Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: An example of the need of validation studies

  1. Byron Freire-Paspuel
  2. Patricio Vega-Mariño
  3. Alberto Velez
  4. Paulina Castillo
  5. Marilyn Cruz
  6. Miguel Angel Garcia-Bereguiain

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Abstract

No abstract available

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  1. Version published to 10.1016/j.jcv.2020.104454
  2. ScreenIT

    SciScore for 10.1101/2020.05.01.20081034: (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:
    Although the main limitation of our study is the sample size (54 specimens), our results support that nCoV-QS kit had a significant lower performance in terms on PPA and sensitivity compared to 2019-nCoV CDC EUA. Also, the lack of any probe for RNA extraction quality control like RdRP and the unreported concentration of positive controls provided for the kit that does not allow viral load calculations, are limitations to be considered when using nCoV-QS kit. Considering the worldwide high demand of reagents for SARS-CoV RT-qPCR diagnosis, supplies shortage is a fact, actually affecting harder to developing countries like Ecuador. Under this scenario, validation studies are helpful to guarantee the quality of the supplies in the market for every country in the world.

    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.

  3. Version published to 10.1101/2020.05.01.20081034 on medRxiv