Literature DB >> 34196711

Evaluation of Three Commercial and Two Non-Commercial Immunoassays for the Detection of Prior Infection to SARS-CoV-2.

Eric J Nilles1,2, Elizabeth W Karlson1,2, Maia Norman1,2,3,4, Tal Gilboa1,2,4, Stephanie Fischinger5, Caroline Atyeo5, Guohai Zhou1,2, Christopher L Bennett1,2,6, Nicole V Tolan1,2, Karina Oganezova1, David R Walt1,2,4, Galit Alter2,5,7, Daimon P Simmons1,2, Peter Schur1,2, Petr Jarolim1,2, Ann E Woolley1,2, Lindsey R Baden1,2.   

Abstract

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. © American Association for Clinical Chemistry 2021. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Entities:  

Keywords:  COVID-19; SARs-CoV-2; antibodies; immunoassays; performance; sensitivity; serology; specificity

Mesh：

Substances：

Year:  2021        PMID： 34196711      PMCID： PMC8420636          DOI： 10.1093/jalm/jfab072

Source DB:  PubMed          Journal:  J Appl Lab Med        ISSN： 2475-7241


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