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Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: comparison with neutralization titers
- Source :
- Clinical Chemistry and Laboratory Medicine (CCLM). 59:1444-1452
- Publication Year :
- 2021
- Publisher :
- Walter de Gruyter GmbH, 2021.
-
Abstract
- 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.
- Subjects :
- 0301 basic medicine
2019-20 coronavirus outbreak
Convalescent plasma
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Clinical Biochemistry
antibodies
clinical performances
immunoassays
neutralization
plaque reduction neutralization test
SARS-CoV-2
serology
Virus
Neutralization
Serology
03 medical and health sciences
0302 clinical medicine
Plaque reduction neutralization test
Medicine
biology
business.industry
Biochemistry (medical)
General Medicine
Titer
030104 developmental biology
030220 oncology & carcinogenesis
Immunology
biology.protein
Antibody
business
Subjects
Details
- ISSN :
- 14374331 and 14346621
- Volume :
- 59
- Database :
- OpenAIRE
- Journal :
- Clinical Chemistry and Laboratory Medicine (CCLM)
- Accession number :
- edsair.doi.dedup.....b4529d465f6f60119a7ebbad0ed5c470