SOLID STATE ENZYME-BASED IMMUNOSENSORS

这项SBIR研究的目标是开发一种新的，通用的， 具有快速、现场 流体中生物学重要分子的定量测定 例如血液、血浆、血清、唾液和尿液。 该原则基于 一种酶放大免疫电化学固相检测器， 可以耦合到不同的前置放大器系统。 可行性 在第一阶段展示。 完成后，用户只需注入 将样本放入分析物专用的一次性检测盒中，并将其插入 分析模块 几分钟后，测得的浓度将为 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，避免了移液的需要; 开发和测试原型系统， 支持商业化。 专属性将通过使用 鉴别抗分析物单克隆抗体和灵敏度， 酶扩增和安培检测产生的反应 产品. 该传感器具有成本低、电极稳定性好等特点 （可忽略的结垢）、一步操作和使用点校准。 如果传感器系统如我们预期的那样工作， 传感器可以扩展到广泛的检测和定量 包括环境毒素，传染性病原体， 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.