【摘要】 目的探讨美国临床和实验室标准化协会(CLSI)EP15-A3在临床生化精密度验证中的应用价值。方法按照EP15-A3精密度5×5设计方案,利用IFCC提供的Rela A(水平1)和Rela B(水平2)样本,分别对肌酐(Cr)、尿素(Urea)、尿酸(UA)、总胆固醇(TC)、三酰甘油(TG)、葡萄糖(Glu)6个临床常用生化指标进行批内和实验室内不精密度验证。每个样本每天1批,每批重复5次,共5 d,每个样本获得25个数据。Grubbs’法计算离群值,单因素方差分析(ANOVA)计算用户批内不精密度(SR)和实验室内不精密度(SWL),分别与厂家声明的批内不精密度(σR)和厂家声明的实验室内不精密度(σWL)进行比较和判断,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 6个生化指标的测定结果均通过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,批内不精密度验证实验中,除Cr(水平1)、TC(水平2)、Glu(水平2)的SR>σR、SR≤UVLR外,其他指标各水平SR均≤σR;实验室内不精密度验证实验中,6个指标两个水平SWL均≤σWL。结论实验室现用的6个Roche生化指标批内与实验室内不精密度达到厂家声明要求,符合质量目标要求。更多还原

【Abstract】 Objective To explore the application value of Clinical and Laboratory Standards Institute( CLSI) guideline EP15-A3 for precision verification in clinical biochemistry. Methods According to the design of EP15-A3 basic 5 × 5 precision experimental procedure,the results of 6 common biochemistry items including creatinine( Cr),urea,uric acid( UA),total cholesterol( TC),triglyceride( TG) and glucose( Glu) were verified for repeatability of intra-assay and imprecision within-laboratory by using the IFCC Rela( level 1) and Rela B( level 2) samples. The basic 5 × 5 design,i. e.,one run per day for five days and five replicates per run,should yield 25 results for same sample. The outliers were calculated by Grubbs’ test,and one way ANOVA test was used to calculate the repeatability variance( SR) of users and the within-laboratory variance( SWL). The manufacturer claims on imprecision,σRandσWL,were compared with the results respectively. SR≤σRand SWL≤σWLimply that the imprecision claims of manufacturer were verified by users. If SR> σRor SWL> σWL,the results should be further compared with the upper verification limit( UVL). SR≤UVLRand SWL≤UVLWLalso imply that the imprecision claims of manufacturer were verified by users. Otherwise,the reasons of imprecision should be searched or the contact with the manufacturer should be needed. Results The results of 6 biochemistry items were all passed through Grubbs’ outliers test,and there were no outliers. The repeatability SR and the within-laboratory SWLwere compared with the manufacturer claims σRand σWLor calculated UVLRand UVLWLrespectively,and showed that in the imprecision verification of intra-assay repeatability experiments SR≤σRwas shown for each level of the 6 items,except for Cr( level 1),TC( level 2),GLU( level 2)which were SR> σR,SR≤UVLR. In within-laboratory imprecision verification experiments,SWL≤σWLwas shown for both level of the 6items. Conclusion The repeatability of intra-assay and within-laboratory imprecision of 6 Roche biochemistry items meet with the manufacturer claims and the requirements of quality objectives.更多还原