Harmonization of six quantitative SARS-CoV-2 serological assays using sera of vaccinated subjects

被引：28

作者：

Ferrari, Davide ^{[1
]}

Clementi, Nicola ^{[2
,3
]}

Spano, Sestina Maria ^{[4
]}

Albitar-Nehme, Sami ^{[5
]}

Ranno, Stefania ^{[5
]}

Colombini, Alessandra ^{[6
]}

Criscuolo, Elena ^{[2
]}

Di Resta, Chiara ^{[3
]}

Tomaiuolo, Rossella ^{[2
,3
]}

Vigano, Marco ^{[6
]}

Mancini, Nicasio ^{[2
,3
]}

De Vecchi, Elena ^{[4
]}

Locatelli, Massimo ^{[3
]}

Mangia, Alessandra ^{[7
]}

Perno, Carlo Federico ^{[5
]}

Banfi, Giuseppe ^{[4
,8
]}

机构：

[1] Univ Parma, SCVSA Dept, I-43121 Parma, Italy

[2] Univ Vita Salute San Raffaele, Lab Microbiol & Virol, I-20158 Milan, Italy

[3] IRCCS Osped San Raffaele, I-20158 Milan, Italy

[4] IRCCS Orthoped Inst Galeazzi, Lab Clin Chem & Microbiol, I-20161 Milan, Italy

[5] Bambino Gesu Pediat Hosp, IRCCS, Microbiol & Immunol Diagnost, Rome, Italy

[6] IRCCS Orthoped Inst Galeazzi, Lab Biotecnol Applicate All Ortopedia, Milan, Italy

[7] IRCCS Fdn, Dept Med Sci, Liver Unit, I-71013 San Giovanni Rotondo, Italy

[8] Univ Vita Salute San Raffaele, I-20158 Milan, Italy

来源：

CLINICA CHIMICA ACTA | 2021年 / 522卷

关键词：

Serological standard; WHO; SARS-CoV-2; COVID-19; Comirnaty vaccine; Neutralization;

D O I：

10.1016/j.cca.2021.08.024

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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.

引用

页码：144 / 151

页数：8

共 23 条

[1] Evaluation of the automated LIAISON® SARS-CoV-2 TrimericS IgG assay for the detection of circulating antibodies [J].