肇庆市三家医院不同检测系统生化指标测定结果可比性研究  

Comparative analysis on the results of serum biochemical markers by different detecting systems in three hospitals of Zhaoqing

作　　者：帅虎[1] 陈雄毅[1] 梅敏[1] 李海珠[1] 刘凌[1] 黄志伟 黄伟健 彭俊云 陆国伟 

机构地区：[1]广东省肇庆市第一人民医院检验科,广东肇庆526020 [2]广东省肇庆市人民医院 [3]广东省高要市人民医院

出　　处：《实验与检验医学》2011年第5期497-500,共4页Experimental and Laboratory Medicine

基　　金：广东省肇庆市科技局立项课题(2011E284)

摘　　要：目的探讨不同医疗机构检验系统间生化检验结果的可比性,为实现不同实验室检验结果互认提供实验数据。方法用同一批号室内质控分别对肇庆市第一人民医院罗氏检测系统、肇庆市第二人民医院岛津检测系统、高要市人民医院奥林巴斯检测系统进行精密度评估,根据美国临床实验室标准协会(CLSI)批准文件EP9-A2,以罗氏检测系统作为目标检测系统,岛津检测系统、奥林巴斯检测系统作为实验检测系统,对14项生化检测项目进行方法学比对和系统偏差估计。结果三家医院14项指标日间精密度都小于1/3CLIA,88允许误差范围;第二人民医院岛津检测系统与第一人民医院罗氏检测系统比较ALT、GGT、TChol存在系统偏差临床不可接受,其余项目符合临床要求;高要市人民医院奥林巴斯检测系统与第一人民医院罗氏检测系统比较,除TB外其余项目系统偏差均符合临床要求,最后对临床不可接受项目参考自建系统的量值溯源程序对其进行校准。结论要实现不同实验室检验结果互认必须对各系统间精密度与系统偏差进行比对分析并对系统偏差进行校准,以保证各系统检测结果误差在临床可按受范围内。Objective To evaluate the comparability within the biochemical results obtained from different detecting systems,and provide experimental data for the mutual recognition of different clinical laboratories.Methods The precision of Roche system from Zhaoqing First People＇s Hospital,Shimadzu system from the Zhaoqing Second People＇s Hospital and Olymplus system from Gaoyao People＇s Hospital were evaluated by Randox control serum.Consulting EP9-A file of CLSI,Roche system was regarded as aim system,Shimadzu system and Olymplus system were regarded as testing systems.Method comparison and bias estimation of fourteen biochemical markers were evaluated.Results Daily precision of detecting systems in three hospitals was all less than one third of CLIA＇88.All markers＇ system biases between Roche system and Shimadzu system were acceptable except ALT,GGT and TChol.All markers＇ system biases between Roche system and Olymplus system were acceptable except TB.The unacceptable markers were calibrated by self-developed calibration procedure.Conclusions It is necessary to evaluate precision,system bias and then recalibrate according to clinical acceptability for the mutual recognition of different detecting systems.

关 键 词：检测系统 比对研究 系统偏差 精密度 

分 类 号：R446.11[医药卫生—诊断学]