Qualitative and quantitative clinical evaluation of the laser-assisted ratio analyser for detection of Helicobacter pylori infection by (13)C-urea breath tests.

Abstract

Currently, the (13)C-urea breath test is the reference method for non-invasive diagnosis of Helicobacter pylori infection and therapy control. Therefore, new technologies have been developed to measure the ratio of (13)CO(2)/(12)CO(2) in breath. The laser-assisted ratio analyser (LARA) device is based on optogalvanic effects of the stimulated CO(2) molecules. In this study, the LARA system is prospectively compared to conventional isotope ratio mass spectrometry (IRMS) analysis of (13)C-urea breath tests. The (13)C-urea breath test was used to screen 103 patients for H. pylori infection. Breath samples were analysed by LARA and IRMS techniques. Seven breath tests could not be analysed by the LARA system, one by IRMS. Out of the remaining 95 breath tests, 13 were positive for H. pylori infection (13.7%). In reference to IRMS analysis (with a cut-off of > 5 delta per thousand at 30 min), LARA produced one false positive and one false negative breath test result giving a sensitivity of 92.3% and a specificity of 98.8%. The mean difference in delta over baseline values between IRMS and LARA measurements was 2.02 delta per thousand +/- 5.48 delta per thousand. LARA allows the reliable qualitative evaluation of 13C-urea breath tests, but the quantitative results differ from IRMS findings.