GB/T 37875-2019 核酸提取纯化试剂盒质量评价技术规范
简介
GB/T 37875-2019
核酸提取纯化试剂盒质量评价技术规范
Technical specification for quality evaluation of nucleic acid extraction and purification kits
2019-08-30 发布
2019-08-30 实施
目 次
前言...........................................1
1范围...........................................1
2规范性引用文件......................................1
3术语和定义、缩略语....................................1
3.1术语和定义.....................................1
3.2缩略语.......................................2
4评价指标.........................................3
4.1产量........................................3
4.2纯度........................................3
4.3完整度.......................................3
4.4重复性.......................................3
4.5再现性.......................................3
4.6批间差异......................................3
4.7细菌内毒素残留...................................3
5评价方法.........................................3
5.1总则........................................3
5.2产量........................................3
5.3纯度........................................3
5.4完整度.......................................4
5.5重复性.......................................4
5.6再现性.......................................4
5.7批间差异......................................4
5.8细菌内毒素残留...................................5
6质量评价报告.................................... 5
附录A （资料性附录）核酸提取产量、纯度、完整度和细菌内毒素残留的测定方法.........6
本标准按殖GB/T 1.1-2009馅出的规则起草.
本标准由国家标准物质硏究中心提出并归口.
GB/T 37875-2019
核酸提取纯化试剂盒质量评价技术规范
Technical specification for quality evaluation of nucleic acid extraction and purification kits
2019-08-30 发布
2019-08-30 实施
目 次
前言...........................................1
1范围...........................................1
2规范性引用文件......................................1
3术语和定义、缩略语....................................1
3.1术语和定义.....................................1
3.2缩略语.......................................2
4评价指标.........................................3
4.1产量........................................3
4.2纯度........................................3
4.3完整度.......................................3
4.4重复性.......................................3
4.5再现性.......................................3
4.6批间差异......................................3
4.7细菌内毒素残留...................................3
5评价方法.........................................3
5.1总则........................................3
5.2产量........................................3
5.3纯度........................................3
5.4完整度.......................................4
5.5重复性.......................................4
5.6再现性.......................................4
5.7批间差异......................................4
5.8细菌内毒素残留...................................5
6质量评价报告.................................... 5
附录A （资料性附录）核酸提取产量、纯度、完整度和细菌内毒素残留的测定方法.........6
本标准按殖GB/T 1.1-2009馅出的规则起草.
本标准由国家标准物质硏究中心提出并归口.
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