Biomaterials for HEV IgM and HEV IgG immunoassay development & manufacturing

Hepatitis E is a significant global public health issue, characterized by inflammation of the liver caused by infection with the Hepatitis E Virus (HEV).

According to the most recent World Health Organization (WHO) data, there were an estimated 19.47 million cases of acute hepatitis E worldwide in 2021. HEV was responsible for 3,450 deaths that year and accounted for 5.4% of global disability-adjusted life years related to acute hepatitis.

This disease is especially prevalent in regions with limited access to clean water, sanitation, and hygiene services, notably in sub-Saharan Africa and parts of South and East Asia[1]. In Europe, the European Centre for Disease Prevention and Control (ECDC) reported a tenfold increase in confirmed HEV cases in the EU/EEA between 2005 and 2015, with over 21,000 cases documented during that decade[2].

The virus is primarily transmitted via the fecal-oral route, most often through the consumption of contaminated water but can also be transmitted via consumption of uncooked or under cooked meat.

The infection is usually self-limiting, resolving within two to six weeks, but in some cases—particularly among pregnant women and individuals with pre-existing liver disease—it can lead to fulminant hepatitis, a severe and potentially fatal form of liver failure[3].

Diagnosis of hepatitis E primarily relies on detecting anti-HEV IgM antibodies in blood, which indicates recent infection and is recommended as the initial test by the WHO¹. Detection of anti-HEV IgG antibodies is also important: IgG appears after IgM and persists for years, serving as a marker of past infection or, when rising titters are observed, supporting acute diagnosis. PCR testing for HEV RNA in blood or stool is used for confirmation, particularly in immunocompromised or chronic cases.

How Werfen can support you

We can support your immunoassay portfolio expansion in the infectious disease with our Hepatitis E Virus biomaterials.

Werfen hepatitis E portfolio consists of the following products.

Contact us for further information on product availability and development stage.

Check our technical note on Recombinant HEV Ag when used in a chemiluminescence prototype for the quantitative detection of antibodies (IgG) to Hepatitis E Virus in human serum.