FDA approves Helicobacter pylori breath test

March 1, 2012

A breath test that detects Helicobacter pylori infection has been approved by the US FDA for use in children aged 3 to 17 years.

A breath test that detects bacterial Helicobacter pylori infection has been approved by the US Food and Drug Administration (FDA) for use in children aged 3 to 17 years. H pylori causes chronic active, chronic persistent, and atrophic gastritis duodenal and gastric ulcers in adults and children.

FDA based its approval of the breath test for children on a multicenter study of 176 patients that demonstrated 95.8% sensitivity and 99.2% specificity for H pylori bacteria compared with a composite reference. A follow-up study 1 to 6 months after therapy showed 83.3% sensitivity and 100% specificity in posttreatment monitoring.

The Centers for Disease Control and Prevention estimates that two-thirds of the world's population is infected with H pylori. Most of those infected have no symptoms.