H. pylori Antibody Rapid Test Cassette, 25T/kit

A rapid test for the qualitative detection of antibodies to Helicobacter pylori (H. pylori) in whole blood, serum, or plasma. For professional in vitro diagnostic use only.

【INTENTED USE】

The H. pylori Antibody Rapid Test Cassette (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 on the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcers, 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 that correlate strongly with histologically confirmed H. pylori infection.6,7,8 The H. pylori Antibody Rapid Test Cassette (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.

【PRINCIPLE】

The H. pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of H. pylori antibodies in whole blood, serum, or plasma. In this test procedure, anti-human IgG is immobilized in the test line region of the test. After the specimen is added to the specimen well of the device, it reacts with H. pylori antigen-coated particles in the test. This mixture migrates chromatographically along the length of the test 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 will always appear in the control line region, indicating that a proper volume of specimen has been added and membrane wicking has occurred.

【REAGENTS】

The test contains H. pylori antigen coated particles and anti-human IgG coated on the membrane.

【PRECAUTIONS】

 For professional in vitro diagnostic use only. Do not use it after the expiration date.  Do not eat, drink or smoke in the area where the specimens or kits are handled.  Do not use test if pouch is damaged  Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.  Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are being tested.  The used test should be discarded according to local regulations.  Humidity and temperature can adversely affect results.