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.
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. 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“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.Other Covid tests typically include nasal or saliva swabs.