The Comparability of Anti-Spike SARS-CoV-2 Antibody Tests is Time-Dependent: a Prospective Observational Study

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Abstract

This work showed that the comparability of apparently standardized SARS-CoV-2 antibody assays (Roche, Abbott; both given in BAU/mL) after vaccination depends on the time of blood withdrawal. Initially (3 weeks after the first dose AZD1222), there were 3 times higher values in the Abbott assay, but this relationship inversed before boosting (11 weeks after the first dose) with Roche 2 times greater than Abbott.

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  1. SciScore for 10.1101/2021.08.26.21262426: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Inclusion criteria were an age ≥18 years and willingness to donate blood in the course of the MedUni Wien Biobank’s healthy blood donor collection (Medical University of Vienna ethics committee vote No. 404/2012)
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Incomplete follow-up samples and seropositivity for anti-nucleocapsid antibodies due to infection with SARS-CoV-2 lead to exclusion.
    anti-nucleocapsid
    suggested: None
    Vaccine-induced antibodies against the viral spike protein were quantified using the Roche Elecsys SARS-CoV-2 S-ECLIA46 and the Abbott Anti-SARS-CoV-2 IgG II47,48.
    Anti-SARS-CoV-2 IgG
    suggested: None
    The Abbott assay also quantifies anti-RBD specific IgG-antibodies (range: 1.0-11,360.0 BAU/mL) and was applied on an Abbott Architect i2000r (Abbott, USA).
    anti-RBD
    suggested: None
    Software and Algorithms
    SentencesResources
    The Abbott assay also quantifies anti-RBD specific IgG-antibodies (range: 1.0-11,360.0 BAU/mL) and was applied on an Abbott Architect i2000r (Abbott, USA).
    Abbott Architect
    suggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    All calculations have been performed using MedCalc 19.7 (MedCalc bvba, Ostend, Belgium) and SPSS 26 (IBM, Armonk, USA).
    MedCalc
    suggested: (MedCalc, RRID:SCR_015044)
    SPSS
    suggested: (SPSS, RRID:SCR_002865)
    Graphs were drawn with Prism 9 (GraphPad, La Jolla, USA).
    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:
    This study has several strengths and limitations: although 50 participants might be considered a relatively small cohort, we have shown in previous work that this number is sufficient for such comparative approaches and that our data could be replicated in much larger cohorts27,76. One strength of our study is that we followed exact time points for blood sampling in the context of a prospective observational study. Furthermore, our cohort using AZD1222 (inducing significantly lower median antibody levels than, e.g., BNT162b2) has the advantage of a broader distribution of values across the measurable spectrum with a very low proportion of results above 1,000 BAU/mL. As this value represents the upper limit of referencing with the WHO SARS-CoV-2 antibody standard, a linear relationship is no longer guaranteed for values above this, leading to unwanted biases in comparing different antibody tests. In summary, with the present work, we show for the first time that the comparability of quantitative anti-spike SARS-CoV-2 antibody tests is highly dependent on the timing of blood collection. Therefore, it does not seem feasible to compare different quantitative SARS-COV-2 antibody results without standardization of the time of collection.

    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.


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