目的 分析梅毒血清抗体检测中雅培ARCHITECT i2000化学发光微粒子免疫检测法(chemiluminescent particle immunoassay, CMIA)在梅毒血清抗体诊断中的价值,探讨CMIA在梅毒筛查中的临床应用策略。方法 收集武警特色医学中心梅毒螺旋体抗体CMIA检测阳性的血清样本271例(S/CO≥1.0),同时采用梅毒螺旋体明胶颗粒凝集试验(treponema pallidum particle agglutination, TPPA)对这些样本进行复检。以TPPA作为参照,采用受试者工作特征曲线(operating characteristic curve, ROC)对CMIA的梅毒血清抗体检出能力进行评价。根据S/CO值把标本分为4组,分别为A组(1.0≤S/CO＜3.0,n=85),B组(3.0≤S/CO＜5.0,n=26),C组(5.0≤S/CO＜7.0,n=17)和D组(S/CO≥7.0,n=143),比较4组间复检阳性率的差异。构建复检阈值-阳性符合率曲线图,分析CMIA复检的最佳S/CO值。结果 271例CMIA检测阳性样本中,196例TPPA复检阳性。A组到D组的TPPA复检阳性符合率分别为20.00%、76.92%、94.12%和100.00%。4组间阳性符合率差异有统计学意义(W=14253,P<0.001)。当复检阈值设为5.1时,TPPA复查的阳性符合率达到100.00%。结论 CMIA对梅毒血清抗体具有较好的诊断性能,当S/CO值＞5.1时,可直接发报告,当S/CO值在1.0~5.1,应进行TPPA复检,能够减少假阳性报告。

Objective To investigate the applicability of Abbott ARCHITECT I2000 based chemiluminescent particle immunoassay (CMIA) in detecting serum syphilis antibodies. Methods Two hundred and seventy-one cases of CMIA positive serum samples (S/CO≥1.0) in syphilis screening were collected before these samples were retested using treponema pallidum particle agglutination (TPPA). The ability of CMIA to detect TPPA-positive cases was evaluated via receiver operating characteristic curve (ROC) analysis. Furthermore, these CMIA positive samples were divided into four groups according to their S/CO values: group A (1.0≤S/CO<3.0, n=85), group B (3.0≤S/CO<5.0, n=26), group C (5.0≤S/CO<7.0, n=17) and group D (S/CO≥7.0, n=143). The differences in TPPA positive rates among the four groups were analyzed. Meanwhile, a cutoff-positive rate curve was drawn to identify the optimal retest cutoff using TPPA. Results Among the 271 CMIA positive samples, 196 cases were positive for TPPA. The positive coincidence rates of TPPA retest from group A to group D were 20.00%, 76.92%, 94.12% and 100.00%, respectively, so the difference was statistically significant (W = 14253, P<0.001). When the reexamination cutoff was 5.1, the positive rate of TPPA reexamination reached 100%. Conclusions CMIA is of great value in detecting syphilis serum antibodies. It is recommended that positive CMIA results can be reported directly when S/CO value is above 5.1, and that TPPA reexamination shoud be performed when S/CO values range from 1.0 to 5.1. This strategy might be able to reduce false positive reports.