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Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Clin+Chem+Lab+Med 2021 ; 59 (8): 1444-1452 Nephropedia Template TP
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Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: comparison with neutralization titers #MMPMID33855843
Padoan A; Bonfante F; Cosma C; Di Chiara C; Sciacovelli L; Pagliari M; Bortolami A; Costenaro P; Musso G; Basso D; Giaquinto C; Plebani M
Clin Chem Lab Med 2021[Jul]; 59 (8): 1444-1452 PMID33855843show ga
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 (rho=0.689) and multivariate (rho=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.