recomCLIA HEV IgG

Hepatitis E is an acute viral disease of the liver caused by the hepatitis E virus (HEV), for which several genotypes have been described. Genotypes 1 and 2 are transmitted via the fecal–oral route, most commonly through contaminated drinking water, and are typical of developing countries. In contrast, genotypes 3 and 4 are zoonotic and are transmitted mainly through the consumption of insufficiently heat-treated meat, as well as via blood products and organ transplants. The risk of a severe disease course is increased in pregnant women, immunocompromised patients, and individuals with pre-existing liver disease.

The cornerstone of hepatitis E diagnosis is the serological detection of anti-HEV IgM and IgG antibodies. The presence of IgM antibodies indicates an acute or recently acquired infection, whereas the detection of IgG antibodies reflects a past infection or an immune status. Serological testing represents a rapid, accessible, and easily implementable routine method, suitable for initial diagnosis, screening, and epidemiological surveillance.

Anti-HEV IgG and IgM CLIA assays are characterized by high diagnostic sensitivity and specificity, ensuring reliable identification of infection at different stages of the disease. Thanks to automated processing and rapid availability of results, they significantly support accurate clinical decision-making and timely patient management.