recomLine Helicobacter
against Helicobacter pylori type I and type II in human serum or plasma
Mikrogen recomLine Helicobacter 2.0 tests are serological, qualitative in vitro line immunoassays for the detection of antibodies against ten selected Helicobacter pylori antigens. The detection of antibodies against the two most important virulence factors CagA and VacA are of high diagnostic importance. These two virulence factors significantly increase the risk for premalignant changes, gastric carcinoma, MALT lymphoma and ulcer. Humoral immune responses against the GroEL, HtrA, NapA, HP231, and CtkA bioma rkersare associated with more severe disease progression.
Products
Advantages
- Sensitivity: > 99% IgG positive results of gold standard positive patients
- Specificity: 100% IgG and IgA negative results of gold standard negative patients.
- Excellent correlation with the gold standard of Helicobacter pylori diagnostics - culture and histology
- Benefit from the advantages of serology - reliable results at all times, even with low colonization density
- Identification of highly virulent Helicobacter pylori type I infections using CagA
- Detection of antibodies against ten relevant biomarkers and virulence factors associated with more severe disease progression
- Simple and clear interpretation through easy-to-read banding
- Partial and full automation, software-based evaluation (recomScan) and integration with laboratory information system possible
Highest sensitivity and specificity through the use of recombinant antigens:
Antigen Description Virulence factor Specific for Typ I / Typ II CagA Cytotoxin associated gene A yes TYP I VacA Vaculating cytotoxin A yes TYP I /TYP II GroEL Chaperone no TYP I / TYP II FliD Flagella hook associated protein no TYP I / TYP II HpaA Neuraminyllactose-binding hemagglutinin, Adhesin yes TYP I / TYP II gGT gamma-Glutamyl Transpeptidase yes TYP I /TYP II HtrA High temperature requirement serine protease A no TYP I /TYP II NapA Neutrophil activating protein yes TYP I / TYP II HP231 Oxidoreductase no TYP I / TYP II CtkA Serin/Threonin Kinase yes TYP I / TYP II
Safe and reliable
Validity check by integrated, strip-specific cutoff and antibody class controls
Flexible and compatible
Combination of all microgen line immunoassays possible - uniform processing and interchangeable reagents
High Standard
CE mark: The recomLine Helicobacter tests meets the high standard of the EC Directive 98/79/EC for in vitro diagnostic medical devices.