H.pylori is a spiral shaped bacterium, found in the gastric mucous layer or epithelial lining of the stomach, and is associated with 90% of duodenal and 80% of gastric ulcers which double a person’s risk of gastric cancer, the second most common cancer worldwide.
Two thirds of the world’s population is infected with H.pylori which is characterized by a burning sensation in the upper abdomen when the stomach is empty. Approximately 25 million people in the USA are infected with H.pylori, comprised predominantly of older adults, African Americans, Hispanics and lower socioeconomic groups in addition to half of the early childhood population in China and Colombia. Each year 500,000 to 850,000 new cases of peptic ulcer disease are reported resulting in one million patients hospitalized annually.
Current testing methods involve biopsy during endoscopy combined with rapid urease test, histological examination and microbial culture. All of these methods are time consuming and invasive requiring medical supervision and laboratory equipment. H.pylori colonies tend to form in clusters that can often be missed during biopsy resulting in a false negative diagnosis. Urease testing is inconvenient requiring the ingestion of isotopically labeled urea in addition to specialized instrumentation.
Screening with an OnSite H.pylori antigen rapid test does not require fasting and is a quick, reliable method to detect active infection in symptomatic patients in addition to monitoring the effectiveness of antibiotic treatment.