FDA Authorizes 1st Breath Test For COVID-19
April 14, 2022 4:52PM PDT
WASHINGTON (AP) – The Food and Drug Administration has issued an emergency use authorization for what it says is the first device that can detect COVID-19 in breath samples.
The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said Thursday, and can be used in doctor’s 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.
The FDA says the device is 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
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