FDA Authorizes Breath Test for COVID-19 Diagnosis
The breathalyzer is the size of a piece of carry-on luggage.
- I've been covering technology and mobile for 12 years, first as a telecommunications reporter and assistant editor at ZDNet in Australia, then as CNET's West Coast head of breaking news, and now in the Thought Leadership team.
The US Food and Drug Administration on Thursday issued emergency use authorization for a COVID-19 diagnostic test using breath samples. The InspectIR COVID-19 Breathalyzer test detects five chemical compounds found in the exhaled breath of COVID patients.
The test is conducted using an instrument the size of "a piece of carry-on luggage" in hospitals, clinics and testing sites, the FDA said in a press release. Each instrument can be used to test 160 samples per day.
"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.
Read also: What We Know About COVID Subvariant BA.2, or 'Stealth Omicron'
The InspectIR COVID-19 Breathalyzer was found to accurately identify positive COVID cases 91.2% of the time in a study of 2,409 people. It was 99.3% accurate when correctly identifying negative samples.
Positive results should be confirmed with molecular tests, the FDA said.
Other Wellness Guides
Personal Care
Sleep
Fitness
Nutrition
Medical and Mental Health