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FDA authorizes 1st breath test for COVID-19 infection

The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect  in breath samples.

The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor鈥檚 offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.

Dr. Jeff Shuren, director of the FDA鈥檚 Center for Devices and Radiological Health, called the device 鈥測et another example of the rapid innovation occurring with diagnostic tests for COVID-19.鈥

The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.