Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department

  1. Jean-Claude NguyenVan
  2. Camille Gerlier
  3. Benoît Pilmis
  4. Assaf Mizrahi
  5. Gauthier Péan de Ponfilly
  6. Amir Khaterchi
  7. Vincent Enouf
  8. Olivier Ganansia
  9. Alban Le Monnier

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Abstract

No abstract available

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  1. Version published to 10.1016/j.jcv.2021.105021
  2. ScreenIT

    SciScore for 10.1101/2021.03.29.21253909: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethical statement: This study followed the Standards for Reporting Diagnostic Accuracy study (STARD) guidelines and was favourable approved by the local clinical ethic committee board called “Comité de protection des Personnes Nord Ouest” N° IRB 2020-A02758-31.
    Consent: Informed oral consent for participation was obtained from each participant, in accordance with French law.
    RandomizationThe lack of identification of the order of collection and the size of the study ensures that the swabs were randomly distributed.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Testing methods: The ID NOW COVID-19 assay (Abbott, Chicago, Il, USA) is an isothermal nucleic acid amplification-based.
    Abbott
    suggested: (Abbott, RRID:SCR_010477)

    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:
    Our study has several limitations. First, the ID NOW COVID-19 assay itself has only one target, the RdRP gene. To date, the published isothermal amplification technology tests did not evaluate SARS-CoV-2 using two target genes (18). Second, this work was conducted during an epidemic peak and so the results should be viewed in the context of the conditions during such a period. Positive predictive values decrease when tests are performed with a lower prevalence of the disease, thus the results cannot be extrapolated to a lower prevalence period. Third, this study was conducted on the relatively small number of samples in a single care center setting. Therefore the results may be specific to the population of this center and may not be applicable to another patient group such as children for example. Use of rapid diagnostic test at triage in other care settings would depend on the organization of each ED and, importantly, on the availability of compliant and trained staff.

    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 10.1101/2021.03.29.21253909v1 on medRxiv