Vesper Hubert W, Miller W Gregory, Myers Gary L
Centers for Disease Control and Prevention, Division of Laboratory Sciences, Atlanta, GA 30341, USA.
Clin Biochem Rev. 2007 Nov;28(4):139-47.
Maintaining accurate laboratory measurements over time is crucial for assuring appropriate patient care and disease management. Accurate results over time and location are achieved by standardising measurements and establishing traceability to a reference system. Reference materials are key components of such reference systems and for establishing traceability. Commutability of reference materials is a critical property to ensure they are fit for use. Commutability is defined as the equivalence of the mathematical relationships between the results of different measurement procedures for a reference material and for representative samples from healthy and diseased individuals. This material characteristic is of special importance for measurement procedures that are optimised for measuring analytes directly in patient samples. The commutability of a reference material is measurement procedure specific and its assessment requires special experimental designs. This review explains the importance of commutability and summarises different experimental approaches described in the literature that have been used to assess the commutability of reference materials in clinical chemistry.
长期保持准确的实验室测量对于确保恰当的患者护理和疾病管理至关重要。通过标准化测量并建立与参考系统的可追溯性,可在不同时间和地点获得准确的结果。参考物质是此类参考系统以及建立可追溯性的关键组成部分。参考物质的互换性是确保其适用性的关键属性。互换性定义为针对参考物质以及来自健康个体和患病个体的代表性样本,不同测量程序结果之间数学关系的等效性。这种物质特性对于直接在患者样本中测量分析物的优化测量程序尤为重要。参考物质的互换性是特定于测量程序的,其评估需要特殊的实验设计。本综述解释了互换性的重要性,并总结了文献中描述的用于评估临床化学中参考物质互换性的不同实验方法。