FDA Approves COVID-19 Breathalyzer Test
- April 15, 2022
The Food and Drug Administration (FDA) issued an emergency use authorization for the first COVID-19 diagnostic test that detects chemical compounds in breath samples, the agency announced April 14.
The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds associated with SARS-CoV-2 infection in exhaled breath, FDA said.
The performance of the breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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 and better position the U.S. for the next public health emergency.”