浅谈国内外医疗机构临床检测实验室自建项目的监管模式  

Discussion on the Supervision Mode of Laboratory Developed Test in Domestic and Foreign Medical Institutions

作　　者：赵庆亚 刘歆 ZHAO Qing-ya;LIU Xin(Shanghai Review and Verification Center for Medical Devices and Cosmetics,Shanghai 200020)

机构地区：[1]上海市医疗器械化妆品审评核查中心,上海200020

出　　处：《中国医疗器械信息》2023年第23期1-3,49,共4页China Medical Device Information

摘　　要：近年来,以二代测序、流式细胞及质谱技术为代表的实验室自建项目已在临床检测中得到普遍应用,并在罕见病的临床诊疗及肿瘤的精准治疗中发挥重要作用,但该模式涉及的医疗机构自制体外诊断试剂在现有监管法规层面处于模糊地带,安全性和有效性也存在一定风险。文章研究了国内外医疗机构自建项目的监管历史和现状,通过我国与美国、欧盟实验室自建项目的对比,从不同角度分析国内外相关监管制度沿革,以期在政策环境和可行性的基础上,为我国进一步完善医疗机构临床检测实验室自建项目的监管提供参考。In recent years,the laboratory developed test(LDT)has been widely used in clinical testing,which was including mass spectrometry,flow cytometry and next-generation sequencing technology.LDT has played an important role in rare clinical diagnosis and treatment.However,the self-made in vitro diagnostic reagents involved in this model have ambiguous areas at the level of existing regulatory regulations,and there are certain risks in safety and effectiveness.The paper studied the regulatory history and current situation of laboratory developed test in domestic and foreign medical institutions.Through the comparison of projects in the United States,European Union and China,the evolution of relevant regulatory systems in domestic and foreign is analyzed from different angles.Based on the policy environment and feasibility,it aims to provide reference for further improving the supervision of laboratory developed test in medical institutions of China.

关 键 词：医疗机构 实验室自建项目 临床检测 医疗器械监管 体外诊断试剂 

分 类 号：TH789[机械工程—仪器科学与技术]