两种新型冠状病毒免疫学检测方法的应用评价  

Application evaluation of two immunological methods of SARS-CoV-2

作　　者：郑仲华 黄鑫鑫 张欢[1] 邹丽容[1] 胡瑶 李振翠 郭前方 刘美真[1] 梁丽君[1] 李柏生[1] ZHENG Zhonghua;HUANG Xinxin;ZHANG Huan;ZOU Lirong;HU Yao;LI Zhencui;GUO Qianfang;LIU Meizhen;LIANG Lijun;LI Bosheng(Guangdong Provincial Center for Disease Control and Prevention,Guangdong Workstation for Emerging Infectious Disease Control and Prevention,Guangzhou 511430,China)

机构地区：[1]广东省疾病预防控制中心,广东新发突发传染病防治工作站,广州511430 [2]南方医科大学公共卫生学院,广州510515

出　　处：《中国免疫学杂志》2023年第2期395-398,共4页Chinese Journal of Immunology

基　　金：广东省医学科学技术研究基金项目(A2020055)。

摘　　要：目的:为有效检测新型冠状病毒特异性抗体(新冠抗体),利用化学发光法和胶体金法分别检测已完成中和试验的92份血清,对两种方法的敏感度和特异度等进行初步比较和评价,为大规模人群免疫后血清SARS-CoV-2抗体水平监测提供参考。方法:采用病毒中和试验、胶体金试剂盒和全自动化学发光分析仪分别对样本开展SARS-CoV-2特异性抗体检测,计算诊断特异度、敏感度、阴阳性预测值和符合率。结果:化学发光法的灵敏度为100.00%,高于胶体金法的71.64%;胶体金法的特异度为92.00%,高于化学发光法的64.00%;胶体金法阴阳性预测值分别为54.76%和96.00%,而化学发光法的阴阳性预测值分别为100.00%和88.16%;胶体金法和化学发光法的Kappa值分别为0.525和0.721。结论:以微量病毒中和抗体试验为金标准,化学发光法的灵敏度和Kappa值较高,适用于SARS-CoV-2病例辅助性快速检测;胶体金法测定SARS-CoV-2特异度总抗体的灵敏度一般,特异度较高,其使用简便快速、成本低廉,在条件限制、需要及时监测等情况下,适用于快速大规模筛查以及阳性样本初步检测。随着新冠疫苗在人群中大规模免疫,有必要开发一种更加高效便捷可用的检测方法用于监测人群保护性抗体水平。Objective:In order to effectively detect SARS-CoV-2 specific antibody,92 serums of neutralizing tests were detected by chemiluminescence and colloidal gold method respectively.The sensitivity and specificity of the two methods were preliminarily compared and evaluated,providing a reference for monitoring the serum level of SARS-CoV-2 specific antibody after large-scale human immunization.Methods:Virus neutralization test,colloidal gold kit and automatic chemiluminescence analyzer were used to detect SARS-CoV-2 specific antibodies in samples,and the diagnostic specificity,sensitivity,negative and positive predictive value and coincidence rate were calculated.Results:The sensitivity of chemiluminescence method was 100.00%,which was higher than 71.64%of colloidal gold method;the specificity of colloidal gold method was 92.00%,which was higher than 64.00%of chemiluminescence method;the positive and negative predictive values of colloidal gold method were 54.76%and 96.00%,while these values of chemiluminescence method were 100.00%and 88.16%;the Kappa values of colloidal gold method and chemiluminescence method were respectively 0.525 and 0.721.Conclusion:If the micro virus neutralization antibody test is taken as the gold standard,the sensitivity and Kappa value of chemiluminescence method are higher than the colloidal gold method,so it is more suitable for the auxiliary rapid detection of SARS-CoV-2;colloidal gold method for the determination of SARS-CoV-2 has general sensitivity and high specificity,but due to its simple and rapid use and low cost,it needs to be monitored in time in some scenes,such as limited conditions,rapid largescale screening and preliminary detection of positive samples.With the large-scale immunization of SARS-CoV-2 in the population,it is necessary to develop a more efficient,convenient and available detection method for monitoring the level of protective antibodies in the population.

关 键 词：新型冠状病毒 中和试验 化学发光法 胶体金法 

分 类 号：R446.61[医药卫生—诊断学] R392.7[医药卫生—临床医学] R511