U.S. FDA authorizes first COVID-19 diagnostic test using breath samples

Special: Battle Against Novel Coronavirus

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization on Thursday for the country's first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor's offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage, according to the FDA.

The results of the test will show in less than three minutes.

The performance of the test, called InspectIR COVID-19 Breathalyzer, was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test was shown to have 91.2 percent sensitivity and 99.3 percent specificity, according to the FDA.

"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.