期刊
CLINICA CHIMICA ACTA
卷 522, 期 -, 页码 144-151出版社
ELSEVIER
DOI: 10.1016/j.cca.2021.08.024
关键词
Serological standard; WHO; SARS-CoV-2; COVID-19; Comirnaty vaccine; Neutralization
资金
- Ministry of Health of Italy [COVID-2020-12371619]
A reproducible and highly concentrated working standard (WS) specific to IgG against SARS-CoV-2 Spike-glycoprotein was developed for evaluation of post-vaccinated individuals. The WS showed good linearity and reproducibility, but exhibited different behavior compared to the WHO-IS, requiring additional factors for result harmonization.
Background and aims: Vaccines, to limit SARS-CoV-2 infection, were produced and reliable assays are needed for their evaluation. The WHO produced an International-Standard (WHO-IS) to facilitate the standardization/ comparison of serological methods. The WHO-IS, produced in limited amount, was never tested for reproducibility. This study aims at developing a reproducible and accessible working standard (WS) to complement the WHO-IS. Materials and methods: Sera from vaccinated individuals were used to produce the WSs. The WHO-IS, the WSs and single serum samples (n = 48) were tested on 6 quantitative serological devices. Neutralization assays were performed for the 48 samples and compared with their antibody titers. Results: The WS carry an antibody titer 20-fold higher than the WHO-IS. It was reproducible, showed both good linearity and insignificant intra- and inter-laboratory variability. However, the WSs behave differently from the WHO-IS. Analysis of the 48 samples showed that single correlation factors are not sufficient to harmonize results from different assays. Yet, all the devices predict neutralization activity based on the antibody titer. Conclusions: A reproducible and highly concentrated WS, specific for IgG against SARS-CoV-2 Spike-glycoprotein was produced. Such characteristics make it particularly suited for the harmonization of commercially available assays and the consequent evaluation of post-vaccinated individuals.
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