Quality assessment and harmonization of laboratories across Europe for multiple SARS‐CoV‐2 serology assays

Background and Objectives There is a need for conversion of SARS‐CoV‐2 serology data from different laboratories to a harmonized international unit. We aimed to compare the performance of multiple SARS‐CoV‐2 antibody serology assays among 25 laboratories across 12 European countries. Materials and M...

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Bibliographic Details
Published in:Vox sanguinis 2023-08, Vol.118 (8), p.666-673
Main Authors: Steenhuis, Maurice, Wouters, Elise, Schrezenmeier, Hubert, Rispens, Theo, Tiberghien, Pierre, Harvala, Heli, Feys, Hendrik B., Schoot, C. Ellen
Format: Article
Language:English
Subjects:
Antibodies
Assaying
Calibration
Clinical trials
convalescent
conversion factor
COVID‐19
harmonization
Laboratories
Plasma
Quality assessment
Quality control
Reagents
Serology
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Standardization
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Summary:Background and Objectives There is a need for conversion of SARS‐CoV‐2 serology data from different laboratories to a harmonized international unit. We aimed to compare the performance of multiple SARS‐CoV‐2 antibody serology assays among 25 laboratories across 12 European countries. Materials and Methods To investigate this we have distributed to all participating laboratories a panel of 15 SARS‐CoV‐2 plasma samples and a single batch of pooled plasma calibrated to the WHO IS 20/136 standard. Results All assays showed excellent discrimination between SARS‐CoV‐2 seronegative plasma samples and pre‐vaccinated seropositive plasma samples but differed substantially in raw antibody titres. Titres could be harmonized to binding antibody units per millilitre by calibration in relation to a reference reagent. Conclusion The standardization of antibody quantification is of paramount importance to allow interpretation and comparison of serology data reported in clinical trials in order to identify donor cohorts from whom the most effective convalescent plasma can be collected.
ISSN:0042-9007
1423-0410
DOI:10.1111/vox.13480