that routinely faced are the complexity of physiology, the need for standardization of platelet testing methodology, and the necessity for appropriate interpretation of the test results. PMID:24489427

  11. ESOL Tests and Testing

    ERIC Educational Resources Information Center

    Stoynoff, Stephen; Chapelle, Carol A.

    2005-01-01

    This book describes how ESOL tests and test users have changed greatly in the past few decades. Some widely used ESOL tests have been revised, with a number of new tests incorporating advances in computer technology. In addition, many more ESOL practitioners than in the past are responsible for selecting and using tests. The authors introduce…

  12. Platelet function tests in clinical cardiology: unfulfilled expectations.

    PubMed

    Gorog, Diana A; Fuster, Valentin

    2013-05-28

    This review is a critical evaluation of publications in the past decade on the usefulness of platelet function tests (PFTs) in clinical cardiology, in aiding diagnosis, predicting risk, and monitoring therapy. The ideal PFT should: 1) detect baseline platelet hyperreactivity; 2) allow individualization of antiplatelet medication; 3) predict thrombotic risk; and 4) predict bleeding risk. The practicalities of clinical cardiology demand rapid, accurate, and reliable tests that are simple to operate at the bedside and available 24 h a day, 7 days a week. Point-of-care PFTs most widely evaluated clinically include PFA-100 and VerifyNow. None of these tests can reliably detect platelet hyperreactivity and thus identify a prothrombotic state. Identification of antiplatelet nonresponsiveness or hyporesponsiveness is highly test specific, and does not allow individualization of therapy. The power of PFTs in predicting thrombotic events for a given individual is variable and often modest, and alteration of antithrombotic treatment on the basis of the results of PFTs has not been shown to alter clinical outcome. PFTs in current mainstream use cannot reliably assess bleeding risk. These tests have been in use for over a decade, but the hopes raised by PFTs in clinical practice remain unfulfilled. Although physiologically relevant measurement of platelet function now is more important than ever, a critical reappraisal of available techniques in light of clinical requirements is needed. The use of native blood, global stimulus instead of individual agonists, contribution of thrombin generation by activated platelets to the test results, and establishment of a PFT therapeutic range for each antiplatelet drug should be considered and is discussed. PMID:23541972

  13. HIV Testing

    MedlinePLUS

    ... people may test false-negative with this test. RNA tests detect the virus directly (instead of the ... tested again at the 3-month mark. For RNA tests or antibody/antigen tests, that timeframe may ...

  14. Elevation of urinary adipsin in preeclampsia: correlation with urine protein concentration and the potential use for a rapid diagnostic test.

    PubMed

    Wang, Tao; Zhou, Rong; Gao, Linbo; Wang, Yanyun; Song, Changping; Gong, Yunhui; Jia, Jin; Xiong, Wei; Dai, Li; Zhang, Lin; Hu, Huaizhong

    2014-10-01

    Early diagnosis and treatment of preeclampsia are essential for prevention of seizure development and fetus maturation. Although various methods have been developed for predicting or monitoring the onset of preeclampsia, a simple assay that can be used as a home or point of care test remains unavailable. We attempted to find a urinary protein that could be used as a biomarker for developing such a test. Urinary samples were collected from 124 preeclampsia and 135 healthy pregnant women for screening using a protein array technology and quantification by ELISA. A urinary protein, adipsin, was found significantly increased, and the adipsin creatinine ratio was closely correlated with the urinary 24-hour protein in patients with preeclampsia. When combined with the increased diastolic blood pressure (?90 mm Hg), the sensitivity was 90.3% and the specificity reached 100.0% for preeclampsia diagnosis. We then developed a laminar flow immunoassay for rapid diagnosis, and the sensitivity and specificity were 89.04% and 100%, respectively, when combined with increased diastolic blood pressure. Because of the easiness of sample collection, assay conduction, and result interpretation, this urine test can be potentially used as a home test for monitoring preeclampsia onset for high-risk pregnant women and as a rapid test for a preliminary diagnosis for emergency patients at hospitals. PMID:24958499

