The Food and Drug Administration on Thursday issued an emergency use authorization for the first COVID-19 test that uses breath samples. The test, which must be done by a trained operator, can provide a result in around three minutes.
The InspectIR Covid-19 Breathalyzer test, which is about the size of a piece of carry-on luggage, works by detecting chemicals associated with the virus that causes the disease in a breath sample.
A study of the device found that it accurately identified more than 91% of positive samples and nearly 100% of negative samples. Similar sensitivity was found in another study that focused on the Omicron coronavirus variant. However, a positive result should be confirmed with a PCR test, the FDA said.
“[This] 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.”
