血脂6项在Beckman AU系列多个检测系统精密度、不确定度的评估及可比性分析  

Precision and uncertainty evaluation and comparison analysis of 6 items blood lipids index on different Beckman AU biochemical testing systems

作　　者：向加林[1] 任勇[1] 杨小理[1] 杨艳[1] 欧阳旭红[1] 韩昵薇[1] 尹玲[1] 

机构地区：[1]遵义医学院附属医院医学检验科,贵州遵义563000

出　　处：《国际检验医学杂志》2015年第14期2007-2008,共2页International Journal of Laboratory Medicine

摘　　要：目的评估实验室内Beckman AU系列全自动生化分析仪5套检测系统三酰甘油(TG)、总胆固醇(TCHO)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、载脂蛋白A1(APOA1)、载脂蛋白B(APOB)6项指标的精密度、不确定度及结果的可比性。方法采用NCCLS EP15-A2方案,进行精密度、可比性分析,批内及日间精密度、各仪器间检测结果的一致性以1/4、1/3、1/2CLIA′88TEa为评价标准。利用校准品不确定度、基于室内质控、室间质评数据评估这些项目的不确定度。结果 5套检测系统血脂6项指标的批内精密度、日间精密度、相对偏倚均符合临床要求;TG扩展不确定度为0.079、0.035mmol/L,TCHO扩展不确定度为0.248、0.157mmol/L,HDL-C扩展不确定度为0.144、0.018mmol/L,LDL-C扩展不确定度为0.140、0.186mmol/L,APOA1扩展不确定度为0.148、0.090mmol/L,APOB扩展不确定度为0.104、0.058mmol/L。结论血脂6项检测结果在Beckman AU系列5套检测系统精密度良好且相同项各结果呈显著相关,结果一致且可比,对各分析项目测量不确定度的评定直观表达不同因素对测量结果的影响程度,评定简单易行。Objective To evaluate the precision and uncertainty and comparison analysis of 6items blood lipids index among 5different Beckman AU biochemical testing systems,such as triglyceride（TG）,total cholesterol（TCHO）,high density lipoprotein cholesterol（HDL-C）,low density lipoprotein cholesterol（LDL-C）,apolipoproteins A1（APOA1）,apolipoproteins B（APOB）.Methods According to the document the EP15-A2 of national Committee for Clinical Laboratory Standards,6items blood lipids index were respectively detected by 5different Beckman AU biochemical testing systems to obtain precision and comparison.The intraand inter-precision and results of comparability among different system were low than 1/4or 1/3or 1/2CLIA′88as evaluation standard,respectively.The measurement uncertainty of these items were evaluated by the calibrator uncertainty and internal quality control and external quality control.Results The intra-and inter-or day-to-day precision and relative bias were accepted by clinical requirements.The expanded measurement uncertainty for TG was 0.079mmol/L and 0.035mmol/L.The expanded measurement uncertainty for TCHO was 0.248 mmol/L and 0.157 mmol/L.The expanded measurement uncertainty for HDL-C was 0.144mmol/L and 0.018mmol/L.The expanded measurement uncertainty for LDL-C was 0.140mmol/L and 0.186mmol/L.The expanded measurement uncertainty for APOA1 was 0.148mmol/L and 0.090mmol/L.The expanded measurement uncertainty for APOB was 0.104mmol/L and 0.058mmol/L.Conclusion The results of 6items blood lipids index respectively show well precision and significantly correlation among 5different Beckman AU biochemical testing systems and the results were comparable,and the influence factor of detection results were expression directly by evaluating the measurement uncertainty of 6items blood lipids index.This way of assessment is simple.

关 键 词：精密度 不确定度 可比性 生化分析 血脂 

分 类 号：R446.1[医药卫生—诊断学]