临床生化检验测量不确定度的评估

目的探讨测量不确定度在临床生化检验中的应用。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,对本实验室生化检测项目的测量不确定度进行评估,按测量不确定度评估的过程,分析不确定度分量的来源并分别按A类和B类进行评估,合成标准不确定度,计算扩展不确定度。结果不确定度分量来源主要包括：测量的不精密度、校准品的不确定度。其中,不精密度分量按美国临床和实验室标准协会（CLSI）EP5A文件评定,校准品的不确定度分量根据厂家的溯源性报告评定。结论该研究只评估测量过程的不确定度,临床生化检验常规测量中应根据具体情况分析不确定度分量的来源,对测量结果进行不确定度的评估。

Evaluation of measurement uncertainty in clinical biochemical detection

Objective To study the application of measurement uncertainty in the clinical biochemical detection.Methods Based on the Implementation Guide of Measurement Uncertainty Requirements the provided by China National Accreditation Board for Conformity Assessment（CNAS）,also referring to other measurement uncertainty guide documents,the measurement uncertainty of our biochemical laboratory test items were assessed.According the evaluating process of measurement uncertainty,the sources of uncertainty were analyzed and divided into the class A and B for evaluating,synthetizing the standard uncertainty and calculating the expanded uncertainty.Results The uncertainty mainly originated from measurement imprecision and calibrator uncertainty.The component of imprecision was evaluated based on CLSI EP5A documents and the component of calibrator uncertainty was evaluated based on the manufacturer′s traceability assessment report.Conclusion This study only evaluates the measurement uncertainty during detection process.In the routine clinical biochemical detection items,the sources of components uncertainty should be analyzed according to concrete conditions and the results should be performed the assessment of measurement uncertainty.