SBIR Phase II: ELISA Biosensor for Rapid Bioterrorism Related Agent Diagnosis

该小型企业创新研究（SBIR）第二阶段项目建议开发一种自包含的酶联免疫吸附测定（ELISA）生物芯片，用于快速和确证性临床诊断多种生物威胁病原体，如抗原，抗体，毒素和病毒。ELISA芯片利用微流体技术在小芯片平台上自动化和简化测定过程。 塑料芯片（试剂预装）将是负担得起的，并准备使用，并将消除对连接到庞大的外部水库和泵系统在目前的大型临床实验室系统中使用的管道网络的需要。 之前的第一阶段工作成功地开发了微流控芯片平台和读取器系统，并使用炭疽毒素保护性抗原（PA）和土拉弗朗西斯菌进行了检测。第二阶段项目将侧重于系统优化、集成和面板测试，并将在第三阶段将原型改进为商业产品。该项目的商业应用将在国土安全领域，用于检测生物战剂（BWA）和管理BWA疑似患者。 基于ELISA的生物芯片具有用作快速检测标准的潜力，以在微生物学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性，也为临床诊断领域提供了商业机会。

This Small Business Innovation Research (SBIR) Phase II project proposes to develop a self-contained enzyme-linked immunosorbent assay (ELISA) biochip for rapid and confirmatory clinical diagnosis of multiple bio-threat pathogens such as antigens, antibodies, toxins, and viruses. The ELISA chip utilizes microfluidic technology to automate and simplify the assay process on a small chip platform. The plastic chip (reagent pre-loaded) will be affordable and ready for use, and will eliminate the need for a network of tubing connected to bulky external reservoirs and pump systems used in current large clinical laboratory systems. Prior Phase I work successfully developed the microfluidic chip platform and the reader system, and performed assays with anthrax toxin protective antigen (PA) and Francisella tularensis. The Phase II project will focus on system optimization, integration and panel tests, and will result in a prototype to be refined into a commercial product in Phase III.The commercial application of this project will be in the area of homeland security, for 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 commercial opportunities in the field of clinical diagnostics.