Clinical Information

The causal relationship between the urease-producing bacterium, Helicobacter pylori, and chronic active gastritis, duodenal ulcer, and nonulcer dyspepsia is well established. Conventional methods for the diagnosis of active Helicobacter pylori infection include evaluation of biopsied gastric tissue by histopathology and culture. Less invasive assays include testing for the presence of Helicobacter pylori antigen is stool specimens and detection of Helicobacter pylori urease production by the Urea Breath Test (UBT). Serologic testing for the presence of IgM/IgG/IgA class antibodies to Helicobacter pylori is also performed; however, this is not recommended by either the American College of Gastroenterologists nor the American Gastroenterological Association (AGA) as an accurate marker for active disease. These serologic markers can remain elevated despite resolution of active disease and may lead to misdiagnosis and/or inappropriate treatment.

Recommendations for use of the (13)C-Urea Breath Test (Meretek UBT) were recently provided by the Digestive Health Initiative, a joint committee assembled with representatives from the AGA, the American Society for Gastrointestinal Endoscopy (ASGE), and the American Association for the Study of Liver Diseases (AASLD).(1) These recommendations include the following statements: "When endoscopy is not clinically indicated, the primary diagnosis of Helicobacter pylori infection can be made serologically or with the UBT. When endoscopy is clinically indicated, the primary diagnosis should be established by biopsy urease testing and/or histology. Available evidence suggests that confirmation of Helicobacter pylori eradication is not mandatory in most situations because of costs associated with testing. However, for selected patients with complicated ulcer disease, low-grade gastric mucosa-associated lymphoid tissue lymphoma, and following resection of early gastric cancer, it is appropriate to confirm eradication. In other situations, the decision to confirm Helicobacter pylori eradication should be made on a case-by-case basis."

This consensus group further specifies that there is no indication to test asymptomatic people and that testing for Helicobacter pylori is only recommended if treatment is planned.

The (13)C-Urea Breath Test (Meretek UBT) is a highly sensitive and specific noninvasive, nonradioactive test for diagnosing Helicobacter pylori infection prior to antimicrobial treatment and for assessing whether the organism has been successfully eradicated following antimicrobial therapy.

In 2 recent large prospective studies, the (13)C-UBT was shown to be as, or more, sensitive and specific for diagnosing Helicobacter pylori active infection than culture, PCR, stain, rapid urease testing of biopsy tissue, or serology.

When the test is used to assess eradication, it should be performed 4 to 6 weeks after completion of antimicrobial treatment.

See Helicobacter pylori Diagnostic Algorithm in Special Instructions.