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Helicobacter pylori Antigen, EIA, Stool

Helicobacter pylori Antigen, EIA, Stool

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Helicobacter pylori Antigen, EIA, Stool

  

Clinical Use

  • Diagnose H pylori infection

  • Therapeutic monitoring and documentation of eradication in patients with H pylori infection

Clinical Background

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

Three methods can be used to diagnose H pylori infection:

1.  Upper GI tract biopsy, histologic exam, rapid urease testing, culture
2.  Urea breath test employing 14C or 13C-urea

3.  Stool antigen detection

This method detects H pylori antigen in stool specimens and can be used for diagnosis, therapeutic monitoring, and proof of eradication post treatment.

Method

This enzyme immunoassay employs a mixture of monoclonal anti-H pylori antibodies as capture antibody and a mixture of peroxidase-conjugated monoclonal anti-H pylori antibodies as detection antibody. Based on the intensity of color developed, results are reported as H pylori antigen detected, not detected, or indeterminate.

Performance characteristics have not been established for watery diarrheal stools or for asymptomatic individuals.

Interpretive Information

A positive result (antigen detected) is indicative of H pylori presence. A negative result (antigen not detected) indicates absence of H pylori or an antigenic level below the assay limit of detection. The test has a sensitivity and specificity of 96% for detecting H pylori infection. False-negative results may be obtained on specimens from patients who have ingested selected medications (antimicrobials, proton pump inhibitors, bismuth preparations) within the 2 weeks prior to specimen collection. If clinically indicated, the test may be repeated on a new specimen obtained 2 weeks after stopping treatment with these medications. Positive results are not affected by medication.

A positive result 7 days after starting therapy is indicative of ineffective treatment or recurrence. Testing for eradication should be performed 4 weeks post therapy; a negative result at this time indicates eradication of the infection.

Indeterminate results require retesting with a new specimen.

 

Content reviewed 12/2012

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