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 serum antibodies which correlate strongly with histologically confirmed H. pylori infection.6,7 The One Step H. pylori Test Cassette (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 serum or plasma in just minutes.
The H. pylori One Step Test Cassette (Serum/Plasma) is a qualitative membrane strip based immunoassay for the detection of H. pylori antibodies in serum or plasma. In this test procedure, anti-human IgG is immobilized in the test line region of the cassette. After a serum or plasma specimen is placed in the specimen well, it reacts with H. pylori antigen coated particles in the test. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the specimen contains H. pylori antibodies, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain H. pylori antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line indicating that proper volume of specimen has been added and membrane wicking has occurred.
The kit can be stored at room temperature or refrigerated (2-30°C). The test cassette is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.