不同实验室之间总胆红素测定结果“互认”的可行性研究  

Study on Mutual Approve of the Results of Total Bilirubin Among Different Laboratories

作　　者：王建兵[1] 陈梅[2] 徐建华[3] 郭龙华[4] 曹永坚[5] 黄宪章[3] 庄俊华[3] 

机构地区：[1]广东省中医院大学城分院,广州510120 [2]中山大学第二附属医院,广州510120 [3]广东省中医院总院,广州510120 [4]广东省中医院二沙分院,广州510120 [5]广东省中医院芳村分院,广州510120

出　　处：《现代检验医学杂志》2008年第5期63-65,共3页Journal of Modern Laboratory Medicine

基　　金：广东省自然科学基金资助(7004832)

摘　　要：目的通过开展实验室之间总胆红素的可比性研究,探讨不同实验室间测定结果实施结果互认的可行性。方法以日立7170A生化分析仪,罗氏试剂及程序,C.fas校准品和质控品组成的检测系统作为目标检测系统,检测系统2,3,4,5为待评系统,测量新鲜血清样本总胆红素,并对数据进行统计学分析。结果经相关性分析,各待评检测系统与目标系统之间的相关系数r2均大于0.95,临床可接受性能评价为检测系统2与系统1之间的系统误差部分可接受,检测系统4与系统1之间的系统误差不可接受,检测系统3,5与系统1及检测系统4与系统2之间的系统误差临床可以接受。结论测定方法相同,两系统之间结果可互认;测定方法不同,两系统之间结果不可比,两系统之间系统误差临床不可接受。通过溯源,测定方法不同,两系统之间结果同样具有可比性。Objective To study the comparability on the results of total bilirubin（TBIL） among different laboratories and application in examination results mutual approve. Methods With the analysis system 1 with the Hitachi 7170A biochemical analyzers ,Roche reagent and program,Roche c. fas calibration as a target system,detecting systems 2,3,4 and 5 as comment system,the TBIL was analysed in 25 patient fresh sera. Results The correlation coefficient was all above 0. 95, the system bias between system 2 and system 1 was partly accepted in clinical ,the system bias between system 4 and system 1 was not accepted in clinical and the system bias between system 3,5 and system 1,system 4 and system 2 was accepted in clinical. Conclusion If test methodology was same ,the examination results can be mutual approve. If test methodology was different,the results can＇t be comparable,and the system bias between two systems can＇t be accepted in clinical. If test methodology was different ,the results can be comparable by traceability.

关 键 词：总胆红素 分析系统 互认 溯源 

分 类 号：R446.112[医药卫生—诊断学]