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 (PRNT50) 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 PRNT50 test were available. An elevated correlation was obtained between the SARS-CoV-2 RBD IgG assay and the PRNT50 titer at univariate (ρ=0.689) and multivariate (ρ=0.712) analyses. CONCLUSIONS: SARS-CoV-2 S-RBD IgG assay shows satisfactory analytical and clinical performances, and a strong correlation with sera neutralizing activity.
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 (PRNT50) 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 PRNT50 test were available. An elevated correlation was obtained between the SARS-CoV-2 RBD IgG assay and the PRNT50 titer at univariate (ρ=0.689) and multivariate (ρ=0.712) analyses. CONCLUSIONS:SARS-CoV-2 S-RBD IgG assay shows satisfactory analytical and clinical performances, and a strong correlation with sera neutralizing activity.
Authors: Costanza Di Chiara; Anna Cantarutti; Paola Costenaro; Daniele Donà; Francesco Bonfante; Chiara Cosma; Martina Ferrarese; Sandra Cozzani; Maria Raffaella Petrara; Francesco Carmona; Cecilia Liberati; Paolo Palma; Giovanni Di Salvo; Anita De Rossi; Mario Plebani; Andrea Padoan; Carlo Giaquinto Journal: JAMA Netw Open Date: 2022-07-01
Authors: Luca Bosa; Costanza Di Chiara; Paola Gaio; Chiara Cosma; Andrea Padoan; Sandra Cozzani; Giorgio Perilongo; Mario Plebani; Carlo Giaquinto; Daniele Donà; Mara Cananzi Journal: Front Pediatr Date: 2022-02-10 Impact factor: 3.418
Authors: Alexander E Egger; Christian Irsara; Barbara Holzer; Christoph Winkler; Rosa Bellmann-Weiler; Günter Weiss; Boris Hartmann; Wolfgang Prokop; Gregor Hoermann; Andrea Griesmacher; Markus Anliker Journal: J Clin Virol Plus Date: 2021-12-08