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

  1. Ashley David Otter
  2. Abbie Bown
  3. Silvia D’Arcangelo
  4. Daniel Bailey
  5. Amanda Semper
  6. Jacqueline Hewson
  7. Matthew Catton
  8. Prem Perumal
  9. Angela Sweed
  10. Jessica Jones
  11. Heli Harvala
  12. Abigail Lamikanra
  13. Maria Zambon
  14. Nick Andrews
  15. Heather Whitaker
  16. Ezra Linley
  17. Alexander J Mentzer
  18. Donal Skelly
  19. Julian C. Knight
  20. Paul Klenerman
  21. PHE Porton Euroimmun testing group
  22. Gayatri Amirthalingam
  23. Stephen Taylor
  24. Cathy Rowe
  25. Richard Vipond
  26. Tim Brooks
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Abstract

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Abstract

In March 2020, the Rare and Imported Pathogens Laboratory at 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. In the following 12 months, the laboratory tested more than 160,000 samples, facilitating a wide range of research and informing PHE, 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 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 inter-assay precision, correlation to neutralisation and assay linearity.

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