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1

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

PubMed

Point-of-care testing (POCT) has revolutionized clinical decision making in the intensive care unit. Much of the credit for successful systems today could not have happened without the vision of the Connectivity Industry Consortium (CIC). The intent of this working group, first convened in 1999, was to ensure that all POCT devices could connect with any data management system, by-passing frustrations and concerns about separate connections, proprietary software, computer modifications, and other barriers to implementation. The CIC believed that the adoption of a common connectivity standard would finally enable hospitals to pursue POCT initiatives without concerns about compatibility of various bedside laboratory devices and hospital data management systems. More than a decade later, some POCT devices are not compliant with the CIC standards, either due to a lack of technological updating or the manufacturer's unwillingness to embrace the fundamental requirements of the CIC standards. Glucose meters, originally connected in the early 1990s, are the most advanced POCT devices, and their relative sophistication is serving as the benchmark for other laboratory instrumentation at the point of care. Through a discussion of the preanalytical, analytical and postanalytical phases of glucose testing, the complexities of POCT will be illustrated, along with factors relating to safety, quality assurance, and patient outcomes. PMID:21407006

Cvitkovic, Michaela

2011-01-01

2

Pharmacist Testers in Multidisciplinary Health care Team Expand HIV Point-of-Care Testing Program.  

PubMed

Knowledge of HIV serostatus is the first step to accessing treatment, reducing transmission, and mitigating public health challenges. We describe the expansion of an HIV point-of-care testing (POCT) program within a health care system utilizing pharmacists as testers. The testing program's expansion is detailed and its impact assessed. The POCT program was evaluated by comparing the number of traditional HIV venipuncture tests to the number of POCTs performed across the health system as well as comparing the number of POCTs performed by clinical pharmacists to the number of tests at other POCT locations. Although pharmacists' contributions to HIV prevention are well documented, pharmacists' involvement in HIV testing initiatives is still nascent. Our POCT program demonstrates an effective HIV testing initiative driven by pharmacists and other health care providers. PMID:24326407

Sherman, Elizabeth M; Elrod, Shara; Allen, Deberenia; Eckardt, Paula

2014-12-01

3

Existing and Emerging Technologies for Point-of-Care Testing  

PubMed Central

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

St John, Andrew; Price, Christopher P

2014-01-01

4

Point-of-care testing informatics.  

PubMed

Managing patient test data and documenting regulatory compliance for tests performed at the point of care have traditionally been significant problems. In many situations, manual record-keeping has proven entirely inadequate for maintaining the integrity of the patient medical record or for providing an audit trail for quality assurance activities. Starting in the 1990s, a number of companies began to develop and market point-of-care data management systems. Over time, these data management systems have become increasingly sophisticated. It is now possible to interface multiple point-of-care devices from different manufacturers to a central data manager that is bidirectionally interfaced to the laboratory and hospital information systems. Despite these advances, many challenges remain. True real-time point-of-care "connectivity" across an entire institution has yet to be achieved, and there is still no satisfactory solution for manually performed visually read tests, some of which are commonly performed at the point of care. In the future, wireless point-of-care connectivity solutions hold great promise, but these technologies are yet to be fully developed. PMID:19840679

Kim, Ji Yeon; Lewandrowski, Kent

2009-09-01

5

[Description of the processes involved in the control of point-of-care testing].  

PubMed

Compliance to EN ISO 22870 standard for point-of-care testing (POCT) accreditation is close to those of EN ISO 15189 in central laboratory. However, it is mandatory to master the elements which are specific to POCT. In this paper, we describe the two main processes involved to help medical biologists to achieve standard requirements, particularly in the risk assessment study. The first process concerns the deployment of a POCT device in a hospital outside laboratory and the second is the classical process of medical biology testing, outlining the steps which are different from the laboratory testing process. Furthermore, we reference, in front of each sub-process described, the different articles published in the present volume detailing specific guidelines to master them. PMID:22736701

Vaubourdolle, M; Annaix, V; Goudable, J; Pernet, P

2012-02-01

6

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

PubMed

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

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

2010-07-01

7

Perceptions of an Ideal Point-of-Care Test for Sexually Transmitted Infections - A Qualitative Study of Focus Group Discussions with Medical Providers  

Microsoft Academic Search

BackgroundA point-of-care test (POCT) for sexually transmitted infections (STIs), which offers immediate diagnosis resulting in patients receiving diagnosis and treatment in a single visit, has the ability to address some of the STI control needs. However, needs assessment from STI experts and end users about currently available STI POCTs and their future new development has not been evaluated since World

Yu-Hsiang Hsieh; M. Terry Hogan; Mathilda Barnes; Mary Jett-Goheen; Jill Huppert; Anne M. Rompalo; Charlotte A. Gaydos; Patricia Kissinger

2010-01-01

8

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

PubMed Central

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

Parco, Sergio; Visconti, Patrizia; Vascotto, Fulvia

2014-01-01

9

Medical, economic, and regulatory factors affecting point-of-care testing. A report of the conference on factors affecting point-of-care testing, Philadelphia, PA 6-7 May 1994.  

PubMed

On 6-7 May 1994, the National Academy of Clinical Biochemistry sponsored a conference on point-of-care testing (POCT) in Philadelphia, PA. Several other organizations including the American Association for Clinical Chemistry, the Centers for Disease Control and Prevention, the Clinical Laboratory Management Association, the National Laboratory Training Network Eastern Area Resource Office, and Thomas Jefferson University co-sponsored the program, which brought together approximately 225 healthcare professionals involved in the decision making processes of implementing and overseeing POCT. These individuals included clinical chemists, medical technologists, clinicians, pathologists, nurse managers, respiratory therapists, laboratory and hospital administrators, and manufacturers of point-of-care devices. The conference focused primarily on the critical care setting, but some attention was given to the more general patient setting. The panelists assessed POCT from four perspectives: (1) medical aspects, (2) delivery options for achieving rapid turn-around time, (3) the economics of the different delivery options, and (4) legislative, regulatory, and legal issues. At the completion of the meeting, areas of agreement and disagreement were summarized. In addition, areas requiring further research and standardization were delineated. The impact of the conference on laboratory practices was evaluated by means of a questionnaire sent to hospital-based healthcare personnel approximately 6 months after the meeting. PMID:8737588

Seamonds, B

1996-05-30

10

Paper based point-of-care testing disc for multiplex whole cell bacteria analysis.  

PubMed

Point-of-care testing (POCT) of infectious bacterial agents offers substantial benefits for disease diagnosis, mainly by shortening the time required to obtain results and by making the test available bedside or at remote care centers. Immunochromatographic lateral flow biosensors offer a low cost, highly sensitive platform for POCT. In this article, we describe the fabrication and testing of a multiplex immuno-disc sensor for the specific detection of Pseudomonas aeruginosa and Staphylococcus aureus. Antibody conjugated gold nanoparticles were used as the signaling agents. The detection range of the bacteria lies within 500-5000 CFU/ml. The advantage of the immuno-disc sensor is that it does not require any preprocessing of biological sample and is capable of whole cell bacterial detection. We also describe the design and fabrication of a compact portable device which converts the color intensity of the gold nanoparticles that accumulate at the test region into a quantitative voltage reading proportional to the bacterial concentration in the sample. The combination of the immuno-disc and the portable color reader provides a rapid, sensitive, low cost, and quantitative tool for the detection of a panel of infectious agents present in the patient sample. PMID:21592765

Li, Chen-zhong; Vandenberg, Katherine; Prabhulkar, Shradha; Zhu, Xuena; Schneper, Lisa; Methee, Kalai; Rosser, Charles J; Almeide, Eugenio

2011-07-15

11

The implementation of an external quality assurance method for point- of- care tests for HIV and syphilis in Tanzania  

PubMed Central

Background External quality assurance (EQA) programmes, which are routinely used in laboratories, have not been widely implemented for point-of- care tests (POCTs). A study was performed in ten health centres in Tanzania, to implement the use of dried blood spots (DBS) as an EQA method for HIV and syphilis (POCTs). Method DBS samples were collected for retesting at a reference laboratory and the results compared to the POCT results obtained at the clinic. In total, 2341 DBS samples were collected from 10 rural health facilities over a period of nine months, of which 92.5% were correctly collected and spotted. Results The EQA method was easily implemented by healthcare workers under routine conditions in Northern Tanzania. For HIV, 967 out of 972 samples (99.5%) were concordant between DBS and POCT results. For syphilis, the sensitivity of syphilis tests varied between clinics with a median of 96% (25th and 75th quartile; 95-98%). The specificity of syphilis POCT was consistent compared to laboratory based test using DBS, with a median of 96% (25th and 75th quartiles; 95-98%). Conclusion Overall, the quality of testing varied at clinics and EQA results can be used to identify clinics where healthcare workers require remedial training, suggesting the necessity for stringent quality assurance programmes for POC testing. As Tanzania embarks on scaling up HIV and syphilis testing, DBS can be a useful and robust tool to monitor the quality of testing performed by healthcare workers and trigger corrective action to ensure accuracy of test results. PMID:24206624

2013-01-01

12

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

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.

Davis, Konrad; Helman, Donald; Abadie, Jude

2014-01-01

13

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

PubMed

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

Kost, Gerald J; Tran, Nam K

2005-11-01

14

Point-of-Care Testing of Hemostasis in Cardiac Surgery  

PubMed Central

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

Prisco, Domenico; Paniccia, Rita

2003-01-01

15

Point-of-care testing of cholesterol and triglycerides for epidemiologic studies: evaluation of the multicare-in system.  

PubMed

Cardiovascular disease is the leading cause of death in the world with 80% of cardiovascular events that occur in low- and middle-income countries. Reliable data on the prevalence of risk factors in developing countries can be obtained in door-to-door epidemiologic studies with the use of automatic instruments. This study was performed to assess the sensitivity and specificity of a low-cost and manageable point-of-care testing (POCT) instrument (HPS MultiCare-in, Italy) for cholesterol and triglyceride assays. Plasma blood samples were obtained from consecutive subjects referred to our clinic for diagnostic evaluation. The analyzer currently used in our central laboratory (ADVIA 2400; Siemens, Deerfield, Ill) was used as comparison method. The inter-assay imprecision (expressed as variation coefficient) of the MultiCare POCT system was 4.51% (range, 2.38%-8.54%) and was 3.29% (range, 1.06%-7.45%) for cholesterol and triglycerides systems, respectively. The mean percent bias for capillary samples was 3.5 +/- 4.3% for total cholesterol and -2.4 +/- 4.9% for triglycerides. The difference in results obtained by nonprofessionals compared with professionals (practicability testing) was 0.28 +/- 7.61% and 1.26 +/- 9.86%, respectively (P value was nonsignificant for both). Sensitivity and specificity measurements were 95.7% and 61.9% (threshold value of cholesterol 190 mg/dL) and 98% and 93.5% (threshold value of triglycerides 170 mg/dL), respectively. POCT instruments are essential to perform epidemiologic studies while avoiding transportation and storage of biologic material. The characteristics of sensitivity and specificity as well as diagnostic accuracy make the POCT instrument useful for obtaining an accurate stratification of a study population. PMID:19138651

Rapi, Stefano; Bazzini, Cristina; Tozzetti, Camilla; Sbolci, Valentina; Modesti, Pietro Amedeo

2009-02-01

16

Economic Evidence and Point-of-Care Testing.  

PubMed

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

St John, Andrew; Price, Christopher P

2013-08-01

17

Point-of-care nucleic acid testing for infectious diseases  

PubMed Central

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

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

2013-01-01

18

Diagnostic accuracy of point-of-care testing for acute coronary syndromes, heart failure and thromboembolic events in primary care: a cluster-randomised controlled trial  

PubMed Central

Background Evidence of the clinical benefit of 3-in-1 point-of-care testing (POCT) for cardiac troponin T (cTnT), N-terminal pro-brain natriuretic peptide (NT-proBNP) and D-dimer in cardiovascular risk stratification at primary care level for diagnosing acute coronary syndromes (ACS), heart failure (HF) and thromboembolic events (TE) is very limited. The aim of this study is to analyse the diagnostic accuracy of POCT in primary care. Methods Prospective multicentre controlled trial cluster-randomised to POCT-assisted diagnosis and conventional diagnosis (controls). Men and women presenting in 68 primary care practices in Zurich County (Switzerland) with chest pain or symptoms of dyspnoea or TE were consecutively included after baseline consultation and working diagnosis. A follow-up visit including confirmed diagnosis was performed to determine the accuracy of the working diagnosis, and comparison of working diagnosis accuracy between the two groups. Results The 218 POCT patients and 151 conventional diagnosis controls were mostly similar in characteristics, symptoms and pre-existing diagnoses, but differed in working diagnosis frequencies. However, the follow-up visit showed no statistical intergroup difference in confirmed diagnosis frequencies. Working diagnoses overall were significantly more correct in the POCT group (75.7% vs 59.6%, p = 0.002), as were the working diagnoses of ACS/HF/TE (69.8% vs 45.2%, p = 0.002). All three biomarker tests showed good sensitivity and specificity. Conclusion POCT confers substantial benefit in primary care by correctly diagnosing significantly more patients. Trial registration DRKS: DRKS00000709 PMID:21435203

2011-01-01

19

Au@Pt Nanoparticle Encapsulated Target-Responsive Hydrogel with Volumetric Bar-Chart Chip Readout for Quantitative Point-of-Care Testing.  

PubMed

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

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

2014-11-10

20

[Usefulness of POCT in critical care medicine].  

PubMed

The need for speedy and accurate test results is becoming increasingly urgent in the areas of emergency medicine and ICU. The form of emergency testing is changing from conventional testing conducted by laboratory technicians to point-of-care testing (POCT) performed by the doctor or nurse. Therefore, the skill and time of the technician, which used to be expended for emergency testing, is now utilized for maintenance and precision control of POCT equipment so that the doctors and nurses can conduct POCT with confidence at all times. We also attempted point of prehospital care testing (POPCT), comprised of prehospital care and POCT. Here, the laboratory technician rides with the doctor to provide patient information to the clinicians from the perspective of a laboratory technician in the field to support emergency treatment. This has not yet been made fully practical, but the usefulness of POCT in critical care medicine seems to be essential to the forthcoming advanced emergency medicine, considering its usefulness outside the hospital environment. PMID:10639820

Fukuda, A; Ishida, H; Kubota, M; Kojima, Y

1999-12-01

21

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

E-print Network

to the development of dip stick devices, and these devices evolved to self-contained lateral flow tests (eMicrofluidics and point-of-care testing DOI: 10.1039/b817915h In many ways, the intrinsic features of microfluidics are a natural fit for a point- of-care (POC) diagnostics device (i.e. a diagnostic test performed

Sia, Samuel K.

22

Feasibility of Performing Multiple Point of Care Testing for HIV Anti-Retroviral Treatment Initiation and Monitoring from Multiple or Single Fingersticks  

PubMed Central

Background Point of Care testing (POCT) provides on-site, rapid, accessible results. With current South African anti-retroviral treatment guidelines, up to 4 fingersticks /patient/clinic visit could be required if utilizing POC. We determined the feasibility and accuracy of a nurse performing multiple POCT on multiple fingersticks followed by simplification of the process by performance of multiple POC on a single fingerstick. Method and Findings Random HIV positive adult patients presenting at a HIV treatment clinic in South Africa, for ART initiation/ monitoring, were approached to participate in the study between April-June 2012. Phase I: n=150 patients approached for multiple POCT on multiple fingersticks. Phase II: n=150 patients approached for multiple POCT on a single fingerstick. The following POC tests were performed by a dedicated nurse: PIMA (CD4), HemoCue (hemoglobin), Reflotron (alanine aminotransferase, creatinine). A venepuncture specimen was taken for predicate laboratory methodology. Normal laboratory ranges and Royal College of Pathologists Australasia (RCPA) allowable differences were used as guidelines for comparison. In 67% of participants, ?3 tests were requested per visit. All POCT were accurate but ranged in variability. Phase I: Hemoglobin was accurate (3.2%CV) while CD4, alanine aminotransferase and creatinine showed increased variability (16.3%CV; 9.3%CV; 12.9%CV respectively). PIMA generated a misclassification of 12.4%. Phase II: Hemoglobin, alanine aminotransferase and creatinine showed good accuracy (3.2%CV, 8.7%CV, 6.4%CV respectively) with increased variability on CD4 (12.4%CV) but low clinical misclassification (4.1%). No trends were observed for the sequence in which POC was performed on a single fingerstick. Overall, PIMA CD4 generated the highest error rate (16-19%). Conclusions Multiple POCT for ART initiation and/or monitoring can be performed practically by a dedicated nurse on multiple fingersticks. The process is as accurate as predicate methodology and can be simplified using a single fingerstick. PMID:24376873

Gous, Natasha; Scott, Lesley; Potgieter, Joachim; Ntabeni, Lumka; Enslin, Sharon; Newman, Ronel; Stevens, Wendy

2013-01-01

23

Documentation of Quality Control and Operator Training at Point-of-Care Testing: A College of American Pathologists Q-Probes Study of 106 Institutions.  

PubMed

Context .- Operator training, quality control, and proper follow-up for out-of-range quality control (QC) events are crucial steps that must be adequately performed and documented to ensure excellent patient care and regulatory compliance. Objective .- To examine point-of-care testing (POCT) personnel training and QC documentation/compliance. Design .- Participants in a POCT documentation study of the College of American Pathologists Q-Probes program collected data retrospectively for glucose and urine dipstick testing regarding test operators, operator competency assessment, and QC documentation. Documentation was assessed for participant adherence to 4 quality indicators: (1) whether test operator training was up to date, (2) whether the test operator names were noted in the test records, (3) whether QC was performed, and (4) whether out-of-range QC events were followed up. Data were analyzed for associations with institutional demographic and practice variables. Results .- The institutional median number of POCT personnel was 648 for blood glucose and 76 for urine dipstick testing, with a median number of 105?948 glucose tests and 9113 urine tests performed. Ninety-four percent (3830 of 4074) of the test operators completed training or competency assessment within the prior 12 months, 96.8% (21?603 of 22?317) of the test records documented the operator, and 95.7% (19?632 of 20?514) of the expected QC events (per institutional regulations) were documented. Approximately 3% (659 of 20?514) of the QC events were outside the designated range (an average of 6 out-of-range QC events were identified per institution [n = 106]). Of the out-of-range QC events, 92.6% (610 of 659) had documentation of appropriate follow-up. Most laboratories (176 of 179; 98.3%) violated specimen requirements by storing POCT urine specimens for less than 24 hours. Conclusions .- There was greater than 90% compliance for POCT documentation and nearly 96% of expected QC events were properly documented. PMID:25357106

Dyhdalo, Kathryn S; Howanitz, Peter J; Wilkinson, David S; Souers, Rhona J; Jones, Bruce A

2014-11-01

24

Expanding HIV rapid testing via point-of-care paraprofessionals.  

PubMed

HIV counselling and testing has traditionally been performed by highly trained professionals in clinical settings. With HIV rapid testing, a reliable and easy to use diagnostic tool, paraprofessionals can be trained to administer on-site HIV testing in a variety of non-traditional settings, broadening the HIV detection rates. Our objective was to create a robust and sustainable paraprofessional training module to facilitate off-site HIV rapid testing in non-clinical settings. Trainees attended a series of training sessions involving HIV education, rapid test instructions and communication techniques. After these sessions, trainees competently carried out HIV rapid testing in homeless shelters throughout the Los Angeles county. Agencies motivated to expand HIV screening programmes may use trained paraprofessionals to administer a full range of services (recruitment, pretest counselling, test administration, interpretation of results, post-test counselling and documentation) through this training model and enabling more highly trained healthcare providers to focus efforts on patients identified as HIV-positive. PMID:18725556

Knapp, Herschel; Anaya, Henry D; Feld, Jamie E

2008-09-01

25

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

PubMed Central

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

Park, Ki Sang; Heo, Hyuk

2013-01-01

26

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

PubMed Central

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

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

2013-01-01

27

Towards a point-of-care test for active tuberculosis: obstacles and opportunities  

Microsoft Academic Search

Limited access to diagnostic services and the poor performance of current tests result in a failure to detect millions of tuberculosis cases each year. An accurate test that could be used at the point of care to allow faster initiation of treatment would decrease death rates and could reduce disease transmission. Previous attempts to develop such a test have failed,

Peter Daley; Ruth McNerney

2011-01-01

28

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

PubMed Central

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

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

29

Trends in miniaturized total analysis systems for point-of-care testing in clinical chemistry  

Microsoft Academic Search

A currently emerging approach enables more widespread monitoring of health parameters in disease prevention and biomarker monitoring. Miniaturisation provides the means for the production of small, fast and easy-to-operate devices for reduced-cost healthcare testing at the point-of-care (POC) or even for household use. A critical overview is given on the present state and requirements of POC testing, on µTAS elements

Anna J. Tudos; Geert A. J. Besselink; Richard B. M. Schasfoort

2001-01-01

30

[Guidelines for point-of-care testing quality management according to ISO 22870].  

PubMed

In this paper, we focus on the additional requirements of EN ISO 22870 compared to those described in Chapter 4: Quality Management of EN ISO 15189. They concern the quality policy, the management reviews and the audits. Thus, we propose a template of quality policy statement, and specific requirements for conducting management review of POCT are given. Finally, a questionnaire for performing an audit of POCT activities is proposed. The composition and activities of the multidisciplinary group for the supervision of POCT activities, which is also a specific requirement of EN ISO 22870, is discussed in another article of this volume. PMID:22736704

Pernet, P; Szymanowicz, A; Oddoze, C; Vassault, A; Annaix, V; Gruson, A; Boisson, M

2012-02-01

31

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

PubMed Central

Point-of-care (POC) tests are an important strategy to address the epidemic of sexually transmitted infections (STIs) among both adolescents and young adults. While access to care and confidentiality are major barriers to STI care, POC tests allow the clinician to provide immediate and confidential test results and treatment. In addition, POC test results constitute a “teachable moment”; that is, an opportunity to provide immediate feedback to the patient that may impact his/her risk behaviors. This paper reviews published data and manufacturer’s product literature describing current point-of-care STI tests, including studies of test performance as well as impact on treatment intervals and disease spread. It presents theoretical and proposed pitfalls and solutions of implementing POC tests in clinical settings, non-traditional settings, and home care venues. We reviewed the available STI tests according to the World Health Organization (WHO) criteria for judging POC tests: the “ASSURRED” criteria (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment-free, Delivered). PMID:20401167

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

2010-01-01

32

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

PubMed Central

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

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

2013-01-01

33

Simple, rapid, and affordable point-of-care test for the serodiagnosis of typhoid fever.  

PubMed

We developed a point-of-care test for the serodiagnosis of typhoid fever in the format of an immunochromatographic lateral flow assay. The flow assay for typhoid fever is based on the detection of Salmonella enterica serotype Typhi lipopolysaccharide-specific immunoglobulin M (IgM) antibodies. The assay was evaluated on serum samples collected in a hospital in South Sulawesi, Indonesia, where typhoid fever is endemic, and the results were compared with culture and Widal test. The sensitivity of this typhoid fever IgM flow assay for samples collected at 1st diagnosis from patients with culture-confirmed typhoid fever was determined to be 59.3%. The sensitivity ranged from 41.2% to 89.5%, depending on the duration of illness. A specificity of 97.8% was calculated based on results obtained for patients with clinical suspicion of typhoid fever that was later excluded. The assay is ideal for use as a point-of-care test in health care centers that lack the expertise and facilities to perform culture or the less specific Widal test. Because of its simplicity, the assay may also be used as a field test in remote areas. PMID:18276100

Pastoor, Rob; Hatta, Mochammad; Abdoel, Theresia H; Smits, Henk L

2008-06-01

34

Development of a digital microfluidic platform for point of care testing  

PubMed Central

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

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

2009-01-01

35

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

PubMed

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

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

2013-04-15

36

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

PubMed

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

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

2014-01-01

37

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

PubMed Central

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

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

2014-01-01

38

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

PubMed

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

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

2014-08-01

39

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

PubMed Central

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

Blacksell, Stuart D.

2012-01-01

40

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

PubMed

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

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

2014-01-01

41

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

PubMed Central

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

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

2014-01-01

42

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

PubMed Central

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

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

2013-01-01

43

Integrated point of care testing system based on low cost polymer biochips  

NASA Astrophysics Data System (ADS)

A new diagnostic testing device is proposed for point of care (POC) applications. It consists of a microfluidic cartridge with a polymer biochip and an instrument for reading the biochip and controlling the microfluidics. This system allows a very easy determination of several parameters e.g. in patients blood automatically. The biochip is made of a thin polymer foil serving as waveguiding element and as carrier for the receptors on the biochip surface. A sensitive TIRF (total internal reflection fluorescence) readout is realised. Optical elements for incoupling and outcoupling of light are integrated into the foil. Beside the TIRF element, the disposable microfluidic cartridge integrates a sample inlet, several reservoirs for reagents, fluidic microchannels and electrochemical micropumps. Sandwich assays for the detection of clinically relevant parameters have been investigated. This hardware configuration forms the basis for a fully automated compact low cost device using cost efficient disposables.

Brandenburg, Albrecht; Curdt, Franziska; Nestler, Joerg; Otto, Thomas; Wunderlich, Kai; Michel, Dirk

2009-02-01

44

The impact of inpatient point-of-care blood glucose quality control testing.  

PubMed

Analyze the effectiveness of mandated point-of-care (POC) blood glucose (BG) meter quality control (QC) testing. All POC BG QC tests were analyzed to evaluate operator and strip/meter error rates and institutional cost. POC BG QC test failure (17/103,580 over 24 months) was low and no meters failed subsequent linearity testing. Examining individual QC measures shows that operator error occurs frequently and total error rate is related to QC familiarity (>50 QC tests/month, 2.4%; <50 QC tests/month, 3.8%, p < .001). Even among the most competent operators, strip/meter error (1.2 ± 0.3%) accounted for 50% of total error. Compared with manufacturer-recommended QC testing, Joint Commission mandated POC BG QC testing during 2008/2009 incurred excess costs of approximately US$127,000. POC BG meter failure within current guidelines is rare and does not justify the cost of daily QC testing. Frequent QC testing can identify operators needing retraining in POC testing. Strip/meter QC errors are common, are not prevented by current QC testing standards, and may contribute to clinical errors. PMID:22812686

Corl, Dawn E; Yin, Tom S; Hoofnagle, Andrew N; Whitney, Joanne D; Hirsch, Irl B; Wisse, Brent E

2012-01-01

45

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

PubMed Central

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

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

2014-01-01

46

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

PubMed Central

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

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

2013-01-01

47

Point-of-Care Testing at the Disaster-Emergency-Critical Care Interface  

PubMed Central

Point-of-care (POC) testing allows for medical testing to be performed across the disaster-emergency-critical care continuum. The disaster-emergency-critical care continuum begins with the identification of at-risk patients, followed by patient stabilization, and ultimately transfer to an alternate care facility or mobile hospital for comprehensive critical care. Gaps at the interfaces for each of these settings leads to excess mortality and morbidity. Disaster victims are at risk for acute myocardial infarctions, acute kidney injury (AKI), and sepsis. However cardiac biomarker testing, renal function testing, and multiplex rapid pathogen detection are often unavailable or inadequate during disasters. Cardiac biomarker reagents require refrigeration; traditional renal function tests (i.e., serum creatinine) exhibit poor sensitivity for predicting AKI in critically ill patients, and culture-based pathogen detection is too slow to help initiate early-directed antimicrobial therapy. We propose three value propositions detailing how rapid, POC, and environmentally hardened cardiac biomarker, AKI and multiplex pathogen testing harmonizes the interface between disaster, emergency, and critical care. PMID:24039548

Tran, Nam K.; Godwin, Zachary; Bockhold, Jennifer

2013-01-01

48

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

NASA Astrophysics Data System (ADS)

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

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

2010-05-01

49

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

PubMed Central

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

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

2012-01-01

50

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

PubMed Central

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

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

2014-01-01

51

Point-of-care diagnostics - is this driven by supply or demand?  

PubMed

The diagnostic point-of-care testing (POCT) market is about one-third of the in vitro diagnostic (IVD) testing market but, although there are many different POCT products, most are for pregnancy and monitoring of diabetes (? 70% of all POCT). Despite the small contribution outside these areas there is huge investment from both suppliers and users of POCT to establish new products and increase the infrastructure for their use. The review is focused on determining the balance between the different drivers of supply and demand and how they have impacted the conflicts seen in POCT evolution. The conflicts have been based on a mix of analytical, regulatory, political and commercial aspects and here the supply and demand drivers are examined separately to determine whether the conflicts are real or whether there are hidden synergies. The focus is on recent publications, with reference to some key historical articles, so that the full environment can be assessed. It is concluded that the synergies between supply and demand now overcome the conflicts where clinical and economic benefit can be demonstrated. PMID:23488530

Huckle, D

2010-05-01

52

Point-of-care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy.  

