AmeriDx Fecal H. pylori Ag Rapid Test Kit is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori (H. pylori) antigens in human stool specimen. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment, and to confirm the eradication of H. pylori in patients with peptic ulcer.
SUMMARY AND EXPLANATION
H. pylori is a corkscrew-shaped, gram-negative rod bacterium that lives in the mucous layer of the stomach. H. pylori infection is now accepted as the most common cause of gastritis, and is etiologically involved in gastric ulcer, duodenal ulcer, gastric adenocarcinoma, and primary gastric B-cell lymphoma. This very common organism has infected at least half of the world% population. H. pylori infection is typically acquired in childhood and once acquired, infection persists chronically, possibly continuing in the stomach throughout the person's life. Damage to the gastric structure and function of stomach is constant and direct. Approximately one in six of H. pylori infections develop into peptic ulcer disease and a small portion of H. pylori infections lead to gastric cancer. The diagnostic tests for H. pylori can be classified into two categories: invasive and noninvasive tests. Direct detection by invasive test procedures requires an endoscopy and biopsy specimens from antrum and stomach body.
AmeriDx® Fecal H. pylori Ag Rapid Test Kit directly detects antigens in specimens for an active infection. This test is simple and easy to perform with test results that can be visually interpreted within 10 minutes
AmeriDx® H. pylori Ag Rapid Test Kit is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of a diluted stool sample is added into the sample well of the test cassette. The sample flows through a label pad containing H. pylori antibody coupled to red-colored colloidal gold. If the sample contains H. pylori antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary act