Biosensor Assays for Diagnosis of Chronic HCV Infection

DESCRIPTION (provided by applicant): This Phase I SBIR application is submitted in response to the call by DHHS for new tests for qualitative measurement of HCV RNA for diagnosis of chronic HCV infection in patients. The need is for HCV RNA assays that areas reliable but less expensive and resource-demanding than current molecular assays. The new test proposed for research and development consists of rapid sample isolation, innovative signal amplification, and detection with a new proprietary Alderon biosensor. The innovation in this research lies in the creation of a new, inexpensive, low-cost, assay for HCV RNA by development of integrated RNA isolation and advanced electrochemical (eSystem) detection, whose feasibility and performance characteristics will be investigated in research with three specific aims. In Aim 1, we will seek to demonstrate a simple mode of making the viral RNA in biofluid samples available for our downstream eSystem assays. In Aim 2, we will investigate innovative HCV RNA detec