Clinical Evaluation of BD Veritor SARS-CoV-2 and Flu A+B Assay for Point-Of-Care System

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Abstract

COVID-19 and flu are two respiratory illnesses which share similar clinical symptoms. The BD Veritor SARS-CoV-2/Flu assay has high sensitivity and specificity for detecting the SARS-CoV-2 and influenza A/B, the two etiologic agents causing COVID-19 and flu, respectively.

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  1. SciScore for 10.1101/2021.05.04.21256323: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study protocol was approved by the Advarra Institutional Review Board (IRB).
    Sex as a biological variablenot detected.
    RandomizationThe specimens were tested in a randomized and blinded fashion.
    BlindingAll study operators performing the Veritor SARS-CoV-2/Flu assay were blinded to reference method results.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Clinical performance data from the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B (“Veritor SARS-CoV-2/Flu”; Becton, Dickinson and Company; BD Life Sciences – Integrated Diagnostics Solutions, Sparks, MD, USA) was compared to both the Lyra® SARS-CoV-2 RT-PCR Assay (
    Company; BD
    suggested: None

    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:
    Limitations: The test for Flu A and Flu B was conducted by using materials obtained from pre-selected frozen remnants. Unbiased subjects with no confirmed diagnosis should be considered for testing. Conclusions: The Veritor SARS-CoV-2/Flu assay met US FDA-EUA acceptance criteria for SARS-CoV-2 detection. The test sensitivity of the Veritor SARS-CoV-2/Flu assay for Flu A and B detection was in agreement with the previously cleared Veritor System Flu A+B assay. Dual detection capability for the etiologic agents causing COVID-19 and influenza will allow efficient differentiation between the two illnesses and will inform physicians regarding diagnosis and, therefore, the proper treatment and disease management for patients exhibiting similar symptoms. Dual testing may be especially important for the duration of the COVID-19 pandemic as it overlaps with flu season and could have a major impact in decentralized health care settings.

    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.


    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.