体外诊断技术与产业发展形势分析  

Technical progress and industrial development of in vitro diagnostic

作　　者：魏巍 李荣[2] 李治非 武瑞君 杨阳 葛胜祥[3] 苏月[1] Wei Wei;Li Rong;Li Zhifei;Wu Ruijun;Yang Yang;Ge Shengxiang;Su Yue(Department of Drugs and Medical Devices,China National Center for Biotechnology Development,Beijing 100039,China;Shanghai Information Center for Life Sciences,Shanghai Institute of Nutrition and Health,Chinese Academy of Sciences,Shanghai 200031,China;Department of Laboratory Medicine,School of Public Health,Xiamen University,Xiamen 361005,China)

机构地区：[1]中国生物技术发展中心化学药与医疗器械处,北京100039 [2]中国科学院上海生命科学信息中心,中国科学院上海营养与健康研究所,上海200031 [3]厦门大学公共卫生学院实验医学系,厦门361005

出　　处：《中华检验医学杂志》2022年第7期758-762,共5页Chinese Journal of Laboratory Medicine

摘　　要：体外诊断是临床诊断信息的重要来源,为疾病的预防、诊断和治疗提供了重要决策依据,是推动分级诊疗,实现精准医疗,支撑健康中国建设和应对重大突发性公共卫生事件的必备手段。本文结合我国体外诊断发展取得的长足进展和面临的短板弱项,分析阐述体外诊断的需求、政策支撑情况、技术和产业发展趋势以及加快产业化发展的路径,旨在推进我国体外诊断科技与产业高质量发展。In vitro diagnosis(IVD)is an important source of clinical diagnostic information,and provides an important decision basis for disease prevention,diagnosis and treatment.IVD is a necessary tool for promoting graded diagnosis and treatment,realizing precision medicine,constructing a"Healthy China"and responding to major public health emergencies.Combining the great progress made in the development of in vitro diagnostics in China and the shortcomings and weaknesses faced by it,this article analyzed the demand for IVD,policy support,technical and industrial development trends,and the ways to accelerate the industrialization development,aiming to promote the development and improvement of IVD in China.

关 键 词：诊断 临床实验室技术 产业发展 专利分析 

分 类 号：F426.4[经济管理—产业经济] R44[医药卫生—诊断学]