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FDA Authorizes Tests That Detects COVID-19 in Breath

by Caché Roberts
April 15, 2022
Reading Time: 1 min read
0
FDA Approves Drug "Opzelura" to Treat Vitiligo in Individuals 12 and Older

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The Food and Drug Administration issues an emergency device that detects COVID-19 the breath samples.

According to the New York Post, “the InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage.”

The test provides results within three minutes and can be used in doctor’s offices, hospitals, and mobile testing sites.

However, not just anyone can get their hands on it, health officials must use the device, and the test has to be supervised by a licensed health care provider.

Dr. Jeff Shuren, director of the FDA Center for Devices, calls the device “another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

FDA says that the device is 91.2% accurate at identifying positive tests and 99.3% accurate at identifying negative tests.

The agency concludes, “InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day. 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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