Comparison of five Anti-SARS-CoV-2 antibody assays across three doses of BNT162b2 reveals insufficient standardization of SARS-CoV-2 serology

•The results of the different SARS-CoV-2 antibody tests are not interchangeable.•Despite standardization with the WHO standard, there are significant differences.•After vaccination with BNT162b2, differences between tests change over time.•Standardization of SARS-CoV-2 antibody binding assays still...

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Bibliographic Details
Published in:Journal of clinical virology 2023-01, Vol.158, p.105345-105345, Article 105345
Main Authors: Perkmann, Thomas, Mucher, Patrick, Ösze, Darlene, Müller, Antonia, Perkmann-Nagele, Nicole, Koller, Thomas, Radakovics, Astrid, Flieder, Ines, Repl, Manuela, Marculescu, Rodrig, Wolzt, Michael, Wagner, Oswald F., Binder, Christoph J., Haslacher, Helmuth
Format: Article
Language:English
Subjects:
Antibodies, Viral
Antibody assays
BNT162 Vaccine
COVID-19
Humans
Immunoglobulin G
SARS-CoV-2
Serology
Standardization
Vaccination
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Summary:•The results of the different SARS-CoV-2 antibody tests are not interchangeable.•Despite standardization with the WHO standard, there are significant differences.•After vaccination with BNT162b2, differences between tests change over time.•Standardization of SARS-CoV-2 antibody binding assays still needs to be improved.•Therefore, only values measured with the same test system should be compared. To investigate the comparability of WHO standard referenced commercial SARS-CoV-2 antibody tests over three doses of BNT162b2 vaccine and up to 14 months. 114 subjects (without previous SARS-CoV-2 infection or immunosuppressive medication) vaccinated with three doses of BNT162b2 were included in this study. Antibody levels were quantified 3 weeks after the first dose, 5–6 weeks and 7 months after the second dose, and 4–5 weeks and 4 months after the third dose using the Roche Elecsys SARS-CoV-2 S, the Abbott SARS-CoV-2 IgG II Quant, the DiaSorin LIAISON SARS-CoV-2 TrimericS IgG, the GenScript cPASS sVNT and the TECO sVNT assays. For each time point analyzed, systematic differences are evident between the results in BAU/mL of the three antibody binding assays. The assay ratios change in a time-dependent manner even beyond administering the third dose (Roche measuring 9 and 3 times higher than Abbott and DiaSorin, respectively). However, changes decrease in magnitude with increasing time intervals from the first dose. IgG-based assays show better agreement across them than with Roche (overall correlations: Abbott x DiaSorin: ρ = 0.94 vs. Abbott x Roche: ρ=0.89, p 
ISSN:1386-6532
1873-5967
DOI:10.1016/j.jcv.2022.105345