CLIA Helicobacter MONO IgG
Chemiluminescence kit for the detection of IgG antibodies to Helicobacter pylori in human serum or plasma
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KleeYa® Automated CLIA Analyser
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This kit in detail
- Detection of IgG antibodies to Helicobacter pylori
- Screening H. pylori infection or reinfection
- Treatment monitoring
- Intended for human serum and citrate plasma
- Clinically significant strain of H. pylori with high content of CagA (120 kDa) and VacA (87 kDa) proteins used
Description
Helicobacter pylori is a key pathogenic factor in infection of the gastric mucosa, particularly in the pyloric antrum and duodenum. It causes B-type chronic gastritis which may evolve in gastric ulcers or the atrophy of stomach lining. Moreover, it increases the risk of gastric carcinoma. H. pylori infection is often associated with dyspepsia, epigastric pain, peptic ulcer disease, or MALT lymphoma.
Commonly used non-invasive tests of H. pylori infection are suitable for monitoring of treatment efficiency as well as for screening for infection or reinfection. Non-invasive techniques involve a breath test, stool antigen assays, and serological methods (detection of IgA, IgG, and IgM antibodies in the serum). Eradication of the microbial agent is followed by a decrease of the antibody level.
IgA antibodies are produced both in the acute phase of the disease and in chronic infection of the gastric mucosa (along with IgG antibodies). Increased level of IgA antibodies was also described in patients with a risk of gastric carcinoma. The presence of IgG antibodies indicates contact with H. pylori , but it does not provide any evidence of infection activity. IgM antibodies increased in the acute stage of the disease are not produced by all patients.
Technical data
- 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: 10 μL
- Measuring range: 10 – 640 U/ml
- Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
- Note: The kits are CE-IVD certified and intended for professional use.
Specifications
- Catalog Number: CL-HMG100
- Size: 100 tests
- Regulatory status: CE IVD
- Clinical topic: Infectious Diseases
- Diagnostic panel: Gastrointestinal Diseases
- Producer: TestLine Clinical Diagnostics s.r.o.
References
- 2406850,15758899,11190069,1348298,9712234,25071324,1775923,26523098
- Reagent Cartridge with specific reagents for the assay
- magnetic particles
- calibrators
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Safety information
Product brochure
Declaration of conformity
Frequently paired with this kit
Other assays and instruments lab teams add alongside the CLIA Helicobacter MONO IgG.
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