  15. Test Architecture, Test Retrofit

    ERIC Educational Resources Information Center

    Fulcher, Glenn; Davidson, Fred

    2009-01-01

    Just like buildings, tests are designed and built for specific purposes, people, and uses. However, both buildings and tests grow and change over time as the needs of their users change. Sometimes, they are also both used for purposes other than those intended in the original designs. This paper explores architecture as a metaphor for language…

  16. Usefulness of C-reactive protein testing in acute cough/respiratory tract infection: an open cluster-randomized clinical trial with C-reactive protein testing in the intervention group

    PubMed Central

    2014-01-01

    Background Point of care testing for C-reactive protein (CRP) has shown promise as a measure to reduce unnecessary antibiotic prescribing in respiratory tract infections (RTI), but its use in primary care is still controversial. We aimed to evaluate the effect of CRP testing on the prescription of antibiotics, referral for radiography, and the outcome of patients in general practice with acute cough/RTI. Methods An open-cluster randomized clinical trial was conducted, with CRP testing performed in the intervention group. Antibiotic prescribing and referral for radiography were the main outcome measures. Results A total of 179 patients were included: 101 in the intervention group and 78 in the control group. The two groups were similar in clinical characteristics. In the intervention group, the antibiotic prescribing rate was 37.6%, which was significantly lower than that in the control group (58.9%) (P?=?0.006). Referral for chest X-ray was also significantly lower in the intervention group (55.4%) than in the control group (75.6%) (P?=?0.004). The recovery rate, as recorded by the GPs, was 92.9% and 93.6% in the intervention and control groups, respectively. Conclusion The study showed that CRP testing in patients with acute cough/RTI may reduce antibiotic prescribing and referral for radiography, probably without compromising recovery. Trial registration The trial was registered in the ClinicalTrials.gov Protocol Registration System (identification number: NCT01794819). PMID:24886066

  17. Rapid in vivo detection of isoniazid-sensitive Mycobacterium tuberculosis by breath test

    PubMed Central

    Maiga, Mariama C.; Atudorei, Viorel; Sharp, Zachary D.; Bishai, William R.; Timmins, Graham S.

    2014-01-01

    There is urgent need for rapid, point of care diagnostic tools for tuberculosis (TB) and drug sensitivity. Current methods based on in vitro growth take weeks, while DNA amplification can neither differentiate live from dead organisms nor determine phenotypic drug resistance. Here we show the development and evaluation of a rapid breath test for isoniazid (INH)-sensitive TB based on detection of labeled N2 gas formed specifically from labeled INH by mycobacterial KatG enzyme. In vitro data shows the assay is specific, dependent on mycobacterial abundance, and discriminates between INH-sensitive and resistant (S315T mutant KatG) TB. In vivo, the assay is rapid with maximal detection of 15N2 in exhaled breath of infected rabbits within five to ten minutes. No increase in 15N2 is detected in un-infected animals, and the increases in 15N2 are dependent on infection dose. This test may allow rapid detection of INH-sensitive TB. PMID:25247851

  18. An integrated electrochemical device based on immunochromatographic test strip and enzyme labels for sensitive detection of disease-related biomarkers

    SciTech Connect

    Zou, Zhexiang; Wang, Jun; Wang, Hua; Li, Yao Q.; Lin, Yuehe

    2012-05-30

    A novel electrochemical biosensing device that integrates an immunochromatographic test strip and a screen-printed electrode (SPE) connected to a portable electrochemical analyzer was presented for rapid, sensitive, and quantitative detection of disease-related biomarker in human blood samples. The principle of the sensor is based on sandwich immunoreactions between a biomarker and a pair of its antibodies on the test strip, followed by highly sensitive square-wave voltammetry (SWV) detection. Horseradish peroxidase (HRP) was used as a signal reporter for electrochemical readout. Hepatitis B surface antigen (HBsAg) was employed as a model protein biomarker to demonstrate the analytical performance of the sensor in this study. Some critical parameters governing the performance of the sensor were investigated in detail. The sensor was further utilized to detect HBsAg in human plasma with an average recovery of 91.3%. In comparison, a colorimetric immunochromatographic test strip assay (ITSA) was also conducted. The result shows that the SWV detection in the electrochemical sensor is much more sensitive for the quantitative determination of HBsAg than the colorimetric detection, indicating that such a sensor is a promising platform for rapid and sensitive point-of-care testing/screening of disease-related biomarkers in a large population

