SARS-CoV-2抗体检测在新型冠状病毒肺炎诊断中的应用价值

Role of severe acute respiratory syndrome coronavirus 2 antibody detections in the diagnosis of corona virus disease 2019

目的探讨血清严重急性呼吸综合征冠状病毒(SARS-CoV-2)IgM和IgG抗体检测在新型冠状病毒肺炎(COVID-19)诊断中的价值。方法选取COVID-19患者173例(COVID-19组),其中140例SARSCoV-2首次核酸检测阳性,33例多次检测后呈阳性。以101例排除COVID-19的患者作为对照组。采用胶体金免疫层析法(CGIA)检测SARS-CoV-2 IgM和IgG抗体,采用荧光定量聚合酶链反应(PCR)检测SARS-CoV-2核酸。以临床诊断为金标准,分析SARS-CoV-2 IgM和IgG抗体诊断COVID-19的效能。结果 SARS-CoV-2 IgM和IgG抗体的敏感性分别为76.9%、74.6%,特异性分别为94.0%、95.1%,临床总符合率分别为83.2%、82.1%,与临床诊断的一致性均较好(kappa值分别为0.663、0.644)。受试者工作特征(ROC)曲线分析结果显示,SARS-CoV-2 IgM和IgG抗体诊断COVID-19的曲线下面积(AUC)均为0.85。结论 SARS-CoV-2抗体检测具有较高的敏感性、特异性和临床总符合率,可用于COVID-19的辅助诊断。

Objective To investigate the role of severe acute respiratory syndrome coronavirus 2(SARSCoV-2)IgM and IgG antibody detections in the diagnosis of corona virus disease 2019(COVID-19).Methods A total of 173 patients diagnosed with COVID-19 were enrolled.There were 140 cases of being positive for the first time of SARS-CoV-2 nucleic acid test and 33 cases of being eventually diagnosed for several times of SARS-CoV-2 nucleic acid test.Totally,101 patients without COVID-19 were enrolled as control group.Colloidal gold immunochromatography assay(CGIA)was used to detect SARS-CoV-2 IgM and IgG antibodies,and fluorescence quantitative polymerase chain reaction(PCR)was used to detect SARS-CoV-2 nucleic acid.Taking clinical diagnosis as gold standard,the efficiency of SARS-CoV-2 IgM and IgG antibody detections in the diagnosis of COVID-19 was analyzed.Results The sensitivities of SARS-CoV-2 IgM and IgG antibody detections were 76.9%and 74.6%,the specificities were 94.0%and 95.1%,and the consistency rates were 83.2%and 82.1%,which were well consistent with the clinical diagnosis(kappa values were 0.663 and 0.644),respectively.Receiver operating characteristic(ROC)curve analysis showed that the areas under curves(AUC)of SARS-CoV-2 IgM and IgG antibody detections for the diagnosis of COVID-19 were 0.85.Conclusions The detections of SARS-CoV-2 antibodies have high sensitivities,specificities and consistency rates,which can be used for the auxiliary diagnosis of COVID-19.