Helicobacter Pylori Breath Test for Children Approved

pylori tests. It is accurate and noninvasive. No blood, stool, or biopsy is needed—patients avoid the potential risks and discomforts associated with more invasive testing methods.

The test is based on the ability of H. pylori to break down urea into carbon dioxide, which is then absorbed from the stomach and eliminated in the breath. For the test, patients swallow a capsule containing urea made from an isotope of carbon. If H. pylori are present in the stomach, the urea is broken up and turned into carbon dioxide. The carbon dioxide is absorbed across the lining of the stomach and into the blood. It then travels in the blood to the lungs where it is excreted in the breath. Samples of exhaled breath are collected, and the isotopic carbon in the exhaled carbon dioxide is measured.

The BreathTek UBT test for H.pylori is manufactured by Otsuka America Pharmaceutical (Rockville, MD, USA). It was approved by the US Food and Drug Administration (FDA; Silver Spring, MD, USA) for adults in 1996. The first breath test for use in children was approved by the FDA on February 22, 2012.

The FDA based its approval of the BreathTek UBT test for children on a multicenter study of 176 patients, comparing its performance to a composite reference method and demonstrating 95.8 % sensitivity and 99.2 % 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 % and the specificity was 100%.

The American College of Gastroenterology considers the urea breath test (UBT) to be the most reliable nonendoscopic method for discovering H.pylori infections. By assessing the entire gastric mucosa, BreathTek UBT avoids the sampling errors seen in biopsy methods.

H. pylori infections cause chronic stomach inflammation (gastritis) and ulcers. Most people with this infection do not 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.

“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, PhD, director of the Office of In Vitro Diagnostic device evaluation and safety in FDA’s Center for Devices and Radiological Health.

Related Links:
Otsuka America Pharmaceutical
US Food and Drug Administration
The American College of Gastroenterology