Performance characteristics of five antigen-detecting rapid diagnostic test (Ag-RDT) for SARS-CoV-2 asymptomatic infection: a head-to-head benchmark comparison
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Abstract
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SciScore for 10.1101/2021.02.11.21251553: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study protocol was approved by the ethics committee of Hospital Germans Trias i Pujol (Badalona, Spain). Sex as a biological variable not detected. Randomization not detected. Blinding All Ag-RDT determinations were performed in parallel by two blinded technicians, who used approximately 100 μL of 1:2 mix of each kit buffer and the sample previously homogenized. Power Analysis Outcomes and statistical analysis: We calculated that a sample size of at least 73 positive specimens and 165 negative specimens would give 80% power to estimate overall sensitivity and specificity of Ag-RDT assays in our study. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open …
SciScore for 10.1101/2021.02.11.21251553: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study protocol was approved by the ethics committee of Hospital Germans Trias i Pujol (Badalona, Spain). Sex as a biological variable not detected. Randomization not detected. Blinding All Ag-RDT determinations were performed in parallel by two blinded technicians, who used approximately 100 μL of 1:2 mix of each kit buffer and the sample previously homogenized. Power Analysis Outcomes and statistical analysis: We calculated that a sample size of at least 73 positive specimens and 165 negative specimens would give 80% power to estimate overall sensitivity and specificity of Ag-RDT assays in our study. Table 2: Resources
No key resources detected.
Results 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:Our study has several strengths and limitations. We used the same fresh set of samples for assessing five different Ag-RDTs and the sample size met the FIND recommendation for retrospective assessments of the clinical performance of these tests. Furthermore, to our knowledge, this is the first head-to-head comparison of Ag-RDT in asymptomatic screenings, an intended use proposed by various authors.4,9,16,22 On the other hand, our study was limited by the small number of specimens with Ct <30, a threshold deemed of interest for the use of Ag-RDT in screenings of the general population. In our sample, specimens below this threshold accounted for 30%; however, other authors have reported proportions of nearly 60% in random screenings of the general population.22 Of note, we used specimens in transport medium. This approach is convenient for mass screening strategies in which individuals with positive Ag-RDT results may need further diagnostic confirmation by PCR. However, only one manufacturer (i.e., the Roche assay) provided instructions on how to process samples collected in virus transport medium. The consistency of our results across assays, particularly regarding negative results, suggests that the use of this media had a little or negligible impact on test performance. Finally, it is worth mentioning that all nasopharyngeal swabs in our analysis were collected by trained healthcare professionals. According to a recent report of lateral flow viral antigen detection devices,...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
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.
Results from scite Reference Check: We found no unreliable references.
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