Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA

Robust assay development for SARS-CoV-2 serological testing requires assessment of asymptomatic and non-hospitalised individuals to determine if assays are sensitive to mild antibody responses. Our study evaluated the performance characteristics of two high-throughput SARS-CoV-2 IgG nucleocapsid ass...

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Autores principales:	Dinesh Mohanraj, Kelly Bicknell, Malini Bhole, Caroline Webber, Lorna Taylor, Alison Whitelegg
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	SARS-CoV-2 Roche Elecsys SARS-CoV-2 antibody assay Abbott IgG antibody assay The Binding Site total antibody assay Medicine R
Acceso en línea:	https://doaj.org/article/cbf08496ca4240828788bffd618ed282
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spelling	oai:doaj.org-article:cbf08496ca4240828788bffd618ed2822021-11-25T19:11:13ZAntibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA10.3390/vaccines91113102076-393Xhttps://doaj.org/article/cbf08496ca4240828788bffd618ed2822021-11-01T00:00:00Zhttps://www.mdpi.com/2076-393X/9/11/1310https://doaj.org/toc/2076-393XRobust assay development for SARS-CoV-2 serological testing requires assessment of asymptomatic and non-hospitalised individuals to determine if assays are sensitive to mild antibody responses. Our study evaluated the performance characteristics of two high-throughput SARS-CoV-2 IgG nucleocapsid assays (Abbott Architect and Roche) and The Binding Site (TBS) Anti-Spike IgG/A/M ELISA kit in samples from healthcare workers (HCWs). The 252 samples were collected from multi-site NHS trusts and analysed for SARS-CoV-2 serology. Assay performance was evaluated between these three platforms and ROC curves were used to redefine the Abbott threshold. Concordance between Abbott and TBS was 66%. Any discrepant results were analysed using Roche, which showed 100% concordance with TBS. Analysis conducted in HCWs within 58 days post-PCR result demonstrated 100% sensitivity for both Abbott and Roche. Longitudinal analysis for >100 days post-PCR led to sensitivity of 77.2% and 100% for Abbott and Roche, respectively. A redefined Abbott threshold (0.64) increased sensitivity to 90%, producing results comparable to TBS and Roche. The manufacturer’s threshold set by Abbott contributes to lower sensitivity and elevated false-negative occurrences. Abbott performance improved upon re-optimisation of the cut-off threshold. Our findings provided evidence that TBS can be used as bespoke alternative for SARS-CoV-2 serology analysis where high-throughput platforms are not feasible on site.Dinesh MohanrajKelly BicknellMalini BholeCaroline WebberLorna TaylorAlison WhiteleggMDPI AGarticleSARS-CoV-2Roche Elecsys SARS-CoV-2 antibody assayAbbott IgG antibody assayThe Binding Site total antibody assayMedicineRENVaccines, Vol 9, Iss 1310, p 1310 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	SARS-CoV-2 Roche Elecsys SARS-CoV-2 antibody assay Abbott IgG antibody assay The Binding Site total antibody assay Medicine R
spellingShingle	SARS-CoV-2 Roche Elecsys SARS-CoV-2 antibody assay Abbott IgG antibody assay The Binding Site total antibody assay Medicine R Dinesh Mohanraj Kelly Bicknell Malini Bhole Caroline Webber Lorna Taylor Alison Whitelegg Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA
description	Robust assay development for SARS-CoV-2 serological testing requires assessment of asymptomatic and non-hospitalised individuals to determine if assays are sensitive to mild antibody responses. Our study evaluated the performance characteristics of two high-throughput SARS-CoV-2 IgG nucleocapsid assays (Abbott Architect and Roche) and The Binding Site (TBS) Anti-Spike IgG/A/M ELISA kit in samples from healthcare workers (HCWs). The 252 samples were collected from multi-site NHS trusts and analysed for SARS-CoV-2 serology. Assay performance was evaluated between these three platforms and ROC curves were used to redefine the Abbott threshold. Concordance between Abbott and TBS was 66%. Any discrepant results were analysed using Roche, which showed 100% concordance with TBS. Analysis conducted in HCWs within 58 days post-PCR result demonstrated 100% sensitivity for both Abbott and Roche. Longitudinal analysis for >100 days post-PCR led to sensitivity of 77.2% and 100% for Abbott and Roche, respectively. A redefined Abbott threshold (0.64) increased sensitivity to 90%, producing results comparable to TBS and Roche. The manufacturer’s threshold set by Abbott contributes to lower sensitivity and elevated false-negative occurrences. Abbott performance improved upon re-optimisation of the cut-off threshold. Our findings provided evidence that TBS can be used as bespoke alternative for SARS-CoV-2 serology analysis where high-throughput platforms are not feasible on site.
format	article
author	Dinesh Mohanraj Kelly Bicknell Malini Bhole Caroline Webber Lorna Taylor Alison Whitelegg
author_facet	Dinesh Mohanraj Kelly Bicknell Malini Bhole Caroline Webber Lorna Taylor Alison Whitelegg
author_sort	Dinesh Mohanraj
title	Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA
title_short	Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA
title_full	Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA
title_fullStr	Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA
title_full_unstemmed	Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA
title_sort	antibody responses to sars-cov-2 infection—comparative determination of seroprevalence in two high-throughput assays versus a sensitive spike protein elisa
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/cbf08496ca4240828788bffd618ed282
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Antibody Responses to SARS-CoV-2 Infection—Comparative Determination of Seroprevalence in Two High-Throughput Assays versus a Sensitive Spike Protein ELISA

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