期刊
JOURNAL OF APPLIED LABORATORY MEDICINE
卷 6, 期 6, 页码 1561-1570出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/jalm/jfab072
关键词
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资金
- National Institutes of Health [UL1TR001102, U01 HG008685, OT2OD026553, P30 AR070253]
- Chleck Foundation
- Massachusetts Consortium on Pathogen Readiness
- Centers for Disease Control and Prevention [U01 GH002238]
- NIH [K08 AR075850, UM1AI069412]
This study evaluated the performance of 5 different immunoassays for detecting prior infection with SARS-CoV-2, with Roche assay showing the highest specificity and Simoa immunoassay demonstrating the highest sensitivity across different days post-symptom onset.
Background: Serological testing provides a record of prior infection with SARS-CoV-2, but assay performance requires independent assessment. Methods: We evaluated 3 commercial (Roche Diagnostics pan-IG, and Epitope Diagnostics IgM and IgG) and 2 non-commercial (Simoa and Ragon/MGH IgG) immunoassays against 1083 unique samples that included 251 PCR-positive and 832 prepandemic samples. Results: The Roche assay registered the highest specificity 99.6% (3/832 false positives), the Ragon/MGH assay 99.5% (4/832), the primary Simoa assay model 99.0% (8/832), and the Epitope IgG and IgM 99.0% (8/830) and 99.5% (4/830), respectively. Overall sensitivities for the Simoa, Roche pan-IG, Epitope IgG, Ragon/MGH IgG, and Epitope IgM were 92.0%, 82.9%, 82.5%, 64.5% and 47.0%, respectively. The Simoa immunoassay demonstrated the highest sensitivity among samples stratified by days postsymptom onset (PSO), <8 days PSO (57.69%) 8-14 days PSO (93.51%), 15-21 days PSO (100%), and > 21 days PSO (95.18%). Conclusions: All assays demonstrated high to very high specificities while sensitivities were variable across assays.
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