Biohit Plc has received on 13.12.2004 FDA clearance for the Company ‘s Helicobacter pylori IgG ELISA kit. Test is based on an enzyme immunoassay technique with partially purified H. pylori bacterial antigen adsorbed on a microplate and a detection antibody labeled with horseradish peroxidase (HRP).
Helicobacter pylori infection is the most important cause of chronic gastritis. Another mechanism for gastritis and severe atrophic gastritis is the autoimmune mechanism. This kit is intended to aid in the diagnosis of H. pylori infection.
Helicobacter pylori is a spiral shaped, gram-negative bacterium that colonizes in the human stomach. The organism is found in the mucous layer of the stomach overlying the gastric epithelium and it does not appear to invade tissue. However, the mucosa underneath the area of the H. pylori colonization is invariably inflamed; this condition is referred to as chronic superficial or non-atrophic gastritis, which, if untreated persists for life. Nevertheless, the chronic inflammatory process can lead to atrophic gastritis, which has been linked with peptic ulceration and gastric cancer, two of the most important diseases of the upper gastrointestinal tract. The presence of antibodies to CagA H. pylori strains have been linked with the development of atrophic gastritis in corpus.
The epidemiological evidence indicates a link between gastric adenocarcinoma, mucosa associated lymphoid tissue (MALT) lymphoma and H. pylori infection.