Antibody titers measured by commercial assays are correlated with neutralizing antibody titers calibrated by international standards

  1. Yu-An Kung
  2. Chung-Guei Huang
  3. Sheng-Yu Huang
  4. Kuan-Ting Liu
  5. Peng-Nien Huang
  6. Kar-Yee Yu
  7. Shu-Li Yang
  8. Chia-Pei Chen
  9. Ching-Yun Cheng
  10. Yueh-Te Lin
  11. Yen-Chin Liu
  12. Guang-Wu Chen
  13. Shin-Ru Shih

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Abstract

The World Health Organization (WHO) has highlighted the importance of an international standard (IS) for SARS-CoV-2 neutralizing antibody titer detection, with the aim of calibrating different diagnostic techniques. In this study, IS was applied to calibrate neutralizing antibody titers (IU/mL) and binding antibody titers (BAU/mL) in response to SARS-CoV-2 vaccines. Serum samples were collected from participants receiving the Moderna (n = 20) and Pfizer (n = 20) vaccines at three time points: pre-vaccination, after one dose, and after two doses. We obtained geometric mean titers of 1404.16 and 928.75 IU/mL for neutralizing antibodies after two doses of the Moderna and Pfizer vaccines, respectively. These values provide an important baseline for vaccine development and the implementation of non-inferiority trials. We also compared three commercially available kits from Roche, Abbott, and MeDiPro for the detection of COVID-19 antibodies based on binding affinity to S1 and/or RBD. Our results demonstrated that antibody titers measured by commercial assays are highly correlated with neutralizing antibody titers calibrated by IS.

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  1. ScreenIT

    SciScore for 10.1101/2021.07.16.21260618: (What is this?)

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

    Table 1: Rigor

    EthicsField Sample Permit: The serum samples were collected and followed by protocol SDP-003, Human Biological Specimens Collection, data September
    IRB: 22, 2017 and the qualifications of Principle Investigator (Robert Pyrtle, M.D.) were reviewed and approved by Diagnostics Investigational Review Board (Cummaquid, Massachusetts, USA).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    After washing, horseradish peroxidase (HRP)-tagged anti-human antibodies (Abcam, Cambridge, UK), diluted 1:10,000 in blocking buffer, were added to the wells (100 μL/well), and the plate was incubated for 1 h at 37°C.
    anti-human antibodies ( Abcam , Cambridge , UK) ,
    suggested: None
    The electrochemiluminescence immunoassay (ECLIA) (i.e., Roche Elecsys Anti-SARS-CoV-2 S assay) was used for the detection of antibodies against the RBD of S protein; <0.80 U/mL was considered negative and ≥0.80 U/mL was considered positive for anti-SARS-CoV-2 S protein.
    anti-SARS-CoV-2 S protein .
    suggested: None
    Experimental Models: Cell Lines
    SentencesResources
    Cell culture and virus: African green monkey kidney (Vero E6) cells (CRL-1586) were purchased from the American Type Culture Collection (ATCC, Bethesda, MD, USA) and maintained in Dulbecco’s modified Eagle’s medium (DMEM; Gibco, Waltham, MA, USA) containing 10% fetal bovine serum (FBS; Gibco) at 37°C.
    Vero E6
    suggested: None
    Software and Algorithms
    SentencesResources
    The serum samples were collected and followed by protocol SDP-003, Human Biological Specimens Collection, data September
    Human Biological
    suggested: ( Human Biological Data Interchange , RRID:SCR_004591)
    Geometric mean titers (GMTs) were calculated with 95% confidence intervals (CIs) using GraphPad Prism version 8 (GraphPad Software, Inc., CA, USA).
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)
    Statistical analysis: Statistical analyses were performed using GraphPad Prism version 8 (GraphPad Software, Inc., CA, USA).
    GraphPad Prism
    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: 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.

    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.

  2. Version published to 10.1101/2021.07.16.21260618 on medRxiv