化学发光法和酶联免疫吸附试验检测梅毒螺旋体抗体的比较分析

Comparative Analysis of Detecting Treponema Pallidum Antibody by Chemiluminescence Immune Assay with Enzyme Linked Immunosorbent Assay

目的 比较化学发光法（CLIA）与酶联免疫吸附试验（ELISA法）检测梅毒螺旋体抗体的价值.方法 对2012年3月～12月份用化学发光法（CLIA）检测的门诊和住院患者血清梅毒螺旋体抗体阳性及可疑血清标本161份,采用ELISA法进行检测,用苍白密螺旋体颗粒凝集试验（TPPA法）进行确证.结果 化学发光法阳性161例标本中,ELISA法阳性155例,阴性6例,TPPA法阳性147例,阴性14例,说明CLIA法敏感度高于ELISA法,又高于TPPA法.CLIA法和ELISA法敏感度分别为100%,96.52%;特异度分别为98.81%,98.52%;诊断率为99.62%,99.50%.两种方法符合率95.15%,CLIA法敏感度和特异度均高于ELISA法.结论 ELISA试验过程是手工操作,干扰因素多,CLIA法成本虽然高,但是检测过程自动化,重复性好,敏感度高,快速,且结果准确可以量化,判断更具客观性,很适宜批量检测,可推荐作为临床实验室梅毒螺旋体的筛选以及梅毒患者治疗效果的判断方法.

Objective To compare the value of detection of treponema pallidum antibody by chemiluminescence immune assay （CLIA） with enzyme linked immunosorbent assay（ELIS/k）. Methods Detected by ELISA and corroborated by treponema pallidum particle agglutination test（TPPA） the 161 serum specimens that collected from the clinic and hospital patients with treponema pallidum antibody positive and suspicious serum by CLIA from March to December in 2012. Results The sensi- tivity of the CLIA was higher than ELISA,was higher than that of TPPA（In the 161 positive eases by CLIA, the positive and negative cases was 155 and 6 by ELISA and 147 and 14 by TPPA）. The sensitivity, specificity and diagnostic rate was 100% ,98.81% and 99.62%o by CLIA, and 96.52%, 98. 52%, 99.50% by ELISA. The coincidence rate was 95.15% of CLIA and ELISA,and CLIA had a higher sensitivity and specificity. Conclusion ELISA is a manual operation and has many interference factors. CLIA has a high cost,but it can he operated automatically,good repeatability,high sensitivity and fast. Moreover,the results can be quantified accurately,judged objectively and it is very suitable for batch test. Therefore, CLIA can be recommended as screening of treponema pallidum by clinical laboratory and judging the curative effect of the syphilis patients.