To investigate the detection threshold of Treponema pallidum specific antibody method by chemiluminescent immunoassay (CLIA) in Siemens ADVIA Centaur XP for Syphilis serological test, and compare with the results derived from CMIA, TP-WB and TPPA method. The result can serve as reference for the application of CLIA. In total 30 887 samples screened by Treponema pallidum specific antibody method were collected by Abbott architect i2000 CMIA from July 2018 to July 2019 in Yanda Hospital of Hebei Province. We selected 153 patients with the ratio of sample absorbance to critical value (S/CO) of 1-9 by CMIA screening of Treponema pallidum specific antibody as the research objects. The reverse sequence of syphilis serological detection was adopted, and TP-WB and TPPA were used as the confirmation methods respectively. MedCalc software was used to analyze the results of ROC curve, and the cut-off value was obtained. Chi square test was used to test the difference significance of counting data. The detection results of Treponema pallidum specific antibody in the same batch of serum samples were unequal by different methods. There was no significant difference between CLIA method and TPPA method, but significant difference between CLIA method with TP-WB method and CMIA method was found. TPPA test results and TP-WB test results were taken as gold standards, ROC curve analysis showed that the best diagnostic cutoff value of CLIA method was 4.01 and 16.06, respectively, and the area under the curve was 0.961 and 0.838. The suggested cutoff value of CLIA method is quite different when using different syphilis serological test methods as the gold standard, Therefore, when the S/CO value determined by CLIA is between 1.00 to 16.06, TP-WB method should be recommended as the first choice in laboratory serological test for recheck and confirmation to avoid clinical misdiagnosis.
本研究旨在探讨西门子ADVIA Centaur XP 梅毒血清学试验化学发光免疫分析法 (CLIA) 检测梅毒螺旋体特异性抗体的测量阈值，并与化学发光微粒子免疫分析法 (CMIA)、梅毒螺旋体免疫印迹法 (TP-WB) 及梅毒螺旋体抗体颗粒凝集试验 (TPPA) 法检测结果进行比较，为CLIA 方法的规范应用提供参考。收集河北燕达医院2018 年7 月至2019 年7 月雅培ARCHITECT i2000 CMIA 法检测梅毒螺旋体特异性抗体筛查样本30 887 例，选取CMIA 法筛查梅毒特异性抗体中样品吸光度与临界值的比值 (S/CO) 为1–9 的153 例患者为研究对象，采用梅毒血清学检测逆序流程，并分别以TP-WB 及TPPA 法为确认方法，运用MedCalc 对结果进行受试者工作特征曲线 (ROC 曲线) 分析，获得截断值，采用卡方检验进行计数资料的差异显著性检验。采用不同方法对同一批血清样本梅毒螺旋体特异性抗体的检测结果存在差异，CLIA 法与TPPA 法差异不显著，与TP-WB 法及CMIA 法差异显著；分别以TPPA 检测结果和TP-WB 检测结果为金标准，ROC 曲线分析发现，CLIA 法的最佳诊断截断值分别为4.01 和16.06，曲线下面积分别为0.961 和0.838。采用不同梅毒血清学试验方法作为金标准时，CLIA 法建议截断值差异较大，因此，CLIA 测定梅毒抗体S/CO 为1.00–16.06 时，实验室血清学检测应推荐首选TP-WB 方法学进行复核确证，避免临床误诊发生。.
Keywords: Treponema pallidum; chemiluminescence immunoassay; syphilis immuno blotting; threshold value.