三种血清学检测方法在妊娠期妇女梅毒筛查中的应用评估

Evaluation on Three Serological Detection Methods for Syphilis Screening in Pregnant Women

目的评估三种血清学检测方法在妊娠期妇女梅毒筛查中的应用。方法采集妊娠期妇女空腹肘静脉血清,应用甲苯胺红不加热血清试验(TRUST)、酶联免疫吸附试验(ELISA)、胶体金免疫层析试验(GICA)、梅毒螺旋体颗粒凝集试验(TPPA)以及荧光实时定量聚合酶链反应(qRT-PCR)等5种方法同时进行检测。以TPPA和q RT-PCR方法同时阳性判断为梅毒感染。结果共采集妊娠妇女血清标本1 587份,梅毒感染阳性率3.2%。TRUST方法诊断梅毒的敏感性、特异性、阳性预测值和阴性预测值分别为72.5%、97.2%、46.3%和99.1%,ELISA方法分别为94.1%、98.9%、73.8%和99.8%,GICA方法为78.4%、99.0%、71.4%和99.3%。ELISA方法与TRUST和GICA方法的敏感性差异均有统计学意义(P<0.05);TRUST的阳性预测值与ELISA和GICA方法的差异均有统计学意义(P<0.05)。结论 ELISA方法在妊娠妇女梅毒筛查中有较高的敏感性、特异性和阳性预测值,多种检测方法的联合应用可为临床及时治疗妊娠梅毒,阻断其母婴传播提供可靠的保障。

Objective To evaluate three serological detection methods for syphilis screening in pregnant women. Methods The serum samples ofpregnant women were collected and detected by Toluidine Red Unheated Serum Test （TRUST）, Enzyme Linked Immunosorbent Assay （ELISA）, Gold Immunochromatography Assay （GICA）, Treponema Pallidum Particle Assay （TPPA） and Real-Time Quantitative Polymerase Chain Reaction （qRT-PCR）. Syphilis infection in pregnant women was made definite diagnosis with positive TPPA and qRT-PCR simultaneously. Results 1 587 serum samples were collected, and the positive rate of syphilis was 3.2%. The diagnostic sensitivity, specificity, positive predictive value, negative predictive value of TRUST was 72.5%, 97.2%, 46.3% and 99.1% respectively versus ELISA 94.1%, 98.9%, 73.8% and 99.8%, GICA 78.4%, 99.0%, 1.4% and 99.3% respectively. The difference of sensitivity between ELISA and TRUST or GICA was statistically significant （P 〈 0.05）, the difference of positive predictive value between TRUST and ELISA or GICA also was statistically significant （P 〈 0.05）. Conclusion The diagnostic sensitivity, specificity, positive predictive value of ELISA was higher for syphilis screening in pregnant women, the combined application of many methods can prompt treatment of patient and block mother-to-child transmission.