National Genetics Reference Laboratory (Wessex), Salisbury District Hospital, Salisbury, UK.
Eur J Hum Genet. 2010 Dec;18(12):1276-88. doi: 10.1038/ejhg.2010.101. Epub 2010 Jul 28.
The validation and verification of laboratory methods and procedures before their use in clinical testing is essential for providing a safe and useful service to clinicians and patients. This paper outlines the principles of validation and verification in the context of clinical human molecular genetic testing. We describe implementation processes, types of tests and their key validation components, and suggest some relevant statistical approaches that can be used by individual laboratories to ensure that tests are conducted to defined standards.
在将实验室方法和程序用于临床检测之前，对其进行验证和确认对于向临床医生和患者提供安全有用的服务至关重要。本文概述了临床人类分子遗传学检测背景下的验证和确认原则。我们描述了实施流程、测试类型及其关键验证组件，并提出了一些相关的统计方法，供各个实验室用于确保测试符合既定标准。
