Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals

  1. Yoshihiko Kiyasu
  2. Yuto Takeuchi
  3. Yusaku Akashi
  4. Daisuke Kato
  5. Miwa Kuwahara
  6. Shino Muramatsu
  7. Shigeyuki Notake
  8. Atsuo Ueda
  9. Koji Nakamura
  10. Hiroichi Ishikawa
  11. Hiromichi Suzuki

Reviewed by

Read the full article

Discuss this preprint

Start a discussion What are Sciety discussions?

Listed in

Log in to save this article

Abstract

No abstract available

Article activity feed

  1. Version published to 10.1016/j.jiac.2021.07.005
  2. ScreenIT

    SciScore for 10.1101/2021.04.01.21254813: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The ethics committee of TMCH approved the present study (approval number: 2020-033).
    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:
    Several limitations associated with the present study warrant mention. First, the results were obtained at a single PCR center during one epidemic season. Whether the same results would be obtained in other regions or during other epidemics requires additional validation. Second, this study did not include patients who had received the vaccine, and the accuracy of the test on SARS-CoV-2-infected patients after vaccination needs to be verified in the future. Third, we did not perform a genetic analysis of the detected SARS-CoV-2 variants and did not study the effect of genetic mutation on the antigen test results. Nevertheless, according to manufacturer’s information for use (version 4.0), QuickNavi™-COVID19 Ag reacts with both the SARS-CoV-2 UK variant (VOC-202012/01) and the Brazilian variant (501Y.V3, P.1 ), and the degrees of reaction with these variants are the same as those with the Wuhan strain. In conclusion, despite showing very high specificity, the QuickNavi™-COVID19 Ag has lower sensitivity for detecting SARS-CoV-2 in asymptomatic individuals as compared with its sensitivity in symptomatic patients. Nevertheless, given its high convenience and specificity, this antigen test could be used as a supplementary COVID-19 assessment for asymptomatic individuals, as long as the results are interpreted appropriately.

    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 10.1101/2021.04.01.21254813 on medRxiv