肝功能11项在Olympus AU系列多个检测系统中的精密度评价及可比性分析

Precision evaluation and comparison analysis of 11 items of hepatic function index on different Olympus AU biochemical testing systems

目的探讨实验室内Olympus AU系列全自动生化分析仪多个检测系统肝功能11项的精密度及可比性分析。方法参照美国国家临床实验室标准化委员会EP15-A方案,BIO-RAD常规化学质控品高、低2个浓度,每天分析一个批次,每批次重复测定4次,连续5个工作日分别对肝功能11项检测项目精密度进行分析;收集患者标本20份,分别于两台生化分析仪AU5400-1、AU5400-2的4个检测单元(参比系统X,比较系统Y1、Y2、Y3)进行检测,每天测定4份,连续测定5天,并对肝功能11项结果可比性分析。结果 AU5400 4个检测单元肝功能11项精密度分别按1/4、1/3CLIA′88标准或厂家声明,批内精密度、批间精密度均在可接受范围,比较系统Y1、Y2、Y3各项目相对偏倚均小于1/2TEa CLIA′88或厂家声明,各项目相关系数均r2>0.95。结论肝功能11项检测结果在Olympus AU系列4个检测系统精密度良好且相同项各结果呈显著相关,测定结果一致且具可比性。

Objective To explore the precision evaluation and comparison analysis of 11 items of hepatic function index on different Olympus AU biochemical testing systems in laboratory.Methods According to the document EP15-A of national Committee for Clinical Laboratory Standards,11 items of hepatic function index were respectively detected by four different Olympus AU biochemic testing systems（reference system X,Comparison system Y1,Y2,Y3） to obtain precision and results of cmparability analysis.BIO-RAD routine biochemistry high and low controls were used to evaluate the precision of 11 items by repeatedly and continuously detecting 4 times,5 days in one assay.20 patients′ serum were collected and analysed comparability through detecting 4 samples per day and 5 days.All results were subjected to analysis of correlation.Results The intra-and inter-precision precision coefficients of 11 items of hepatic function were in the range of 1/4 or 1/3CLIA′88 or the statement of manufacturers.The relative bias level of Y1 or Y2 or Y3 comparable systems were low than 1/2 TEa CLIA′88 or the statement of manufacturers,r20.95.Conclusion The results of 11 items of hepatic function index show well precision and significantly correlation between four different Olympus AU biochemic testing systems,the testing results might be concordant and comparable.