罗氏Cobas e602检测梅毒螺旋体抗体的临床应用与实验评价

目的 对罗氏Cobas e602全自动电化学发光免疫分析仪检测梅毒螺旋体特异性抗体阳性结果进行回顾性分析,探讨其结果真阳性率及最佳阈值。方法 对广东省中医院大学城医院2016年7月1日—2017年6月30日住院和门诊患者18 908例标本使用电化学发光免疫分析法（electro-chemiluminescence immunoassay, ECLIA）检测梅毒螺旋体特异性抗体,筛查出的阳性样本进行梅毒螺旋体明胶凝集试验（ Treponema pallidum particle assay,TPPA）确证,运用统计学方法和受试者工作特征曲线（receiver operating characteristic curve ,ROC曲线）对检测结果进行真阳性率分析和确定最佳阈值（阳性预测值≥95％）。结果 对18 908例标本中罗氏Cobas e602筛查出301例阳性标本进行TPPA法确证,结果得出真阳性标本252例,真阳性率为83.72％,其中S/CO≥33真阳性率为100％。运用ROC曲线分析得出最佳阈值为19.085。结论 罗氏Cobas e602检测梅毒螺旋体特异性抗体真阳性率为83.72％,检测最佳阈值为19.085,当仪器检测出S/CO值小于19.085时须做TPPA确证试验并结合临床综合判断结果。

Clinical application and experimental evaluation of Treponema pallidum antibody detected by Roche Cobas e602

Objective Roche Cobas e602 automatic chemiluminescence microparticle immunoassay for the detection of positive results of Treponema pallidum specific antibodies were retrospectively analyzed, and to explore the true positive rate of the results and optimum threshold. Methods Totally 18 908 inpatients and outpatients in Guangdong Provincial Hospital of Chinese Medicine from July 1, 2016 to June 30, 2017 were tested for Treponema pallidum specific antibody by Electro-Chemiluminescence Immunoassay (ECLIA ).The positive samples were confirmed by Treponema pallidum particle assay(TPPA).Using the statistical methods and receiver operating characteristic curve (ROC curve) to analyze the true positive rate and optimum threshold (the positive predictive value ≥ 95%) . Results Totally 301 positive specimens screened from Roche Cobas e602 in 18 908 specimens were confirmed by TPPA . The results showed that the true positive specimens were 252 cases and the true positive rate was 83.72%.When S/CO ≥ 33, the true positive rate was 100%.The ROC curve analysis showed that the optimum threshold was 19.085. Conclusions The true positive rate of Roche Cobas e602 detection for Treponema pallidum specific antibody was 83.72%.The optimum threshold was 19.085.Therefore,when the S/CO result was less than 19.085,we have to do the TPPA experiment and combined with clinical judgment.