Unitest H.Pylori Cassette

The H. pylori Rapid Test Device (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in whole blood,serum, or plasma to aid in the diagnosis of H. pylori infection.

SUMMARY

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 noninvasive methods are used to diagnose H. pylori infection in patients with symptoms of gastrointestinal disease. Specimen dependent and costly invasive diagnostic methods which 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 serum antibodies which correlate strongly with histologically confirmed H. pylori

infection.6,7,8

The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of H.pylori antigen coated particles and anti-human IgG to qualitatively and selectively detect H. pylori antibodies in whole blood, serum, or plasma in just minutes.

MATERIALS

Materials Provided

• Test devices

• Disposable specimen droppers

• Buffer (for whole blood only)

• Package insert

TEST PROCEDURE

**"This product is not distributed in the European Union. It does not bear the CE marking as it has not undergone the conformity assessment procedures of the European Directive 98/79/EC, for in vitro medical devices".

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