Helicobacter pylori Antigen, EIA, Stool - Cleveland HeartLab, Inc.

CPT Code: 87338
Order Code: 1375
Alternative Names: H. pylori Antigen, H. pylori Stool Antigen
ABN Requirement: No
Specimen: Stool
Minimum Volume: 0.5 mL or 0.5 g or 20 mm diameter
Container: Sterile, plastic leak-proof container (no preservatives)

Collection:

Collect 0.5 mL or 0.5 g of semisolid stool or 20 mm diameter of solid stool and transfer to properly labeled sterile, plastic, leak-proof container.
Note: Do NOT place stool in preservative, transport medium, or swab. Watery, diarrheal stool is NOT acceptable.

Patient Preparation: To confirm eradication, testing should be done at least 4 weeks following the completion of treatment. However, a positive test result 7 days post therapy is indicative of treatment failure.

This test is cleared for use with specimens from pediatric patients.

For initial diagnostic purposes, no special patient preparation is required. Patients are not required to be off of medications or to fast before this test. While positive test results from patients taking agents such as proton pump inhibitors and antimicrobials should be considered accurate, false negative results may be obtained. For this reason, physicians may suggest the patient go off medications for two weeks and repeat test if negative results are obtained.

Transport: Store stool frozen at -20°C after collection and ship the same day per packaging instructions provided with the Cleveland HeartLab shipping box.

Stability:

Ambient (15-25°C): Not Acceptable
Refrigerated (2-8°C): 72 hours
Frozen (-20°C): 30 days

Causes for Rejection: Specimens other than stool; improper labeling; samples not stored properly; samples older than stability limits; watery, diarrheal stool; stool in preservative, transport media, or swab

Methodology: Immunoassay (IA)

Turn Around Time: 2 to 4 days

Reference Range: Not detected

Clinical Significance: Colonization with H. pylori is associated with increased risk of patients developing gastritis, peptic ulcer disease, and gastric adenocarcinoma. Stool antigen testing provides a sensitive measure of infection including during and after treatment.

Limitations: There may be possible false-negative results associated with recent PPI use.

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.