Development of a point of care lateral flow diagnostic to test for acute and past hepatitis E (HEV) in saliva

Baldwin, Richard; Pisanic, Nora

Abstract

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 sample. Hepatitis E (HEV) is a viral hepatitis that has high mortality rates in immunocompromised and pregnant individuals. HEV can develop into an acute, severe liver disease that is fatal in about 2% of all cases. Approximately 28 million people were newly infected with HEV in 2013. There 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 disease. The proposed diagnostic test is based on a lateral flow test strip format that is inexpensive, rapid, can be read by eye, and has a multi-year shelf life without refrigeration. Saliva sampling is minimally invasive and greatly facilitates study participation and continuous monitoring of at-risk areas. This is a collaborative proposal between nanoComposix, hepatitis E experts from the Johns Hopkins Bloomberg School of Public Health (JHBSP) and Salimetrics, a world leader in salivary diagnostics. Our team is ideally suited to transition a salivary HEV test developed by JHSBP on a Luminex platform into a point of care lateral flow assay (LFA) for research and clinical use. The 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.

Public Health Relevance

There are a number of different viruses that result in a hepatitis infection that can cause serious liver inflammation and damage. Hepatitis E (HEV) is a harmful variant that does not have an FDA approved diagnostic for point of care use. In 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.