两种梅毒血清学检测方法敏感度和特异度比较  

Sensitivity and specificity of two serological test methods in syphilis detection

作　　者：陈兰兰[1] 邵婧[1] 刘义庆[1] 段文冰[1] 张培莉[1] 牛登冉 张炳昌[1] 

机构地区：[1]山东大学附属省立医院检验医学部,济南250021

出　　处：《中国医药》2017年第4期606-609,共4页China Medicine

基　　金：山东省自然科学基金（ZR2016HM52）;山东省科学技术发展计划（2014GGH218041）;山东省临床重点专科建设项目（鲁卫医字2013-26）

摘　　要：目的比较目前临床试验室常用的2种梅毒血清学检测方法的敏感度和特异度。方法收集2014年7—12月来山东大学附属省立医院就诊的门诊和住院患者随机标本1 000例，预留的确诊梅毒阳性标本54例，预留的干扰标本60例，预留的临界标本26例，分别用雅培微粒子化学发光法（CMIA）和罗氏电化学发光法（ECLIA）进行检测，最后用蛋白质印迹法做确认。比较CMIA和ECLIA在随机样本检测中的一致性，以及在随机标本、确诊标本、干扰标本和临界标本检测中的敏感度和特异度。结果在随机样本检测结果中，2种检测方法阳性结果一致性为77.78%，阴性结果一致性为99.60%；CMIA的敏感度（100.00%）略高于ECLIA的87.50%，但CMIA特异度相对较低。在确诊样本检测中，2种方法敏感度均为100.00%。在干扰样本检测中，2种方法特异度均为100.00%。在临界样本检测中，2种方法均有较高的敏感度和特异度，但是存在一定数量的假阳性（CMIA 53.85%、ECLIA 3.85%）。结论CMIA和ECLIA在梅毒检测中均有较高的敏感度和特异度，但均不能排除假阳性样本，尤其是在临界值附近的检测结果，更需要谨慎解读并结合临床实际情况，必要时可选择第3种方法做进一步确认。ObjectiveTo compare sensitivity and specificity of 2 common serological test methods for syphilis detection in clinical laboratory. MethodsTotally 1 000 blood samples were randomly chosen from outpatients and inpatients in Shandong Provincial Hospital Affiliated to Shandong University from July to December 2014; 54 cases of syphilis positive, 60 cases of disturbances and 26 cases of critical samples were reserved. Chemiluminescent microparticle immunoassay（CMIA）and electrochemiluminescene immunoassay （ECLIA） were used for syphilis detection; western blot method was used for confirmation. Consistency, sensitivity and specificity of CMIA and ECLIA in detection of random samples, diagnosed samples, disturbance samples and critical samples were analyzed. ResultsThe consistency of CMIA and ECLIA in detection of random samples was 77.78% in positive results and 99.60% in negative results; the sensitivity of CMIA was 100.00% and the sensitivity of ECLIA was 87.50%, but CMIA had a low specificity. Sensitivities of CMIA and ECLIA in detection of diagnosed samples were both 100.00%. Specificities of CMIA and ECLIA in detection of disturbance samples were both 100.00%. In detection of critical samples, both methods had high sensitivity and specificity, but there was also a certain number of false positive results（CMIA 53.85% and ECLIA 3.85%）. ConclusionsBoth CMIA and ECLIA have high sensitivity and specificity in syphilis detection, meanwhile false positive results can not be excluded, especially when the results are closed to critical value.

关 键 词：梅毒螺旋体抗体 化学发光测定法 微粒子化学发光免疫分析 印迹法 蛋白质 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]