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Updated: Jun 24, 2026
Breath Collection from Children for Disease Biomarker Discovery
Published on: February 14, 2019
Urea breath test in children: the United States prospective, multicenter study
Yoram Elitsur1, Vasundhara Tolia, Mark A Gilger
1Pediatric Gastroenterology, Joan C. Edwards School of Medicine, Marshall University, Huntington, West Virginia 25701, USA. elitsur@marshall.edu
Insights
The 13C-urea breath test (UBT) is accurate for diagnosing Helicobacter pylori infections in children. The urea hydrolysis rate (UHR) method showed excellent results across all pediatric age groups.
Area of Science:
- Pediatric Gastroenterology
- Infectious Diseases
- Diagnostic Testing
Background:
- The urea breath test (UBT) is the gold standard for diagnosing Helicobacter pylori infections in adults.
- Helicobacter pylori infection diagnosis in children requires accurate and reliable methods.
Purpose of the Study:
- To evaluate the accuracy and utility of the 13C-urea breath test (UBT) for diagnosing H. pylori infections in children in the United States.
- To compare the performance of different calculation methods (delta over baseline and urea hydrolysis rate) for the 13C-UBT in pediatric populations.
Main Methods:
- A total of 176 children underwent a 13C-UBT using the US adult protocol.
- Results were compared against established criteria for H. pylori positivity (culture, rapid urease testing, histology).
- Two methods for evaluating UBT results were used: delta over baseline (DOB) and urea hydrolysis rate (UHR).
Main Results:
- The 13C-UBT demonstrated high accuracy, with sensitivity and specificity of 97.9% and 96.1% (DOB method) and 95.8% and 99.2% (UHR method), respectively.
- The UHR method showed superior performance in younger children (2-5 years old) with 100% sensitivity and specificity.
- 48 out of 176 children evaluated were confirmed to be infected with H. pylori.
Conclusions:
- The US standard 13C-UBT is a simple and accurate diagnostic tool for H. pylori infections in children.
- The UHR calculation method for 13C-UBT provides excellent diagnostic results for pediatric patients across all age groups.
Background:
The urea breath test (UBT) is generally considered the gold standard for the diagnosis of Helicobacter pylori infections in adults.
Goals:
To investigate the utility and accuracy of urea breath testing in children from the United States.
Methods:
Children scheduled to undergo upper gastrointestinal endoscopy for various clinical symptoms underwent a 13C-UBT using the US standard protocol for adults. Results were compared with rapid urease testing (RUT), culture, and histology. H. pylori positivity was defined according to the FDA, Division of Anti-Infective Drug Products criteria, i.e. positive culture and/or positive RUT and histology. H. pylori negativity was defined as all tests negative. Results were evaluated by delta over baseline (DOB) and urea hydrolysis rate (UHR).
Results:
A total of 176 children from five centers were evaluated; 48 were infected. Compared to the defined standard, the results with the UBT based on delta over baseline (DOB) cut-off value (positive: > or = 2.4 per thousand) showed that the sensitivity and specificity of the UBT were 97.9% and 96.1%, respectively. Based on the UHR cut-off value (positive: > or = 10.0 microg/min), the sensitivity and specificity were 95.8% and 99.2%. In young children (2- to 5-year olds), sensitivity and specificity of UHR method were higher than the DOB method (100% and 100% vs 100% and 82.4%, respectively).
Conclusion:
The US standard (13)C-UBT proved to be both simple and accurate for the diagnosis of H. pylori infections in children. The UHR method to calculate of (13)C-UBT result provided excellent results for children of all ages.
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