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

Autor: Ashley David Otter, Abbie Bown, Silvia D’Arcangelo, Daniel Bailey, Amanda Semper, Jacqueline Hewson, Matthew Catton, Prem Perumal, Angela Sweed, Deborah Fox McKee, Jessica Jones, Heli Harvala, Abigail Lamikanra, Maria Zambon, Nick Andrews, Heather Whitaker, Ezra Linley, Alexander J. Mentzer, Donal Skelly, Julian C. Knight, Paul Klenerman, Gayatri Amirthalingam, Stephen Taylor, Cathy Rowe, Richard Vipond, Tim Brooks
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Microbiology Spectrum, Vol 10, Iss 1 (2022)
Druh dokumentu: article
ISSN: 2165-0497
DOI: 10.1128/spectrum.02289-21
Popis: 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.
Databáze: Directory of Open Access Journals