Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

Stools will be collected and tested, at a later date, in a clinical performance study with an
investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.

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