CONTEXT: One of the limitations of 13C-urea breath test for Helicobacter pylori infection diagnosis in Brazil is the substrate acquisition in capsule presentation. OBJECTIVES: The purpose of this study was to evaluate a capsule-based 13C-urea, manipulated by the Pharmacy Division, for the clinical practice. METHODS: Fifty patients underwent the conventional and the capsule breath test. Samples were collected at the baseline and after 10, 20 and 30 minutes of 13C-urea ingestion. Urease and histology were used as gold standard in 83 patients. RESULTS: In a total of 50 patients, 17 were positive with the conventional 13C-urea (75 mg) breath test at 10, 20 and 30 minutes. When these patients repeated breath test with capsule (50 mg), 17 were positive at 20 minutes and 15 at 10 and 30 minutes. The relative sensitivity of 13C-urea with capsule was 100% at 20 minutes and 88.24% at 10 and at 30 minutes. The relative specificity was 100% at all time intervals. Among 83 patients that underwent capsule breath test and endoscopy the capsule breath test presented 100% of sensitivity and specificity. CONCLUSIONS: Capsule based breath test with 50 mg 13C-urea at twenty minutes was found highly sensitive and specific for the clinical setting.
CONTEXT: One of the limitations of 13C-urea breath test for Helicobacter pylori infection diagnosis in Brazil is the substrate acquisition in capsule presentation. OBJECTIVES: The purpose of this study was to evaluate a capsule-based 13C-urea, manipulated by the Pharmacy Division, for the clinical practice. METHODS: Fifty patients underwent the conventional and the capsule breath test. Samples were collected at the baseline and after 10, 20 and 30 minutes of 13C-urea ingestion. Urease and histology were used as gold standard in 83 patients. RESULTS: In a total of 50 patients, 17 were positive with the conventional 13C-urea (75 mg) breath test at 10, 20 and 30 minutes. When these patients repeated breath test with capsule (50 mg), 17 were positive at 20 minutes and 15 at 10 and 30 minutes. The relative sensitivity of 13C-urea with capsule was 100% at 20 minutes and 88.24% at 10 and at 30 minutes. The relative specificity was 100% at all time intervals. Among 83 patients that underwent capsule breath test and endoscopy the capsule breath test presented 100% of sensitivity and specificity. CONCLUSIONS: Capsule based breath test with 50 mg 13C-urea at twenty minutes was found highly sensitive and specific for the clinical setting.