Analysis of external quality assessment samples revealed crucial performance differences between commercial RT-PCR assays for SARS-CoV-2 detection when taking extraction methods and real-time-PCR instruments into account

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Abstract

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  1. SciScore for 10.1101/2020.09.18.20185744: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot 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:
    The study in hand has certain limitations. Not all possible combinations of components were performed due to limited sample volumes. For the same reasons it was not possible to perform multiple testing of the respective test algorithms. It should also be noted that the volumes of the primary samples used for the extraction as well as the volumes of the eluates applied in the RT-PCR differed up to a double (Tab. 1). Lastly the performance of the test components used might have changed by the time of publication since the suppliers continuously improve these. We therefore conclude that, despite a scarcity of resources, diagnostic laboratories have to not only implement available kits immediately and thoroughly but also to determine the effects of different extraction methods and PCR instruments in order to enhance the accuracy of the diagnostic kits in use. Moreover, the knowledge about the influence of both determinants on Ct values with regard to SARS-CoV-2 RT-PCR testing should lead to a more careful interpretation of the obtained results. During supply shortages clinical samples may be triaged depending on the clinical course of the patient. For example, therapy depending testing has to be prioritized and performed with the most accurate analytical matrix available.

    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.