A rapid, low-dose, 13C-urea tablet for the detection of Helicobacter pylori infection before and after treatment

Background: A new urea breath test (UBT) has been described which uses a tablet formulation of (13) C-urea with citric acid and allows breath sampling to be performed as early as 10 min after ingestion of the tablet. Aim: To assess the diagnostic accuracy of tablet-based (13) C-UBTs (50 and 100 mg (13) C-urea) before and after Helicobacter pylori eradication treatment, compared with an endoscopy gold standard and a conventional (13) C-UBT (75 mg (13) C-urea). Methods: Two hundred dyspeptic patients underwent endoscopy, followed by tablet-based (13) C-UBTs (50 and 100 mg (13) C-urea) and a conventional (13) C-UBT (75 mg (13) C-urea). H. pylori -infected patients were prescribed treatment and asked to return 4-6 weeks after the end of therapy for repeat endoscopy and (13) C-UBTs. Results: One hundred and thirteen patients were infected with H. pylori . The sensitivity and specificity of the conventional (13) C-UBT were both 100%; the sensitivity and specificity of the 100-mg tablet-based (13) C-UBT were 100% and 98.85%, respectively. For the 50-mg tablet-based (13) C-UBT, cut-off values of the difference over baseline of between 1.65 and 3.15 provided a sensitivity and specificity of 100%. At follow-up, the sensitivity and specificity of the conventional and 100-mg tablet-based (13) C-UBTs were both 100%. For the 50-mg tablet-based (13) C-UBT, cut-off values of the difference over baseline of between 1.49 and 1.56 gave a sensitivity and specificity of 100%. Conclusions: New 10-min (13) C-UBTs using tablet formulations of (13) C-urea with citric acid are reliable for the assessment of H. pylori status pre- and post-treatment.