SBIR Phase II:Sensitive, Rapid Heterogeneous Immunoassays Based on Surface Enhanced Raman Scattering and Gold Nanoparticle Labels

This Small Business Innovation Research (SBIR) Phase II project continues the development of an innovative diagnostic technology based on surface-enhanced Raman scattering (SERS) through its combination with gold nanoparticle labels, high-speed fluid handling, and sandwich-based immunoassays. This project, which builds on the successes of the SBIR Phase I effort, reflects a clear market need for high-speed, low-cost testing capable of providing rapid results commensurate with clinical diagnostic demands. As a market-entry point, the overarching goal is to create an extensible, multiplexed diagnostics platform for the causative agents of herpes: herpes simplex virus type 1 and type 2 (HSV-1 and HSV-2). Herpes has reached near pandemic levels in the United States and other countries around the world. The development of such a detection platform would have clear utility across the diagnostics marketplace, from the physician's office and in-hospital POC to third-party clinical diagnostic laboratories, as a multiplexed platform for sexually transmitted diseases and beyond. The broader impacts of this research are realized with the development of a technique capable of providing absolute quantitation of HSV and many other viral diseases. Such a diagnostic tool would find a niche in large clinical laboratories, in research laboratories evaluating the antiviral efficacy of candidate vaccines, and with pathologists for defining infective pathogen thresholds, setting the stage for this technology to emerge as one of the premier tools in an arsenal of diagnostic technologies.