The US Food and Drug Administration (FDA) has approved the first breath test for use in children ages 3 to 17 years to detect Helicobacter pylori (H. pylori) bacterial infections, responsible for chronic stomach inflammation (gastritis) and ulcers.
The FDA first cleared the BreathTek UBT test for adults in 1996. The US Centers for Disease Control and Prevention (CDC) estimates that approximately two-thirds of the world’s population is infected with H. pylori. Most people with this infection never have any symptoms but have a two- to six-fold increased risk of developing gastric cancer and mucosal-associated-lymphoid-type lymphoma compared with uninfected people.
BreathTek UBT is manufactured by Rockville, Maryland-based Otsuka America Pharmaceutical.
“Results from this test, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can quickly indicate infection, which allows a physician to initiate appropriate health measures in a timely manner,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health.
The FDA based its approval of the BreathTek UBT test for children on a multi-centre study of 176 patients, comparing its performance to a composite reference method and demonstrating 95.8 per cent sensitivity and 99.2 per cent specificity. An additional study was done at 1 to 6 months after therapy to support use for post-treatment monitoring of patients. The sensitivity was 83.3 per cent and the specificity was 100 per cent.