FDA authorizes the first breath test for detecting COVID-19
The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage and can be used in doctor’s offices, hospitals and mobile testing sites.
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.
“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.”