Background. This study was aimed to investigate the application of SARS-CoV-2 IgM and IgG antibodies in diagnosis of COVID-19 infection. Method. This study enrolled a total of 178 patients at Huangshi Central Hospital from January to February 2020. Among them, 68 patients were SARS-CoV-2 infected, confirmed with nucleic acid test (NAT) and CT imaging. Nine patients were in the suspected group (NAT negative) with fever and other respiratory symptoms. 101 patients were in the control group with other diseases and negative to SARS-CoV-2 infection. After serum samples were collected, SARS-CoV-2 IgG and IgM antibodies were tested by chemiluminescence immunoassay (CLIA) for all patients. Results. The specificity of serum IgM and IgG antibodies to SARS-CoV-2 was 99.01% (100/101) and 96.04% (97/101), respectively, and the sensitivity was 88.24% (60/68) and 97.06% (66/68), respectively. The combined detection rate of SARS-CoV-2 IgM and IgG antibodies was 98.53% (67/68). Conclusion. Combined detection of serum SARS-CoV-2 IgM and IgG antibodies had better sensitivity compared with single IgM or IgG antibody testing, which can be used as an important diagnostic tool for SARS-CoV-2 infection and a screening tool of potential SARS-CoV-2 carriers in clinics, hospitals, and accredited scientific laboratories.

中文翻译：

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血清IgM/IgG抗体联合检测是临床诊断SARS-CoV-2感染的重要关键

背景。本研究旨在探讨 SARS-CoV-2 IgM 和 IgG 抗体在 COVID-19 感染诊断中的应用。方法。本研究于 2020 年 1 月至 2020 年 2 月在黄石市中心医院共招募了 178 名患者。其中 68 名患者为 SARS-CoV-2 感染，经核酸检测（NAT）和 CT 成像证实。疑似组中有 9 名患者（NAT 阴性）出现发热和其他呼吸道症状。对照组中有 101 名患有其他疾病且对 SARS-CoV-2 感染呈阴性的患者。采集血清样本后，所有患者均通过化学发光免疫测定法 (CLIA) 检测 SARS-CoV-2 IgG 和 IgM 抗体。结果. 血清IgM和IgG抗体对SARS-CoV-2的特异性分别为99.01%（100/101）和96.04%（97/101），敏感性分别为88.24%（60/68）和97.06%（66/ 68），分别。SARS-CoV-2 IgM和IgG抗体的联合检出率为98.53%（67/68）。结论。血清 SARS-CoV-2 IgM 和 IgG 抗体联合检测比单一 IgM 或 IgG 抗体检测灵敏度更高，可作为 SARS-CoV-2 感染的重要诊断工具和潜在 SARS-CoV 的筛查工具-2 诊所、医院和认可的科学实验室的载体。