Validation of the PyloPlus Urea Breath Test System in pediatric patients

Abstract

ABSTRACT 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. IMPORTANCE For the diagnosis and post-treatment monitoring of H. pylori infection, non-invasive testing methodologies improve patient comfort, particularly for children. Previously, only the BreathTek UBT had FDA approval for use in pediatric patients and required an adjustment calculation based on age, height, and weight of the patient. The purpose of this study was to evaluate the performance of the PyloPlus UBT assay in a pediatric population.

Keywords

• Helicobacter pylori
• urea breath test
• pediatric
• non-invasive