SBIR Topic 133: Development of a Serological Test for Herpes Simplex Types 1 and 2 Infections

Herpes Simplex Virus (HSV), is one of the most common viruses in humans and infect about 70% adults in the U.S. To date, there is no cure for HSV infection or effective vaccine. Early detection of the infection can assist patients in effective disease management while also reducing the risk of transmission. Consequently, the timely and accurate identification of HSV is essential in order to curtail the transmission of HSV. Serological testing for antibodies specific to HSV include enzyme-linked immunosorbent assays (ELISA) and Western blot assays. Western Blot Serology has been the "gold standard" but requires a high level of technical ability, time and expense to perform. Many ELISA based serological tests for HSV suffer from relatively high false positive rates, and are unable to detect HSV-2 antibodies in HSV-1 seropositive patients. There is a pressing demand for an HSV serological test that offers both high specificity and sensitivity and the ability to distinguish between HSV-1 and HSV-2 infections. In this proposal, we are developing a point-of-care (POC) rapid test for HSV serological detection. Rapid tests reduce the need for multiple patient visits, enable timely treatment, and facilitate the containment of infectious disease outbreaks.