A rapid test for the qualitative detection of antibodies (IgG and IgM) to Helicobacter pylori (H. pylori) in serum or plasma. For professional in vitro diagnostic use only.
H. pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.1,2 Both invasive and non-invasive methods are used to diagnose H. pylori infection in patients with symptoms of gastrointestinal disease. Specimen-dependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture, and/or histologic staining.3 Non-invasive techniques include the urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and serological methods.4,5 Individuals infected with H. pylori develop antibodies which correlate strongly with histological confirmed H. pylori infection.6,7,8 The H. pylori Antibody IgG / IgM Rapid Test Cassette (Serum/Plasma) is a simple test that utilizes a combination of H. pylori antigen coated particles and anti-human IgG/IgM to qualitatively and selectively detect H. pylori antibodies in serum or plasm.
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