recomLine Helicobacter IgG 2.0
recomLine Helicobacter IgA 2.0
Line immunoassay using recombinant antigens for the detection and differentiation of IgG and IgA antibodies against Helicobacter pylori type I and type II
The gram-negative, microaerophilic bacterium was described in 1983 by Warren and Marshall. It colonises the human stomach and is able to persist there in the long term.
Approx. 50% of all humans worldwide are infected with Helicobacter pylori. While all those infected develop a chronic inflammation of the gastric mucosa, this leads to complaint symptoms only in a part of the patients. The Helicobacter pylori infection is believed to be linked to various gastric disorders, such as gastric ulcers, gastric adenocarcinomas and MALT lymphomas. As for its cause, host-related factors (social factors as well as nutritional and environmental factors) are, besides various virulent strains, also named as causal factors.
The recomLine Helicobacter 2.0 detects antibodies against ten selected Helicobacter pylori antigens. The detection of antibodies against the two most important virulence factors, CagA and VacA, is of high diagnostic significance. These two virulence factors markedly increase the risk of premalignant changes, gastric carcinoma, MALT lymphoma and ulcer. The humoral immune response to the biomarkers GroEL, HtrA, NapA, HP231 and CtkA is associated with a severe course of disease.
The recomLine Helicobacter 2.0 is the first serological test to present this selection of diagnostically relevant Helicobacter pylori markers.
Product advantages
Reliable diagnostics:
• Excellent correlation with the gold standard of Helicobacter pylori diagnostics - culture and histology
• Sensitivity: > 99% IgG-positive results in patients who are positive according to the gold standard
• Specificity: 100% IgG- and IgA-negative results in patients who are negative according to the gold Standard
• Safe evaluation due to strip specific controls (reaction, cut-off and conjugate control)
• Take advantage of serology - anytime reliable results even with low bacterial load
• CE label: The recomLine Helicobacter 2.0 tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices
Meaningful diagnostics:
• Identification of highly virulent Helicobacter pylori type I infections by means of CagA
• Detection of antibodies against ten relevant biomarkers and virulence factors associated with severe courses of disease
Fast and easy diagnostics:
• Fast and easy to use due to automation and software based Evaluation
• Test procedure and reagents identical in all MIKROGEN line assays - reagents exchangeable
Testprinciple and procedure
1st Incubation
A test strip loaded with Helicobacter pylori antigens is incubated with diluted serum or plasma in a dish for 1 hour.
wash 3 times
2nd Incubation
Peroxidase conjugated anti-human antibodies (IgG specific) are added. Incubate for 45 minutes.
wash 3 times
Color reaction
8 minutes after addition of the coloring solution, insoluble colored bands develop at the sites on the test strips occupied by antibodies.
Evaluation
Diagnostic Sensitivity
Diagnostic Specificity
Analysis of clinically defined patient samples