  19. Evaluation of a Density-Based Rapid Diagnostic Test for Sickle Cell Disease in a Clinical Setting in Zambia

    PubMed Central

    Hennek, Jonathan W.; Mantina, Hamakwa; Lee, S. Y. Ryan; Patton, Matthew R.; Sambo, Pauline; Sinyangwe, Silvester; Kankasa, Chipepo; Chintu, Chifumbe; Brugnara, Carlo; Stossel, Thomas P.; Whitesides, George M.

    2014-01-01

    Although simple and low-cost interventions for sickle cell disease (SCD) exist in many developing countries, child mortality associated with SCD remains high, in part, because of the lack of access to diagnostic tests for SCD. A density-based test using aqueous multiphase systems (SCD-AMPS) is a candidate for a low-cost, point-of-care diagnostic for SCD. In this paper, the field evaluation of SCD-AMPS in a large (n?=?505) case-control study in Zambia is described. Of the two variations of the SCD-AMPS used, the best system (SCD-AMPS-2) demonstrated a sensitivity of 86% (82–90%) and a specificity of 60% (53–67%). Subsequent analysis identified potential sources of false positives that include clotting, variation between batches of SCD-AMPS, and shipping conditions. Importantly, SCD-AMPS-2 was 84% (62–94%) sensitive in detecting SCD in children between 6 months and 1 year old. In addition to an evaluation of performance, an assessment of end-user operability was done with health workers in rural clinics in Zambia. These health workers rated the SCD-AMPS tests to be as simple to use as lateral flow tests for malaria and HIV. PMID:25490722

  20. Pinworm test

    MedlinePLUS

    Oxyuriasis test; Enterobiasis test; Tape test ... diagnose this infection is to do a tape test. The best time to do this is in ... to determine if there are eggs. The tape test may need to be done on 3 separate ...

  1. Modelling the cost?effectiveness of introducing rapid syphilis tests into an antenatal syphilis screening programme in Mwanza, Tanzania

    PubMed Central

    Vickerman, P; Peeling, R W; Terris?Prestholt, F; Changalucha, J; Mabey, D; Watson?Jones, D; Watts, C

    2006-01-01

    Objectives A study found screening (with rapid plasma reagin (RPR)) pregnant women for maternal syphilis was cost?effective in Mwanza, Tanzania. Recently, four rapid point?of?care (POC) syphilis tests were evaluated in Mwanza, and found to have reasonable sensitivity/specificity. This analysis estimates the relative cost?effectiveness of using these POC tests in the Mwanza syphilis screening intervention. Methods Empirical cost and epidemiological data were used to model the potential benefit of using POC tests instead of RPR. Reductions in costs relating to training, supplies, and equipment were estimated, and any changes in impact due to test sensitivity were included. Additional modelling explored how the results vary with prevalence of past infection, misclassified RPR results, and if not all women return for treatment. Results The cost?effectiveness of using POC tests is mainly dependent on their cost and sensitivity for high titre active syphilis (HTAS). Savings due to reductions in training and equipment are small. Current POC tests may save more disability?adjusted life years (DALYs) than the RPR test in Mwanza, but the test cost needs to be test worsens by 15% if its HTAS sensitivity had been 75% instead of 86%, and by 25–65% if 20–40% of women had not returned for treatment. In such settings, POC tests could improve cost?effectiveness. Lastly, the cost?effectiveness of POC tests is affected little by the prevalence of syphilis, false RPR?positives, and past infections. Discussion Although the price of most POC tests needs to be reduced to make them as cost?effective as RPR, their simplicity and limited requirements for electricity/equipment suggest their use could improve the coverage of antenatal syphilis screening in developing countries. PMID:17215276

