合理选择梅毒反向筛查试验的临床研究

目的分析梅毒螺旋体酶联免疫吸附试验(TP-ELISA),梅毒螺旋体明胶颗粒凝集试验(TPPA),快速血浆反应素试验(RPR)三种常用梅毒筛查试验的特点,选择可靠的梅毒反向筛查流程,以提高检测准确性和筛查效率,避免漏检、误诊。方法回顾性分析11 673例梅毒血清抗体检测标本的TP-ELISA、RPR和TPPA的检测数据。结果RPR的特异度为99.9%,灵敏度为33.6%,假阴率66.4%,假阳性率0.052%,总符合率为99.1%,阳性率0.48%与TP-ELISA和TPPA比较均有显著性差异(P0.05)。TP-ELISA的特异度为99.8%,灵敏度为100%,假阴性率0,假阳性率0.156%,总符合率为99.8%,阳性率1.43%与TPPA比较无显著性差异(P0.05),RPR和TP-ELISA分别与TPPA进行一致性比较,Kappa系数为0.484和0.942。结论 ELISA灵敏度高,适合于初筛;TPPA特异度好,适合于初筛后的确认试验;RPR仅适合于确认试验后梅毒治疗滴度检查及疗效监测。

The clinical investigation of rational selection of reverse syphilis screening tests

Objective To investigate TP- enzyme-linked immunosorbent assay（ ELISA）,rapid plasma reagin test（ RPR）,treponema pallidum gelatin particle agglutination test（ TPPA） the characteristics of three kinds of commonly used test and select reliable reverse syphilis screening process,in order to improve the detection accuracy and screening efficiency,avoid leak and misdiagnosis. Methods Retrospective detection data analysis was performed in TP- ELISA,RPR,TPPA test in 11 673 cases of patients. Results The specific degree of the RPR was99. 9%,sensitivity was 33. 6%,false negative rate was 66. 4%,false- positive rate was 0. 052%,the total coincidence rate was 99. 1%,positive rate was 0. 48%,which had had significant difference compared with TP- ELISA and TPPA（ P〈0. 05）. The specific degree of the ELISA was 99. 8%,sensitivity was 100%,false negative rate was 0%,false positive rate was 0. 156%,the total coincidence rate was 99. 8%,positive rate was 1. 43%,which did not show significant difference compared with TPPA（ P〉0. 05）. RPR and TP- ELISA and TPPA are compared respectively,and the consistency Kappa coefficient was 0. 484 and 0. 942. Conclusion ELISA had the advantages of high sensitivity,be suitable for screening. The specificity of TPPA was good,be suitable for confirmation test after the screening. RPR was only suitable for confirmation test after inspection and monitoring the efficacy of treatment of syphilis titer.