FDA approves Helicobacter pylori breath test

Article

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.

Recent Videos
Paul Kruszka, MD
Herbert Bravo, MD
Tina Tan, MD
Paul Kruszka, MD, MPH, FACMG
Stephanie Anne Deutsch, MD, MS, MSCR, FAAP
H. Westley Phillips, MD
David Turkewitz, MD
H. Westley Phillips, MD
© 2024 MJH Life Sciences

All rights reserved.