中国医疗器械杂志2024,Vol.48Issue(3) :343-345.DOI:10.12455/j.issn.1671-7104.230523

中枢神经系统感染病原体宏基因组测序试剂性能评估关注点

Concerns of Performance Evaluation on Central Nervous System Infection Pathogen Metagenome Sequencing Reagent

包雯 刘容枝
中国医疗器械杂志2024,Vol.48Issue(3) :343-345.DOI:10.12455/j.issn.1671-7104.230523

中枢神经系统感染病原体宏基因组测序试剂性能评估关注点

Concerns of Performance Evaluation on Central Nervous System Infection Pathogen Metagenome Sequencing Reagent

包雯 1刘容枝1
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作者信息

  • 1. 国家药品监督管理局医疗器械技术审评中心,北京市,100081
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摘要

从性能评估的角度,简述中枢神经系统感染病原体宏基因组测序试剂检测的病原体范围、企业参考品的设置、反应体系的研究以及分析性能评估等研究内容的关注点,包括研究方法以及质量控制要求等.该研究意在提高产品研发效率,推动行业发展.

Abstract

From the perspective of the performance evaluation,concerns of the range of pathogens,establishment of enterprise reference material,reaction system study and analytical performances evaluation of central nervous system infection pathogen metagenome sequencing reagent are briefly described,including study methods and quality control requirements.This study is intended to increase the research and development efficiency of products,and contribute to the development of associated industry.

关键词

中枢神经系统感染病原体/宏基因组测序试剂/分析性能评估

Key words

central nervous system infection pathogen/metagenome sequencing reagent/analytical performances evaluation

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出版年

2024
中国医疗器械杂志
上海市医疗器械检测所

中国医疗器械杂志

CSTPCD
影响因子:0.503
ISSN:1671-7104
参考文献量3
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