化学发光法检测新型冠状病毒IgM、IgG抗体假阳性分析  

The Analysis of the False Positive Results of 2019-nCoV IgM and IgG Tests by Chemiluminescence Assay

作　　者：陈亚利 胡明[1] CHEN Yali;HU Ming(Department of Clinical Laboratory,Beijing Luhe Hospital,Capital Medical University,Beijing 101100,China)

机构地区：[1]首都医科大学附属北京潞河医院感染性疾病科,北京101100

出　　处：《标记免疫分析与临床》2022年第2期224-229,共6页Labeled Immunoassays and Clinical Medicine

基　　金：2020年度北京市临床重点专科项目(编号:20210209)。

摘　　要：目的探讨化学发光法检测新型冠状病毒(2019 novel coronavirus,2019-nCoV)特异性抗体IgM和IgG假阳性的影响因素。方法回顾性研究2020年6月至2021年3月首都医科大学附属北京潞河医院感染性疾病科就诊的患者25671例,收集受检者流行病学史、疫苗接种史、既往史、过敏史及实验室检查指标(包括2019-nCoV抗体和核酸检测结果)。采集血液标本应用磁微粒化学发光法检测2019-nCoV IgM、IgG抗体。采集咽拭子应用RT-PCR方法检测2019-nCoV核酸。结果25671例受检者标本中,2019-nCoV核酸检测全部阴性,化学发光法检测2019-nCoV IgM抗体阳性者共214例,IgM抗体阳性受检者中既往患过新型冠状病毒肺炎者(coronavirus disease 2019,COVID-19)3例(0.01%),接种新冠疫苗者171例(0.67%),假阳性者40例(0.16%)。2019-nCoV IgG抗体阳性者共541例,IgG抗体阳性受检者中既往患过COVID-19者4例(0.02%),接种新冠疫苗者498例(1.94%),假阳性者39例(0.15%)。IgM抗体假阳性率为0.14%,IgG抗体假阳性率为0.15%,二者差异无统计学意义(χ^(2)=0.013,P=0.910)。IgM假阳性抗体滴度为2.02 S/CO(1.42~3.32),IgM真阳性抗体滴度为2.09 S/CO(1.42~3.41),二者相比差异无统计学意义(Z=-0.205,P=0.837);IgG假阳性滴度为1.56 S/CO(1.24~2.24),IgG真阳性滴度为5.94 S/CO(2.62~18.38),二者相比差异有统计学意义(Z=-7.672,P 0x0E䥺Symbol|@@0x0F0.001)。其中男性女性IgM假阳性率分别为0.18%(28/15189)、0.11%(12/10482),差异无统计学意义(χ^(2)=1.789,P=0.181);IgG假阳性率分别为0.13%(20/15189)、0.18%(19/10482),差异无统计学意义(χ^(2)=1.005,P=0.316)。年龄组≤20、21~30、31~40、41~50、51~60、>60岁组间IgM假阳性率差异无统计学意义(χ^(2)=9.127,P=0.087),IgG抗体假阳性率在各年龄组间差异有统计学意义(χ^(2)=28.394,P<0.001),其中>60岁老年组的IgG抗体的假阳性率最高。假阳性受检者中高血压、糖尿病、冠心病、脑血管病、肿瘤患者占比较高。动态随访�Objective To investigate the influence factors of false positive results of IgM and IgG specific antibodies detected by chemiluminescence assay for novel coronavirus(2019-nCoV).Methods A retrospective study was conducted on 25,671 patients admitted to Beijing Luhe Hospital from July 1,2020 to Mar 31,2021.Blood samples were collected and detected by chemiluminescence method for specific antibody IgM and IgG.All positive patients were tested by real-time fluorescence PCR novel coronavirus nucleic acid.Epidemiological history,vaccination history,past history,allergy history and laboratory indicators(including 2019-nCoV antibody and nucleic acid test results)were collected.Blood samples were collected for the detection of 2019-nCoV IgM,IgG antibody by magnetic particle chemiluminescence.The nucleic acid of 2019-nCoV was detected by RT-PCR.Results Among the 25,671 samples tested,all the nucleic acid tests of 2019-nCoV were negative,while 214 samples were positive for 2019-nCoV IgM antibody detected by chemiluminescence,and 3(0.01%)of the IgM antibody positive samples had a history of COVID-19.There were 171 cases(0.67%)who received 2019-nCoV vaccine and 40 cases(0.16%)who were false positive.A total of 541 patients were positive for 2019-nCoV IgG antibody,including 4 patients(0.02%)who had previously contracted COVID-19 and 498 patients(1.94%)who had received 2019-nCoV vaccine.39 cases(0.15%)were found to have false positive.IgM antibody and IgG antibody had a false positive rate of 0.14%and 0.15%respectively(χ^(2)=0.013,P=0.910;χ^(2)=1.789,P=0.181);IgM false positive antibody titer was 2.02 S/CO(1.42,3.32),and IgM true positive antibody titer was 2.09 S/CO(1.42,3.41).There was no significant difference between the two(Z=-0.205,P=0.837)(Table 1);IgG false positive titer was 1.56 S/CO(1.24,2.24),IgG true positive titer was 5.94 S/CO(2.62,18.38),and the difference between the two was statistically significant(Z=-7.672,P 0x0E䥺Symbol|@@0x0F0.001).IgM false positive rate of male and female were 0.18%(28/15189)and 0.11%

关 键 词：化学发光法 新型冠状病毒 特异性抗体 假阳性 

分 类 号：R373.9[医药卫生—病原生物学]