酶联免疫吸附法、甲苯胺红不加热血清试验、明胶颗粒凝集法检测梅毒血清抗体比较

The comparative study of three serologic tests for syphilis:enzyme linked immunosorbent assay,toluidine red unheated serum test,treponema pallidum particle agglutination assay

目的比较酶联免疫吸附法(TP-ELISA)、甲苯胺红不加热血清试验(TRUST)、明胶颗粒凝集法(TP-PA)三种梅毒血清学检测方法的效果,选择适合临床诊断和治疗的梅毒血清学筛查流程。方法对我院2010年9月～2011年5月期间临床住院及门诊14 307例血清标本同时进行TP-ELISA法和TRUST初筛,对TP-ELISA与TRUST结果不符的标本及TP-ELISA法(S/CO值)在0.70～0.99的标本进一步做TP-PA检测。结果 (1)对14 307例标本筛查出203例TP-ELISA阳性。203例TP-ELISA中115例TRUST阳性,88例TRUST阴性。TP-ELISA阳性检出率为1.42%(203/14307),TRUST的阳性检出率为0.80%(115/14307);TP-ELISA阳性TRUST阴性的标本88例,TRUST的漏检率为43.35%(88/203);对这88例血清标本进一步做TP-PA,其中1例阴性,TP-ELISA的假阳性率为0.49%(1/203)。(2)TP-ELISA法初筛S/CO值在0.70～0.99的标本23例,其TRUST均为阴性;TP-PA阳性2例,阴性21例。结论 (1)TP-PA和ELISA检测方法结果基本一致,检出率均优于TRUST。(2)对于TP-ELISA法初筛S/CO值在0.70～0.99之间同时TRUST为阴性的血清标本,建议做TP-PA确认实验,以排除假阴性。

Objective To compare the serological detection of syphilis by three serologic tests：enzyme linked immunosorbent assay （ELISA）, toluidine red unheated serum test （TRUST）, treponema pallidum particle agglutination assay（ TP-PA） and find out suitable way for diagnosis of syphilis. Methods A total of 14 307 clinical inpatient and outpatient serum samples were screened in our hospital from September 2010 to May 2011 simultaneously by TRUST and TP-ELISA. Of the inconsistent samples by TP-ELISA and TRUST and the samples with S/CO value of 0. 70 - 0. 99 by TP-ELISA were further evaluated by TP-PA. Results （ 1 ） There were 203 positive samples by TP-ELISA and the positive detection rate was 1.42%. Out of the 203 positive samples, 115 were TRUST-positive and 88 were TRUST-negative. The positive detection rate of TRUST was 0. 80% and the missed diagnostic rate was 43.35 % （88/203）. Out of the 88 TRUST-negative sample, 1 was TP-PA negative, hence the false positive rate of TP-ELISA was 0. 49% （1/203）. （2）There were 23 samples with S/CO value of 0. 70 to 0. 99 by TP- ELISA. All of them were TRUST-negative, 21 were TP-PA negative, and 2 were TP-PR positive. Conclusion （1） TP-PA and ELISA detection methods are basically similar and were better than that of TRUST. （2） TRUST- negative samples with S/CO value of 0. 70 to 0. 99 by TP-EL1SA, should confirmed by TP-PA so as to rule out false negativity.