Abstract
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.
Keywords: COVID-19; Evaluation; SARS-CoV-2; Sensitivity; Serological test; Specificity.
【저자키워드】 COVID-19, serological test, SARS-CoV-2, sensitivity, specificity, Evaluation, 【초록키워드】 IgG, IgM, antibody, COVID-19 pandemic, viral infections, heterogeneity, ELISA, cross-reactivity, respiratory viruses, specificity, IgA, sera, Patient, serological, expression, positive RT-PCR, exclusion criteria, post-symptom onset, specimen, positive, Complete, independent, reactive, defined, investigated, evaluated, excluded, were excluded, 【제목키워드】 ELISA,