FDA Authorizes First Breathalyzer Test To Detect COVID-19
The U.S. Food and Drug Administration authorized the first breathalyzer test to detect COVID-19.
On Thursday, the FDA announced that it was issuing an emergency use authorization for the InspectIR COVID-19 Breathalyzer, which detects coronavirus infections through breath samples. The test can provide results in under three minutes.
So far, widely available COVID-19 tests are administered by swabbing inside people’s nostrils with a Q-tip and then testing the sample, with results taking anywhere from a few minutes for a rapid test to days for a PCR test.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a release from the agency. He noted that this innovation could help with the current pandemic and “better position the U.S. for the next public health emergency.”
In a study of over 2,000 people, the test was found to have 91.2% sensitivity (the rate of COVID-positive samples correctly identified) and 99.3% specificity (the rate of negative samples correctly identified). Clinical trials started in 2020, but the device was also tested specifically on the omicron variant, the FDA said.
Health care providers can use the test, which is about the size of carry-on luggage, on patients in doctor’s offices, hospitals and mobile testing sites, according to the FDA.
As the highly contagious omicron BA.2 subvariant of the coronavirus has been spreading in the U.S., cases nationwide have begun to tick back up. Case levels are still currently far lower than they were during the major winter spike. Vaccination remains the best method of protection against hospitalization and death from the virus.