scholarly journals Diagnostic Accuracy of Point-of-Care Tests Measuring Glycosylated Haemoglobin (HbA1c) for Glycemic Control: A Field Study in India

Cureus ◽  
2021 ◽  
Author(s):  
Sagar Khadanga ◽  
Gyanendra Singh ◽  
Abhijit P Pakhare ◽  
Rajnish Joshi
Keyword(s):  
Glycemic Control ◽  
Diagnostic Accuracy ◽  
Field Study ◽  
Point Of Care ◽  
Glycosylated Haemoglobin ◽  
Point Of Care Tests

scholarly journals Diagnostic Accuracy and Feasibility of Point-Of-Care Glycosylated Hemoglobin Estimation in Field Conditions in India

2019 ◽  
Author(s):  
Sagar Khadanga ◽  
Abhijit Pakhare ◽  
Rajnish Joshi
Keyword(s):  
Glycemic Control ◽  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Glycosylated Hemoglobin ◽  
Ambient Air ◽  
Failure Rates ◽  
Reference Standard ◽  
Index Tests ◽  
Point Of Care Tests ◽  
Hba1c Levels

Background: Measurement of glycosylated hemoglobin (HbA1c) levels is standard of care in assessment of glycemic control among diabetes mellitus patients. Traditional high performance liquid chromatography (HPLC) based tests are expensive, need specialized equipment, and have a longer turn-around-time. Point-of-care tests to estimate HbA1c levels are now commercially available but with only limited studies from developed nations. We performed this study to understand diagnostic accuracy of two commercially available HbA1c point-of-care test. Methods: The study was conducted in an urban and a rural outpatient clinic in central India. We compared HbA1c estimated from two index tests (Hemocue Hb501, Sweden; SD Biosensor, South Korea) from capillary blood samples and compared it with HPLC, as a reference standard in an independent and a blinded manner. We estimated diagnostic accuracy of the index tests as compared to the reference standard. Results: The area under Reciever Operating Curve (ROC) for SDBiosensor device was 0.935 (95% CI = 0.886–0.983), and for HemocueHb501 device was 0.938 (95% CI = 0.893–0.984). A SDBiosensor device HbA1c value of above 7.0% = 53 mmol/mol (positive test) correctly predicted poor glycemic control 92% times (vs. 81.58% for HemocueHb501divice). A HemocueHb501device HbA1c value of less than 7.0% = 53 mmol/mol (negative test) correctly predicted optimal glycemic control 91% times (vs. 85% by SDBiosensor device). There were 4, and 11 device failures, and 14 and 12 test failures with SDBiosensor device and HemocueHb501 device respectively. Ambient air temperatures were no different for the test failure rates as compared to the test success events. Conclusion: Commercially available point-of-care tests evaluated in this study are comparable and an acceptable alternative to HPLC based measurements for assessment of glycemic control. Tests and device failure rates of both the index tests were similar.

scholarly journals Risk of bias and limits of reporting in diagnostic accuracy studies for commercial point-of-care tests for respiratory pathogens

2018 ◽  
Vol 146 (6) ◽  
pp. 747-756
Author(s):  
J.M. Hughes ◽  
C. Penney ◽  
S. Boyd ◽  
P. Daley
Keyword(s):  
Diagnostic Accuracy ◽  
Test Performance ◽  
Point Of Care ◽  
Risk Of Bias ◽  
Financial Impact ◽  
Test Accuracy ◽  
Respiratory Pathogens ◽  
Study Results ◽  
Group A ◽  
Point Of Care Tests

AbstractCommercial point-of-care (POC) diagnostic tests for Group A Streptococcus, Streptococcus pneumoniae, and influenza virus have large potential diagnostic and financial impact. Many published reports on test performance, often funded by diagnostics companies, are prone to bias. The Standards for Reporting of Diagnostic Accuracy (STARD 2015) are a protocol to encourage accurate, transparent reporting. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool evaluates risk of bias and transportability of results. We used these tools to evaluate diagnostic test accuracy studies of POC studies for three respiratory pathogens. For the 96 studies analysed, compliance was <25% for 14/34 STARD 2015 standards, and 3/7 QUADAS-2 domains showed a high risk of bias. All reports lacked reporting of at least one criterion. These biases should be considered in the interpretation of study results.

scholarly journals The diagnostic accuracy of isothermal nucleic acid point-of-care tests for human coronaviruses: A systematic review and meta-analysis

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Pakpoom Subsoontorn ◽  
Manupat Lohitnavy ◽  
Chuenjid Kongkaew
Keyword(s):  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Diagnostic Test ◽  
Point Of Care ◽  
Meta Analysis ◽  
Isothermal Amplification ◽  
Diagnostic Test Accuracy ◽  
Test Accuracy ◽  
Index Test ◽  
Point Of Care Tests

