Millions of Americans are infected by the hepatitis B virus (HBV)-many of whom have no reason to believe they are infected. There is a need to track down America's millions of HBV victims-as well as a corresponding need for innovative technology to test blood for HBV. HBV is clearly a national medical priority. The overall goal of this project is to further develop and then integrate core sensor and enzyme immunoassay technologies into a novel technique for the rapid and accurate measurement of HBV levels in blood. We are targeting diagnostic (detection) applications as well as quantitative measurement needs (to monitor viral levels and treatment efficacy). The feasibility of our approach was clearly demonstrated during Phase I. The Phase II goal is to demonstrate/validate/optimize the integration of a unique electrochemical measurement method with proprietary electrochemical enzyme immunoassay architecture to produce a new diagnostic/monitoring capability for """"""""real time,"""""""" cost-effective HBV assessment in an outpatient setting. The product we envision is a disposable HBV test strip that can be read by an inexpensive, small (hand-held) instrument. It would represent a key development in medical diagnostics that would address major domestic and international market needs for low-cost HBV screening and monitoring.
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