The serological testing of anti‐SARS‐CoV‐2 immunoglobulin G (IgG) and/or IgM is widely used in the diagnosis of COVID‐19. However, its diagnostic efficacy remains unclear. In this study, we searched for diagnostic studies from the Web of Science, PubMed, Embase, CNKI, and Wanfang databases to calculate the pooled diagnostic accuracy measures using bivariate random‐effects model meta‐analysis. As a result, 22 from a total of 1613 articles, including 2282 patients with SARS‐CoV‐2 and 1485 healthy persons or patients without SARS‐CoV‐2, were selected for a meta‐analysis. Pooled sensitivity, specificity, and area under curve of the summary receiver operator curve (SROC) were: (a) 0.85 (95% confidence interval [CI]: 0.79‐0.90), 0.99 (95% CI: 0.98‐1.00), and 0.99 (95% CI: 0.97‐0.99) for anti‐SARS‐CoV‐2 IgG and (b) 0.74 (95% CI: 0.65‐0.81), 0.99 (95% CI: 0.97‐1.00), and 0.95 (95% CI: 0.93‐0.97) for IgM. A subgroup analysis among detection methods indicated the sensitivity of IgG and IgM using enzyme‐linked immunosorbent assay were slightly lower than those using gold immunochromatography assay (GICA) and chemiluminescence immunoassay (P  > .05). These results showed that the detection of anti‐SARS‐CoV‐2 IgG and IgM had high diagnostic efficiency to assist the diagnosis of SARS‐CoV‐2 infection. And, GICA might be used as the preferred method for its accuracy and simplicity.

中文翻译：

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抗 SARS-CoV-2 IgG/IgM 检测对 COVID-19 的诊断效果：荟萃分析。

抗 SARS-CoV-2 免疫球蛋白 G (IgG) 和/或 IgM 的血清学检测广泛用于 COVID-19 的诊断。然而，其诊断效果仍不清楚。在本研究中，我们从 Web of Science、PubMed、Embase、CNKI 和万方数据库中搜索了诊断研究，以使用双变量随机效应模型荟萃分析计算汇总的诊断准确性度量。结果，从总共 1613 篇文章中选择了 22 篇进行荟萃分析，其中包括 2282 名 SARS-CoV-2 患者和 1485 名健康人或未感染 SARS-CoV-2 的患者。汇总接受者操作曲线 (SROC) 的汇总敏感性、特异性和曲线下面积分别为：(a) 0.85（95% 置信区间 [CI]：0.79-0.90）、0.99（95% CI：0.98-1.00）和抗 SARS-CoV-2 IgG 为 0.99 (95% CI: 0.97-0.99) 和 (b) 0.74 (95% CI: 0.65-0.81), 0.99 (95% CI: 0.97-1.00)，IgM 为 0.95 (95% CI: 0.93-0.97)。检测方法的亚组分析表明，使用酶联免疫吸附法检测 IgG 和 IgM 的灵敏度略低于使用金免疫层析法（GICA）和化学发光免疫法的检测方法。P  > .05)。这些结果表明，检测抗 SARS-CoV-2 IgG 和 IgM 具有较高的诊断效率，有助于诊断 SARS-CoV-2 感染。而且，由于其准确性和简单性，GICA 可能被用作首选方法。