摘要
体外诊断(in vitro diagnostic,IVD)试剂作为大健康产业的重要一环,在疾病的预防、诊断、治疗等方面发挥着至关重要的作用.近年来,特别是新型冠状病毒感染发生后,我国IVD产业发展迅速,但仍不能满足临床诊疗的需求.通过桌面研究、专家访谈、生产企业和医院调研等形式开展研究,分析了上海市体外诊断试剂产业发展的现状,从原材料、创新能力、临床试验等方面总结了行业高质量发展面临的问题,并提出促进本市体外诊断试剂产业高质量创新发展的参考建议.
Abstract
As an important part of the Big Health Industry,in vitro diagnostic(IVD)reagents play a vital role in the prevention,diagnosis and treatment of diseases.In recent years,especially after the novel coronavirus infection,IVD industry has developed rapidly in China,but it still cannot meet the needs of clinical use.By conducting desk research,expert interview,manufacturer survey and hospital survey,this study analyzed the development status of IVD industry in Shanghai,summarized the problems encountered in the high-quality development from the aspects of raw materials,innovation ability,and clinical trials,etc.,and proposed recommendations for promoting the high-quality innovation and development of IVD industry in Shanghai.
维普
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