USA Updates FDA authorizes test that detects COVID-19 in breath TOU

USA Updates FDA authorizes test that detects COVID-19 in breath

 TOU

USA Updates FDA authorizes test that detects COVID-19 in breath

TOU

WASHINGTON – The Food and Drug Administration issued an emergency use authorization on Thursday, saying it is the first device that can detect COVID-19 in breath samples.

The InspectIR COVID-19 Breathalyzer carry-on is about the size of a piece of 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, should be done 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 “another example of the rapid innovation that accompanies clinical trials 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.

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

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