三种敏感的心肌肌钙蛋白Ⅰ检测方法分析性能评价及临床应用  

The analytical performance assessment and clinical practice of three sensitive cardiac troponin Ⅰ assays

作　　者：张春燕 宋凌燕[1] 吴炯[1] 宋斌斌[1] 王蓓丽[1] 唐斌[2] 郭玮[1] 潘柏申[1] 

机构地区：[1]复旦大学附属中山医院检验科,上海200032 [2]复旦大学附属中山医院心内科,上海200032

出　　处：《中华检验医学杂志》2010年第9期819-824,共6页Chinese Journal of Laboratory Medicine

基　　金：基金项目：上海市科委科研计划项目（08411960400）部分资助

摘　　要：目的 评价3种敏感cTnI检测方法的分析性能,并观察比较临床应用,为实验室选择检测方法提供帮助.方法 收集表面健康人群（474名）及急诊胸痛入院患者（112例）血清,评价雅培、贝克曼-库尔特和强生3种敏感cTnI检测方法的功能灵敏度（CV=10%）,建立相应的参考范围,根据Apple提出的评判模式对3种系统的分析性能进行比较,比较不同检测方法之间的相关性,评估不同检测方法的初步临床应用价值,并对实验室自建参考范围进行验证.结果 雅培、贝克曼-库尔特和强生检测方法CV=10%和表面健康人群第99百分位值分别为0.030μg/L和0.021 μg/L、0.04 μg/L和0.02μg/L以及0.013 μg/L和0.026μg/L.胸痛入院患者入院即刻样本ROC曲线分析显示,雅培、贝克曼-库尔特和强生检测方法的曲线下面积（AUC）分别为0.852、0.909和0.910,对任两种检测方法比较AUC,差异无统计学意义（Z1=1.18,Z2=1.21,Z3=0.026,P值均＞0.05） 入院即刻样本的AMI诊断性能比较中,使用实验室自建和厂商声明为判断值之间的一致性较好（雅培、贝克曼-库尔特和强生Kappa值分别为1.000、0.730、0.893,P值均＜0.01）.结论 本实验采用的3种敏感cTnI检测方法中有两种方法的分析性能达到＂临床可接受＂水平,一种达到了＂导则可接受＂水平.3种方法均能检测到部分表面健康人血中的cTnI,方法间的检测结果存在差异,临床应用的诊断特性差异不明显.Objective To assess the analytical performance of three sensitive cardiac troponin Ⅰ assays and compare the clinical application to provide help in choosing the detection method for clinical laboratory. Methods A total of 474 serum samples were collected from apparently healthy subjects and a total of 112 serum samples were collected from patients presenting with symptoms suggestive of acute myocardial infarction. The functional sensitivities of three assays from Abbott, Beckman-Coulter and Ortho were determined （ CV = 10% ）. The reference ranges have been established. The analytic performance was compared according to the assessment mode described by Apple. The relationship was compared among the different assays. The preliminary clinical application value for different detection methods has been evaluated and validated with self-established reference ranges. Results The functional sensitivities （ CV = 10% ） of the cTnI assays for Abbott, Beckman-Coulter and Ortho were 0. 030, 0. 04 and 0. 013 μg/L, respectively.The 99th percentiles of cTnI in healthy volunteers were 0. 021, 0. 02 and 0. 026 μg/L respectively. The analytical data of ROC curve showed that the area under curve （AUC） of the cTnI assays for Abbott,Beckman-Coulter and Ortho for diagnosis of AMI was 0. 852,0. 909 and 0. 910,respectively. There was no statistical difference between any two methods（Z1 = 1.18 ,Z2 = 1.21 ,Z3 =0. 026,all P 〉0. 05）. There were good consistency between the 99th percentile obtained from our laboratory and suggested by manufacturers （Kappa value were 1. 000, 0. 730 and 0. 893 respectively, all P 〈 0. 01 ）. Conclusions The analytical performance of two cTnl assays is ＂clinical accepted＂ ,the other one is accepted according to guideline. All of them could detect cTnI in apparently healthy subjects. There exist differences among three assays, but their diagnostic characteristics for AMI are not significantly different.

关 键 词：肌钙蛋白Ⅰ 心肌梗死 诊断技术和方法 评价研究 

分 类 号：R446.6[医药卫生—诊断学]