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  • An automated chemiluminesce...
    Liu, Binjian; Su, Xibin; Yu, George; Yang, Shuling; Wang, Feng; Huang, Tao; Zhou, Liuyong; Hui, Zhiqiang; Liao, Yixian; Qiu, Yuan; Huang, Juan; Gao, Hong; Liu, Justin; Zhong, Yaoqi

    International journal of infectious diseases, 02/2022, Letnik: 115
    Journal Article

    •Chemiluminescent immunoassay can replace microneutralization test for testing severe acute respiratory syndrome coronavirus-2 neutralizing antibodies.•Mathematical models can evaluate the effectiveness, protectiveness and durability of vaccines.•Only 5.35% of vaccinees had protective capability of NAb following the second dose of vaccine.•People should receive a third dose of vaccine, and the vaccine should be administered once every 6 months. A specific and sensitive automated chemiluminescent immunoassay (CLIA) was developed to detect neutralizing antibody (NAb) levels. This assay can be used for the diagnosis of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection, treatment and vaccine evaluation. The SARS-CoV-2 receptor-binding domain (RBD) and a stabilized version of the spike ectodomain as antigens were detected by CLIA. Sera NAb titers and concentrations from 860 SARS-CoV-2 vaccinees, 232 SARS-CoV-2 convalescent patients and 675 healthy individuals were tested by microneutralization test (MNT) and CLIA, respectively. Mathematical models were established to evaluate the relationship between two variables in different groups. With the RBD-based CLIA protocol, CLIA can be used to replace MNT to test SARS-CoV-2 NAb. Vaccine effectiveness, protectiveness and durability can be evaluated effectively by mathematical models. It is Analysing the relationship between NAb titers and concentrations, R2 for the decision-making tree was 0.870 and that of progressive linear fitting was 0.821. The receiver operating characteristic curve indicated specificity of 78.1%, sensitivity of 87.4%, cut-off value of 6.43 AU/mL and borderline range of 5.79–7.07 AU/mL for CLIA. Three-quarters (75.4%) of vaccinees were found to be NAb positive, and 5.35% vaccinees had NAb protective capability. The half-life of NAb in vaccinees was 10–11 weeks.for vaccinees to take a NAb assay periodically. Display omitted