全自动化学发光微粒子免疫分析法在梅毒螺旋体特异性抗体检测中的应用
Application of automatic chemiluminescent microparticle immunoassay in detection of Treponema pallidum specific antibodies
时小淋 1吴美慧1
作者信息
- 1. 264200 山东威海,青岛大学附属威海市立第二医院检验科
- 折叠
摘要
目的 探讨化学发光微粒子免疫分析法(CMIA)在梅毒螺旋体特异性抗体筛查中的临床应用,分析其假阳性率和影响因素.方法 收集 2023 年 1-7 月在青岛大学附属威海市立第二医院体检、门诊就诊及住院患者的 11015 份血清标本,均采用CMIA进行初筛,对S/CO≥1 的阳性标本采用梅毒螺旋体明胶凝集试验(TPPA)进行复检,以TPPA为确证方法,比较不同S/CO值的CMIA与TPPA阳性标本的符合率.采用Graphpad Prism 9 统计软件,绘制受试者工作特征曲线(ROC曲线)并计算ROC曲线下面积(AUC),评估CMIA对梅毒的预测价值.将患者根据年龄分为<40 岁组(60 例)、40～65 岁组(55 例)和>65 岁组(26 例),计算各组CMIA检测的假阳性率.结果 CMIA的阳性检出率为 1.28%,TPPA的阳性检出率为 1.07%.当S/CO值为 1～2 时,假阳性率为 93.75%,当S/CO>10 时,假阳性率为 1.00%.CMIA的AUC为 0.973,95%可信区间(95%CI)为 0.948～0.998,CMIA检测梅毒抗体的最佳截断值为 4.62,诊断梅毒的敏感度为 93.2%,特异度为 91.3%.年龄<40 岁组、40～65 岁组和>65 岁组的CMIA假阳性率分别为18.33%(11/60)、7.27%(4/55)和 44.44%(8/26).结论 CMIA具有高敏感度、高自动化、高通量等特点,可以用于梅毒大规模筛查试验,但CMIA对孕妇和老年人群具有较高的假阳性率,需同时结合TPPA进行复检,提高检测的准确度.
Abstract
Objective To investigate the clinical application of chemiluminescent microparticle immunoassay(CMIA)in the screening of Treponema pallidum specific antibodies,and to analyze the false positive rate and influencing factors.Methods A total of 11015 serum samples from physical examiners,outpatient visiters and inpatients in Weihai Second Hospital Affiliated to Qingdao University from January to July,2023 were collected.CMIA method was used for preliminary screening,and the positive samples with S/CO≥1 were re-examined using Treponema pallidum particle agglutination test(TPPA).TPPA was used as the confirmation method to compare the coincidence rate of CMIA with TPPA of different S/CO values.The receiver operater characteristic(ROC)curve was drawn and the area under ROC curve(AUC)was calculated to evaluate the predictive value of CMIA for syphilis using Graphpad Prism 9 software.The patients were divided into three groups according to age such as＜40 years old group(60 cases),40-65 years old group(55 cases)and＞65 years old group(26 cases),and the false positive rates of CMIA in each group were calculated.Results The positive rate of CMIA was 1.28%and that of TPPA was 1.07%.When S/CO value was 1-2,the false positive rate was 93.75%,and when S/CO value was＞10,the false positive rate was 1.00%.The AUC of CMIA was 0.973,95%confidence interval(95%CI)was 0.948-0.998,and the cut off value for detection of syphilis antibody by CMIA was 4.62.The sensitivity and specificity for diagnosis of syphilis were 93.2%and 91.3%.The false positive rates of CMIA in＜40 years old group,40-65 years old group and＞65 years old group were 18.33%(11/60),7.27%(4/55)and 44.44%(8/26),respectively.Conclusions CMIA has high sensitivity,high automation and high throughput,which could be used as a mass screening test for syphilis.However,CMIA has high false positive rate for pregnant women and elderly population,and it needs to be combined with TPPA to improve the accuracy of syphilis results.
关键词
梅毒/化学发光微粒子免疫分析法/假阳性/孕妇Key words
Syphilis/Chemiluminescent microparticle immunoassay/False positive/Pregnant woman引用本文复制引用
出版年
2024
NETL
NSTL
万方数据