微粒子化学发光法和梅毒螺旋体明胶颗粒凝集试验检测梅毒抗体的一致性比较  

Correlation analysis of chemiluminescence microparticle assay and TPPA in detecting antibody of Treponema pallidum

作　　者：张旭东[1] 马艳华[1] 周少聪[1] 张莉[2] 

机构地区：[1]武警广东总队医院检验科,广州510507 [2]武警后勤学院药剂教研室,天津300162

出　　处：《武警医学》2012年第9期756-757,760,共3页Medical Journal of the Chinese People's Armed Police Force

摘　　要：目的评价微粒子化学发光免疫技术(chemiluminescence microparticle immunoassay,CMIA)检测临床血清标本梅毒螺旋体抗体的敏感性和特异性。方法用梅毒螺旋体明胶颗粒凝集试验(treponema pallidum particle agglutination test,TP-PA)法作为对照标准,采用CMIA法检测4686例血清标本,并用Kappa检验评价两种检测方法对同一个样本的化验结果的一致性。结果 4686例血清标本中用CMIA法检出阳性率5.48%,TPPA法检出阳性率5.14%。以TPPA为金标准,CMIA法敏感性为99.17%,特异性为99.60%。其中CMIA法检测血清S/CO值>4.00的215例,用TPPA确认214例阳性,阳性预测值(PPV)为99.53%。结论 CMIA法可替代TPPA法进行梅毒螺旋体特异性抗体检测,对于CMIA法检测S/CO值1.0～4.0的需进一步复检。Objective To study the sensitivity and specificity of chemiluminescence microparticle immunoassay （CMIA） in detecting Treponema pallidum antibodies in serum specimens. Methods With TPPA as a control standard ,4 686 serum samples col lected from inpatients and outpatients at this hospital between February and May in 2011 were assayed by CMIA. Kappa test was ap plied to evaluate the consistency of the two detection methods on the same specimen. Results In the 4686 serum samples, the positive rate of CMIA and TPPA was 5.48% and 5.14% , respectively. With TPPA as the relative standard method, the sensitivity and specific ity of CMIA were 99.17% （239/241）and 99.60% （4427/4445）, respectively. 214 of the 215 samples detected as S/CO 〉 4.00 by CMIA were diagnosed as positive by TPPA,suggesting a positive predictive value（PPV）of99.53% （214/215）. Conclusions CMIA can replace TPPA in detecting Treponema Pallidum antibody. However, the positive results of S/CO value 1.0 -4.0 in CMIA need to be re - examined to ensure the accuracy of test results.

关 键 词：梅毒 微粒子化学发光法 梅毒螺旋体明胶颗粒凝集试验 一致性 阳性预测值 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]