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.
【저자키워드】 SARS-CoV-2, coronavirus, Neutralizing antibodies, immunoassays, assay development, 【초록키워드】 neutralization, SARS-COV-2 infection, Laboratory, sensitivity, specificity, Antibody responses, SARS-CoV-2 antibodies, Characteristics, Surveillance, outbreak, anti-SARS-CoV-2 IgG, implementation, Research, Pathogens, correlation, security, United Kingdom, SARS-CoV-2 antibody response, characterization, Precision, SARS-CoV-2 antibody responses, National, Department, Public Health England, serology assays, DHSC, UK Government, tested, addition, 【제목키워드】 COVID-19, IgG, response, Public, Extended,