Evaluation of a New Spike (S)-Protein-Based Commercial Immunoassay for the Detection of Anti-SARS-CoV-2 IgG

  1. Kirsten Alexandra Eberhardt
  2. Felix Dewald
  3. Eva Heger
  4. Lutz Gieselmann
  5. Kanika Vanshylla
  6. Maike Wirtz
  7. Franziska Kleipass
  8. Wibke Johannis
  9. Philipp Schommers
  10. Henning Gruell
  11. Karl August Brensing
  12. Roman-Ulrich Müller
  13. Max Augustin
  14. Clara Lehmann
  15. Manuel Koch
  16. Florian Klein
  17. Veronica Di Cristanziano

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Abstract

Background: The investigation of the antibody response to SARS-CoV-2 represents a key aspect in facing the COVID-19 pandemic. In the present study, we compared the new Immundiagnostik IDK® anti-SARS-CoV-2 S1 IgG assay with four widely-used commercial serological assays for the detection of antibodies targeting S (spike) and NC (nucleocapsid) proteins. Methods: Serum samples were taken from an unbiased group of convalescent patients and from a negative control group. Sample were simultaneously analyzed by the new Immundiagnostik IDK® anti-SARS-CoV-2 S1 IgG assay, by the DiaSorin LIAISON® SARS-CoV-2 S1/S2 IgG assay, and by the Euroimmun anti-SARS-CoV-2 S1 IgG ELISA. Antibodies binding NC were detected by the Abbott SARS-CoV-2 IgG assay and by the pan-immunoglobulin immunoassay Roche Elecsys® anti-SARS-CoV-2. Moreover, we investigated samples of a group of COVID-19 convalescent subjects that were primarily tested S1 IgG non-reactive. Samples were also tested by live virus and pseudovirus neutralization tests. Results: Overall, the IDK® anti-SARS-CoV-2 S1 IgG assay showed the highest sensitivity among the evaluated spike (S) protein-based assays. Additionally, the Immundiagnostik assay correlated well with serum-neutralizing activity. Conclusions: The novel IDK® anti-SARS-CoV-2 S1 IgG assay showed high sensitivity and specificity, representing a valid option for use in the routine diagnostic.

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  1. Version published to 10.3390/microorganisms9040733
  2. ScreenIT

    SciScore for 10.1101/2021.03.10.21253288: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Ethical considerations: All subjects gave their informed consent for inclusion before they participated in the study.
    IRB: The study was conducted in accordance with the Declaration of Helsinki and samples were collected and analyzed under protocols approved by the Institutional Review Board of the University of Cologne, Germany (16-054 and 20-1187).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    NC protein antibodies were detected by the SARS-CoV-2 IgG assay (CMIA) provided by Abbott on the Alinity I (Abbott, Abbott Park, Illinois, United States) and by the pan-immunoglobulin immunoassay Elecsys® Anti-SARS-CoV-2 (ECLIA) on the Cobas e (Roche Diagnostics, Mannheim, Germany).
    Anti-SARS-CoV-2
    suggested: None
    Supplementary Table 1: Dataset; Supplementary Table 2: Sensitivity of five commercially available serological tests, combination of tests, and one virus-neutralizing immunoassay in a cohort with previous infection with SARS-CoV-2.; Supplementary Table 3: Sensitivity of four commercially available serological tests, combination of tests, and one virus-neutralizing immunoassay in a cohort with previous infection with SARS-CoV-2 but undetectable IgG antibodies by the Euroimmun assay; Supplementary Table 4: Specificity of five commercially available serological tests, combination of tests, and one virus-neutralizing immunoassay in a SARS-CoV-2 negative control group.
    undetectable IgG
    suggested: None
    Experimental Models: Cell Lines
    SentencesResources
    Pseudovirus assay to determine SARS-CoV-2 neutralizing activity (PVN): For testing SARS-CoV-2 neutralizing activity using pseudovirus, serial dilutions of serum (heat inactivated at 56°C for 45 min) were coincubated with pseudovirus supernatants for 1 h at 37°C and thereafter, 293T cells engineered to express ACE2 were added [25].
    293T
    suggested: NCBI_Iran Cat# C498, RRID:CVCL_0063)
    Software and Algorithms
    SentencesResources
    NC protein antibodies were detected by the SARS-CoV-2 IgG assay (CMIA) provided by Abbott on the Alinity I (Abbott, Abbott Park, Illinois, United States) and by the pan-immunoglobulin immunoassay Elecsys® Anti-SARS-CoV-2 (ECLIA) on the Cobas e (Roche Diagnostics, Mannheim, Germany).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)

    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

    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 10.1101/2021.03.10.21253288 on medRxiv