AI Article Synopsis
- The study evaluated the analytical and clinical performance of a SARS-CoV-2 RBD IgG assay using a large sample size of 546, which included positive and negative subjects, to better understand COVID-19 immunity.
- The assay demonstrated high sensitivity (99.0%) and specificity (92.5%) after 14 days post symptom onset, along with good precision and linearity in its measurements.
- A strong correlation was found between the RBD IgG assay results and neutralizing antibody titers, highlighting its reliability as a tool for assessing immune response to SARS-CoV-2.
Article 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 (PRNT) 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 test were available. An elevated correlation was obtained between the SARS-CoV-2 RBD IgG assay and the PRNT titer at univariate (=0.689) and multivariate (=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.
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| http://dx.doi.org/10.1515/cclm-2021-0313 | DOI Listing |
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