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目的为了解我院门诊及住院患者梅毒感染情况,探讨梅毒抗体血清学筛查方法甲苯胺红不加热血清试验(Toluidine Red Unheated Serum Test,TRUST)和梅毒螺旋体酶联免疫吸附试验(Enzyne-Linked Immunosorbent Assay with Treponemal Pallidam Antigen,TP-ELISA)联合检测及明胶颗粒间接凝集试验(Particle Agglutination Assay,TPPA)在梅毒筛查中的意义。方法对2012年1月-2013年1月来我院就诊的门诊及住院患者7 072例用TRUST法及TP-ELISA法同步进行梅毒抗体血清学筛查,对检出的阳性标本用明胶颗粒间接凝集试验(Particle Agglutination Assay,TPPA)进行确认。结果 7 072份标本中经TPPA确认试验阳性104例,占同期门诊及住院患者的1.47%。TRUST法灵敏度为69.23%(72/104),假阳性率为5.77%(6/104),漏检率为30.77%(32/104);ELISA法灵敏度为98.08%(102/104),假阳性率为13.46%(14/104),假阴性率为1.92%(2/104)。结论联合应用TRUST和TP-ELISA两种血清学方法可提高梅毒的检出率,应作为产前、术前及输血前梅毒检测的常规筛查方法和策略。对TRUST或TP-ELISA法任何一种试验阳性者均应进行TPPA检测,进一步提高阳性检测结果的可信度,避免医疗纠纷的发生。
Objective To understand the prevalence of syphilis infection in outpatients and inpatients in our hospital and to explore the method of serological screening of syphilis antibody.We used Toluidine Red Unheated Serum Test (TRUST) and Enzyne-Linked Immunosorbent Assay with Treponemal Pallidam Antigen, TP-ELISA) and the significance of Particle Agglutination Assay (TPPA) in the screening of syphilis. Methods A total of 7072 outpatients and inpatients from January 2012 to January 2013 in our hospital were enrolled in this study. Serum screening of syphilis antibody was performed simultaneously with TRUST and TP-ELISA. The positive samples were detected with gelatin particles Confirmation of Particle Agglutination Assay (TPPA). Results Of the 7 072 specimens confirmed by TPPA, 104 were positive, accounting for 1.47% of outpatients and inpatients during the same period. The sensitivity of TRUST method was 69.23% (72/104), the false positive rate was 5.77% (6/104), the missed detection rate was 30.77% (32/104). The sensitivity of ELISA was 98.08% (102/104) The rate was 13.46% (14/104) and the false negative rate was 1.92% (2/104). Conclusion The combined application of TRUST and TP-ELISA serological methods can increase the detection rate of syphilis, and should be used as a routine screening method and strategy for prenatal, preoperative and pre-transfusion syphilis testing. TPPA test should be conducted on any TRACK positive or TP-ELISA test to further increase the credibility of positive test results and avoid medical disputes.