A
breath test for Helicobacter pylori infection available for adults may
also be used in children and teens from 3- to 17-years-old, the FDA said
Friday.
H. pylori is
responsible for chronic gastritis and most stomach ulcers. Infection
also is associated with a two- to sixfold higher risk of gastric cancer
and mucosal-associated, lymphoid-type lymphoma, the agency said.
Sold under the brand name BreathTek UBT, the test was approved for
adults in 1996. The FDA expanded the approval to include younger
patients on the basis of a 176-patient trial in which the test's
performance was compared with a standard laboratory method.
Results indicated sensitivity of 95.8% and specificity of 99.2% for the breath test, the FDA said.
In an evaluation of the test's usefulness for treatment monitoring, its
sensitivity was 83.3% and specificity was 100% when used one to six
months after therapy.
BreathTek UBT is manufactured by Otsuka America Pharmaceutical of Rockville, Md
H. Pylori Breath Test OK for Kids, FDA Say By John Gever, Senior Editor, MedPage Today Published: February 25, 2012
