The Food and Drug Administration on Thursday issued an emergency use authorization for what it said 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, 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.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
Officials warned residents and tourists packing Mediterranean destinations on Tuesday to stay indoors during the hottest hours as the second heat wave in as many weeks hits the region and Greece, Spain and Switzerland battled wildfires.
While the East Coast grappled with the aftermath of downpours that closed roads and rendered the water supply undrinkable in places, the West and other parts of the country contended with sizzling temperatures and unsafe air quality attributed to Canadian wildfires.
U.S. officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends tens of thousands of American children to the hospital each year.
