自建生化检测系统血清微量元素的测量不确定度评定  

Uncertainty Estimation of Measurement of Serum Trace Elements Determination by the Self-developed Biochemical Detecting System

作　　者：周远青[1] 梁瑞莲[1] 谢健敏[1] 梁玉全[1] 罗建伟[1] 梁洁莹[1] 

机构地区：[1]南方医科大学附属顺德第一人民医院检验科,广东顺德528300

出　　处：《黑龙江医学》2012年第12期881-884,共4页Heilongjiang Medical Journal

摘　　要：目的对自建生化检测系统血清微量元素铜(Cu)、锌(Zn)、铁(Fe)检测结果进行测量不确定度评定,合理表述其检测结果的分散性。方法通过对自建生化检测系统检测血清微量元素铜、锌、铁的测量过程进行分析,确定不确定度的来源,采用不确定度A类评定方法(即实验室提供的方法学性能数据,包括批内重复性CVW和批间重复性CVB,以变异系数表示)和不确定度B类评定方法(即室间质评所提供的数据所产生的不确定度,以方法偏倚的不确定度Ubias表示)量化不确定度分量,并确定扩展不确定度。结果自建生化检测系统检测血清铜、锌、铁的各不确定度分量分别为:CVCWu=1.2%,CVCBu=2.4%,UCbiuas=11.3%;CVZWn=1.6%,CVZBn=1.6%,UZbinas=6.8%;CVFWe=0.5%,CVFBe=2.9%,UFbieas=5.7%;在95%的置信水平,包含因子取1.96时三个项目的扩展不确定度(U)分别为:UCu=23.2%,UZn=14.3%,UFe=12.8%。结论在临床检验中对检测系统的检测结果进行测量不确定度评定,可以更客观合理地表述其检测结果的分散性。Objective To estimate the uncertainty of the self-developed biochemical detecting system for trace elements copper（Cu）,zinc（Zn） and iron（Fe）,and present the dispersion of results reasonably.Methods The source of uncertainty was determined through analyzing the process of the self-developed biochemical detecting system testing Cu,Zn,Fe.The uncertainty components were quantified by using Class A evaluation method of uncertainty（ie,performance of methodology datas laboratory provided,including intra-batch repeatability and inter batch repeatability,said the coefficient of variation CVW and CVB respectively） and Class B uncertainty evaluation method（ie,datas external quality assessment provided,said the percentage deviation Ubias）,and to determine the expanded uncertainty.Results The uncertainty components of the self-developed biochemical detecting system testing Cu,Zn and Fe were CVCuW=1.2%,CVCuB=2.4%,UCubias=11.3%;CVZnW=1.6%,CVZnB=1.6%,UZnbias=6.8%;CVFeW=0.5%,CVFeB=2.9%,UFebias=5.7%.While coverage factor taking 1.96,the expanded uncertainty of three items were UCu=23.2%,UZn=14.3%,UFe=12.8% at 95% confidence level.Conclusion Evaluating the uncertainty of test results of the detecting system can be more objective and reasonable when the results dispersion in the clinical laboratory are presented.

关 键 词：自建生化检测系统 微量元素 测量不确定度 

分 类 号：R446.1[医药卫生—诊断学]