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. The BreathTek UBT test demonstrated 95.8 percent sensitivity and 99.2 percent specificity. An additional study was conducted one to six months after therapy to support use for post-treatment monitoring of patients. The sensitivity was 83.3 percent and the specificity was 100 percent.
BreathTek UBT is manufactured by Otsuka America Pharmaceutical, based in Rockville, Md.
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