生物样本分析实验室不确定度评定方法及在实验室质量控制中的应用

摘要

目的:提供一种生物样本分析实验室评价自身检测能力的途径,最终提高实验室的检测质量.方法:通过分析测量不确定度评定在国内的应用现状,并详细解析生物样本分析实验室测量不确定度的步骤,从内、外质量控制两方面说明不确定度对生物样本分析实验室的影响.结果与结论:国内实验室主要通过建立数学模型来考察不确定度的来源,再进行评估.不确定度评定是个持续不断的过程,在生物样本分析实验室质量控制中要从整体情况对不确定度进行评估和把握.因此,生物样本分析实验室可以通过不确定度的评定找到评价自身检测能力的方法,找到最大不确定度,逐步将其消除或降低,最终提高实验室检测质量.%OBJECTIVE:To provide a way to evaluate test capability for biological sample analysis laboratory,so as to im-prove this test quality. METHODS:By analyzing the use of measurement uncertainty in China and detailing the steps of biological sample analysis laboratory measurement uncertainty,the effects of measurement uncertainty on biological sample analysis laborato-ry are illustrated from two aspects of inner and outer quality control. RESULTS & CONCLUSIONS:National laboratories mainly examine the source of uncertainty through establishing mathematical model,and then uncertainty is evaluated. Uncertainty evalua-tion is a continuous process. Uncertainty assessment and assurance is the overall situation in a biological sample analysis laboratory quality control. Thus,biological sample analysis laboratory can find a method of self-testing capabilities by uncertainty evaluation, find the maximum uncertainty and eliminate or reduce it gradually,ultimately improve laboratory testing quality.