均相酶免疫分析技术在治疗药物监测中的应用

Homogeneous Enzyme Immunoassay and Its Application in Therapeutic Drug Monitoring

均相酶免疫技术是一种基于液相均相竞争性反应体系的免疫测定技术,目前,基于该技术建立的药物浓度测定方法以其独特优势已成功应用于临床治疗药物和兴奋剂等小分子以及蛋白质等大分子的检测,但大多依靠进口试剂。本文对均相酶免疫技术的研究现状、技术原理、技术优点进行了综述,重点介绍了该技术在治疗药物监测方面的临床应用以及需要注意的问题,并对该技术的应用前景进行了展望。该技术具有检测速度快、特异性强、自动化程度高等优点,但面临进口试剂价格昂贵、运送周期长等问题,因此我国对该技术的自主研发平台及试剂需求显得尤为迫切。

The Homogeneous Enzyme Immunoassay(HEIA) is a liquid competitive immunoassay. Detection methods developed based on this system are applied for testing of a variety of small molecules, such as therapeutic drugs and stimulants, as well as macromolecules successfully, while most depend on commercially imported kits. We are summarizing here the current research status, test principle and advantages of HEIA, especially its clinical applications in therapeutic drug monitoring(TDM)and issues that should be noticed in TDM. Further details on HEIA development and future utilizations for clinical testing are also discussed. Tests developed with this system are fast, specific and automated. This methodology can be widely used for TDM, while the commercially imported kits based on it are expensive with long delivery cycles. It is urgent to develop products with domestic independent intellectual property rights.