First COVID breath test authorized by FDA

Joseph Wilkinson
New York Daily News (TNS)
The Food and Drug Administration says medical offices and mobile testing sites can start using the InspectIR COVID-19 Breathalyzer to detect COVID-19. (Mario Tama/Getty Images/TNS)

It’s a breath of fresh air.

A breath test for COVID-19 was approved Thursday for the first time in the U.S.

The Food and Drug Administration said medical offices and mobile testing sites could start using the InspectIR COVID-19 Breathalyzer to detect COVID-19. It can provide results in less than three minutes.

The breath test correctly detected 91.2% of positive samples and 99.3% of negative samples in a test-run among 2,409 people, the FDA said in a press release. It performed similar against the initial and omicron variants of COVID-19.

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“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” FDA higher-up Dr. Jeff Shuren said in the release. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic.”

The FDA said positive tests should be confirmed with a follow-up PCR test.

Researchers have been attempting to develop COVID breath tests since 2020, but none gained FDA approval before Thursday.