FDA

FDA Authorizes First COVID-19 Breath Test

The agency granted emergency use authorization for the test, which detects chemical compounds in breath samples. A positive result should be confirmed with a molecular test

Published April 14, 2022 • Updated on April 15, 2022 at 6:17 pm

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The Food and Drug Administration on Thursday authorized the first Covid-19 test that uses breath samples.

The InspectIR COVID-19 Breathalyzer test has to be done by a trained operator, but the FDA said it can provide a result in around three minutes.

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The test detects chemicals associated with the virus that causes the disease in a breath sample, and if it’s positive it should be followed up by a molecular test, the agency said in a statement.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.