FDA Authorizes First COVID Breath Test. Here's What to Know

Testing capacity is expected to increase by approximately 64,000 samples per month

The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.

The InspectIR COVID-19 Breathalyzer test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.

From how accurate the device is to how frequently some say it will be used, here's what you need to know:

The breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites. 

The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”

The U.S. is experiencing a wave of cases of the BA.2 omicron subvariant. BA.2 accounts for around 86 percent of U.S. cases, according to the Centers for Disease Control and Prevention.

Although the country’s COVID hospitalizations are at an all-time low, average daily case numbers have risen by 9 percent in the last two weeks, according to NBC News’ tally. Many experts agree that the true scale of the virus’s spread is far larger, because infections are being undercounted.

While mask rules in many areas of the country have been relaxed or eliminated as cases have fallen, federal mask requirements for travelers on airplanes, trains and other transit systems have been extended into May.

In announcing the extension through May 3, the CDC on Wednesday pointed to increases in cases in the U.S.

Philadelphia on Monday announced it is reinstating an indoor mask mandate, citing rising case counts.

Associated Press/NBC News/NBC Chicago
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