Clinical evaluation of the rapid nucleic acid amplification point-of-care test (Smart Gene SARS-CoV-2) in the analysis of nasopharyngeal and anterior nasal samples

  1. Yoshihiko Kiyasu
  2. Masato Owaku
  3. Yusaku Akashi
  4. Yuto Takeuchi
  5. Kenji Narahara
  6. Sunao Mori
  7. Takashi Nagano
  8. Shigeyuki Notake
  9. Atsuo Ueda
  10. Koji Nakamura
  11. Hiroichi Ishikawa
  12. Hiromichi Suzuki

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Abstract

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  1. Version published to 10.1016/j.jiac.2021.12.027
  2. ScreenIT

    SciScore for 10.1101/2021.08.25.21262583: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All subjects provided their consent for enrollment.
    IRB: The ethics committee of TMCH approved the present study (approval number: 2021-008).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The N2 primer/probe set (Nihon Gene Research Laboratories, Miyagi, Japan) was employed for the reference real-time RT-PCR assay, as suggested by the “Manual for the Detection of Pathogen 2019-nCoV Ver. 2.9.1” issued by the National Institute of Infectious Diseases of Japan (NIID) [10].
    Nihon Gene Research Laboratories
    suggested: (University of Southern California; Los Angeles; USA, RRID:SCR_008093)

    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 was associated with some limitations. First, we did not analyze the sequences of the viruses detected in this study. Thus, the effect of genetic mutation on the performance of Smart Gene SARS-CoV-2 was not evaluated. Second, this study was conducted in a limited season and area, and it may be necessary to verify whether similar results can be obtained throughout the year or in another area. Finally, the reference real-time RT-PCR assay used frozen stored purified extraction, and such storage and transportation methods may have affected the test results. In conclusion, current study showed that Smart Gene SARS-CoV-2 had sufficient analytical performance in the detection of SARS-CoV-2 in nasopharyngeal and anterior nasal samples.

    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.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.08.25.21262583 on medRxiv