Test Code: 11939


Clinical Use

  • Differential diagnosis of patients with peptic ulcer disease and chronic active gastritis
  • Therapeutic monitoring in patients with Helicobacter pylori infection
  • Consistent with the AGA Test and Treat Guidelines

Clinical Background

Helicobacter pylori (H. pylori) is associated very strongly with peptic ulcer disease (duodenal and gastric) and chronic active gastritis. H. pylori is also an independent risk factor for gastric cancer and primary malignant lymphoma of the stomach. The infection can be treated successfully with a combination of three drugs for 10 to 14 days.

Four methods can be used to diagnose H. pylori

  • upper GI tract biopsy, microscopic exam, rapid urease testing, culture
  • urea breath test employing C or C-urea
  • antibody detection
  • antigen detection

This method detects H. pylori antigen in stool specimens and can be used for diagnosis or therapeutic monitoring.


Individuals Suitable For Testing

Adults and pediatric patients


Specimen Requirements

1 g random stool specimen in sterile screw-cap container. Collect minimum 0.5 mL of liquid/semi-solid stool or 20 mm diameter solid stool and transfer to properly labeled sterile leak proof container. Do not place stool in preservative transport media or swab. Watery, diarrheal stool is not acceptable.


CPT Code*

87338


Method

This enzyme immunoassay employs a polyclonal anti-H. pylori capture antibody adsorbed in microwells and a peroxidase-conjugated polyclonal detection antibody. Based on the intensity of color developed, results are reported as H. pylori antigen not detected, equivocal, or detected.


Reference Range

H. pylori Antigen: Not Detected


Interpretive Information

A positive result (antigen detected) is indicative of H. pylori presence (96% sensitivity); however some individuals may have H. pylori antigen but no disease. A negative result (antigen not detected) indicates absence of H. pylori or an antigenic level below the assay limit of detection (184 ng H. pylori protein/ml of stool) (96% specificity). False negative results may be obtained on specimens from patients who have ingested selected compounds (antimicrobials, proton pump inhibitors, Bismuth preparations) within the two weeks prior to specimen collection. In populations with disease prevalence ranging from 34% to 69% (average 52%), the positive and negative predictive values were 96%.

A positive result >7 days post therapy is indicative of treatment failure. A negative result >4 weeks post therapy indicates eradication of the infection.

*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 payor being billed.

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