PubMed

OBJECTIVES To identify opportunities to perform point-of-care (POC) testing and/or screening for infectious diseases in community pharmacies, provide an overview of such tests and how they are used in current practice, discuss how the Clinical Laboratory Improvement Amendments of 1988 (CLIA) affect pharmacists performing POC testing, and identify and discuss barriers and provide recommendations for those wanting to establish POC testing for infectious diseases services in community pharmacies. DATA SOURCES PubMed and Google Scholar were searched from November 2012 through May 2013 and encompassed the years 2000 and beyond for the narrative review section of this article using the search terms rapid diagnostic tests, POC testing and infectious diseases, pharmacy services, CLIA waiver, and collaborative drug therapy management. All state boards of pharmacy in the United States were contacted and their regulatory and legislative websites accessed in 2012 and January 2013 to review relevant pharmacy practice laws. DATA SYNTHESIS POC testing for infectious diseases represents a significant opportunity to expand services in community pharmacies. Pharmacist education and training are addressing knowledge deficits in good laboratory practices and test performance and interpretation. Federal regulations do not define the qualifications for those who perform CLIA-waived tests, yet few pharmacists perform such services. Fewer than 20% of states address POC testing in their statutes and regulations governing pharmacy. CONCLUSION POC testing for infectious diseases could benefit patients and society and represents an opportunity to expand pharmacy services in community pharmacies. Existing barriers to the implementation of such services in community pharmacies, including deficits in pharmacist training and education along with state regulatory and legislative variance and vagueness in statutes governing pharmacy, are not insurmountable. PMID:24632931

Gubbins, Paul O; Klepser, Michael E; Dering-Anderson, Allison M; Bauer, Karri A; Darin, Kristin M; Klepser, Stephanie; Matthias, Kathryn R; Scarsi, Kimberly

2014-01-01

53

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

PubMed

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

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

54

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

PubMed Central

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

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

2012-01-01

55

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

PubMed Central

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

2013-01-01

56

Point-of-care versus central laboratory testing: an economic analysis in an academic medical center.  

PubMed

A cost-effectiveness study was conducted to determine time and labor costs for point-of-care (POC) versus central laboratory testing. A prospective, observational time and motion study was carried out at a teaching hospital located in Philadelphia, Pennsylvania. The cohort consisted of 210 patients presenting to the emergency department who were triaged at the urgent or emergent level during a 4-week period. Patients who had blood drawn for a seven-chemistry profile (Chem-7), which includes analysis of sodium, potassium, chloride, carbon dioxide, blood urea nitrogen, glucose, and creatinine, or for cell blood count (CBC) tests as part of regular care, also had an additional split sample drawn for POC analysis of sodium, potassium, chloride, blood urea nitrogen, glucose, and/or hematocrit. Blood drawn for POC analysis did not require additional needlestick(s), nor did it alter regular care procedures. Physicians and all emergency department staff participating in the care of the patients were blinded to POC test results. Main outcome measures included test turn-around time (TAT), physician determination of impact of rapid TAT and laboratory values on therapeutic approach, and cost per test for POC versus central laboratory testing. POC TAT was a mean of 8 minutes (time from blood drawn to results shown on the POC device display). Central laboratory TAT was a mean of 59 minutes (time from blood drawn to entry of results into mainframe computer). Therapeutic TAT was a mean of 1 hour and 25 minutes (time from blood drawn to analysis in central laboratory, to when the physician viewed test results). After therapeutic course of care was decided for the patient, physicians reported that POC testing, independent of other rate-limiting steps, would have resulted in earlier therapeutic action for 40 of 210 (19.0%) patients. The cost per test for Chem-7 and CBC tests was $11.14 and $9.48, respectively. The cost per test for POC analysis ranged from $14.37 to $16.67, depending on the POC test volume (estimated volume based on 20% to 50% of emergency department patients that had either Chem-7 or CBC test done applied over the useful life of the POC testing equipment) and the personnel (nurse or emergency department technician) who performed the test. With an increasing volume of POC tests performed per unit time, costs for POC testing would be reduced substantially. POC test costs are volume dependent under current reimbursement mechanisms for emergency department patient care services, for example, fee-for-service payment.(ABSTRACT TRUNCATED AT 400 WORDS) PMID:7859247

Tsai, W W; Nash, D B; Seamonds, B; Weir, G J

1994-01-01

57

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

PubMed

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

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

2014-10-01

58

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

NASA Astrophysics Data System (ADS)

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.

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

59

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

PubMed Central

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

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

2012-01-01

60

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

PubMed

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

Park, Jason Y; Kricka, Larry J

2014-09-01

61

Point of care testing for antiretroviral therapy-related lactic acidosis in resource-poor settings.  

PubMed

Lactic acidosis is a rare but potentially life-threatening complication of antiretroviral therapy (ART) and is commonly considered in the differential diagnosis of patients on ART. In the developing world, definitive diagnosis by laboratory measurement of lactate may be impossible. Point-of-care devices are available that provide simple, accurate measurements of lactic acid levels at relatively low cost. Their use in an HIV treatment programme in rural Haiti has greatly assisted clinical decision-making in patients with symptoms suggestive of lactic acidosis. PMID:16514312

Ivers, Louise C; Mukherjee, Joia S

2006-03-21

62

Could point-of-care testing be effective for reducing the prevalence of trichomoniasis in remote Aboriginal communities?  

PubMed

High prevalence of trichomoniasis is reported for many remote Indigenous communities despite intensive screening and treatment programs. Mathematical modelling has previously been used to show that point-of-care (POC) testing for gonorrhoea and chlamydia has the potential to increase the impact of screening in reducing the prevalence of these sexually transmissible infections. The study was extended to estimate the impact of a rapid POC test for trichomoniasis. The results suggest that POC testing in place of conventional testing will also provide additional reductions in trichomoniasis prevalence. However, more emphasis should be placed on testing for trichomoniasis in older women due to the high prevalence observed in this group. PMID:25141073

Hui, Ben B; Ward, James; Causer, Louise; Guy, Rebecca J; Law, Matthew G; Regan, David G

2014-09-01

63

A newly designed optical biochip for a TDM-POCT device  

NASA Astrophysics Data System (ADS)

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

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

2014-03-01

64

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

PubMed Central

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

Kapoor, Dheeraj; Srivastava, Meghana; Singh, Pritam

2014-01-01

65

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

PubMed

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

Kapoor, Dheeraj; Srivastava, Meghana; Singh, Pritam

2014-07-01

66

[Advance in loop-mediated isothermal amplification technique and its applications in point-of-care testing platforms].  

PubMed

Loop-mediated isothermal amplification (LAMP) is a novel in vitro nucleic acid amplification method conducted under isothermal conditions with the advantages of high specificity, sensitivity, rapidity and easy detection. Since it was established in 2000, it has been widely applied in various fields of analytical science including the diagnosis of a variety of pathogens, identification of embryo sex, detection of genetically modified organisms and cancer gene identification. Additionally, significant progress has been made in the optimization of the LAMP method, such as accelerated reactions, simplified sample processing, the realization of multiplex amplification, and the enhanced specificity of reaction and detection methods. LAMP technology also shows much potential to be adopted as part of point-of-care testing platforms by the micromation, automation and integration with other technologies such as Lab-on-a-Chip and digital nucleic acid amplification. This review summarizes the latest advances in the LAMP technique and its applications in developing point-of-care testing platforms. PMID:25272605

Guan, Li; Ma, Xue-Jun

2014-07-01

67

Sensitivity of a point of care tick-test for the development of Lyme borreliosis  

PubMed Central

Background A commercially available self-test for the detection of Borrelia burgdorferi sensu lato in ticks was evaluated for its ability to predict erythema migrans formation. Findings The self-test was performed on 127 Ixodes ricinus from 122 humans that reported tick bites at enrolment and occurrence of symptoms during follow-up. The self-test gave negative results on all the 122 individuals, 14 of whom reported erythema migrans (EM) at follow-up of which 10 were confirmed by their GP. The estimated sensitivity of the self-test for prediction of EM formation is 0% (95% CI: 0%-28%). Conclusions This self-test is not suitable for reducing the number needed to treat in a post-exposure prophylaxis setting as it already missed all the obvious early Lyme borreliosis cases. PMID:24304944

2013-01-01

68

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

PubMed

Abstract Overcrowding of the emergency department (ED) is rapidly becoming a global challenge and a major source of concern for emergency physicians. The evaluation of cardiac biomarkers is critical for confirming diagnoses and expediting treatment decisions to reduce overcrowding, however, physicians currently face the dilemma of choosing between slow and accurate central-based laboratory tests, or faster but imprecise assays. With improvements in technology, point-of-care testing (POCT) systems facilitate the efficient and high-throughput evaluation of biomarkers, such as troponin (cTn), brain natriuretic peptide (BNP) and neutrophil gelatinase-associated lipocalin (NGAL). In this context, POCT may help ED physicians to confirm a diagnosis of conditions, such as acute coronary syndrome, heart failure or kidney damage. Compared with classic laboratory methods, the use of cTn, BNP, and NGAL POCT has shown comparable sensitivity, specificity and failure rate, but with the potential to provide prompt and accurate diagnosis, shorten hospital stay, and alleviate the burden on the ED. Despite this potential, the full advantages of rapid delivery results will only be reached if POCT is implemented within hospital standardized procedures and ED staff receive appropriate training. PMID:24864300

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

2014-10-01

69

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

PubMed Central

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

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

70

Cost-effectiveness of point-of-care C-reactive protein testing to inform antibiotic prescribing decisions  

PubMed Central

Background Point-of-care C-reactive protein (POCCRP) is a biomarker of inflammation that offers clinicians a rapid POC test to guide antibiotic prescribing decisions for acute cough and lower respiratory tract infections (LRTI). However, evidence that POCCRP is cost-effective is limited, particularly outside experimental settings. Aim To assess the cost-effectiveness of POCCRP as a diagnostic tool for acute cough and LRTI from the perspective of the health service. Design and setting Observational study of the presentation, management, and outcomes of patients with acute cough and LRTI in primary care settings in Norway and Sweden. Method Using hierarchical regression, data were analysed in terms of the effect on antibiotic use, cost, and patient outcomes (symptom severity after 7 and 14 days, time to recovery, and EQ-5D), while controlling for patient characteristics (self-reported symptom severity, comorbidities, and health-related quality of life) at first attendance. Results POCCRP testing is associated with non-significant positive reductions in antibiotic prescribing (P = 0.078) and increased cost (P = 0.092). Despite the uncertainty, POCCRP testing is also associated with a cost per quality-adjusted life year (QALY) gain of €9391. At a willingness-to-pay threshold of €30 000 per QALY gained, there is a 70% probability of CRP being cost-effective. Conclusion POCCRP testing is likely to provide a cost-effective diagnostic intervention both in terms of reducing antibiotic prescribing and in terms of QALYs gained. PMID:23834883

Oppong, Raymond; Jit, Mark; Smith, Richard D; Butler, Christopher C; Melbye, Hasse; Molstad, Sigvard; Coast, Joanna

2013-01-01

71

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

PubMed Central

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

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

2014-01-01

72

Field performance of a rapid point-of-care diagnostic test for antenatal syphilis screening in the Amazon region, Brazil.  

PubMed

We evaluated an immunochromatographic point-of-care (POC) syphilis test in 712 pregnant women under field conditions in remote communities of the Amazon region (Brazil), and identified risk factors for syphilis. Women were screened by POC test using whole blood obtained by fingerprick, the fluorescent treponemal antibody absorption (FTA-Abs) test as the gold standard and the Venereal Diseases Research Laboratory (VDRL) test to determine test performance in active syphilis. Multivariate analysis was conducted to identify factors associated with syphilis infection. Among women, 2.2% had syphilis (positive FTA-Abs) and 0.8% active syphilis (FTA-Abs and VDRL positive). In all, 2.2% of samples were positive by the POC test. The sensitivity, specificity, positive and negative predictive values were 62.5% (95% confidence interval [CI]: 38.6-81.5), 99.1% (95% CI: 98.1-99.6), 62.5% (95% CI: 38.6-81.5) and 99.1% (95% CI: 98.1-99.6), respectively. The POC test identified 62.5% (10/16) of syphilis cases, 66.7% (4/6) of active syphilis cases and all high-titre syphilis cases (VDRL > 1:8). Older age was associated with syphilis infection. The rapid test performed moderately well as a screening tool for low-risk populations. This combined with on-site testing and same day treatment could expand antenatal syphilis screening programmes in distant communities characterized by difficult access to antenatal services and infrequent clinical follow-up visits. PMID:21364061

Benzaken, A S; Sabidó, M; Galban, E; Pedroza, V; Araújo, A J G; Peeling, R W; Mabey, D

2011-01-01

73

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

PubMed Central

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

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

2014-01-01

74

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

PubMed

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

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

2014-01-01

75

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

PubMed Central

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

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

2014-01-01

76

The Clinical Situation of Point-of-Care Testing and Its Future Development at the Emergency Department in Shanghai.  

PubMed

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

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

77

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

PubMed Central

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

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

2013-01-01

78

Screening for Aspirin Responsiveness After Transient Ischemic Attack and Stroke Comparison of 2 Point-of-Care Platelet Function Tests With Optical Aggregometry  

Microsoft Academic Search

Background and Purpose—Recent studies suggest that patients who do not respond to aspirin (ASA) therapy may be at increased risk of ischemic vascular events. The availability of simple to use point-of-care (POC) platelet function tests now potentially allows aspirin nonresponsiveness to be identified in routine clinical practice. However, there are very few data on whether the different tests produce consistent

Paul Harrison; Helen Segal; Kevin Blasbery; Charlene Furtado; Louise Silver; Peter M. Rothwell

79

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)

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.

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

2008-04-01

80

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

Microsoft Academic Search

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,

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

81

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

PubMed

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

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

82

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

PubMed

Canine parvovirus (CPV) and canine distemper virus (CDV) are highly infectious and often fatal diseases with worldwide distributions, and are important population management considerations in animal shelters. A point-of-care ELISA test kit is available to detect serum antibodies to CPV and CDV, and presumptively to predict protective status. The aim of this study was to determine the diagnostic accuracy of the test compared to CPV hemagglutination inhibition titers and CDV serum neutralization titers determined by a reference laboratory, using sera collected from dogs housed at animal shelters. The ELISA test was used under both field and laboratory conditions and duplicate specimens were processed using an extra wash step. The test kit yielded accurate results (CPV: sensitivity 92.3%, specificity 93.5%; CDV: sensitivity 75.7%, specificity 91.8%) under field conditions. CDV sensitivity was improved by performing the test under laboratory conditions and using an optical density (OD) meter (laboratory performed 94.0%; OD 88.1%). Point-of-care ELISA testing for serum CPV and CDV antibody titers was demonstrated to be a useful tool for determining antibody status when making decisions regarding the need for CPV and/or CDV vaccination and also in animal shelters for population management. PMID:22381707

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

2012-08-01

83

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

Microsoft Academic Search

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

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

84

Evaluation of a point-of-care immunodot assay for predicting results of allergen-specific intradermal and immunoglobulin E serological tests.  

PubMed

Immunotherapy to prevent recurrence of clinical signs of atopic dermatitis (AD) is based on intradermal or serological tests that assist in identifying allergen-specific immunoglobulin E hypersensitivities. Unfortunately, the results of such tests can be negatively influenced by several factors, which include the age of the patients, the season of testing and the administration of anti-allergic drugs. Screening to predict when these expensive tests will be useful would benefit owners of dogs with AD. The objectives of this study were to determine whether a point-of-care allergen-specific immunodot assay (Allercept E-Screen, Heska Corp., Ft Collins, CO, USA) could predict results of either intradermal or Allercept full panel serological tests in atopic dogs. Thirty dogs living in the south-eastern USA were diagnosed with AD in accordance with current standards. Allergen-specific intradermal, serological and E-Screen tests were performed in all subjects. For flea, house dust mite and pollen allergens altogether, results of the E-Screen assay agreed with those of intradermal and serological tests in 26/30 dogs (87%) and 25/30 dogs (83%), respectively. In this group of dogs, the probabilities of obtaining intradermal or serological tests positive for these allergens were 70 and 67%, respectively. If either skin or serum tests were performed only in dogs with positive E-Screen tests, the probability of obtaining positive results would be increased from 70 to 95% and from 67 to 90%, respectively. In this population of dogs with AD, results of the E-Screen point-of-care immunodot assay was found to often agree with those of allergen-specific intradermal or Allercept tests for selected allergen groups. PMID:15842542

Olivry, Thierry; Jackson, Hilary A; Murphy, K Marcy; Tater, Kathy C; Roberts, Malcolm

2005-04-01

85

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

PubMed Central

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

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

86

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

PubMed Central

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

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

2014-01-01

87

Strategies for hepatitis C testing and linkage to care for vulnerable populations: point-of-care and standard HCV testing in a mobile medical clinic.  

PubMed

Despite new Hepatitis C virus (HCV) therapeutic advances, challenges remain for HCV testing and linking patients to care. A point-of-care (POC) HCV antibody testing strategy was compared to traditional serological testing to determine patient preferences for type of testing and linkage to treatment in an innovative mobile medical clinic (MMC). From 2012 to 2013, all 1,345 MMC clients in New Haven, CT underwent a routine health assessment, including for HCV. Based on patient preferences, clients could select between standard phlebotomy or POC HCV testing, with results available in approximately 1 week versus 20 min, respectively. Outcomes included: (1) accepting HCV testing; (2) preference for rapid POC HCV testing; and (3) linkage to HCV care. All clients with reactive test results were referred to a HCV specialty clinic. Among the 438 (32.6 %) clients accepting HCV testing, HCV prevalence was 6.2 % (N = 27), and 209 (47.7 %) preferred POC testing. Significant correlates of accepting HCV testing was lower for the "baby boomer" generation (AOR 0.67; 95 % CI 0.46-0.97) and white race (AOR 0.55; 95 % CI 0.36-0.78) and higher for having had a prior STI diagnosis (AOR 5.03; 95 % CI 1.76-14.26), prior injection drug use (AOR 2.21; 95 % CI 1.12-4.46), and being US-born (AOR 1.76; 95 % CI 1.25-2.46). Those diagnosed with HCV and preferring POC testing (N = 16) were significantly more likely than those choosing standard testing (N = 11) to be linked to HCV care within 30 days (93.8 vs. 18.2 %; p < 0.0001). HCV testing is feasible in MMCs. While patients equally preferred POC and standard HCV testing strategies, HCV-infected patients choosing POC testing were significantly more likely to be linked to HCV treatment. Important differences in risk and background were associated with type of HCV testing strategy selected. HCV testing strategies should be balanced based on costs, convenience, and ability to link to HCV treatment. PMID:25135842

Morano, Jamie P; Zelenev, Alexei; Lombard, Andrea; Marcus, Ruthanne; Gibson, Britton A; Altice, Frederick L

2014-10-01

88

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

PubMed Central

Purpose To identify factors that determine patients’ intentions to use point-of-care medical devices, ie, portable coagulometer devices for self-testing of the international normalized ratio (INR) required for ongoing monitoring of blood-coagulation intensity among patients on long-term oral anticoagulation therapy with vitamin K antagonists, eg, warfarin. Methods A cross-sectional study that applied the technology-acceptance model through a self-completed questionnaire, which was administered to a convenience sample of 125 outpatients attending outpatient anticoagulation services at a district general hospital in London, UK. Data were analyzed using descriptive statistics, factor analyses, and structural equation modeling. Results The participants were mainly male (64%) and aged ? 71 years (60%). All these patients were attending the hospital outpatient anticoagulation clinic for INR testing; only two patients were currently using INR self-testing, 84% of patients had no knowledge about INR self-testing using a portable coagulometer device, and 96% of patients were never offered the option of the INR self-testing. A significant structural equation model explaining 79% of the variance in patients’ intentions to use INR self-testing was observed. The significant predictors that directly affected patients’ intention to use INR self-testing were the perception of technology (? = 0.92, P < 0.001), trust in doctor (? = ?0.24, P = 0.028), and affordability (? = 0.15, P = 0.016). In addition, the perception of technology was significantly affected by trust in doctor (? = 0.43, P = 0.002), age (? = ?0.32, P < 0.001), and affordability (? = 0.23, P = 0.013); thereby, the intention to use INR self-testing was indirectly affected by trust in doctor (? = 0.40), age (? = ?0.29), and affordability (? = 0.21) via the perception of technology. Conclusion Patients’ intentions to use portable coagulometers for INR self-testing are affected by patients’ perceptions about the INR testing device, the cost of device, trust in doctors/clinicians, and the age of the patient, which need to be considered prior to any intervention involving INR self-testing by patients. Manufacturers should focus on increasing the affordability of INR testing devices for patients’ self-testing and on the potential role of medical practitioners in supporting use of these medical devices as patients move from hospital to home testing. PMID:23300344

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

2013-01-01

89

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

Federal Register 2010, 2011, 2012, 2013

...Tests and Kits for the Detection of Colon and Rectal Cancer, Breast Cancer, and Lung Cancer AGENCY: National Institutes of...association and risk-stratification of colon and rectal cancer, breast cancer, and lung cancer. DATES: Only...

2013-12-06

90

Feasibility and Field Performance of a Simultaneous Syphilis and HIV Point-of-Care Test Based Screening Strategy in at Risk Populations in Edmonton, Canada  

PubMed Central

Few studies have evaluated the feasibility of delivering syphilis point-of-care (POC) testing in outreach (nonclinical) settings in resource rich countries. The objectives of the study were to evaluate the feasibility and diagnostic performance of performing both HIV and syphilis POC testing in outreach settings and to document new cases identified in the study population. 1,265 outreach testing visits were offered syphilis and HIV POC testing and 81.5% (n = 1,031) consented to testing. In our population, the SD Bioline 3.0 Syphilis Test had a sensitivity of 85.3% [CI (68.9–95.0)], specificity of 100.0% [CI (99.6–100.0)], positive predictive value (PPV) of 100.0% [CI (88.1–100.0)], and negative predictive value (NPV) of 99.5% [CI (98.9–99.8)]. Test characteristics for the INSTI HIV-1/HIV-2 Antibody Test had a 100.0% sensitivity [CI (39.8–100.00], 99.8 specificity [CI (99.3–100)], 66.7% PPV [CI (22.3–95.7)], and 100.0% NPV [CI (99.6–100.0)]. Four new cases of syphilis and four new HIV cases were diagnosed. In summary, at risk population seeking STI testing found POC tests to be acceptable, the POC tests performed well in outreach settings, and new cases of syphilis and HIV were identified and linked to treatment and care. PMID:24527210

Bergman, Joshua; Gratrix, Jennifer; Plitt, Sabrina; Fenton, Jayne; Archibald, Chris; Wong, Tom; Singh, Ameeta E.

2013-01-01

91

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

PubMed Central

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.

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

2014-01-01

92

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

PubMed

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

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

2014-01-01

93

Comparison of Point of Care (POC) Testing of Glucose by B Braun Glucometer and Hemocue Glucose 201+ Analyser Versus Centralised Testing in Neonatal Intensive Care Unit (NICU)  

PubMed Central

Background: Neonatal hypoglycemia is the most common carbohydrate metabolic disturbance seen in case of neonates and especially in preterm neonates. Accurate and rapid determination of hypoglycemia and its prompt treatment is of utmost importance to decrease morbidity and mortality of neonates. Aims: To estimate blood glucose in neonates and test the efficacy of HemoCue Glucose 201+ analyser and B Braun Glucometer by comparing with centralised laboratory testing. To compare the blood glucose in capillary and venous blood samples of neonates. Settings and Design: Hospital setting; Comparative Study Materials and Methods: After obtaining informed consent, all neonates admitted to Neonatal Intensive Care Unit (NICU) were screened for blood sugar. Capillary and venous blood glucose was estimated employing HemoCue Glucose 201+ analyser and B Braun Glucometer. Simultaneously, the same venous sample was collected in fluoride tube and sent to central clinical biochemistry laboratory for glucose estimation. When anaemia or polycythemia was clinically suspected the same venous sample was sent for estimation of Hematocrit (Hct). Statistical Analysis: Comparison of blood glucose concentration of B Braun glucometer, HemoCue Glucose 201+ analyser and centralis/ed plasma glucose levels was done by using students test. All the statistical analysis were done using software SPSS 6 version. Results: Mean values of blood glucose (100.2 + 48.4) with B Braun glucometer was significantly higher (p=0.003) when compared to plasma glucose values (76.95 + 45.99) estimated in central laboratory and HemoCue glucose 201+ analyser (82.9 + 51.4). HemoCue glucose 201+ analyser did not show significant difference (p=0.463) with central laboratory testing. There was no significant difference between the capillary and venous sample estimated in both the instruments. Estimation with HemoCue glucose 201+ analyser correlated well with central laboratory testing in neonates with blood glucose <55mg/dl, Conclusion: We conclude that HemoCue glucose 201+ analyser appears to be a suitable point of care (POC) blood glucose measurement device in neonates on both capillary and venous blood samples, as it showed a good correlation with central laboratory values without significant interference from Hct.

M E, Sumathi; Gowda Y C, Beere; Suhail S, Mohamed

2014-01-01

94

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

PubMed Central

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

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

2013-01-01

95

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

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

Howick, Jeremy; Cals, Jochen W L; Jones, Caroline; Price, Christopher P; Pluddemann, 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

96

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

PubMed Central

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

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

2010-01-01

97

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

PubMed Central

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

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

2013-01-01

98

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

PubMed

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

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

2013-01-01

99

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

PubMed Central

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

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

2013-01-01

100

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

PubMed

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

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

2014-12-01

101

Laboratory Evaluation of a New Lateral-Flow-Based Point-of-Care Rapid Test for Assessment of Chronic Systemic Inflammation  

PubMed Central

The determination of C-reactive protein (CRP) by means of a highly sensitive laboratory method as an independent biomarker for assessment of chronic systemic vascular inflammation and cardiovascular risk is recommended by therapeutic guidelines for diabetes and cardiovascular disease in the United States and in Europe. The purpose of this investigation was to investigate the specificity and sensitivity of a newly developed lateral-flow-based point-of-care (POC) rapid test with semi-quantitative visual reading in comparison with a laboratory reference standard method. The high-sensitivity CRP concentrations of 66 samples were determined by means of turbidimetry and the POC test (5 ?l serum/10 ?l capillary whole blood, 10 minutes) was independently performed by three investigators blinded to each other's results. The visual readings were classified, as recommended by the American Heart Association, to represent a low risk (0–1 mg/liter), moderate risk (>1–3 mg/liter), or high risk (>3–10 mg/liter) or to indicate an unspecific inflammation (>10 mg/liter). According to the reference method, there were 17 samples in the low-risk group, 19 samples in the moderate-risk group, and 26 samples in the high-risk group, and 4 samples showed an unspecific inflammation. All three investigators reached very conclusive results. The range of agreement between the visual readings of the investigators and the laboratory method ranged between 94% and 97%. The sensitivity for assessment of moderate-to-high cardiovascular risk was 100% (45/45 were detected), and the specificity ranged between 90% and 95%. The newly developed lateral-flow-based POC rapid test showed an excellent agreement between individual visual reading and the laboratory reference method. It may therefore be suitable for a fast and convenient screening, which, after laboratory test confirmation, may help to identify patients with elevated risk of macrovascular disease. PMID:20513339

Siebenhaar, Renate; Mushholt, Petra B.; Forst, Thomas; Weber, Matthias M.; Maurer, Robert; Pfutzner, Andreas

2010-01-01

102

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

PubMed Central

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

2014-01-01

103

Correlation Between Point-of-Care Platelet Function Testing and Bleeding After Coronary Angiography According to Two Different Definitions for Bleeding.  

PubMed

Platelet function testing could be useful when assessing the risk for bleeding during treatment with antiplatelet drugs. This has been indicated in several studies, including the Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-Bleeding (ARMYDA-BLEEDS) study, which demonstrated that testing with a point-of-care assay correlated with bleeding events after percutaneous coronary intervention. To standardize bleeding definitions, the Bleeding Academic Research Consortium (BARC) published a consensus report, which is in need of data-driven validation. Hence, the investigators conducted an observational, prospective, single-center study of 474 patients receiving clopidogrel and aspirin who underwent coronary angiography with or without percutaneous coronary intervention from October 2006 to May 2011. Platelet reactivity was measured with adenosine diphosphate-induced single-platelet function testing (Plateletworks) at the start of coronary angiography. The primary end point was the 30-day incidence of bleeding as defined by BARC and ARMYDA-BLEEDS. The aim of the present study was to investigate the relation between on-treatment platelet reactivity and the 30-day incidence of bleeding complications according to the BARC and ARMYDA-BLEEDS definitions. Patients in the first platelet aggregation quartile had a higher frequency of type 2 or higher BARC bleeding and ARMYDA-BLEEDS-defined bleeding <30 days after coronary angiography compared with the fourth quartile (16.9% vs 6.7%, p = 0.014, and 8.5% vs 1.7%, p = 0.016, respectively) and the third quartile (16.9% vs 7.7%, p = 0.031, and 8.5% vs 2.6%, p = 0.048, respectively). In conclusion, patients with low on-treatment platelet reactivity at the time of intervention had a significantly higher incidence of bleeding according to the BARC and ARMYDA-BLEEDS definitions <30 days after coronary angiography with or without percutaneous coronary intervention. PMID:25220849

Holm, Manne; Tornvall, Per; Dalén, Magnus; van der Linden, Jan

2014-11-01

104

Point-of-Care Test for Detection of Urogenital Chlamydia in Women Shows Low Sensitivity. A Performance Evaluation Study in Two Clinics in Suriname  

PubMed Central

Background In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity results. However, one study sponsored by the manufacturer (Diagnostics for the Real World) reported over 80% sensitivity with their Chlamydia Rapid Test (CRT). We evaluated the performance of this CRT in a non–manufacturer-sponsored trial. Methods Between July 2009 and February 2010, we included samples from 912 women in both high- and low-risk clinics for sexually transmitted infections (STIs) in Paramaribo, Suriname. Sensitivity, specificity, positive- and negative predictive values (PPV and NPV) for CRT compared to NAAT (Aptima, Gen-Probe) were determined. Quantitative Ct load and human cell load were determined in all CRT and/or NAAT positive samples. Results CRT compared to NAAT showed a sensitivity and specificity of 41.2% (95% CI, 31.9%–50.9%) and 96.4% (95% CI, 95.0%–97.5%), respectively. PPV and NPV were 59.2% (95% CI, 47.5%–70.1%) and 92.9% (95% CI, 91.0%–94.5%), respectively. Quantitative Ct bacterial load was 73 times higher in NAAT-positive/CRT-positive samples compared to NAAT-positive/CRT-negative samples (p<0.001). Human cell load did not differ between true-positive and false-negative CRT results (p?=?0.835). Sensitivity of CRT in samples with low Ct load was 12.5% (95% CI, 5.2%–24.2%) and in samples with high Ct load 73.5% (95% CI, 59.9%–84.4%). Conclusions The sensitivity of CRT for detecting urogenital Ct in this non–manufacturer-sponsored study did not meet the expectations as described previously. The CRT missed samples with a low Ct load. Improved POC are needed as meaningful diagnostic to reduce the disease burden of Ct. PMID:22393383

van der Helm, Jannie J.; Sabajo, Leslie O. A.; Grunberg, Antoon W.; Morre, Servaas A.; Speksnijder, Arjen G. C. L.; de Vries, Henry J. C.

