An in vitro diagnostic medical device that helps to diagnose Helicobacter pylori infection by qualitatively detecting urease activity of H. pylori in human gastric biopsy tissue
Simple and easy to use
Optimized for Point of Care with a small diagnostic kit
No need to use extra reader
High diagnostic accuracy
Economical inspection (individual packaging)
H. pylori is the most common and widely distributed bacteria in the world, infecting more than half of the world's population. H. pylori mainly infects the gastric mucosa and causes gastritis, gastric ulcers, duodenal ulcers, gastric adenocarcinoma, and gastric lymphoma. It is found on the surface of the gastric mucosa or in the gastric mucus, and it is very rare for it to penetrate the gastric mucosa cells themselves and infect them. The Bio helicobacter test is an in vitro diagnostic medical device that uses a biopsy of the gastric mucosa to examine the infection of H. pylori living in the human gastric mucosa. The reagent contains urea, a substrate of urease secreted by A. pylori, and a pH indicator. When urea is decomposed by urease, ammonium ions are generated and the overall pH of the reagent increases. At this time, the pH indicator develops color, determining the result.