Hepatitis E virus (HEV) is a non-enveloped, single- stranded RNA virus identified in 1990. Infection with HEV induces acute or sub-clinical liver diseases similar to hepatitis A. HEV infections, endemic and frequently epidemic in developing countries, is seen also in developed countries in a sporadic form with or without a history of traveling to endemic area. The overall case-fatality is 0.5~3%, and much higher (15~25%) among pregnant women.

The Biorex Diagnostics HEV kits are enzyme linked immunosorbent assays (ELISA) intended for the qualitative detection of Hepatitis E virus antigen, in human or plasma specimens. It is intended for use in clinical laboratories for the diagnosis and management of patients related to infection with hepatitis E Virus.