DEVELOPMENT OF A POINT OF CARE LATERAL FLOW DIAGNOSTIC TO TEST FOR ACUTE AND PAST HEPATITIS E (HEV) IN SALIVA

The goal of this Phase I research project is to develop a point of care lateral flow assay to determine the presenceof a serological response to hepatitis E virus in a saliva sample. Hepatitis E (HEV) is a viral hepatitis that hashigh mortality rates in immunocompromised and pregnant individuals. HEV can develop into an acute, severeliver disease that is fatal in about 2% of all cases. Approximately 28 million people were newly infected withHEV in 2013. There is currently no FDA approved point of care diagnostic for HEV which has limited the abilityof researchers and health care professionals to track and diagnosis the disease. The proposed diagnostic testis based on a lateral flow test strip format that is inexpensive, rapid, can be read by eye, and has a multi-yearshelf life without refrigeration. Saliva sampling is minimally invasive and greatly facilitates study participation andcontinuous monitoring of at-risk areas. This is a collaborative proposal between nanoComposix, hepatitis Eexperts from the Johns Hopkins Bloomberg School of Public Health (JHBSP) and Salimetrics, a world leader insalivary diagnostics. Our team is ideally suited to transition a salivary HEV test developed by JHSBP on aLuminex platform into a point of care lateral flow assay (LFA) for research and clinical use. The development ofa salivary HEV LFA will enable population-based research studies to better understand the epidemiology anddisease ecology of HEV and provide an effective and inexpensive test for surveillance and rapid diagnosis tomitigate future HEV epidemics.