Harmonization of Determination of SARS-CoV-2 Antibodies: Is It Always Possible?

  1. Ruggero Dittadi

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Abstract

A WHO standard was prepared with the aim of harmonizing assays detecting antibodies against SARS-CoV-2, but the issue is currently being debated. We re-evaluated a previously studied set of cases (108 specimens of 48 patients and 60 specimens of 20 vaccinated subjects, collected after 14 days from the first dose and 14 days and 3 months after a second dose of the Comirnaty BNT162b2 vaccine), calculating the ratios between the results of two methods (SARS-CoV-2 IgG anti-RBD, SNIBE, and anti-SARS-CoV-2 QuantiVac ELISA IgG, Euroimmun). In the vaccinated subjects, the ratios of the results between methods according to the WHO standard were relatively dispersed, but the harmonization results were good. On the other hand, in patient samples, the variability between tests was very high, and the harmonization was unsatisfactory (median ratios between methods 2.23, 10th–90th percentile: 1.1–5.6). Interestingly, in patient samples, the harmonization depends on the time from the onset of symptoms and greatly improves after 6 months since the diagnosis. Forty patient specimens and thirty-one of the vaccinated subjects after the second dose were also evaluated with a third method (Access SARS-CoV-2 IgG (1st IS), Beckman Coulter), obtaining a similar trend. We can conclude that the actual effectiveness of harmonization between methods may vary depending on the scenario in which they will be used.

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  1. Version published to 10.3390/diagnostics12020483
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    SciScore for 10.1101/2021.12.13.21267669: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    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.

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  3. Version published to 10.1101/2021.12.13.21267669v1 on medRxiv