Comparison of two methods for the in-vivo diagnosis of Helicobacter pylori infection using a tablet of C-13-urea

BACKGROUND. The urea Breath-test is a widely-used method to detect the presence of Helicobacter pylori (HP) infection. Recently, new technologies were introduced, to obtain an immediate test result by continuous breath samples analysis after labeled urea intake. The total test duration is shorter than 20 minutes. METHODS. The study compared two diagnostic methods requiring the administration of EXPIROBACTER (R) (Sofar SpA, Trezzano Rosa, Milan, Italy) 100 mg as a source of labeled urea. Subjects with clinical indication to urea breath test for H. pylori were enrolled. This study was designed to directly compare the accuracy of urea breath test performed with both the classic method and BreathID (R) (Exalenz Bioscience, Inc., Manasquan, NJ, USA). Each patient simultaneously underwent to both tests, to measure the concordance between the results (positive or negative test), minimizing the risks of differences related to the intra- and inter-individual variability. RESULTS. Forty-six subjects were enrolled. Forty-one patients (91.1%) were found negative with both methods and 5 (10.1%) were positive for H. pylori infection in both tests. Correlation between the two methods was excellent(kappa=1.00). BreathID (R) was significantly preferred by patients, with a 7.83 (95% CI: 3.35 to 12.30, P=0.001) difference in mean patient satisfaction, measured by a Visual Analogue Scale (VAS). No adverse event was observed. CONCLUSIONS. Correlation between the two methods was excellent. Moreover, the patient satisfaction, measured by VAS, showed a significantly greater acceptance of BreathID (R) method. This study support the use of a product containing C-13-urea 100 mg and citric acid for immediate determination of HP infection by urea breath test performed with BreathID (R)