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FDA Authorizes Breath Test for COVID-19 Diagnosis

The breathalyzer is the size of a piece of carry-on luggage.

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Sarah Tew/CNET
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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.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.