TY - JOUR
T1 - 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
AU - Otter, Ashley David
AU - Bown, Abbie
AU - D'Arcangelo, Silvia
AU - Bailey, Daniel
AU - Semper, Amanda
AU - Hewson, Jacqueline
AU - Catton, Matthew
AU - Perumal, Prem
AU - Sweed, Angela
AU - Fox McKee, Deborah
AU - Jones, Jessica
AU - Harvala, Heli
AU - Lamikanra, Abigail
AU - Zambon, Maria
AU - Andrews, Nick
AU - Whitaker, Heather
AU - Linley, Ezra
AU - Mentzer, Alexander J.
AU - Skelly, Donal
AU - Knight, Julian C.
AU - Klenerman, Paul
AU - Amirthalingam, Gayatri
AU - Taylor, Stephen
AU - Rowe, Cathy
AU - Vipond, Richard
AU - Brooks, Tim
N1 - Funding Information:
This project was funded as part of the DHSC serological assay evaluation procedure. A.J.M. and D.T.S. are funded by the ISARIC-4C Medical Research Council (grant MC_PC_19059) as part of the ISARIC Coronavirus Clinical Characterization Consortium (ISARIC-4C), COMBAT Consortium, OUH clinical and research staff, and patients.
Publisher Copyright:
© 2022 American Society for Microbiology. All rights reserved.
PY - 2022/2
Y1 - 2022/2
N2 - 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 populationlevel 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.
AB - 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 populationlevel 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.
KW - Assay development
KW - Coronavirus
KW - Immunoassays
KW - Neutralizing antibodies
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85125239764&partnerID=8YFLogxK
U2 - 10.1128/spectrum.02289-21
DO - 10.1128/spectrum.02289-21
M3 - Article
AN - SCOPUS:85125239764
SN - 2165-0497
VL - 10
JO - Microbiology Spectrum
JF - Microbiology Spectrum
IS - 1
M1 - e02289-21
ER -
