Clinical evaluation of five different automated SARS-CoV-2 serology assays in a cohort of hospitalized COVID-19 patients
Clinical evaluation of five different automated SARS-CoV-2 serology assays in a cohort of hospitalized COVID-19 patients
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DOI：
10.1016/j.jcv.2020.104549
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发表时间：
2020-09-01
影响因子：
8.8
通讯作者：
Luetgehetmann, Marc
中科院分区：
文献类型：
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作者：
Pflueger, Lisa Sophie;Bannasch, Johannes H.;Luetgehetmann, Marc
背景：全球sars - cov -2免疫检测市场正变得越来越拥挤，各种形式、靶点和技术的抗体检测越来越多，仔细评估对于了解单个检测结果的影响至关重要。在这里，我们评估了五种自动免疫测定在一组临床样品上的临床表现。方法：对75例新冠肺炎确诊患者和320例健康献血者的血清/血浆样本进行2次IgG和3次总抗体sars - cov -2免疫检测。所有的测试设置都是自动化的工作流程。结果：检测阳性（发病时间为10天）在68.4% ~ 81.6%之间（Diasorin 68.4%, euroimmune 70.3%, Siemens 73.7%, Roche 79.0%, Wantai 81.6%）。所有检测方法均显示bbb99 %的高特异性（euroimmune, Diasorin: 99.1%, Wantai: 99.4%），但只有两种检测方法的特异性高于99.5% （Roche: 99.7%, Siemens: 100%）。有趣的是，两种检测方法的假阳性结果没有重叠。血透素与免疫IgG定量结果相关性最强（r(2) = 0.76）。总的来说，我们观察到女性和男性患者的测试结果分布没有差异（p值：0.18 - 0.87）。重症患者与危重患者在Euroimmun、Diasorin、Wantai和Siemens检测中存在显著差异（p值：0.041）。结论：各项指标均具有良好的临床效果。我们的数据证实了CDC推荐的正交试验策略可以提高临床特异性。然而，在该队列中，住院时检测阳性的次优率强调了分子诊断对于排除/确认活动性SARS-CoV-2感染的重要性。
Background: The global market for SARS-CoV-2-immunoassays is becoming ever more crowded with antibodytests of various formats, targets and technologies, careful evaluation is crucial for understanding the implications of individual test results. Here, we evaluate the clinical performance of five automated immunoassays on a set of clinical samples.Methods: Serum/plasma samples of 75 confirmed COVID-19 patients and 320 pre-pandemic serum samples of healthy blood donors were subjected to two IgG and three total antibody SARS-CoV-2-immunoassays. All test setups were automated workflows.Results: Positivity of assays (onset of symptoms > 10 days) ranged between 68.4 % and 81.6 % (Diasorin 68.4 %, Euroimmun 70.3 %, Siemens 73.7 %, Roche 79.0 % and Wantai 81.6 %). All examined assays demonstrated high specificity of > 99 % (Euroimmun, Diasorin: 99.1 %, Wantai: 99.4 %) but only two reached levels above 99.5 % (Roche: 99.7 %, Siemens 100 %). Interestingly, there was no overlap in false positive results between the assays. The strongest correlation of quantitative results was observed between the Diasorin and Euroimmun IgG tests (r(2) = 0.76). Overall, we observed no difference in the distribution of test results between female and male patients (p-values: 0.18 - 0.87). A significant difference between severely versus critically ill patients was demonstrated for the Euroimmun, Diasorin, Wantai and Siemens assays (p-values:0.041).Conclusion: All assays showed good clinical performance. Our data confirm that orthogonal test strategies as recommended by the CDC can enhance clinical specificity. However, the suboptimal rates of test positivity found at time of hospitalization in this cohort underline the importance of molecular diagnostics to rule out/confirm active infection with SARS-CoV-2.