Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests for people with suspected COVID-19 in the community

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Abstract

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  1. SciScore for 10.1101/2021.02.21.21252153: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: Adults above the aged 18 years or older who presented at the test centre, were able to understand the written instructions in Dutch and provided verbal informed consent procedure and contact information (e-mail address and telephone number) were deemed for inclusion.
    IRB: Ethics: The study protocol was reviewed by the Dutch ‘Medical research Ethics Committees United’ (MEC-U).
    RandomizationStudy procedure: Eligible participants were randomly allocated to either a test lane distributing the BD RDT self-testing kit or a test lane distributing the Roche RDT self-testing kit.
    Blindingnot detected.
    Power AnalysisWe assumed the diagnostic accuracy to be lower than when performed by professionals, and based the sample size calculation on an expected sensitivity of 80% for infectious individuals, with a margin of error of 7%, type I error of 5% and power of 90%.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Univariate and multivariate logistic regression analyses were performed using Statsmodels v0.12.2 to examine whether following variables were independently associated with a false negative result in self-test for COVID-19 as compared to the qRT-PCR: Antigen rapid test used (BD RDT or Roche RDT), Age, Sex, current COVID-19 related symptom, Ct-value lower than the Ct-value at which the chance (p) of having a positive viral culture was p = 0.5, and the responses to the statements included in the survey.
    Statsmodels
    suggested: (statsmodel, RRID:SCR_016074)
    Adjusted Wald confidence intervals (CI) for the sensitivity and specificity of self-testing as compared to RT-PCR overall, RT-PCR with an expected contagious viral load, and composite reference standard were calculated using Scipy v.1.17.0.
    Scipy
    suggested: (SciPy, RRID:SCR_008058)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.