Microdose 14C-urea breath test offers diagnosis of Helicobacter pylori in 10 minutes
Peura, D.A.; Pambianco, D.J.; Dye, K.R.; Lind, C.; Frierson, H.F.; Hoffman, S.R.; Combs, M.J.; Guilfoyle, E.; Marshall, B.J.
American Journal of Gastroenterology 91(2): 233-238
1996
ISSN/ISBN: 0002-9270 PMID: 8607486 Document Number: 469043
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 mu-Ci 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 gtoreq 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 (PY test) 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.