Helicobacter pylori Antigen, EIA, Stool

Test Code
34838

CPT Codes
87338

Preferred Specimen
0.5 mL or 0.5 grams semi-solid stool or 20 mm diameter of solid stool, collected in a properly labeled, plastic leak-proof container

Patient Preparation
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.

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.

Other Acceptable Specimens
0.5 mL or 0.5 grams semi-solid stool or 20 mm solid stool collected in Cary-Blair stool culture transport medium or C&S transport medium

Instructions
Collect 0.5 mL of semisolid stool or 20 mm diameter of solid stool and transfer to a properly labeled plastic leakproof container.

Transport Temperature
Unpreserved: Frozen
Preserved: Room temperature

Specimen Stability
Unpreserved
Room temperature: 4 days
Refrigerated: 4 days
Frozen: 14 days

Preserved
Room temperature: 4 days
Refrigerated: 4 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Concentrated fecal specimens • Stool in transport media other than those listed • Swab • Expired transport media

Methodology
Immunoassay (IA)

Setup Schedule
Set up: Daily; Report available: 1-4 days

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

Reference Range
See Laboratory Report

Clinical Significance
The importance of Helicobacter pylori in gastrointestinal diseases has increased greatly since Marshall and Warren described the presence of Campylobacter-like organisms in the antral mucosa of patients with histological evidence of antrum gastritis and peptic ulcers, especially duodenal ulcers. The strong correlation between the presence of H. pylori within histologically confirmed gastritis, peptic ulcer disease and gastric carcinoma and lymphoma, as well as disease resolution after H. pylori eradication, indicates a causative relationship. The ecological niche in humans appears to be restricted to the stomach and duodenum. Patients who harbor the organism are divided into two basic groups. The first are those who are said to be "colonized". These patients have the organism, yet have no signs of gastrointestinal disease. Those with gastrointestinal symptoms and a positive H. pylori antigen test are considered to be infected.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153



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.