  2. Testing 1985

    ERIC Educational Resources Information Center

    Hunter, William J.; And Others

    1985-01-01

    Presents articles on test anxiety, personality tests, history of tests and benefits to be derived from their use, tests as tools in career decision-making, temperament needs for certain jobs (as determined by personality tests), interest inventories, testing exceptional students, and testing to evaluate vocational needs of special needs groups.…

  3. Thyroid Tests

    MedlinePLUS

    ... on Endocrine and Metabolic Diseases : Thyroid Tests Thyroid Tests On this page: What is the thyroid? What ... Top ] Why do health care providers perform thyroid tests? Health care providers perform thyroid tests to assess ...

  4. Coombs test

    MedlinePLUS

    Direct antiglobulin test; Indirect antiglobulin test ... No special preparation is necessary for this test. ... There are two types of the Coombs test: Direct Indirect The ... that are stuck to the surface of red blood cells. Many diseases ...

  5. Pharmacogenomic Testing

    MedlinePLUS

    ... related screening Reimbursement for Genetic Testing Whole Genome Sequencing Working with healthcare professionals Learn More Pharmacogenomics and ... Testing & Counseling Compensation for Genetic Testing Whole Genome Sequencing Screening vs. Testing What Is Genetic Counseling? Participating ...

  6. Predictive Testing

    MedlinePLUS

    ... help you make the decision. What Is Predictive Genetic Testing Predictive genetic testing searches for genetic changes, or ... Support Group Financial Planning Who Should I Tell? Genetic Testing & Counseling Compensation for Genetic Testing Whole Genome Sequencing ...

  7. Systematic review and meta-analysis of antigen detection tests for the diagnosis of tuberculosis.

    PubMed

    Flores, L L; Steingart, K R; Dendukuri, N; Schiller, I; Minion, J; Pai, M; Ramsay, A; Henry, M; Laal, S

    2011-10-01

    Tests that detect Mycobacterium tuberculosis antigens in clinical specimens could provide rapid direct evidence of active disease. We performed a systematic review to assess the diagnostic accuracy of antigen detection tests for active tuberculosis (TB) according to standard methods and summarized test performance using bivariate random effects meta-analysis. Overall, study quality was a concern. For pulmonary TB (47 studies, 5,036 participants), sensitivity estimates ranged from 2% to 100% and specificity from 33% to 100%. Lipoarabinomannan (LAM) was the antigen most frequently targeted (23 studies, 49%). The pooled sensitivity of urine LAM was higher in HIV-infected than HIV-uninfected individuals (47%; 95% confidence interval [CI], 26 to 68% versus 14%; 95% CI, 4 to 38%); pooled specificity estimates were similar: 96%; 95% CI, 81 to 100% and 97%; 95% CI, 86 to 100%, respectively. For extrapulmonary TB (21 studies, 1,616 participants), sensitivity estimates ranged from 0% to 100% and specificity estimates from 62% to 100%. Five studies targeting LAM, ESAT-6, Ag85 complex, and the 65-kDa antigen in cerebrospinal fluid, when pooled, yielded the highest sensitivity (87%; 95% CI, 61 to 98%), but low specificity (84%; 95% CI, 60 to 95%). Because of the limited number of studies targeting any specific antigen other than LAM, we could not draw firm conclusions about the overall clinical usefulness of these tests. Further studies are warranted to determine the value of LAM detection for TB meningitis in high-HIV-prevalence settings. Considering that antigen detection tests could be translated into rapid point-of-care tests, research to improve their performance is urgently needed. PMID:21832100

  8. Multiplex electrical detection of avian influenza and human immunodeficiency virus with an underlap-embedded silicon nanowire field-effect transistor.

