Microdose 14C-Urea Breath Test Offers Diagnosis of Helicobacter pylori in 10 Minutes

Peura, David A.; Pambianco, Daniel J.; Dye, Kevin R.; Lind, Christopher D.; Frierson, Henry F.; Hoffman, Susie R.; Combs, Matthew J.; Guilfoyle, Elizabeth; Marshall, Barry J.
February 1996
American Journal of Gastroenterology;Feb1996, Vol. 91 Issue 2, p233
Academic Journal
Objectives: The urea breath test diagnoses Helicobacter pylori infection of the stomach by identifying the urease enzyme activity of the bacterium. In this "microdose" version of the test, 1 µCi 14C-urea is given orally in a capsule. Our objectives were: 1) to evaluate a microdose 14C-urea breath test capsule in a gastroenterology outpatient setting, 2) to determine the diagnostic ranges of the 14C-urea breath test for HP-positive and HP-negative patients, 3) to define the sensitivity and specificity of the test, and 4) to see whether breath sample results changed when they were mailed to a remote site for analysis. Methods: In a prospective blinded study, we breath-tested 200 fasted patients before elective outpatient endoscopy. At endoscopy, two gastric biopsy samples were taken and were examined for curved organisms; a third biopsy specimen was evaluated with a rapid urease test (CLOtest). Breath samples were mailed in aluminized balloons to a testing laboratory. Results: Using a single breath sample collected at 10 min, with ≥200 dpm as positive, the breath test correctly classified 63 of 65 HP-positive patients (sensitivity 97%, CI 89-99%), and 128 of 135 HP-negative patients (specificity 95%, CI 90-98%). Radiation exposure from the test equated to natural background received in 1 day. No adverse events were caused by the breath test. Conclusions: The 14C-urea capsule breath test (PYtest) is a convenient noninvasive test for the detection of gastric H. pylori infection. Accuracy is equivalent to invasive methods such as histology. Results can be obtained within 15 min if a counting instrument is nearby, or breath samples can be mailed to a testing laboratory for analysis.


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