临床生物化学实验室测量不确定度的评估

Estimation of the measurement uncertainty in clinical biochemistry laboratory

目的通过临床生物化学实验室肌酐(Cr)测量不确定度的评估,探讨医学实验室认可工作中测量不确定度的评估方法和程序。方法以中国合格评定国家认可委员会(CNAS)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,对本实验室血清Cr的测量不确定度进行评估。结果血清Cr浓度为59.65μmol/L时,所有不确定度分量影响的合成不确定度为2.69μmol/L,取95%可信区间,包含因子k=2,则血清扩展不确定度U=5.38μmol/L;排除生物学变异和分析前因素后,其他不确定度分量影响的合成不确定度为0.75μmol/L。结论我们所建立的测量不确定度评估方法简单方便,能分析不同因素对测量结果的影响程度,可用于医学实验室认可工作。

Objective To investigate the method and process of estimating the measurement uncertainty in Medicine Laboratory Accreditation,by analyzing the measurement uncertainty of serum creatinine in clinical biochemistry laboratory.Methods Based on the Implementation Guide of requirement of measurement uncertainty provided by CNAS and other guidelines,we estimated the measurement uncertainty of serum creatinine in clinical biochemistry laboratory.Results When concentration of serum creatinine was 59.65 μmol/L,the combined standard uncertainty was 2.69 μmol/L and the expanded uncertainty was 5.38 μmol/L with a coverage factor of 2.When the factors of biological variation and pre-analytical variation were excluded,the combined standard uncertainty was 0.75 μmol/L.Conclusions The method described by our laboratory may be used to analyze the contributions of the different parameters.It could be simply and easily used in Medicine Laboratory Accreditation.