First COVID breath test authorized by FDA
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.
“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.