Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip

  1. Thierry Prazuck
  2. Mathilda Colin
  3. Susanna Giachè
  4. Camélia Gubavu
  5. Aymeric Seve
  6. Vincent Rzepecki
  7. Marie Chevereau-Choquet
  8. Catherine Kiani
  9. Victor Rodot
  10. Elsa Lionnet
  11. Laura Courtellemont
  12. Jérôme Guinard
  13. Gilles Pialoux
  14. Laurent Hocqueloux

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Abstract

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  1. Version published to 10.1371/journal.pone.0237694
  2. ScreenIT

    SciScore for 10.1101/2020.05.27.20112888: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethics Approval: The study was approved by the local Ethics Committee on March 17th 2020, and informed consent was obtained from each participant.
    Consent: Ethics Approval: The study was approved by the local Ethics Committee on March 17th 2020, and informed consent was obtained from each participant.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Rapid diagnostic tests to be assessed: The SARS-CoV-2 IgG/IgM antibody test kits, COVID-PRESTO® and COVID-DUO®, are targeting on the antibodies specific to N-protein of SARS-CoV-2.
    SARS-CoV-2 IgG/IgM
    suggested: None
    These tests use anti-human IgM antibody (test line IgM), anti-human IgG antibody (test line IgG) and rabbit IgG (control line C) immobilized on a nitrocellulose strip.
    anti-human IgM
    suggested: None
    anti-human IgG
    suggested: None
    rabbit IgG
    suggested: None
    When a specimen is added to the sample well, followed by assay buffer, IgM and IgG antibodies, if present, will bind to COVID-19 conjugates forming an antigen-antibodies complex.
    IgG
    suggested: None

    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:
    This study has several limitations. Firstly, the date of onset of symptoms related to SARS-CoV-2 infection implied recall of facts from memory. This recall bias could lead to some imprecise classification when stratifying the samples by days between onset of symptoms and date of blood samples. Secondly, few patients with a negative serology could have been re-tested with a second blood sample. In these conditions, we were not able to study the dynamics of seroconversion on individual level. Thirdly, there were still negative tests in RT-PCR positive patients up to 15 days after onset. The reasons are multiple and include the relatively low titers of antibody in the early stages of infection as reported by others [16] and the difference in individual immune response antibody production. Lastly, the strength of antibody response depends on several factors, including age, severity of disease, and certain conditions like immunodeficiency disorders. Therefore it would have been interesting to stratify the population depending on immune health. Indeed, we had few subjects with profound immunosuppression who were still negative 15 days after onset. We know, however, that seroconversion could occur later in such patients [17] [18]. Future studies should focus on seroconversion from Day 15 to Day 30 in highly immunocompromised patients infected with COVID-19. However, the highly immunosuppressed patient in this study was well documented to seroconvert between day 15 and day 19, which ...

    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 10.1101/2020.05.27.20112888 on medRxiv