recomCLIA HEV IgG
The chemiluminescent assay is intended for the detection of IgG antibodies against hepatitis E virus in human serum and plasma.
The chemiluminescent assay is intended for the detection of IgG antibodies against hepatitis E virus in human serum and plasma.
| Catalog Number: | 75004 |
|---|---|
| Size: | 100 tests |
| Regulatory status: | CE IVD |
| Clinical topic: | Infectious Diseases |
| Diagnostic panel: | Gastrointestinal Diseases |
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.
| Assay time | 30 min |
| Assay stability | 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C |
| Sample matrix | Serum, Plasma |
| Sample volume | 13 μl |
| Measuring range | 0,20 - 7,0 IU/ml |
| Complementary products | AnchorĀ® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer |
| Note | The kits are CE-IVD certified and intended for professional use. |