Evaluation of Commercial Anti-SARS-CoV-2 Antibody Assays and Comparison of Standardized Titers in Vaccinated Health Care Workers

  1. Kahina Saker
  2. Vanessa Escuret
  3. Virginie Pitiot
  4. Amélie Massardier-Pilonchéry
  5. Stéphane Paul
  6. Bouchra Mokdad
  7. Carole Langlois-Jacques
  8. Muriel Rabilloud
  9. David Goncalves
  10. Nicole Fabien
  11. Nicolas Guibert
  12. Jean-Baptiste Fassier
  13. Antonin Bal
  14. Sophie Trouillet-Assant
  15. Mary-Anne Trabaud

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Abstract

With the availability of vaccines, commercial assays detecting anti-severe acute respiratory syndrome coronavirus-2 antibodies (Ab) evolved toward quantitative assays directed to the spike glycoprotein or its receptor binding domain (RBD). The main objective of the present study was to compare the Ab titers obtained with quantitative commercial binding Ab assays, after one dose (convalescent individuals) or two doses (naive individuals) of vaccine, in health care workers (HCW).

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  1. Version published to 10.1128/jcm.01746-21
  2. ScreenIT

    SciScore for 10.1101/2021.08.24.21262475: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Written informed consent was obtained from all participants; ethics approval was obtained from the regional review board for biomedical research in April 2020 (Comité de Protection des Personnes Sud Méditerranée I, Marseille, France; ID RCB 2020-A00932-37), and the study was registered on ClinicalTrials.gov (NCT04341142).
    IRB: Written informed consent was obtained from all participants; ethics approval was obtained from the regional review board for biomedical research in April 2020 (Comité de Protection des Personnes Sud Méditerranée I, Marseille, France; ID RCB 2020-A00932-37), and the study was registered on ClinicalTrials.gov (NCT04341142).
    Sex as a biological variable, excluding pregnant women (HCW; n=150) who were scheduled to receive 2 doses of Pfizer BioNtech vaccine (n=94; BNT162b2/BNT162b2) or 1 dose of AstraZeneca vaccine followed by 1 dose of Pfizer BioNtech vaccine (n=56; ChAdOx1/BNT162b2) were included.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Five were quantitative: Siemens Healthineers (Erlangen, Germany) Atellica® IM SARS-CoV-2 IgG (sCOVG), DiaSorin (Saluggia, Italy) Liaison® SARS-CoV-2 TrimericS IgG, bioMérieux (Marcy l’Etoile, France) Vidas® SARS-CoV-2 IgG, Abbott (Abbott park, Il, USA)
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    Among the participants 26 who were previously infected with SARS-CoV-2 (convalescent group; 17.4%) had only one vaccine injection (Pfizer BioNtech, n=15 or Astra Zeneca, n=11); for these the second sample was omitted.
    BioNtech
    suggested: None
    The Bland-Altman method was used to measure the mean difference and 95% limit of agreement between log-transformed concentrations obtained with each assay Statistical analyses were conducted using GraphPad Prism® software (version 8; GraphPad software, La Jolla, CA, USA).
    GraphPad Prism®
    suggested: (GraphPad Prism, RRID:SCR_002798)
    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:
    A limitation of this study is that the specificity analysis was limited to a small group of patients with auto-immune diseases or mycoplasma infection. However, assay specificity analyses have been performed by manufacturers and independent groups (2, 4–6) showing specificity ≥99% for all the quantitative assays. In addition, not all commercial quantitative anti-SARS-CoV-2 Ab assays were evaluated limiting the scope of the conclusions. Furthermore, neutralizing Ab were not investigated that could have helped determine whether anti-RBD or anti-spike assays are the most correlated with virus neutralization. However, before investigating this, harmonization of neutralizing Ab titers is also necessary to determine a common threshold from which vaccine protection could be predicted, allowing then to find the corresponding threshold with high throughput binding Ab assays. A study comparing different cell-based assays (with either live or pseudotyped viruses) to measure neutralization in vitro is rather reassuring, although differences were found according to the viruses used for pseudotyping (15). However, comparison of cell-based assays with surrogate virus neutralization tests (sVNT) that are based on ELISA, and measuring the competition of Ab and RBD for the binding to ACE, the cellular entry receptor of the virus, did not find good agreement; this is inconvenient, as these assays could be promising given that they have potential for large-scale. In conclusion, the evaluated ass...

    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.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.08.24.21262475 on medRxiv