2012-01-01

105

Effect of acetylcholinesterase (AChE) point-of-care testing in OP poisoning on knowledge, attitudes and practices of treating physicians in Sri Lanka  

PubMed Central

Background Toxicology and Emergency medicine textbooks recommend measurement of acetylcholinesterase (AChE) in all symptomatic cases of organophosphorus (OP) poisoning but laboratory facilities are limited in rural Asia. The accuracy of point-of-care (POC) acetylcholinesterase testing has been demonstrated but it remains to be shown whether results would be valued by clinicians. This study aims to assess the effect of seeing AChE POC test results on the knowledge, attitudes and practices of doctors who frequently manage OP poisoning. Methods We surveyed 23 clinicians, who had different levels of exposure to seeing AChE levels in OP poisoned patients, on a) knowledge of OP poisoning and biomarker interpretation, b) attitudes towards AChE in guiding poison management, oxime therapy and discharge decisions, and c) practices of ordering AChE in poisoning scenarios. Results An overall high proportion of doctors valued the test (68-89%). However, we paradoxically found that doctors who were more experienced in seeing AChE results valued the test less. Lower proportions valued the test in guidance of acute poisoning management (50%, p = 0.015) and guidance of oxime therapy (25%, p = 0.008), and it was apparent it would not generally be used to facilitate early discharge. The highest proportion of respondents valued it on admission (p < 0.001). A lack of correlation of test results with the clinical picture, and a perception that the test was a waste of money when compared to clinical observation alone were also comments raised by some of the respondents. Greater experience with seeing AChE test results was associated with increased knowledge (p = 0.034). However, a disproportionate lack of knowledge on interpretation of biomarkers and the pharmacology of oxime therapy (12-50%) was noted, when compared with knowledge on the mechanism of OP poisoning and management (78-90%). Conclusions Our findings suggest an AChE POC test may not be valued by rural doctors. The practical use of AChE in OP poisoning management is complex, and a poor understanding of how to interpret test results may have affected its perceived utility. Future research should evaluate the impact of providing both AChE and training in interpretation on clinicians’ attitudes and practice. PMID:24589276

2014-01-01

106

Clopidogrel metaboliser status based on point-of-care CYP2C19 genetic testing in patients with coronary artery disease.  

PubMed

We compared results obtained with the Nanosphere Verigene® System, a novel point-of-care (POC) genetic test capable of analysing 11 CYP2C19 variants within 3 hours, to an established, validated genotyping method (Affymetrix™ DMET+; reference assay) for identifying extensive and reduced metabolisers of clopidogrel. Based on genotyping, patients (N=82) with stable coronary artery disease on clopidogrel 75 mg daily were defined as extensive metabolisers (*1/*1, *1/*17, *17/*17), reduced metabolisers (*1/*2, *1/*8, *2/*2, *2/*3), or of indeterminate metaboliser status (*2/*17). Pharmacokinetic exposure to clopidogrel's active metabolite and pharmacodynamic measures with P2Y12 reaction units (PRU) (VerifyNow®P2Y12 assay) and VASP PRI (PRI) were also assessed. There was a 99.9% overall concordance of marker-level data between the Nanosphere Verigene and DMET+ systems in identifying the CYP2C19 variants and 100% agreement in classifying the patients as extensive (n=59) or reduced metabolisers (n=15). Extensive metabolisers had significantly higher active metabolite exposure than reduced metabolisers (LS means 12.6 ng*h/ml vs 7.7 ng*h/ml; p<0.001). Extensive metabolisers also had lower PRU (LS means 158 vs 212; p=0.003) and VASP PRI (LS means 48% vs 63%, p=0.01) compared to reduced metabolisers. Rates of high on-treatment platelet reactivity were higher in reduced metabolisers compared to extensive metabolisers (VASP PRI ? 50%: 79% vs 47%; PRU >235: 33% vs 16%). The Nanosphere Verigene CBS system identified 11 CYP2C19 alleles in less than 3 hours with a high degree of accuracy when compared to a conventional method, and was further validated against pharmacokinetic and pharmacodynamic phenotypes. PMID:24402637

Erlinge, David; James, Stefan; Duvvuru, Suman; Jakubowski, Joseph A; Wagner, Henrik; Varenhorst, Christoph; Tantry, Udaya S; Brown, Patricia B; Small, David; Moser, Brian A; Sundseth, Scott S; Walker, Joseph R; Winters, Kenneth J; Gurbel, Paul A

2014-05-01

107

Feasibility of a Microarray-Based Point-of-Care CYP2C19 Genotyping Test for Predicting Clopidogrel On-Treatment Platelet Reactivity  

PubMed Central

Clopidogrel is a prodrug which is converted into active metabolite by cytochrome P450 isoenzyme, CYP2C19. Numerous polymorphisms of CYP2C19 are reported, and a strong link exists between loss-of-function (LOF) or gain-of-function polymorphisms, clopidogrel metabolism, and clinical outcome. Hence, a fully automated point-of-care CYP2C19 genotyping assay is more likely to bring personalized antiplatelet therapy into real practice. We assessed the feasibility of the Verigene 2C19/CBS Nucleic Acid Test, a fully automated microarray-based assay, compared to bidirectional sequencing, and performed VerifyNow P2Y12 assay to evaluate the effect of CYP2C19 polymorphisms on on-treatment platelet reactivity in 57 Korean patients treated with clopidogrel after percutaneous coronary intervention. The Verigene 2C19/CBS assay identified ?2, ?3, and ?17 polymorphisms with 100% concordance to bidirectional sequencing in 180 minutes with little hands-on time. Patients were classified into 4 groups: extensive (?1/?1; n = 12, 21.1%), intermediate (?1/?2, ?1/?3; n = 33, 57.9%), poor (?2/?2, ?2/?3, and ?3/?3; n = 11, 19.3%), and ultrarapid metabolizers (?1/?17; n = 1, 1.8%). The prevalence of the CYP2C19???2, ?3, and ?17 alleles was 36.0%, 12.3%, and 0.9%. Platelet reactivity showed gene dose response according to the number of CYP2C19 LOF allele. In conclusion, the Verigene 2C19/CBS assay gave accurate CYP2C19 genotype results which were in well match with the differing on-treatment platelet reactivity. PMID:23607088

Chae, Hyojin; Kim, Myungshin; Koh, Yoon-Seok; Hwang, Byung-Hee; Kang, Min-Kyu; Kim, Yonggoo; Park, Hae-il; Chang, Kiyuk

2013-01-01

108

Ninety-Minute Exclusion of Acute Myocardial Infarction By Use of Quantitative Point-of-Care Testing of Myoglobin and Troponin I  

Microsoft Academic Search

Background—Diagnostic strategies with ECG and serum cardiac markers have been used to rule out acute myocardial infarction in 6 to 12 hours. The present study evaluated whether a multimarker strategy that used point-of-care measurement of myoglobin, creatine kinase (CK)-MB, and troponin I could exclude acute myocardial infarction in #3 hours. Methods and Results—We prospectively enrolled consecutive patients (n 5817) in

James McCord; Richard M. Nowak; Peter A. McCullough; Craig Foreback; Steven Borzak; Glenn Tokarski; Michael C. Tomlanovich; Gordon Jacobsen; W. Douglas Weaver

109

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

PubMed

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

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

2012-02-01

110

Rapid Syphilis Tests as Catalysts for Health Systems Strengthening: A Case Study from Peru  

PubMed Central

Objectives Untreated maternal syphilis leads to adverse pregnancy outcomes. The use of point of care tests (POCT) offers an opportunity to improve screening coverage for syphilis and other aspects of health systems. Our objective is to present the experience of the introduction of POCT for syphilis in Peru and describe how new technology can catalyze health system strengthening. Methods The study was implemented from September 2009–November 2010 to assess the feasibility of the use of a POCT for syphilis for screening pregnant women in Lima, Peru. Outcomes measured included access to syphilis screening, treatment coverage, partner treatment, effect on patient flow and service efficiency, acceptability among providers and patients, and sustainability. Results Before the introduction of POCT, a pregnant woman needed 6 visits to the health center in 27 days before she received her syphilis result. We trained 604 health providers and implemented the POCT for syphilis as the “two for one strategy”, offering with one finger stick both syphilis and HIV testing. Implementation of the POCT resulted in testing and treatment on the first visit. Screening and treatment coverages for syphilis improved significantly compared with the previous year. Implementation of POCT has been scaled up nationally since the study ended, and coverages for screening, treatment and partner treatment have remained over 92%. Conclusions Implementation of POCT for syphilis proved feasible and acceptable, and led to improvement in several aspects of health services. For the process to be effective we highlight the importance of: (1) engaging the authorities; (2) dissipating tensions between providers and identifying champions; (3) training according to the needs; (4) providing monitoring, supervision, support and recognition; (5) sharing results and discussing actions together; (6) consulting and obtaining feedback from users; and (7) integrating with other services such as with rapid HIV testing. PMID:23840552

García, Patricia J.; Cárcamo, César P.; Chiappe, Marina; Valderrama, Maria; La Rosa, Sayda; Holmes, King K.; Mabey, David C. W.; Peeling, Rosanna W.

2013-01-01

111

Evaluation of an immunochromatographic point-of-care test for the simultaneous detection of nontreponemal and treponemal antibodies in patients with syphilis.  

PubMed

We described the evaluation of the Syphilis Screening & Confirm Assay for the simultaneous detection of nontreponemal and treponemal antibodies. A total of 248 samples were evaluated. The sensitivity of the tests was 98.8%, 99.5% and 98.9%, while specificity was 94.7%, 88.9% and 93.2%, respectively, as compared with the rapid plasma reagin, Treponema pallidum hemagglutination assay, and fluorescent treponemal antibody absorption tests. PMID:25013972

Castro, Rita; Lopes, Ângela; da Luz Martins Pereira, Filomena

2014-08-01

112

Day-to-day fluctuation of point-of-care circulating cathodic antigen test scores and faecal egg counts in children infected with Schistosoma mansoni in Ethiopia  

PubMed Central

Background Determining the variation of circulating cathodic antigen (CCA) in urine and egg counts variation in stool between days in Schistosoma mansoni (S. mansoni) infected individuals is vital to decide whether or not to rely on a single-sample test for diagnosis of Schistosomiasis. In this study, the magnitude of day-to-day variation in urine-CCA test scores and in faecal egg counts was evaluated in school children in Ethiopia. Methods A total of 620 school children (age 8 to 12 years) were examined for S. mansoni infection using double Kato-Katz and single urine-CCA cassette methods (batch 32727) on three consecutive days. Results The prevalence of S. mansoni infection was 81.1% based on triple urine-CCA-cassette test and 53.1% based on six Kato-Katz thick smears. Among the study participants, 26.3% showed fluctuation in urine CCA and 32.4% showed fluctuation in egg output. Mean egg count as well as number of cases in each class of intensity and intensity of cassette band color varied over the three days of examination. Over 85% of the children that showed day-to-day variations in status of S. mansoni infection from negative to positive or vice versa by the Kato-Katz and the CCA methods had light intensity of infection. The fluctuation in both the CCA test scores and faecal egg count was not associated with age and sex. Conclusions The current study showed day-to-day variation in CCA and Kato-Katz test results of children infected with S. mansoni. This indicates the necessity of more than one urine or stool samples to be collected on different days for more reliable diagnosis of S. mansoni infection in low endemic areas. PMID:24742192

2014-01-01

113

Rapid Point-of-Care Test To Detect Broad Ranges of Protective Antigen-Specific Immunoglobulin G Concentrations in Recipients of the U.S.Licensed Anthrax Vaccine  

Microsoft Academic Search

Currently, there is no routine monitoring of an immune response to the anthrax vaccine. Simple on-site tests are needed to evaluate the antibody response of anthrax-vaccinated individuals in the Armed Forces and others at high risk. Using a prototype lateral flow assay (LFA) (R. E. Biagini, D. L. Sammons, J. P. Smith, B. A. MacKenzie, C. A. F. Striley, J.

Diane R. Bienek; Raymond E. Biagini; David G. Charlton; Jerome P. Smith; Deborah L. Sammons; Shirley A. Robertson

2008-01-01

114

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

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

Nayer, Jamshed; Aggarwal, Praveen; Galwankar, Sagar

2014-01-01

115

Multiplexed fluorescence detection for point of care  

NASA Astrophysics Data System (ADS)

We report on the development of a portable fluorescence detection system. By combining a CMOS sensor and crosspolarization scheme, we achieved multiplexed detection with a single white emission LED excitation. We demonstrated fluorescence detection of Fluorescein and Rhodamine B in PDMS channels and achieved 1?M limit of detection (LOD). Microparticles with green and red fluorescence were detected simultaneously without changing the light sources or filters. We were able to clearly resolve microparticles, even if aggregated. The compact microfluorescence approach offers high spatial and spectral resolution, and is suitable for multiplexed detection in point-of-care applications.

Shen, Li; Ratterman, Mike; Stites, Tyler; Klotzkin, David; Papautsky, Ian

2012-03-01

116

Point of Care Technologies for HIV  

PubMed Central

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

Hewlett, Indira K.

2014-01-01

117

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

E-print Network

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 ...

Zimmerman, Julia C

2011-01-01

118

Identification of patients with microscopic hematuria who are at greater risk for the presence of bladder tumors using a dedicated questionnaire and point of care urine test--a study by the members of Association of Urooncology, Turkey.  

PubMed

In patients with microscopic hematuria there is a need for better identification of those who are at greater risk of harbouring bladder tumors. The RisikoCheck® questionnaire has a strong correlation with the presence of urothelial carcinoma (UC) of the bladder and in combination with other available tests may help identify patients who require detailed clinical investigations due to increased risk of presence of bladder tumors. This study aimed to evaluate the efficacy of RisikoCheck® questionnaire together with NMP-22® (BladderChek®) as a point-of-care urine test in predicting the presence of bladder tumors in patients presenting with microscopic hematuria as the sole finding. In this multi-institutional prospective evaluation of 303 consecutive patients without a history of urothelial carcinoma (UC), RisikoCheck® risk group assessment, urinary tract imaging and cystourethroscopy as well as urine cytology and Nuclear Matrix Protein-22 (NMP-22 BladderChek) testing were performed where available. The sensitivity, specificity, negative predictive value (NPV), and positive predictive values (PPV) for the risk adapted approach were calculated. All patients underwent cystoscopy, and tumors were detected in 18 (5.9%). Urine cytology and NMP-22 was positive for malignancy in 9 (3.2%) and 12 (7.5%) of patients, respectively. A total of 43 (14%) patients were in the high risk group according to the RisikoCheck® questionnaire. The sensitivity and specificity of the questionnaire in detecting a bladder tumor was 61.5 % and 84.0 % in the high risk group. In patients with either a positive NMP-22 test or high risk category RisikoCheck®, 23.6% had bladder tumors with a corresponding sensitivity of 54.2% and specificity of 88.6%. If both tests were negative only 3.3% of the patients had bladder tumors. The results of our study suggest that the efficacy of diagnostic evaluation of patients with microscopic hematuria may be further enhanced by combining RisikoCheck® questionnaire with NMP-22. PMID:25124612

Turkeri, Levent; Mangir, Na?ide; Gunlusoy, Bulent; Yildirim, Asif; Baltaci, Sumer; Kaplan, Mustafa; Bozlu, Murat; Mungan, Aydin

2014-01-01

119

Challenges of Diagnosing Acute HIV-1 Subtype C Infection in African Women: Performance of a Clinical Algorithm and the Need for Point-of-Care Nucleic-Acid Based Testing  

PubMed Central

Background Prompt diagnosis of acute HIV infection (AHI) benefits the individual and provides opportunities for public health intervention. The aim of this study was to describe most common signs and symptoms of AHI, correlate these with early disease progression and develop a clinical algorithm to identify acute HIV cases in resource limited setting. Methods 245 South African women at high-risk of HIV-1 were assessed for AHI and received monthly HIV-1 antibody and RNA testing. Signs and symptoms at first HIV-positive visit were compared to HIV-negative visits. Logistic regression identified clinical predictors of AHI. A model-based score was assigned to each predictor to create a risk score for every woman. Results Twenty-eight women seroconverted after a total of 390 person-years of follow-up with an HIV incidence of 7.2/100 person-years (95%CI 4.5–9.8). Fifty-seven percent reported ?1 sign or symptom at the AHI visit. Factors predictive of AHI included age <25 years (OR?=?3.2; 1.4–7.1), rash (OR?=?6.1; 2.4–15.4), sore throat (OR?=?2.7; 1.0–7.6), weight loss (OR?=?4.4; 1.5–13.4), genital ulcers (OR?=?8.0; 1.6–39.5) and vaginal discharge (OR?=?5.4; 1.6–18.4). A risk score of 2 correctly predicted AHI in 50.0% of cases. The number of signs and symptoms correlated with higher HIV-1 RNA at diagnosis (r?=?0.63; p<0.001). Conclusions Accurate recognition of signs and symptoms of AHI is critical for early diagnosis of HIV infection. Our algorithm may assist in risk-stratifying individuals for AHI, especially in resource-limited settings where there is no routine testing for AHI. Independent validation of the algorithm on another cohort is needed to assess its utility further. Point-of-care antigen or viral load technology is required, however, to detect asymptomatic, antibody negative cases enabling early interventions and prevention of transmission. PMID:23646162

Mlisana, Koleka; Sobieszczyk, Magdalena; Werner, Lise; Feinstein, Addi; van Loggerenberg, Francois; Naicker, Nivashnee; Williamson, Carolyn; Garrett, Nigel

2013-01-01

120

Programming paper networks for point of care diagnostics  

NASA Astrophysics Data System (ADS)

Lateral flow tests (LFTs) are well-suited for rapid point-of-care testing in low resource settings. The wicking action of the paper strip moves the sample and reagents through the device without a need for pumps, but LFTs are typically limited to tests that can be carried out in a single fluidic step. The materials from LFTs can be reconfigured to create paper networks that automatically carry out multi-step fluidic operations, while retaining the same easy-to-use format as a conventional LFT. Here, we describe basic principles of wicking and system-level behavior of paper networks by analogy to electrical circuits. We describe key design principles for a previously-developed 2D paper network (2DPN) and introduce an alternative linear paper network (Pseudo-1DPN) that takes advantage of system-level behavior to perform clean sequential fluid delivery while reducing device running time.

Dharmaraja, Shivani; Lafleur, Lisa; Byrnes, Samantha; Kauffman, Peter; Buser, Josh; Toley, Bhushan; Fu, Elain; Yager, Paul; Lutz, Barry

2013-03-01

121

Optical imaging techniques for point-of-care diagnostics.  

PubMed

Improving 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 enables 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 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 a significant impact on global health by facilitating effective and affordable POC diagnostics. PMID:23044793

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

2013-01-01

122

Optical Imaging Techniques for Point-of-care Diagnostics  

PubMed Central

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

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

2012-01-01

123

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)

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.

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

124

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

PubMed

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

Huckle, David

2006-07-01

125

Advances in hemoglobin A1c point of care technology.  

PubMed

Measurement of hemoglobin A1c (A1C) has long been accepted as the best indicator of glucose control over time. Assays for A1C use technologies based on either charge differences (high-pressure liquid chromatography) or structure (boronate affinity or immunoassay combined with general chemistry). These technologies are generally employed in expensive laboratory instruments. More recently, A1C technology has been incorporated into point of care (POC) devices, allowing for immediate availability of A1C measurements, greatly facilitating diabetes care in both specialist and general practices. POC A1C tests should have acceptable performance, standardization to national reference, National Glycohemoglobin Standardization Program (NGSP) certification, simple operation without need for costly instrumentation, and Clinical Laboratory Improvement Amendments (CLIA) waiver. CLIA-waived POC technology includes Bio-Rad MicroMat II (distributed by Cholestech as GDX) and the Axis-Shield Afinion, both of which utilize boronate affinity. The DCA 2000(R)+ utilizes combined immunoassay and general chemistry. These instruments cost $1000 to $3000 and require regular maintenance, making them appropriate only for high-volume physician offices. The newly improved A1CNow+ also utilizes combined immunoassay and general chemistry, but the small, inexpensive, disposable monitor can be used by patients as well as by health care professionals. The new version of A1CNow+ has improved performance through recent introduction of automated solid state chemistry manufacturing, improved fluidics and automated assembly of the test cartridge, error-correcting software, and unitary meter calibration with factory calibration directly to the NGSP reference standard. PMID:19885097

Bode, Bruce W; Irvin, Benjamin R; Pierce, Jeffrey A; Allen, Michael; Clark, Annette L

2007-05-01

126

A handheld point-of-care genomic diagnostic system.  

PubMed

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

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

2013-01-01

127

A Handheld Point-of-Care Genomic Diagnostic System  

PubMed Central

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

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

2013-01-01

128

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

PubMed

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

Vardell, Emily; Paulaitis, Gediminas Geddy

2012-01-01

129

A centrifugal Lab-in-a-tubing platform enabling automatic point-of-care blood diagnostics  

Microsoft Academic Search

Blood analyses are the most common clinical diagnostic methods. Lab-on-a-chip technology, stemmed from concepts of microsystem microfabrication and microfluidics, provides an automatic, rapid, cost-effective and point-of-care solution for a wide variety of blood analyses. In general, blood separation is the first step for subsequent blood tests in clinical diagnosis. In this study, a rapid prototyping of out-of-plane valves using low

Tingjie Li; Qiuquan Guo; Limin Zhang; Jun Yang

2011-01-01

130

Handheld tools assess medical necessity at the point of care.  

PubMed

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

Pollard, Dan

2002-01-01

131

Point-of-care pathology with miniature microscopes  

PubMed Central

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

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

2011-01-01

132

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

PubMed Central

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

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

2011-01-01

133

Lensless imaging for point-of-care testing  

E-print Network

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 +] ...

Moon, SangJun

134

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

Federal Register 2010, 2011, 2012, 2013

...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...

2010-01-15

135

PDAs bring information competence to the point-of-care.  

PubMed

The ability of nursing faculty and students to efficiently obtain accurate information at the point-of-care is a critical aspect of providing quality patient care. Personalized Digital Assistants (PDAs) can provide instant access to entire textbooks of information where it is needed most, in the dynamic learning environment of the clinical setting. With a growing trend in higher education to include instruction on information competency in the curriculum, the use of PDAs in nursing education needs to be explored. This article discusses the use of PDAs by faculty and students within one nursing program. Results from a survey of faculty and students demonstrated a clear discrepancy in their use of PDAs. Although students recognized the benefits of PDA use in the clinical setting, they did not want owning a PDA to be a program requirement. Discussed are several approaches being used to overcome identified barriers to PDA use and ownership. PMID:16646904

Altmann, Tanya K; Brady, Debra

2005-01-01

136

Characterizing physicians' information needs at the point of care.  

PubMed

Physicians have many information needs that arise at the point of care yet go unmet for a variety of reasons, including uncertainty about which information resources to select. In this study, we aimed to identify the various types of physician information needs and how these needs relate to physicians' use of the database PubMed and the evidence summary tool UpToDate. We conducted semi-structured interviews with physicians (Stanford University, United States; n = 13; and University Medical Center Utrecht, the Netherlands; n = 9), eliciting participants' descriptions of their information needs and related use of PubMed and/or UpToDate. Using thematic analysis, we identified six information needs: refreshing, confirming, logistics, teaching, idea generating and personal learning. Participants from both institutions similarly described their information needs and selection of resources. The identification of these six information needs and their relation to PubMed and UpToDate expands upon previously identified physician information needs and may be useful to medical educators designing evidence-based practice training for physicians. PMID:24865885

Maggio, Lauren A; Cate, Olle Ten; Moorhead, Laura L; van Stiphout, Feikje; Kramer, Bianca M R; Ter Braak, Edith; Posley, Keith; Irby, David; O'Brien, Bridget C

2014-11-01

137

Point-of-care, portable microfluidic blood analyzer system  

NASA Astrophysics Data System (ADS)

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.

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

2012-03-01

138

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

PubMed Central

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

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

2012-01-01

139

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

NASA Astrophysics Data System (ADS)

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.

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

2013-06-01

140

Attention and usability issues in mobile health information systems at point-of-care  

Microsoft Academic Search

In point-of-care situations, use of mobile devices may demand much of the physicians attention and may disturb the communication with the patient. By using minimal attention user interface design and context awareness, attention theft from mobile devices at point-of-care can be reduced.

Ole Andreas Alsos

2008-01-01

141

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

E-print Network

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

Demirci, Utkan

142

Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction  

Microsoft Academic Search

Background: Creatine kinase MB (CK-MB), and cardiac troponin I (cTnI) are important biomarkers for the diagnosis and rule-out of acute myocardial infarction (AMI) of patients who presented to the emergency department (ED) with chest pain. With new rapid ED assessment protocols, there is increasing pressure to produce results with a short turnaround time (TAT), and point-of-care (POC) testing is one

Alan H. B Wu; Andrew Smith; Robert H Christenson; MaryAnn M Murakami; Fred S Apple

2004-01-01

143

Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction  

Microsoft Academic Search

Background: Creatine kinase MB (CK-MB), and cardiac troponin I (cTnI) are important biomarkers for the diagnosis and rule-out of acute myocardial infarction (AMI) of patients who presented to the emergency department (ED) with chest pain. With new rapid ED assessment protocols, there is increasing pressure to produce results with a short turnaround time (TAT), and point-of-care (POC) testing is one

Alan H. B. Wu; Andrew Smith; Robert H. Christenson; MaryAnn M. Murakami; Fred S. Apple

144

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

PubMed Central

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

Gaydos, Charlotte; Hardick, Justin

2014-01-01

145

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

NASA Astrophysics Data System (ADS)

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.

Vaitkuviene, A.; G?gžna, V.; Varanius, D.; Vaitkus, J.

2011-09-01

146

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

PubMed Central

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

Boruff, Jill T; Bilodeau, Edward

2012-01-01

147

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

PubMed Central

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

Byrnes, Samantha; Thiessen, Gregory; Fu, Elain

2014-01-01

148

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

PubMed

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

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

2014-11-15

149

Economic evaluation of point-of-care diagnostic technologies for infectious diseases.  

PubMed

We review the growing number of economic evaluations of individual point-of-care (POC) tests for diagnosis of infectious diseases in resource-limited settings that use either cohort studies or mathematical models. We focus on studies that evaluate POC diagnostic tests for the control of human immunodeficiency virus (HIV) and malaria, tools that are central to the WHO prevention guidelines for infectious diseases in developing countries. Although rapid diagnostic tests for HIV and malaria seem to be cost-effective in these standard analyses, these do not take into account the reduction in patients' waiting time and the number of clinic visits required to receive results, or future benefits from the reduction in antimalarial drug pressure. Those additional cost reductions would be considerably greater with POC rapid tests, and the cost-effectiveness of POC tests would therefore be improved. Findings from cost-effectiveness analyses suggest that, despite the relatively small additional cost incurred, decision-makers should strongly consider using POC tests throughout or during parts of HIV and malaria epidemics, where this is feasible in terms of local human resources and logistical conditions. PMID:20670289

Loubiere, S; Moatti, J-P

2010-08-01

150

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

Federal Register 2010, 2011, 2012, 2013

...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...

