Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays

Abstract Serological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to as...

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Autores principales:	Rebeca Santano, Diana Barrios, Fàtima Crispi, Francesca Crovetto, Marta Vidal, Jordi Chi, Luis Izquierdo, Eduard Gratacós, Gemma Moncunill, Carlota Dobaño
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/c3dbe39f18724f4eaa11861c19674e89
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spelling	oai:doaj.org-article:c3dbe39f18724f4eaa11861c19674e892021-12-02T18:48:01ZAgreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays10.1038/s41598-021-98296-y2045-2322https://doaj.org/article/c3dbe39f18724f4eaa11861c19674e892021-09-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-98296-yhttps://doaj.org/toc/2045-2322Abstract Serological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and the COVID-19 ELISA IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.Rebeca SantanoDiana BarriosFàtima CrispiFrancesca CrovettoMarta VidalJordi ChiLuis IzquierdoEduard GratacósGemma MoncunillCarlota DobañoNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-7 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Rebeca Santano Diana Barrios Fàtima Crispi Francesca Crovetto Marta Vidal Jordi Chi Luis Izquierdo Eduard Gratacós Gemma Moncunill Carlota Dobaño Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays
description	Abstract Serological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and the COVID-19 ELISA IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.
format	article
author	Rebeca Santano Diana Barrios Fàtima Crispi Francesca Crovetto Marta Vidal Jordi Chi Luis Izquierdo Eduard Gratacós Gemma Moncunill Carlota Dobaño
author_facet	Rebeca Santano Diana Barrios Fàtima Crispi Francesca Crovetto Marta Vidal Jordi Chi Luis Izquierdo Eduard Gratacós Gemma Moncunill Carlota Dobaño
author_sort	Rebeca Santano
title	Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays
title_short	Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays
title_full	Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays
title_fullStr	Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays
title_full_unstemmed	Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays
title_sort	agreement between commercially available elisa and in-house luminex sars-cov-2 antibody immunoassays
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/c3dbe39f18724f4eaa11861c19674e89
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Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays

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