Intended Use

The H.pylori Antigen Rapid Test Kit is a rapid chromatographic immunoassay for the qualitative detection of H.pylori antigen in feces.

Summary

H.pylori is associated with a variety of gastrointestinal diseases included non-ulcer dyspepsia, duodenal and gastric ulcer and active, chronic gastritis. The prevalence of H. pylori infection could exceed 90% in patients with signs and symptoms of gastrointestinal diseases. Recent studies indicate an association of H.pylori infection with stomach cancer. H. pylori colonizing in the gastrointestinal system elicits specific antibody responses which aids in the diagnosis of H. Pylori infection and in monitoring the prognosis of the treatment of H. pylori related diseases. Antibiotics in combination with bismuth compounds have been shown to be effective in treating active H. pylori infection. Successful eradication of H. pylori is associated with clinical improvement in patients with gastrointestinal diseases providing a further evidence. One step H.pylori Ag Test is a simple, visual qualitative test that detects H.pylori antigen in feces. The test is based on immunochromatography and can give a result within 15 minutes.

Principle

The H.pylori Antigen Rapid Test Kit is a qualitative membrane strip based immunoassay for the detection of H.pylori antigen in feces. In this test procedure, H.pylori antibody is immobilized in the test line region of the device. After an adequate volume of test specimen is placed in the specimen well, it reacts with H.pylori antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized H.pylori antibody. If the specimen contains H.pylori antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain H.pylori antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.