FDA authorizes breath test that can detect COVID-19 in three minutes
The 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.
InspectIR's test works by analyzing a person's breath using "gas chromatography gas mass-spectrometry" to detect five compounds typically exhaled when people are infected by SARS-CoV-2.
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.
InspectIR has been using similar technology in other tests to detect drugs in people's breath, according to the company's website,
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.
"In less than three (3) minutes, our device(s) can tell if a person may be actively infected and precluded from entrance/admission to a facility. The only way to ensure a true safety protocol is to understand if people are well enough to be there 'right now,'" the company's president wrote in a 2021 post.
Like with the rapid at-home COVID-19 tests that have surged in popularity over recent months, the FDA says positive results from the newly authorized breathalyzer "should be confirmed with a molecular test."
While most COVID-19 tests rely on swabs, the FDA has greenlighted other alternatives to look for signs of the virus. Back in August 2020, the agency authorized a test from Yale that looked for infection using saliva samples. Last year, an antibody test earned the FDA's emergency authorization using a finger prick.
The federal government has also backed the development of an array of new types of COVID-19 tests, including at-home kits that might one day be able to test for flu and COVID-19 infections with a single swab.
"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," said Shuren.