应用CLSIEP15-A3验证糖化血红蛋白分析仪的精密度  

The application of CLSI EP15-A3 for precision verification in three glycated hemoglobin measurement systems

作　　者：林莉[1] 刘冬冬[1] 刘丹[1] 韦少丹 林馥嘉[1] 陈林[1] 罗福东[1] 郑楚宏 徐建华[1] LIN Li;LIU Dong-dong;LIU Dan(Department of Laboratory,Guangdong Provincial Hospital of Chinese Medicine. Guangdong Guangzhou 510120)

机构地区：[1]广东省中医院检验医学部,广东广州510120 [2]广东医科大学检验学院,广东东莞523808

出　　处：《医学检验与临床》2019年第1期1-5,共5页Medical Laboratory Science and Clinics

基　　金：国家自然科学基金(81572088);“十二五”国家科技支撑计划(2013BAI02B04);“十二五”国家科技支撑计划(2012BAI37B01);广东省中医院拔尖人才项目(2014-47).

摘　　要：目的:根据美国临床和实验室标准化协会(CLSI)EP15-A3文件的相关规定,验证三台糖化血红蛋白仪(日立7180生化分析仪、Sebia Minicap FP毛细管电泳仪、Trinity Biotech Priemier Hb 9210TM分析仪)的精密度.方法:按照EP15-A3精密度5×5设计方案,利用仪器原装配套质控品Sebia(水平1、水平2)、9210(水平1、水平2)、Roche(水平1、水平2)进行批内和实验室内不精密度验证.每个质控样本每天1批,每批重复5次,共5天,每个样本获得25数据.使用Grubbs'法计算离群值,使用单因素方差分析(ANOVA)计算批内不精密度(SR)和实验室内不精密度(SWL),分别与厂家给出的批内不精密度(σR)和实验室内不精密度(σWL)进行比较和分析.如果SR≤σR、SWL≤σWL,则用户验证了厂家不精密度声明.如果SR>σR或SWL>σWL,则各自继续与其上限验证值(UVL)比较,如果SR≤UVLR、SWL≤UVLWL,同样用户验证了厂家不精密度声明.否则,需查找原因或与厂家联系.结果:三台糖化血红蛋白仪的测定结果均通过Grubbs'法离群值检查,各项目无离群值.SR和SWL分别与σR、σWL或UVLR、UVLWL比较,结果显示,批内不精密度验证实验中,除Sebia(水平1、水平2)、Roche(水平2),SSR>σR,SR≤UVLR外,其他各水平均SR≤σR.实验室内不精密度验证实验中,除Sebia(水平2)、SWL>σWL,SWL≤UVLWL外,其他水平均SWL≤σWL.结论:实验室现用的三台糖化血红蛋白仪的不精密度达到厂家声明要求,符合质量目标要求.Objective: Depending on the relevant provisions of Clinical and Laboratory Standards Institute (CLSI) uideline EP15- A3, the precision of three glycosylated hemoglobin instruments including Hitachi 7180biochemical analyzer, Sebia Minicap FP capillary electrophoresis apparatus, Trinity Biotech Priemier Hb 9210TM analyzer was verified. Methods: According to the EPl5-A3 basic 5×5 precision experimental procedure design, Roche were calculated estimates for repeatability and within laboratory imprecision by using the quality control samples of three glycated hemoglobin measurement systems including Sebia, 9210.The basic 5×5 design for five days, one run per day, five replicates per run should yield a total of 25 results per sample. Grubbs' test was used to calculate the outliers, the one way ANOVA was used to calculate the user's repeatability variance (SR) and the within-laboratory variance (SWL) and then respectively comparing with manufacturer claims αR and αWL. IfSR≤σR and SWL≤σWL, it means users verify the manufacturer's imprecision claims. If SR>σR or SWL>σWL, Each continue to comparing with upper verification limit (UVL). IfSR≤UVLR and SWL≤UVLWL, it also means users verify the manufacturer's imprecision claims. Otherwise, they need to find reason or contact with the manufacturer. Results: The three glycated hemoglobin measurement systems results were get through Grubbs' outliers test, and there were no outliers. The repeatability SR and the within-laboratory SWL respectively comparing with manufacturer claims σR and σWL or calculated UVLR and UVLWL , result shows that in repeatability imprecision verification experiments, each measurement systems' level SR≤σR. except Sebia、RocheSR>αR, SR≤UVLR.The three glycated hemoglobin measurement systems in within-laboratory imprecision verification experiments, each measurement systems,level SWL≤σWL, except Sebia、SWL>σWL, SWL≤UVLWL. Conclusion;The repeatability and within-laboratory imprecision of three glycated hemoglobin measurement syst

关 键 词：精密度 分析性能 验证 EP15-A3 

分 类 号：R446.11[医药卫生—诊断学]