The 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 enterically transmitted by the hepatitis E virus (HEV). The virus is shed in the stools of infected persons, and enters the human body through the intestine. It is transmitted mainly through contaminated drinking water. Every year, there are an estimated 20 million HEV infections worldwide, leading to an estimated 3.3 million symptomatic cases of hepatitis E. WHO estimates that hepatitis E caused approximately 44,000 deaths in 2015 (accounting for 3.3% of the mortality due to viral hepatitis).