SBIR/STTR Award attributes
The goal of this Phase I research project is to develop a point of care lateral flow assay to determine the presence of a serological response to hepatitis E virus in a saliva sampleHepatitis EHEVis a viral hepatitis that has high mortality rates in immunocompromised and pregnant individualsHEV can develop into an acutesevere liver disease that is fatal in aboutof all casesApproximatelymillion people were newly infected with HEV inThere is currently no FDA approved point of care diagnostic for HEV which has limited the ability of researchers and health care professionals to track and diagnosis the diseaseThe proposed diagnostic test is based on a lateral flow test strip format that is inexpensiverapidcan be read by eyeand has a multi year shelf life without refrigerationSaliva sampling is minimally invasive and greatly facilitates study participation and continuous monitoring of at risk areasThis is a collaborative proposal between nanoComposixhepatitis E experts from the Johns Hopkins Bloomberg School of Public HealthJHBSPand Salimetricsa world leader in salivary diagnosticsOur team is ideally suited to transition a salivary HEV test developed by JHSBP on a Luminex platform into a point of care lateral flow assayLFAfor research and clinical useThe development of a salivary HEV LFA will enable population based research studies to better understand the epidemiology and disease ecology of HEV and provide an effective and inexpensive test for surveillance and rapid diagnosis to mitigate future HEV epidemics Project narrative There are a number of different viruses that result in a hepatitis infection that can cause serious liver inflammation and damageHepatitis EHEVis a harmful variant that does not have an FDA approved diagnostic for point of care useIn this project we will develop a lateral flow salivary diagnostic test for HEV that will allow researchers and health care workers to rapidly and non invasively collect HEV infection data and monitor populations for outbreaks
