Expected use
The rapid H. pylori Ag test is a lateral flow chromatographic immunoassay for the qualitative detection of H. pylori antigen in human fecal specimens. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of H. pylori infection. Any specimen reactive with the H. pylori Ag Rapid Test should be confirmed by alternative test methods and clinical findings.
Summary and explanation
Helicobacter pylori is associated with a variety of gastrointestinal diseases including non-ulcer dyspepsia, gastric and duodenal ulcers, 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 can be spread through ingestion of food or water contaminated with fecal matter.
Antibiotics in combination with bismuth compounds have been shown to be effective in treating active H. Pylori infection. H. pylori infection is currently detected by endoscopy and biopsy-based invasive testing methods (i.e., histology, culture) or non-invasive testing methods such as the urea breath test (UBT), the serological antibodies and stool antigen test. UBT requires expensive laboratory equipment and the consumption of a radioactive reagent.
Serologic antibody tests do not distinguish between currently active infections and past exposures or infections that have been cured. The stool antigen test detects the antigen present in the stool, indicating an active H. pylori infection. It can also be used to monitor the effectiveness of treatment and the recurrence of an infection.
