A rapid test for the qualitative detection of Hepatitis E virus in serum or plasma. For professional in vitro diagnostic use only.
Hepatitis E is a recurring infection in developing countries. In less frequent, isolated cases, it has also been reported in developed countries. Identified in 1990, Hepatitis E (HEV) is a non-enveloped, single-stranded RNA virus where infection can lead to acute (or subclinical) liver disease, like that associated to hepatitis A infection. Fatality rates are generally low - averaging 0.5-3 percent for most patients, while pregnant women hold elevated averages around 15-25 percent. In 1995 a theory was introduced that HEV was transmitted to humans from animals (zoonosis). Then, in 1997 and 2001, respectively, HEV was identified as transmitted from swine and from birds. After that time, HEV infection transmission has been associated with several animals, for example, wild monkeys, deer, cow, goats, rodents, dogs, and chickens. Found in both developing and developed countries, these HEV infections (including anti-HEV) consisted of viremia and feces excretion of HEV-affected animals, such as those listed above. A direct link to acute hepatitis E in humans from eating uncooked deer meat, was also reported. Even in supermarkets in Japan, HEV genome sequences have been identified in pork livers. Serology has been enhanced in relation to the discovery of conformational epitopes in HEV. Diagnosis, epidemiology, zoonosis-related studies, and development of a vaccine have all been strengthened by the occurrence of long-lasting and protective HEV antibodies1-13 . The HEV IgM Rapid Test Cassette (Serum/Plasma) is a rapid test to be used to detect IgM anti-HEV in less than 20 minutes by untrained or minimally skilled personnel, without cumbersome laboratory equipmen.
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