FDA approves 1st exhalation test for COVID-19 infection

WASHINGTON (AP) – The Food and Drug Administration on Thursday issued an emergency use permit for what it said was the first device to detect COVID-19 in exhalation samples.

The InspectIR COVID-19 Breathalyzer is about the size of a piece of hand luggage, the FDA said, and can be used in doctors’ offices, hospitals and mobile test sites. The test, which can give results in less than three minutes, must be performed under the supervision of an authorized healthcare provider.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “another example of the rapid innovation happening with diagnostic tests for COVID-19.”

The FDA said the device was 91.2% accurate to identify positive test specimens and 99.3% accurate to identify negative test specimens.

“InspectIR expects to be able to produce approximately 100 instruments per week, each of which can be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, the test capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”

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