Strip immunoassay with recombinant antigens for the detection of IgG or IgM antibodies against Hepatitis E virus (HEV) in human serum or plasma

Hepatitis E virus (HEV) is one of the most common causes of faecal-orally acquired hepatitis in developing countries world-wide, usually resulting from contaminated drinking water. In recent years reports of sporadic HEV infections in industrialised countries without travel-association have been more frequent, often with a subclinical or asymptomatic course. Almost all of these so-called autochthonous cases of hepatitis E are associated with genotype 3 of HEV which shows a high sequence-homology to genotype 3 isolates from pigs. The possibility of a zoonotic infection from pigs or other animals to humans seems to play a role as well as the transmission from person-to-person through contaminated foods or blood products.

Acute hepatitis E is a severe illness with a comparable clinical presentation to hepatitis A. Typical signs of hepatitis E include flu-like symptoms, vomiting, diarrhoea, fever, arthralgia and headache usually associated with a rise in liver enzyme values. Cholestatic jaundice that develops during the course of disease can persist for several weeks. HEV infection is usually self-limiting. In endemic regions in a high percentage of cases HEV infections during pregnancy follow a fulminant course, accompanied by a high mortality rate of approx. 20%. In males and non-pregnant females the mortality rate is 0.5% - 4.0%.

The recomLine HEV IgG/IgM uses purified recombinant antigens, thus guaranteeing reproducibly high sensitivity and specificity. The selection of homologous proteins from two different genotypes (genotype 1 and genotype 3) provides a high sensitivity also in non-endemic areas with a high percentage of autochthonous cases of hepatitis E.

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