A novel 13C-urea breath test device for the diagnosis of Helicobacter pylori infection: continuous online measurements allow for faster test results with high accuracy

Abstract

Objective: The aim of this study is to determine the accuracy of a novel laptop sized 13C-Urea breath test analyzer that continuously measures expired breath and to use its advantages to decrease testing time.

Methods: One hundred and eighty-six subjects (mean age of 47.8 years) were tested simultaneously by the BreathID system (Oridion, Israel), and by the traditional IRMS. BreathID continuously measured the expired breath for a ratio of 13CO(2):12CO(2.) This value was expressed as delta over baseline (DOB) and displayed graphically on a screen in real time.

Results: One hundred and one subjects were positive and 85 were negative for H. pylori by isotope ratio mass spectrometry (IRMS). The correlation for the BreathID system at 30 minutes was 100% for positive cases and 98% for negative cases. Analysis of the continuous curves generated by the BreathID for all patients permitted definition of different DOB thresholds for a positive or negative result at shorter time intervals. Thus, after 6 minutes a conclusive test result could be obtained for 64% of subjects, and after 10 minutes for 92% of subjects.

Conclusions: The 13C-Urea breath test utilizing the technology of molecular correlation spectrometry is an accurate method for determining infection by H. pylori. The advantage of continuous measurements can shorten testing time without compromising accuracy.