2011-08-17

151

Haemoglobin A1c: comparing performance of two point of care devices with laboratory analyser  

PubMed Central

Background Measurement of HbA1c has been widely used for long-term monitoring and management of diabetes control. There is increasing use of point-of-care (POC) devices for measuring HbA1c where quicker results would allow immediate clinical management decisions to be made. Therefore, it is important to evaluate and compare the performance of such devices to the reference laboratory method. Findings A total of 274 venous blood was collected from normal healthy adults during the community screening programmes. The performance of POC devices, Afinion and Quo-test were compared to central laboratory HPLC method; Adams A1c HA 8160. Both POC devices showed good correlation to HA 8160 with r?=?0.94 (p?test respectively. The means difference were statistically higher between POC and HA 8160 with 0.23% (95% CI 0.19-0.26, p?test respectively. Conclusions Both POC devices could be considered in health clinics for diabetes management but not to be used for the diagnostic purposes. PMID:24344903

2013-01-01

152

Diagnosing Dengue at the Point-of-Care: Utility of a Rapid Combined Diagnostic Kit in Singapore  

PubMed Central

WHO recommendations for dengue diagnosis require laboratory facilities. Antibody-based rapid diagnostic tests (RDTs) have performed poorly, and clinical diagnosis remains the mainstay in dengue-endemic countries. We evaluated a combination antigen-antibody RDT for point-of-care testing in a high-prevalence setting. In this prospective cohort study, adults were enrolled from a tertiary infectious disease centre for evaluation of undifferentiated febrile illness from October 2011 to May 2012. SD Bioline Dengue Duo was evaluated at point-of-care against a WHO-based reference standard of viral isolation, RT-PCR, NS1-, IgM-, and IgG-ELISA. 246 adults were enrolled (median age 34 years, range 18–69), of which 197 could be confirmed definitively as either dengue or non-dengue. DENV-2 was the predominant serotype (79.5%) and the ratio of primary to secondary cases was 1?1.1. There were no test failures and minimal interobserver variation with a Fleiss’ kappa of 0.983 (95% CI 0.827–1.00). Overall sensitivity and specificity were 93.9% (95% CI 88.8–96.8%) and 92.0% (95% CI 81.2–96.9%) respectively. Using WHO clinical criteria alone for diagnosis had similar sensitivities (95.9%, 95% CI 91.4–98.1%) and lower specificities (20.0%, 95% CI 11.2–33.0%). No significant difference in performance was found when testing early versus late presenters, primary versus secondary cases, or DENV-1 versus DENV-2 infections. The use of a combination RDT fulfills WHO ASSURED criteria for point-of-care testing and can enhance dengue diagnosis in an endemic setting. This has the potential to markedly improve clinical management of dengue in the field. PMID:24646519

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

2014-01-01

153

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

PubMed

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

Huckle, David

2008-11-01

154

A Liposome-Based Impedance Sensing Device for Point-of-Care Viral Load Determination  

NASA Astrophysics Data System (ADS)

A simple platform for enumeration of human pathogens is greatly needed for infectious disease diagnostics, particularly in resource-limited settings. Viruses such as HIV present a particular challenge due to low levels in body fluids and sub-micron size, but techniques for quantification can be achieved with bio-micro/nanotechnology. Toward this goal of a rapid, low-cost point-of-care platform for viral load measurements, we demonstrate an amplification technique based on sensing of liposome tags. Liposomes are prepared by hydration of dipalmitoylphosphatidylcholine (DPPC) film with PBS, redistribution at a range of concentrations, and lysis in hypotonic media which frees encapsulated ions and alters conductivity of the solution. Impedance spectra are obtained with an LCR meter and microfluidic device patterned with inter-digitated electrodes. The resulting measurements are shown to relate to liposome number, demonstrating the utility of this technique for an assay in which the liposome functions as a tag for smaller particles. Real-time monitoring of liposome lysis demonstrates the basis for a rapid diagnostic test. These liposomes can be conjugated to IgG antibody to produce specificity for antigens such as HIV gp120 as the basis for a future impedance-based viral load device.

Damhorst, Gregory; Smith, Cartney; Salm, Eric; Ni, Hengkan; Hassan, Umer; Kong, Hyun Joon; Bashir, Rashid

2013-03-01

155

Agarose-Based Microfluidic Device for Point-of-Care Concentration and Detection of Pathogen.  

PubMed

Preconcentration of pathogens from patient samples represents a great challenge in point-of-care (POC) diagnostics. Here, a low-cost, rapid, and portable agarose-based microfluidic device was developed to concentrate biological fluid from micro- to picoliter volume. The microfluidic concentrator consisted of a glass slide simply covered by an agarose layer with a binary tree-shaped microchannel, in which pathogens could be concentrated at the end of the microchannel due to the capillary effect and the strong water permeability of the agarose gel. The fluorescent Escherichia coli strain OP50 was used to demonstrate the capacity of the agarose-based device. Results showed that 90% recovery efficiency could be achieved with a million-fold volume reduction from 400 ?L to 400 pL. For concentration of 1 × 10(3) cells mL(-1) bacteria, approximately ten million-fold enrichment in cell density was realized with volume reduction from 100 ?L to 1.6 pL. Urine and blood plasma samples were further tested to validate the developed method. In conjugation with fluorescence immunoassay, we successfully applied the method to the concentration and detection of infectious Staphylococcus aureus in clinics. The agarose-based microfluidic concentrator provided an efficient approach for POC detection of pathogens. PMID:25264815

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

2014-11-01

156

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

SciTech Connect

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.

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

157

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

PubMed Central

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

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

2012-01-01

158

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

PubMed

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

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

2013-11-01

159

The Mobile Mock Operating Room: Bringing Team Training to the Point of Care  

Microsoft Academic Search

Objectives: We examined the effectiveness of an innovative mobile mock operating room (MMOR) configuration to support realistic interdisciplinary operating room team training implemented at the point of care. Methods: The MMOR, created and used to support the System for Teamwork Effectiveness and Patient Safety (STEPS) training program, included a portable high-fidelity, computerized mannequin; an inanimate surgical procedure model; software for

John T. Paige; Valeriy Kozmenko; Tong Yang; Ramnarayan Paragi Gururaja; Isidore Cohn; Charles Hilton; Sheila Chauvin

160

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

E-print Network

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

Chen, Sheng-Wei

161

Evaluation of a new point-of-care serologic assay for herpes simplex virus type 2 infection.  

PubMed

Herpes simplex virus type 2 infection is one of the most common sexually transmitted diseases. Because presentation is often atypical or subclinical, serologic testing is necessary for diagnosis, treatment, and counseling. In an urban clinic that specializes in the treatment of sexually transmitted disease, a new point-of-care rapid serologic test was compared with enzyme-linked immunosorbent assay or Western blot for the detection of herpes simplex virus type 2. With use of an enzyme-linked immunosorbent assay index cutoff value of 1.1, the rapid test was found to have a sensitivity of 97%, a specificity of 98%, a positive predictive value of 92%, and a negative predictive value of 99%. Increasing the cutoff index value to 3.5 increased the test sensitivity to 100%. PMID:18840082

Philip, Susan S; Ahrens, Katherine; Shayevich, Clara; de la Roca, Romeo; Williams, MaryAnn; Wilson, Daniel; Bernstein, Kyle; Klausner, Jeffrey D

2008-11-15

162

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

PubMed

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

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

2013-01-01

163

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

PubMed Central

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

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

2013-01-01

164

A Review of Online Evidence-based Practice Point-of-Care Information Summary Providers  

PubMed Central

Background Busy clinicians need easy access to evidence-based information to inform their clinical practice. Publishers and organizations have designed specific tools to meet doctors’ needs at the point of care. Objective The aim of this study was to describe online point-of-care summaries and evaluate their breadth, content development, and editorial policy against their claims of being “evidence-based.” Methods We searched Medline, Google, librarian association websites, and information conference proceedings from January to December 2008. We included English Web-based point-of-care summaries designed to deliver predigested, rapidly accessible, comprehensive, periodically updated, evidence-based information to clinicians. Two investigators independently extracted data on the general characteristics and content presentation of summaries. We assessed and ranked point-of-care products according to: (1) coverage (volume) of medical conditions, (2) editorial quality, and (3) evidence-based methodology. We explored how these factors were associated. Results We retrieved 30 eligible summaries. Of these products, 18 met our inclusion criteria and were qualitatively described, and 16 provided sufficient data for quantitative evaluation. The median volume of medical conditions covered was 80.6% (interquartile range, 68.9% - 84.2%) and varied for the different products. Similarly, differences emerged for editorial policy (median 8.0, interquartile range 5.8 - 10.3) and evidence-based methodology scores (median 10.0, interquartile range 1.0 - 12.8) on a 15-point scale. None of these dimensions turned out to be significantly associated with the other dimensions (editorial quality and volume, Spearman rank correlation r = -0.001, P = .99; evidence-based methodology and volume, r = -0.19, P = .48; editorial and evidence-based methodology, r = 0.43, P =.09). Conclusions Publishers are moving to develop point-of-care summary products. Some of these have better profiles than others, and there is room for improved reporting of the strengths and weaknesses of these products. PMID:20610379

Liberati, Alessandro; Moschetti, Ivan; Tagliabue, Ludovica; Moja, Lorenzo

2010-01-01

165

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

NASA Astrophysics Data System (ADS)

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.

Yao, Mingjin

166

Microelectrical sensors as emerging platforms for protein biomarker detection in point-of-care diagnostics.  

PubMed

Current methods used to measure protein expression on microarrays, such as labeled fluorescent imaging, are not well suited for real-time, diagnostic measurements at the point of care. Studies have shown that microelectrical sensors utilizing silica nanowire, impedimetric, surface acoustic wave, magnetic nanoparticle and microantenna technologies have the potential to impact disease diagnosis by offering sensing characteristics that rival conventional sensing techniques. Their ability to transduce protein binding events into electrical signals may prove essential for the development of next-generation point-of-care devices for molecular diagnostics, where they could be easily integrated with microarray, microfluidic and telemetry technologies. However, common limitations associated with the microelectrical sensors, including problems with sensor fabrication and sensitivity, must first be resolved. This review describes governing technical concepts and provides examples demonstrating the use of various microelectrical sensors in the diagnosis of disease via protein biomarkers. PMID:19817557

Arruda, David L; Wilson, William C; Nguyen, Crystal; Yao, Qi W; Caiazzo, Robert J; Talpasanu, Ilie; Dow, Douglas E; Liu, Brian C-S

2009-10-01

167

Microelectrical sensors as emerging platforms for protein biomarker detection in point-of-care diagnostics  

PubMed Central

Current methods used to measure protein expression on microarrays, such as labeled fluorescent imaging, are not well suited for real-time, diagnostic measurements at the point of care. Studies have shown that microelectrical sensors utilizing silica nanowire, impedimetric, surface acoustic wave, magnetic nanoparticle and microantenna technologies have the potential to impact disease diagnosis by offering sensing characteristics that rival conventional sensing techniques. Their ability to transduce protein binding events into electrical signals may prove essential for the development of next-generation point-of-care devices for molecular diagnostics, where they could be easily integrated with microarray, microfluidic and telemetry technologies. However, common limitations associated with the microelectrical sensors, including problems with sensor fabrication and sensitivity, must first be resolved. This review describes governing technical concepts and provides examples demonstrating the use of various microelectrical sensors in the diagnosis of disease via protein biomarkers. PMID:19817557

Arruda, David L; Wilson, William C; Nguyen, Crystal; Yao, Qi W; Caiazzo, Robert J; Talpasanu, Ilie; Dow, Douglas E; Liu, Brian C-S

2009-01-01

168

Portable Amplifier Design for a Novel EEG Monitor in Point-of-Care Applications  

PubMed Central

The Electroencephalography (EEG) is a common diagnostic tool for neurological diseases and dysfunctions, such as epilepsy and insomnia. However, the current EEG technology cannot be utilized quickly and conveniently at the point of care due to the complex skin preparation procedures required and the inconvenient EEG data acquisition systems. This work presents a portable amplifier design that integrates a set of skin screw electrodes and a wireless data link. The battery-operated amplifier contains an instrumentation amplifier, two noninverting amplifiers, two high-pass filters, and a low-pass filter. It is able to magnify the EEG signals over 10,000 times and has a high impedance, low noise, small size and low weight. Our electrode and amplifier are ideal for point-of-care applications, especially during transportation of patients suffering from traumatic brain injury or stroke. PMID:25339843

Luan, Bo; Sun, Mingui; Jia, Wenyan

2014-01-01

169

Paying the doctor: evidence-based decisions at the point-of-care and the role of fee-for-service incentives.  

PubMed

This article develops a framework for understanding how financial and nonfinancial incentives can complicate point-of-care decision-making by physicians, leading to the overuse or underuse of healthcare services. By examining the types of decisions that clinicians and patients make at the point-of-care, the framework clarifies how incentives can distort physicians' decisions about testing, diagnosis and treatment, as well as efforts to enhance patient adherence. The analysis highlights contributing factors that promote and impede evidence-based decision-making, using examples from the 'Choosing Wisely' program. It concludes with a summary of how the existing fee-for-service payment system in the USA may contribute to the problems of over- and under-testing, diagnosis and treatment, highlighted through the efforts of Choosing Wisely. PMID:24236623

Rich, Eugene C; Lake, Timothy K; Valenzano, Christal Stone; Maxfield, Myles M

2013-05-01

170

Evaluation of Platelet Aggregation Using a Point-Of-Care Instrument in Retired Racing Greyhounds  

Microsoft Academic Search

Veterinarians involved in Greyhound rescue have anecdotally observed that 10-15% of Greyhounds bleed profusely after simple surgical procedures. In most patients, platelet counts and hemostasis profiles are normal; therefore, it is possible that these dogs have platelet dysfunction. The PFA-100a is a novel point-of-care platelet function analyzer that has recently been evaluated as a rapid method to assess platelet function

C. G. Couto; A. Lara; M. C. Iazbik; M. B. Brooks

2006-01-01

171

Efficacy of Abciximab Induced Platelet Blockade Using a Rapid Point of Care Assay  

Microsoft Academic Search

Anciximab provides potent, but variable degrees of platelet inhibition both during the duration of intravenous administration and at 12 hours following therapy. Platelet function was assessed using the PC-RPFA system in 78 patients scheduled for percutaneous coronary revascularization who were administered the standard abciximab weight-adjusted bolus and 12-hour infusion. The PC-RPFA system is a cartridge-based, semiautomated point-of-care whole-blood assay that

Dean J. Kereiakes; Michele Mueller; Wendy Howard; Pam Lacock; Linda C. Anderson; Thomas M. Broderick; Eli M. Roth; Charles W. Abbottsmith

1999-01-01

172

Microfluidic origami for point-of-care extraction of nucleic acids from viscous samples  

Microsoft Academic Search

We present a low-cost microfluidic origami device for point-of-care extraction of bacterial DNA from raw viscous samples – a challenge for conventional microfluidic systems. The core idea is a novel method for sequencing arbitrarily complex chemical and physical processing steps through sequential folding of 2D surfaces. This folding creates temporary paper fluidic circuits substituting capillary flow for pumps, and folding

A. V. Govindarajan; S. Ramachandran; G. D. Vigil; P. Yager; K. F. Bohringer

2011-01-01

173

Matching point-of care devices to clinicians for positive outcomes.  

PubMed

Home care clinicians' use of point-of-care (POC) technology has increased 63% in the past 5 years. Although there are more POC system choices, matching the right device to each clinician's role is a challenge. This article clarifies the uses of laptop or notebook computer, personal digital assistants (PDAs), telephony, or automated telehealth, suggesting ways these technologies can result in clinical efficiencies, care coordination, and regulatory compliance. PMID:16010145

Utterback, Karen; Waldo, Billie H

2005-07-01

174

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

PubMed Central

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

2014-01-01

175

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

Microsoft Academic Search

BACKGROUND: To test the hypothesis that point-of-care assays of platelet reactivity would demonstrate reduced response to antiplatelet therapy in patients who experienced Drug Eluting Stent (DES) ST whilst on dual antiplatelet therapy compared to matched DES controls. Whilst the aetiology of stent thrombosis (ST) is multifactorial there is increasing evidence from laboratory-based assays that hyporesponsiveness to antiplatelet therapy is a

Alex R Hobson; Graham Petley; Geraint Morton; Keith D Dawkins; Nick P Curzen

2008-01-01

176

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

PubMed Central

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

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

177

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

NASA Astrophysics Data System (ADS)

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.

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

2013-05-01

178

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

PubMed Central

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

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

2014-01-01

179

Parallel optical coherence tomography (pOCT) for industrial 3D inspection  

NASA Astrophysics Data System (ADS)

Industry rely a lot on vision for in line or off line quality inspection. Whereas most of these applications use 2D vision, the need for 3D vision is increasing. Optical Coherence Tomography (OCT) is widely used in medical application to obtain 3D images of biological tissues but is still limited to low-speed and high price instruments in industrial applications. We developed a CMOS camera specially designed for parallel OCT (p-OCT). The advantage of this method over other OCT techniques is its high speed and its ability to maintain a high lateral resolution over large measurement depths. Our camera can acquire up to one million 2D images per second. The amplitude and phase of the modulated signal is calculated within every pixel. Up to 10'000 such amplitude and phase results can be returned in a second, for every pixel. We will present our instrument, which includes a rugged and compact interferometer aligned with a robotized assembly technique. This imaging interferometer is scanned during acquisition, allowing to maintain a high lateral resolution (typically 2 micron) over several millimeters. The interferometer is easily interchangeable (snap-in magnets) in order to choose the ideal magnification for the application. This compact and versatile system can be built directly on a robot arm or scanned over large objects.

Lambelet, Patrick

2011-05-01

180

Appendicitis Diagnosed by Emergency Physician Performed Point-of-Care Transvaginal Ultrasound: Case Series  

PubMed Central

Lower abdominal pain in females of reproductive age continues to be a diagnostic dilemma for the emergency physician (EP). Point-of-care ultrasound (US) allows for rapid, accurate, and safe evaluation of abdominal and pelvic pain in both the pregnant and non-pregnant patient. We present 3 cases of females presenting with right lower quadrant and adnexal tenderness where transvaginal ultrasonography revealed acute appendicitis. The discussion focuses on the use of EP- performed transvaginal US in gynecologic and intra-abdominal pathology and discusses the use of a staged approach to evaluation using US and computed tomography, as indicated. PMID:24106529

Bramante, Robert; Radomski, Marek; Nelson, Mathew; Raio, Christopher

2013-01-01

181

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

PubMed

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

Shin, Dong Jin; Wang, Tza-Huei

2014-11-01

182

Transport and use of point-of-care ultrasound by a disaster medical assistance team.  

PubMed

The role of ultrasound in disaster medicine has not been not well established. This report describes the transport and use of point-of-care ultrasound by a Disaster Medical Assistance Team (DMAT) responding to a mass-casualty incident due to a cyclone. Ultrasound-competent physicians on the team were able to use portable ultrasound on cyclone casualties to exclude intra-abdominal hemorrhage, pericardial fluid, pneumothoraces, and hemothoraces. Information obtained using ultrasound made initial patient management, and subsequent decisions regarding triage for transport safer and based on more detailed clinical information. PMID:19591309

Mazur, Stefan M; Rippey, James

2009-01-01

183

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

PubMed Central

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

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

2012-01-01

184

Point-of-Care Microdevices for Blood Plasma Analysis in Viral Infectious Diseases.  

PubMed

Each year, outbreaks of viral infections cause illness, disability, death, and economic loss. As learned from past incidents, the detrimental impact grows exponentially without effective quarantine. Therefore, rapid on-site detection and analysis are highly desired. In addition, for high-risk areas of viral contamination, close monitoring should be provided during the potential disease incubation period. As the epidemic progresses, a response protocol needs tobe rapidly implemented and the virus evolution fully tracked. For these scenarios, point-of-care microdevices can provide sensitive, accurate, rapid and low-cost analysis for a large population, especially in handling complex patient samples, such as blood, urine and saliva. Blood plasma can be considered as a mine of information containing sources and clues of biomarkers, including nucleic acids, immunoglobulin and other proteins, as well as pathogens for clinical diagnosis. However, blood plasma is also the most complicated body fluid. For targeted plasma biomarker detection or untargeted plasma biomarker discovery, the challenges can be as difficult as identifying a needle in a haystack. A useful platform must not only pursue single performance characteristics, but also excel at multiple performance parameters, such as speed, accuracy, sensitivity, selectivity, cost, portability, reliability, and user friendliness. Throughout the decades, tremendous progress has been made in point-of-care microdevices for viral infectious diseases. In this paper, we review fully integrated lab-on-chip systems for blood analysis of viral infectious disease. PMID:24879614

Yeh, Yin-Ting; Nisic, Merisa; Yu, Xu; Xia, Yiqiu; Zheng, Si-Yang

2014-11-01

185

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

PubMed

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

Rusling, James F; Kumar, Challa V; Gutkind, J Silvio; Patel, Vyomesh

2010-10-01

186

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

PubMed Central

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

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

2010-01-01

187

Fibre optics sensors in tear electrolyte analysis: towards a novel point of care potassium sensor.  

PubMed

The diagnosis of ocular disease is increasingly important in optometric practice and there is a need for cost effective point of care assays to assist in that. Although tears are a potentially valuable source of diagnostic information difficulties associated with sample collection and limited sample size together with sample storage and transport have proved major limitations. Progressive developments in electronics and fibre optics together with innovation in sensing technology mean that the construction of inexpensive point of care fibre optic sensing devices is now possible. Tear electrolytes are an obvious family of target analytes, not least to complement the availability of devices that make the routine measurement of tear osmolarity possible in the clinic. In this paper we describe the design, fabrication and calibration of a fibre-optic based electrolyte sensor for the quantification of potassium in tears using the ex vivo contact lens as the sample source. The technology is generic and the same principles can be used in the development of calcium and magnesium sensors. An important objective of this sensor technology development is to provide information at the point of routine optometric examination, which would provide supportive evidence of tear abnormality. PMID:22409950

Harvey, Daniel; Hayes, Neil W; Tighe, Brian

2012-06-01

188

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

PubMed

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

Kuiper, RuthAnne

2010-01-01

189

Recent advances in cortisol sensing technologies for point-of-care application.  

PubMed

Everyday lifestyle related issues are the main cause of psychological stress, which contributes to health disparities experienced by individuals. Prolonged exposure to stress leads to the activation of signaling pathways from the brain that leads to release of cortisol from the adrenal cortex. Various biomarkers have been affected by psychological stress, but cortisol "a steroid hormone" is known as a potential biomarker for its estimation. Cortisol can also be used as a target analyte marker to determine the effect of exposure such as organophosphates on central nervous system, which alters the endocrine system, leading to imbalance in cortisol secretion. Cortisol secretion of individuals depends on day-night cycle and field environment hence its detection at point-of-care (POC) is deemed essential to provide personalized healthcare. Chromatographic techniques have been traditionally used to detect cortisol. The issues relating to assay formation, system complexity, and multistep extraction/purification limits its application in the field. In order to overcome these issues and to make portable and effective miniaturized platform, various immunoassays sensing strategies are being explored. However, electrochemical immunosensing of cortisol is considered as a recent advancement towards POC application. Highly sensitive, label-free and selective cortisol immunosensor based on microelectrodes are being integrated with the microfluidic system for automated diurnal cortisol monitoring useful for personalized healthcare. Although the reported sensing devices for cortisol detection may have a great scope to improve portability, electronic designing, performance of the integrated sensor, data safety and lifetime for point-of-care applications, This review is an attempt to describe the various cortisol sensing platforms and their potential to be integrated into a wearable system for online and continuous monitoring of cortisol rhythm at POC as a function of one's environment. PMID:24212052

Kaushik, Ajeet; Vasudev, Abhay; Arya, Sunil K; Pasha, Syed Khalid; Bhansali, Shekhar

2014-03-15

190

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

NASA Astrophysics Data System (ADS)

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.

Liu, Hongxing; Xing, Da; Zhou, Xiaoming

2014-09-01

191

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

PubMed

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

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

2011-05-21

192

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

PubMed

We present a novel "Lab-on-DVD" system and demonstrate its capability for rapid and low-cost HIV diagnostics by counting CD4+ cells isolated from whole blood. We show that a commercial DVD drive can, with certain modifications, be turned into an improved DVD-based laser scanning microscope (DVD-LSM). The system consists of a multi-layered disposable polymer disc and a modified commercial DVD reader with rotational control for sample handling, temperature control for optimized bioassay, a photodiode array for detection, and software for signal processing and user interface - all the necessary components required for a truly integrated lab-on-a-chip system, with the capability to deliver high-resolution images down to 1 ?m in size. Using discs modified with antibodies, we specifically captured CD4+ cells from whole blood, demonstrating single cell resolution imaging. The novel integrated DVD platform with sub-micron image resolution brings, for the first time, affordable cellular diagnostic testing to the point-of-care and should be readily applicable at resource-limited settings. PMID:23440071

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

2013-04-21

193

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

PubMed

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

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

2014-03-26

194

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

PubMed Central

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?

2014-01-01

195

Point-of-care blood gases, electrolytes, chemistries, hemoglobin, and hematocrit measurement in venous samples from pet rabbits.  

PubMed

Point-of-care testing is an attractive option in rabbit medicine, because it permits rapid analysis of a panel of electrolytes, chemistries, blood gases, hemoglobin, and hematocrit, requiring only 65 ?L of blood. The purpose of this study was to evaluate the performance of a portable clinical analyzer for measurement of pH, partial pressure of CO2, Na, chloride, potassium, blood urea nitrogen, glucose, hematocrit, and hemoglobin in healthy and diseased rabbits. Blood samples obtained from 30 pet rabbits were analyzed immediately after collection by the portable clinical analyzer (PCA) and immediately thereafter (time <20 sec) by a reference analyzer. Bland-Altman plots and Passing-Bablok regression analysis were used to compare the results. Limits of agreement were wide for all the variables studied, with the exception of pH. Most variables presented significant proportional and/or constant bias. The current study provides sufficient evidence that the PCA presents reliability for pH, although its low agreement with a reference analyzer for the other variables does not support their interchangeability. Limits of agreement provided for each variable allow researchers to evaluate if the PCA is reliable enough for their scope. To the authors' knowledge, the present is the first report evaluating a PCA in the rabbit. PMID:25028433

Selleri, Paolo; Di Girolamo, Nicola

2014-01-01

196

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

NASA Astrophysics Data System (ADS)

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.

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

197

Selection of Antigens and Development of Prototype Tests for Point-of-Care Leprosy Diagnosis  

Microsoft Academic Search

Leprosy can be a devastating chronic infection that causes nerve function impairment and associated disfigurement. Despite the recent reduction in the number of registered worldwide leprosy cases as a result of the widespread use of multidrug therapy, the number of new cases detected each year remains relatively stable. The diagnosis of leprosy is currently based on the appearance of clinical

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

2008-01-01

198

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

E-print Network

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 ...

Pollock, Nira R.

199

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

NASA Astrophysics Data System (ADS)

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.

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

2012-03-01

200

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

PubMed Central

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

Niemz, Angelika; Boyle, David S

2013-01-01

201

Technical Performance Evaluation of the MyT4 Point of Care Technology for CD4+ T Cell Enumeration  

PubMed Central

Objective Though absolute CD4+ T cell enumeration is the primary gateway to antiretroviral therapy initiation for HIV-positive patients in all developing countries, patient access to this critical diagnostic test is relatively poor. We technically evaluated the performance of a newly developed point-of-care CD4+ T cell technology, the MyT4, compared with conventional CD4+ T cell testing technologies. Design Over 250 HIV-positive patients were consecutively enrolled and their blood tested on the MyT4, BD FACSCalibur, and BD FACSCount. Results Compared with the BD FACSCount, the MyT4 had an r2 of 0.7269 and a mean bias of ?23.37 cells/µl. Compared with the BD FACSCalibur, the MyT4 had an r2 of 0.5825 and a mean bias of ?46.58 cells/µl. Kenya currently uses a CD4+ T cell test threshold of 350 cells/µl to determine patient eligibility for antiretroviral therapy. At this threshold, the MyT4 had a sensitivity of 95.3% (95% CI: 88.4–98.7%) and a specificity of 87.9% (95% CI: 82.3–92.3%) compared with the BD FACSCount and sensitivity and specificity of 88.2% (95% CI: 79.4–94.2%) and 84.2% (95% CI: 78.2–89.2%), respectively, compared with the BD FACSCalibur. Finally, the MyT4 had a coefficient of variation of 12.80% compared with 14.03% for the BD FACSCalibur. Conclusions We conclude that the MyT4 performed well at the current 350 cells/µl ART initiation eligibility threshold when used by lower cadres of health care facility staff in rural clinics compared to conventional CD4+ T cell technologies. PMID:25229408

Mwau, Matilu; Kadima, Silvia; Mwende, Joy; Adhiambo, Maureen; Akinyi, Catherine; Prescott, Marta; Lusike, Judi; Hungu, Jackson; Vojnov, Lara

2014-01-01

202

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

PubMed

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

Ibaida, Ayman; Khalil, Ibrahim

2013-05-21

203

A novel handheld fluorescent microarray reader for point-of-care diagnostic.  

