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FDA authorizes first COVID breath test. Here’s What You Need to Know – NBC Chicago

The Food and Drug Administration on Thursday issued emergency use authorization for what it says is the first device capable of detecting COVID-19 in breath samples.

The InspectIR COVID-19 Breathalyzer test, which can provide results in less than three minutes, should be performed under the supervision of a licensed healthcare provider.

From the accuracy of the device to how often some say it will be used, here’s what you need to know:

The breathalyzer is about the size of a carry-on, 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 in identifying positive test samples and 99.3% accurate in 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 that is happening 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 United States is experiencing a surge of cases of the BA.2 omicron subvariant. BA.2 accounts for about 86% of cases in the United States, according to the Centers for Disease Control and Prevention.

Although the country’s COVID hospitalizations are at an all-time high, the average number of daily cases has risen 9% over the past two weeks, according to NBC News’ tally. Many experts agree that the true scale of the virus’ spread is much greater, as infections are underestimated.

While mask rules in many parts of the country have been relaxed or removed as cases have plummeted, federal mask requirements for travelers on planes, trains and other public transit systems have been extended until May.

In announcing the extension until May 3, the CDC pointed to an increase in cases in the United States on Wednesday.

Philadelphia announced Monday it was reinstating an indoor mask mandate, citing rising case numbers.

NBC Chicago

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