
recomWell Helicobacter IgG
recomWell Helicobacter IgA
Enzyme immunoassay with antigens produced by recombinant techniques for the deÂtection of IgG and IgA antibodies against Helicobacter pylori
The gram-negative, spiral-shaped bacterium Helicobacter pylori was described by Warren and Marschall in 1983. The connection between chronic Type B gastritis and Helicobacter pylori has been well studied. In fact, there is a causal relation between Helicobacter pylori and almost all duodenal and stomach ulcers. Moreover, Helicobacter pylori is associated with an increased risk of gastric adenocarcinomas. Apart from strains of different virulence, host factors may also be responsible for this phenomenon.
An infection with Helicobacter pylori induces a specific immune response. As a rule, antibodies of the classes IgG and IgA can be detected. Only small amounts of IgM antibodies are identified. Indeed, there is a decrease in the antibody concentration after successful eradication through combined antibiotic therapy.
The eradication of Helicobacter pylori cures not only gastritis or peptic ulcer, but also low-malignant gastric MALT lymphomas. Although peptic ulcers are also cured without eradication of Helicobacter pylori, there is a recurrence within one year in up to half of all the cases in the absence of permanent acid suppression treatment. The rate of recurrence is less than 5 % per year after successful microbial eradication.
Product advantages
- Recombinant antigens, therefore
- Highest sensitivity and specificity
- No cross reactions
- Excellent discrimination between negative and positive results
- Use of recombinant CagA. Therefore detection of infection with virulent type I strains possible
- Separate detection of IgG and IgA antibodies possible
- Identical procedure for IgG and IgA determination
- Easy to quantify
- Easy test procedure; automation possible
- Test procedure and reagents identical in all MIKROGEN ELISA - reagents exchangeable
- Break-a-parts: single simple examination possible
- CE label: The recomWell Helicobacter tests meet the high standard of the EC 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.
Evaluation
Specificity: Negative sera/blood donors
Sensitivity: Clinically defined sera (histology/culture)
Accuracy