Herpes Simplex Virus (HSV) infection can cause a wide spectrum of illnesses ranging from asymptomatic to severe systemic illness and death. After primary infection, the virus enters a later state from which recurrent infections may arise. The primary infection is seldom fatal unless it occurs in a neonate. Recurrence is generally not fatal unless it occurs in an immunocompromised individual or within the central nervous system. Early detection of an active HSV infection using a rapid and sensitive assay is essential in some situations to allow timely initiation of treatment as culture can take up to a week in low titer infection. A new, fast, and reliable non-radioactive enzyme linked immunosorbent DNA assay has been developed and found to be highly sensitive for the human papillomavirus. This test system will be adapted for use in the detection and typing of HSV-1 and HSV-2. Phase I study will test the feasibility of using this system to detect and type HSV. It will consist of isolating and preparing large specific probes (totaling 30-40 kilobases) for HSV-1 and HSV-2 and testing these probes for analytical sensitivity, specificity, and crossreactivity to other viruses, bacteria, and human DNA. A Phase 11 study would optimize the assay and evaluate its performance on clinical specimens compared to cell culture and polymerase chain reaction.Awardee's statement of the potential commercial applications of the research:Production of kits for the detection of herpes simplex virus (HSV) infection in clinical specimens, where rapid turnaround and high sensitivity are important. Individual probe mixes can be used to type the specimen into HSV-I or HSV-2, or a mixed probe format would give a positive/negative answer for clinical specimens being tested for HSV infection.National Institute on Allergy and Infectious Diseases (NIAID)
