recomWell HEV IgG
recomWell HEV IgM
Enzyme immunoassay with antigens produced by recombinant techniques for the detection of IgG and IgM antibodies against hepatitis E Virus (HEV) in human serum or plasma.
Hepatitis E virus (HEV) is one of the leading causes of faecal-orally acquired hepatitis worldwide, usually resulting from contaminated drinking water. In developed countries, hepatitis E is usually transmitted through infected pork, which was not sufficiently cooked. HEV can be transmitted through blood products, blood transfusions and organ donation. In Europe most cases of hepatitis E are caused by the HEV genotype 3.
The HEV infection usually remains symptomatic. Acute hepatitis E is an illness with a clinical presentation comparable 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%.
For the recomWell HEV IgG, IgM purified recombinant antigens of the HEV genotypes 1 and 3 are used, thus guaranteeing reproducibly high sensitivity and specificity. The other HEV-genotypes 2 and 4 can be diagnosed by crossreactivity. The recomWell HEV IgG, IgM is highly suitable as a screening assay, especially in case of negative resulting hepatitis A-C-screening assay findings.
Product advantages
- Recombinant antigens
- High sensitivity and specificity
- Excellent discrimination between negative and positive results
- Very good linearity using HEV IgG WHO international standard
- Sensitive detection of all four HEV genotypes occurring worldwide, including autochthonous HEV infections caused by HEV genotype 3
- Separate detection of IgG and IgM antibodies
- Identical procedure for IgG and IgM determination
- Test procedure and reagents identical in all MIKROGEN recomWell ELISA - reagents exchangeable
- Easy test procedure; quantification; automation possible
- Break-a-part: single sample examination possible
- CE label: The recomWell HEV tests meet the high standards of the European directive 98/79/EC on in vitro diagnostic medical devices
Testprinciple and procedure
Indirect sandwich test. Recombinant antigens are bound to the solid Phase.
1st Incubation
Add patient samples diluted 1:101 (sample: 10 μl of serum or plasma), incubate for 1 h at 37 °C.
wash 4 times
2nd Incubation
Add peroxidase conjugated anti-human IgG or IgM antibodies (conjugate), incubate for 30 min at 37 °C.
wash 4 times
Color reaction
Add ready-to-use TMB solution and incubate for 30 min at room temperature. Stop the substrate reaction with H3PO4 and measure the extinction at 450 nm.
