肌酐清除率测量不确定度的评估及应用  

Estimation of the Measurement Uncertainty of Creatinine Clearance Rate

作　　者：李江[1] 杨辉[1] 鲁涛[1] 赵兴波[1] 鄢盛恺[1] 

机构地区：[1]卫生部中日友好医院检验科,北京100029

出　　处：《现代检验医学杂志》2010年第6期4-8,共5页Journal of Modern Laboratory Medicine

基　　金：中国合格评定国家认可中心2010年度科技计划资助项目（J1008）.

摘　　要：目的 探讨不同因素对临床生物化学实验室肌酐清除率的影响,对肌酐清除率测量不确定度进行评估.方法 以中国合格评估国家认可委员会提供的＜测量不确定度要求的实施指南＞为基础,参考其他测量不确定度指南文件,对该实验室血清和尿液肌酐的测量不确定度进行评估,并通过计算得出肌酐清除率的测量不确定度.结果 患者1和患者2的肌酐清除率为66.88 ml/min和30.93 ml/min时,其扩展不确定度为16.98 ml/min和7.84 ml/min,相对标准不确定度为12.7%和12.67%;排除生物学变异和分析前影响后,扩展不确定度为5.48 ml/min和2.50 ml/min,相对标准不确定度为4.09%和4.04%.结论 标本浓度对不确定度评估无影响,在排除个体生物学变异后,分析前因素对肌酐清除率测量不确定度评估影响巨大,对指导我们完善实验室质量管理程序意义重大.Objective To explore the effects of the different parameters on the results of creatinine clearance rate of clinical biochemistry laboratory, and estimate the measurement uncertainty of creatinine clearance rate. Methods Based on the Implementation Guide of requirement of measurement uncertainty provided by CNAS and other guidelines,the measure- ment uncertainty of serum and urine ereatinine in laboratory was estimated,and the measurement uncertainty of creatinine clearance rate was also calculated. Results When the creatinine clearance rate of patient 1 and 2 were 66.88 ml/min and 30. 93ml/min,the expanded uncertainty were 16.98 ml/min and 7.84 ml/min,and the relative standard uncertainty were 12.7% and 12.67%,respectively. The factors of biological variation excluded ,the expanded uncertainty was 5.48 ml/min and 2.50 ml/min,and the relative standard uncertainty were 4. 090/oo and 4.04% ,respectively. Conclusion The concentra- tion of samples had no effect on the uncertainty estimation. The impact of biological variability excluded ,preanalytical vari- ation is the major factor for estimating the measurement uncertainty of creatinine clearance rate. These will help us improv- ing the laboratory quality management progress.

关 键 词：肌酐清除率 测量不确定度 

分 类 号：R446.112[医药卫生—诊断学]