Fraser Callum G
Biochemical Medicine, Tayside University Hospitals NHS Trust, Ninewells Hospital and Medical School, Dundee DD1 9SY, Scotland.
EJIFCC. 2001 Apr 5;13(1):3-8. eCollection 2001 Apr.
Quality specifications for the reliability performance characteristics of laboratory tests, particularly precision and bias, are necessary prerequisites for creation and control of analytical quality. Many strategies have been promulgated for setting these. Recently, the available approaches have been fixed into a hierarchical framework that has now been agreed by experts in the field to be the best current approach to a global strategy to set quality specifications in laboratory medicine. They should be incorporated into quality planning strategies everywhere i rrespective of the settings in which laboratory medicine is practised, including POCT. Models higher in the hierarchy are preferred to lower approaches but lower approaches are better than none and should be used if all that are available.
实验室检测可靠性性能特征的质量规范,尤其是精密度和偏差,是建立和控制分析质量的必要前提条件。已经颁布了许多设定这些规范的策略。最近,现有的方法已被整合到一个分层框架中,该框架现已得到该领域专家的认可,是目前制定检验医学质量规范全球策略的最佳方法。无论检验医学在何种环境下开展,包括即时检验(POCT),这些规范都应纳入各地的质量规划策略中。层次结构中较高的模型优于较低的方法,但较低的方法总比没有好,如果只有较低的方法可用,也应采用。