摘要
目的使用新冠肺炎确诊病例血液样本对荧光免疫层析法、胶体金法和微量病毒中和抗体试验等血清学方法进行评价,比较3种试验方法检测结果的差异,为临床治疗和流行病学调查提供技术手段。方法采用新型冠状病毒(2019 novel coronavirus,2019-nCoV)IgG/IgM抗体联检试剂(荧光免疫层析法)和2019-nCoV抗体检测试剂盒(胶体金法)及由广东省疾病预防控制中心实验室分离的2019-nCoV病毒株建立的微量病毒中和抗体试验对临床确诊患者血液样本进行检测。结果本研究收集广东省第二人民医院2019-nCoV临床确诊患者血液样本113份,患者年龄中位数为47.50(32.00,57.00)岁,性别比2.77∶1;患者微量病毒中和抗体试验最高滴度1∶1024;以微量病毒中和抗体试验结果作为金标准时,胶体金法检测灵敏度高于免疫层析法(94.74%vs 82.46%),两者Kappa值分别为85.84%和75.24%,阴性和阳性预测值分别为94.44%、91.53%和83.87%、92.16%。结论在检测2019-nCoV的血清学方法中,以微量病毒中和抗体试验为金标准时,相比荧光免疫层析法,胶体金法灵敏度和Kappa值更高,更适宜于2019-nCoV病例的快速检测。
Objective To detect blood samples from clinically confirmed cases infected with the 2019 novel coronavirus(2019-nCoV)by fluorescence immunochromatography,colloidal gold immunoassay and micro neutralization test and compare differences in result and provide useful approaches to clinical and epidemiological investigation.Methods The 2019-nCoV IgG/IgM antibody kit(Fluorescent immuno-chromatography)and the 2019-nCoV antibody test kit(Colloidal gold immunoassay)from Guangzhou Wanfu biotechnology Limited by Share Ltd,and the micro neutralization test established by a 2019-nCoV strain isolated by the laboratory in Guangdong Provincial Center for Diseases Control and Prevention were used to detect serum samples of clinically confirmed patients,in the Guangdong Province Second People′s Hospital,China.Results A total of 113 serum samples from clinically confirmed cases infected with the 2019-nCoV were collected in Guangdong 2nd People′s Hospital.The median age of the patients was 47.50(32.00,57.00)years and the gender ratio was 2.77∶1;The highest neutralizing antibody titer of micro neutralization test was 1∶1024;Taking the result of micro neutralization test as gold standard,the sensitivity for colloidal gold immunoassay was greater than that of fluorescence immunochromatography(94.74%vs 82.46%),and the Kappa value for colloidal gold immunoassay and fluorescence immunochromatography was 85.84%and 75.24%respectively;at the same time,the negative predictive value and the positive predictive value for them were 94.44%,91.53%and 83.87%,92.16%respectively.Conclusions In the serological method for the detection of the 2019-nCoV infection,the sensitivity and Kappa value for colloidal gold immunoassay were higher than those of fluorescent immunochromatography when the result of micro neutralization test was taken as the gold standard,which was more suitable for rapid detection of cases with the 2019-nCoV infection.
作者
苏娟
梁丹
黎薇
莫艳玲
廖剑洪
郑焕英
柯昌文
Su Juan;Liang Dan;Li Wei;Mo Yanling;Liao Jianhong;Zheng Huanying;Ke Changwen(Pathogenic Microorganism Inspection Institute,Guangdong Provincial Center for Disease Control and Prevention,Guangzhou 511430,China;Shantou University Medical College,Shantou 515041,China)
出处
《中华实验和临床病毒学杂志》
CAS
CSCD
2021年第6期680-683,共4页
Chinese Journal of Experimental and Clinical Virology
基金
广东省新型冠状病毒科技攻关项目(2020111107001)。
关键词
胶体金法
荧光免疫层析法
微量病毒中和抗体试验
新型冠状病毒
Colloidal gold immunoassay
Fluorescence immunochromatography
Micro neutralization test
2019 Novel coronavirus
作者简介
通信作者:柯昌文,Email:kecw1965@aliyun.com,电话:020-31051236。
