Abstract: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 intraassay and imprecision withinlaboratory 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 withinlaboratory variance (SWL). The manufacturer claims on imprecision, σR and σWL, were compared with the results respectively. SR≤σR and SWL≤σWL imply that the imprecision claims of manufacturer were verified by users. If SR>σR or SWL>σWL, the results should be further compared with the upper verification limit (UVL). SR≤UVLR and SWL≤UVLWL also 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 withinlaboratory SWL were compared with the manufacturer claims σR and σWL or calculated UVLR and UVLWL respectively, and showed that in the imprecision verification of intraassay repeatability experiments SR≤σR was 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 withinlaboratory imprecision verification experiments, SWL ≤σWL was shown for both level of the 6 items. 〖 Conclusion:The repeatability of intraassay and withinlaboratory imprecision of 6 Roche biochemistry items meet with the manufacturer claims and the requirements of quality objectives.