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

This Small Business Innovation Research (SBIR) Phase I project develops a diagnostic platform for herpes viruses by combining gold nanoparticle labels, high-speed fluid handling, and sandwich-based heterogeneous immunoassays with advances in surface enhanced Raman scattering (SERS). Herpes has reached near epidemic levels in the United States and other countries. Current diagnostic approaches severely limit broad level testing of the causative agents of this disease, herpes simplex viruses types 1 and 2 (HSV-1 and HSV-2). This application reflects the increase in market need for a high-speed, low-cost testing platform capable of quantifying HSV levels critical to diagnosis (tens to hundreds of viruses per milliliter of sample). The broader impacts of this research are demonstrated by the urgent need for reliable techniques that can be deployed as rapid, low-cost analysis methods ranging from point-of-care (POC) diagnostics in the doctor?s office or hospital, to laboratory testing. Presently more than 50 million Americans have genital herpes, with another 1% of the U.S. population predicted to become infected annually. A 1999 survey showed ~20% of pregnant women tested positively for HSV-2 antibodies. If economic and rapid POC testing were available as a litmus test for HSV-2 in maternity wards, more informed decisions for herpes necessitated cesarean deliveries could be made, thereby protecting the immune-compromised neonates. A technique capable of quantifying HSV at the noted levels would also find a niche in the researcher?s laboratory in evaluating the antiviral effectiveness of candidate vaccines, as well as by pathologists in defining infective pathogen thresholds.