归一化偏差在医学实验室能力验证中的应用价值

Application Value of Normalized Deviation in the Medical Laboratory Capacity Validation

目的探讨归一化偏差(En值)在医学实验室胆固醇、甘油三酯、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇实验室能力验证中的应用价值。方法通过国家卫生健康委临床检验中心2020年能力验证计划脂类正确度验证(NCCL-C-16-2020)报告数据与实验室检测系统测量不确定度,计算胆固醇、甘油三酯、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇的En值,对实验室该项目在高、低不同浓度范围的检测能力进行评估。结果通过En值分析可知,低、高不同浓度水平的En值,胆固醇检测系统的|En|分别为0.995与1.174;甘油三酯检测系统的|En|分别为0.548与0.199;高密度脂蛋白胆固醇检测系统的|En|分别为0.943与2.077;低密度脂蛋白胆固醇检测系统的|En|分别为1.320与4.396。结论实验室甘油三酯检测能力可达到计量标准的要求;胆固醇与高密度脂蛋白胆固醇在低浓度水平具有较高的检测能力,在高浓度水平的检测能力有所下降;低密度脂蛋白胆固醇的检测能力仍需进一步加强;En值可作为一种定量评价实验室检测能力的指标,用于实验室检测能力的评估。

Objective To explore the application value of normalization deviation(En value)in the laboratory competence verification of medical laboratory,including the cholesterol,triglyceride,high density lipoprotein cholesterol and low density lipoprotein cholesterol.Methods The En values of cholesterol,triglyceride,high-density lipoprotein cholesterol and low-density lipoprotein cholesterol were calculated according to the report data for lipid correctness verification of the Clinical Laboratory Laboratory Center of the National Health Commission in 2020(NCCL-C-16-2020)and the measurement uncertainty of the laboratory testing system,and then the ability of the laboratory to detect the project in different concentration ranges of high and low were evaluated.Results The Low and high levels samples En values were different according to En value analysis,cholesterol testing system|En|were 0.995 and 1.174;Triglyceride detection system|En|were 0.548 and 0.199;High-density lipoprotein cholesterol detection system|En|were 0.943 and 2.077;Low density lipoprotein cholesterol testing system|En|were 1.320 and 4.396.Conclusions The capacity of triglyceride detection in laboratory meets the requirements of measurement standard.The detection ability of cholesterol and high-density lipoprotein cholesterol has high detection ability at low concentration level,but the detection ability decreases at high concentration level.The ability to detect low density lipoprotein cholesterol still needs to be further strengthened.These results suggest that En value could be used as a quantitative index to evaluate the laboratory testing ability.