Performance of an automated anti-SARS-CoV-2 immunoassay in prepandemic cohorts

  1. Elena Riester
  2. Beda Krieter
  3. Peter Findeisen
  4. Michael Laimighofer
  5. Kathrin Schoenfeld
  6. Tina Laengin
  7. Christoph Niederhauser

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Abstract

Background

The Elecsys® Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) was developed to provide an accurate and reliable method for the detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated the specificity of the Elecsys Anti-SARS-CoV-2 immunoassay in prepandemic sample cohorts across five sites in Germany, Austria and Switzerland.

Methods

Specificity of the immunoassay was evaluated using anonymised, frozen, residual serum and/or plasma samples from blood donors or routine diagnostic testing. All samples were collected before September 2019 and therefore presumed negative for SARS-CoV-2-specific antibodies. Cohorts included samples from blood donors, pregnant women and paediatric patients. Point estimates and 95% confidence intervals (CIs) were calculated.

Results

Overall specificities for the Elecsys Anti-SARS-CoV-2 immunoassay in 9575 samples from blood donors (n = 6714) and diagnostic specimens (n = 2861) were 99.82% (95% CI 99.69-99.91) and 99.93% (95% CI 99.75-99.99), respectively. Among 2256 samples from pregnant women, specificity was 99.91% (95% CI 99.68-99.99). Among 205 paediatric samples, specificity was 100% (95% CI 98.22-100).

Conclusion

The Elecsys Anti-SARS-CoV-2 immunoassay demonstrated a very high specificity across blood donor samples and diagnostic specimens from Germany, Austria and Switzerland. Our findings support the use of the Elecsys Anti-SARS-CoV-2 immunoassay as a potential tool for determination of an immune response following previous exposure to SARS-CoV-2 in the general population, including in blood donors, pregnant women and paediatric populations.

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  1. ScreenIT

    SciScore for 10.1101/2020.08.07.20169987: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study protocol was submitted to institutional review boards at study sites in Innsbruck (Austria) and Bern (Switzerland) prior to study initiation; ethical approval was granted for Innsbruck, and a waiver granted for Bern.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisStatistical analysis: An appropriate sample size was calculated using a previously published formula, to ensure α = 5% and power = 80%.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    All samples were obtained before September 2019 and were presumed negative for SARS-CoV-2-specific antibodies.
    SARS-CoV-2-specific
    suggested: None
    23,24 The Elecsys Anti-SARS-CoV-2 immunoassay detects antibodies independent of isotype, detecting predominantly mature, high-affinity IgG but also IgA and IgM antibodies.
    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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

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  2. Version published to 10.1101/2020.08.07.20169987v1 on medRxiv