PubMed

A novel handheld optical sensor for quantification of fluorescent microarrays, the so-called portMD-113 has been developed. On the surface of a planar waveguide, the spots of different fluorescently labeled biological complexes are excited by the evanescent field of the guided light. The emitted fluorescence signals of the spots are independently and simultaneously detected applying our system, which consists of a pinehole array, a microlens array, an interference filter and a detector array. As it is demonstrated in comparative measurements, the detection limit of this sensor is close to that of commercial top microarray readers, e.g. of modern laser scanners, while it has remarkable and important advantages over them. Namely, the device comprises only a few low-cost, lightweight and small components without applying any moving or energy-intensive elements, which results in turn in a commercially competitive, handheld and compact design and in the possibility to be supplied simply by a battery or a personal computer. These advantageous properties open prospects e.g. for point-of-care medical checks, as well. PMID:23612063

Kozma, P; Lehmann, A; Wunderlich, K; Michel, D; Schumacher, S; Ehrentreich-Förster, E; Bier, F F

2013-09-15

204

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

PubMed

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

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

2012-07-01

205

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

PubMed

There is a growing demand to integrate biosensors with microfluidics to provide miniaturized platforms with many favorable properties, such as reduced sample volume, decreased processing time, low cost analysis and low reagent consumption. These microfluidics-integrated biosensors would also have numerous advantages such as laminar flow, minimal handling of hazardous materials, multiple sample detection in parallel, portability and versatility in design. Microfluidics involves the science and technology of manipulation of fluids at the micro- to nano-liter level. It is predicted that combining biosensors with microfluidic chips will yield enhanced analytical capability, and widen the possibilities for applications in clinical diagnostics. The recent developments in microfluidics have helped researchers working in industries and educational institutes to adopt some of these platforms for point-of-care (POC) diagnostics. This review focuses on the latest advancements in the fields of microfluidic biosensing technologies, and on the challenges and possible solutions for translation of this technology for POC diagnostic applications. We also discuss the fabrication techniques required for developing microfluidic-integrated biosensors, recently reported biomarkers, and the prospects of POC diagnostics in the medical industry. PMID:24019250

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

2013-11-01

206

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

PubMed Central

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

Jokerst, Jesse V

2011-01-01

207

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

PubMed

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

Shiparski, Laurie; Authier, Philip

2013-01-01

208

Development of miniaturized, portable magnetic resonance relaxometry system for point-of-care medical diagnosis.  

PubMed

A novel, compact-sized (19 cm × 16 cm) and portable (500 g) magnetic resonance relaxometry system is designed and developed. We overcame several key engineering barriers so that magnetic resonance technology can be potentially used for disease diagnosis-monitoring in point-of-care settings, directly on biological cells and tissues. The whole system consists of a coin-sized permanent magnet (0.76 T), miniaturized radio-frequency microcoil probe, compact lumped-circuit duplexer, and single board 1-W power amplifier, in which a field programmable gate array -based spectrometer is used for pulse excitation, signal acquisition, and data processing. We show that by measuring the proton transverse relaxation rates from a large pool of natural abundance proton-nuclei presence in less than 1 ?L of red blood cells, one can indirectly deduce the relative magnetic susceptibility of the bulk cells within a few minutes of signal acquisition time. Such rapid and sensitive blood screening system can be used to monitor the fluctuation of the bulk magnetic susceptibility of the biological cells (e.g., human blood cells), where unusual state of the bulk magnetic susceptibility is related to a number of diseases. PMID:23020427

Peng, Weng Kung; Chen, Lan; Han, Jongyoon

2012-09-01

209

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

PubMed Central

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

Patel, Pranav; Yillah, Jasmin; Weidmann, Manfred; Mendez, Jairo A.; Nakoune, Emmanuel Rivalyn; Niedrig, Matthias

2012-01-01

210

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

PubMed Central

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. PMID:24799039

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

2014-01-01

211

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

NASA Astrophysics Data System (ADS)

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.

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

2014-05-01

212

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

ERIC Educational Resources Information Center

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…

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

2009-01-01

213

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

E-print Network

expensive and more effective than treatment at later stages. Built on Sandia's advancements in labThe rapid, automated, point-of-care system (RapiDx) developed by Sandia National Laboratories threats. If a crowd is exposed to dangerous biotoxins, potentially Lab-on-a-Chip Technology for Portable

Singh, Anup

214

AC electrokinetics-enhanced capacitive immunosensor for point-of-care serodiagnosis of infectious diseases.  

PubMed

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

Li, Shanshan; Cui, Haochen; Yuan, Quan; Wu, Jie; Wadhwa, Ashutosh; Eda, Shigetoshi; Jiang, Hongyuan

2014-01-15

215

Rapid Point of Care Analyzer for the Measurement of Cyanide in Blood  

PubMed Central

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

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

216

Evaluation of point-of-care analyzers' ability to reduce bias in conductivity-based hematocrit measurement during cardiopulmonary bypass.  

PubMed

Most point-of-care testing analyzers use the conductivity method to measure hematocrit (hct). During open-heart surgery, blood-conductivity is influenced by shifts in electrolyte and colloid concentrations caused by infusion media used, and this may lead to considerable bias in the hct measurement. We evaluated to what extent different analyzers correcting for 0, 1, 2, or 3 factors, respectively, compensated for this electrolyte/colloid interference: (1) the conductivity method with no correction (IRMA), (2) with a [Na(+)]-correction (GEM Premier 3000), (3) with a [Na(+)]/[K(+)]-correction (i-STAT), and (4) with a [Na(+)]/[K(+)]-correction in combination with an algorithm that estimates the protein dilution [i-STAT in cardiopulmonary bypass (CPB)-mode]. Bias in hct was measured during three consecutive stages of a CPB procedure: (I) before CPB, (II) start of CPB and (III) after cardioplegia. In order of high to low electrolyte/colloid interference: the analyzer with no correction, [Na(+)]-correction, [Na(+)/]/[K(+)]-correction, and [Na(+)/]/[K(+)]/estimated protein-correction showed a change of bias from stage I to stage III of -3.9 ± 0.5, -3.4 ± 0.4, -2.1 ± 0.5, -0.3 ± 0.5%. We conclude that correcting for more parameters (Na(+), K(+), estimated protein) gives less bias, but residual bias remains even after [Na(+)/]/[K(+)]/estimated protein-correction. This suggests that a satisfactory algorithm should also correct for other colloidal factors than protein. PMID:23990287

Teerenstra, Steven; Steinfelder-Visscher, Jacoline; Gunnewiek, Jacqueline Klein; Weerwind, Patrick W

2014-04-01

217

Surface enhanced Raman spectroscopy based nanoparticle assays for rapid, point-of-care diagnostics  

NASA Astrophysics Data System (ADS)

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.

Driscoll, Ashley J.

218

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

PubMed

Functionalized magnetic nanoparticles are important components in biorecognition and medical diagnostics. Here, we present a review of our contribution to this interdisciplinary research field. We start by describing a simple one-step process for the synthesis of highly uniform ferrite nanoparticles (d = 20-200 nm) and their functionalization with amino acids via carboxyl groups. For real-world applications, we used admicellar polymerization to produce 200 nm diameter 'FG beads', consisting of several 40 nm diameter ferrite nanoparticles encapsulated in a co-polymer of styrene and glycidyl methacrylate for high throughput molecular screening. The highly dispersive FG beads were functionalized with an ethylene glycol diglycidyl ether spacer and used for affinity purification of methotrexate-an anti-cancer agent. We synthesized sub-100 nm diameter magnetic nanocapsules by exploiting the self-assembly of viral capsid protein pentamers, where single 8, 20, and 27 nm nanoparticles were encapsulated with VP1 pentamers for applications including MRI contrast agents. The FG beads are now commercially available for use in fully automated bio-screening systems. We also incorporated europium complexes inside a polymer matrix to produce 140 nm diameter fluorescent-ferrite beads (FF beads), which emit at 618 nm. These FF beads were used for immunofluorescent staining for diagnosis of cancer metastases to lymph nodes during cancer resection surgery by labeling tumor cell epidermal growth factor receptor (EGFRs), and for the detection of brain natriuretic peptide (BNP)-a hormone secreted in excess amounts by the heart when stressed-to a level of 2.0 pg ml(-1). We also describe our work on Hall biosensors made using InSb and GaAs/InGaAs/AlGaAs 2DEG heterostructures integrated with gold current strips to reduce measurement times. Our approach for the detection of sub-200 nm magnetic bead is also described: we exploit the magnetically induced capture of micrometer sized 'probe beads' by nanometer sized 'target beads', enabling the detection of small concentrations of beads as small as 8 nm in 'pumpless' microcapillary systems. Finally, we describe a 'label-less homogeneous' procedure referred to as 'magneto-optical transmission (MT) sensing', where the optical transmission of a solution containing rotating linear chains of magnetic nanobeads was used to detect biomolecules with pM-level sensitivity with a dynamic range of more than four orders of magnitude. Our research on the synthesis and applications of nanoparticles is particularly suitable for point of care diagnostics. PMID:20935358

Sandhu, Adarsh; Handa, Hiroshi; Abe, Masanori

2010-11-01

219

Characterizing the limited use of point-of-care ultrasound in Colombian emergency medicine residencies  

PubMed Central

Background Emergency medicine (EM) is a growing specialty in Colombia with five residency programs in the country. EM leadership is interested in incorporating point-of-care (POC) ultrasound into a standardized national EM residency curriculum. This study is a nationwide survey of Colombian EM residents designed to explore the current state of POC ultrasound use within EM residencies and examine specific barriers preventing its expansion. Methods We conducted a mix-methodology study of all available current EM residents in the five EM residencies in Colombia. The quantitative survey assessed previous ultrasound experience, current use of various applications, desire for further training, and perceived barriers to expanded use. Focus group discussions (FGDs) were conducted with current EM residents to gather additional qualitative insight into their practice patterns and perceived barriers to clinician-performed ultrasound. Results Sixty-nine EM residents completed the quantitative survey, a response rate of 85% of all current EM residents in Colombia; 52% of resident respondents had previously used ultrasound during their training. Of these, 58% indicated that they had performed <10 scans and 17% reported >40 scans. The most frequently used applications indicated by respondents were trauma, obstetrics, and procedures including vascular access. A quarter indicated they had previously received some ultrasound training, but almost all expressed an interest in learning more. Significant barriers included lack of trained teachers (indicated by 78% of respondents), absence of machines (57%), and limited time (41%). In FGDs, the barriers identified were inter-specialty conflicts over the control of ultrasonography, both institutionally and nationally, and program-specific curriculum decisions to include POC ultrasound. Conclusion While currently limited in their access, EM residents in Colombia have a strong interest in integrating POC ultrasound into their training. Current barriers to expanded use include traditional barriers such as a lack of equipment seen in many developing countries, as well as inter-specialty conflicts typical of developed countries. Further collaboration is underway to help overcome these obstacles and integrate POC ultrasound into Colombian EM residency training. PMID:24499650

2014-01-01

220

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

NASA Astrophysics Data System (ADS)

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.

Sandhu, Adarsh; Handa, Hiroshi; Abe, Masanori

2010-11-01

221

Point-of-care multiplexed assays of nucleic acids using microcapillary-based loop-mediated isothermal amplification.  

PubMed

This report demonstrates a straightforward, robust, multiplexed and point-of-care microcapillary-based loop-mediated isothermal amplification (cLAMP) for assaying nucleic acids. This assay integrates capillaries (glass or plastic) to introduce and house sample/reagents, segments of water droplets to prevent contamination, pocket warmers to provide heat, and a hand-held flashlight for a visual readout of the fluorescent signal. The cLAMP system allows the simultaneous detection of two RNA targets of human immunodeficiency virus (HIV) from multiple plasma samples, and achieves a high sensitivity of two copies of standard plasmid. As few nucleic acid detection methods can be wholly independent of external power supply and equipment, our cLAMP holds great promise for point-of-care applications in resource-poor settings. PMID:24937125

Zhang, Yi; Zhang, Lu; Sun, Jiashu; Liu, Yulei; Ma, Xingjie; Cui, Shangjin; Ma, Liying; Xi, Jianzhong Jeff; Jiang, Xingyu

2014-07-15

222

ENGINEERING A POINT-OF-CARE VIRAL CONCENTRATION DEVICE FOR RAPID MOLECULAR DIAGNOSTICS OF INFLUENZA IN HUMAN RESPIRATORY SPECIMENS  

E-print Network

Air flow control layer double-sided acrylic adhesive Air flow fixture Polycarbonate Teflon porous membrane Air flow Sample flow 0.1 mm 0.2 mm 0.1 mm 3.18 mm 1.7 mm 1.3 mm Sideview Sample inlet Sample interface Air flow chamber Disposable chip ATCC influenza A/PR/8/34 samples from cell culturePoint-of- care

223

A multiplexed nucleic acid microsystem for point-of-care detection of HIV co-infection with MTB and PCP.  

PubMed

Many individuals infected with the human immunodeficiency virus (HIV), especially children in African countries, die of co-infections with Mycobacterium tuberculosis (MTB) (coinfection rate: 50%) or Pneumocystis carinii pneumonia (PCP) (coinfection rate: 81%). The present proposal describes a rapid, portable, low-cost, multiplexed point-of-care diagnostic technique for simultaneously detecting HIV, MTB, and PCP. This technique incorporates a creative micro-device (hardware) and a loop-mediated isothermal amplification strategy (software). PMID:24209377

Xu, Lingjia; Kong, Jilie

2013-12-15

224

Lensfree computational microscopy tools for cell and tissue imaging at the point-of-care and in low-resource settings  

PubMed Central

The recent revolution in digital technologies and information processing methods present important opportunities to transform the way optical imaging is performed, particularly toward improving the throughput of microscopes while at the same time reducing their relative cost and complexity. Lensfree computational microscopy is rapidly emerging toward this end, and by discarding lenses and other bulky optical components of conventional imaging systems, and relying on digital computation instead, it can achieve both reflection and transmission mode microscopy over a large field-of-view within compact, cost-effective and mechanically robust architectures. Such high throughput and miniaturized imaging devices can provide a complementary toolset for telemedicine applications and point-of-care diagnostics by facilitating complex and critical tasks such as cytometry and microscopic analysis of e.g., blood smears, Pap tests and tissue samples. In this article, the basics of these lensfree microscopy modalities will be reviewed, and their clinically relevant applications will be discussed. PMID:22433451

Isikman, Serhan O.; Greenbaum, Alon; Lee, Myungjun; Bishara, Waheb; Mudanyali, Onur; Su, Ting-Wei; Ozcan, Aydogan

2013-01-01

225

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

PubMed Central

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

2013-01-01

226

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

PubMed Central

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

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

2014-01-01

227

[Guidelines for documentation management mastery according to the EN ISO 22870].  

PubMed

This article proposes to organize the documentation system of point-of-care testing (POCT) to meet the requirements of EN ISO 22870. In a first part, we propose provisions to improve the control of documents circulating outside the laboratory and aimed at non-laboratory staff. Then we review POCT-related records and we propose an organization facilitating their audit. In the last part, a model of POCT quality plan is proposed : in addition to the quality manual, this document defines the specific measures taken in order to ensure the control of POCT. PMID:22736705

Pernet, P; Szymanowicz, A; Goudable, J; Guimont, M C

2012-02-01

228

Speed and Accuracy of a Point of Care Web-Based Knowledge Resource for Clinicians: A Controlled Crossover Trial  

PubMed Central

Background Effective knowledge translation at the point of care requires that clinicians quickly find correct answers to clinical questions, and that they have appropriate confidence in their answers. Web-based knowledge resources can facilitate this process. Objective The objective of our study was to evaluate a novel Web-based knowledge resource in comparison with other available Web-based resources, using outcomes of accuracy, time, and confidence. Methods We conducted a controlled, crossover trial involving 59 practicing clinicians. Each participant answered questions related to two clinical scenarios. For one scenario, participants used a locally developed Web-based resource, and for the second scenario, they used other self-selected Web-based resources. The local knowledge resource (“AskMayoExpert”) was designed to provide very concise evidence-based answers to commonly asked clinical questions. Outcomes included time to a correct response with at least 80% confidence (primary outcome), accuracy, time, and confidence. Results Answers were more often accurate when using the local resource than when using other Web-based resources, with odds ratio 6.2 (95% CI 2.6-14.5; P<.001) when averaged across scenarios. Time to find an answer was faster, and confidence in that answer was consistently higher, for the local resource (P<.001). Overconfidence was also less frequent with the local resource. In a time-to-event analysis, the chance of responding correctly with at least 80% confidence was 2.5 times greater when using the local resource than with other resources (95% CI 1.6-3.8; P<.001). Conclusions Clinicians using a Web-based knowledge resource designed to provide quick, concise answers at the point of care found answers with greater accuracy and confidence than when using other self-selected Web-based resources. Further study to improve the design and implementation of knowledge resources may improve point of care learning. PMID:24566739

Enders, Felicity; Linderbaum, Jane A; Zwart, Dale; Lloyd, Farrell J

2014-01-01

229

Diagnosis of Appendicitis by a Pediatric Emergency Medicine Attending using Point-of-Care Ultrasound: A Case Report  

PubMed Central

Over the past decade Point-of-Care Ultrasound (POC US) is increasingly performed in adult emergency medicine for a variety of indications. Pediatric emergency medicine has been much slower to embrace POC US. The authors report a case of a 15-year-old boy that presented to the pediatric emergency department with abdominal pain. A diagnosis of appendicitis was made using real-time POC US by a pediatric emergency medicine attending. Knowledge of the sonographic characteristics of appendicitis can help the physician in the prompt diagnosis of this condition, thereby reducing morbidity and mortality that may result from a delay in diagnosis. PMID:20848383

Eakin, Paul J; Franke, Adrian A

2010-01-01

230

Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy  

PubMed Central

Executive Summary Subject of the Evidence-Based Analysis The purpose of this evidence based analysis report is to examine the safety and effectiveness of point-of-care (POC) international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy (OAT). Clinical Need: Target Population and Condition Long-term OAT is typically required by patients with mechanical heart valves, chronic atrial fibrillation, venous thromboembolism, myocardial infarction, stroke, and/or peripheral arterial occlusion. It is estimated that approximately 1% of the population receives anticoagulation treatment and, by applying this value to Ontario, there are an estimated 132,000 patients on OAT in the province, a figure that is expected to increase with the aging population. Patients on OAT are regularly monitored and their medications adjusted to ensure that their INR scores remain in the therapeutic range. This can be challenging due to the narrow therapeutic window of warfarin and variation in individual responses. Optimal INR scores depend on the underlying indication for treatment and patient level characteristics, but for most patients the therapeutic range is an INR score of between 2.0 and 3.0. The current standard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics (ACCs). Patients also regularly visit a hospital or community-based facility to provide a venous blood samples (venipuncture) that are then sent to a laboratory for INR analysis. Experts, however, have commented that there may be under-utilization of OAT due to patient factors, physician factors, or regional practice variations and that sub-optimal patient management may also occur. There is currently no population-based Ontario data to permit the assessment of patient care, but recent systematic reviews have estimated that less that 50% of patients receive OAT on a routine basis and that patients are in the therapeutic range only 64% of the time. Overview of POC INR Devices POC INR devices offer an alternative to laboratory-based testing and venipuncture, enabling INR determination from a fingerstick sample of whole blood. Independent evaluations have shown POC devices to have an acceptable level of precision. They permit INR results to be determined immediately, allowing for more rapid medication adjustments. POC devices can be used in a variety of settings including physician offices, ACCs, long-term care facilities, pharmacies, or by the patients themselves through self-testing (PST) or self-management (PSM) techniques. With PST, patients measure their INR values and then contact their physician for instructions on dose adjustment, whereas with PSM, patients adjust the medication themselves based on pre-set algorithms. These models are not suitable for all patients and require the identification and education of suitable candidates. Potential advantages of POC devices include improved convenience to patients, better treatment compliance and satisfaction, more frequent monitoring and fewer thromboembolic and hemorrhagic complications. Potential disadvantages of the device include the tendency to underestimate high INR values and overestimate low INR values, low thromboplastin sensitivity, inability to calculate a mean normal PT, and errors in INR determination in patients with antiphospholipid antibodies with certain instruments. Although treatment satisfaction and quality of life (QoL) may improve with POC INR monitoring, some patients may experience increased anxiety or preoccupation with their disease with these strategies. Evidence-Based Analysis Methods Research Questions 1. Effectiveness Does POC INR monitoring improve clinical outcomes in various settings compared to standard laboratory-based testing? Does POC INR monitoring impact patient satisfaction, QoL, compliance, acceptability, convenience compared to standard laboratory-based INR determination? Settings include primary care settings with use of POC INR dev

2009-01-01

231

A novel ?-fluidic whole blood coagulation assay based on Rayleigh surface-acoustic waves as a point-of-care method to detect anticoagulants  

PubMed Central

A universal coagulation test that reliably detects prolonged coagulation time in patients, irrespective of the anticoagulant administered, has not been available to date. An easily miniaturised, novel ?-fluidic universal coagulation test employing surface acoustic waves (SAW) is presented here. SAW was employed to instantly mix and recalcify 6??l citrated whole blood and image correlation analysis was used to quantify clot formation kinetics. The detection of clinically relevant anticoagulant dosing with old anticoagulants (unfractionated heparin, argatroban) and new anticoagulants (dabigatran, rivaroxaban) has been tested and compared to standard plasma coagulation assays. The applicability of this novel method has been confirmed in a small patient population. Coagulation was dose-proportionally prolonged with heparin, argatroban, dabigatran, and rivaroxaban, comparable to standard tests. Aspirin and clopidogrel did not interfere with the SAW-induced clotting time (SAW-CT), whereas the strong GPIIb/IIIa-inhibitor abciximab did interfere. Preliminary clinical data prove the suitability of the SAW-CT in patients being treated with warfarin, rivaroxaban, or dabigatran. The system principally allows assessment of whole blood coagulation in humans in a point-of-care setting. This method could be used in stroke units, emergency vehicles, general and intensive care wards, as well as for laboratory and home testing of coagulation. PMID:24404078

Meyer dos Santos, Sascha; Zorn, Anita; Guttenberg, Zeno; Picard-Willems, Bettina; Klaffling, Christina; Nelson, Karen; Klinkhardt, Ute; Harder, Sebastian

2013-01-01

232

Point-of-Care Differentiation of Kawasaki Disease from Other Febrile Illnesses  

PubMed Central

Objective To test whether statistical learning on clinical and laboratory test patterns would lead to an algorithm for Kawasaki disease (KD) diagnosis that could aid clinicians. Study design Demographic, clinical, and laboratory data were prospectively collected for subjects with KD and febrile controls (FCs) using a standardized data collection form. Results Our multivariate models were trained with a cohort of 276 patients with KD and 243 FCs (who shared some features of KD) and validated with a cohort of 136 patients with KD and 121 FCs using either clinical data, laboratory test results, or their combination. Our KD scoring method stratified the subjects into subgroups with low (FC diagnosis, negative predictive value >95%), intermediate, and high (KD diagnosis, positive predictive value >95%) scores. Combining both clinical and laboratory test results, the algorithm diagnosed 81.2% of all training and 74.3% of all testing of patients with KD in the high score group and 67.5% of all training and 62.8% of all testing FCs in the low score group. Conclusions Our KD scoring metric and the associated data system with online (http://translationalmedicine.stanford.edu/cgi-bin/KD/kd.pl) and smartphone applications are easily accessible, inexpensive tools to improve the differentiation of most children with KD from FCs with other pediatric illnesses. PMID:22819274

Ling, Xuefeng B.; Kanegaye, John T.; Ji, Jun; Peng, Sihua; Sato, Yuichiro; Tremoulet, Adriana; Burns, Jane C.; Cohen, Harvey J.

2014-01-01

233

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

PubMed Central

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

Bhalla, Ashish

2014-01-01

234

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

NASA Astrophysics Data System (ADS)

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.

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

2013-05-01

235

Point-of-care diagnostics, a major opportunity for change in traditional diagnostic approaches: potential and limitations.  

PubMed

'Point-of-care' (POC) diagnostics are a powerful emerging healthcare approach. They can rapidly provide statistically significant results, are simple to use, do not require specialized equipment and are cost-effective. For these reasons, they have the potential to play a major role in revolutionizing the diagnosis, initiation and monitoring of treatment of major global diseases. This review focuses on antibody-based POC devices that target four major global diseases: cardiovascular diseases, prostate cancer, HIV infection and tuberculosis. The key statistics and pathology of each disease is described in detail, followed by an in-depth discussion on emerging POC devices that target each disease, highlighting their potential and limitations. PMID:25300742

McPartlin, Daniel A; O'Kennedy, Richard J

2014-11-01

236

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

NASA Astrophysics Data System (ADS)

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

Sayegh, Samir I.; Taghian, Alphonse

2013-02-01

237

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

PubMed

Complementary metal oxide semiconductor (CMOS)-based image sensors have received increased attention owing to the possibility of incorporating them into portable diagnostic devices. The present research examined the efficiency and sensitivity of a CMOS image sensor for the detection of antigen-antibody interactions involving interferon gamma protein without the aid of expensive instruments. The highest detection sensitivity of about 1 fg/ml primary antibody was achieved simply by a transmission mechanism. When photons are prevented from hitting the sensor surface, a reduction in digital output occurs in which the number of photons hitting the sensor surface is approximately proportional to the digital number. Nanoscale variation in substrate thickness after protein binding can be detected with high sensitivity by the CMOS image sensor. Therefore, this technique can be easily applied to smartphones or any clinical diagnostic devices for the detection of several biological entities, with high impact on the development of point-of-care applications. PMID:21773736

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

2011-09-01

238

Evaluation of the veterinary application of a point-of-care device measuring white blood cell counts.  

PubMed

A point-of-care device (POCD) for measuring total white blood cell count was evaluated for feline, canine, equine and bovine blood samples collected into EDTA. Mean biases were -9.2% (range, -12% to -6.3%) for feline samples, 20.2% (range, 15.3-25.1%) for canine samples, -7.1% (range, -8.3% to -5.9%) for equine samples, and 0.7% (range, -1.1% to 2.5%) for bovine samples. The results were influenced by the presence of nucleated red blood cells. The POCD provided precise, reliable data for feline, equine and bovine samples but the values obtained for the canine counts were overestimations. PMID:22503717

Riond, Barbara; Hofmann-Lehmann, Regina; Lutz, Hans

2012-10-01

239

A lateral flow paper microarray for rapid allergy point of care diagnostics.  

PubMed

There is a growing need for multiplexed specific IgE tests that can accurately evaluate patient sensitization profiles. However, currently available commercial tests are either single/low-plexed or require sophisticated instrumentation at considerable cost per assay. Here, we present a novel convenient lateral flow microarray-based device that employs a novel dual labelled gold nanoparticle-strategy for rapid and sensitive detection of a panel of 15 specific IgE responses in 35 clinical serum samples. Each gold nanoparticle was conjugated to an optimized ratio of HRP and anti-IgE, allowing significant enzymatic amplification to improve the sensitivity of the assay as compared to commercially available detection reagents. The mean inter-assay variability of the developed LFM assay was 12% CV, and analysis of a cohort of clinical samples (n = 35) revealed good general agreement with ImmunoCAP, yet with a varying performance among allergens (AUC = [0.54-0.88], threshold 1 kU). Due to the rapid and simple procedure, inexpensive materials and read-out by means of a consumer flatbed scanner, the presented assay may provide an interesting low-cost alternative to existing multiplexed methods when thresholds >1 kU are acceptable. PMID:24690935

Chinnasamy, Thiruppathiraja; Segerink, Loes I; Nystrand, Mats; Gantelius, Jesper; Svahn, Helene Andersson

2014-05-21

240

Reference intervals for coagulation times using two point-of-care analysers in healthy pet rabbits (Oryctolagus cuniculus).  

PubMed

The purpose of this study was to establish reference intervals for prothrombin time (PT) and activated partial prothrombin time (aPTT) in healthy rabbits using two different point-of-care analysers (Idexx Coag DX and MS Quick Vet Coag Combo). These intervals would be useful in the diagnosis of coagulopathies and in the determination of coagulation status in critical patients. We are unaware of reports of coagulation values in pet rabbits. Blood samples were analysed from 81 clinically healthy pet rabbits under three years of age (49 females and 32 males). The reference intervals were as follows (non-parametric method for the MS Quick Vet Coag Combo and Box-Cox Robust method for the Idexx Coag DX, p<0.05 limit for statistical significance): PT (MS Quick Vet Coag Combo)=N=33, 17.2-28.5; PT (Idexx Coag DX)=N=48, 10.0-14.8, aPTT (MS Quick Vet Coag Combo)=N=33, 103.2-159.2 and aPTT (Idexx Coag DX)=N=48, 104.2-159.1. PT was significantly longer using the MS Quick Vet Coag Combo. aPTT was significantly shorter with the MS Quick Vet Coag Combo. On each type of analyser, there was no significant difference between sexes and blood sampling sites. A significant difference was present for the use or not of anaesthesia with the MS Quick Vet Coag Combo analyser. This study on healthy pet rabbits will be useful in point-of-care diagnosis of coagulopathies. PMID:24722233

Mentré, V; Bulliot, C; Linsart, A; Ronot, P

2014-06-28

241

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

PubMed Central

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

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

2014-01-01

242

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

NASA Astrophysics Data System (ADS)

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.

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

2012-02-01

243

A 10-minute point-of-care assay for detection of blood protein adducts resulting from low level exposure to organophosphate nerve agents.  

