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Updated: Jun 18, 2026
Detection of SARS-CoV-2 Receptor-Binding Domain Antibody using a HiBiT-Based Bioreporter
Published on: August 12, 2021
Improvements and limits of anti SARS-CoV-2 antibodies assays by WHO (NIBSC 20/136) standardization
Davide Giavarina1, Mariarosa Carta1
1Laboratory Medicine, St. Bortolo Hospital, Vicenza, Italy.
Objectives:
A few CLIA automated immunoassays for the recognition of anti S1-RBD SARS-CoV-2 antibodies have recently been placed on the market. Preliminary data demonstrate a high correlation between methods but wide differences in absolute concentrations. A new WHO international standard for anti-SARS-CoV-2 immunoglobulin, NIBSC code 20/136, has been recently introduced to reduce the differences. The aim of this study is thus to verify the harmonization made by NIBSC 20/136 on Ab anti S1-RBD measurement on real samples.
Methods:
The following assays were studied: LIAISON® SARS-CoV-2 TrimericS IgG (DiaSorin); Elecsys® anti-SARS-CoV-2 S (ROCHE); Atellica IM SARS-CoV-2 IgG (sCOVG) (Siemens); MAGLUMI® SARS-CoV-2 S-RBD IgG (Snibe), measuring 210 samples from 70 health workers with no previous SARS-CoV2 infection, during their Pfizer-BioNTech's BNT162b2 vaccination period.
Results:
The recalculation of concentrations based on the NIBSC 20/136 standardization improve the analytical and diagnostic comparability but do not cancel this variability between methods: recalibrated results remain different across methods, both in terms of tendency and single data.
Conclusions:
The recalculation of concentrations based on the NIBSC 20/136 standardization improves the analytical and diagnostic comparability but does not cancel the differences between methods: recalibrated results remain different across methods, both in terms of tendency and single data.
