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

This proposal addresses the significant need for more sensitive and specific diagnostic biomarkers for infection with Schistosoma species, particularly in elimination settings. Schistosomiasis is second only to malaria in terms of socioeconomic and public health importance in the tropics and sub-tropics. In humans, it is mainly caused by infection with one of three species: Schistosoma mansoni, S. haematobium, or S. japonicum. Infection occurs when skin encounters contaminated freshwater. Parasite cercariae penetrate the skin and over several weeks mature into adult worms that live in the blood vessels of the body and shed large numbers of eggs resulting in inflammation that can lead to end organ damage. The current gold standard of diagnosis is microscopy, as serology cannot yet distinguish between active and former infection. However, sensitivity of microscopy is low in light infections and regions of low endemicity. In this project, screening and point-of care serological tests will be developed. Phase I will focus on identification of highly sensitive and specific novel biomarkers common to all three major schistosome species but with minimal to no homology with other helminths as well as the development of prototype ELISA and lateral flow assay.