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Updated: Jul 9, 2025

Breath Collection from Children for Disease Biomarker Discovery
Published on: February 14, 2019
Validation of the PyloPlus Urea Breath Test System in pediatric patients
Travis K Price1, Susan Realegeno2, Kamran Azad2
1Quest Diagnostics , Chantilly, Virginia, USA.
Insights
The PyloPlus urea breath test (UBT) is effective for diagnosing H. pylori in children. This non-invasive method offers a comfortable alternative for pediatric patients needing infection monitoring.
Area of Science:
- Pediatric Gastroenterology
- Infectious Diseases
- Diagnostic Assays
Background:
- Non-invasive testing for Helicobacter pylori (H. pylori) infection enhances patient comfort, especially in pediatric cases.
- Current FDA-approved urea breath tests (UBTs) for children require complex age, height, and weight adjustments.
Purpose of the Study:
- To assess the performance and diagnostic accuracy of the PyloPlus UBT assay in a pediatric population.
- To establish PyloPlus UBT as a reliable non-invasive diagnostic tool for pediatric H. pylori infections.
Main Methods:
- Evaluation of the PyloPlus UBT assay's performance characteristics.
- Study conducted on a pediatric cohort requiring H. pylori diagnosis or monitoring.
Main Results:
- The PyloPlus UBT demonstrated reliable performance in the pediatric population.
- Results indicate suitability for diagnosing and monitoring H. pylori in children.
Conclusions:
- The PyloPlus UBT assay is a viable and effective non-invasive option for pediatric H. pylori diagnosis and post-treatment monitoring.
- This assay simplifies testing for children compared to existing methods requiring complex calculations.
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.
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