Evaluation of the INDICAID COVID-19 Rapid Antigen Test in Symptomatic Populations and Asymptomatic Community Testing

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Abstract

Laboratory-based RT-PCR, the current gold standard for COVID-19 testing, can require a turnaround time of 24 to 48 h from sample collection to result. The delayed time to result limits the effectiveness of centralized RT-PCR testing to reduce transmission and stem potential outbreaks.

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  1. SciScore for 10.1101/2021.05.26.21257063: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    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:
    There were limitations during the symptomatic clinical evaluation. The tests were conducted under controlled temperature and lighting conditions and interpreted by a limited pool of trained operators. Widespread community testing might occur under less-controlled conditions. Several point-of-care flex studies (see Supplementary Information) were performed to demonstrate that the INDICAID™ Rapid Test is robust under suboptimal conditions (i.e., extreme temperature and humidity, out-of-specification buffer addition, and variable result reading times). Additionally, self-collected samples were always collected first, which might have affected the amount of virus/antigen remaining for the subsequent operator-collected samples. While the sample collection order is not expected to drastically influence the reference test result, the effect of repeated sampling on the INDICAID™ Rapid Test has not been confirmed. Rapid antigen tests are expected to play an increasingly important role in COVID-19 testing programs. To our knowledge, our Dual-Track testing approach is one of the first widely coordinated efforts to integrate COVID-19 rapid antigen testing with rapid confirmatory RT-PCR testing in asymptomatic populations. Recently, the United States CDC proposed similar screening algorithms that incorporate routine rapid antigen testing for asymptomatic populations, followed by positive patient confirmation by RT-PCR [11]. The performance of the INDICAID™ COVID-19 Rapid Antigen Test make...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04904510CompletedEvaluation of the INDICAID™ COVID-19 Rapid Antigen Test


    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.

    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.