登革病毒检测相关体外诊断试剂上市前监管要求研究  

Research on Pre-marketing Regulatory Requirements of in vitro Diagnostic Reagents Related to Dengue Virus Detection

作　　者：燕娟 李颖 李丽莉[2] Yan Juan;Li Ying;Li Lili(Center for Food and Drug Inspection of NMPA,Beijing 100076,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]国家药品监督管理局食品药品核查中心,北京100076 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2025年第4期407-414,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:为登革病毒检测体外诊断试剂的研发方向及产品上市提供参考。方法:对我国目前登革病毒感染的临床诊断方法进行阐述,对已批准的体外诊断试剂产品进行梳理,结合疾病临床诊断需求及相关产品的上市情况,深入分析登革病毒检测体外诊断试剂的研发方向及上市前监管要求。结果与结论:登革病毒实验室检测有多种方法,不同检测方法有其自身的优势及局限性。目前,国家药品监督管理局共批准11个产品,其中9个为抗原、抗原抗体联合、抗体免疫学检测方法,另外2个为核酸检测。但是,灵敏度高、特异性好的核酸检测方法试剂盒较少,不能满足临床需求。建议相关生产企业加大此类产品开发力度,科学合理地开展产品评价。产品设计开发应结合疾病的临床诊断需求,产品评价应结合产品预期用途、检测的标志物及预期适用人群等具体情况,科学、合理地进行评价,充分评价产品临床性能,促进产品的尽快上市。Objective:To provide reference for the research and development direction and product marketingof in vitro diagnostic reagents for dengue virus detection.Methods:The current clinical diagnostic methods fordengue virus infection in China were elaborated,the approved in vitro diagnostic reagent products were sortedout,and the research and development direction and pre-marketing regulatory requirements of dengue virusdetection in vitro diagnostic reagents were analyzed based on the clinical diagnostic needs of the disease andthe market situation of related products.Results and Conclusion:There are multiple methods for laboratorytesting of dengue virus,each with its own advantages and limitations.At present,the National Medical ProductsAdministration has approved a total of 11 products,of which 9 are antigen,antigen antibody combination,antibody immunological testing methods,and the other 2 are nucleic acid testing.However,there are few highlysensitive and specific nucleic acid testing kits available,which cannot meet clinical needs.It is recommendedthat relevant production enterprises increase their efforts in developing such products and conduct productevaluations in a scientific and reasonable manner.Product development should be based on the clinicaldiagnostic needs of the disease,and product evaluation should be scientifically and reasonably evaluated basedon specific conditions such as the expected use of the product,the detected biomarkers,and the expected targetaudience.The clinical performance of the product should be fully evaluated to promote its rapid marketing.

关 键 词：登革病毒 体外诊断试剂 批准产品概况 监管要求 

分 类 号：R95[医药卫生—药学]