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FDA authorizes first breath test for COVID-19 infection

The Food and Drug Administration on Thursday issued emergency use authorization for what it says is the first device capable of detecting COVID-19 in breath samples.

The InspectIR COVID-19 breathalyzer is about the size of a carry-on, 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, should be performed under the supervision of a licensed healthcare 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 that is happening with diagnostic tests for COVID-19.”

The FDA said the device was 91.2% accurate in identifying positive test samples and 99.3% accurate in 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.”

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