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U.S. FDA approves 1st device to detect COVID-19 through breath samples

Click to play video: 'U.S. FDA approves breath test for COVID-19, some Canadian researchers want to see it brought here' U.S. FDA approves breath test for COVID-19, some Canadian researchers want to see it brought here
WATCH: U.S. FDA approves breath test for COVID-19, some Canadian researchers want to see it brought here – Apr 15, 2022

The U.S. 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.”

Read more: COVID-19 rapid tests an imperfect and necessary tool in potential sixth wave, experts say

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

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“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.”

Click to play video: 'BC researchers developing breath test for COVID-19' BC researchers developing breath test for COVID-19
BC researchers developing breath test for COVID-19 – Mar 12, 2021

The device does not appear in the lists of testing devices Health Canada has approved or is currently reviewing.

—With files from Global News

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