【摘要】 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。更多还原

【Abstract】 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 department,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.更多还原