布鲁菌IgM/IgG抗体检测试剂性能评估技术审评关注点  

Concerns of technical evaluation on performance of human brucellosis IgM/IgG antibody detection reagent

作　　者：包雯 BAO Wen(Center for Medical Device Evaluation NMPA,Beijing 100081,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,北京100081

出　　处：《国际检验医学杂志》2024年第13期1637-1639,共3页International Journal of Laboratory Medicine

摘　　要：从技术审评的角度,简述布鲁菌IgM/IgG抗体检测试剂注册申报资料中产品风险管理、原材料的研究、企业参考品的设置、生产工艺及反应体系的研究、分析性能评估及阳性判断值确定等章节的关注点,包括研究方法及质量控制要求等,以便提高产品研发效率,推动行业发展。From the view of the technical evaluation,concerns of product risk management,study on raw materials,establishment of enterprise reference material,process and reaction system study,analytical performances evaluation and cut-off value determination of human brucellosis IgM/IgG antibody detection reagent are briefly described in the chapters of the application documents,including study methods and quality control requirements,in order to increase the research and development efficiency of products,and contribute to the development of associated industry.

关 键 词：布鲁菌IgM/IgG抗体检测试剂 分析性能评估 阳性判断值确定 

分 类 号：R446.5[医药卫生—诊断学]