SOLID STATE ENZYME-BASED IMMUNOSENSORS

这项SBIR研究的目标是开发一种新的、通用的、 免疫电化学传感器系统能够快速、现场、 液体中生物重要分子的定量测定 如血液、血浆、血清、唾液和尿液。这一原则是基于 一种酶放大，免疫电化学，固相检测器，可以 耦合到不同的报告-放大系统。可行性是 在阶段I中演示。完成后，用户只需注入 将样品放入分析物专用处理柱中，并将其插入 分析模块。几分钟后，测量到的浓度将是 已显示。第二阶段的研究将侧重于优化系统； 开发一种易于使用的仪器，消除对移液的需要； 以及开发和测试能够吸引第三阶段的原型系统 支持商业化。专门性将通过使用 抗分析物单抗与敏感性的鉴别 酶扩增与反应生成的安培检测 产品。研制的传感器具有成本低、电极稳定性好等特点。 (污垢可忽略不计)，L一步操作，并使用点校准。 如果传感器系统如我们预期的那样工作，那么 传感器可以扩展到广泛的检测和定量 各种病原体，包括环境毒素、传染病病原体、 抗体、滥用药物、诊断生物分子和治疗药物。

The objective of this SBIR research is to develop a new, generic, immunoelectrochemical sensor system with capabilities for rapid, on-site, quantitative determination of biologically important molecules in fluids such as blood, plasma, serum, saliva, and urine. The principle is based on an enzyme-amplified, immunoelectrochemical, solid phase detector that can be coupled to different reporter-amplifier systems. Feasibility was demonstrated in Phase I. When complete, a user should only need to inject a sample into an analyte-specific, disposal cartridge and insert it into an analytical module. After a few minutes the measured concentration will be displayed. Phase II research will focus on optimizing the system; developing an easily-used instrument that obviates the need for pipetting; and developing and testing prototype systems able to attract Phase III support for commercialization. Specificity will be achieved through use of discriminating anti-analyte monoclonal antibodies and sensitivity through enzyme amplification and amperometric detection of generated reaction products. The developed sensor will feature low cost, electrode stability (negligible fouling),l one-step operation, and point of use calibration. If the sensor system functions as we anticipate, the capability of the sensor could be extended to the detection and quantitation of a wide variety of agents including environmental toxins, infectious agents, antibodies, drugs of abuse, diagnostic biomolecules and therapeutic drugs.