Diagnostic accuracy of six commercial SARS-CoV-2 IgG/total antibody assays and identification of SARS-CoV-2 neutralizing antibodies in convalescent sera

  1. Annabelle Strömer
  2. Olaf Grobe
  3. Ruben Rose
  4. Helmut Fickenscher
  5. Thomas Lorentz
  6. Andi Krumbholz

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Abstract

The reliable detection of immunoglobulin G (IgG) or total antibodies directed against the novel severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is important for clinical diagnostics and epidemiological studies.

Here, we compare the diagnostic accuracy of six commercially available SARS-CoV-2 IgG (Abbott SARS-CoV-2 IgG; Diasorin Liaison ® SARS-CoV-2 S1/2 IgG; Epitope EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit; Euroimmun Anti-SARS-CoV-2 ELISA (IgG); Mikrogen recom Well SARS-CoV-2 IgG) or total SARS-CoV-2 antibody assays (Roche Elecsys Anti-SARS-CoV-2).

The test sensitivities were analyzed with a set of 34 sera obtained from 26 patients after PCR-confirmed SARS-CoV-2 infection and varied from 76.9% (Euroimmun) to 96.2% (Abbott). The majority of assay results were confirmed in a laboratory-developed plaque reduction neutralization test and by a SARS-CoV-2 IgG-specific line assay including measurement of generally low IgG avidities (Mikrogen recom Line Coronavirus IgG [Avidität], prototype).

Moreover, 100 stored sera collected during summer 2018 (N = 50) and winter season 2018/2019 (N = 50) were included to demonstrate test specificities. These varied from 96.0% (DiaSorin) to 100% (Epitope EDI™).

A subset of sera were retested with a lateral flow test (STANDARD Q COVID-19 IgM/IgG Duo) and a considerably lower sensitivity was noted.

Overall, the diagnostic accuracy of the six SARS-CoV-2 IgG/total antibody assays was good and varied from 92.9% (Euroimmun) to 98.4% (Abbott). Due to the different specificities, results of commercially available SARS-CoV-2 antibody tests should be interpreted with caution. A high proportion of antibody-positive patient sera demonstrated neutralizing capacity against SARS-CoV-2.

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  1. ScreenIT

    SciScore for 10.1101/2020.06.15.20131672: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The Ethics committee of the Medical Faculty of the Kiel University approved the setting of this study (AZ D467/20).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    These samples should contain SARS-CoV-2 IgG/total antibodies and, therefore, were considered to determine serological assay sensitivities.
    SARS-CoV-2 IgG/total
    suggested: None
    Germany; Mikrogen recomWell SARS-CoV-2 IgG, Mikrogen GmbH, Neuried, Germany) as well as one total SARS-CoV-2 antibody test (Roche Elecsys Anti-SARS-CoV-2
    SARS-CoV-2
    suggested: None
    Exemplarily, 18 sera were retested in a rapid lateral flow assay that distinguishes SARS-CoV-2 IgG- and IgM-antibodies (STANDARD Q COVID-19 IgM/IgG Duo, SD Biosensor, Suwon-si, Republic of Korea).
    SARS-CoV-2 IgG-
    suggested: None
    Experimental Models: Cell Lines
    SentencesResources
    Forty-seven sera were also tested under biosafety level 3 conditions in a plaque reduction neutralization assay (PRNT) using an own SARS-CoV-2 isolate (M16502) and Vero cells (order no. 605372, CLS Cell Lines Service GmbH, Eppelheim, Germany).
    Vero
    suggested: None
    Software and Algorithms
    SentencesResources
    All tests were conducted strictly following the recommendations of the manufacturers on an Architect (Abbott), a Liaison XL (DiaSorin), a Cobas e 411 (Roche) or for the assays of Epitope, Euroimmun and Mikrogen on the BEP 2000 system (Siemens Healthcare GmbH, Erlangen, Germany), respectively.
    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.

  2. Version published to 10.1101/2020.06.15.20131672v1 on medRxiv