两种典型床旁检测技术的核心原理与关键设计开发控制要素解析

      Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies

      • 摘要: 床旁检测技术(point-of-care testing, POCT)作为一种新兴的诊断技术,因具有操作简便、反应快速、携带方便等众多优势,逐渐成为临床诊断领域的重要内容。该研究主要介绍了床旁检测中侧向流检测技术和核酸扩增技术两种主流技术的基本技术原理、应用及在设计开发中的质量控制点,旨在为设备制造商、研发人员及监管机构提供技术参考。

         

        Abstract: Point-of-care testing (POCT), as an emerging diagnostic technology, is gradually becoming an important part of the clinical diagnostic field due to its advantages, such as ease of operation, rapid response, and portability. This paper primarily introduces two mainstream technologies in POCT: lateral flow assays and nucleic acid amplification. It covers the basic principles, applications, and quality control points in design and development of the two mainstream technologies, aiming to provide a technical reference for device manufacturers, researchers, and regulatory agencies.

         

      /

      返回文章
      返回