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breath test for Helicobacter pylori infection

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


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