دورية أكاديمية
Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: Comparison with neutralization titers
العنوان: | Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: Comparison with neutralization titers |
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المؤلفون: | 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. |
المساهمون: | 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. |
بيانات النشر: | De Gruyter Open Ltd |
سنة النشر: | 2021 |
المجموعة: | Padua Research Archive (IRIS - Università degli Studi di Padova) |
مصطلحات موضوعية: | antibodie, clinical performance, immunoassay, neutralization, plaque reduction neutralization test, SARS-CoV-2, serology |
الوصف: | 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. 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. 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. SARS-CoV-2 S-RBD IgG assay shows satisfactory analytical and clinical performances, and a strong correlation with sera neutralizing activity. |
نوع الوثيقة: | article in journal/newspaper |
وصف الملف: | ELETTRONICO |
اللغة: | English |
العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/33855843; info:eu-repo/semantics/altIdentifier/wos/WOS:000667954800022; volume:0; issue:0; journal:CLINICAL CHEMISTRY AND LABORATORY MEDICINE; http://hdl.handle.net/11577/3391075Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85104587275 |
DOI: | 10.1515/cclm-2021-0313 |
الإتاحة: | https://doi.org/10.1515/cclm-2021-0313Test http://hdl.handle.net/11577/3391075Test |
حقوق: | info:eu-repo/semantics/openAccess |
رقم الانضمام: | edsbas.F00AC4D |
قاعدة البيانات: | BASE |
DOI: | 10.1515/cclm-2021-0313 |
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