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recomCLIA HEV IgG

The chemiluminescent assay is intended for the detection of IgG antibodies against hepatitis E virus in human serum and plasma.

New
Catalog Number: 75004
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: Infectious Diseases
Diagnostic panel: Gastrointestinal Diseases
recomCLIA HEV IgG recomCLIA HEV IgG

Hepatitis E (HEV) is a viral liver disease with a worldwide distribution that, under European conditions, is most commonly associated with zoonotic transmission. The infection often occurs asymptomatically or with non-specific clinical symptoms, which significantly complicates its clinical recognition. However, in risk groups, particularly immunocompromised patients and pregnant women, HEV may lead to a severe or even life-threatening course, including the development of chronic hepatitis.

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.

Technical specifications

Technical data
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Technical data

Assay time30 min
Assay stability30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
Sample matrix Serum, Plasma
Sample volume13 μl
Measuring range0,20 - 7,0 IU/ml
Complementary productsAnchorĀ® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
Note

The kits are CE-IVD certified and intended for professional use.

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