Results of a prospective comparison pilot validation study of a low-dose tablet formulation 13C urea and citric acid breath test employing a novel automated nondispersive isotope selective infrared spectroscopy analyser for the diagnosis of Helicobacter pylori infection

Low Dose Capsule Based 13c-Urea Breath Test Compared With the Conventional 13c-Urea Breath Test and Invasive Tests

“…Although the effects of increasing gastric pH by H 2 -receptor antagonists and sodium bicarbonate solution and of density of H. pylori were already explored during 13 C-urea breath test in solution by Graham et al (12) that concluded H 2 -receptor antagonists differ from proton pump inhibitors as high intragastric pH may cause a reduction in urease activity, unrelated to a reduced bacterial load and reversed by citric acid. When capsule based breath test was validated against a gold standard (urease and histology), the sensitivity and the specificity were high and comparable to previous reports with 13 C-urea in capsule presentation that showed sensitivity of 95%-100% and specificity of 92-100% (7,13,25,27,28) . In conclusion, capsule based breath test with 50 mg 13 C-urea at 20 minutes was found suitable for the clinical setting with 100% sensitivity and specificity.…”

“…However, the conventional test with liquid 13 C-urea in orange juice may suffer the influence of urease-producing oral flora, increasing 13 CO 2 excre-tion in earlier sample collections with false-positive results, also a higher dose is necessary (7,25,27) . Capsule based 13 C-urea breath test has been reported with lower dose than the conventional test with high sensitivity and specificity, avoiding bacterial oral flora interference, and in a shorter time (7,25,27,28) . One of the limitations for 13 C-urea breath test to be incorporated into daily gastroenterology practice in Brazil is the substrate ( 13 C-urea) acquisition in capsule presentation (6) .…”