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Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: comparison with neutralization titers by Andrea Padoan; Francesco Bonfante; Chiara Cosma; Costanza Di Chiara; Laura Sciacovelli; Matteo Pagliari; Alessio Bortolami; Paola Costenaro; Giulia Musso; Daniela Basso; Carlo Giaquinto; Mario Plebani is a Medicine article available to read on EtoBox.
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Objectives: SARS-CoV-2 serology presents an important role in several aspects of COVID-19 pandemic. Immunoassays performances have to be accurately evaluated and correlated with neutralizing antibodies. We investigated the analytical and clinical performances of a SARS-CoV-2 RBD IgG assay, automated on a high throughput platform, and the correlation of the antibodies (Ab) levels with the plaque reduction neutralization (PRNT 50 ) Ab titers. Methods: A series of 546 samples were evaluated by SARS-CoV-2 RBD IgG assay (Snibe diagnostics), including 171 negative and 168 positive SARS-CoV-2 subjects and a further group of 207 subjects of the COVID-19 family clusters follow-up cohort. Results: Assay imprecision ranged from 3.98 to 12.18% being satisfactory at low and medium levels; linearity was excellent in all the measurement range. Considering specimens collected after 14 days post symptoms onset, overall sensitivity and specificity were 99.0 and 92.5%, respectively. A total of 281 leftover samples results of the PRNT 50 test were available. An elevated correlation was obtained between the SARS-CoV-2 RBD IgG assay and the PRNT 50 titer at univariate (ρ=0.689) and multivariate (ρ=0.712
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- Author
- Andrea Padoan; Francesco Bonfante; Chiara Cosma; Costanza Di Chiara; Laura Sciacovelli; Matteo Pagliari; Alessio Bortolami; Paola Costenaro; Giulia Musso; Daniela Basso; Carlo Giaquinto; Mario Plebani
- Publisher
- Walter de Gruyter GmbH
- Published
- 2021
- Language
- EN
- Field
- Medicine (Health Sciences)