AbstractMany recent studies reported coronavirus point-of-care tests (POCTs) based on isothermal amplification. However, the performances of these tests have not been systematically evaluated. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy was used as a guideline for conducting this systematic review. We searched peer-reviewed and preprint articles in PubMed, BioRxiv and MedRxiv up to 28 September 2020 to identify studies that provide data to calculate sensitivity, specificity and diagnostic odds ratio (DOR). Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) was applied for assessing quality of included studies and Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) was followed for reporting. We included 81 studies from 65 research articles on POCTs of SARS, MERS and COVID-19. Most studies had high risk of patient selection and index test bias but low risk in other domains. Diagnostic specificities were high (> 0.95) for included studies while sensitivities varied depending on type of assays and sample used. Most studies (n = 51) used reverse transcription loop-mediated isothermal amplification (RT-LAMP) to diagnose coronaviruses. RT-LAMP of RNA purified from COVID-19 patient samples had pooled sensitivity at 0.94 (95% CI: 0.90–0.96). RT-LAMP of crude samples had substantially lower sensitivity at 0.78 (95% CI: 0.65–0.87). Abbott ID Now performance was similar to RT-LAMP of crude samples. Diagnostic performances by CRISPR and RT-LAMP on purified RNA were similar. Other diagnostic platforms including RT- recombinase assisted amplification (RT-RAA) and SAMBA-II also offered high sensitivity (> 0.95). Future studies should focus on the use of un-bias patient cohorts, double-blinded index test and detection assays that do not require RNA extraction.

scholarly journals A multi-center field study of two point-of-care tests for circulating Wuchereria bancrofti antigenemia in Africa

2017 ◽  
Vol 11 (9) ◽  
pp. e0005703 ◽  
Author(s):  
Cédric B. Chesnais ◽  
Naomi-Pitchouna Awaca-Uvon ◽  
Fatoma K. Bolay ◽  
Michel Boussinesq ◽  
Peter U. Fischer ◽  
...  
Keyword(s):  
Field Study ◽  
Point Of Care ◽  
Wuchereria Bancrofti ◽  
Point Of Care Tests

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

2016 ◽  
Vol 130 ◽  
pp. 18-32 ◽  
Author(s):  
Elise H. Tatone ◽  
Jessica L. Gordon ◽  
Jessie Hubbs ◽  
Stephen J. LeBlanc ◽  
Trevor J. DeVries ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Dairy Cows ◽  
Point Of Care ◽  
Meta Analysis ◽  
Point Of Care Tests

Diagnostic accuracy of rapid point-of-care tests for detecting syphilis infection

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Edith Angel-Müller ◽  
Carlos Fernando Grillo-Ardila ◽  
Jairo Amaya-Guio ◽  
Nicolas Torres-Montañez
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Syphilis Infection ◽  
Point Of Care Tests

Diagnostic Accuracy of Point of Care Tests for Diagnosing Celiac Disease

2019 ◽  
Vol 53 (7) ◽  
pp. 535-542 ◽  
Author(s):  
Prashant Singh ◽  
Ananya Arora ◽  
Tor A. Strand ◽  
Daniel A. Leffler ◽  
Markku Mäki ◽  
...  
Keyword(s):  
Celiac Disease ◽  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Point Of Care Tests

Diagnostic Accuracy of Point-of-Care Tests for Detecting Albuminuria

2014 ◽  
Vol 160 (8) ◽  
pp. 550 ◽  
Author(s):  
Malcolm P. McTaggart ◽  
Ronald G. Newall ◽  
Jennifer A. Hirst ◽  
Clare R. Bankhead ◽  
Edmund J. Lamb ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Point Of Care Tests

scholarly journals Diagnostic Accuracy and User-Friendliness of 5 Point-of-Care D-Dimer Tests for the Exclusion of Deep Vein Thrombosis

2010 ◽  
Vol 56 (11) ◽  
pp. 1758-1766 ◽  
Author(s):  
Geert-Jan Geersing ◽  
Diane B Toll ◽  
Kristel JM Janssen ◽  
Ruud Oudega ◽  
Marloes JC Blikman ◽  
...  
Keyword(s):  
Primary Care ◽  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Reference Method ◽  
Roc Curves ◽  
Color Contrast ◽  
User Friendliness ◽  
Predictive Values ◽  
Point Of Care Tests ◽  
D Dimer

BACKGROUND Point-of-care D-dimer tests have recently been introduced to enable rapid exclusion of deep venous thrombosis (DVT) without the need to refer a patient for conventional laboratory-based D-dimer testing. Before implementation in practice, however, the diagnostic accuracy of each test should be validated. METHODS We analyzed data of 577 prospectively identified consecutive primary care patients suspected to have DVT, who underwent 5 point-of-care D-dimer tests—4 quantitative (Vidas®, Pathfast™, Cardiac®, and Triage®) and 1 qualitative (Clearview Simplify®)—and ultrasonography as the reference method. We evaluated the tests for the accuracy of their measurements and submitted a questionnaire to 20 users to assess the user-friendliness of each test. RESULTS All D-dimer tests showed negative predictive values higher than 98%. Sensitivity was high for all point-of-care tests, with a range of 0.91 (Clearview Simplify) to 0.99 (Vidas). Specificity varied between 0.39 (Pathfast) and 0.64 (Clearview Simplify). The quantitative point-of-care tests showed similar and high discriminative power for DVT, according to calculated areas under the ROC curves (range 0.88–0.89). The quantitative Vidas and Pathfast devices showed limited user-friendliness for primary care, owing to a laborious calibration process and long analyzer warm-up time compared to the Cardiac and Triage. For the qualitative Clearview Simplify assay, no analyzer or calibration was needed, but interpretation of a test result was sometimes difficult because of poor color contrast. CONCLUSIONS Point-of-care D-dimer assays show good and similar diagnostic accuracy. The quantitative Cardiac and Triage and the qualitative Clearview Simplify D-dimer seem most user-friendly for excluding DVT in the doctor's office.

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