Accuracy of breath tests using low doses of 13C-urea to diagnose Helocobacter pylori infection: a randomized controlled trial

Gatta, L.; Ricci, C.; Tampieri, A.; Oshborn, J.; Ferna, F.; Bernabucci, V.; Vaira, D.
April 2006
Gut;Apr2006, Vol. 55 Issue 4, p457
Academic Journal
Background: The 13C-urea breath test (UBT) for detecting Helicobacter pylon infection is ion-invasive method based on the organism's urease activity. Since its first description, the method has been extensively modified. However, only the dose of 13C-urea and the measurement equipment are directly related to the cost of the test. Aims: (1) To assess the diagnostic accuracy before eradication therapy of three UBTs using 25, 15, and 10 mg of 13C-urea, respectively; and 121 to determine diagnostic performance in the post-eradication setting showing the highest values for sensitivity and specificity with the lowest dose of C-urea. Methods: Three hundred consecutive patients were randomised to be tested with one of the three UBTs. All patients underwent upper endoscopy with biopsies. A total of 222 more patients were enrolled to evaluate the second aim. Infected patients were offered treatment and asked to return 4-6 weeks after the end of therapy to perform endoscopic follow up and to carry out 13C-UBT. Results: In the pretreatment setting, 13C-UBT 25 mg had a sensitivity of 100% 195% confidence interval (CI) 91.8-1001 and a specificity of 100% 195% CI 93.7-1001; 13C-UBT 10 mg had a sensitivity of 96.1% 195% CI 86.8-98.91 and a specificity of 100% (95% Cl 92.6-100); and 13C-UBT 10 mg had a sensitivity of 89.1% (95% CI 77-95.31 and a specificity of 100% 195% Cl 93.3-1001. As the test with the best performance and the lowest dose of 13C-urea was 13C-UBT 15 mg, it was evaluated after treatment, reporting a sensitivity of 100% 195% CI 79.6-1001 and a specificity of 98.9% 195% Cl 94.3-99.81. Discussion: UBTs using 25 and 15 mg of 13C-urea were both accurate in the diagnosis of H. pylori infection in untreated patients. 13C-UBT 15 mg was also accurate for follow up of patients after treatment.


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