FDA authorizes first breath test for COVID-19 infection

FDA authorizes first breath test for COVID-19 infection

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The U.S. Food and Drug Administration issued an emergency use authorization Thursday, saying it is the first device that can detect COVID-19 in a breath sample.

The FDA said the InspectIR COVID-19 breath analyzer is about the size of carry-on luggage and can be used in doctor’s offices, hospitals and mobile testing sites. The test can provide results in less than three minutes and must be administered 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 “another example of rapid innovation in diagnostic testing for COVID-19.”

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

“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 production level, testing capacity using the InspectIR COVID-19 breath analyzer is expected to increase by approximately 64,000 samples per month.”

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