Performance evaluation of the Simtomax® CoronaCheck rapid diagnostic test

  1. P.J. Ducrest
  2. A. Freymond
  3. J.-M. Segura

Reviewed by

Read the full article

Listed in

Log in to save this article

Abstract

No abstract available

Article activity feed

  1. Version published to 10.1016/j.jviromet.2021.114178
  2. ScreenIT

    SciScore for 10.1101/2020.10.28.20219667: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    BlindingIgG and IgM responses were read after 15 minutes following manufacturer’s instructions, blinded to the reference method results.
    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:
    There are however several limitations to this study. First, we present here the results of a method evaluation study and not a seroprevalence study. Therefore, the PPV obtained here (based on a 32.9% proportion of cases defined as laboratory confirmed SARS-CoV-2 by RT-PCR) will be lower in a low prevalence setting, e.g. when testing the asymptomatic population. Another limitation of this validation study lies in the limited sample size leading to broad 95% confidence intervals, requiring confirmation of these data at a larger scale. Also, here we used plasma and the test was performed in a laboratory environment; we may expect different results in real-life at patients’ bed and using capillary blood. Finally, our present conclusions only apply to the Augurix RDT, and must not be generalized to other currently available RDTs. In conclusion, Augurix RDT is not meant to replace a SARS-CoV-2 RT-PCR diagnostic test in the first week of the disease, but could be a reliable option for assessing the SARS-CoV-2 serology in moderate to high COVID-19 prevalence settings, i.e. when testing the sub-population of individuals having presented COVID-19 symptoms, especially in situations where automated ECLIA or ELISA are not available, with samples collected between at least 15 days and up to 180 days after the onset of symptoms.

    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 10.1101/2020.10.28.20219667v1 on medRxiv