期刊
JOURNAL OF CLINICAL VIROLOGY
卷 142, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.jcv.2021.104931
关键词
SARS-CoV-2; COVID-19; Serological test; Evaluation; Specificity; Sensitivity
类别
资金
- Foundation for Innovative New Diagnostics (FIND)
This study evaluated the performance of 16 serological tests for SARS-CoV-2, finding 13 tests with over 90% sensitivity at 15 days post-symptom onset and 97% specificity. No systematic cross-reactivity was observed, but heterogeneities across tests were found.
Background: In response to the current COVID-19 pandemic, multiple companies marketed serological tests. Rigorous, independent and comparative performances of these assays on defined clinical specimens are needed. Methods: In a first preliminary phase, we investigated 16 IgG, IgM, IgA and pan Ig serological ELISA using a panel of 180 sera, comprising 97 sera from patients with a positive RT-PCR, and 83 negative sera sampled before November 1, 2019. In a second phase and to complete the evaluation on the full panel (100 positive and 300 negative), tests that passed pre-defined exclusion criteria of 90% sensitivity and 97% specificity were further evaluated on 220 additional sera chosen to assess possible cross-reactivity with other human viral infections. Results: Among the 16 tests evaluated in the preliminary phase, two were excluded due to insufficient sensitivity at 15 days post-symptom onset and one was excluded due to poor specificity. Of the 13 tests evaluated using the full panel comprised of a diverse pool of sera including those reactive against known respiratory viruses, no systematic cross-reactivity was observed. However, heterogeneities across tests were found. Consistent with kinetics of antibody expression, maximal sensitivity was found two weeks post-symptom onset. Conclusion: In this independent evaluation, we compared the performance of 16 SARS-CoV-2 serological tests using well-characterized sera and found 13 tests with more than 90% sensitivity at 15 days post-symptom onset and 97% specificity across a diverse range of negative samples.
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