化学发光法检测梅毒特异性抗体进行梅毒筛查的可行性评价

The feasibility evaluation on detecting specific antibody of Treponema pallidum by chemiluminescence immunoassay for screening syphilis

目的探讨化学发光法(CLIA)检测梅毒特异性抗体对梅毒进行筛查的可行性。方法收集2012年5月-2012年9月临床需做梅毒筛查试验的标本2 633份,对试验标本分别作CLIA和梅毒甲苯胺红不加热血清试验(TRUST),其中任一方法阳性标本再使用苍白密螺旋体明胶颗粒凝集试验(TPPA)进行确认。结果 CLIA检测阳性120例,阳性率为4.56%,TRUST检测阳性87例,阳性率为3.30%,两种方法检出阳性率差异有统计学意义(P<0.01),以TPPA为参比方法,CLIA的敏感性为99.17%,特异性为99.96%,阳性预测值为99.17%,阴性预测值为99.96%;TRUST敏感性为67.50%,特异性为99.76%,阳性预测值为94.18%,阴性预测值为98.47%。结论 TRUST筛查梅毒存在一定的假阳性和假阴性,而使用CLIA检测梅毒特异性抗体进行梅毒筛查的方法是可行的,特异性、敏感性优于目前使用的TRUST。

OBJECTIVE To investigate the feasibility on detecting specific antibody of Treponema pallidum by chemiluminescence immunoassay（CLIA） for screening syphilis. METHODS From May to Sep. 2012, 2633 clinical samples were screened for syphilis by CLIA and toluidine red unheated serum test（TRUST） respectively, and the positive samples detected by either of the two methods were further confirmed by T. pallidum gelatin particle agglutination test （TPPA）. RESULTS Totally 120 and 87 positive samples were detected by CLIA and TRUST with positive rate of 4. 56% and 3.30%, respectively. There was a significant difference in the positive rates between CLIA and TRUST（P〈0. 001）. With TPPA as the reference method, the sensitivity,specificity,positive predictive value and negative predictive value for CLIA wex：e 99. 17%, 99. 96%, 99. 17% and 99.96%, and for TRUST were 67. 50% , 99. 76%, 94. 18% and 98. 47%, respectively. CONCLUSION TRUST screening of syphilis has several false positive and false negative results, while detecting specific antibody of T. pallidum by CLIA for screening syphilis is feasible, which is superior to TRUST currently used in specificity and sensitivity.