化学发光微粒免疫分析法检测抗TP抗体的性能评价和应用

目的探讨化学发光微粒免疫分析法(CMIA)检测抗梅毒螺旋体(TP)抗体的性能和S/CO值设定方案。方法采用CMIA检测116例患者的血清抗TP抗体,同时用荧光螺旋体抗体吸收试验(FTA-ABS)确认。分别以FTA-ABS检测结果和临床诊断结果作为标准,采用受试者工作特征(ROC)曲线评价CMIA检测抗TP抗体的性能。结果采用CMIA检测116例患者的抗TP抗体,其中有98例S/CO值>1.1、18例S/CO值≤1.1;FTA-ABS检测结果为阳性70例、弱阳性16例、阴性30例;临床诊断结果为阳性58例、阴性58例。ROC曲线分析结果显示,以FTA-ABS结果为标准,CMIA检测抗TP抗体的曲线下面积为0.885,CMIA S/CO值的最佳临界值为3.66,敏感性为95.7%,特异性为80.0%,Youden指数为0.757,当CMIA检测抗TP抗体的阳性预测值≥95%时,S/CO值为4.25;以临床诊断结果为标准,CMIA检测抗TP抗体的曲线下面积为0.944,CMIA S/CO值的最佳临界值为4.25,敏感性为87.9%,特异性为88.5%,Youden指数为0.764。结论 CMIA的敏感性高,无漏诊,有一定的误诊率,适合作为初筛实验。

Evaluation on chemiluminescence microparticle immunoassay in the detection of anti-TP antibody

Objective To investigate the performance and signal-to-cutoff(S/CO)ratio setting scheme for the detection of anti-Treponema pallidum(TP) antibody by chemiluminescence microparticle immunoassay(CMIA). Methods Anti-TP antibody was detected in 116 patients by CMIA,which was confirmed by fluorescent treponemal antibody absorption test(FTA-ABS). The results of FTA-ABS were used as gold standard. The performance of CMIA was evaluated by receiver operating characteristic(ROC) curve. Results There were 116 patients detected by CMIA,including 98 patients with S/CO>1.1 and 18 patients with S/CO≤1.1,of which 70 cases were positive,16 cases were weakly positive,and 30 cases were negative by FTA-ABS. The clinical diagnosis results were positive in 58 cases and negative in 58 cases. According to the FTA-ABS results,the area under curve of anti-TP antibody detected by CMIA was 0.885,and the Youden index was 0.757. The optimal cut-off value of anti-TP antibody S/CO ratio of CMIA was 3.66,the sensitivity was 95.7%,and the specificity was 80.0%. When the positive predictive value of anti-TP antibody detected by CMIA was ≥95%,the S/CO ratio was 4.25. According to the clinical diagnosis results,the area under curve of anti-TP antibody detected by CMIA was 0.944,and the Youden index was 0.764. The optimal cut-off value of anti-TP antibody S/CO ratio of CMIA was 4.25,the sensitivity was 87.9%,and the specificity was 88.5%. Conclusions CMIA has high sensitivity,no missed diagnosis and certain case misdiagnosis rate,so it is suitable for preliminary screening.