Helicobacter pylori with Clarithromycin Resistance Prediction, Molecular Detection, PCR, Feces

Test Code

12614

CPT Codes
87798<br>Restricted Client Code

Preferred Specimen

1 gram or 5 mL stool collected in transport medium (Cary-Blair or Para-Pak C & S)

Patient Preparation
Proton pump inhibitors, histamine H2-receptor antagonists and other antacids, as well as antibiotics and bismuth compounds, should be discontinued at least 2 weeks prior to testing.

Minimum Volume

1 g or 5 mL

Instructions

1. Collect fresh fecal specimen and submit 1 gram or 5 mL in container with transport medium.
2. Place feces in preservative within 2 hours of collection.
3. Place vial in a sealed plastic bag and send ambient or refrigerated. Specimens sent frozen will be rejected.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Fecal swab • ESwab transport medium • Feces in gel transport medium • ECOFIX preservative formalin PVA fixative • Unpreserved stool

Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)

FDA Status
This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

Setup Schedule

Set up: Mon-Fri; Report available: 4-6 days

Reference Range

Not detected

Clinical Significance

Aiding in the diagnosis of Helicobacter pylori infection and prediction of clarithromycin resistance or susceptibility directly from stool.

The CPT Codes provided in this document 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 payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.