Department of Pathology, Virginia Commonwealth University, Richmond, VA;
European Commission, Joint Research Centre (JRC), Directorate F, Geel, Belgium.
Clin Chem. 2018 Mar;64(3):447-454. doi: 10.1373/clinchem.2017.277525. Epub 2018 Jan 18.
Commutability is a property of a reference material (RM) that relates to the closeness of agreement between results for an RM and results for clinical samples (CSs) when measured by ≥2 measurement procedures (MPs). Commutability of RMs used in a calibration traceability scheme is an essential property for them to be fit for purpose. Similarly, commutability of trueness controls or external quality assessment samples is essential when those materials are used to assess trueness of results for CSs. This report is part 1 of a 3-part series describing how to assess commutability of RMs. Part 1 defines commutability and addresses critical components of the experimental design for commutability assessment, including selection of individual CSs, use of pooled CSs, qualification of MPs for inclusion, establishing criteria for the determination that an RM is commutable, generalization of commutability conclusions to future measurements made with the MPs included in the assessment, and information regarding commutability to be included in the certificate for an RM. Parts 2 and 3 in the series present 2 different statistical approaches to commutability assessment that use fixed criteria related to the medical decisions that will be made using the laboratory test results.
互换性是参考物质（RM）的一种属性，它与通过≥2 种测量程序（MP）测量 RM 与临床样本（CS）的结果之间的接近程度有关。校准可溯源性方案中使用的 RM 的互换性是其适合用途的必要属性。同样，当这些材料用于评估 CS 结果的准确性时，准确性控制品或外部质量评估样本的互换性也是必要的。本报告是描述如何评估 RM 互换性的三部分系列报告的第 1 部分。第 1 部分定义了互换性，并讨论了互换性评估实验设计的关键组成部分，包括个体 CS 的选择、混合 CS 的使用、合格 MP 的纳入、确定 RM 可互换性的标准的建立、将评估中包含的 MPs 进行未来测量的互换性结论进行推广，以及关于 RM 证书中包含的互换性信息。该系列报告的第 2 部分和第 3 部分介绍了 2 种不同的统计方法，这些方法使用与使用实验室测试结果做出的医学决策相关的固定标准来评估互换性。
