中国药物警戒 ›› 2012, Vol. 9 ›› Issue (6): 340-343.

• 政策与法规研究 • 上一篇    下一篇

流感病毒核酸检测试剂注册申报临床研究技术要求探讨

李耀华   

  1. 国家食品药品监督管理局医疗器械技术审评中心，北京100044
  • 收稿日期:2012-02-17 出版日期:2012-06-10 发布日期:2015-08-10
  • 作者简介:李耀华，男，硕士，工程师，临床检验，IVD产品技术审评。

Registration Clinical Research Technical Requirements to the Influenza Virus Nucleic Acid Detection Reagents

LI Yao-hua   

  1. Center for Medical Device Evaluation, SFDA, Beijing 100044, China
  • Received:2012-02-17 Online:2012-06-10 Published:2015-08-10

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摘要： 本文综合我国流行性感冒病毒既往流行特点、相关法规要求以及获得上市批准的检测试剂等方面内容，探讨流行性感冒病毒核酸检测试剂注册申报时的临床试验设计要求。本文重点阐述了伦理要求、方案设计、参比方法、临床研究单位选择、统计学分析以及临床报告撰写等内容，为此类体外诊断试剂的注册申报提供指导性建议。

关键词: 流行性感冒病毒, 体外诊断, 临床试验

Abstract: Based on the characteristic of influenza virus prevalence trend, related regulations and assay reagents, this article illustrated the clinical trial design requirements for influenza virus nucleic acid detection reagent registration. Ethical issues, protocol design, comparative method, study site, statistical analysis and clinical trial report were all involved and provided guidelines for the specific reagent registration.

Key words: influenza virus, in vitro diagnostic, clinical trial