Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (Ab), immunoglobulin G (IgG), and IgM against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was a Danish national collaboration and evaluated 15 commercial and one in-house anti-SARS-CoV-2 assays in 16 laboratories. Sensitivity was evaluated using 150 samples from individuals with asymptomatic, mild, or moderate COVID-19, nonhospitalized or hospitalized, confirmed by nucleic acid amplification tests (NAAT); samples were collected 13 to 73 days either from symptom onset or from positive NAAT (patients without symptoms). Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from >586 blood donors and patients with autoimmune diseases, cytomegalovirus or Epstein-Barr virus infections, and acute viral infections. A specificity of ≥99% was achieved by all total-Ab and IgG assays except one, DiaSorin Liaison XL IgG (97.2%). Sensitivities in descending order were Wantai ELISA total Ab (96.7%), CUH-NOVO in-house ELISA total Ab (96.0%), Ortho Vitros total Ab (95.3%), YHLO iFlash IgG (94.0%), Ortho Vitros IgG (93.3%), Siemens Atellica total Ab (93.2%), Roche Elecsys total Ab (92.7%), Abbott Architect IgG (90.0%), Abbott Alinity IgG (median 88.0%), DiaSorin Liaison XL IgG (median 84.6%), Siemens Vista total Ab (81.0%), Euroimmun/ELISA IgG (78.0%), and Snibe Maglumi IgG (median 78.0%). However, confidence intervals overlapped for several assays. The IgM results were variable, with the Wantai IgM ELISA showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.

中文翻译：

---

16 个临床实验室的 16 种血清学 SARS-CoV-2 免疫测定的比较

需要对严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 进行血清学检测以支持临床诊断和流行病学调查。最近，已经开发出大规模检测针对 SARS-CoV-2 抗原的总抗体 (Ab)、免疫球蛋白 G (IgG) 和 IgM 的检测方法，但有关这些检测方法的诊断准确性的数据有限。这项研究是丹麦国家合作项目，评估了 16 个实验室的 15 项商业化验和一项内部抗 SARS-CoV-2 化验。使用来自无症状、轻度或中度 COVID-19、非住院或住院患者的 150 个样本进行敏感性评估，并经核酸扩增测试 (NAAT) 确认；样本是在症状出现或 NAAT 阳性（无症状患者）后 13 至 73 天收集的。在 SARS-CoV-2 流行之前从超过 586 名献血者和患有自身免疫性疾病、巨细胞病毒或 Epstein-Barr 病毒感染以及急性病毒感染的患者收集的样本中评估了特异性和交叉反应性。除了 DiaSorin Liaison XL IgG (97.2%) 之外，所有总抗体和 IgG 检测的特异性均达到 ≥99%。灵敏度从高到低依次为万泰 ELISA 总抗体 (96.7%)、CUH-NOVO 内部 ELISA 总抗体 (96.0%)、Ortho Vitros 总抗体 (95.3%)、YHLO iFlash IgG (94.0%)、Ortho Vitros IgG (93.3) %)、Siemens Atellica 总抗体 (93.2%)、Roche Elecsys 总抗体 (92.7%)、Abbott Architect IgG (90.0%)、Abbott Alinity IgG（中位数 88.0%）、DiaSorin Liaison XL IgG（中位数 84.6%）、Siemens Vista总抗体 (81.0%)、Euroimmun/ELISA IgG (78.0%) 和 Snibe Maglumi IgG（中位数 78.0%）。然而，多个测定的置信区间重叠。IgM 结果各不相同，万泰 IgM ELISA 显示出最高的敏感性 (82.7%) 和特异性 (99%)。血清阳性率随着症状出现时间和症状严重程度的增加而增加。