Gantzer Mary Lou, Miller W Greg
BioCore Diagnostics, LLC, 801 W. Baltimore Street, Baltimore, MD 21201, USA.
Clin Biochem Rev. 2012 Aug;33(3):95-100.
Clinical laboratory measurement results must be comparable among different measurement procedures, different locations and different times in order to be used appropriately for identifying and managing disease conditions. Harmonisation in the broad sense is the overall process of achieving comparability of results among clinical laboratory measurement procedures that measure the same measurand. The term standardisation is used when comparable results among measurement procedures are based on calibration traceability to SI using a reference measurement procedure of the highest available order. When there is no higher order reference measurement procedure available, and it is unlikely that one can be developed, the term harmonisation refers to any process for achieving comparable results among measurement procedures for an individual measurand.This review explains calibration traceability and focuses on the principles of harmonisation for those measurands for which a reference measurement procedure does not exist. We discuss the value of harmonisation, the importance of commutable reference materials, the barriers to harmonisation that exist today, and conclude with a discussion of a current global effort to improve the state of harmonisation.
临床实验室测量结果必须在不同测量程序、不同地点和不同时间之间具有可比性,以便能够适当地用于识别和管理疾病状况。广义上的协调是指在测量相同被测量物的临床实验室测量程序之间实现结果可比性的总体过程。当测量程序之间的可比结果基于使用最高可用级别的参考测量程序溯源至国际单位制(SI)的校准时,使用“标准化”一词。当没有更高等级的参考测量程序可用,且不太可能开发出这样的程序时,“协调”一词指的是针对单个被测量物在测量程序之间实现可比结果的任何过程。本综述解释了校准溯源性,并重点关注对于不存在参考测量程序的被测量物的协调原则。我们讨论了协调的价值、可互换参考物质的重要性、当今存在的协调障碍,并以对当前全球改善协调状况的努力的讨论作为结尾。