    PubMed

    Kim, Jee-Yeon; Ahn, Jae-Hyuk; Moon, Dong-Il; Park, Tae Jung; Lee, Sang Yup; Choi, Yang-Kyu

    2014-05-15

    The label-free electrical detection of the binding of antibodies and antigens of avian influenza (AI) and human immunodeficiency (HIV) viruses is demonstrated through an underlap-embedded silicon (Si) nanowire field-effect transistor. The proposed sensor was fabricated on a silicon bulk wafer by a top-down process. Specifically, a Si nanowire was fabricated by a combined isotropic and anisotropic patterning technique, which is one route plasma etching process. The sensor was fabricated by a self-aligned process to the gate with tilted implantation, and it allows precise control of the underlap region. This was problematic in earlier underlap field-effect transistors fabricated by a conventional gate-last process. As a sensing metric to detect the binding of a targeted antibody, the transfer characteristic change was traced. Before and after differences between the antibody binding results were caused by changes in the channel potential on the underlap region due to the charge effect arising from the biomolecules; this is also supported by a simulation. Furthermore, the multiplex detection of AI and HIV is demonstrated, showing distinctive selectivity in each case. Thus, the proposed device has inherent benefits for the label-free, electrical, and multiplex detection of biomolecules. Moreover, its processes are compatible with commercialized technology presently used to fabricate semiconductor devices. This advantage is attractive for those involved in the construction of a point-of-care testing (POCT) system on a chip involving simple, low-cost and low-risk fabrication processes of novel structures and materials. PMID:24374298

  9. System for portable nucleic acid testing in low resource settings

    NASA Astrophysics Data System (ADS)

    Lu, Hsiang-Wei; Roskos, Kristina; Hickerson, Anna I.; Carey, Thomas; Niemz, Angelika

    2013-03-01

    Our overall goal is to enable timely diagnosis of infectious diseases through nucleic acid testing at the point-of-care and in low resource settings, via a compact system that integrates nucleic acid sample preparation, isothermal DNA amplification, and nucleic acid lateral flow (NALF) detection. We herein present an interim milestone, the design of the amplification and detection subsystem, and the characterization of thermal and fluidic control and assay execution within this system. Using an earlier prototype of the amplification and detection unit, comprised of a disposable cartridge containing flexible pouches, passive valves, and electrolysis-driven pumps, in conjunction with a small heater, we have demonstrated successful execution of an established and clinically validated isothermal loop-mediated amplification (LAMP) reaction targeting Mycobacterium tuberculosis (M.tb) DNA, coupled to NALF detection. The refined design presented herein incorporates miniaturized and integrated electrolytic pumps, novel passive valves, overall design changes to facilitate integration with an upstream sample preparation unit, and a refined instrument design that automates pumping, heating, and timing. Nucleic acid amplification occurs in a two-layer pouch that facilitates fluid handling and appropriate thermal control. The disposable cartridge is manufactured using low-cost and scalable techniques and forms a closed system to prevent workplace contamination by amplicons. In a parallel effort, we are developing a sample preparation unit based on similar design principles, which performs mechanical lysis of mycobacteria and DNA extraction from liquefied and disinfected sputum. Our next step is to combine sample preparation, amplification, and detection in a final integrated cartridge and device, to enable fully automated sample-in to answer-out diagnosis of active tuberculosis in primary care facilities of low-resource and high-burden countries.

  10. DVD technology-based molecular diagnosis platform: quantitative pregnancy test on a disc.

    PubMed

    Li, Xiaochun; Weng, Samuel; Ge, Bixia; Yao, Zhihui; Yu, Hua-Zhong

    2014-05-21

    A diagnosis platform based entirely on DVD technology was developed for on-site quantitation of molecular analytes of interest, e.g., human chorionic gonadotropin (hCG) in urine samples ("quantitative pregnancy test on a disc"). An hCG-specific monoclonal antibody-binding assay prepared on a regular DVD-R was labeled with nanogold-streptavidin conjugates for signal enhancement with a customized silver-staining protocol. An unmodified, conventional computer optical drive was used for assay reading, and free disc-quality analysis software for data processing. The performance (sensitivity and selectivity) of this DVD assay is comparable to that of well-established colorimetric methods (determination of optical darkness ratios) and standard enzyme-linked immunosorbent assays (ELISA). As validated by examining its linear correlation with the ELISA results on the same set of samples, the DVD assay promises to be a low-cost, multiplex, point-of-care (POC) diagnostic tool for physicians and even for individuals at home, producing prompt results. PMID:24695902

