Fecal Helicobacter pylori-Antigen ELISA

Fecal Helicobacter pylori-Antigen ELISA is intended for the quantitative determination of Helicobacter pylori antigen in feces. The human pathogen Helicobacter pylori (H. pylori) is a bacterium that has been found in the stomachs of humans in all parts of the world. In developing countries, 70 to 90% of the population carries H. pylori mostly already acquired before the age of 10 years. In developed countries the prevalence of infection ranges from 25 to 50%. H. pylori infections are transmitted via the oral-oral, the fecaloral route or iatrogenic. H. pylori is characterized by a strong urease activity and some strains additionally produce a cytotoxin (Vac A). These extracellular products contribute to the pathogenesis by direct damage of the gastric epithelium accompanied by a chronic inflammation with enhanced levels of inflammation mediators. About 10% of the infected persons develop H. pylori associated gastritis and secundary diseases like chronic active gastritis, Ulcus ventriculi, Ulcus duodeni, gastric cancer and MALT lymphoma. Diagnosis is usually based on gastroendoscopy combined with the detection of the pathogen in biopsy material by culture, histology and rapid urease test. Culture from biopsy material is difficult and not always successful. The 14C breath test which is often performed as follow up test, detects CO2 released by the bacterial urease from radioactive labeled urea in patients breath. This method is not invasive but the need for special equipment and the uptake of radioactive urea by the patients are disadvantageous. Immunological tests which enable the direct detection of H. pylori antigens from stool specimens are available and may be used for therapeutic surveillance.