当代体外诊断历史变迁与分析展望
Contemporary Historical Development and Analysis of In Vitro Diagnostics(IVD)
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摘要: 本研究通过梳理当代体外诊断(IVD)关键要素的演进历程,从体外诊断的兴起和发展,到分子诊断和精准医疗的崛起,从临床实验室到POCT即时诊断的演变,从基础研发走向产业的全球监管,并对体外诊断前景展望,从而阐明生物医学技术发展与应用的复杂过程和价值。Abstract: By analyzing the contemporary key elements evolution of in vitro diagnostics (IVD), especially the rise in vitro diagnostic to the development of molecular diagnostics and precision medicine, from clinical laboratory to POCT, from basic research to the global regulation industry, this research is to expound the complex process and value of biomedical technology development and application.