乙型肝炎病毒检测方法的现状研究  

The Research on the Current Status of Hepatitis B Virus Detection Methods

作　　者：高飞[1] 宁霄[1] 罗春媚 兰华林 王佳庆[3] 周海卫[1] GAO Fei;NING Xiao;LUO Chunmei;LAN Hualin;WANG Jiaqing;ZHOU Haiwei(National Institutes for Food and Drug Control,Beijing 100050,China;Chongqing Centre for Medical Devices Control,Chongqing 400714,China;Clinical Trial Center,Beijing Tiantan Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]重庆医疗器械质量检验中心,重庆400714 [3]首都医科大学附属北京天坛医院临床试验中心,北京100050

出　　处：《标记免疫分析与临床》2024年第7期1338-1343,共6页Labeled Immunoassays and Clinical Medicine

基　　金：国家重点研发计划(编号:2021YFC2401100)。

摘　　要：HBV感染是我国最主要的传染性疾病之一,目前临床主要使用体外诊断试剂对该病毒进行准确快速的检测,体外诊断试剂盒的方法学主要包括:免疫学方法和分子生物学方法。本文通过PubMed(检索时限自2017年1月至2023年12月)和万方数据库(检索时限自2017年1月至2023年12月)检索乙型肝炎病毒(hepatitis B virus,HBV)的检测方法、相关试剂盒的生产和临床应用的相关文献,详细列举最新检测方法的进展并比较不同方法学的优缺点,全面分析和讨论了我国目前乙型肝炎病毒检测的现状和研究进展。研究发现,我国HBV检测用商品化试剂盒的方法学分布存在集中现象,试剂盒的生产存在“东部多,西部少,大分散,小聚集”的特点。HBV infection is one of the main infectious diseases in China,and in current clinical practice,in vitro diagnostic reagents are mainly used for accurate and rapid detection of the virus.The methodology of in vitro diagnostic kits mainly includes immunological methods and molecular biology methods.We retrieved literatures through PubMed(search period from January,2017 to December,2023)and Wanfang database(search period from January,2017 to December,2023).We then summarized the latest research progress of detection methods,production of related test kits,and clinical applications of hepatitis B virus(HBV)in relevant literature.This article comprehensively summarizes and discusses the current status and research progress of hepatitis B virus detection in China by listing in details of the progress of the latest detection methods and comparing the advantages and disadvantages of different methods.Recent research has shown that the methodological distribution of commercialized HBV testing kits in China is concentrated,and the production of kits is characterized by a pattern as follows:more in the eastern region of China,while less in the western region of China;large dispersion,and small aggregation.

关 键 词：乙型肝炎病毒 检测方法 集中现象 

分 类 号：R373.2[医药卫生—病原生物学]