关于医学实验室不确定度的评估

Uncertainty Assessment of Medical Laboratory

随着医学实验室标准化工作的开展,国际标准化组织(ISO)在关于医学实验室能力评定的文件(ISO15189)中提出了对实验数值不确定度评估的要求。介绍了不确定度的概念,并对如何应用实验方法与参考方法的比较、利用实验室内与室间质控数据等方法得到不确定度的来源,不确定度与传统的系统和随机误差的关系进行了分析,为临床检验工作中不确定度的深入研究提供了新的思路。

With the standardization of medical laboratory carried out, International Organization for Standardization （ISO） presented the uncertainty assessment requirements of experimental values in the file about medical laboratory capacity assessment （IS015189）. Uncertainty is throughout the testing process, which relates to not only the main factors such as testing equipment, measuring equipment, testing methods, but also the quality control before and after analysis. Such items are described as the concept of uncertainty, comparison of experimental methods and reference methods, getting the source of uncertainty by quality control data in laboratory or inter laboratory, relationship between uncertainty and the traditional system or random errors.[Chinese Medical Equipment Journal, 2010,31 （2） ： 90-92,94]