Evaluation of a novel continuous real time C-13 urea breath analyser for Helicobacter pylori

Aim: To evaluate the sensitivity and specificity of a new C-13 urea breath test, Oridion BreathID, for the diagnosis of Helicobacter pylori. Methods: A total of 97 consecutive symptomatic patients referred for upper endoscopy were included in the 'pre-therapy' part of the study. After endos copy the patients were analysed for H. pylori by Oridion BreathID. BreathID continuously sampled the subject's breath for 20 min, and displayed the re sults on the BreathID screen in real time. Results of the BreathID were com pared with the 'gold standard' (rapid urease test and histology). We also p rospectively tested the validity of BreathID in comparison to isotope ratio mass spectrometry, in 40 patients referred to monitor the efficacy of H. p ylori eradication treatment. Results: Complete agreement was observed between the 'gold standard' and th e Breath ID test in 96.9% (94 out of 97) of the patients. The sensitivity a nd specificity of BreathID were 97.8% and 96.1%, respectively. The correlat ion between BreathID and isotope ratio mass spectrometry breath test was 10 0%. Conclusions: The Oridion BreathID has comparable sensitivity and specificit y to the claims of the currently available urea breath tests. Furthermore, BreathID has the potential advantages of ease of use with minimal medical s taff requirement, and real time rapid results (20 min maximum) which may ma ke the BreathID preferable to other urea breath test assays.