化学发光法检测受血者梅毒螺旋体特异性抗体的方法学评价

Evaluation of specific antibodies of blood receiver sera to Treponema paUidum by chemiluminescence immunoassay

目的通过与梅毒螺旋体微量血凝试验（TPHA）和蛋白印迹试验法（WB）比较评估梅毒血清学筛查法化学发光法（CLIA）的性能。方法回顾性研究18494例受血者血清标本CLIA和TPHA检测梅毒螺旋体特异性抗体结果，对CLIA和（或）TPHA结果阳性177例标本用WB检测确认。同时用CLIA、TPHA和WB检测了81例各期梅毒患者血清、55例有潜在干扰的患者血清和250例阴性对照血清梅毒抗体。结果以WB检测结果为金标准，CLIA方法的灵敏度为98．4％，显著高于TPHA（94．4％）（X^2=5．76，P〈0．05）；CLIA方法特异性为100％，高于TPHA方法特异性（99．7％），但差异无统计学意义（z。=1．0，P〉0．05）。结论CLIA法具有高度敏感性和特异性，适合于临床实验室进行梅毒筛查。

Objective The purpose of this study was to evaluate the diagnostic performance of chemiluminescence immunoassay （CLIA）, in comparison with that of the following currently used treponemal tests： hemagglutination test （TPHA）, and Western Blot （WB）. Methods First, a retrospective study was performed with a panel of 18 494 blood receiver sera by CLIA and TPHA, the specific antibody against T. pallidum in 177 were positive sera by CLIA and/or TPHA, 81 clinical and serologically characterized syphilitic sera, 55 sera obtained from subjects with potentially interfering diseases, and 250 healthy sera were negative were detected by CLIA, TPHA and WB. Results The results of WB as the gold standard, the sensitivity of CLIA （98.4%） was significantly higher than that of TPHA （94.4%） （X^2 = 5.76 ,P 〈 0.05 ）, the specificity of CLIA （ 100% ） was similar to that of TPHA （ 99. 7% ） （X^2 = 1. 0, P 〉 0. 05 ）. Conclusion CLIA is characterized with higher sensitivity and specificity, It is suitable for screening Syphilis in clinical laboratory.