The Helicobacter pylori Ag Rapid test is a lateral flow
chromatographic immunoassay for the qualitative detection of H.pylori antigen in human faecal.It is intended for use in evaluating the serologic status to H.pylori.
Helicobacter pylori is a spiral bacterium cultured from human gastric mucosa by Marshall in 1982.Studies have indicated that the prewence of H.pylori is associated with a variety of gastrointestinal disease including gastritis,duodenal and gastric ulcer,non-ulcer dyspepsia,gastric adenocarcinoma and lymphoma.The organism is present in 95-98% of patients with duodenal ulcer and 60-90% of patients with gastric ulcers.The studies have also demonstrated that removal of the organism of symptoms and cure of diseases. There are several methods of diagnosing H pylori infection including invasive procedures using mucosa biopsies taken during endoscopy (mainly culture, histology and the rapid urease test) and noninvasive procedures (mainly 13c or 14 Curea breath tests(UBTs) and serological tests).But invasive procedures suffer form biopsies and endoscopy,and the UBTs require expensive equipment or is harmful to patients.Because H pylori antibody titers fall very slowly even after successful eradication,tests lack of specificity and sensitivity.
Reagents and Materials Provided
1.Individually sealed foil pouches containing:
a.One cassette test device.
2.Sample extraction tubes,each containing 2ml of extraction
3.One package insert(instruction for use).