梅毒螺旋体抗体酶联免疫吸附试验作为初筛方法的梅毒逆向筛查程序的可行性分析

Feasibility analysis of TP-ELISA as a screening method for syphilis reverse screening program

目的:探讨TP-ELISA作为初筛方法的梅毒逆向筛查程序的可行性分析。方法:选择2016年1月至2017年6月在大连大学附属中山医院各门诊及病房就诊的梅毒筛查者,并收集其标本15378份,采用梅毒螺旋体抗体酶联免疫吸附试验(TP-ELISA)、梅毒螺旋体明胶颗粒凝集试验(TPPA)与甲苯胺红不加热血清学试验(TRUST)筛选分析。以TPPA为标准,比较各种方法的特异性、灵敏度以及总符合率,统计TP-ELISA的S/CO值与TPPA阳性结果的相关性。结果:TPPA筛查阳性率为3. 57%,TP-ELISA筛查阳性率为3. 83%,TRUST筛查阳性率为2. 38%。TP-ELISA的灵敏度(98. 9%)明显优于TRUST(64. 3%),差异具有统计学意义(P <0. 01)。TP-ELISA与TRUST特异性与符合率差异无统计学意义(P> 0. 05)。梅毒筛查时,TP-ELISA与TPPA在梅毒筛查时有较好的一致性(K=0. 945),TRUST与TPPA一致性不明显(K=0. 639)。根据梅毒抗体检测的特点以及实验室TP-ELISA的检测方法,当≤1. 0时,S/CO为阳性,> 1. 0时S/CO为阳性。TP-ELISA检测结果的假阳性样本率为75. 00%(54/72),其主要是发生在S/CO值1. 0～2. 99之间。随着TP-ELISA的S/CO的数值增高,TPPA的符合率也依次增加,S/CO> 5. 0时,TPPA的阳性率为100%。TRUST的检测阳性样本有13例,患者主要有妇产科正常妊娠8例,口腔科牙周炎3例,心内、呼吸2例。TP-ELISA假阴性6例,其中分布为泌尿科患者3例,骨科患者1例,妇产科患者2例,其被疑为梅毒早期。TP-ELISA假阳性患者72例。结论:TP-ELISA的灵敏度和特异性显著优于TRUST,有利于梅毒筛查效果,值得临床上大样本筛查。

Objective:To explore the feasibility of TP-ELISA as a screening method for syphilis reverse screening program.Methods:A total of 15378 specimens were collected from January 2001 to June 2017 in the outpatient and ward offices of our hospital.Screening was conducted by trypsin antibody-linked immunosorbent assay(TP-ELISA),treponema pallidum particle agglutination assay(TPPA) and toluidine red unheated serological test(TRUST).The specificity,sensitivity and total coincidence rate of each method were compared with TPPA,and the correlation between TP/ELISA S/CO and TPPA positive results was statistically analyzed.Results:The positive screening rate of TPPA,TP-ELISA and TRUST was 3.57%,3.83%and 2.38%respectively.The sensitivity of TP-ELISA(98.9%)was significantly better than that of TRUST(64.3%),with statistically significant difference(P<0.01).The differences in specificity and compliance rates between TP-ELISA and TRUST were not statistically significant(P>0.05).In terms of syphilis screening,TP-ELISA and TPPA had a good consistency(K=0.945),while the consistency between TRUST and TPPA was not significant(K=0.639).According to the characteristics of the antibody detection of syphilis and the test method of the laboratory TP-ELISA,S/CO was positive when no less than 1.0,and was negative when>1.0.The TP-ELISA test results had a false positive sample rate of 75.00%(54/72),which was mainly between the S/CO value of 1.0~2.99.With the increase in S/CO of TP-ELISA,the compliance rate of TPPA also increased and TPPA reached 100%with the ratio of S/CO>5.0.Among the 13 test positive samples of TRUST,there were 8 cases of normal pregnancy,3 cases of oral cavity and 2 cases in the heart and breathing.Among the 6 cases of TP-ELISA false negative,there were 3 cases in urology department,a case in orthopedic department and 2 cases in gynecologic and obstetric department,all were suspected of early syphilis.There were 72 cases of TPELISA false positive.Conclusions:The sensitivity and specificity of TP-ELISA is significantly better than that of TRUST,which is beneficial to the screening of syphilis and worthy of large sample screening in clinic.