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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。
Objective To investigate the clinical value of CLSI EP15-A3 in the validation of clinical biochemical precision. Methods According to the precision design of 5 × 5 of EP15-A3, the levels of creatinine (Cr), urea (Urea), uric acid (UA), total cholesterol Cholesterol (TC), triglyceride (TG), glucose (Glu) six commonly used biochemical indicators of intra-laboratory and laboratory testing of imprecision. One batch per day per sample, 5 replications per batch for 5 days, with 25 data for each sample. Grubbs’ method was used to calculate outliers and single-factor analysis of variance (ANOVA) to calculate intra-assay user-specific inaccuracy (SR) and intra-laboratory inaccuracy (SWL) Laboratory statement of laboratory precision (σWL) to compare and judge, if SR ≤ σR, SWL ≤ σWL, the user verified the manufacturer’s imprecise statement. If SR> σR or SWL> σWL, then each continues to compare with its upper limit verification value (UVL). If SR≤UVLR, SWL≤UVLWL, the same user validates the manufacturer’s imprecise statement. Otherwise, find out the reason or contact the manufacturer. Results The results of six biochemical indexes were all checked by Grubbs’ method. There was no outliers in each item. SR and SWL were compared with σR, σWL or UVLR and UVLWL, respectively. In in-batch imprecision validation experiments, SR> σR except Cr (level 1), TC (level 2) and Glu , Other indicators of the level of SR are ≤ σR; laboratory precision test, six indicators of two levels of SWL are ≤ σWL. Conclusion The 6 Roche biochemical indicators used in laboratory are in-factory and in-laboratory inaccuracy, meet the requirements of manufacturer’s statement, and meet the quality target requirements.