FDA approves Helicobacter pylori breath test for children. |
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FDA: The FDA based its approval of the BreathTek UBT test for children on a multi-center study of 176 patients, comparing its performance to a composite reference method and demonstrating 95.8 percent sensitivity and 99.2 percent 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 percent and the specificity was 100 percent. |