ELISA法与TRUST法、胶体金法检测梅毒抗体的临床应用和方法学评价

Clinical Utilization and Methodological Evaluation of ELISA, TRUST and GICA for the detection of antibodies against treponema pallidum

目的探讨酶联免疫吸附试验(ELISA)、甲苯胺红不加热血清试验(TRUST)和胶体金免疫层析法(GICA)对梅毒(Syphilis)诊断的临床应用和价值。方法分别采用ELISA、TRUST及胶体金法3种不同的血清学方法对240例皮肤科门诊患者标本和术前患者标本进行检测,结果均以梅毒螺旋体明胶凝集试验(TPPA)进行确认,比较ELISA、TRUST和胶体金法对梅毒的诊断价值。结果在对79例阳性和161例阴性标本的检测中,TRUST、胶体金法、ELISA诊断梅毒的敏感度分别为64.6%、94.9%、98.7%,特异度分别为97.5%、98.8%、100%;TRUST法与TPPA法检测结果差异有统计学意义(P<0.01χ,2=16.53),而ELISA、胶体金法与TPPA法差异无统计学意义(ELISA:P>0.05,χ2=0.00;胶体金法:P>0.05,χ2=0.17)。结论 ELISA法检测梅毒螺旋体抗体具有较高的敏感度和特异度及TPPA法有较高的一致性,可用于临床大批量样本初筛和梅毒感染的确诊。

Objective To investigate the clinical utilization and the value of enzyme-linked immunosorben assay（ELISA）,toluidine red untreated serum test（TRUST）,and gold-immunochromatography assay（GICA） in the di-agnosis of syphilis.Methods Each of three serological tests including ELISA,TRUST and GICA was employed to detect the samples in 240 cases from outpatients in dermatology and preoperative patients.The results were confirmed by treponema pallidum particle assay（TPPA）.And the diagnostic value was compared between ELISA,TRUST and GICA with TPPA.Results 79 positive and 161 negative samples were measured,and the overall sensitivity for syphi-lis by the TRUST,GICA and ELISA test were 64.6%,94.9% and 98.7%,respectively,while the specificity were 97.5%,98.8% and 100%;There was a significant difference in the detection result between TRUST and TPPA method（P0.01,χ2=16.53）,while no marked difference was noted between ELISA and TPPA,also between GICA and TPPA.Conclusion ELISA can be applied to preliminary screening in batches in the clinical settings and the final diagnosis of syphilis,with higher sensitivity and specificity.