xxx测定试剂盒（xxx法）分析性能评估资料xxxx公司目录目录.................................................................................................................11．概述.............................................................................................................12．**试剂盒及相关信息.......................................................................................12.1**试剂盒批号和规格...........................................................................................12.2校准品和质控品...................................................................................................12.3试验仪器...............................................................................................................13性能评估资料...................................................................................................13.1空白吸光度评估资料...........................................................................................13.1.1实验要求.........................................................................................................13.1.2实验方法.........................................................................................................13.1.3实验结果.........................................................................................................13.2准确性评估资料....................................................................................................23.2.1实验要求.......................................................................................................23.2.2实验方法.........................................................................................................23.2.3实验结果.........................................................................................................23.3分析灵敏度评估资料............................................................................................23.3.1实验要求.........................................................................................................23.3.2实验方法...........................................................................................................23.3.3实验结果.........................................................................................................23.4重复性评估资料...................................................................................................23.4.1实验要求.......................................................................................................23.4.2实验方法.........................................................................................................23.4.3实验结果.......................................................................................................23.5批间差评估资料....................................................................................................33.5.1实验要求.........................................................................................................33.5.2实验方法...........................................................................................................33.5.3实验结果.........................................................................................................33.6线性范围评估资料...........................................................................................
