tetano
Editor, Senior Moderator
Microbiol Spectr
. 2022 Feb 23;10(1):e0228921.
doi: 10.1128/spectrum.02289-21. Epub 2022 Feb 23.
Implementation and Extended Evaluation of the Euroimmun Anti-SARS-CoV-2 IgG Assay and Its Contribution to the United Kingdom's COVID-19 Public Health Response
Ashley David Otter[SUP] 1 2 [/SUP], Abbie Bown[SUP] 1 [/SUP], Silvia D'Arcangelo[SUP] 1 2 [/SUP], Daniel Bailey[SUP] 1 [/SUP], Amanda Semper[SUP] 3 [/SUP], Jacqueline Hewson[SUP] 2 [/SUP], Matthew Catton[SUP] 1 [/SUP], Prem Perumal[SUP] 1 [/SUP], Angela Sweed[SUP] 1 [/SUP], Deborah Fox McKee[SUP] 1 [/SUP], Jessica Jones[SUP] 3 [/SUP], Heli Harvala[SUP] 4 [/SUP], Abigail Lamikanra[SUP] 4 [/SUP], Maria Zambon[SUP] 5 [/SUP], Nick Andrews[SUP] 5 [/SUP], Heather Whitaker[SUP] 5 [/SUP], Ezra Linley[SUP] 6 [/SUP], Alexander J Mentzer[SUP] 7 8 [/SUP], Donal Skelly[SUP] 8 9 10 [/SUP], Julian C Knight[SUP] 7 [/SUP], Paul Klenerman[SUP] 9 [/SUP], UKHSA Porton Euroimmun testing group[SUP] 11 [/SUP]; Gayatri Amirthalingam[SUP] 5 [/SUP], Stephen Taylor[SUP] 12 [/SUP], Cathy Rowe[SUP] 2 11 [/SUP], Richard Vipond[SUP] 1 3 [/SUP], Tim Brooks[SUP] 3 [/SUP]
Affiliations
Abstract
In March 2020, the Rare and Imported Pathogens Laboratory at the UK Health Security Agency (UKHSA) (formerly Public Health England [PHE]) Porton Down, was tasked by the Department of Health and Social Care with setting up a national surveillance laboratory facility to study SARS-CoV-2 antibody responses and population-level sero-surveillance in response to the growing SARS-CoV-2 outbreak. In the following 12 months, the laboratory tested more than 160,000 samples, facilitating a wide range of research and informing UKHSA, DHSC, and UK government policy. Here we describe the implementation and use of the Euroimmun anti-SARS-CoV-2 IgG assay and provide an extended evaluation of its performance. We present a markedly improved overall sensitivity of 91.39% (≥14 days 92.74%, ≥21 days 93.59%) compared to our small-scale early study, and a specificity of 98.56%. In addition, we detail extended characteristics of the Euroimmun assay: intra- and interassay precision, correlation to neutralization, and assay linearity. IMPORTANCE Serology assays have been useful in determining those with previous SARS-CoV-2 infection in a wide range of research and serosurveillance projects. However, assays vary in their sensitivity at detecting SARS-CoV-2 antibodies. Here, we detail an extended evaluation and characterization of the Euroimmun anti-SARS-CoV-2 IgG assay, one that has been widely used within the United Kingdom on over 160,000 samples to date.
Keywords: SARS-CoV-2; assay development; coronavirus; immunoassays; neutralizing antibodies.
. 2022 Feb 23;10(1):e0228921.
doi: 10.1128/spectrum.02289-21. Epub 2022 Feb 23.
Implementation and Extended Evaluation of the Euroimmun Anti-SARS-CoV-2 IgG Assay and Its Contribution to the United Kingdom's COVID-19 Public Health Response
Ashley David Otter[SUP] 1 2 [/SUP], Abbie Bown[SUP] 1 [/SUP], Silvia D'Arcangelo[SUP] 1 2 [/SUP], Daniel Bailey[SUP] 1 [/SUP], Amanda Semper[SUP] 3 [/SUP], Jacqueline Hewson[SUP] 2 [/SUP], Matthew Catton[SUP] 1 [/SUP], Prem Perumal[SUP] 1 [/SUP], Angela Sweed[SUP] 1 [/SUP], Deborah Fox McKee[SUP] 1 [/SUP], Jessica Jones[SUP] 3 [/SUP], Heli Harvala[SUP] 4 [/SUP], Abigail Lamikanra[SUP] 4 [/SUP], Maria Zambon[SUP] 5 [/SUP], Nick Andrews[SUP] 5 [/SUP], Heather Whitaker[SUP] 5 [/SUP], Ezra Linley[SUP] 6 [/SUP], Alexander J Mentzer[SUP] 7 8 [/SUP], Donal Skelly[SUP] 8 9 10 [/SUP], Julian C Knight[SUP] 7 [/SUP], Paul Klenerman[SUP] 9 [/SUP], UKHSA Porton Euroimmun testing group[SUP] 11 [/SUP]; Gayatri Amirthalingam[SUP] 5 [/SUP], Stephen Taylor[SUP] 12 [/SUP], Cathy Rowe[SUP] 2 11 [/SUP], Richard Vipond[SUP] 1 3 [/SUP], Tim Brooks[SUP] 3 [/SUP]
Affiliations
- PMID: 35196807
- DOI: 10.1128/spectrum.02289-21
Abstract
In March 2020, the Rare and Imported Pathogens Laboratory at the UK Health Security Agency (UKHSA) (formerly Public Health England [PHE]) Porton Down, was tasked by the Department of Health and Social Care with setting up a national surveillance laboratory facility to study SARS-CoV-2 antibody responses and population-level sero-surveillance in response to the growing SARS-CoV-2 outbreak. In the following 12 months, the laboratory tested more than 160,000 samples, facilitating a wide range of research and informing UKHSA, DHSC, and UK government policy. Here we describe the implementation and use of the Euroimmun anti-SARS-CoV-2 IgG assay and provide an extended evaluation of its performance. We present a markedly improved overall sensitivity of 91.39% (≥14 days 92.74%, ≥21 days 93.59%) compared to our small-scale early study, and a specificity of 98.56%. In addition, we detail extended characteristics of the Euroimmun assay: intra- and interassay precision, correlation to neutralization, and assay linearity. IMPORTANCE Serology assays have been useful in determining those with previous SARS-CoV-2 infection in a wide range of research and serosurveillance projects. However, assays vary in their sensitivity at detecting SARS-CoV-2 antibodies. Here, we detail an extended evaluation and characterization of the Euroimmun anti-SARS-CoV-2 IgG assay, one that has been widely used within the United Kingdom on over 160,000 samples to date.
Keywords: SARS-CoV-2; assay development; coronavirus; immunoassays; neutralizing antibodies.