4种以重组梅毒螺旋体抗原为基础的梅毒快速诊断试验的临床评价  

Clinical evaluation of 4 recombinant Treponema pallidum antigen based rapid tests in the diagnosis of syphilis

作　　者：王林娜[1] 郑和义[1] 李军[1] 王晓峰[1] 邵燕玲[1] 王玉琪[1] 刘秀荣[1] 

机构地区：[1]中国医学科学院,中国协和医科大学北京协和医院皮肤性病科,北京100730

出　　处：《临床皮肤科杂志》2005年第11期726-728,共3页Journal of Clinical Dermatology

基　　金：WHO梅毒快速诊断基金资助项目(RFA-SDI-2001-02)

摘　　要：目的:评估4种以重组梅毒螺旋体抗原为基础的梅毒快速诊断试剂盒的敏感性和特异性,及其在临床应用中的可操作性。方法:选择860例性传播疾病(STD)门诊患者,签署知情同意书并采集其静脉血。分别取全血和血清进行梅毒螺旋体血凝试验(TPHA)及4种试剂盒的检测。检测方法分别按照说明书进行。结果:以TPHA为标准,结果分别为:①AbbottDetermineSyphilisTPtest:血清敏感性为100%,特异性为98.9%;全血敏感性为81.9%,特异性为99.4%。②SDBIOLINESyphilis3.0test:血清敏感性为95.5%,特异性为97.9%;全血敏感性为87.6%,特异性为99.4%。③VISITECT-SYPHILIStest:血清敏感性为94.0%,特异性为98.1%;全血敏感性为73.5%,特异性为99.7%。④Syphicheck-WBtest:血清敏感性为67.4%,特异性为98.8%;全血敏感性为64.0%,特异性为99.7%。结论:4种试剂盒均具有优良的临床操作性能,适用于STD门诊的梅毒快速检测。而且这4种快速诊断试剂盒在血清中的检测比全血具有更高的敏感性。Objective： To assess the sensitivity, specificity and feasibility of the 4 rapid tests in the diagnosis of syphilis. Methods：A total of 860 patients were selected from the STD clinic. Venous blood was collected after each patient signed the informed consent. The 4 rapid tests and TPHA were performed by using whole blood and serum respectively. Each test was performed strictly according to its instruction. TPHA was used as the gold standard. Results： ① Abbott Determine Syphilis TP test：for serum specimens the sensitivity was 100% and specificity was 98.9%. For whole blood specimens the sensitivity was 81.9% and specificity was 99.4%. ②SD BIOLINE Syphilis 3.0 test：for serum specimens the sensitivity was 95.5% and specificity was 97.9%. For whole blood specimens the sensitivity was 87.6% and specificity was 99.4%. ③VISI-TECT-SYPHILIS test：for serum specimens the sensitivity was 94.0% and specificity was 98.1%. For whole blood specimens the sensitivity was 73.5% and specificity was 99.7%. ④Syphicheck-WB test：for serum specimens the sensitivity was 67.4% and specificity was 98.8%. For whole blood specimens the sensitivity was 64.0% and specificity was 99.7%. Conclusions： These 4 rapid tests show good performance and are suitable for clinical use in STD clinic for the diagnosis of syphilis. Fur-thermore, they are more sensitive in using serum specimens than in using whole blood.

关 键 词：梅毒 诊断 梅毒螺旋体 抗原 重组 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]