A rapid-release 50-mg tablet-based 13C-urea breath test for the diagnosis of Helicobacter pylori infection

Aliment Pharmacol Ther. 2003 Jan;17(2):253-7. doi: 10.1046/j.1365-2036.2003.01417.x.

Abstract

Background: Recently, a rapid-release 100-mg 13C-urea tablet with citrate supplement (Diabact UBT) showed excellent performance in a European population.

Aim: To investigate the accuracy of a 50-mg tablet-based 13C-urea breath test protocol.

Methods: : Consecutive dyspeptic patients referred for upper endoscopy were recruited. 13C-Urea breath test was performed using a 50-mg 13C-urea tablet (Diabact UBT) and compared with the gold standard (rapid urease test and histology). Baseline, 10-min, 20-min and 30-min breath samples were collected in all cases. The cut-off values at each measurement interval were determined by three standard deviations above the mean excess delta 13CO2 excretion of Helicobacter pylori-negative patients.

Results: Two hundred patients (150 before therapy and 50 after therapy) were available for analysis, with a mean age of 48.4 years, and 99 patients (50%) were H. pylori positive. The sensitivity and specificity of the 50-mg tablet-based 13C-urea breath test at 10 min, 20 min and 30 min were 100% and 98%, 100% and 100%, and 100% and 98%, respectively.

Conclusion: A 20-min, 50-mg tablet-based 13C-urea breath test (Diabact UBT) protocol is highly accurate for the diagnosis of H. pylori infection.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Breath Tests
  • Carbon Isotopes
  • Citric Acid / administration & dosage
  • Drug Combinations
  • Dyspepsia / microbiology
  • Female
  • Helicobacter Infections / diagnosis*
  • Helicobacter pylori*
  • Humans
  • Male
  • Middle Aged
  • Sensitivity and Specificity
  • Tablets
  • Urea / administration & dosage
  • Urea / analysis*

Substances

  • Carbon Isotopes
  • Drug Combinations
  • Tablets
  • Citric Acid
  • Urea