Urea Breath Test in Children: The United States Prospective, Multicenter Study

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: ≥ 2.4‰) showed that the sensitivity and specificity of the UBT were 97.9% and 96.1%, respectively. Based on the UHR cut-off value (positive: ≥ 10.0 µg/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 ¹³C-UBT proved to be both simple and accurate for the diagnosis of H. pylori infections in children. The UHR method to calculate of ¹³C-UBT result provided excellent results for children of all ages.