Department of Clinical Laboratory, Beijing Chao-Yang Hospital Affiliated to Capital Medical University, Beijing, P.R. China.
Department of Clinical Laboratory, Fengtai Teaching Hospital of Capital Medical University, Beijing, P.R. China.
Clin Chem Lab Med. 2018 Jan 26;56(2):242-248. doi: 10.1515/cclm-2017-0511.
Measurement uncertainty (MU) characterizes the dispersion of the quantity values attributed to a measurand. Although this concept was introduced to medical laboratories some years ago, not all medical researchers are familiar with it. Therefore, the evaluation and expression of MU must be highlighted. In this paper, the evaluation of MU is described by using four different approaches from different quality assessment data.
In accordance with Guide to the Expression of Uncertainty of Measurement (GUM) principles, human serum γ-glutamyltransferase (GGT) level was defined as the measurand. Main sources of MU were analyzed; individual components of MU were evaluated, followed by calculation of standard uncertainty, the combined standard uncertainty and the expanded uncertainty.
In method 1, the median of expanded uncertainty (k=2) of GGT in lower level (65±1 U/L) was 5 U/L (9%, 95% confidence interval) and in higher level (116±2 U/L) was 8% (95% confidence interval), respectively. The results of method 2 were lower than that of method 1. There were no significant differences between the two other methods compared with the method 1.
Three out of the four different approaches based on different quality assessment data yielded similar results. Proficiency testing or external quality assessment data used for MU evaluation can be regarded as a supplementary method in clinical laboratory.
测量不确定度(MU)描述了赋予被测量值的分散性。尽管这个概念在几年前就被引入到医学实验室中,但并非所有医学研究人员都熟悉它。因此,必须强调 MU 的评估和表达。在本文中,使用了从不同质量评估数据中得出的四种不同方法来描述 MU 的评估。
根据测量不确定度表示指南(GUM)原则,将人血清γ-谷氨酰转移酶(GGT)水平定义为被测量。分析了 MU 的主要来源;评估了 MU 的各个组成部分,然后计算了标准不确定度、合并标准不确定度和扩展不确定度。
在方法 1 中,低水平(65±1 U/L)GGT 的扩展不确定度(k=2)中位数分别为 5 U/L(9%,95%置信区间)和高水平(116±2 U/L)为 8%(95%置信区间)。方法 2 的结果低于方法 1。与方法 1 相比,另外两种方法之间没有显著差异。
基于不同质量评估数据的四种不同方法中的三种得出了相似的结果。用于 MU 评估的能力验证或外部质量评估数据可被视为临床实验室的补充方法。