PubMed

The OrganoTox test is a rapid, point-of-care assay capable of detecting clinically relevant organophosphate (OP) poisoning after low-level exposure to sarin, soman, tabun, or VX chemical nerve agents. The test utilizes either a finger stick peripheral blood sample or plasma specimen. While high-level nerve agent exposure can quickly lead to death, low-level exposure produces vague, nondescript signs and symptoms that are not easily clinically differentiated from other conditions. In initial testing, the OrganoTox test was used to detect the presence of blood protein-nerve agent adducts in exposed blood samples. In order to mimic the in vivo exposure as closely as possible, nerve agents stored in organic solvents were spiked in minute quantities into whole blood samples. For performance testing, 40 plasma samples were spiked with sarin, soman, tabun, or VX and 10 normal plasma samples were used as the negative control. The 40 nerve agent-spiked plasma samples included 10 replicates of each agent. At the clinically relevant low-level exposure of 10 ng/ml, the OrganoTox test demonstrated 100% sensitivity for soman, tabun, and VX and 80% sensitivity for sarin. The OrganoTox test demonstrated greater than 97% specificity with 150 blood samples obtained from healthy adults. No cross-reactivity or interference from pesticide precursor compounds was found. A rapid test for nerve agent exposure will help identify affected patients earlier in the clinical course and trigger more appropriate medical management in a more timely manner. PMID:23200942

VanDine, Robert; Babu, Uma Mahesh; Condon, Peter; Mendez, Arlene; Sambursky, Robert

2013-03-25

244

Point-of-care assessment of platelet reactivity in the emergency department may facilitate rapid rule-out of acute coronary syndromes: a prospective cohort pilot feasibility study  

PubMed Central

Objective Accurate, efficient and cost-effective disposition of patients presenting to emergency departments (EDs) with symptoms suggestive of acute coronary syndromes (ACS) is a growing priority. Platelet activation is an early feature in the pathogenesis of ACS; thus, we sought to obtain an insight into whether point-of-care testing of platelet function: (1) may assist in the rule-out of ACS; (2) may provide additional predictive value in identifying patients with non-cardiac symptoms versus ACS-positive patients and (3) is logistically feasible in the ED. Design Prospective cohort feasibility study. Setting Two urban tertiary care sites, one located in the USA and the second in Argentina. Participants 509 adult patients presenting with symptoms of ACS. Main outcome measures Platelet reactivity was quantified using the Platelet Function Analyzer-100, with closure time (seconds required for blood, aspirated under high shear, to occlude a 150?µm aperture) serving as the primary endpoint. Closure times were categorised as ‘normal’ or ‘prolonged’, defined objectively as the 90th centile of the distribution for all participants enrolled in the study. Diagnosis of ACS was made using the standard criteria. The use of antiplatelet agents was not an exclusion criterion. Results Closure times for the study population ranged from 47 to 300?s, with a 90th centile value of 138?s. The proportion of patients with closure times ?138?s was significantly higher in patients with non-cardiac symptoms (41/330; 12.4%) versus the ACS-positive cohort (2/105 (1.9%); p=0.0006). The specificity of ‘prolonged’ closure times (?138?s) for a diagnosis of non-cardiac symptoms was 98.1%, with a positive predictive value of 95.4%. Multivariate analysis revealed that the closure time provided incremental, independent predictive value in the rule-out of ACS. Conclusions Point-of-care assessment of platelet reactivity is feasible in the ED and may facilitate the rapid rule-out of ACS in patients with prolonged closure times. PMID:24441051

Darling, Chad E; Sala Mercado, Javier A; Quiroga-Castro, Walter; Tecco, Gabriel F; Zelaya, Felix R; Conci, Eduardo C; Sala, Jose P; Smith, Craig S; Michelson, Alan D; Whittaker, Peter; Welch, Robert D; Przyklenk, Karin

2014-01-01

245

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

NASA Astrophysics Data System (ADS)

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.

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

2013-03-01

246

Short communication: validation of a point-of-care glucometer for use in dairy cows.  

PubMed

The purpose of this study was to evaluate the diagnostic performance of a hand-held electronic glucometer (Precision Xtra; Abbott Diabetes Care Inc., Mississauga, ON, Canada) for cow-side use in dairy cattle. This device has been validated for measuring blood concentrations of ?-hydroxybutyrate in dairy cows. This study was designed to assess the accuracy of whole-blood glucose measurements from the glucose meter relative to a reference chemical analyzer in a diagnostic laboratory. Duplicate samples were taken from the same cows at the same time, into blood tubes with either the glycolysis-inhibiting preservative sodium fluoride (NaF) or without preservative. Glucometer readings were taken on whole blood with no preservative, and laboratory measurements were conducted on serum preserved with NaF. Blood samples were collected from cows between 3 wk before and 5 wk after calving, including during a glucose tolerance test conducted 1 wk before expected calving. Passing-Bablok and Bland-Altman data analyses were used to evaluate the performance of the glucometer relative to the laboratory results. A strong correlation was observed in 709 samples from 81 cows between the hand-held meter and serum from samples preserved with NaF (R(2)=0.95). Overall, 96% of measurements with the glucometer fell within the 95% confidence limits of analysis in the laboratory, although at higher-than-physiologic glucose concentrations (>5.2mmol/L) the glucometer tended to overestimate. The hand-held glucometer appears suitable for rapid measurement of glucose under field conditions in dairy cattle. PMID:23684029

Wittrock, J A M; Duffield, T F; LeBlanc, S J

2013-07-01

247

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

PubMed Central

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

2014-01-01

248

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

PubMed Central

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

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

2013-01-01

249

Electrochemistry provides a point-of-care approach for the marker indicative of Pseudomonas aeruginosa infection of cystic fibrosis patients.  

PubMed

It has recently been demonstrated that 2-aminoacetophenone (2-AA) is a chemical indicator in exhaled air/breath of Pseudomonas aeruginosa infection associated with progressive life threatening decline of lung function in cystic fibrosis sufferers [Scott-Thomas et al., BMC Pulm. Med., 2010, 10, 56]. Currently the detection of 2-AA involves laboratory based instrumentation such as mass spectrometry and a hand-held point-of-care type breath device would be ideal in providing real-time results within seconds to accelerate patient care decision-making processes. To this end, we demonstrate proof-of-concept that the chemical marker 2-AA, indicative of Pseudomonas aeruginosa infection, can be measured using electrochemical based sensing strategies. A range of commercially available electrode substrates are explored demonstrating for the first time that 2-AA is electrochemically active within aqueous based solutions providing an (electro)analytical signal. Glassy carbon, boron-doped diamond and platinum electrodes have been explored towards the electrochemical oxidation of 2-AA. Electrode fouling is observed requiring pre-treatment in the form of mechanical polishing between voltammetric scans and measurements. To alleviate this, screen-printed graphite electrodes are shown to be a more viable option for implementation into breath sensing devices and overcome the fouling problem since due to their low cost and disposable nature, a new electrode can be used for each measurement. The analytical utility of the platinum, screen-printed and boron-doped diamond electrodes were found to correspond to 6.85, 7.66 and 4.86 mM respectively. The challenges associated with the electrochemical sensing of 2-AA in breath that need to be overcome are discussed. This generic approach where electrochemical based technology is used to provide measurements for chemical markers in exhaled air/breath for medical diagnostics termed electrochemical breathprints (ec-breathprints), has the potential to be developed into a hand-held point-of-care breath diagnostic tool for identifying Pseudomonas aeruginosa infection in exhaled air/breath. PMID:24926967

Metters, Jonathan P; Kampouris, Dimitrios K; Banks, Craig E

2014-08-21

250

Nursing Reference Center ™ iPhone App Now Available ~ EBSCO Publishing Releases Only Evidence-based, Point-of-care Nursing Mobile Application Available Today ~  

E-print Network

release of an iPhone application for Nursing Reference Center ™. This new app from EBSCO represents the only evidence-based, point-of-care nursing mobile application available today. The Nursing Reference Center iPhone app allows nurses to access point-of-care nursing content anytime and anywhere with EBSCO’s mobile technology. Users are able to search and browse the content quickly via their Apple iPhone, iPod Touch or iPad. Available free from the iTunes App Store, Nursing Reference Center customers can take advantage of this mobile technology at no additional cost. Features available with the new app include the ability to navigate through topics with a table of contents, view recent or saved searches and adjust content that is being searched via a categories page. The app also provides many of the same features that users are accustomed to such as an option to sort by relevance or date, save or email an item and auto complete functionality to suggest a search. Nursing Reference Center offers staff nurses, nurse administrators, nursing students, nurse faculty and hospital librarians the best available and most recent clinical evidence-more- from thousands of full-text documents. The application features more than 2,200 clinically organized quick lessons, 700 evidence-based care sheets, over 1,100 drug monographs and 1,300 Nursing Practice and Skills & Skill Competency Checklists. This point-of-care resource supports all five Magnet Components and is updated on a weekly basis. Nursing Reference Center also includes continuing education modules, detailed medical illustrations, the latest medical news, legal cases, research instruments, unique point-of-care reference books, and more. Nursing Reference Center provides relevant clinical resources to nurses and other health care professionals, directly at the point-of-care. Additional point-of-care resources offered by EBSCO

Mass November

251

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

NASA Astrophysics Data System (ADS)

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.

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

252

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

PubMed

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

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

2014-01-21

253

A customized Raman system for point-of-care detection of arthropathic crystals in the synovial fluid.  

PubMed

Monosodium urate (MSU) and calcium pyrophosphate dihydrate (CPPD) are the most frequently observed crystals in joint space, leading to painful arthropathies. Correct diagnosis of the crystal identity is critical for the appropriate course of treatment. In this work, a custom Raman device in combination with a practical and efficient sample preparation method is used for chemically selective diagnosis of MSU and CPPD crystals in an automated fashion. The samples were prepared by brief enzymatic digestion treatment of synovial fluid followed by a customized filtration process which was able to congregate crystals over a submillimeter sized spot. The data acquisition and collection were automated to collect multiple spectra distributed over the filtration spot. The performance of the cost-efficient Raman system was compared to a research-grade high fidelity Raman instrument. The custom-designed Raman device could detect MSU crystals at sub-clinical concentrations of 0.1 ?g mL(-1) and 1 ?g mL(-1) for CPPD crystals. This practical sample preparation approach in tandem with the low-cost customized Raman device has potential to be a novel tool for point-and-shoot Raman diagnosis of arthritic crystals in synovial fluid at the point of care. PMID:24419093

Li, Bolan; Yang, Shan; Akkus, Ozan

2014-02-21

254

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

PubMed Central

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

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

2014-01-01

255

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

PubMed Central

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

2013-01-01

256

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

PubMed

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

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

2013-12-17

257

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

PubMed

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

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

2013-09-01

258

Rapid Intraoperative Immunoassay of Parathyroid Hormone and Other Hormones: A New Paradigm for Point-of-Care Testing  

Microsoft Academic Search

Background: The first description of the use of a rapid assay for the measurement of intact parathyroid hor- mone (PTH) in patients undergoing parathyroidectomy for hyperparathyroidism was reported in 1988. Subse- quent improvements in the analytical performance of the rapid intraoperative PTH assay allowed the estab- lishment of its clinical utility in the surgical manage- ment of hyperparathyroidism. These modifications

Lori J. Sokoll; Frank H. Wians; Alan T. Remaley

259

Saliva-based creatine kinase MB measurement as a potential point-of-care testing for detection of myocardial infarction  

Microsoft Academic Search

Myocardial infarction (MI) is the main cause of death all over the world. Biomarkers of cardiac necrosis are of great importance\\u000a in the diagnosis of MI. The aim of this study was to determine probable changes of creatine kinase MB isoform (CK-MB) levels\\u000a in saliva of patients with acute MI. A case–control study was carried out on 30 patients with

Iraj Mirzaii-Dizgah; Seyed Fakhreddin Hejazi; Esmail Riahi; Mohammad Mohsen Salehi

260

Cost-effectiveness of point-of-care viral load monitoring of ART in resource-limited settings: Mathematical modelling study  

PubMed Central

Background Monitoring of HIV viral load in patients on combination antiretroviral therapy (ART) is not generally available in resource-limited settings. We examined the cost-effectiveness of qualitative point-of-care viral load tests (POC-VL) in sub-Saharan Africa. Design Mathematical model based on longitudinal data from the Gugulethu and Khayelitsha township ART programmes in Cape Town, South Africa. Methods Cohorts of patients on ART monitored by POC-VL, CD4 cell count or clinically were simulated. Scenario A considered the more accurate detection of treatment failure with POC-VL only, Scenario B also considered the effect on HIV transmission. Scenario C further assumed that the risk of virologic failure is halved with POC-VL due to improved adherence. We estimated the change in costs per quality-adjusted life-year gained (incremental cost-effectiveness ratios, ICER) of POC-VL compared to CD4 and clinical monitoring. Results POC-VL tests with detection limits <1000 copies/ml increased costs due to unnecessary switches to second-line ART, without improving survival. Assuming POC-VL unit costs between US$5–US$20 and detection limits between 1000 and 10000 copies/ml, the ICER of POC-VL was US$4010–US$9230 compared to clinical and US$5960–US$25540 compared to CD4 monitoring. In Scenario B the corresponding ICERs were US$2450–US$5830 and US$2230–US$10380. In Scenario C the ICER ranged between US$960–US$2500 compared to clinical monitoring and between cost-saving and US$2460 compared to CD4 monitoring. Conclusions The cost-effectiveness of POC-VL for monitoring ART is improved by a higher detection limit, by taking the reduction in new HIV infections into account and when assuming that failure of first-line ART is reduced due to targeted adherence counselling. PMID:23462219

ESTILL, Janne; EGGER, Matthias; BLASER, Nello; VIZCAYA, Luisa SALAZAR; GARONE, Daniela; WOOD, Robin; CAMPBELL, Jennifer; HALLETT, Timothy B.; KEISER, Olivia

2013-01-01

261

Risk of Cross Transmission with Point-of-Care Ultrasound System: Effect of a Glass-Sealed Control Panel on Microbial Contamination.  

PubMed

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

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

262

A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen  

PubMed Central

Background Clinical trials are widely considered the gold standard in comparative effectiveness research (CER) but the high cost and complexity of traditional trials and concerns about generalizability to broad patient populations and general clinical practice limit their appeal. Unsuccessful implementation of CER results limits the value of even the highest quality trials. Planning for a trial comparing two standard strategies of insulin administration for hospitalized patients led us to develop a new method for a clinical trial designed to be embedded directly into the clinical care setting thereby lowering the cost, increasing the pragmatic nature of the overall trial, strengthening implementation, and creating an integrated environment of research-based care. Purpose We describe a novel randomized clinical trial that uses the informatics and statistics infrastructure of the Veterans Affairs Healthcare System (VA) to illustrate one key component (called the point-of-care clinical trial – POC-CT) of a ‘learning healthcare system,’ and settles a clinical question of interest to the VA. Methods This study is an open-label, randomized trial comparing sliding scale regular insulin to a weight-based regimen for control of hyperglycemia, using the primary outcome length of stay, in non-ICU inpatients within the northeast region of the VA. All non-ICU patients who require in-hospital insulin therapy are eligible for the trial, and the VA’s automated systems will be used to assess eligibility and present the possibility of randomization to the clinician at the point of care. Clinicians will indicate their approval for informed consent to be obtained by study staff. Adaptive randomization will assign up to 3000 patients, preferentially to the currently ‘winning’ strategy, and all care will proceed according to usual practices. Based on a Bayesian stopping rule, the study has acceptable frequentist operating characteristics (Type I error 6%, power 86%) against a 12% reduction of median length of stay from 5 to 4.4 days. The adaptive stopping rule promotes implementation of a successful treatment strategy. Limitations Despite clinical equipoise, individual healthcare providers may have strong treatment preferences that jeopardize the success and implementation of the trial design, leading to low rates of randomization. Unblinded treatment assignment may bias results. In addition, generalization of clinical results to other healthcare systems may be limited by differences in patient population. Generalizability of the POC-CT method depends on the level of informatics and statistics infrastructure available to a healthcare system. Conclusions The methods proposed will demonstrate outcome-based evaluation of control of hyperglycemia in hospitalized veterans. By institutionalizing a process of statistically sound and efficient learning, and by integrating that learning with automatic implementation of best practice, the participating VA Healthcare Systems will accelerate improvements in the effectiveness of care. PMID:21478329

Fiore, Louis D; Brophy, Mary; Ferguson, Ryan E; D'Avolio, Leonard; Hermos, John A; Lew, Robert A; Doros, Gheorghe; Conrad, Chester H; O'Neil, Joseph A ("Gus"); Sabin, Thomas P; Kaufman, James; Swartz, Stephen L; Lawler, Elizabeth; Liang, Matthew H; Gaziano, J Michael; Lavori, Philip W

2011-01-01

263

Accuracy and reliability of the i-STAT point-of-care device for the determination of haemoglobin concentration before and after major blood loss.  

PubMed

We investigated the accuracy of i-STAT(®) (Abbott Point of Care Inc., Princeton, NJ, USA) haemoglobin (Hb) measurement in surgical patients with an estimated blood loss of ?25% of total blood volume. Blood tests for i-STAT(®) Hb, laboratory Hb (Sysmex XE-2100(™), Sysmex Corporation, Kobe, Japan) and total plasma proteins were obtained at the start of surgery (T=0) and when an estimated 25% total blood volume loss had occurred (T=1). Thirty-one patients were recruited. The coefficient of variation of the paired i-STAT(®) Hb estimates was 2.8% and 2.9% at T=0 and T=1, respectively. The mean difference between i-STAT(®) and laboratory Hb was -7.6 g/l (standard deviation 6.5) at T=0 and -5.1 g/l (standard deviation 12) at T=1. The mean total plasma protein difference (total plasma protein T=0 minus T=1) was 13.6 g/l (95% confidence interval 10.2 to 17.0). There was poor correlation between total plasma protein and bias in i-STAT(®) measurements. The i-STAT(®) Hb had an acceptable coefficient of variation, but the Hb levels were lower than those estimated by the laboratory. The standard deviation of i-STAT(®) Hb was greater after ?25% estimated total blood volume loss. Clinicians should not use the i-STAT(®) Hb in isolation for clinical decision-making when considering blood transfusion in a situation of 25% or greater blood loss. PMID:24967765

Ng, W L; Short, T G; Gunn, K N; Fuge, G S; Slon, B

2014-07-01

264

Enhancing the performance of a point-of-care CD4+ T-cell counting microchip through monocyte depletion for HIV/AIDS diagnostics  

PubMed Central

CD4+ T cell counts are important tests used to stage HIV-postive patients, enabling clinicians to make informed antiretroviral treatment decisions and to monitor the therapeutic outcomes. However, state-of-the-art CD4 counting methods based on flow cytometry are not applicable in resource-limited settings, due to their high cost and technical requirements. In previous work, we reported the development of a cell isolation microchip that can be used at the point of care for CD4 counts. In that microfluidic chip, CD4+ T cells were separated from 10 ?L of whole blood, and enumerated via either light microscopy or impedance sensing. The microchip counts matched flow cytometry results in the intermediate CD4 count range, between 200–800 cells/?L, but displayed a positive bias at absolute CD4 counts below 200 cells/?L, due largely to monocyte contamination. To enhance the performance in the low CD4 count range, we report here an improved design of a two-stage microfluidic device to deplete monocytes from whole blood, followed by CD4+ T cell capture. Using the double-stage device combined with a high viscosity rinsing solution, we obtained microchip CD4 counts comparable to flow cytometry results in the full clinically relevant range. In addition to CD4 counting, the strategy of contaminant depletion prior to target cell isolation can be easily adapted to immunoaffinity capture of other cell types that lack a unique surface marker from a complex biological fluid. PMID:19417901

Cheng, Xuanhong; Gupta, Amit; Chen, Chihchen; Tompkins, Ronald G.; Rodriguez, William; Toner, Mehmet

2014-01-01

265

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

PubMed Central

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

Burrows, Suzetta C.; Moore, Kelly M.; Lemkau, Jr., Henry L.

2001-01-01

266

A Randomized Controlled Trial of Point-of-Care Evidence to Improve the Antibiotic Prescribing Practices for Otitis Media in Children  

Microsoft Academic Search

ABSTRACT. Context. Prescribing practices for otitis media are not consistent with current evidence-based recommendations. Objective. To determine whether point-of-care evi- dence delivery regarding the use and duration of antibi- otics for otitis media decreases the duration of therapy from 10 days and decreases the frequency of prescrip- tions written. Design. Randomized, controlled trial. Setting. Primary care pediatric clinic affiliated with

Michelle M. Garrison; Mph Frederick P. Rivara; Robert L. Davis

267

Potential of a simplified measurement scheme and device structure for a low cost label-free point-of-care capacitive biosensor  

Microsoft Academic Search

A simplified measurement scheme and device structure aiming at developing a low cost, label-free, point-of-care capacitive biosensor were investigated. The detection principle is the increase of low frequency capacitance between two planar Al electrodes observed after antibody–antigen interaction. The electrodes, deposited on oxidized Si wafers, were covered with an antibody layer, with and without using self-assembled thiol monolayer. Immunoglobulin G

Elder A. de Vasconcelos; Newton G. Peres; Cintya O. Pereira; Valdinete L. da Silva; Eronides F. da Silva Jr.; Rosa F. Dutra

2009-01-01

268

Assessment of cardiac pathology by point-of-care ultrasonography performed by a novice examiner is comparable to the gold standard  

PubMed Central

Background The aim of the study was to compare the diagnostic accuracy of point-of-care cardiac ultrasonography performed by a novice examiner against results from a specialist in cardiology with expert skills in echocardiography, with regard to the assessment of six clinically relevant cardiac conditions in a population of ward patients from the Department of Cardiology or the Department of Cardiothoracic Surgery. Methods Cardiac ultrasonography was performed by a novice examiner at the bedside and images were interpreted in a point-of-care context with dichotomous outcomes (yes/no). Six outcome categories were defined: 1) pericardial effusion (?10 mm), 2) left ventricular dilatation (?62 mm), 3) right ventricular dilatation (?42 mm or???left ventricular diameter), 4) left ventricular hypertrophy (?13 mm), 5) left ventricular failure (EF???40%), 6) aortic stenosis (maximum flow velocity ?3 m/s). The examiner was blinded to the patients’ medical history and results from previous echocardiographic examinations. Results from the interpreted point-of-care ultrasonography examination were compared with echocardiographic diagnosis made by a specialist in cardiology. Results A total of 102 medical and surgical patients were included. Assessments were made in six categories totalling 612 assessments. There was agreement between the novice examiner and the specialist in 95.6% of the cases; overall sensitivity was 0.91 and specificity was 0.97. Positive predictive value was 0.92 and negative predictive value was 0.97. Kappa statistics showed good agreement between observers (?=0.88). Conclusions This study showed that a novice examiner was able to detect common and significant heart pathology in six different categories with good accuracy using POC ultrasonography. PMID:24330752

2013-01-01

269

Duplex molecular assay intended for point-of-care diagnosis of influenza A/B virus infection.  

PubMed

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

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

2013-09-01

270

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

PubMed Central

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

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

2013-01-01

271

Potential of a simplified measurement scheme and device structure for a low cost label-free point-of-care capacitive biosensor.  

PubMed

A simplified measurement scheme and device structure aiming at developing a low cost, label-free, point-of-care capacitive biosensor were investigated. The detection principle is the increase of low frequency capacitance between two planar Al electrodes observed after antibody-antigen interaction. The electrodes, deposited on oxidized Si wafers, were covered with an antibody layer, with and without using self-assembled thiol monolayer. Immunoglobulin G (IgG) and cardiac troponin T (TnT) were used as analytes to asses this proposal. The device was able to detect successfully TnT levels in the range 0.07 to 6.83ng/mL in human serum from patients with cardiac diseases and in the range 0.01ng/mL to 5ng/mL for TnT in phosphate buffer saline. An equivalent circuit model able to reproduce the general behavior of experimental capacitance versus frequency curves was presented. The investigated features that have potential to reduce costs and simplify measurements were: use of single, low frequency (1kHz) measurement signal, within the range of low cost portable capacitance meters; employment of a lower cost electrode material, aluminum, instead of gold electrodes; and use of simple and miniaturized planar two-electrodes arrangement, thus making a portable system for point-of-care applications. PMID:19836941

de Vasconcelos, Elder A; Peres, Newton G; Pereira, Cintya O; da Silva, Valdinete L; da Silva, Eronides F; Dutra, Rosa F

2009-12-15

272

Development of a point-of-care assay system for high-sensitivity C-reactive protein in whole blood  

Microsoft Academic Search

Background: C-reactive protein (CRP) is emerging as a potential risk predictor for future cardiovascular diseases (CVD). High sensitivity assays have been developed and applied for clinical purposes. Methods: The fluorescence immunochromatographic assay was employed to detect and quantify CRP in whole blood. It consisted of a fluorescence (FL) antibody detector buffer, a test strip housed in a disposable cartridge, and

Jae Soon Ahn; Sunga Choi; Sang Ho Jang; Hyuk Jae Chang; Jae Hoon Kim; Ki Bong Nahm; Sang Wook Oh; Eui Yul Choi

2003-01-01

273

Point-of-Care Lateral Flow Assays for Tuberculosis and Cryptococcal Antigenuria Predict Death in HIV Infected Adults in Uganda  

PubMed Central

Background Mortality in hospitalized, febrile patients in Sub-Saharan Africa is high due to HIV-infected, severely immunosuppressed patients with opportunistic co-infection, particularly disseminated tuberculosis (TB) and cryptococcal disease. We sought to determine if a positive lateral flow assay (LFA) result for urine lipoarabinomannan (LAM) and cryptococcal antigenuria was associated with mortality. Methods 351 hospitalized, HIV-positive adults with symptoms consistent with TB and who were able to provide both urine and sputum specimens were prospectively enrolled at Mulago National Referral Hospital in Uganda as part of a prospective accuracy evaluation of the lateral flow Determine TB LAM test. Stored frozen urine was retrospectively tested for cryptococcal antigen (CRAG) using the LFA. We fitted a multinomial logistic regression model to analyze factors associated with death within 2 months after initial presentation. Results The median CD4 of the participants was 57 (IQR: 14–179) cells/µl and 41% (145) were microbiologically confirmed TB cases. LAM LFA was positive in 38% (134), 7% (25) were CRAG positive, and 43% (151) were positive for either test in urine. Overall, 21% (75) died within the first 2 months, and a total of 32% (114) were confirmed dead by 6 months. At 2 months, 30% of LAM or CRAG positive patients were confirmed dead compared to 15.0% of those who were negative. In an adjusted model, LAM or CRAG positive results were associated with an increased risk of death (RRR 2.29, 95% CI: 1.29, 4.05; P?=?0.005). Conclusions In hospitalized HIV-infected patients, LAM or CRAG LFA positivity was associated with subsequent death within 2 months. Further studies are warranted to examine the impact of POC diagnostic ‘test and treat’ approach on patient-centered outcomes. PMID:25000489

Manabe, Yukari C.; Nonyane, Bareng A. S.; Nakiyingi, Lydia; Mbabazi, Olive; Lubega, Gloria; Shah, Maunank; Moulton, Lawrence H.; Joloba, Moses; Ellner, Jerrold; Dorman, Susan E.

2014-01-01

274

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

PubMed Central

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

Bru, Juan; Berger, Christopher A

2012-01-01

275

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

PubMed Central

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

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

2013-01-01

276

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

SciTech Connect

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.

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

2007-04-11

277

Does Provision of Point-of-Care CD4 Technology and Early Knowledge of CD4 Levels Affect Early Initiation and Retention on Antiretroviral Treatment in HIV-Positive Pregnant Women in the Context of Option B+ for PMTCT?  

PubMed

: Evidence for Elimination (E4E) is a collaborative project established in 2012 as part of the INSPIRE (INtegrating and Scaling up PMTCT through Implementation REsearch) initiative. E4E is a cluster-randomized trial with 2 arms; Standard of care and "POC Plus" [in which point-of-care (POC) CD4 devices and related counseling support are provided]; aimed at improving retention-in-care of HIV-infected pregnant women and mothers. In November 2013, Zimbabwe adopted Option B+ for HIV-positive pregnant women under which antiretroviral treatment eligibility is no longer based on CD4 count. However, Ministry of Health and Child Care guidelines still require baseline and 6-monthly CD4 testing for treatment monitoring, until viral load testing becomes widely available. Considering the current limited capacity for viral-load testing, the significant investments in CD4 testing already made and the historical reliance on CD4 by health care workers for determining eligibility for antiretroviral treatment, E4E seeks to compare the impact of the provision of POC CD4 technology and early knowledge of CD4 levels on retention-in-care at 12 months, with the current standard of routine, laboratory-based CD4 testing. The study also compares rates of initiation and time-to-initiation between the 2 arms and according to level of maternal CD4 count, the cost of retaining HIV-positive pregnant women in care and the acceptability and feasibility of POC CD4 in the context of Option B+. Outcome measures are derived from routine health systems data. E4E will provide data on POC CD4 testing and retention-in-care associated with Option B+ and serve as an early learning platform to inform implementation of Option B+ in Zimbabwe. PMID:25310120

Mangwiro, Alexio-Zambezi; Makomva, Kudzai; Bhattacharya, Antoinette; Bhattacharya, Gaurav; Gotora, Tendai; Owen, Mila; Mushavi, Angela; Mangwanya, Douglas; Zinyowera, Sekesai; Rusakaniko, Simbarashe; Mugurungi, Owen; Zizhou, Simukai; Busumani, William; Masuka, Nyasha

2014-11-01

278

Disruptive Innovation: Point of Care  

Microsoft Academic Search

\\u000a Authors’ note: It is important for the reader to understand that these essential elements of a PCMH were defined exclusively\\u000a by physician organizations. The authors have used the term Medical Home to be more inclusive of all health practitioners.\\u000a This fourth edition of Nursing Informatics is replete with examples of how information technology (IT) can help nurses work safer and

John S. Silva; Nancy Seybold; Marion J. Ball

279

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)

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).

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

2009-02-01

280

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

PubMed

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

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

2012-01-01

281

Exogenous fluorescent tracer agents based on pegylated pyrazine dyes for real-time point-of-care measurement of glomerular filtration rate.  

