An aid in the diagnosis of patients suspected of H pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks.

Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.

For best results, patients should cease use of proton pump inhibitors for 2 weeks prior to testing and cease antimicrobials/bismuth for 4 weeks prior to testing per ACG clinical guidelines.  These agents are known to suppress H. pylori and can cause false negatives. In these cases, a new fecal sample should be collected and tested in the appropriate timeframe after treatment has stopped.

Positive results from patients that have used antibiotics, PPI's or bismuth compounds in the timeframes above prior to fecal sample collection are still considered accurate.