浅谈诺如病毒核酸检测试剂评价  

Evaluation of Norovirus Nucleic Acid Detection Reagents

作　　者：陈慧毅 CHEN Hui-yi(Center for Medical Device Evaluation,NMPA,Beijing 100081)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《中国医疗器械信息》2021年第21期7-8,131,共3页China Medical Device Information

摘　　要：诺如病毒导致的儿童和成年人急性胃肠炎经常出现聚集发病,已经成为比较严重的公共卫生事件。近几年诺如病毒核酸检测试剂申报企业数量也在逐年上升,为提高此类产品的质量和方便监管人员的审评尺度,文章介绍了诺如病毒核酸检测试剂的性能要求和研发过程中可能需要关注的问题。Acute gastroenteritis in children and adults caused by norovirus often occurs in clusters,which has become a serious public health event.In recent years,the number of enterprises applying for norovirus nucleic acid detection reagent is also increasing year by year.In order to improve the quality of such products and facilitate the review scale of supervisors,this paper briefly introduces the performance requirements of norovirus nucleic acid detection reagent and the problems that may need attention in the process of research and development.

关 键 词：诺如病毒 分析性能 基因 

分 类 号：R446.5[医药卫生—诊断学]