WASHINGTON (AP) — The U.S. Food and Drug Administration has issued an emergency use authorization for what it says is the first device capable of detecting COVID-19 in breath samples.
The InspectIR COVID-19 breath analyzer is about the size of a piece of carry-on luggage, the agency said Thursday. It can be used in medical offices, hospitals and mobile testing stations. The test can provide results in less than three minutes, but it must be used under the supervision of a licensed health professional.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the device is “yet another example of the rapid innovation happening with COVID-19 diagnostic tests.” 19”.
The FDA said the device is 91.2% accurate in identifying positive samples and 99.3% accurate in detecting negative samples.
“InspectIR anticipates being able to produce about 100 instruments per week, each of which can be used to test approximately 160 samples per day,” the agency noted. “With this level of production, testing capacity using the InspectIR COVID-19 breath analyzer is anticipated to increase by about 64,000 samples per month.”