Performance Characteristics of the Vidas SARS-CoV-2 IgM and IgG Serological Assays

  1. Nathalie Renard
  2. Soizic Daniel
  3. Nadège Cayet
  4. Matthieu Pecquet
  5. Frédérique Raymond
  6. Sylvie Pons
  7. Julien Lupo
  8. Carole Tourneur
  9. Catherine Pretis
  10. Guillaume Gerez
  11. Patrick Blasco
  12. Maxime Combe
  13. Imen Canova
  14. Mylène Lesénéchal
  15. Franck Berthier

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Abstract

The COVID-19 pandemic, caused by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread worldwide. Serological testing for SARS-CoV-2-specific antibodies plays an important role in understanding and controlling the pandemic, notably through epidemiological surveillance.

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  1. Version published to 10.1128/jcm.02292-20
  2. ScreenIT

    SciScore for 10.1101/2020.09.28.20196030: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Patients and samples: SARS-CoV-2-positive samples were collected after approval by the Ethics Committee RCB 2020-A00932-37.
    Consent: Informed consent was obtained in accordance with the local regulations.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    In a second step, human IgM (VIDAS® SARS-CoV-2 IgM) or IgG (VIDAS® SARS-CoV-2 IgG) are specifically detected by mouse monoclonal antibodies conjugated to alkaline phosphatase and directed against human IgM or IgG, respectively.
    SARS-CoV-2 IgG
    suggested: None
    human IgM
    suggested: None
    The assay is conducted with a standard (S1) and a positive control (C1) that contains humanized recombinant anti-SARS-CoV-2 antibody, either IgM or IgG depending on the assay.
    anti-SARS-CoV-2
    suggested: None
    IgM
    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 presents several limitations. First, assay sensitivity was evaluated on confirmed but not on suspected SARS-CoV-2 cases (i.e. patients with symptoms but negative by PCR). It would be interesting to evaluate and confirm the benefit of SARS-CoV-2 IgM and IgG serology to complement PCR testing (13, 14, 17, 18). On the other hand, recent reports suggested that the identification rate of false-negative PCR results using serology testing might be marginal, between ∼1% (20) and ∼4% (62). Second, assay sensitivity was determined on symptomatic (hospitalized and non-hospitalized) COVID-19 patients. The sensitivity of the VIDAS® SARS-CoV-2 IgM and IgG assays in asymptomatic SARS-CoV-2-infected individuals, who may represent most of the infected patients, remains to be evaluated. In conclusion, VIDAS® SARS-CoV-2 IgM and IgG are highly sensitive and specific assays for the reliable screening of patients after acute SARS-CoV-2 infections (and likely after vaccination, when available). Moreover, the VIDAS® SARS-CoV-2 IgG assay fulfils the specificity requirement for its use in seroepidemiology studies and is well suited for the detection of past SARS-CoV-2 infections. Further studies are necessary to confirm its suitability for the detection of SARS-CoV-2 neutralizing antibodies and to define correlates of immune protection.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04341142RecruitingAssessment of Serological Techniques for Screening Patients …

    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 10.1101/2020.09.28.20196030 on medRxiv