ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2023
Comparison of five Anti-SARS-CoV-2 antibody assays across three doses of BNT162b2 reveals insufficient standardization of SARS-CoV-2 serology.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Seroprevalence of SARS-CoV-2 antibodies among healthy blood donors: a systematic review and meta-analysis.BMC public health · 2024Pooled it
- Harmonization of IgG antibody values against the SARS-CoV-2 Spike protein.Scientific reports · 2026Article
- The impact of statistical adjustment for assay performance on inferences from SARS-CoV-2 serological surveillance studies.American journal of epidemiology · 2025Article
- COVID-19 vaccination-infection status and immunological profile from India: A case study for prioritizing at risk population for targeted immunization.Journal of family medicine and primary care · 2025Article
- Germline variants and mosaic chromosomal alterations affect COVID-19 vaccine immunogenicity.Cell genomics · 2025Article
- Review
- Testing for SARS-CoV-2: lessons learned and current use cases.Clinical microbiology reviews · 2024Review
- Utility of accessible SARS-CoV-2 specific immunoassays in vaccinated adults with a history of advanced HIV infection.Scientific reports · 2024Article
- Evaluation of inflammatory biomarkers and their association with anti-SARS-CoV-2 antibody titers in healthcare workers vaccinated with BNT162B2.Frontiers in immunology · 2024Article
- Redefining serological diagnostics with immunoaffinity proteomics.Clinical proteomics · 2023Review
- Antibody response in elderly vaccinated four times with an mRNA anti-COVID-19 vaccine.Scientific reports · 2023Article
- Breakthrough infections with SARS-CoV-2 omicron efficiently boost antibodies from previous BNT162b2 vaccinations.Journal of clinical virology plus · 2023Article
- Clinical and laboratory considerations: determining an antibody-based composite correlate of risk for reinfection with SARS-CoV-2 or severe COVID-19.Frontiers in public health · 2023Article
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Authors and funding
14 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo investigate the comparability of WHO standard referenced commercial SARS-CoV-2 antibody tests over three doses of BNT162b2 vaccine and up to 14 months.
methods114 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.
resultsFor 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 < 0.0001; DiaSorin x Roche: ρ = 0.87, p < 0.0001), but results are not interchangeable. The sVNTs suggest an underestimation of antibody levels by Roche and slight overestimation by both IgG assays after the first vaccine dose.
conclusionsStandardization of SARS-CoV-2 antibody binding assays still needs to be improved to allow reliable use of variable assay systems for longitudinal analyses.
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