PubMed

Novel pyrazine carboxamides bearing hydrophilic poly(ethylene glycol) (PEG) moieties were designed, synthesized, and evaluated for use as fluorescent glomerular filtration rate (GFR) tracer agents. Among these, compounds 4d and 5c that contain about 48 ethylene oxide units in the PEG chain exhibited the most favorable physicochemical and renal clearance properties. In vitro studies show that these two compounds have low plasma protein binding, a necessary condition for renal excretion. In vivo animal model results show that 4d and 5c have a higher urine recovery of the injected dose than iothalamate (a commonly considered gold standard GFR agent). Pharmacokinetic studies show that these two compounds exhibit a plasma clearance equivalent to iothalamate, but with a faster (i.e. lower) terminal half-life than iothalamate (possibly from restricted distribution into the extracellular space due to large molecular size and hydrodynamic volume). Furthermore, the plasma clearance of 4d and 5c remained unchanged upon blockage of the tubular secretion pathway with probenecid, a necessary condition for establishment of clearance via glomerular filtration exclusively. Finally, noninvasive real-time monitoring of this class of compounds was demonstrated by pharmacokinetic clearance of 5c by optical measurements in rat model, which correlates strongly with plasma concentration of the tracer. Hence, 4d and 5c are promising candidates for translation to the clinic as exogenous fluorescent tracer agents in real-time point-of-care monitoring of GFR. PMID:22459210

Poreddy, Amruta R; Neumann, William L; Freskos, John N; Rajagopalan, Raghavan; Asmelash, Bethel; Gaston, Kimberly R; Fitch, Richard M; Galen, Karen P; Shieh, Jeng-Jong; Dorshow, Richard B

2012-04-15

282

TLC-Asthma: an integrated information system for patient-centered monitoring, case management, and point-of-care decision support.  

PubMed

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

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

283

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

PubMed Central

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

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

284

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

PubMed Central

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

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

285

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

NASA Astrophysics Data System (ADS)

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.

Rehse, Steven J.; Miziolek, Andrzej W.

2012-06-01

286

The effects of short- and long-term hypoxia on hemolymph gas values in the American horseshoe crab (Limulus polyphemus) using a point-of-care analyzer.  

PubMed

Hemolymph gas parameters were evaluated using a point-of-care analyzer in healthy American horseshoe crabs (Limulus polyphemus) at rest and after short- and long-term removal from water. Baseline vascular pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide, bicarbonate, base excess, total carbon dioxide, and lactate concentrations were determined from hemolymph samples collected from 10 horseshoe crabs (group 1) submerged in water and were compared with values after removal from water for 5 min, and after recovery in water for 10 min and for longer than 60 min (range, 61-221 min). Hemolymph gas parameters were also determined in 12 horseshoe crabs (group 2) after shipment out of water for 24 hr and were compared with values obtained from group 1 animals. Baseline hemolymph gas values of the American horseshoe crab are within range for other aquatic vertebrates. After removal from water for 5 min, all group 1 crabs developed severe hypoxia, with PO2 levels falling below the detectable limit of the analyzer. Group 2 crabs had pronounced respiratory acidosis, and their PO2 values were significantly below baseline values of group 1 animals. PMID:20597209

Allender, Matthew C; Schumacher, Juergen; George, Robert; Milam, Jennifer; Odoi, Agricola

2010-06-01

287

Evaluation of point-of-care haemoglobin measuring devices: a comparison of Radical-7™ pulse co-oximetry, HemoCue(®) and laboratory haemoglobin measurements in obstetric patients*.  

PubMed

We prospectively compared two point-of-care haemoglobin concentration measuring devices with laboratory measurements to determine their accuracy in women undergoing caesarean section delivery. The two devices were the Masimo Rainbow SET(®) Radical -7™ pulse co-oximeter and the HemoCue(®) HB 201+, which is a cuvette-type system that uses photometry. Co-oximeter readings and HemoCue measurements were taken before and after surgery, and compared with laboratory measurements of haemoglobin concentration taken at the same time. We analysed data from 137 patients using Bland-Altman plots. Limits of agreement for co-oximeter readings were -2.19 to 3.41?g.dl(-1) and for the HemoCue were -1.52 to 1.79?g.dl(-1) . The bias (mean difference) for the co-oximeter was -0.61 g.dl(-1) (95% CI 0.36 to -0.86) and for the HemoCue was 0.13?g.dl(-1) (95% CI -0.015 to 0.28). [corrected] Overall, 110/274 (40%) co-oximeter readings were within 1 g.dl(-1) of laboratory values compared with 247/274 (90%) HemoCue measurements (p

Skelton, V A; Wijayasinghe, N; Sharafudeen, S; Sange, A; Parry, N S; Junghans, C

2013-01-01

288

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

PubMed

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. PMID:24699532

Wu, Hsin-Yu; Cunningham, Brian T

2014-05-21

289

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

NASA Astrophysics Data System (ADS)

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

Wu, Hsin-Yu; Cunningham, Brian T.

2014-04-01

290

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

PubMed Central

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

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

2013-01-01

291

Testing for Celiac Disease  

MedlinePLUS

... diagnostic test results, patients must be on a gluten-containing diet. [ Top ] tTG The tTG-IgA test ... used to assess initiation and maintenance of a gluten-free diet. Point-of-care tTG tests have ...

292

With Home Testing, Consumers Take Charge of Their Health  

MedlinePLUS

... result] and what it means." Nichols directs the Clinical Chemistry Laboratory and Point-of-Care Testing at Baystate ... Us Your Comments ©2001 - by American Association for Clinical Chemistry • Contact Us | Terms of Use | Privacy We comply ...

293

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

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

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

294

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

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

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

2014-07-01

295

Diagnostic accuracy of a low-cost, urine antigen, point-of-care screening assay for HIV-associated pulmonary tuberculosis before antiretroviral therapy: a descriptive study  

PubMed Central

Summary Background The diagnostic accuracy of sputum smear microscopy and routine chest radiology for HIV-associated tuberculosis is poor, and culture-based diagnosis is slow, expensive, and is unavailable in most resource-limited settings. We assessed the diagnostic accuracy of a urine antigen test Determine TB-LAM Ag (Determine TB-LAM; Alere, Waltham, MA, USA) for screening for HIV-associated pulmonary tuberculosis before antiretroviral therapy (ART). Methods In this descriptive study, consecutive adults referred to a community-based ART clinic in Gugulethu township, South Africa, were all screened for tuberculosis by obtaining sputum samples for fluorescence microscopy, automated liquid culture (gold-standard test), and Xpert MTB/RIF assays (Cepheid, Sunnyvale, CA, USA) and urine samples for the Clearview TB-ELISA (TB-ELISA; Alere, Waltham, MA, USA) and Determine TB-LAM test. Patients with Mycobacterium tuberculosis cultured from one or more sputum samples were defined as cases of tuberculosis. The diagnostic accuracy of Determine TB-LAM used alone or combined with sputum smear microscopy was compared with that of sputum culture and the Xpert MTB/RIF assay for all patients and subgroups of patients stratified by CD4 cell count. Findings Patients were recruited between March 12, 2010, and April 20, 2011. Of 602 patients enrolled, 542 were able to provide one or more sputum samples, and 94 had culture-positive tuberculosis (prevalence 17·4%, 95% CI 14·2–20·8). Complete results from all tests were available for 516 patients (median CD4 count, 169·5 cells per ?L; IQR 100–233), including 85 culture-positive tuberculosis, 24 of whom (28·2%, 95% CI 19·0–39·0) had sputum smear-positive disease. Determine TB-LAM test strips provided results within 30 min. Agreement was very high between two independent readers of the test strips (?=0·97) and between the test strips and TB-ELISA (?=0·84). Determine TB-LAM had highest sensitivity at low CD4 cell counts: 66·7% (95% CI 41·0–86·7) at <50 cells per ?L, 51·7% (32·5–70·6) at <100 cells per ?L, and 39·0% (26·5–52·6) at <200 cells per ?L; specificity was greater than 98% for all strata. When combined with smear microscopy (either test positive), sensitivity was 72·2% (95% CI 46·5–90·3) at CD4 counts less than 50 cells per ?L, 65·5% (45·7–82·1) at less than 100 cells per ?L, and 52·5% (39·1–65·7) at less than 200 cells per ?L, which did not differ statistically from the sensitivities obtained by testing a single sputum sample with the Xpert MTB/RIF assay. Interpretation Determine TB-LAM is a simple, low-cost, alternative to existing diagnostic assays for tuberculosis screening in HIV-infected patients with very low CD4 cell counts and provides important incremental yield when combined with sputum smear microscopy. Funding Wellcome Trust. PMID:22015305

Lawn, Stephen D; Kerkhoff, Andrew D; Vogt, Monica; Wood, Robin

2012-01-01

296

Fecal Occult Blood and Fecal Calprotectin as Point-of-Care Markers of Intestinal Morbidity in Ugandan Children with Schistosoma mansoni Infection  

PubMed Central

Background Calprotectin is a calcium-binding cytoplasmic protein found in neutrophils and increasingly used as a marker of bowel inflammation. Fecal occult blood (FOB) is also a dependable indicator of bowel morbidity. The objective of our study was to determine the applicability of these tests as surrogate markers of Schistosoma mansoni intestinal morbidity before and after treatment with praziquantel (PZQ). Methods 216 children (ages 3–9 years old) from Buliisa District in Lake Albert, Uganda were examined and treated with PZQ at baseline in October 2012 with 211 of them re-examined 24 days later for S. mansoni and other soil transmitted helminths (STH). POC calprotectin and FOB assays were performed at both time points on a subset of children. Associations between the test results and infection were analysed by logistic regression. Results Fecal calprotectin concentrations of 150–300 µg/g were associated with S. mansoni egg patent infection both at baseline and follow up (OR: 12.5 P?=?0.05; OR: 6.8 P?=?0.02). FOB had a very strong association with baseline anemia (OR: 9.2 P?=?0.03) and medium and high egg intensity schistosomiasis at follow up (OR: 6.6 P?=?0.03; OR: 51.3 P?=?0.003). Both tests were strongly associated with heavy intensity S. mansoni infections. There was a significant decrease in FOB and calprotectin test positivity after PZQ treatment in those children who had egg patent schistosomiasis at baseline. Conclusions Both FOB and calprotectin rapid assays were found to correlate positively and strongly with egg patent S. mansoni infection with a positive ameloriation response after PZQ treatment indicative of short term reversion of morbidity. Both tests were appropriate for use in the field with excellent operational performance and reliability. Due to its lower-cost which makes its scale-up of use affordable, FOB could be immediately adopted as a monitoring tool for PC campaigns for efficacy evaluation before and after treatment. PMID:24244777

Bustinduy, Amaya L.; Sousa-Figueiredo, Jose C.; Adriko, Moses; Betson, Martha; Fenwick, Alan; Kabatereine, Narcis; Stothard, J. Russell

2013-01-01

297

Point of care ultrasound strikes again.  

PubMed

Abstract 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

Ockerse, P; Mallin, M

2014-11-01

298

ACT Test  

MedlinePLUS

... available for download at http://www.massgeneral.org/pathology/assets/poct/MGH-Medtronic-ACT-Plus-procedure.pdf ... May 29). Activated Clotting Time. Massachusetts General Hospital Pathology Service [On-line information]. Available online through http:// ...

299

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

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

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

2014-10-01

300

A comparison of the VerifyNow P2Y12 point-of-care device and light transmission aggregometry to monitor platelet function with prasugrel and clopidogrel: an integrated analysis.  

PubMed

We compared platelet function results obtained with the VerifyNow P2Y12 (VN-P2Y12) point-of-care device and the light transmission aggregometry (5 and 20 microM adenosine diphosphate) method using an integrated database of eight clinical trials with a total of 591 subjects. The study was performed in healthy subjects, patients with coronary artery disease, patients with end-stage renal disease, and patients with acute coronary syndrome after treatment with prasugrel or clopidogrel. Analyses focused on loading doses of 60 mg prasugrel or 600 mg clopidogrel and daily maintenance doses of 10 mg prasugrel or 75 or 150 mg clopidogrel. Similar patterns of platelet inhibition were observed for light transmission aggregometry versus VN-P2Y12 and assay results were well correlated (r approximately 0.7), although a sigmoidal model may more accurately represent the relationship between light transmission aggregometry and VN-P2Y12, because VN-P2Y12 was relatively less sensitive to low and high levels of inhibition. The percentage of poor responders was less with prasugrel compared with clopidogrel by both assays, but the percentages tended to differ between the assays. The VN-P2Y12 "BASE" channel appeared to be susceptible to high levels of P2Y12 blockade, which would underestimate the VN-P2Y12-reported percent inhibition in individuals who respond well to loading doses of thienopyridines. This integrated analysis supports the findings of earlier individual studies comparing these methodologies that assess platelet function. PMID:20386460

Jakubowski, Joseph A; Li, Ying G; Small, David S; Payne, Christopher D; Tomlin, Molly E; Luo, Junxiang; Winters, Kenneth J

2010-07-01

301

Characterizing the Patient Flow Pathway during Chest pain Diagnosis in an Emergency Department  

Microsoft Academic Search

\\u000a This paper aims to report on the practical application of a rule-out protocol that utilizes point-of-care testing (POCT) at\\u000a the Royal Victoria Hospital, Belfast. The protocol is used in the emergency department (ED) for patients presenting with chest\\u000a pain. Data was collected during the period 20\\/09\\/07 - 08\\/02\\/08 on 137 patients. 25.5% patients arrived by ambulance, 34.3%\\u000a patients were directed

D. Dixon; J. Eatock; F. J. FitzGibbon; S. Robinson; L. Rocke; L. Swales

302

Miniaturization and globalization of clinical laboratory activities.  

PubMed

Clinical laboratories provide an invaluable service to millions of people around the world in the form of quality diagnostic care. Within the clinical laboratory industry the impetus for change has come from technological development (miniaturization, nanotechnology, and their collective effect on point-of-care testing; POCT) and the increasingly global nature of laboratory services. Potential technological gains in POCT include: the development of bio-sensors, microarrays, genetics and proteomics testing, and enhanced web connectivity. In globalization, prospective opportunities lie in: medical tourism, the migration of healthcare workers, cross-border delivery of testing, and the establishment of accredited laboratories in previously unexplored markets. Accompanying these impressive opportunities are equally imposing challenges. Difficulty transitioning from research to clinical use, poor infrastructure in developing countries, cultural differences and national barriers to global trade are only a few examples. Dealing with the issues presented by globalization and the impact of developing technology on POCT, and on the clinical laboratory services industry in general, will be a daunting task. Despite such concerns, with appropriate countermeasures it will be possible to address the challenges posed. Future laboratory success will be largely dependent on one's ability to adapt in this perpetually shifting landscape. PMID:21175379

Melo, Murilo R; Clark, Samantha; Barrio, Daniel

2011-04-01

303

Escherichia coli counting using lens-free imaging for sepsis diagnosis  

NASA Astrophysics Data System (ADS)

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.

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

2009-09-01

304

Integrating pharmacokinetics into point-of-care information systems.  

PubMed

Computer-based patient care information systems (PCIS) have emerged as an integral component of healthcare organisations. Currently, 4 models of PCIS exist: the centralised model, the hub-and-spoke model, the network model, and the distributed model. The centralised model has the advantage of a central patient database; however, a major disadvantage of this model is the inability to easily interface with other software packages. The hub-and-spoke model links satellite or feeder systems into a mainframe computer; thus, each satellite has the ability to work independently. This system is limited by the ability to interface satellite systems with the mainframe computer. The network model works via a local area network (LAN) using client server technology which allows for high speed data access and transfer. The network model does not provide an integrated view of patient information and can access only 1 host system at a time. The distributed model is similar to the network model in design but provides for data and system integration via relational databases. This allows for the creation of a central data repository and support for decision-support tools. Computer-assisted decision support has the potential to significantly improve clinical decision-making. Six types of computer-assisted decision-support have been defined: alerting, interpreting, assisting, critiquing, diagnosing and managing. Software representing each type of decision-support software has been incorporated into clinical practice; however, with the exception of drug interaction programs, widespread incorporation of decision-support software into PCIS is uncommon. Clinical pharmacokinetic programs are a category of pharmacy-related decision-support software, and current clinical pharmacokinetic software systems can be categorised as interpreting, assisting or critiquing decision-support. Despite the potential for significant clinical contributions, the integration of clinical pharmacokinetic software into PCIS is uncommon. Most packages are available only as stand alone programs or as a module of a pharmacy information system. These packages usually maintain their own centralised database and require special file transfer protocols for integration. Although PCIS are becoming more commonplace, the integration of commercial clinical pharmacokinetic packages into PCIS is limited. New technology using standardised and relational databases should allow for easier integration in the future. PMID:8877247

Leader, W G; Pestotnik, S L; Chandler, M H

1996-09-01

305

Point-of-care fluorescence immunoassay for prostate specific antigen  

Microsoft Academic Search

BackgroundProstate specific antigen (PSA) is widely used as a clinical marker for diagnosis, screening, and prognosis of prostate cancer. A fluorescence (FL) dye-incorporated immunochromatographic assay (ICA) was developed for detection of PSA concentration in whole blood or serum.

Sang Wook Oh; Young Min Kim; Hyun Jeong Kim; Sung Joong Kim; Jin-Sun Cho; Eui Yul Choi

2009-01-01

306

C-Reactive Protein Testing Does Not Decrease Antibiotic Use for Acute Cough Illness When Compared to a Clinical Algorithm  

Microsoft Academic Search

Background: Antibiotics are commonly overused in adults seeking emergency department (ED) care for acute cough illness. Objective: To evaluate the effect of a point-of-care C-reactive protein (CRP) blood test on antibiotic treatment of acute cough illness in adults. Methods: A randomized controlled trial was conducted in a single urban ED in the United States. The participants were adults (age ?

Ralph Gonzales; Eva M. Aagaard; Carlos A. Camargo; O. John Ma; Mark Plautz; Judith H. Maselli; Charles E. McCulloch; Sara K. Levin; Joshua P. Metlay

2011-01-01

307

The utility of immunoassays for urine drug testing.  

PubMed

Substance abuse is a significant problem in the United States, with cocaine, marijuana, alcohol and heroin as the most commonly abused drugs. This article focuses on urine drug testing to evaluate potential drug abuse or overdose in the emergent care setting using qualitative immunoassays. Discussion is included regarding the principles of how to validate qualitative immunoassays; how to decide on appropriate specimen type, test menu and cutoff; the limitations of immunoassays; how to communicate test results to clinicians; and use of urine drug testing at point of care. PMID:22939301

Melanson, Stacy E F

2012-09-01

308

Testing  

MedlinePLUS

... mutation, and must be identified through further testing. Prenatal Testing Prenatal testing is used to determine if a fetus has ... used: In amniocentesis , the most common form of prenatal testing, a very fine needle is inserted into the ...

309

Meeting the challenges of globalisation and miniaturisation in laboratory services.  

PubMed

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

Melo, Murilo R; Rosenfeld, Luiz Gastăo

2007-12-01

310

Evaluation of Four Hematology and a Chemistry Portable Benchtop Analyzers Using Nonhuman Primate Blood  

PubMed Central

Background: Near patient testing (NPT) and point-of-care testing (POCT) using portable benchtop analyzers has become necessary in many areas of the medical community, including biocontainment. Methods: We evaluated the Beckman AcT diff, Abaxis Vetscan HMII (2 instruments), Abbott Cell-Dyn 1800, and Abaxis Vetscan VS2 for within-run precision and correlation to central laboratory instruments using NHP blood. Results: Compared to the central laboratory instruments, the Beckman AcT diff correlated on 80%; the HMII instruments on 31% and 44%, the CD1800 on 31%, and the VS2 on 71% of assays. For assays with published manufacturers precision guidelines, the AcT diff met all nine, the HMII instruments met one and six of six, and the CD 1800 met one of six. Conclusions: Laboratories using NPT/POCT must test their individual instruments for precision and correlation, identify assays that are reliable, and exclude or develop supplemental procedures for assays that are not. PMID:19793178

Snider, C. L.; Dick, E. J.; McGlasson, D. L.; Robbins, M. C.; Sholund, R. L.; Bommineni, Y. R.; Hubbard, G. B.

2009-01-01

311

Testing.  

ERIC Educational Resources Information Center

Seven short articles on the use of standardized tests in the United States are presented. Topics include: (1) the effects on school restructuring during the 1990's of the backlash against standardized tests; (2) the movement to replace multiple-choice standardized testing and its relationship with curricular goals; (3) the influence of…

McCurdy, Jack, Ed.; Speich, Don

1991-01-01

312

Express Testing Makes for More Effective Vet Visit  

NASA Technical Reports Server (NTRS)

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.

2003-01-01

313

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

PubMed

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

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

2014-01-01

314

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

PubMed Central

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

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

2014-01-01

315

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

NASA Astrophysics Data System (ADS)

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.

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

2014-10-01

316

Image decoding of photonic crystal beads array in the microfluidic chip for multiplex assays.  

PubMed

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

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

2014-01-01

317

Herpes simplex virus type 2 serological testing at a community court: predictors of test acceptance and seropositivity among female defendants.  

PubMed

Despite the high prevalence of herpes simplex virus type 2 (HSV-2), testing for asymptomatic infections is uncommon. One population for whom targeted interventions may be prioritized include individuals involved with the correctional system. Here we describe the acceptability of a novel HSV-2 screening program, implemented in a court setting, as a possible intervention for corrections-involved women. Female defendants completed an interviewer administered survey assessing factors associated with uptake/refusal of free point-of-care HSV-2 serologic testing and HSV-2 seropositivity. Participants included 143 women, 18-62 years old (mean 32.85) with diverse ethnicities. The majority (65.7%) accepted testing and 62.4% tested HSV-2 seropositive. Factors independently associated with test acceptance included higher perceived susceptibility to genital herpes infection and not receiving a preventative health screen. Women who were seropositive tended to be older, Black, report having previous STI, and be arrested on a prostitution charge. Findings suggest point-of-care testing in a court setting is acceptable to women and can be implemented to improve case finding of STI. PMID:23467289

Roth, A M; Van Der Pol, B; Fortenberry, J D; Reece, M; Dodge, B; Certo, D; Zimet, G D

2013-03-01

318

Bedside procalcitonin and acute care.  

PubMed

Procalcitonin (PCT) is a 116-amino acid protein with a sequence identical to that of the prohormone of calcitonin. Under normal conditions a specific protease cleaves all PCT to calcitonin, katacalcin and an N-terminal residue and hence in healthy individual PCT levels are either too low or undetectable. However, in severe bacterial infections or septic conditions, intact PCT is found in the blood and the concentrations of PCT may reach up to 1000 ng/ml. Point-of-care testing (POCT) is an important diagnostic tool used in various locations in the hospital, especially in intensive care unit (ICU), the operating room (OR), and emergency set-ups. Laboratory test results are often pivotal to fast decisions in majority of areas where patients are critical. Testing provides physicians with valuable knowledge about the emergency in the patients so that appropriate therapeutic interventions can be made quickly. Early detection of rising PCT levels has great significance and helps in diagnosing and managing the patients quickly. This review highlights various facts about PCT in point-of-care scenarios. PMID:25337486

Singh, Manpreet; Anand, Lakesh

2014-07-01

319

Bedside procalcitonin and acute care  

PubMed Central

Procalcitonin (PCT) is a 116-amino acid protein with a sequence identical to that of the prohormone of calcitonin. Under normal conditions a specific protease cleaves all PCT to calcitonin, katacalcin and an N-terminal residue and hence in healthy individual PCT levels are either too low or undetectable. However, in severe bacterial infections or septic conditions, intact PCT is found in the blood and the concentrations of PCT may reach up to 1000 ng/ml. Point-of-care testing (POCT) is an important diagnostic tool used in various locations in the hospital, especially in intensive care unit (ICU), the operating room (OR), and emergency set-ups. Laboratory test results are often pivotal to fast decisions in majority of areas where patients are critical. Testing provides physicians with valuable knowledge about the emergency in the patients so that appropriate therapeutic interventions can be made quickly. Early detection of rising PCT levels has great significance and helps in diagnosing and managing the patients quickly. This review highlights various facts about PCT in point-of-care scenarios. PMID:25337486

Singh, Manpreet; Anand, Lakesh

2014-01-01

320

Oral fluid nanosensor test: saliva as a diagnostic tool for oral health.  

PubMed

High-impact diseases, especially cancer, are challenging to diagnose without supplementing laboratory testing. Even with laboratory tools, definitive diagnosis often remains elusive. The oral fluid nanosensor test technology platform combines cutting-edge technologies--such as self-assembled monolayers, bionanotechnology, cyclic enzymatic amplification, and microfluidics--with several well-established techniques including microinjection molding, hybridization-based detection, and molecular purification. The intended use of the OFNASET is for the point-of-care multiplex detection of salivary biomarkers for oral cancer. PMID:23097828

Pujari, Mallayya; Bahirwani, Shraddha; Balaji, P; Kaul, Rachna; Shah, Bina; Daryani, Deepak; Iqbal, Sidra

2012-09-01

321

A simple and portable device for the quantification of TNF-? in human plasma by means of on-chip magnetic bead-based proximity ligation assay.  

PubMed

There is a general need in healthcare systems all around the world to reduce costs in terms of time and money without compromising patients outcome. Point-of-Care Testing (POCT) is currently being used in some applications (e.g. POC coagulation devices) as an alternative to already established standard central laboratory tests to overcome sample transportation and long turnaround times. The main objective of this investigation was to quantify Tumour Necrosis Factor-alpha (TNF-?) on-chip within the clinical relevant range of 5-100 pg/mL in human pooled plasma. The novel solid-phase assay developed in this study was a magnetic bead-based proximity ligation assay (PLA) in which one of the assay proximity probes was directly immobilised onto streptavidin-coated magnetic beads. The portable device was based on a disposable and single-use cyclo-olefin polymer (COP) microfluidic chip interfaced with a quantitative real-time polymerase chain reaction (qPCR) device previously developed in-house. Sample volume was 10 µL and total assay time under 3 h. The POC device and assay developed offer portability, smaller reagent and sample consumption, and faster time-to-results compared with standard ELISAs. Determination and monitoring of TNF-? therapy at the point-of-care will help to improve clinical and/or economical outcome in governmental healthcare budgets. PMID:24316452

Castro-López, Vanessa; Elizalde, Jorge; Pacek, Marcin; Hijona, Elizabeth; Bujanda, Luis

2014-04-15

322

Rapid non-invasive tests for diagnostics of infectious diseases  

NASA Astrophysics Data System (ADS)

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.

Malamud, Daniel

2014-06-01

323

Testing, Testing.  

ERIC Educational Resources Information Center

Lessons designed to prepare students for standardized tests are replacing lessons designed to help children think. Instead of national standardized test scores, schools should use local criterion-referenced tests; take a baseline measurement; compare test scores with districts having similar demographics; compare students, not grade levels; and…

Kaufhold, John A.

1995-01-01

324

Testing Testing Testing.  

ERIC Educational Resources Information Center

Articles in this special section consider (1) flow in test taking (Craig Deville); (2) testwiseness (Thomas O'Neill); (3) test length (Benjamin Wright); (4) cross-language test equating (Richard W. Woodcock and Ana Munoz-Sandoval); (5) computer-assisted testing and testwiseness (Richard Gershon and Betty Bergstrom); and (6) Web-enhanced testing

Deville, Craig; O'Neill, Thomas; Wright, Benjamin D.; Woodcock, Richard W.; Munoz-Sandoval, Ana; Gershon, Richard C.; Bergstrom, Betty

1998-01-01

325

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

PubMed Central

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

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

1999-01-01

326

Point-of-care technology: integration for improved delivery of care.  

PubMed

The growing complexity of technology, equipment, and devices involved in patient care delivery can be staggering and overwhelming. Technology is intended to be a tool to help clinicians, but it can also be a frustrating hindrance if not thoughtfully planned and strategically aligned. Critical care nurses are key partners in the collaborations needed to improve safety and quality through health information technology (IT). Nurses must advocate for systems that are interoperable and adapted to the context of care experiences. The involvement and collaboration between clinicians, information technology specialists, biomedical engineers, and vendors has never been more relevant and applicable. Working together strategically with a shared vision can effectively provide a seamless clinical workflow, maximize technology investments, and ultimately improve patient care delivery and outcomes. Developing a strategic integrated clinical and IT roadmap is a critical component of today's health care environment. How can technology strategy be aligned from the executive suite to the bedside caregiver? What is the model for using clinical workflows to drive technology adoption? How can the voice of the critical care nurse strengthen this process? How can success be assured from the initial assessment and selection of technology to a sustainable support model? What is the vendor's role as a strategic partner and "co-caregiver"? PMID:24896558

Gregory, Debbie; Buckner, Martha

2014-01-01

327

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

Federal Register 2010, 2011, 2012, 2013

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost......

