化学发光法检测梅毒特异性抗体在临床筛查试验中的应用评价  

Evaluation of the chemiluminescence immunoassay for diagnosis of syphilis in the clinical screening test

作　　者：张晓红[1] 张倩[1] 周学红[1] 耿红艳[1] 刘向祎[1] 

机构地区：[1]首都医科大学附属北京同仁医院检验科,100730

出　　处：《中华检验医学杂志》2014年第10期780-783,共4页Chinese Journal of Laboratory Medicine

摘　　要：目的：对化学发光法检测梅毒螺旋体（ TP）特异性抗体在临床筛查试验中的特异性进行评价。方法对北京同仁医院检验科梅毒螺旋体特异性抗体的检测结果进行回顾性分析。采用雅培化学发光法梅毒特异性抗体检测试剂对2011年8月至2012年7月期间65774份术前检查患者血清标本进行检测，初筛阳性标本附加甲苯胺红不加热血清试验（ TRUST），并采用梅毒螺旋体明胶凝集试验（ TPPA）进行复检。对化学发光法与TPPA试验检测结果不一致的标本采用免疫印迹法（ WB）进行确证，经SPSS 17．0软件对结果进行统计分析。结果65774份术前检查患者血清标本中，共筛检出940份抗-TP抗体阳性标本，经TPPA试验复检后，843份为阳性，97份为阴性；TRUST试验检测结果为阳性330份，阴性610份。97份TPPA试验检测结果为阴性的血清标本中，经WB试验确证，18份为阳性，7份为不确定，72份为阴性。结论化学发光法梅毒特异性抗体检测试剂的特异性为99．89％，TPPA试验可作为常规临床实验室中梅毒特异性抗体筛查试验的一种有效的补充试验。必要时，可选用免疫印迹法进行确证。Objective To evaluate the specificity of Architect chemiluminescence immunoassay （ CLIA） for diagnosis of syphilis in the clinical screening test.Methods 65 774 syphilis specific antibody results in the Beijing Tongren Hospital were retrospectively analyzed.In this study, Architect CLIA for diagnosis of syphilis was used as a screening test for the pre-operative patients from August 2011 to July 2012.All the repeatedly reactive samples were tested by the tolulized red unheated serum test （ TRUST） and Treponema pallidum particle agglutination （ TPPA） assay.Samples with with discordant results were verified by western blot （ WB） Finally, all the results were statistically analyzed by software SPSS 17.0.Results Among 65 774 samples, 940 （1.43%） were found to be repeatedly reactive using the Architect CLIA.Of these sera, 330 （ 35.11%） were reactive and 610 （ 64.89%） were nonreactive by TRUST.Because a TRUST titer of 1：1was not always sufficient to confirm a TPPA reactive result, all the samples with CLIA reactive results were finally performed by TPPA assays.The results showed that 843 （ 89.68%） were positive and 97 （10.32%） were negative.After arbitrated by the WB, out of 97 TPPA negative sera, 18 （18.56%） were positive;7（7.22%） were indeterminate and 72（74.23%） were negative.Conclusions The specificity of Architect CLIA for diagnosis of syphilis was 99.89%.The results showed that confirmation by TPPA on sera with screening test for syphilis by Architect CLIA effectively decreased the false-positive results and could be suitable for a routine supplementary for syphilis.However, if necessary, the WB should be further utilized.

关 键 词：密螺旋体 苍白 抗体 细菌 化学发光测定法 免疫检测 凝集试验 梅毒血清诊断 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]