Helicobacter Pylori Sample Collection Protocol Post 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 previously diagnosed with H. pylori infection

- Subject received and completed FDA approved treatment option

- Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment
option

- Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared
Fecal Antigen Test

- Subject will undergo EGD and gastric biopsy as part of routine care to measure H.
pylori post-therapy response

- 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 occurred ≤ 7 days prior to stool collection

- Willing and able to sign the IRB approved Informed Consent form for this study project

Exclusion Criteria:

- Subject with current severe H. pylori infection

- Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4
weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors
prior to collection

- Pregnant or lactating

- Inability or unwilling to perform required study procedures

- Subject is unable or unwilling to provide informed consent