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。
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.
作者
包雯
刘容枝
BAO Wen;LIU Rongzhi(Center for Medical Device Evaluation NMPA,Beijing,100081)
出处
《中国医疗器械杂志》
2024年第3期343-345,共3页
Chinese Journal of Medical Instrumentation
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
central nervous system infection pathogen
metagenome sequencing reagent
analytical performances evaluation
