Saunders Nick, Sharp Ian
PHE Microbiology Services Colindale, 61 Colindale Avenue, London, NW9 5EQ, UK.
Methods Mol Biol. 2015;1247:77-105. doi: 10.1007/978-1-4939-2004-4_6.
This chapter describes the process of validating in-house molecular assays although the principles described are equally relevant to all diagnostic assays. The best practice principles described below are based on the In Vitro Diagnostic Medical Devices Directive (IVDD) and associated documentation. Although compliance with these regulations is not required for diagnostic reagents used on animals, the principles are equally relevant to validation of all diagnostic assays, whatever their purpose.
本章描述了内部分子检测方法的验证过程，尽管所描述的原则同样适用于所有诊断检测。以下所述的最佳实践原则基于体外诊断医疗器械指令（IVDD）及相关文件。虽然动物用诊断试剂无需遵守这些规定，但这些原则同样适用于所有诊断检测方法的验证，无论其用途如何。
