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
2018 ◽  
Vol 146 (6) ◽  
pp. 747-756
Author(s):  
J.M. Hughes ◽  
C. Penney ◽  
S. Boyd ◽  
P. Daley

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.


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Pakpoom Subsoontorn ◽  
Manupat Lohitnavy ◽  
Chuenjid Kongkaew

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.


2016 ◽  
Vol 130 ◽  
pp. 18-32 ◽  
Author(s):  
Elise H. Tatone ◽  
Jessica L. Gordon ◽  
Jessie Hubbs ◽  
Stephen J. LeBlanc ◽  
Trevor J. DeVries ◽  
...  

2019 ◽  
Vol 53 (7) ◽  
pp. 535-542 ◽  
Author(s):  
Prashant Singh ◽  
Ananya Arora ◽  
Tor A. Strand ◽  
Daniel A. Leffler ◽  
Markku Mäki ◽  
...  

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

2010 ◽  
Vol 56 (11) ◽  
pp. 1758-1766 ◽  
Author(s):  
Geert-Jan Geersing ◽  
Diane B Toll ◽  
Kristel JM Janssen ◽  
Ruud Oudega ◽  
Marloes JC Blikman ◽  
...  

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.


2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Pasha Normahani ◽  
Sepideh Poushpas ◽  
Mays Alaa ◽  
Vassiliki Bravis ◽  
Viknesh Sounderajah ◽  
...  

Perfusion ◽  
2002 ◽  
Vol 17 (1) ◽  
pp. 23-26 ◽  
Author(s):  
Davide Giavarina ◽  
Mariarosa Carta ◽  
Alessandro Fabbri ◽  
Jacopo Manfredi ◽  
Edoardo Gasparotto ◽  
...  

The correct monitoring of heparin therapy and its reversal determines the successful conduct of cardiovascular surgery with extracorporeal circulation (ECC). The activated coagulation time (ACT) and the heparin management test (HMT) are the most frequently used tests in the operating room. Three compact monitors for ACT or HMT are here evaluated. Forty samples were obtained, at 10-min intervals, from eight patients during ECC. The ACT or HMT was immediately performed using: Hemochron Junior™ ACT, CoaguCeck™ Pro (ACT) and Rapid Point Coag (HMT). Data were compared between them and with the heparin levels, measured as anti-Xa. The simple least squares linear regression among, respectively, Hemochron Junior ACT, CoaguCeck Pro ACT, Rapid Point Coag HMT and anti-Xa activity were i= 452.3, s= 15.2, Sy/x= 37.5, r= 0.18; i= 411.9, s= 22.1, Sy/x= 48.7, r= 0.21 and i= 479.4, s= 9.0, Sy/x= 9.3; r= 0.41. CoaguCeck Pro ACT results were above the upper detection limit (500 s) in 37 of 40 determinations. The comparison between ACT Hemocron and HMT Rapid Point Coag shows i= 35.7, s= 0.9, Sy/x= 35.4, r= 0.68, with a bias of 29.0 s (CI: 17.9-40.1), 95% of agreement between -41.5 s (CI: -60.7 to -22.3) and 99.5 s (CI: 80.4-118.7). Taking a concentration of 2.0 U/ml of heparin to discriminate between high- and low-risk conditions, receiver-operator characteristic (ROC) curve was used to rank the performance of the methods. Areas under the ROC curve± SE for Hemochron Junior ACT and Rapid Point Coag HMT were 0.629± 0.097 and 0.543± 0.096. The results obtained by HMT appear similar to those obtained by the ACT for monitoring high-dose heparin therapy in patients undergoing ECC. HMT appeared to perform better than ACT in measuring the heparin effect, while the ROC analysis gives a little more accuracy for ACT. Neither of the two methods is able to achieve enough evidence of diagnostic accuracy. Since these tests are widely used, and there are no laboratory alternatives, a real comparison with the outcome of the patients should be helpful for an evidence-based evaluation of these point-of-care tests.


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