我国免疫分析仪发展现状与趋势研究  

Research on the Current Status and Trends in the Development of Immunoassay Analyzers in China

作　　者：黄芝香 钱文文 郑建 徐向彩 HUANG Zhi-xiang;QIAN Wen-wen;ZHENG Jian;XU Xiang-cai(Zhejiang Institute of Medical Device Testing;Key Laboratory of Safety Evaluation of Medical Devices of Zhejiang Province;NMPA Key Laboratory for Biomedical Optics)

机构地区：[1]浙江省医疗器械检验研究院 [2]浙江省医疗器械安全性评价研究重点实验室 [3]国家药品监督管理局生物医学光学重点实验室

出　　处：《中国食品药品监管》2024年第3期114-121,共8页China Food & Drug Administration Magazine

摘　　要：免疫分析技术作为疾病分析的重要手段,一直是生命科学领域研究的重点。近些年随着科学技术的不断发展,免疫诊断已逐渐成为体外诊断行业最大的细分领域。免疫分析仪作为免疫诊断的定量分析仪器,其发展规模、技术水平影响着免疫诊断行业高质量快速发展的程度。本文概述了免疫分析仪行业的发展现状,分析了各细分领域的注册情况以及竞争格局,总结了免疫分析仪行业存在的问题,并对行业的未来发展趋势进行了展望。As an important means of disease analysis,immunoassay technology has consistently been a focus of life science research.In recent years,with continuous technological advancements,immunoassay has emerged as the largest subdivision of the in vitro diagnosis industry.As quantitative analytical instruments for immunoassay,immunoassay analyzers significantly impact the high quality and rapid development of the immune diagnostics industry.This study overviews the current development status of the immunoassay analyzer industry,analyzes the registration scenarios and competition pattern in various subdivisions,summarizes existing issues in the immunoassay analyzer industry,and offers insights into the future development trends.

关 键 词：免疫分析仪 免疫诊断 体外诊断 化学发光免疫分析 荧光免疫分析 

分 类 号：R95[医药卫生—药学]