Stöckl D, Baadenhuijsen H, Fraser C G, Libeer J C, Petersen P H, Ricós C
Institut für Standardisierung und Dokumentation im medizinischen Laboratorium e. V. (INSTAND e. V.), Düsseldorf, Germany.
Eur J Clin Chem Clin Biochem. 1995 Mar;33(3):157-69.
The aim of the Working Group was to describe guidelines for deriving desirable analytical goals in laboratory medicine. First, a literature review is given of the different approaches used until now, and some of the most important studies are presented in detail. These approaches are then discussed critically, and the analytical goals proposed by the group are outlined with respect to monitoring and diagnostic testing. The group recommends that, most realistically, analytical quality specifications be biologically based. For diagnostic testing, the aim is achievement of accuracy, allowing the use of common reference intervals when populations are homogeneous for a given quantity. For monitoring (within an individual laboratory and performed with the same instrument), analytical performance should aim at stable operation and low imprecision compared with the within-subject biological variation. Method accuracy is also very important for the comparability of results from different laboratories or instruments.
该工作组的目的是描述制定检验医学理想分析目标的指南。首先，对迄今所采用的不同方法进行文献综述，并详细介绍一些最重要的研究。然后对这些方法进行批判性讨论，并概述该小组就监测和诊断检测提出的分析目标。该小组建议，最现实的做法是，分析质量规范应以生物学为基础。对于诊断检测，目标是实现准确性，在给定数量的人群同质时允许使用通用参考区间。对于监测（在单个实验室内部且使用同一台仪器进行），与个体内生物学变异相比，分析性能应旨在实现稳定运行和低不精密度。方法准确性对于不同实验室或仪器的结果可比性也非常重要。
