生物样品分析方法的有效性验证

How to validate a bio-analytical method

对于新建立的生物样品分析方法,首先必须进行方法有效性验证。生物样品分析方法有效性验证内容应包括选择性、线性、准确度、精密度、检测限、最低定量限、稳定性和提取回收率等。应用LC-MSn方法时还应验证基质效应。根据T2007国际法庭毒理年会上关于生物样品分析方法有效性验证讨论的主要内容,作者结合实际工作中的经验,阐述方法有效性验证的详细过程。可供建立生物样品分析方法时参考。

It is imperative that any newly established bio-analytical method is validated thoroughly, using standardised parameters. The purpose of this article is to provide recommendations on how to validate a new bio-analytical method. Based on author＇s personal experience and some interesting discussion points from the conference of ＂International Association of Forensic Toxicologists＂ in 2007, the authors propose these essential requirements for validating a new analytical method. The key parameters of method validation include selectivity, linearity, accuracy, precision, LOD （limit of detection）, LLOQ （the lower limit of quantitation）, stability and the extraction recovery. For any bio-analytical method using LC-MS^n （Liquid chromatography-mass spectrometry）, studies of matrix effect should also be included in addition of the above parameters.