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

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.