About: Evaluation of two commercial and two non-commercial immunoassays for the detection of prior infection to SARS-CoV-2

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About: Evaluation of two commercial and two non-commercial immunoassays for the detection of prior infection to SARS-CoV-2 Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Evaluation of two commercial and two non-commercial immunoassays for the detection of prior infection to SARS-CoV-2
Creator	Alter, Galit Baden, Lindsey Atyeo, Caroline Bennett, Christopher Fischinger, Stephanie Gilboa, Tal Jarolim, Petr Karlson, Elizabeth Nilles, Eric Norman, Maia Oganezova, Karina Schur, Peter Simmons, Daimon Tolan, Nicole Walt, David Zhou, Guohai
source	MedRxiv; Medline; PMC
abstract	BACKGROUND: Seroepidemiology is an important tool to characterize the epidemiology and immunobiology of SARS-CoV-2 but many immunoassays have not been externally validated raising questions about reliability of study findings. To ensure meaningful data, particularly in a low seroprevalence population, assays need to be rigorously characterized with high specificity. METHODS: We evaluated two commercial (Roche Diagnostics and Epitope Diagnostics IgM/IgG) and two non-commercial (Simoa and Ragon/MGH IgG) immunoassays against 68 confirmed positive and 232 pre-pandemic negative controls. Sensitivity was stratified by time from symptom onset. The Simoa multiplex assay applied three pre-defined algorithm models to determine sample result. RESULTS: The Roche and Ragon/MGH IgG assays each registered 1/232 false positive, the primary Simoa model registered 2/232 false positives, and the Epitope registered 2/230 and 3/230 false positives for the IgG and IgM assays respectively. Sensitivity >21 days post symptom-onset was 100% for all assays except Epitope IgM, but lower and/or with greater variability between assays for samples collected 9–14 days (67–100%) and 15–21 days (69–100%) post-symptom onset. The Simoa and Epitope IgG assays demonstrated excellent sensitivity earlier in the disease course. The Roche and Ragon/MGH assays were less sensitive during early disease, particularly among immunosuppressed individuals. CONCLUSIONS: The Epitope IgG demonstrated good sensitivity and specificity. The Roche and Ragon/MGH IgG assays registered rare false positives with lower early sensitivity. The Simoa assay primary model had excellent sensitivity and few false positives.
has issue date	2020-06-26(xsd:dateTime)
bibo:doi	10.1101/2020.06.24.20139006
bibo:pmid	32607518
has license	cc-by-nc-nd
sha1sum (hex)	c737b5e53996d1da1555e33382fc165cca047ed1
schema:url	https://doi.org/10.1101/2020.06.24.20139006
resource representing a document's title	Evaluation of two commercial and two non-commercial immunoassays for the detection of prior infection to SARS-CoV-2
has PubMed Central identifier	PMC7325183
has PubMed identifier	32607518
schema:publication	medRxiv
resource representing a document's body	covid:c737b5e53996d1da1555e33382fc165cca047ed1#body_text
is schema:about of	named entity 'epidemiology' named entity 'rigorously' named entity 'population' named entity 'ensure' named entity 'SARS-CoV-2' named entity 'RELIABILITY' named entity 'CHARACTERIZED' named entity 'IMPORTANT' named entity 'NEED' named entity 'ENSURE' named entity 'validated' named entity 'SARS-CoV-2' named entity 'immunoassays' named entity 'externally' named entity 'infection' named entity 'epidemiology' named entity 'infection' named entity 'SARS-CoV-2' named entity '5.4' named entity 'standard deviation' named entity 'Roche' named entity 'RT-PCR' named entity 'preprint' named entity 'preprint' named entity 'Roche Diagnostics' named entity '10.5' named entity 'SARS-CoV-2' named entity 'IgM' named entity 'IgG' named entity 'IgA' named entity 'preprint' named entity 'false positives' named entity 'Roche' named entity 'false negatives' named entity 'coronaviruses' named entity 'IgM' named entity 'symptom' named entity 'Simoa' named entity 'negative control' named entity 'SARS-CoV-2' named entity 'respiratory infections' named entity 'symptom' named entity 'IgM' named entity 'immunoassays' named entity 'IgG' named entity 'respiratory infections' named entity 'IgA' named entity 'RT-PCR' named entity 'PPV' named entity 'Version 4.0' named entity '95% CI' named entity 'false positives' named entity 'antigen' named entity 'confidence intervals' named entity 'RBD' named entity 'symptom' named entity 'antibodies' named entity 'positive controls' named entity 'SARS-CoV-2' named entity 'IgA' named entity 'seroconversion' named entity 'spike protein' named entity 'IgM' named entity 'Roche' named entity 'RT-PCR test' named entity 'antigen'

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