| 人类基因检测相关试剂评价国家参考品研制技术要求介绍 |
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| 引用本文： | 曹丽梅,王一平,袁伟媛,黄杰. 人类基因检测相关试剂评价国家参考品研制技术要求介绍[J]. 中国药事, 2018, 32(8): 1108-1111 |
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| 作者姓名： | 曹丽梅 王一平 袁伟媛 黄杰 |
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| 作者单位： | 中国食品药品检定研究院, 北京 102269,中国食品药品检定研究院, 北京 102269,中国食品药品检定研究院, 北京 102269,中国食品药品检定研究院, 北京 102269 |
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| 基金项目： | 国家重点研发计划项目"新一代基因组测序技术、临床用测序设备及配套试剂的研发"（编号2017YFC0906500） |
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| 摘 要： | 目的：进一步规范人类基因检测相关试剂评价国家参考品的研制工作。方法：人类基因检测相关试剂评价国家参考品是指用于人类基因检测相关试剂质量评价的参考物质。本文详细介绍了这类参考物质的原材料筛选、制备、标定、稳定性研究、包装、储存及供应方面的要求。结果与结论：人类基因检测相关试剂评价国家参考品研制过程更加清晰,管理更加规范。
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| 关 键 词： | 人类基因检测试剂 参考品 技术要求 |
| 收稿时间： | 2018-06-19 |
Introduction to the Technical Requirements for the Development of National References for the Evaluation of the Related Reagents of Human Gene Detection |
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| Cao Limei,Wang Yiping,Yuan Weiyuan and Huang Jie. Introduction to the Technical Requirements for the Development of National References for the Evaluation of the Related Reagents of Human Gene Detection[J]. Chinese Pharmaceutical Affairs, 2018, 32(8): 1108-1111 |
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| Authors: | Cao Limei Wang Yiping Yuan Weiyuan Huang Jie |
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| Affiliation: | National Institutes for Food and Drug Control, Beijing 102269, China,National Institutes for Food and Drug Control, Beijing 102269, China,National Institutes for Food and Drug Control, Beijing 102269, China and National Institutes for Food and Drug Control, Beijing 102269, China |
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| Abstract: | Objective:To further standardize the development of national references for the evaluation of the related reagents of human gene detection. Methods:The national references for the related reagents of human gene detection refer to the reference products which are used for quality assessment of the related reagents of human gene detection. This article introduced the requirements for raw materials'' screening, preparation, calibration, stability studies, packaging, storage and supply of the references in details. Results and Conclusion:The development process of national references for the evaluation of the related reagents of human gene detection is made more clearly and is managed more normatively. |
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| Keywords: | the related reagents of human gene detection references technical requirements |
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