新型冠状病毒3种抗体试剂盒的性能评估及临床应用初探  

Performance evaluation and clinical application of three antibody test kits for novel coronavirus

作　　者：谭明凯 区静怡 黄颖 李燕[1] 麦洁雯 马成慧 石亚玲[1] Tan Mingkai;Ou Jingyi;Huang Ying;Li Yan;Mai Jiewen;Ma Chenghui;Shi Yaling(Department of Laboratory Medicine,Guangzhou Eighth People′s Hospital,Guanzhou Medical University,Guangzhou 510060,China;Department of Gastrointestinal Surgery,Guangzhou Eighth People′s Hospital,Guanzhou Medical University,Guangzhou 510060,China)

机构地区：[1]广州市第八人民医院检验科,510060 [2]广州市第八人民医院胃肠外科,510060

出　　处：《中华微生物学和免疫学杂志》2020年第4期250-255,共6页Chinese Journal of Microbiology and Immunology

摘　　要：目的:评估新型冠状病毒(SARS-CoV-2)3种抗体试剂盒的检测性能,探讨SARS-CoV-2抗体检测在临床应用的可行性及优势。方法:选取2020年1—2月广东省广州市第八人民医院收治的SARS-CoV-2感染患者104例作为病例组,51例同期健康体检者作为对照组,回顾性分析我院SARS-CoV-2核酸检测试剂盒在确诊病例中的阳性检出率;分别使用2种胶体金法试剂盒(A和B试剂盒)和1种化学发光免疫分析法试剂盒(C试剂盒)对病例组和对照组血清病毒抗体(IgM/IgG)进行检测。结果:A试剂盒检测SARS-CoV-2特异性IgM和IgG抗体的阳性检出率分别是77.88%(81/104)和65.38%(68/104),临床特异性分别是70.59%(36/51)和100.00%(51/51);检测IgM抗体的假阳性率较高,达29.41%(15/51)。B试剂盒检测SARS-CoV-2特异性总抗体的阳性检出率是63.46%(66/104),临床特异性是94.12%(48/51)。C试剂盒检测SARS-CoV-2特异性IgM和IgG抗体的阳性检出率分别是31.73%(33/104)和64.42%(67/104),临床特异性均为98.04%(50/51)。2种胶体金法试剂盒与化学发光免疫分析法试剂盒检测结果呈中度相关,Kappa值分别是0.462和0.587(Z=6.157,P<0.01;Z=7.345,P<0.01)。C试剂盒对IgG抗体的阳性检出率最高,对于发病14 d后的患者使用C试剂盒检测SARS-CoV-2特异性IgG抗体会更加可靠。所有类型标本总SARS-CoV-2核酸阳性检出率是63.46%(66/104),在咽拭子或痰液的阳性检出率最高,其次是血液、肛拭子,暂时未在尿液标本中检测出病毒核酸。结论:SARS-CoV-2特异性抗体可以在病程的早期或晚期被检测出来,并且抗体检测方法具有检测时间短、操作简单、生物安全度高等优点,可作为对SARS-CoV-2核酸检测阴性疑似病例进行COVID-19诊断的补充检测或者核酸辅助检测。化学发光法试剂盒有较好的灵敏度与特异性,推荐临床实验室使用。Objective To evaluate the performance of three antibody kits for novel coronavirus(SARS-CoV-2)and to investigate the feasibility and advantages of them in clinical application.Methods A total of 104 patients who were admitted to Guangzhou Eighth People′s Hospital with COVID-19 from January to February 2020 were selected as research group.Fifty-one healthy subjects were selected during the same period as negative control group.Serum antibodies(IgM/IgG)against SARS-CoV-2 were detected using two kinds of colloidal gold kits(A and B kits)and one chemiluminescence kit(C kit).The positive rates of SARS-CoV-2 nucleic acid in different samples from patients with COVID-19 were retrospectively analyzed.Results The clinical sensitivity of A kit to detect SARS-CoV-2-specific IgM and IgG was 77.88%(81/104)and 65.38%(68/104),respectively,and the clinical specificity was 70.59%(36/51)and 100.00%(51/51).However,the false positive rate in IgM detection was as high as 29.41%(15/51).The sensitivity of B kit to test total antibodies to SARS-CoV-2 was 63.46%(66/104),and the clinical specificity was 94.12%(48/51).The clinical sensitivity of C kit to detect SARS-CoV-2-specific IgM and IgG were respectively 31.73%(33/104)and 64.42%(67/104),and the clinical specificity were both 98.04%(50/51).There was a moderate correlation between the detection results of two colloidal gold kits and the chemiluminescence kit with the Kappa values of 0.462 and 0.587(Z=6.157,P<0.01;Z=7.345,P<0.01).C kit had the highest positive detection rate for IgG,and would be more reliable to be used for IgG detection in COVID-19 patients 14 d after onset.The total positive detection rate of nucleic acid in all types of samples was 63.46%(66/104).The highest positive detection rate was in throat swabs or sputum samples,followed by those in blood samples and anal swabs.No viral nucleic acid was detected in urine samples for the time being.Conclusions SARS-CoV-2-specific antibodies could be detected in the early or late stage of COVID-19.The method of antibody detect

关 键 词：新型冠状病毒(SARS-CoV-2) 化学发光免疫分析法 胶体金免疫检测 核酸检测 性能评估 临床应用 

分 类 号：R446[医药卫生—诊断学] R5[医药卫生—临床医学]