Performance characteristics of five immunoassays for SARS-CoV-2: a head-to-head benchmark comparison.
Performance characteristics of five immunoassays for SARS-CoV-2: a head-to-head benchmark comparison.
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DOI：
10.1016/s1473-3099(20)30634-4
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发表时间：
2020-12
期刊：
影响因子：
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通讯作者：
National SARS-CoV-2 Serology Assay Evaluation Group
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文献类型：
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作者：
National SARS-CoV-2 Serology Assay Evaluation Group
严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）在2020年引发了全球大流行。检测对于减轻公共卫生和经济影响至关重要。血清学被认为是人群水平监测和潜在的个人水平风险评估的关键。然而，尚未在大型相同样品集上比较免疫测定性能。我们的目的是研究四个高通量商业SARS-CoV-2抗体免疫检测和一种新的384孔ELISA的性能。我们对SARS-CoV-2 IgG检测试剂（Abbott，芝加哥，IL，USA）、LIAISON SARS-CoV-2 S1/S2 IgG检测试剂（DiaSorin，萨卢贾，意大利）、Elecsys抗SARS-CoV-2检测试剂（Roche，巴塞尔，瑞士）、SARS-CoV-2总检测试剂（Siemens，慕尼黑，德国）和新型384孔ELISA（Oxford免疫测定）进行了头对头评估。我们从976份大流行前血液样本（2014年9月4日至2016年10月4日期间收集）和536份实验室确认的SARS-CoV-2感染患者的血液样本中获得了灵敏度和特异性，这些血液样本在症状发作后至少20天收集（2020年2月1日至2020年5月31日期间收集）。使用受试者工作特征（ROC）曲线评估测定阈值。在制造商的阈值下，Abbott检测试剂盒的灵敏度为92.7%（95%CI 90.2 ~ 94.8），特异性99.9%（99.4 -100%）; DiaSorin检测灵敏度为96.2%（94.2 ~ 97.7），特异性为98.9%（98·0-99·4）;对于Oxford免疫测定法，灵敏度为99·1%（97.8 ~ 99.7），特异性为99.0%（98·1-99·5）;罗氏试剂盒的灵敏度为97·2% Siemens检测灵敏度为98.1%（96.6 - 99.1），特异性为99.9%（99.4 -100%）。所有检测均达到至少98%的灵敏度，优化阈值以在症状发作后30天或更长时间采集的样本上达到至少98%的特异性。四种商业化的、广泛可用的检测方法和可扩展的384孔ELISA可用于SARS-CoV-2血清学检测，以实现至少98%的灵敏度和特异性。Siemens测定和Oxford免疫测定实现了这些指标，无需进一步优化。这项免疫测定评估的基准研究应能改进检测策略，并最佳利用血清学检测资源，以造福个人和人群健康。英国公共卫生和英国国家卫生研究所。
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a global pandemic in 2020. Testing is crucial for mitigating public health and economic effects. Serology is considered key to population-level surveillance and potentially individual-level risk assessment. However, immunoassay performance has not been compared on large, identical sample sets. We aimed to investigate the performance of four high-throughput commercial SARS-CoV-2 antibody immunoassays and a novel 384-well ELISA. We did a head-to-head assessment of SARS-CoV-2 IgG assay (Abbott, Chicago, IL, USA), LIAISON SARS-CoV-2 S1/S2 IgG assay (DiaSorin, Saluggia, Italy), Elecsys Anti-SARS-CoV-2 assay (Roche, Basel, Switzerland), SARS-CoV-2 Total assay (Siemens, Munich, Germany), and a novel 384-well ELISA (the Oxford immunoassay). We derived sensitivity and specificity from 976 pre-pandemic blood samples (collected between Sept 4, 2014, and Oct 4, 2016) and 536 blood samples from patients with laboratory-confirmed SARS-CoV-2 infection, collected at least 20 days post symptom onset (collected between Feb 1, 2020, and May 31, 2020). Receiver operating characteristic (ROC) curves were used to assess assay thresholds. At the manufacturers' thresholds, for the Abbott assay sensitivity was 92·7% (95% CI 90·2–94·8) and specificity was 99·9% (99·4–100%); for the DiaSorin assay sensitivity was 96·2% (94·2–97·7) and specificity was 98·9% (98·0–99·4); for the Oxford immunoassay sensitivity was 99·1% (97·8–99·7) and specificity was 99·0% (98·1–99·5); for the Roche assay sensitivity was 97·2% (95·4–98·4) and specificity was 99·8% (99·3–100); and for the Siemens assay sensitivity was 98·1% (96·6–99·1) and specificity was 99·9% (99·4–100%). All assays achieved a sensitivity of at least 98% with thresholds optimised to achieve a specificity of at least 98% on samples taken 30 days or more post symptom onset. Four commercial, widely available assays and a scalable 384-well ELISA can be used for SARS-CoV-2 serological testing to achieve sensitivity and specificity of at least 98%. The Siemens assay and Oxford immunoassay achieved these metrics without further optimisation. This benchmark study in immunoassay assessment should enable refinements of testing strategies and the best use of serological testing resource to benefit individuals and population health. Public Health England and UK National Institute for Health Research.