Validation and implementation of a direct RT-qPCR method for rapid screening of SARS-CoV-2 infection by using non-invasive saliva samples

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Abstract

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  1. SciScore for 10.1101/2020.11.19.20234245: (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

    Software and Algorithms
    SentencesResources
    In case of a positive RT-qPCR result in a NP sample, both the paired biobanked saliva sample collected at the same time point and the series of saliva samples obtained previously from the same participant were retrieved and retrospectively analysed by direct RT-qPCR using GeneFinder COVID-19
    GeneFinder
    suggested: (GENEFINDER, RRID:SCR_009190)

    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:
    A limitation was that significant differences in Ct values were observed for direct RT-qPCR depending on the use of GeneFinder or TaqPath amplification reagents in the analytical validation process. To be noted, GeneFinder kit is designed for performance of 45 amplification cycles whereas TaqPath kit entails 40 cycles, and each of them sets different threshold values set for a positive result (GeneFinder, 40; TaqPath 37). Therefore, we were not able to provide insights into the significance of saliva viral load or Ct values obtained from these two commercial reagent kits. In conclusion, this study showed that a novel direct RT-qPCT on self-collected raw saliva is a simple, safe, and accurate method for first-line screening of SARS-CoV-2. High throughput pilot implementation proved to be feasible, allowed fast analytical workflow, and gained high levels of voluntary participation in a sensitive hospital scenario. Self-collection of saliva by end-users had negligible effects on validity of results. Evidence generated by this study supports the potential scale up of self-collected, saliva-based direct RT-qPCR for enhanced community-wide screening of SARS-CoV-2.

    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.