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目的通过对3种梅毒螺旋体(TP)-lgM抗体检测试剂的性能比较,为推广此项目和临床选择试剂提供参考。方法用荧光梅毒螺旋体抗体吸收试验(FTA-ABS)检测试剂(作为参考试剂)和两种蛋白印迹法(WB)试剂分别检测103例梅毒患者和30例健康对照组血清样本TP-lgM,对结果进行比较分析。结果 103例梅毒患者中的一期梅毒、二期梅毒、胎传梅毒、神经梅毒、隐性梅毒患者,经FTA-ABS法检测,TP-lgM阳性率分别为85.7%(6/7)、100%(20/20)、90.9%(10/11)、33.3%(6/18)、46.8%(22/47)。经Kappa检验分析,WB1试剂与FTA-ABS试剂一致性好(Kappa=0.736),WB2与FTA-ABS试剂、WB1试剂一致性均较差(Kappa=0.565,Kappa=0.566)。结论建议临床使用与“金标准”(FTA-ABS试剂)结果一致性好的WB试剂检测TP-lgM。
Objective To compare the performance of three kinds of detection reagents of Treponema pallidum (TP) -lgM antibody in order to promote this project and clinical choice of reagents. Methods Serum samples of 103 syphilis patients and 30 healthy controls were detected by FTI-ABS (as a reference reagent) and western blot (WB) For comparative analysis. Results The positive rates of TP-lgM in 103 patients with syphilis were 85.7% (6/7) and 100% respectively by FTA-ABS assay in patients with syphilis, secondary syphilis, fetal syphilis, neurosyphilis and latent syphilis, % (20/20), 90.9% (10/11), 33.3% (6/18), 46.8% (22/47). According to Kappa test, WB1 reagent has good consistency with FTA-ABS reagent (Kappa = 0.736), WB2 and FTA-ABS reagent, WB1 reagent have poor consistency (Kappa = 0.565, Kappa = 0.566). Conclusions It is recommended that clinical testing of TP-lgM be performed using a WB reagent with good agreement with the results of the “gold standard” (FTA-ABS reagent).