Test approved for H. pylori
The U.S. Food and Drug Administration (FDA) in Rockville, MD, recently approved a new breath test to detect the bacterium that causes peptic ulcers, Helicobacter pylori. The test, called the Meretek UBT Breath Test Collection Kit, is the first of its kind, says FDA spokeswoman Sharon Snider. Previously, the only way to accurately diagnose H. pylori was by endoscopy and gastric biopsy. Blood tests to detect the bacterium also are available, but they are less dependable, she adds.
With the new test, patients drink a nonradioactive diagnostic drug solution, Pranactin, and exhale into a collection kit. The procedure is performed in a physician’s office and takes about 30 minutes. The breath kit is then sent to the test’s manufacturer, Meretek Diagnostics in Nashville, TN. Results are available in one to two days, says Snider.
Approval of the test was based on data from studies of 499 adults with duodenal ulcer disease at 75 medical sites in the United States and Canada, Snider says. Patients were given endoscopy and biopsy and then given the breath test. Results indicated that the breath test was able to detect the presence of H. pylori in 95% of patients, which is similar to the efficacy of endoscopy with biopsy in detecting the infection, Snider says.
[Editor’s note: The test costs between $200 and $400, according to a Meretek spokesperson. For more information on the test, contact: Meretek Diagnostics, 618 Grassmere Park Drive, Suite 20, Nashville, TN 37211. Telephone: (888) 637-3835.]
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