Passey R B, Maluf K C
Department of Pathology, University of Oklahoma, Oklahoma City 73126.
Arch Pathol Lab Med. 1992 Jul;116(7):732-8.
This article explores federal requirements for validation of analytical methods and available resources. We focus on the contributions of the National Committee for Clinical Laboratory Standards to the problems of method validation. Illustrations are selected from the Committee's EP5-T Evaluation of Precision, EP10-T Preliminary Evaluation of Clinical Chemistry Methods, EP11 Uniformity of Claims, and the National Reference System for the Clinical Laboratory. We also include a list of applicable national and international organizations. Calcium assay by atomic absorption spectrometry using an imprecise diluter illustrates the application of the evaluation protocols as a method validation tool.
本文探讨了分析方法验证的联邦要求以及可用资源。我们重点关注了国家临床实验室标准委员会对方法验证问题所做的贡献。示例选自该委员会的EP5-T《精密度评估》、EP10-T《临床化学方法的初步评估》、EP11《声明的一致性》以及临床实验室国家参考系统。我们还列出了适用的国家和国际组织。使用不精确稀释器的原子吸收光谱法钙测定示例说明了评估方案作为方法验证工具的应用。
