新型冠状病毒抗体检测在疑似病例排查中的应用研究  

Application of 2019 Novel Coronavirus(2019-nCoV)specific antibody detection for suspected cases screening

作　　者：高会霞[1] 李雅楠[1] 刘玉珍[1] 黄颖[1] 许怡[1] 张志[1] 郭云 卢建华 李力[2] 王瑜玲[3] 江平[2] 戴二黑[1] GAO Hui-xia;LI Ya-nan;LIU Yu-zhen;HUANG Ying;XU Yi;ZHANG Zhi;GUO Yun;LU Jian-hua;LI Li;WANG Yu-ling;JIANG Ping;DAI Er-hei(Department of Laboratory Medicine,Fifth Hospital of Shijiazhuang,Hebei Medical University,Shijiazhuang 050021,China;Department of internal medicine,Fifth Hospital of Shijiazhuang,Hebei Medical University,Shijiazhuang 050021,China;Department of Tuberculosis,Fifth Hospital of Shijiazhuang,Hebei Medical University,Shijiazhuang 050021,China)

机构地区：[1]河北医科大学石家庄市第五医院检验科,石家庄050021 [2]河北医科大学石家庄市第五医院内科,石家庄050021 [3]河北医科大学石家庄市第五医院结核科,石家庄050021

出　　处：《中国人兽共患病学报》2021年第12期1102-1107,1134,共7页Chinese Journal of Zoonoses

基　　金：河北省第二批新型冠状病毒感染的肺炎防控应急科研攻关项目(No.20277734D);石家庄市新型冠状病毒肺炎防控应急科研攻关项目(No.201460513A-1)。

摘　　要：目的比较不同原理抗体检测试剂对新冠疑似病例诊断的准确性,对新冠疑似病例提出高效的排查方案,进一步为建立高风险人群的临床筛查路径提供科学依据。方法对76例由于IgM抗体初检阳性被转入定点医院隔离观察的新冠疑似病例,进行鼻咽拭子核酸检测,血清微量病毒中和抗体和3种市售不同原理抗体检测试剂检测,以及肺部CT检查,结合临床症状等信息,综合判断新冠确诊或排除情况,并将3种血清学抗体检测试剂与临床判断结果进行对比分析,比较3种检测方法结果的差异。结果通过综合判断,76例疑似病例中有3例为确诊病例,73例为排除病例。与临床确诊/排除结果比较,3种血清学抗体检测方法中,化学发光总抗体对3例病例入院不同时间点共9份样本均能检出,对73例排除病例入院第1天采集样本的检测特异性为97.26%,高于化学发光法IgM/IgG和胶体金法IgM/IgG单独检测(入院第1 d样本检测特异性均为73.97%)。结论化学发光法检测新冠总抗体具有高灵敏度和高特异性,可以用于疑似病例抗体检测的初筛。针对重点人群筛查,应首先进行2019-nCoV核酸检测,若核酸检测阴性,则采用检测血清总抗体为主要指标的筛查路径。Comparing the accuracy of antibody detection reagents which based on different principles by the diagnosis of suspected cases of new crown,propose an efficient screening plan for suspected cases,and further provide a scientific basis for establishing a clinical screening path for high-risk populations.For 76 suspected cases of COVID-19 that were transferred to designated hospitals for isolation and observation due to the initial IgM antibody test,nasopharyngeal swab nucleic acid tests,serum trace virus neutralizing antibodies and three commercially available antibody test reagents with different principles were tested,combined with lung CT and the examination and clinical symptoms or other information,comprehensively judge the diagnosis or exclusion of the new crown,and compare the three kinds of serological antibody detection reagents with the clinical judgment results to compare the detection rates of the three detection methods.Through comprehensive judgment,3 suspected cases are confirmed cases,and 73 suspected cases are excluded cases.Compared with the clinical diagnosis/exclusion results,among the three serological antibody detection methods,the chemiluminescence total antibody kit detect positive for all the 9 serums collected from the 3 confirmed cases in different time points,the detection specificity is 97.26%for 73 excluded cases,it’s significantly higher than that of the chemiluminescence method IgM/IgG and the colloidal gold method IgM/IgG Separate testing(the specificity is 73.97%on the first day of admission).The chemiluminescence method for the detection of total antibodies to the 2019-nCoV has high sensitivity and high specificity,and can be used for preliminary screening of antibody detection in suspected cases.For the screening of target populations,the 2019-nCoV nucleic acid test should be performed first.If the nucleic acid test is negative,the screening path with the detection of serum total antibodies as the main indicator should be adopted.

关 键 词：新型冠状病毒 核酸 血清学 抗体 

分 类 号：R373.1[医药卫生—病原生物学]