Development of a Highly Specific and Sensitive HSV-1 and HSV-2 Diagnostic Test

Project Summary: Infections with Herpes Simplex Virus type-1 (HSV-1) or Herpes Simplex Virus type-2 (HSV- 2), the causative agents of genital herpes, are highly prevalent worldwide. The World Health Organization (WHO) estimates that more than 3.7 billion people under the age of 50 are infected with HSV-1, and approximately 490 million are infected with HSV-2 worldwide. Despite being preventable, HSV transmission rates remain high as most HSV carriers are unaware of their serostatus owing to the lack of a robust HSV diagnostic suitable for routine population-based screening. Current HSV diagnostics are typically limited to active infections with high viral loads (viral culture and swab-based assays) and have low specificity resulting in false or equivocal test results (serology tests). Rational Vaccines is developing a novel HSV type-specific multiplex assay that will provide improved sensitivity and specificity compared to current HSV diagnostic tests. The objective of this Phase I proposal is to develop and complete proof-of-concept studies for a novel assay for detecting antibodies against HSV-2 in human sera. This innovative assay will fulfill an unmet clinical need for accurate type-specific HSV detection.