临床检验中的测量不确定度

测量不确定度代表测量结果的分散性，是一个反映测量结果质量的参数。有关国际导则已规定测量不确定度评定的一般原则和方法，不确定度评定一般包括鉴别不确定度来源、量化不确定度分量和合并不确定度分量等步骤。不确定度首先在计量学领域普遍采用，现被引入临床检验领域。近年来几个有关临床检验的国际标准都对测量不确定度评定作出要求。对于临床检验参考测量及参考物质定值有关的测量，其不确定度基本可按现有国际导则进行评定。但对于临床实验室检验，影响检验结果或与检验结果有关的因素很多，其测量不确定度评定仍存在许多有待澄清的问题。临床实验室中不确定度的合理评定和应用，可能需要一定程度的国际约定。

Uncertainty of measurement in laboratory medicine

Uncertainty of measurement characterizes the spread of possible results of a measurement and it is a measure of the reliability of a measurement result. General rules for estimating uncertainties have been established by international guides and the estimation typically includes steps of identifying uncertainty sources, quantifying individual uncertainty components, and combining the components. Uncertainty of measurement has been widely used in metrology and now introduced to laboratory medicine. Determining the uncertainty of measurement has become a requirement of several recent international standards related to laboratory medicine. For the reference measurements and measurements related to value assignment to reference materials, estimation of uncertainty can be feasibly done according to the available international guides. For clinical laboratory tests, however, factors affecting or related to the measurement results are complex and challenges, and issues exist in estimating the uncertainty of measurement. International consensus is needed for a sensible use of uncertainties in clinical laboratory measurements.