基于电化学免疫纸芯片的高灵敏度快速检测方法及其在绝经期女性雌激素检测中的应用

Estradiol level in serum is an important means for evaluating safety or benefit-risk in women who receive the hormone replacement therapy. Because of its lower analytic concentrations, large biochemical analyzers, with long detection cycle and turnaround time, larger sample consumption as well as high expense, are now applicated to obtain quantitative detection of Estradiol, which cannot meet the needs of point of care. It is urgent to establish an ultrasensitive, point of care detection method to satisfied the clinic requests. A number of new technology will be developed in this project: 1) micro-fabrication, preparation process and multimedia interfacial problems of nano-materials modified biosensor. 2) isotachophoretic sample focusing on paper-based analytical device 3) the in-depth analysis of the electrochemical immune-response mechanism, Sensitivity, selectivity and anti-interference ability of sex hormones detection. 4) And paper-based microfluidic electrochemical immune device for the ultrasensitive detection of estradiol will be developed and researches for clinical applications will be carried out too. This project could provide novel methods and technical sensor supporting the research of the diagnosis and treatment of ovarian diseases, and promote the breakthrough of frontier technology about the combined rapid immunoassay in the field of medical detection.

雌激素的即时快速检测是绝经期女性安全使用激素替代治疗的有效监测手段，由于雌激素在血清中丰度低，现有常规的定量检测方法需采用大型临检设备，且取血量大、检测周期长、费用高，无法满足雌激素个体化现场快速即时诊疗的要求，因此急需探索微量化、低成本的定量即时快速灵敏检测的新方法。本项目拟基于电化学免疫微电极传感器、等速电泳样品预富集以及纸芯片微流控检测相集成的新方法，围绕高灵敏度直接免疫电化学检测方法相关的复合纳米材料制备和表征，电极的制备和表面界面修饰，纸基载体等速电泳血清预富集的电泳沟道设计和电泳参数优化以及超痕量性激素检测的灵敏度、选择性和抗干扰等等关键科学问题开展研究，以构建雌激素微量、微创、高灵敏度的定量检测方法，并进行真实血液样品应用测试及传感器参数优化的基础性研究，为未来个体化的激素替代诊疗提供定量检测的新手段和技术基础。

雌激素即时快速检测的实现有助于临床和基础研究中更好了解雌激素在体内的变化和分布特点，本项目通过构建纸质芯片，优化芯片沟道结构，以及电极修饰，成功实现了基于免疫电化学的血液中微量雌激素的即时检测工作，检测下限达10pg/ml，在此基础上进一步采用适配体作为雌激素检测的工具，克服雌激素抗体批次见不稳定对检测灵敏度的影响，进一步提升了微量化检测下限至5pg/ml，以上工作为进一步解决可用于以雌激素为代表甾体激素在体内动态监测的工作的奠定了基础。

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