FDA approves first Covid-19 breath test

The US Food and Drug Administration has granted emergency use authorization to a new COVID-19 test that can detect infections with only a sample of a patient's breath, using a device that can yield results in less than three minutes.

The agency says the InspectIR COVID-19 Breathalyzer will only be available for tests "by a qualified, trained operator under the supervision of a health care provider."

"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," Dr. Jeff Shuren, the FDA's top COVID-19 testing official, said in a statement announcing the authorization.

The test, designed for use in hospitals, doctors offices or mobile testing sites, requires a piece of equipment around the size of a piece of carry-on luggage. The FDA says the company will be able to produce around 100 instruments per week. Each test can evaluate around 160 samples every day.

In a study of 2,409 people with and without symptoms, the FDA says the device was able to spot 91.2% of cases and yielded false positives in only 0.7% of results.

The company announced kicking off clinical trials back in 2020, though the FDA says a follow-up study also found the tests had similar accuracy at detecting the Omicron variant.

The company says its COVID breath test could one day be used to screen workers as they return to the office, using a less invasive process than the swabs that most tests currently rely on.