H. Pylori Antigen Test

The ulti med H. pylori Antigen Test Cassette is a rapid visual immunoassay for the qualitative detection of Helicobacter pylori antigen in human faeces. This kit is intended to be used as an aid in the diagnosis of H. pylori infection. Only for professional use.

Summary

Helicobacter pylori (also known as Campylobacter pylori) is a spiral-shaped with a typical flagellum, Gram-negative bacteria, infecting gastric mucosa. It causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma, so as to be classified as carcinogen agent type I. Many H. pylori strains have been isolated: among them, the strain expressing cytotoxin-associated gene A (CagA) antigen is strongly immunogenic and, according to this, it is of utmost clinical importance because it is associated to the cytotoxic factor. It is widely reported in many literature articles that, in infected patients showing antibodies against CagA gene product, the risk of gastric cancer is up to five times higher than the reference group infected with a CagA negative bacterial strain. The presence of the gene itself determines the persistence of the infection.

Test Principle

The ulti med H. pylori Antigen Test Cassette has been designed to detect Helicobacter pylori through visual interpretation of color development in the internal strip. The membrane was immobilized with anti-H. pylori monoclonal antibody on the test region. During the test, the specimen is allowed to react with colored anti-H. pylori monoclonal antibody colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough H. pylori antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.