2013-07-24

328

Rapid Point-of-Care Assay of Enoxaparin Anticoagulant Efficacy in Whole Blood  

PubMed Central

There is the need for a clinical assay to determine the extent to which a patient's blood is effectively anticoagulated by the low-molecular-weight-heparin (LMWH), enoxaparin. There are also urgent clinical situations where it would be important if this could be determined rapidly. The present assay is designed to accomplish this. We only assayed human blood samples that were spiked with known concentrations of enoxaparin. The essential feature of the present assay is the quantification of the efficacy of enoxaparin in a patient's blood sample by degrading it to complete inactivity with heparinase. Two blood samples were drawn into Vacutainer tubes (Becton-Dickenson; Franklin Lakes, NJ) that were spiked with enoxaparin; one sample was digested with heparinase for 5 min at 37 °C, the other sample represented the patient's baseline anticoagulated status. The percent shortening of clotting time in the heparinase-treated sample, as compared to the baseline state, yielded the anticoagulant contribution of enoxaparin. We used the portable, battery operated Hemochron 801 apparatus for measurements of clotting times (International Technidyne Corp., Edison, NJ). The apparatus has 2 thermostatically controlled (37 °C) assay tube wells. We conducted the assays in two types of assay cartridges that are available from the manufacturer of the instrument. One cartridge was modified to increase its sensitivity. We removed the kaolin from the FTK-ACT cartridge by extensive rinsing with distilled water, leaving only the glass surface of the tube, and perhaps the detection magnet, as activators. We called this our minimally activated assay (MAA). The use of a minimally activated assay has been studied by us and others. 2-4 The second cartridge that was studied was an activated partial thromboplastin time (aPTT) assay (A104). This was used as supplied from the manufacturer. The thermostated wells of the instrument were used for both the heparinase digestion and coagulation assays. The assay can be completed within 10 min. The MAA assay showed robust changes in clotting time after heparinase digestion of enoxaparin over a typical clinical concentration range. At 0.2 anti-Xa I.U. of enoxaparin per ml of blood sample, heparinase digestion caused an average decrease of 9.8% (20.4 sec) in clotting time; at 1.0 I.U. per ml of enoxaparin there was a 41.4% decrease (148.8 sec). This report only presents the experimental application of the assay; its value in a clinical setting must still be established. PMID:23093300

Inchiosa, Mario A.; Pothula, Suryanarayana; Kubal, Keshar; Sanchala, Vajubhai T.; Navarro, Iris

2012-01-01

329

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

NASA Astrophysics Data System (ADS)

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.

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

2014-02-01

330

Development and evaluation of a point-of-care interactive patient education kiosk.  

PubMed

We have developed an interactive patient education kiosk. The kiosk provides access to stored health information and to selected Websites via a high-speed Internet connection. The output is bilingual (English or Spanish) and an enclosed printer allows information to be printed and taken home for later reading. Each kiosk records patient usage, as well as the results of a brief, voluntary, online evaluation questionnaire. Three kiosks were placed in the patient waiting area of busy multi-specialty clinics. Two kiosks were active for 2.5 years and one was active for 1.5 years. There were 38,868 user sessions recorded and 2878 users participated in the online survey questionnaire (7% of all user sessions). Patient satisfaction was high; for example, 68% of respondents found some or all of the information they were looking for on the kiosk. In the year following the introduction of the first kiosk (the 2001/02 flu season), there was a 24% increase in the number of patients receiving flu vaccinations within the Palo Alto health-care system, compared with the previous year. Experience to date suggests that the kiosks may increase patient compliance with selected clinical guidelines and instructions. PMID:15603602

Goldschmidt, Leonard; Goodrich, Gregory L

2004-01-01

331

USE OF A PORTABLE POINT-OF-CARE (VETSCAN VS2) BIOCHEMICAL ANALYZER FOR MEASURING PLASMA  

E-print Network

isotopic enrichment of specific bloodand the corresponding isotopic enrichment of specific blood plasmaCl) and) and [U[U--1313 CC66]glucose]glucose ((CamproCampro ScientificScientific, Berlin), Berlin) dlLa1dl,12 0,14 0,16 0,18 0,2 supernatant fibrinogen plasma protein precipitate [at%exc] 15N 13C Isotope

Florida, University of

332

A point-of-care instrument for rapid multiplexed pathogen genotyping.  

PubMed

We are leveraging recent advances in rapid nucleic acid amplification chemistries, self-powered microfluidics, and low-cost optoelectronics to develop instrumentation for pathogen genotyping in the developing world. A growing number of correlations are emerging between genetic mutations in pathogens and their infectivity, origin, and drug resistance. Particularly for diseases like tuberculosis, where multi-drug resistance is a growing concern, a rapid diagnostic which could inform prescription decisions for newly diagnosed patients would not only save lives and reduce prolonged sickness but would help slow the emergence of more virulent strains. Additionally, for pathogens such as HIV, there is a need for new assay formats which can inexpensively and quantitativly monitor pathogen load. We have developed a portable instrument which uses disposable microfluidic assay cartridges pre-loaded with lyophilized reagents for genetic amplification of multiple markers. The cartridges can be adapted for a variety of sample types (blood, sputum, saliva). The instrument controls assay temperature and quantitatively monitors real-time fluorescence signals from 96 individual reaction chambers. The platform can be tailored for different economic situations--from a quantitative electronic readout to a simple binary readout with the naked eye. PMID:22255135

Myers, Frank B; Henrikson, Richard H; Xu, Liyi; Lee, Luke P

2011-01-01

333

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

PubMed Central

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

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

2013-01-01

334

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

E-print Network

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 ...

Warren, Andrew David

335

Biochemical sensor tubing for point-of-care monitoring of intravenous drugs and metabolites  

E-print Network

(pain medication) and urea (urinary metabolite) within their clinically relevant concentration ranges of dialysis. For detection and identification of analytes in a clinical setting, it is not generally the tubing. In this work, detection of IV pain medication (prom- ethazine) and a common urinary metabolite

Cunningham, Brian

336

An information retrieval service to support clinical decision-making at the point of care.  

PubMed Central

The information retrieval systems currently available in general practice, such as Medline, and web search engines are passive and relatively difficult to access during consultations. Emergent technologies, including the National Electronic Library for Health, offer opportunities for more active decision support. We examine the extent to which information retrieval could support primary care consultations by examining the impact of the new technology at different stages of the consultation. We advocate a system whereby professional organisations concerned with quality of care, such as the Royal College of General Practitioners, might contribute the the process. PMID:10824349

Sullivan, F; Gardner, M; van Rijsbergen, K

1999-01-01

337

Multi-color miniature dual-axis confocal microscope for point-of-care pathology  

PubMed Central

We present a miniature micro-electro-mechanical systems (MEMS)-based dual-axis confocal microscope capable of spatially co-registered fluorescence imaging at multiple wavelengths. This device has a 10-mm diameter scan head with a 2-mm diameter tip for convenient use during surgery to guide tumor resection. The microscope has an adjustable focal depth from 20 – 200 microns and is capable of imaging with an axial resolution of 9 microns and in-plane resolution of 4 microns over a field of view of 450 × 450 microns. Simultaneous two-color imaging of individual optical sections is achieved by using a pair of grating-prism assemblies (GRISMs) to compensate for chromatic dispersion in the 2-mm diameter gradient-index (GRIN) relay lens at the distal tip of the device. Experimental measurements of the axial response of the microscope as well as two-color images of a reflective bar target and fresh mouse brain tissues demonstrate the performance of our device and its potential for multi-color in vivo optical-sectioning microscopy. PMID:22739931

Leigh, Steven Y.; Liu, Jonathan T.C.

2013-01-01

338

Assessment of insulin resistance by a 13 C glucose breath test: a new tool for early diagnosis and follow-up of high-risk patients  

Microsoft Academic Search

Background\\/Aims  Insulin resistance (IR) plays an important role in the pathogenesis of diabetes and non-alcoholic fatty liver disease (NAFLD).\\u000a Current methods for insulin resistance detection are cumbersome, or not sensitive enough for early detection and follow-up.\\u000a The BreathID® system can continuously analyse breath samples in real-time at the point-of-care. Here we determined the efficacy of the\\u000a BreathID® using the13C-Glucose breath test

Meir Mizrahi; Gadi Lalazar; Tomer Adar; Itamar Raz; Yaron Ilan

2010-01-01

339

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

PubMed Central

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

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

2014-01-01

340

Reconsidering HIV testing--consent is still the key.  

PubMed

The high quality and easy accessibility of HIV testing in Australia has been one of the reasons for Australia's effective response to the epidemic. However there have been a number of changes in the epidemiology of HIV and new technologies and treatments have emerged since the last Australian HIV policy was released in 1998. Antenatal testing to prevent vertical transmission, the licensing of rapid, point-of-care test kits in the United States and the problem of late diagnosis of infection in some populations are important issues to consider in the context of the drafting of a new HIV testing policy. The terms 'pre- and post-test counselling' are seen, by some, as barriers to HIV testing in the broader community. Reframing the process with a focus on the desired result (i.e. informed consent for voluntary testing) rather than on the process (i.e. pre-test counselling) could be one way to increase the rate of appropriate testing. PMID:16335544

Bowden, Francis J

2005-01-01

341

Does a delay in performing an activated clotting (ACT) test really matter? A study in nonheparinized blood and a single ACT machine.  

PubMed

Activating clotting time (ACT) is a point-of-care, blood clotting test used to monitor anticoagulation. Recently, institutional requirements have required that ACT testing be completed outside the operating room with trained, certified personnel other than anesthesia staff. For this reason, in this study, we looked at whether a delay in processing an ACT makes a significant difference to the ACT results. Twenty patients between 18 and 65 years of age consented to the study, each undergoing non-cardiac surgery, with no intraoperative administration of heparin. The study was approved by our Institutional Review Board. A blood sample was taken from the patient's arterial line in the operating room. Immediately afterward, 1 mL was placed into each of two ACT cartridges and the measurement was done in a Medtronic ACT2 machine. The first ACT value was 126.9 +/- 14.5 seconds. The ACT value at approximately 30 minutes was 108.3 +/- 20.3 seconds (p < .0001). The time between the first and last measurements was 29.4 +/- 3.0 minutes. The results suggest that the ACT values decrease over time between sampling all measurements. At approximately 30 minutes, the ACT values average 15% less than the control measurements. Therefore, it would seem prudent to determine ACT values immediately in the operating room without any delay, using point-of-care testing. PMID:18853832

Philip, Bridget M; Brock-Utne, John G; Lemmens, Harry J M; Jaffe, Richard A; Shuttleworth, Paul E

2008-09-01

342

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

PubMed Central

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

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

2014-01-01

343

Real-Time Optical Antimicrobial Susceptibility Testing  

PubMed Central

Rapid antibiotic susceptibility testing is in high demand in health care fields as antimicrobial-resistant bacterial strains emerge and spread. Here, we describe an optical screening system (oCelloScope) which, based on time-lapse imaging of 96 bacteria-antibiotic combinations at a time, introduces real-time detection of bacterial growth and antimicrobial susceptibility with imaging material to support the automatically generated graphs. Automated antibiotic susceptibility tests of a monoculture showed statistically significant antibiotic effects within 6 min and within 30 min in complex samples from pigs suffering from catheter-associated urinary tract infections. The oCelloScope system provides a fast high-throughput screening method for detecting bacterial susceptibility that might entail an earlier diagnosis and introduction of appropriate targeted therapy and thus combat the threat from multidrug-resistant pathogenic bacteria. The oCelloScope system can be employed for a broad range of applications within bacteriology and might present new vistas as a point-of-care instrument in clinical and veterinary settings. PMID:23596243

Andersen, Klaus R.; J?rgensen, Erik; Droce, Aida; Olesen, Tom; Jensen, Bent B.; Rosenvinge, Flemming S.; Sondergaard, Teis E.

2013-01-01

344

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

PubMed Central

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

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

345

Rapid Detection of the Varicella Zoster Virus  

NASA Technical Reports Server (NTRS)

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.

Lewis, Michelle P.; Harding, Robert

2011-01-01

346

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

PubMed Central

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

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

2012-01-01

347

Laboratory testing under managed care dominance in the USA  

PubMed Central

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

Takemura, Y; Beck, J

2001-01-01

348

Rapid latex agglutination test for the serodiagnosis of human brucellosis.  

PubMed

We developed and evaluated a user-friendly latex agglutination assay for the serodiagnosis of human brucellosis. The assay was obtained by coating colored latex beads with Brucella lipopolysaccharides and drying of the activated beads onto white agglutination cards. Individual cards were sealed in a protective foil to secure stability of the dried reagent and to obtain a test in a single assay format. The latex agglutination assay is simply performed by suspending the dried latex reagent in a drop of serum and looking for macroscopic agglutination of the latex beads by visual inspection. Results are obtained within 30 s after mixing the sample with the test reagent. The sensitivity of the assay was determined to be 89.1% (95% confidence interval [CI], 76-96) for the initial serum samples collected from patients with culture-confirmed brucellosis and the specificity is 98.2% (95% CI, 96-99). The assay is ideal for use as a field test in remote areas and as point-of-care test in hospitals and health care centers that lack the expertise and facilities to perform the more demanding classic serologic tests. PMID:17258083

Abdoel, Theresia H; Smits, Henk L

2007-02-01

349

Test Automation Test Automation  

E-print Network

Test Automation Test Automation Mohammad Mousavi Eindhoven University of Technology, The Netherlands Software Testing 2013 Mousavi: Test Automation #12;Test Automation Outline Test Automation Mousavi: Test Automation #12;Test Automation Why? Challenges of Manual Testing Test-case design: Choosing inputs

Mousavi, Mohammad

350

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

NASA Astrophysics Data System (ADS)

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.

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

2012-11-01

351

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

PubMed

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

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

2015-01-15

352

DNA nanostructure-based ultrasensitive electrochemical microRNA biosensor.  

PubMed

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

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

2013-12-15

353

Moving the solid phase: a platform technology for cartridge based sandwich immunoassays.  

PubMed

We report on a cartridge based platform for complex immunoassay formats that allows for flexible adaption of individual steps. It is a sample-to-answer system which is quantitative as well as sensitive. The target molecules are detected through a magnetic bead-based fluorescence sandwich immunoassay. The beads both constitute the solid phase for immobilizing capture molecules and are used for magnetic field activated incubation. The injection molded cartridge comprises several chambers separated by capillary valves. Chambers contain the assay reagents, through which the beads are manipulated via externally applied magnetic fields. Active incubation is made possible by assembling the beads into microstirrers and systematically scanning through a chamber. The beads are transported by focusing them to form an aggregate which subsequently is dragged through the valves. Once the aggregate enters a chamber, it is re-dispersed and magnetic actuation is used to re-assemble the beads into microstirrers. The assay protocol involves an incubation of sample with antibody coated magnetic beads, followed by steps for washing or separation, labeling with fluorescent detection antibody and finally fluorescence detection. An interleukin-8 assay served as a model for evaluating the system and a concentration as low as 5 pg/mL (0.625 pM) was successfully detected. The platform shows potential to be developed into a diagnostic tool to be used in a point-of-care testing (PoCT) environment. PMID:24091714

Gottheil, Raiah; Baur, Nadja; Becker, Holger; Link, Gorden; Maier, Dimitri; Schneiderhan-Marra, Nicole; Stelzle, Martin

2014-02-01

354

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

PubMed Central

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

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

2014-01-01

355

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

PubMed Central

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. PMID:23162691

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

2012-01-01

356

An integrated microfluidic device utilizing dielectrophoresis and multiplex array PCR for point-of-care detection of pathogens.  

PubMed

The early identification of causative pathogens in clinical specimens that require no cultivation is essential for directing evidence-based antimicrobial treatments in resource limited settings. Here, we describe an integrated microfluidic device for the rapid identification of pathogens in complex physiological matrices such as blood. The device was designed and fabricated using SlipChip technologies, which integrated four channels processing independent samples and identifying up to twenty different pathogens. Briefly, diluted whole human blood samples were directly injected into the device for analysis. The pathogens were extracted from the blood by dielectrophoresis, retained in an array of grooves, and identified by multiplex array PCR in nanoliter volumes with end-point fluorescence detection. The universality of the dielectrophoretic separation of pathogens from physiological fluids was evaluated with a panel of clinical isolates covering predominant bacterial and fungal species. Using this system, we simultaneously identified Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli O157:H7 within 3 h. In addition to the prompt diagnosis of bloodstream infections, this method may also be utilized for differentiating microorganisms in contaminated water and environmental samples. PMID:25082458

Cai, Dongyang; Xiao, Meng; Xu, Peng; Xu, Ying-Chun; Du, Wenbin

2014-10-21

357

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

PubMed Central

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

2013-01-01

358

Development of immunosensors for direct detection of three wound infection biomarkers at point of care using electrochemical impedance spectroscopy.  

PubMed

A method for label-free, electrochemical impedance immunosensing for the detection and quantification of three infection biomarkers in both buffer and directly in the defined model matrix of mock wound fluid is demonstrated. Triggering Receptor-1 Expressed on Myeloid cells (TREM-1) and Matrix MetalloPeptidase 9 (MMP-9) are detected via direct assay and N-3-oxo-dodecanoyl-l-HomoSerineLactone (HSL), relevant in bacterial quorum sensing, is detected using a competition assay. Detection is performed with gold screen-printed electrodes modified with a specific thiolated antibody. Detection is achieved in less than 1h straight from mock wound fluid without any extensive sample preparation steps. The limits of detection of 3.3 pM for TREM-1, 1.1 nM for MMP-9 and 1.4 nM for HSL are either near or below the threshold required to indicate infection. A relatively large dynamic range for sensor response is also found, consistent with interaction between neighbouring antibody-antigen complexes in the close-packed surface layer. Together, these three novel electrochemical immunosensors demonstrate viable multi-parameter sensing with the required sensitivity for rapid wound infection detection directly from a clinically relevant specimen. PMID:22137369

Ciani, Ilenia; Schulze, Holger; Corrigan, Damion K; Henihan, Grace; Giraud, Gerard; Terry, Jonathan G; Walton, Anthony J; Pethig, Ronald; Ghazal, Peter; Crain, Jason; Campbell, Colin J; Bachmann, Till T; Mount, Andrew R

2012-01-15

359

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

PubMed Central

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

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

360

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

Microsoft Academic Search

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

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

2011-01-01

361

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

E-print Network

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

Demirci, Utkan

362

Accuracy of CoaguChek XS for point-of-care antithrombotic monitoring in children with heart disease.  

PubMed

The CoaguChek XS international normalized ratio (INR) assay was compared to INR assay by a standard laboratory method in children with heart disease on anticoagulant therapy. The data comprised 120 pairs of INR values for 42 patients (age <16 yr) who attended a cardiology clinic between 1 May 2007 and 30 January 2008. Parallel INR assays by the CoaguChek XS and the standard method were performed within 1 hr by a single qualified technician and the paired results were evaluated by linear regression and Bland-Altman analysis. The mean difference in the INR values was -0.08 +/- 0.04 units (p = 0.63); the difference between the two results was consistently <0.5 INR units. The slope of the regression line was 0.98 (95% CI: 0.96 to 1.01) and the y-intercept was 0.014 (95% CI: -0.01 to 0.04). In the Bland-Altman analysis, the mean difference in INR between the two methods was 0.08 units and values for 99.4% of the patients fell within the limit of agreement (-0.17 to 0.28 units). In summary, INR assays in children by the CoaguChek XS device are as accurate as the standard method, but faster and more convenient. PMID:20689136

Moon, Ju Ryoung; Jeong, Soo In; Huh, June; Lee, Heung Jae; Park, Pyo Won; Kang, I-Seok

2010-01-01

363

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

E-print Network

array (PNA) surface. The PNA structures are fabricated using a low-cost nanoreplica molding process upon to introduce uorescent dyes into liquid-based medications that are being delivered to the patient's body

Cunningham, Brian

364

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

E-print Network

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 ...

Goldberg, Brian, 1979-

2009-01-01

365

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

NASA Astrophysics Data System (ADS)

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.

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

2013-03-01

366

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

E-print Network

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. ...

Wang, ShuQi

367

Performance and use of HSV type-specific serology test kits.  

PubMed

Herpes simplex virus type-specific serology tests based on glycoprotein gG-1 and/or gG-2 are important diagnostic tools to establish aetiology of genital symptoms and identify patients with unrecognized genital herpes. Clinicians can now select from three very different Food and Drug Administration-licensed kits. Diagnology's POCkittrade mark HSV-2 is a point of care test for herpes simplex virus type 2 (HSV-2) antibodies. Clinicians can perform this test while the patient waits. Focus Technologies' HerpeSelect enzymelinked immunosorbent assays (ELISAs) for herpes simplex virus type 1 (HSV-1) and HSV-2 are more traditional tests that can be semiautomated for high throughput at low cost in laboratories. Focus Technologies' HerpeSelect Immunoblot is a novel strip immunoblot that can be used for low volume testing in laboratories or even by healthcare facilities that are accredited for moderately complex testing. This review summarizes the performance data of these tests and describes how to interpret their results. Finally, situations that warrant follow-up testing are described along with suggested strategies for such testing. PMID:12106510

Ashley, Rhoda L

2002-07-01

368

Serological testing for herpes simplex virus (HSV)-1 and HSV-2 infection.  

PubMed

Serological tests for herpes simplex virus (HSV) that can accurately distinguish between HSV-1 and HSV-2 are now commercially available. These tests detect antibodies to HSV glycoproteins G-1 and G-2, which evoke a type-specific antibody response. Focus Technologies produces the HerpeSelect-1 and HerpeSelect-2 enzyme-linked immunosorbent assay tests and the HSV-1 and HSV-2 HerpeSelect1/2 Immunoblot. Diagnology has marketed POCkit-HSV-2, a point-of-care test for HSV-2 that allows blood from a finger stick to be tested in a clinic. These tests can be used to confirm a genital herpes diagnosis, establish diagnosis of HSV infection in patients with atypical complaints, identify asymptomatic carriers, and identify persons at risk for acquiring HSV. Potential settings for use of these tests include sexually transmitted disease clinics, prenatal clinics, and clinics that care for patients with human immunodeficiency virus. Patient interest in HSV serological tests appears high. PMID:12353203

Wald, Anna; Ashley-Morrow, Rhoda

2002-10-15

369

Rapid HIV testing experience at Veterans Affairs North Texas Health Care System's Homeless Stand Downs.  

PubMed

In the USA, 21% of the estimated 1.1 million people living with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) are unaware they are HIV-infected. In 2011, Veterans Health Administration (VHA)'s Office of Public Health in conjunction with VHA's Health Care for Homeless Veterans Program funded grants to support rapid HIV testing at homeless outreach events because homeless populations are more likely to obtain emergent rather than preventive care and have a higher HIV seroprevalence as compared to the general population. Because of a Veterans Affairs North Texas Health Care System (VANTHCS)'s laboratory testing requirement, VANTHCS partnered with community agencies to offer rapid HIV testing for the first time at VANTHCS' 2011 Homeless Stand Downs in Dallas, Fort Worth, and Texoma, Texas. Homeless Stand Downs are outreach events that connect Veterans with services. Veterans who declined testing were asked their reasons for declining. Comparisons by Homeless Stand Down site used Pearson ?˛, substituting Fisher's Exact tests for expected cell sizes <5. Of the 910 Veterans attending the Homeless Stand Downs, 261 Veterans reported reasons for declining HIV testing, and 133 Veterans were tested, where 92% of the tested Veterans obtained their test results at the events - all tested negative. Veterans' reported reasons for declining HIV testing included previous negative result (n=168), no time to test (n=49), no risk factors (n=36), testing is not a priority (n=11), uninterested in knowing serostatus (n=6), and HIV-infected (n=3). Only "no time to test" differed significantly by Homeless Stand Down site. Nonresponse rate was 54%. Offering rapid HIV testing at Homeless Stand Downs is a promising testing venue since 15% of Veterans attending VANTHCS' Homeless Stand Downs were tested for HIV, and majority obtained their HIV test results at point-of-care while further research is needed to determine how to improve these rates. PMID:23750751

Hooshyar, Dina; Surís, Alina M; Czarnogorski, Maggie; Lepage, James P; Bedimo, Roger; North, Carol S

2014-01-01

370

Clinically actionable genotypes among 10,000 patients with preemptive pharmacogenomic testing.  

PubMed

Since September 2010, more than 10,000 patients have undergone preemptive, panel-based pharmacogenomic testing through the Vanderbilt Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment program. Analysis of the genetic data from the first 9,589 individuals reveals that the frequency of genetic variants is concordant with published allele frequencies. Based on five currently implemented drug-gene interactions, the multiplexed test identified one or more actionable variants in 91% of the genotyped patients and in 96% of African American patients. Using medication exposure data from electronic medical records, we compared a theoretical "reactive," prescription-triggered, serial single-gene testing strategy with our preemptive, multiplexed genotyping approach. Reactive genotyping would have generated 14,656 genetic tests. These data highlight three advantages of preemptive genotyping: (i) the vast majority of patients carry at least one pharmacogenetic variant; (ii) data are available at the point of care; and (iii) there is a substantial reduction in testing burden compared with a reactive strategy. PMID:24253661

Van Driest, S L; Shi, Y; Bowton, E A; Schildcrout, J S; Peterson, J F; Pulley, J; Denny, J C; Roden, D M

2014-04-01

371

Diagnostic efficiency of different amphetamine screening tests--the search for an optimal cutoff.  

PubMed

Increased use of designer drugs (amphetamines and amphetamine-like substances) raises the need for fast screening tests in urine in clinical settings, workplace and drug rehabilitation. Immunological assays currently used are subject to unwanted crossreactivities, partly depending on the cutoff concentrations used. The values recommended in Europe and the USA are 500 and 1000 ng/ml, respectively. In Switzerland, the recommended concentration of 300 ng/ml results in a high rate of false-positive urine samples and expensive, time-consuming confirmation testing. Using the Abbott Axsym analyzer, we found numerous false positives from patients in rehabilitation centers due to concomitant medication. Therefore, the diagnostic sensitivity and specificity of the Abbott test at different cutoff concentrations and the sensitivity of the Roche Cobas Integra, Beckman Synchron and Biosite Triage point-of-care test were examined. HPLC BioRad Remedi was chosen as the method of higher hierarchical order. The specificity of the Axsym analyzer (300 ng/ml) was 86%. At 500 ng/ml or 1000 ng/ml the specificity was increased to 99 or 100%, respectively, while the sensitivity only decreased from 97 to 91 or 81%, respectively. In summary, the cutoff concentration for amphetamine screening tests should not be below 500 ng/ml to avoid a high rate of false-positive results. PMID:15497474

Savoca, Reto; Rentsch, Katharina M; Hubert, Andreas R

2004-01-01

372

Laboratory and clinical evaluation of on-site urine drug testing.  

PubMed

Abstract Aim. Products for on-site urine drug testing offer the possibility to perform screening for drugs of abuse directly at the point-of-care. This is a well-established routine in emergency and dependency clinics but further evaluation of performance is needed due to inherent limitations with the available products. Methods. Urine drug testing by an on-site product was compared with routine laboratory methods. First, on-site testing was performed at the laboratory in addition to the routine method. Second, the on-site testing was performed at a dependency clinic and urine samples were subsequently sent to the laboratory for additional analytical investigation. Results. The on-site testing products did not perform with assigned cut-off levels. The subjective reading between the presence of a spot (i.e. negative test result) being present or no spot (positive result) was difficult in 3.2% of the cases, and occurred for all parameters. The tests performed more accurately in drug negative samples (specificity 96%) but less accurately for detecting positives (sensitivity 79%). Of all incorrect results by the on-site test the proportion of false negatives was 42%. The overall agreement between on-site and laboratory testing was 95% in the laboratory study and 98% in the clinical study. Conclusion. Although a high degree of agreement was observed between on-site and routine laboratory urine drug testing, the performance of on-site testing was not acceptable due to significant number of false negative results. The limited sensitivity of on-site testing compared to laboratory testing reduces the applicability of these tests. PMID:25046332

Beck, Olof; Carlsson, Sten; Tusic, Marinela; Olsson, Robert; Franzen, Lisa; Hulten, Peter

2014-11-01

373

Comparison of a New Immunochromatographic Test to Enzyme-Linked Immunosorbent Assay for Rapid Detection of Immunoglobulin M Antibodies to Hepatitis E Virus in Human Sera  

PubMed Central

An immunochromatographic test for rapid detection of IgM antibodies in patients with acute hepatitis E infection was developed utilizing the well-characterized recombinant protein EP2.1 and monoclonal antibody 4B2. The new rapid test based on a novel reverse-flow technology was able to generate a positive result within 2 to 3 min. Our study showed that this test was able to detect anti-HEV IgM antibodies in 96.7% of the patient samples tested (n = 151) while maintaining an excellent specificity of 98.6% with samples from various patient or healthy control groups (total n = 208). Furthermore, this rapid test gave a good specificity of 90.9% when tested with rheumatoid factor (RF)-positive sera (RF value of ?850 IU/ml; n = 11) although a higher concentration of RF in samples might cause cross-reactivity. The new test has a good agreement of 97.2% with a kappa value of 0.943 when compared with a reference enzyme-linked immunosorbent assay. The positive predictive value and the negative predictive value for the rapid test thus reached 98.0 and 97.6%, respectively. This is the first rapid, point-of-care test for hepatitis E and will be especially useful for the diagnosis of acute hepatitis E virus infection in field and emergency settings and in resource-poor countries. PMID:15879020

Chen, Hsiao Ying; Lu, Yang; Howard, Teresa; Anderson, David; Fong, Priscilla Yiquan; Hu, Wei-Ping; Chia, Chee Poh; Guan, Ming

2005-01-01

374

Test Architecture, Test Retrofit  

ERIC Educational Resources Information Center

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…

Fulcher, Glenn; Davidson, Fred

2009-01-01

375

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

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