Validation of the PyloPlus Urea Breath Test System in pediatric patients

This study evaluated the performance of the PyloPlus Urea Breath Test (UBT) System, a Food and Drug Administration (FDA)-approved assay for diagnosis of Helicobacter pylori infection in adult patients, using samples from 111 pediatric patients (3-17 years old). Both qualitative results (100% correlation) and quantitative delta over baseline values (R-2 = 0.9989) from the PyloPlus UBT strongly correlated with the Meridian BreathTek POCone UBT reference method, which is FDA approved for use in pediatric patients (3-17 years old). The PyloPlus UBT performed comparably to the BreathTek UBT without any calculation correction factors for pediatric samples. Consistent with previous studies, male pediatric patients had a significantly higher positivity rate (64%) than female pediatric patients (33%) (P = 0.001). There was no difference in positivity rate between two performing locations. This study shows that the PyloPlus UBT system can be used for testing pediatric patient specimens.