Analytical and clinical performance of the panbio COVID-19 antigen-detecting rapid diagnostic test
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SciScore for 10.1101/2020.10.30.20223198: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding All Ag-RDT determinations were performed by two blinded technicians, who used 100 μL of 1:3 mix of the Kit buffer and the sample previously thawed and homogenized. Power Analysis Statistical Analysis: We determined the sample size needed to estimate sensitivity with 80% power and precision 2·25% was 944 if the actual sensitivity of the index test was 93·5% (reported by the manufacturer) and specificity with 80% power and 2·25% precision was 450 if the actual specificity was 99·6% (reported by the manufacturer). Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Se… SciScore for 10.1101/2020.10.30.20223198: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding All Ag-RDT determinations were performed by two blinded technicians, who used 100 μL of 1:3 mix of the Kit buffer and the sample previously thawed and homogenized. Power Analysis Statistical Analysis: We determined the sample size needed to estimate sensitivity with 80% power and precision 2·25% was 944 if the actual sensitivity of the index test was 93·5% (reported by the manufacturer) and specificity with 80% power and 2·25% precision was 450 if the actual specificity was 99·6% (reported by the manufacturer). Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources For a positive result, a gold conjugate human IgG specific to SARS-CoV-2 Ag and anti-SARS-CoV-2 antibody form a test line in the result window. anti-SARS-CoV-2suggested: NoneExperimental Models: Cell Lines Sentences Resources Analytical performance of antigen rapid tests: The analytical performance of the Ag-RDT test was assessed using a SARS-CoV-2 isolate (ID EPI_ISL_510689) propagated in Vero E6 cells (ATCC CRL-1586). Vero E6suggested: NoneSoftware and Algorithms Sentences Resources , Standard F COVID-19 Ag FIA (SD Biosensor, Suwon, South Korea), and Panbio™ COVID-19 Ag Test (Abbott Laboratories, Illinois, USA). Abbott Laboratoriessuggested: NoneRapid antigen tests were performed according to the manufacturer’s IFU (Abbott, Illinois, USA) except for the use of a viral transport media (DeltaSwab Virus) and swab storage as a frozen specimen. Abbottsuggested: (Abbott, RRID:SCR_010477)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:On the other hand, it has the limitation of not using the test under the conditions specified by the manufacturer. Our results indicate that the test can be used on frozen samples stored in transport media, thus allowing parallel sampling for Ag-RDT and PCR. However, caution should be taken when using coloured media that may affect the background of the test thin layer. In our experience, a 1:3 dilution with the Kit buffer prevented unspecific signal of yellow-coloured transport media and provided adequate results; nevertheless, we encourage validating this type of approaches before using the test. Likewise, our study was performed on stored samples rather than in a real-life setting. Owing to this last limitation, common in other assessments of the clinical performance of RDT in general,26 we simulated the PPV and NPV assuming a prevalence of disease based on surveillance estimates. According to our simulation, in a low prevalence setting (i.e., 5% prevalence or below), the NPV would be very high (99·6%), and screening will result in 4 (95% CI 3 – 5) false-negative results per thousand tests; the corresponding PPV would be relatively low (81·5%), stressing the need for confirmatory testing with nucleic acid amplification techniques. Irrespective of the predictive values, one must not lose sight of the relationship between the viral load and test sensitivity, a double-edged sword that better suits this test for ensuring lack of infectivity of a subject along a limited time pe...
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.
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