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Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies

In December 2020, WHO presented the first international standard (WHO IS) for anti-SARS-CoV-2 immunoglobulin. This standard is intended to serve as a reference reagent against which serological tests can be calibrated, thus creating better comparability of results between different tests, laboratori...

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Autores principales: Girl, Philipp, Mantel, Sonja, von Buttlar, Heiner, Wölfel, Roman, Müller, Katharina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8953933/
https://www.ncbi.nlm.nih.gov/pubmed/35336984
http://dx.doi.org/10.3390/v14030577
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author Girl, Philipp
Mantel, Sonja
von Buttlar, Heiner
Wölfel, Roman
Müller, Katharina
author_facet Girl, Philipp
Mantel, Sonja
von Buttlar, Heiner
Wölfel, Roman
Müller, Katharina
author_sort Girl, Philipp
collection PubMed
description In December 2020, WHO presented the first international standard (WHO IS) for anti-SARS-CoV-2 immunoglobulin. This standard is intended to serve as a reference reagent against which serological tests can be calibrated, thus creating better comparability of results between different tests, laboratories, etc. Here, we have examined three different commercial ELISA kits for the quantification of SARS-CoV-2 IgG antibodies, namely the Anti-SARS-CoV-2 QuantiVac ELISA (IgG) (Euroimmun, Lübeck, Germany), the SERION ELISA agile (Institut Virion Serion, Würzburg, Germany), and the COVID-19 quantitative IgG ELISA (DeMediTec Diagnostics, Kiel, Germany). According to the manufacturers, all are calibrated against the WHO IS and can provide results in either international units (IU) (DeMediTec) or arbitrary antibody units (BAU) per milliliter (Euroimmun, Virion Serion), which are numerically identical, according to the WHO. A total of 50 serum samples from vaccinated individuals were tested side by side and according to the manufacturer’s instructions. We compared the test results of all three assays with each other to assess comparability and with a quantitative in-house virus neutralization test (micro-NT). In summary, our data are consistent with other studies published on this topic that tested similar assays from different manufacturers. Overall, the agreement between quantitative ELISAs is variable and cannot be used interchangeably despite calibration against a standard. Therefore, interpretation of results must still be individualized and tailored to each case. More importantly, our results highlight that quantitative ELISAs in their current form cannot replace neutralization tests.
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spelling pubmed-89539332022-03-26 Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies Girl, Philipp Mantel, Sonja von Buttlar, Heiner Wölfel, Roman Müller, Katharina Viruses Communication In December 2020, WHO presented the first international standard (WHO IS) for anti-SARS-CoV-2 immunoglobulin. This standard is intended to serve as a reference reagent against which serological tests can be calibrated, thus creating better comparability of results between different tests, laboratories, etc. Here, we have examined three different commercial ELISA kits for the quantification of SARS-CoV-2 IgG antibodies, namely the Anti-SARS-CoV-2 QuantiVac ELISA (IgG) (Euroimmun, Lübeck, Germany), the SERION ELISA agile (Institut Virion Serion, Würzburg, Germany), and the COVID-19 quantitative IgG ELISA (DeMediTec Diagnostics, Kiel, Germany). According to the manufacturers, all are calibrated against the WHO IS and can provide results in either international units (IU) (DeMediTec) or arbitrary antibody units (BAU) per milliliter (Euroimmun, Virion Serion), which are numerically identical, according to the WHO. A total of 50 serum samples from vaccinated individuals were tested side by side and according to the manufacturer’s instructions. We compared the test results of all three assays with each other to assess comparability and with a quantitative in-house virus neutralization test (micro-NT). In summary, our data are consistent with other studies published on this topic that tested similar assays from different manufacturers. Overall, the agreement between quantitative ELISAs is variable and cannot be used interchangeably despite calibration against a standard. Therefore, interpretation of results must still be individualized and tailored to each case. More importantly, our results highlight that quantitative ELISAs in their current form cannot replace neutralization tests. MDPI 2022-03-11 /pmc/articles/PMC8953933/ /pubmed/35336984 http://dx.doi.org/10.3390/v14030577 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Communication
Girl, Philipp
Mantel, Sonja
von Buttlar, Heiner
Wölfel, Roman
Müller, Katharina
Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies
title Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies
title_full Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies
title_fullStr Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies
title_full_unstemmed Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies
title_short Side-By-Side Evaluation of Three Commercial ELISAs for the Quantification of SARS-CoV-2 IgG Antibodies
title_sort side-by-side evaluation of three commercial elisas for the quantification of sars-cov-2 igg antibodies
topic Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8953933/
https://www.ncbi.nlm.nih.gov/pubmed/35336984
http://dx.doi.org/10.3390/v14030577
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