Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

Inclusion Criteria: * Adult ≥ 22 years, either gender * Subject is symptomatic showing signs and symptoms of gastritis * Subject is not under evaluation for post-therapy follow up diagnosis * Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing * Biopsy is obtained from antrum and/or corpus and is tested by CRM * At least two of the three CRM tests are performed * Subject whose EGD with biopsy procedure occurred ≤ 7 days prior to stool collection * Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B Exclusion Criteria: * Any subject that does not meet the inclusion criteria * Subject with current severe H. pylori infection * Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection * Subject recently tested, less than 3 months and knowledge of H. pylori absence * Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment * Pregnant or lactating * Inability or unwilling to perform required study procedures * Subject is unable or unwilling to provide informed consent