Tenn. It was cleared for marketing by FDA to detect the H. pylori bacterium, which is associated with ulcers. Blood tests have also been used to detect H. pylori, but with less dependable results. With the new breath test, the patient drinks a new non- radioactive diagnostic drug solution and then exhales into the collection kit. The procedure is performed in a doctor's office and takes about 30 minutes. The breath kit is sent to Meretek for analysis.
Results are available in a day or two.
FDA's clearance of the test was based on data from studies of 499 adults with duodenal ulcer disease at 75 sites in the United States and Canada. The patients were examined with endoscopy and stomach biopsy and were also given the breath test. H. pylori is a common bacterium which is thought to infect the stomachs of 35 percent of American adults, about 10 percent of whom develop peptic ulcers. The others may not develop ulcers but have chronic gastritis, which can cause indigestion, abdominal pain, gassiness, nausea and other stomach problems. The performance of the test has not been established in patients with chronic gastritis.