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For in vitro diagnostic
PRINCIPLE
Helicobacter pylori has a great capacity to produce urease, an enzyme capable of breaking urea into ammonium and bicarbonate. The high local ammonium concentration enables the microorganism to survive in the very low pH gastric environment. The reagent contains an optimum concentration of urea in a reaction medium prepared to maximize the sensitivity and simplicity of the test.
When the reaction is positive, the pH change produced by the ammoniun ion makes the indicator turn from yellow to magenta.
DIAGNOSTIC USE
Helicobacter pylori is associated with a variety of gastro-intestinal diseases, such as chronic-active gastritis, gastric and duodenal ulcers and gastric adenocarcinoma. About 90% of patients suffering from duodenal or gastric ulcers are infected with H. pylori.
The infection can be detected by different methods. The urea breath test is considered as the reference method. The detection of the microorganism in gastric biopsies by evidentiating its urease activity provides for a reliable and specifi c method for the diagnostic of patients undergoing endoscopy. Single test result could not be used to make a clinical diagnosis. It should integrate clinical and laboratory data.