Concerns of Performance Evaluation on Central Nervous System Infection Pathogen Metagenome Sequencing Reagent
10.12455/j.issn.1671-7104.230523
- VernacularTitle: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
- Author:
Wen BAO
1
;
Rongzhi LIU
Author Information
1. 国家药品监督管理局医疗器械技术审评中心,北京市,100081
- Keywords:
central nervous system infection pathogen;
metagenome sequencing reagent;
analytical performances evaluation
- From:
Chinese Journal of Medical Instrumentation
2024;48(3):343-345
- CountryChina
- Language:Chinese
-
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.