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Validation of a Simplified Carbon-14-Urea Breath Test for Routine Use for Detecting Heliobacter Pylori Noninvasively

Divisions of Nuclear Medicine and Internal Medicine, University of Ulm and Hospital of Neu-Ulm, Ulm, West Germany

Correspondence: For reprints contact: Prof. Dr. Eberhard Henze, Division of Nuclear Medicine, University of Ulm Robert Koch Str. 8, D-7900 Ulm, West Germany.

ABSTRACT

A carbon-14 (¹⁴C) urea breath test for detecting Heliobacter pylori with multiple breath sampling was developed. Carbon-14-urea (110 kBq) administered orally to 18 normal subjects and to 82 patients with Heliobacter infection. The exhaled ¹⁴C-labeled CO₂ was trapped at 10-min intervals for 90 min. The total ¹⁴C activity exhaled over 90 min was integrated and expressed in %activity of the total dose given. In normals, a mean of 0.59% ± 0.24% was measured, resulting in an upper limit of normal of 1.07%. In 82 patients, a sensitivity of 90.2%, a specificity of 83.8%, and a positive predictive value of 90.2% was found. The single probes at intervals of 40–60 min correlated best with the integrated result, with r ranging from 0.986 to 0.990. The test's diagnostic accuracy did not change at all when reevaluated with the 40-, 50-, or 60-min sample data alone. Thus, the ¹⁴C-urea breath test can be applied routinely as a noninvasive, low-cost and one-sample test with high diagnostic accuracy in detecting Heliobacter pylori colonization.