SBIR Phase I: Enzyme-Linked ImmunoSorbent Assay (ELISA) Biosensor for Rapid Bioterrorism Related Agent Diagnosis

这个小型企业创新研究(SBIR)第一阶段项目将开发一种独立的酶联免疫吸附分析(ELISA)生物芯片，用于快速和确证地诊断与生物恐怖有关的病原体。这种ELISA芯片利用微流控技术，在一个小芯片平台上实现自动化和简化检测过程。塑料芯片(预装试剂)价格实惠，可以随时使用，但不需要连接到笨重的外部储液器和泵系统的管道网络，目前大型临床实验室系统和微流体系统中使用的是这种芯片。第一阶段的研究将集中在开发ELISA传感器平台，构建压力驱动的自动化微型机构，集成阅读器系统，执行检测和评估系统的技术优点。该项目的商业应用将是检测生物战剂(BWA)和管理BWA疑似患者。基于酶联免疫吸附试验的生物芯片有可能被用作快速检测标准，以便在微生物检测之前快速产生初步数据。该系统具有极高的灵敏度和特异度，在临床诊断领域也提供了大量的商业机会。

This Small Business Innovation Research (SBIR) Phase I project will develop a self-contained enzyme-linked immunosorbent assay (ELISA) biochip, for rapid and confirmatory diagnosis of bioterrorist related pathogens. The ELISA chip utilizes microfluidic technology to automate and simplify the assay process on a small chip platform. The plastic chip (reagent pre-loaded) is affordable and ready for use, but eliminates the need for a network of tubing connected to bulky external reservoirs and pump systems used in current large clinical laboratory systems and microfluidic systems. The Phase I research will focus on developing the ELISA sensor platform, constructing a pressure driven micro-mechanism for automation, integrating the reader system, performing assays and evaluating the system's technical merits. The commercial application of this project will be in detecting biological warfare agents (BWA) and in managing BWA suspected patients. The ELISA based biochip has the potential to be used as a rapid testing standard to quickly yield preliminary data in advance of microbiology tests. The system, with its extreme sensitivity and specificity, also offers a great deal of commercial opportunities in the field of clinical diagnostics.