Seth J, Sturgeon C M, al-Sadie R, Hanning I, Ellis A R
Department of Clinical Chemistry, University of Edinburgh, UK.
Ann Ist Super Sanita. 1991;27(3):443-52.
External quality assessment schemes (EQAS) have traditionally emphasised the achievement of between-laboratory consensus. Although this is important, the application of EQAS to relatively new and evolving techniques such as immunoassay calls for a wider and more searching remit if the goals of accurate assays, properly used, are to be achieved. This article outlines the principles of EQAS for peptide hormones and tumour markers, emphasising key aspects such as validation of target values, dependency of results on sample type, and assessment of method characteristics such as vulnerability to interfering factors. The latter are considered to be important as they can affect patient care more seriously than modest degrees of imprecision or inaccuracy. EQAS play a unique role in providing objective data on assays performed in many laboratories under routine conditions and the data they provide can guide improvement in diagnostic reagents and laboratory practice.
传统上,外部质量评估计划(EQAS)一直强调实验室间达成共识。尽管这很重要,但如果要实现正确使用准确检测方法的目标,将EQAS应用于免疫分析等相对较新且不断发展的技术,就需要更广泛、更深入的职责范围。本文概述了肽类激素和肿瘤标志物EQAS的原则,强调了关键方面,如靶值的验证、结果对样本类型的依赖性以及对方法特性(如易受干扰因素影响程度)的评估。后者被认为很重要,因为它们对患者护理的影响可能比适度的不精密度或不准确更严重。EQAS在提供许多实验室在常规条件下进行检测的客观数据方面发挥着独特作用,其提供的数据可指导诊断试剂和实验室实践的改进。