四种梅毒螺旋体抗体血清学试验方法的临床评价

Clinical evaluation of different serological diagnosis methods of syphilis

目的使用化学发光免疫分析法（CLIA）和酶联免疫吸附试验（ELISA）替代甲苯胺红不加热血清试验（TRUST）诊断梅毒螺旋体感染的必要性。方法使用目前国内最为常用的梅毒螺旋体感染诊断TRUST试剂、CLIA试剂和ELISA试剂检测300例性病门诊患者标本，同时与梅毒螺旋体明胶颗粒凝集试验（TPPA）的检测结果进行比较，从而得到各种试验的检测假阳性率和假阴性率，敏感性和特异性。结果在对100份阳性和200阴性标本的检测中，TRUST试验的假阳性率和假阴性率分别为10％和15％，CLIA试验的假阳性率和假阴性率分别为1％和3％，ELISA试验的假阳性率和假阴性率分别为1％和4％。CLIA和ELISA的假阳性率和假阴性率均明显低于TRUST试验（P〈0．01）。结论在梅毒螺旋体抗体的临床检测中，有必要使用CLIA和ELISA替代TRUST作为筛检试验。

Objective To determinate the necessity of using chemiluminesent immunoassay （CLIA） and enzyme-linked immuno sorbent assay（ELISA） methods to substitude for to luidine red unheated serum test （TRUST） in the serological diagnosis of treponemal infection . Methods TRUST , CLIA and ELISA kits , the most frequently-used kits in the diagnosis of treponemal infection were used to detect 300 serum samples from STD clinic patients. The results obtained using different kits were compared with the results obtained using treponema pallidum gelatin particle agglutination test （TPPA） method. Results the false positive rate and the false negative rate of the TRUST kit （ 10% and 15% ） were higher than the CLIA kit（ 1% and 3% ） and the ELISA kit （ 1% and 4% ） （ P 〈 0.01 ）. Conclusion It is necessary to use CLIA method and ELISA method to substitude for TRUST in serological diagnosis of treponemal infection.