血清2019新型冠状病毒IgM和IgG抗体联合检测在新型冠状病毒感染中的诊断价值  

The diagnostic value of joint detection of serum IgM and IgG antibodies to 2019-nCoV in 2019-nCoV infection

作　　者：徐万洲[1] 李娟[1] 何晓云[1] 张才庆[1] 梅四青[1] 李从荣[1] 李艳[1] 程少华 张平安[1] Xu Wanzhou;Li Juan;He Xiaoyun;Zhang Caiqing;Mei Siqing;Li Congrong;Li Yan;Cheng Shaohua;Zhang Ping'an(Department of Clinical Laboratory,Renmin Hospital of Wuhan University,Wuhan 430060,China;Department of Quality and Safety Management,Renmin Hospital of Wuhan University,Wuhan 430060,China)

机构地区：[1]武汉大学人民医院检验科,武汉430060 [2]武汉大学人民医院质量和安全管理办公室,武汉430060

出　　处：《中华检验医学杂志》2020年第3期230-233,共4页Chinese Journal of Laboratory Medicine

摘　　要：目的:探讨新型冠状病毒(2019-nCoV)免疫球蛋白M(IgM)和免疫球蛋白G(IgG)抗体检测在新型冠状病毒感染中的诊断价值。方法:本研究采用回顾性研究方法,收集2020年1月20日至2020年2月17日在武汉大学人民医院就诊的门诊和住院患者284例,其中205例为新型冠状病毒肺炎患者,包括2019-nCoV核酸检测阳性的确诊患者186例,以及2019-nCoV核酸检测阴性但临床症状和CT检测结果符合《新型冠状病毒肺炎防控方案(第五版)》患者19例,作为病例组。排除新型冠状病毒肺炎的其他疾病患者79例,作为对照组。采用全自动化学发光免疫分析技术对所有研究对象进行血清2019-nCoV IgM和IgG抗体检测。采用χ^2检验对2019-nCoV IgM和IgG抗体检测和核酸检测结果差异进行统计学分析。结果:血清2019-nCoV IgM和2019-nCoV IgG的临床敏感度分别为70.24%(144/205)和96.10%(197/205),临床特异度分别为96.20%(76/79)和92.41%(73/79)。2019-nCoV抗体检测的阳性预测值为95.63%(197/206),阴性预测值为91.03%(71/78),2019-nCoV核酸检测的阳性预测值为100%(186/186),阴性预测值为80.61%(79/98)。2019-nCoV抗体检测和2019-nCoV核酸诊断2019-nCoV感染的总符合率为88.03%(250/284)。结论:血清2019-nCoV IgM和IgG联合检测可作为新型冠状病毒感染的有效筛查和诊断指标,是新型冠状病毒肺炎核酸检测假阴性的有效互补。Objective To investigate the diagnostic value of immunoglobulin M(IgM)and immunoglobulin G(IgG)antibodies to 2019 Novel Coronavirus(2019-nCoV)in 2019-nCoV infection.Methods This is a retrospective study.Serum samples were collected from 284 patients including outpatients and inpatients in the Renmin Hospital of Wuhan University from January 20 to February 17 in 2020.Among them 205 cases were 2019-nCoV infected patients,including 186 cases confirmed with nucleic acid test and 19 cases diagnosed by clinical symptoms and CT characteristics according to"the New Coronavirus Pneumonia Control Protocol(5th edition)".A total of 79 subjects with other diseases but negative to 2019-nCoV infection were recruited as control group.Serum IgM and IgG antibodies to 2019-nCoV were measured with fully automated immunoassay technology for all subjects.Statistical significance between 2019-nCoV antibodies test and 2019-nCoV nucleic acid test was determined using theχ^2 tests.Results The sensitivity of serum IgM and IgG antibodies to 2019-nCoV were 70.24%(144/205)and 96.10%(197/205)respectively and the specificity were 96.20%(76/79)and 92.41%(73/79)respectively.The positive and negative predictive values of 2019-nCoV antibodies were 95.63%(197/206)and 91.03%(71/78)respectively,and the positive and negative predictive values of 2019-nCoV nucleic acid test were 100%(186/186)and 80.61%(79/98)respectively.The total coincidence rate of diagnosing 2019-nCoV infection between antibody tests and nucleic acid test for 2019-nCoV were 88.03%(250/284).Conclusion Joint detection of serum IgM and IgG antibodies to 2019-nCoV is an effective screening and diagnostic indicators for 2019-nCoV infection,and an effective complement to the false negative results to nucleic acid test.

关 键 词：冠状病毒属 肺炎 病毒性 免疫球蛋白M 免疫球蛋白G 冠状病毒感染 血清学试验 

分 类 号：R446[医药卫生—诊断学] R5[医药卫生—临床医学]