Of the SARS-CoV-2 positive panel, 100 serum samples were initially used, but this was later reduced to 93, as 7 were found to not have a PCR-confirmed prior SARS-CoV-2 infection. In our original small-scale evaluation of the Euroimmun assay, reported in June 2020 ( 13) and derived from samples obtained early in the outbreak, 100 serum samples from SARS-CoV-2 PCR-positives patients (where the time between sampling and symptom onset was known) were used to determine assay sensitivity, while 399 prepandemic negative serum samples, 50 serum samples from 2015 seronegative for Borrelia burgdorferi and 50 confounder samples (with previous confirmed VZV, EBV, CMV infection or rheumatoid positive) were used to determine specificity (left panel on Fig. 1). Thus, the Euroimmun IgG assay (targeting the S1 domain) was selected for the urgent operational requirement and to also provide an indication of the immune profile of subjects. While there is merit in having assays that target different antigens for the determination of differential antibody responses to SARS-CoV-2 infection, the use of spike was judged to be critical for virus entry to cells, and therefore an assay detecting spike protein antibodies seemed the most attractive for initial use. Of these three kits, one targeted antibodies (IgG) against the SARS-CoV-2 spike protein S1 domain, one targeted nucleocapsid, and the third detected antibodies to an unspecified SARS-CoV-2 antigen. An initial market assessment identified only three companies with production kits available. Testing on this scale would require the use of commercial CE-marked serology kits to guarantee the volumes of supply required, the possibility for automation, and the necessary quality control of production batches, with our initial focus on an IgG specific assay. The Rare and Imported Pathogens Laboratory (RIPL) at UKHSA Porton Down was tasked by the UK Government’s Department for Health and Social Care (DHSC) with providing a SARS-CoV-2 serology service in support of a national serosurveillance program. In addition, we detail extended characteristics of the Euroimmun assay: intra- and interassay precision, correlation to neutralization, and assay linearity. 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%. Here we describe the implementation and use of the Euroimmun anti-SARS-CoV-2 IgG assay and provide an extended evaluation of its performance. 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. In March 2020, the Rare and Imported Pathogens Laboratory at the UK Health Security Agency (UKHSA) (formerly Public Health England ) 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.

Igg airborne kingdom