This microorganism, which can be found on the stomach mucosa of infected people, causes very frequent and mostly silent infections that can produce gastritis, gastric ulcers and other serious pathologies. This FDA-cleared, non-invasive test directly measures the antigen in stool (not antibodies) and is used for diagnosing Helicobacter pylori infections. It is also used for monitoring therapeutic efficacy during and after treatment.
The awareness of Helicobacter pylori in gastrointestinal diseases has increased greatly since Marshall and Warren described the presence of Campylobacter-like organisms in the antral mucosa of patients with histological evidence of antrum gastritis and peptic ulcers, especially duodenal ulcers. The strong correlation between the presence of H. pylori and histologically confirmed gastritis, peptic ulcer disease and gastric carcinoma, as well as disease resolution after H. pylori eradication, indicates a causative relationship.
The ecological niche in humans appears to be restricted to the stomach and duodenum. Patients who harbor the organism are divided into two basic groups: a) colonized and b) infected. Patients who test positive for H. pylori yet have no signs or symptoms of gastrointestinal disease are considered “colonized.” Patients who test positive for H. pylori and present with signs or symptoms of gastrointestinal disease are considered “infected.” The process by which a colonized individual becomes infected remains unclear. The process by which patients become colonized is also still under investigation.
Direct detection requires that an invasive biopsy be taken from the upper gastrointestinal tract. The presence of H. pylori is then confirmed by direct microscopic examination, rapid urease testing or culturing of the organism from the biopsy material. This strategy has the advantage of being able to detect active infections while being highly specific with a very high positive predictive value. The invasive approach subjects the patient to unnecessary risk and discomfort.
In contrast, MosaicDX offers the non-invasive HpSA enzyme immunoassay (EIA), an in vitro qualitative procedure for the detection of H. pylori antigens in human stool. Test results can be used to diagnose H. pylori infection, and to monitor patient response during and post therapy. Current scientific literature indicates that testing to confirm eradication should be performed at least four weeks after the completion of therapy.
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