The Biorex Diagnostics HEV lgM Rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibody to hepatitis E virus(HEV) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HEV. It is for professional in vitro diagnostic use only.

Hepatitis E is known as enterically transmitted non-A non-B hepatitis (ET-NANB) and the etiological agent for this disease has been well established as a non-enveloped, positive sense, single stranded RNA virus named as hepatitis E virus (HEV) (1-3). Although the disease is self-limiting with a mortality rate of 1 to 3% in general adult populations, hepatitis E in pregnant women can take more severe forms with a case fatality rate up to 20%, especially during the third trimester.