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Evaluation of sixteen ELISA SARS-CoV-2 serological tests.
- Source :
-
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2021 Sep; Vol. 142, pp. 104931. Date of Electronic Publication: 2021 Jul 22. - Publication Year :
- 2021
-
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.<br />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.<br />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.<br />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.<br /> (Copyright © 2021. Published by Elsevier B.V.)
Details
- Language :
- English
- ISSN :
- 1873-5967
- Volume :
- 142
- Database :
- MEDLINE
- Journal :
- Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
- Publication Type :
- Academic Journal
- Accession number :
- 34365228
- Full Text :
- https://doi.org/10.1016/j.jcv.2021.104931