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

Antimicrobials, proton pump inhibitors and bismuth preparations are known to suppress H. pylori. In these cases, a new fecal sample should be collected and tested 14 days after treatment has stopped.

Positive results from patients that have used antibiotics, PPI's or bismuth compounds in the 14 days prior to fecal sample collection are still considered accurate.

For best results, patient should cease use of antimicrobials, proton pump inhibitors, and bismuth preparations for 2 weeks prior to testing as these agents are known to suppress H. pylori and may cause false negative results.

Screw cap plastic container (non sterile)

Collection container should be screw cap, clean, dry and free of detergent residue.

Stool specimen collection

Refrigerate immediately following collection

Screw cap plastic container (non sterile)

Refrigerated (preferred) - 72 hours

Ambient - NO

Frozen - 12 weeks

Freeze/thaw cycles - stable x3

• Stool in transport media or preservatives
• Stool on swabs
• Dried out stool
• Improper labels (unlabeled or mislabeled)
• Delay in transport
• Improper storage temperature affecting results
• Improper container
• Leaking container resulting in compromised specimen
• Quantity not sufficient (QNS)

Chemiluminescent immunoassay (CLIA)

Negative