Urea breath test
Principles and mechanism
Patients swallow urea labelled with an uncommon isotope, either radioactive carbon-14 or non-radioactive carbon-13. In the subsequent 10-30 minutes, the detection of isotope-labelled carbon dioxide in exhaled breath indicates that the urea was split; this indicates that urease (the enzyme that H. pylori uses to metabolize urea) is present in the stomach, and hence that H. pylori bacteria are present.
For the two different forms of urea, different instrumentation is required; carbon-14 is normally measured by scintilation, carbon-13 by isotope ratio mass spectrometry (IRMS). For carbon 13 a baseline sample before taking urea is required for comparison with the post urea sample.
The difference between the pre and post urea measurements is used to determine infection. This value is compared to a cut-off value. Results below the value are assumed to be negative, those above positive. The cut-off value itself is determined by comparing the results of patients with two or more different detection methods. The value is chosen that gives the best combination of sensitivity and specificity.
The test measures active H. pylori infection. If antibiotics are depressing the amount of H. pylori present or the stomach conditions are less acidic than normal the amount of urease present will be lessened.
Accordingly the test should only be performed 14 days after stopping acid reducing medication (proton pump inhibitors ('PPI')) or 28 days after stopping antibiotic treatment. Some clinicians believe that a reservoir of H pylori in dental plaque can affect the result.
- Surveyor I, Goodwin CS, Mullan BP, Geelhoed E, Warren JR, Murray RN, Waters TE, Sanderson CR. The 14C-urea breath-test for the detection of gastric Campylobacter pylori infection. Med J Aust. 1989; 151(8):435-439. PMID 2593958.
- FDA Talk Paper