Strategic Anti-SARS-CoV-2 Serology Testing in a Low Prevalence Setting: The COVID-19 Contact (CoCo) Study in Healthcare Professionals

  1. Georg M. N. Behrens
  2. Anne Cossmann
  3. Metodi V. Stankov
  4. Bianca Schulte
  5. Hendrik Streeck
  6. Reinhold Förster
  7. Berislav Bosnjak
  8. Stefanie Willenzon
  9. Anna-Lena Boeck
  10. Anh Thu Tran
  11. Thea Thiele
  12. Theresa Graalmann
  13. Moritz Z. Kayser
  14. Anna Zychlinsky Scharff
  15. Christian Dopfer
  16. Alexander Horke
  17. Isabell Pink
  18. Torsten Witte
  19. Martin Wetzke
  20. Diana Ernst
  21. Alexandra Jablonka
  22. Christine Happle

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Abstract

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  1. ScreenIT

    SciScore for 10.1101/2020.08.06.20169250: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study (DRKS00021152) is approved by local authorities (Data Security Management and Institutional Review Board of Hanover Medical School, approval #8973_BO_K_2020).
    Consent: After written informed consent was obtained, participants were asked to provide blood specimens weekly during the first two months, followed by monthly testing.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    For additional secondary analyses in all baseline samples, positive controls, and positive or equivocal positive sera, an anti-SARS-CoV-2 S1 IgA, an anti-SARS-CoV-2 nucleocapsid protein (NCP) IgG ELISA (Euroimmun, Lübeck, Germany), and a WANTAI SARS-CoV-2 antibody rapid test (SZABO SCANDIC, Vienna, Austria - CE) was used (for more details, see Suppl.
    anti-SARS-CoV-2 S1 IgA
    suggested: None
    anti-SARS-CoV-2 nucleocapsid protein (NCP) IgG
    suggested: None
    The surrogate virus neutralisation test (sVNT) will be described elsewhere in detail 17 and is based on the hypothesis that virus neutralising antibodies also interfere with the binding of the receptor-binding domain (RBD) of SARS-CoV-2 to surface-immobilised ACE2.
    ACE2
    suggested: None
    Software and Algorithms
    SentencesResources
    Study participants in the CoCo cohort 1.0 (Figure 1) were enrolled between March 23rd and April 17th 2020.
    CoCo
    suggested: (CoCo, RRID:SCR_010947)
    Statistical analysis: Data were analysed using SPSS® Statistics (Version 26) and GraphPad Prism® (Version 5).
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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:
    Our study has several limitations. We did not perform molecular testing on respiratory specimens, which would provide information on viral carrier status in pauci- or asymptomatic HCP. We did not investigate localised immune responses, e.g. IgA in tears or mucosa fluids, or innate and cellular immune responses resulting from SARS-CoV-2 infection. Our questionnaire primarily focused on respiratory symptoms, which turned out to be of little discriminative value for identifying COVID-19. Our assessment of absolute self-perceived risk is probably a rough estimate, likely reflecting a composition of public and individual risk perception. Of note, this report represents an interim analysis, and the ongoing CoCo cohort 2.0 will likely provide more information on these topics. In summary, our data show a low functional seroconversion rate in HCP, contrasting with a considerable self-perceived infection probability. Self-reported respiratory symptoms appear to be too unspecific to inform pre-test probability and serology test result interpretation. Our data highlight the need for a cautious approach to serology screening and result interpretation in regions with low SARS-CoV-2 infection rates. For analyses of humoral SARS-CoV-2 specific immune response in a low pre-test probability setting, positive results from single measurements should be confirmed by alternative serology tests or functional assays.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

    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.
    • Thank you for including a protocol registration statement.

    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.

  2. Version published to 10.1007/s40121-020-00334-1
  3. Version published to 10.1101/2020.08.06.20169250v1 on medRxiv