呼吸道多重病原体核酸检测试剂批准概况及临床试验要求研究  

The Approval Overview and Clinical Trial Requirements of Respiratory Multiple Pathogen Nucleic Acid Detection Kits

作　　者：余超 李文霞 郑生伟 何静云 Xu Chao;Li Wenxia;Zheng Shengwei;He Jingyun(Center for Medical Device Evaluation,NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100076

出　　处：《中国药事》2025年第4期396-406,共11页Chinese Pharmaceutical Affairs

摘　　要：目的:系统阐述我国呼吸道多重病原体核酸检测试剂产品设计及临床试验要求,为相关产品设计开发及临床试验提供参考。方法:总结分析我国已经批准的呼吸道多重病原体核酸检测试剂,结合该类产品临床预期使用场景及相关诊疗共识,从产品涵盖的病原体组合、产品适用的样本类型、产品预期适用人群及临床试验要求等方面,针对相关产品技术审评过程中的考虑进行深入分析。结果与结论:呼吸道多重病原体核酸检测试剂在呼吸道感染疾病辅助诊断方面具有非常重要的作用,该类产品设计应以产品预期用途为导向,临床试验主要研究者应结合产品设计及预期用途,充分研究临床试验过程中涉及的入组人群、对比方法、病例数量、统计分析等多个因素,更加科学合理地评价产品临床性能,促进产品尽快上市。Objective:To systematically elaborate the design and clinical trial requirements of respiratory multiple pathogen nucleic acid detection kits in China,so as to provide a reference for the development and clinical trials of related products.Methods:The approval overview of respiratory multiple pathogen were summarized.Combining the expected clinical situation and related diagnostic consensus,an in-depth analysis was conducted on the considerations in technical review process of relevant products from the aspects of the combination of pathogens covered,the applicable sample types,the expected applicable population,and clinical trial requirements.Results and Conclusion:Respiratory multiple pathogen nucleic acid detection kits play a significant role in the auxiliary diagnosis of respiratory tract infections.The product design should align with intended use,and the principal investigators of clinical trials should combine the design and intended use of the products,thoroughly studying the enrolled population,comparative methods,number of cases,and statistical analysis to evaluate the clinical performance of the products more scientifically and reasonably,and facilitate timely regulatory approval.

关 键 词：呼吸道病原体 核酸检测 批准概况 临床试验 

分 类 号：R95[医药卫生—药学]