临床化学定量项目测量的不确定度评估分量的分析  

Uncertainty evaluation of quantitative clinical biochemistry analysis

作　　者：梁敏文[1] 郑有为[1] 邸玉玮[1] 董晖[1] 戴耀宗[1] 郑卫东[1] 

机构地区：[1]广东省人民医院/广东省医学科学院病理医学部检验科,广州510080

出　　处：《中国卫生检验杂志》2012年第11期2678-2681,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的:对临床化学定量项目测量的不确定度评估分量进行分析。方法:1.用三种方法(方法 1:u1%=[CVB%2+CVCal%2]1/2、方法 2:u2%=[CVW%2+CVB%2+CVCal%2]1/2和方法 3:u3%=[CVW%2+CVB%2+CVBias%2]1/2)评估钾等10个项目测量的不确定度。2.用方法 2评估封闭检测系统的项目,方法 3评估开放检测系统参加EQA的项目及酶类项目。结果:1.钾等10个项目得到u2%与u1%的r=0.985(P<0.01)、u2%与u3%的r=0.949(P<0.01),u2%与u1%、u3%差异无统计学意义(P均>0.05)。2.封闭检测系统的项目u2%中CVB%为主要分量。3.开放检测系统参加EQA的项目及酶类项目u3%中CVB%、CVBias%为主要分量。结论:三种方法评估临床化学定量项目的测量的不确定度均可行,可根据不同的检测系统采用不同方案。室内质控累积变异、室间质评偏倚是影响测量的不确定度评估的重要分量。Objective：To explore the methods and analyze the component of measurement uncertainty on the items in clinical chemistry lab.Methods： The precision parameters based on clinical sample measurement（CVW%）,IQC data（CVB%）,the calibration uncertainty（ucal%） and the EQA bias（CVbias%） were considered as uncertainty sources.Data from different sources were combined to relative standard uncertainty（u%）,u1% combined from CVB% and ucal%,u2% combined from CVW%,CVB% and ucal%,u3% combined from CVW%,CVB% and CVbias%.Results： In the uncertainty evaluation of 10 items,u2% correlated with u1% and u3%（r=0.985,0.949,both P 0.01）,there was no difference between u2% and u1%,u2% and u3%（P0.05）.For 22 items of closed detecting system,CVB% was the biggest source of u% combined from CVW%,CVB% and ucal%.For 4 items of open detecting system and 7 items without calibration,CVB% and CVbias% were the bigger components of u% combined from CVW%,CVB% and CVbias%.For 9 items of open detecting system and out of EQA plan,CVB% was bigger component of u% combined from CVW% and CVB%.Conclusion： According to different situation of different items,available components were chosen to combine uncertainty.For all the detecting systems,CVB% and CVbias% were the important sources of uncertainty evaluation.

关 键 词：临床化学 测量的不确定度 检测系统 室内质控 室间质评 

分 类 号：R446.1[医药卫生—诊断学]