Research on Contemporary Characteristics and Development Trend of In Vitro Diagnostics

体外诊断技术的发展经历了从经典手工、作坊式设备,到标准化、智能化、自动化管理的全过程.体外诊断在学科理念上也从"医学检验"到"检验医学"发生着重大转变,并为临床提供重要的病理、生理信息,是患者诊疗过程中的主要组成部分.论文通过梳理当代体外诊断(IVD)技术特征和演化趋势,从体外诊断的兴起和发展,分子诊断、精准医疗和POCT即时诊断的演变,产业的全球监管这几个方面,阐明体外诊断发展与应用的全过程及其价值,并对体外诊断前景分析展望.The development of technology of in vitro diagnostics had gone from the original manual method to the whole process of standardization, intelligent, automation management.The discipline concept of in vitro diagnostics are changing from the "Medical examination" to "laboratory medicine", and to provide a significant role in the clinical pathological and physiological information, participate in the diagnosis and treatment of patients with main component.By analyzing the contemporary characteristics and development trend of In Vitro Diagnostics, especially the research on the rise of in vitro diagnostic, the development of molecular diagnostics, precision medicine, POCT and the global industrial regulations,which will expound the whole process and value of in vitro diagnostics development and application.1494-973