Development and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies

A novel clinical assay for the detection and quantitation of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was adapted from an in-house, research-based enzyme-linked immunosorbent assay (ELISA). Development and validation were performed under regulatory guidelines,...

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Autores principales:	Magdalena M. Żak, Aryeh Stock, Daniel Stadlbauer, Wei Zhang, Kirstie Cummings, William Marsiglia, Arsen Zargarov, Fatima Amanat, Monica Tamayo, Carlos Cordon-Cardo, Florian Krammer, Damodara Rao Mendu
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Coronavirus disease 2019 Severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) Antibody tests Diagnosis of COVID-19 ELISA IgG antibody assay Science (General) Q1-390 Social sciences (General) H1-99
Acceso en línea:	https://doaj.org/article/5c72781bae044eaf93031c713d193335
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spelling	oai:doaj.org-article:5c72781bae044eaf93031c713d1933352021-12-04T04:35:24ZDevelopment and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies2405-844010.1016/j.heliyon.2021.e08444https://doaj.org/article/5c72781bae044eaf93031c713d1933352021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2405844021025470https://doaj.org/toc/2405-8440A novel clinical assay for the detection and quantitation of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was adapted from an in-house, research-based enzyme-linked immunosorbent assay (ELISA). Development and validation were performed under regulatory guidelines, and the test obtained emergency use authorization (EUA) from the New York State Department of Health (NYSDOH) and the Food and Drug Administration (FDA). The Mount Sinai coronavirus disease 2019 (COVID-19) antibody assay is an orthogonal, quantitative direct ELISA test which detects antibodies reactive to the receptor binding domain (RBD) and the spike protein of the novel SARS-CoV-2. The assay is performed on 96-well plates coated with either SARS-CoV-2 recombinant RBD or spike proteins. The test is divided into two stages, a qualitative screening assay against RBD and a quantitative assay against the full-length spike protein. The test uses pooled high titer serum as a reference standard. Negative pre-COVID-19 and positive post-COVID-19, PCR-confirmed specimens were incorporated in each ELISA test run, and the assays were performed independently at two different locations.The Mount Sinai COVID-19 serology performed with high sensitivity and specificity, 92.5% (95% CI: 0.785–0.980) and 100% (CI: 0.939–1.000) respectively. Between-run precision was assessed with a single run repeated over 22 days; and within-run precision was assessed with 10 replicates per day over 22 days. Both were within reported acceptance criteria (CV ≤ 20%).This population-based study reveals the applicability and reliability of this novel orthogonal COVID-19 serology test for the detection and quantitation of antibodies against SARS-CoV-2, allowing a broad set of clinical applications, including the broad evaluation of SARS-CoV-2 seroprevalence and antibody profiling in different population subsets.Magdalena M. ŻakAryeh StockDaniel StadlbauerWei ZhangKirstie CummingsWilliam MarsigliaArsen ZargarovFatima AmanatMonica TamayoCarlos Cordon-CardoFlorian KrammerDamodara Rao MenduElsevierarticleCoronavirus disease 2019Severe acute respiratory syndrome coronavirus-2 (SARSCoV-2)Antibody testsDiagnosis of COVID-19ELISAIgG antibody assayScience (General)Q1-390Social sciences (General)H1-99ENHeliyon, Vol 7, Iss 12, Pp e08444- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Coronavirus disease 2019 Severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) Antibody tests Diagnosis of COVID-19 ELISA IgG antibody assay Science (General) Q1-390 Social sciences (General) H1-99
spellingShingle	Coronavirus disease 2019 Severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) Antibody tests Diagnosis of COVID-19 ELISA IgG antibody assay Science (General) Q1-390 Social sciences (General) H1-99 Magdalena M. Żak Aryeh Stock Daniel Stadlbauer Wei Zhang Kirstie Cummings William Marsiglia Arsen Zargarov Fatima Amanat Monica Tamayo Carlos Cordon-Cardo Florian Krammer Damodara Rao Mendu Development and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies
description	A novel clinical assay for the detection and quantitation of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was adapted from an in-house, research-based enzyme-linked immunosorbent assay (ELISA). Development and validation were performed under regulatory guidelines, and the test obtained emergency use authorization (EUA) from the New York State Department of Health (NYSDOH) and the Food and Drug Administration (FDA). The Mount Sinai coronavirus disease 2019 (COVID-19) antibody assay is an orthogonal, quantitative direct ELISA test which detects antibodies reactive to the receptor binding domain (RBD) and the spike protein of the novel SARS-CoV-2. The assay is performed on 96-well plates coated with either SARS-CoV-2 recombinant RBD or spike proteins. The test is divided into two stages, a qualitative screening assay against RBD and a quantitative assay against the full-length spike protein. The test uses pooled high titer serum as a reference standard. Negative pre-COVID-19 and positive post-COVID-19, PCR-confirmed specimens were incorporated in each ELISA test run, and the assays were performed independently at two different locations.The Mount Sinai COVID-19 serology performed with high sensitivity and specificity, 92.5% (95% CI: 0.785–0.980) and 100% (CI: 0.939–1.000) respectively. Between-run precision was assessed with a single run repeated over 22 days; and within-run precision was assessed with 10 replicates per day over 22 days. Both were within reported acceptance criteria (CV ≤ 20%).This population-based study reveals the applicability and reliability of this novel orthogonal COVID-19 serology test for the detection and quantitation of antibodies against SARS-CoV-2, allowing a broad set of clinical applications, including the broad evaluation of SARS-CoV-2 seroprevalence and antibody profiling in different population subsets.
format	article
author	Magdalena M. Żak Aryeh Stock Daniel Stadlbauer Wei Zhang Kirstie Cummings William Marsiglia Arsen Zargarov Fatima Amanat Monica Tamayo Carlos Cordon-Cardo Florian Krammer Damodara Rao Mendu
author_facet	Magdalena M. Żak Aryeh Stock Daniel Stadlbauer Wei Zhang Kirstie Cummings William Marsiglia Arsen Zargarov Fatima Amanat Monica Tamayo Carlos Cordon-Cardo Florian Krammer Damodara Rao Mendu
author_sort	Magdalena M. Żak
title	Development and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies
title_short	Development and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies
title_full	Development and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies
title_fullStr	Development and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies
title_full_unstemmed	Development and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies
title_sort	development and characterization of a quantitative elisa to detect anti-sars-cov-2 spike antibodies
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/5c72781bae044eaf93031c713d193335
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Development and characterization of a quantitative ELISA to detect anti-SARS-CoV-2 spike antibodies

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