The evaluation of a novel digital immunochromatographic assay with silver amplification to detect SARS-CoV-2

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Abstract

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  1. SciScore for 10.1101/2021.05.06.21256738: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All patients provided informed consent to participate in the study, which was approved by the ethics committee of TMCH (approval number: 2020-071).
    IRB: All patients provided informed consent to participate in the study, which was approved by the ethics committee of TMCH (approval number: 2020-071).
    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 reference RT-PCR 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 [9].
    Nihon Gene Research Laboratories
    suggested: (University of Southern California; Los Angeles; USA, RRID:SCR_008093)
    Limits of detection of QuickChaser® Auto SARS-CoV-2 and four commercially available rapid antigen tests: We compared the limit of detection (LOD) of QuickChaser® Auto SARS-CoV-2 with those of four commercially available rapid antigen tests (Espline® SARS-CoV-2, Fujirebio, Tokyo, Japan; QuickNavi™-COVID19 Ag, Denka, Tokyo Japan; Panbio™ COVID-19 Ag Rapid Test Device, Abbott Diagnostics, Illinois, USA; SARS-CoV-2 Rapid Antigen Test, Roche Diagnostics, Rotkreuz, Switzerland).
    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:
    There are several limitations regarding this study. First, reference real-time RT-PCR used frozen samples. While samples were stored at -80 °C, their viral load may have decreased during storage process. Second, we did not investigate whether mutations in SARS-COV-2 affected the diagnostic performance. Third, we did not evaluate saliva or anterior nasal cavity samples. Saliva collection and anterior nasal swabs cause less pain and coughing than nasopharyngeal swabs [18]. Future studies should compare the diagnostic performance of samples obtained using each of these methods. In conclusion, Quick Chaser® Auto SARS-CoV-2 showed satisfactory diagnostic performance of symptomatic patients. The sensitivity was especially high in samples of Ct <30, indicating that the test can accurately detect highly infectious patients.

    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.