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CLIA Helicobacter MONO IgA

Chemiluminescence kit for the detection of IgA antibodies to Helicobacter pylori in human serum or plasma

Catalog Number: CL-HMA100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: Infectious Diseases
Diagnostic panel: Gastrointestinal Diseases
CLIA Helicobacter MONO IgA
  • Detection of IgA 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

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 specifications

Technical data
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Technical data

Assay time30 min
Assay stability30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
Sample matrix Serum, Plasma
Sample volume10 µL
Measuring range10 - 320 U/ml
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic particles, calibrators
Complementary productsWash buffer, Anchor® Tips, Stackable cuvettes, Trigger solutions

The kits are CE-IVD certified and intended for professional use.

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Safety information

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