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FDA authorizes first Covid-19 breath test

The agency granted emergency use authorization for the test, which detects chemical compounds in breath samples. A positive result should be confirmed with a molecular test.
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The Food and Drug Administration on Thursday authorized the first Covid-19 test that uses breath samples.

The InspectIR Covid-19 Breathalyzer test has to be done by a trained operator, but the FDA said it can provide a result in around three minutes.

The test detects chemicals associated with the virus that causes the disease in a breath sample, and if it’s positive, it should be followed up by a molecular test, the agency said in a statement.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

The test uses equipment about the size of a piece of carry-on luggage.

Other Covid tests typically include nasal or saliva swabs.

The polymerase chain reaction, or PCR, test is considered to be the most accurate, but there are also rapid tests, some of which can be done at home.

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.

There have been more than 80.7 million cases in the U.S. since the pandemic began, with more than 992,500 deaths, according to NBC News’ count.

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.

CORRECTION (April 14, 2022, 835 a.m. ET): A previous version of this article misstated the date through which the federal mask requirements for travelers were extended. It is through May 3, not May 15.