Diagnostic Support, Science Group, UK Health Security Agency, Porton, Porton Down, United Kingdom.
SARS-CoV-2 Serosurveillance Laboratory, UK Health Security Agency, Porton, Porton Down, United Kingdom.
Microbiol Spectr. 2022 Feb 23;10(1):e0228921. doi: 10.1128/spectrum.02289-21.
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. 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.
2020 年 3 月，英国卫生安全局（UKHSA）（前身为英国公共卫生署[PHE]）波特兰唐恩的稀有和进口病原体实验室受卫生和社会保障部委托，建立了一个国家监测实验室设施，以研究 SARS-CoV-2 抗体反应和人群水平的血清学监测，以应对不断扩大的 SARS-CoV-2 疫情。在接下来的 12 个月里，该实验室测试了超过 16 万份样本，为广泛的研究提供了便利，并为 UKHSA、DHSC 和英国政府政策提供了信息。在这里，我们描述了 Euroimmun 抗 SARS-CoV-2 IgG 检测试剂盒的实施和使用情况，并对其性能进行了扩展评估。我们发现，与我们早期的小规模研究相比，该检测试剂盒的整体敏感性显著提高，达到 91.39%（≥14 天 92.74%，≥21 天 93.59%），特异性为 98.56%。此外，我们详细介绍了 Euroimmun 检测试剂盒的扩展特性：批内和批间精密度、与中和的相关性以及检测的线性。血清学检测在广泛的研究和血清学监测项目中，对于确定那些曾经感染过 SARS-CoV-2 的人非常有用。然而，检测试剂盒在检测 SARS-CoV-2 抗体的敏感性方面存在差异。在这里，我们详细介绍了 Euroimmun 抗 SARS-CoV-2 IgG 检测试剂盒的扩展评估和特征描述，该试剂盒迄今为止已在英国的 16 万多个样本中得到广泛应用。