  11. Design and evaluation of a portable optical-based biosensor for testing whole blood prothrombin time.

    PubMed

    Yang, Chin-Lung; Huang, Song-Jeng; Chou, Cheng-Wei; Chiou, Yan-Chao; Lin, Kun-Piao; Tsai, Min-Shiun; Young, Kung-Chia

    2013-11-15

    Point-of-care diagnostics (POCD) for blood coagulation benefit patients on-site, but available POCD devices are too expensive to be affordable in many countries. Optically based methodologies are cheap and reliable, and have been exploited in bench-top coagulometers to monitor coagulation with plasma, but not whole blood, which contains cellular components that cause massive interference. However, the POCD testing of whole blood gives a more accurate picture of physiological conditions than does testing plasma. In this study, a portable device for performing the prothrombin time (PT) test was designed, comprising an optical sensor, an electrical processing and control circuit to monitor the optical changes that occurred during the coagulation process in whole blood. The PT was when the slope of the first-order derivative of the coagulation curve, recorded from real-time light transmittance signals, was maximal. The POCD PT testing of 167 samples revealed that 153 (91.6%) were successfully detected and the results were highly consistent with the results of whole blood international normalized ratio (INR) (r=0.985, p<0.001) by the conventional manual method and those of plasma INR (r=0.948, p<0.001) with the ACL TOP 700 bench-top coagulometer (Beckman Colter). Hematological parameters were further analyzed, revealing that fibrinogen titers (p=0.036), red blood cell numbers (p=0.017) and distribution of red cell width (p=0.015) affected the effectiveness of the current POCD PT determination. Furthermore, a highly positive correlation was revealed between fibrinogen titers and the maximum speed of change in transmittance (v/t) (r=0.805, p<0.001), suggesting that fibrinogen might be evaluated simultaneously in this POCD testing. In conclusion, the proposed portable optical-based device performs the highly sensitive and accurate determination of whole blood PT and has commercial potential because of its small volume and low fabrication cost. PMID:24148464

  12. An acetone breath analyzer using cavity ringdown spectroscopy: an initial test with human subjects under various situations

    NASA Astrophysics Data System (ADS)

    Wang, Chuji; Surampudi, Anand B.

    2008-10-01

    We have developed a portable breath acetone analyzer using cavity ringdown spectroscopy (CRDS). The instrument was initially tested by measuring the absorbance of breath gases at a single wavelength (266 nm) from 32 human subjects under various conditions. A background subtraction method, implemented to obtain absorbance differences, from which an upper limit of breath acetone concentration was obtained, is described. The upper limits of breath acetone concentration in the four Type 1 diabetes (T1D) subjects, tested after a 14 h overnight fast, range from 0.80 to 3.97 parts per million by volume (ppmv), higher than the mean acetone concentration (0.49 ppmv) in non-diabetic healthy breath reported in the literature. The preliminary results show that the instrument can tell distinctive differences between the breath from individuals who are healthy and those with T1D. On-line monitoring of breath gases in healthy people post-exercise, post-meals and post-alcohol-consumption was also conducted. This exploratory study demonstrates the first CRDS-based acetone breath analyzer and its potential application for point-of-care, non-invasive, diabetic monitoring.

  13. TSI test

    MedlinePLUS

    ... test if you have signs or symptoms of: Graves disease Toxic multinodular goiter The test is also done ... the last 3 months of pregnancy to predict Graves disease in the baby. The TSI test is most ...

  14. Genomic Testing

    MedlinePLUS

    ... of Page The Need for Reliable Information on Genetic Testing In 2008, the former Secretary's Advisory Committee on ... this database. Top of Page Learn More About Genetic Testing For Consumers Frequently Asked Questions About Genetic Testing, ...

  15. Magnesium Test

    MedlinePLUS

    ...