Performance and Implementation Evaluation of the Abbott BinaxNOW Rapid Antigen Test in a High-Throughput Drive-Through Community Testing Site in Massachusetts
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Abstract
Rapid diagnostic tests (RDTs) for SARS-CoV-2 antigens (Ag) that can be performed at point of care (POC) can supplement molecular testing and help mitigate the COVID-19 pandemic. Deployment of an Ag RDT requires an understanding of its operational and performance characteristics under real-world conditions and in relevant subpopulations.
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SciScore for 10.1101/2021.01.09.21249499: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Verbal consent for dual AN swabbing was obtained from adults and guardians of minors (with verbal assent for ages 7-17). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Analyses utilized Microsoft Excel and GraphPad Prism. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)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…SciScore for 10.1101/2021.01.09.21249499: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Verbal consent for dual AN swabbing was obtained from adults and guardians of minors (with verbal assent for ages 7-17). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Analyses utilized Microsoft Excel and GraphPad Prism. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)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 had some limitations. We recognize that the comparator in our study was RT-PCR performed on an AN swab, as opposed to an NP swab, which is still considered the reference method by the FDA [30]. While AN swabs have had lower sensitivity than NP swabs in some studies, the sensitivity is highly dependent on the sampling technique and assay used [31]. The dry AN swab sampling method used in this study has been shown to have similar sensitivity to paired NP swabs in transport media [17]. We also note that a recent comparison study demonstrated that Ag RDT performance with AN swabs was similar to Ag RDT performance with NP swabs [5]. We were not able to have all tests read by two independent readers, but did so for the majority of tests. Finally, we recognize that our symptomatic pediatric cohort was relatively small and thus the confidence interval relatively wide, exemplifying the challenges in assessing COVID-19 diagnostics in children. There may be important differences in performance characteristics of Ag tests or in viral dynamics corresponding to ages of children, but there were insufficient symptomatic children with positive tests in the study to stratify by age group. Current recommendations from the WHO [32] suggest that Ag RDTs be used in symptomatic individuals within the first 5-7 days of symptoms, with repeat testing or RT-PCR confirmation of negative Ag RDT results if possible. WHO recommendations include testing during suspected outbreaks, monitoring trend...
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.
- Thank you for including a protocol registration statement.
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