Evaluating 10 Commercially Available SARS-CoV-2 Rapid Serological Tests by Use of the STARD (Standards for Reporting of Diagnostic Accuracy Studies) Method
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Abstract
Numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid serological tests have been developed, but their accuracy has usually been assessed using very few samples, and rigorous comparisons between these tests are scarce. In this study, we evaluated and compared 10 commercially available SARS-CoV-2 rapid serological tests using the STARD (Standards for Reporting of Diagnostic Accuracy Studies) methodology.
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SciScore for 10.1101/2020.09.10.20192260: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization Sera from COVID-19 patients were randomly selected and grouped according to the time between onset of symptoms and patient’s blood sampling (0-9 days, 10-14 days, and > 14 days) (Fig. 1A). Blinding not detected. Power Analysis The minimum sample size was calculated assuming an expected sensitivity of 90 (with 5 accuracy) and a specificity of 98 (with 2 accuracy), amounting to 250 true positive samples and 254 true negative samples (power 0.80, alpha 0.05). Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Ten RDTs that could detect either all antibodies or specifically identified IgG or IgM (in blood, … SciScore for 10.1101/2020.09.10.20192260: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization Sera from COVID-19 patients were randomly selected and grouped according to the time between onset of symptoms and patient’s blood sampling (0-9 days, 10-14 days, and > 14 days) (Fig. 1A). Blinding not detected. Power Analysis The minimum sample size was calculated assuming an expected sensitivity of 90 (with 5 accuracy) and a specificity of 98 (with 2 accuracy), amounting to 250 true positive samples and 254 true negative samples (power 0.80, alpha 0.05). Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Ten RDTs that could detect either all antibodies or specifically identified IgG or IgM (in blood, serum, or plasma) were evaluated: (RDT 1) NG-Test IgG-IgM COVID-19 (NG-Biotech, Guipry, France), (RDT 2) Anti SARS-CoV-2 rapid test (Autobio Diagnostic CO, Zhengzhou, China), (RDT 3) Novel Coronavirus -2019-nCOV-Antibody IgG/IgM IgMsuggested: (Thermo Fisher Scientific Cat# MA1-41515, RRID:AB_1087201)NG-Test IgG-IgMsuggested: NoneAnti SARS-CoV-2suggested: NoneSoftware and Algorithms Sentences Resources Data analysis: Each RDT’s sensitivity and specificity was calculated with its respective confidence interval 95 (CI95) using VassarStats (http://http://vassarstats.net/). VassarStatssuggested: (VassarStats, RRID:SCR_010263)Cumulative curves were fitted to an asymmetrical (five-parameter) logistic equation using Graph Prism v6 (25). Graph Prismsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Serological assays and RDTs are being increasingly used across the world to address other tests’ limitations, but most commercially available RDTs have had their accuracy verified on only a small number of sera without including negative samples to evaluate cross-reactivity. Moreover, their usefulness for patient management in active hospital settings and among the general public has almost never been rigorously evaluated (27, 28). By demonstrating the feasibility and accuracy of rapid serological immunoassays with a substantially more robust sample size than has previously been described, we add depth to the evolving conversation surrounding SARSCoV-2 testing strategies. We hope that knowing the analytical performance of nearly a dozen commercially available tests, and by providing comparative detail, we will allow clinicians to select and use these tests with more confidence and certainty. This study is, to our knowledge, the first to compare diagnostic performance and time-toseropositivity in nearly a dozen SAR-CoV-2 RDTs using a large sample size (250 selected samples each for specificity and sensitivity, more than double other peer-reviewed, published RDT evaluations). Other studies evaluating antibody tests have also not included samples from patients with non-SARS-CoV-2 infections to evaluate specificity. Overall, after the appearance of symptoms, seroconversion occurred on Days 7-9 for 50 of COVID positive patients (Table 1), with >95 seroconverting after 14 days usin...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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