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FDA authorizes first breath test to detect coronavirus – The Washington Post

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The Food and Drug Administration on Thursday authorized a first-of-its-kind test that detects coronavirus using breath samples. The agency says the test delivers results within three minutes, but cautioned that it would fail to detect nearly one in 10 positive cases.

The InspectIR COVID-19 Breathalyzer, which is about as big as a piece of carry-on luggage and was designed by Frisco, Texas-based InspectIR Systems, requires test subjects to blow into a straw attached to the device for up to 10 seconds. According to the FDA, the breath test detected 91 percent of positive cases and more than 99 percent of negative cases in a trial of about 2,400 patients, putting its performance roughly on par or better than at-home nasal-swab tests recently authorized by the FDA. But unlike at-home tests, the breath test must be administered by a trained operator.

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People who test positive using the breath test should then get a confirmatory PCR test, the FDA said.

Experts said that the breath test could eventually be used as a quick screening device at large events, given its ease-of-use and quick turnaround time compared to rapid tests that often require at least 15 minutes to wait for results.

“It looked good, not great, in terms of sensitivity,” said former FDA commissioner Scott Gottlieb. “So good enough as a belt-and-suspenders if you want to have an extra layer of protection at an event like the Gridiron Dinner,” he added, referring to the dozens of infections linked to a gala held this month in Washington.

Since authorizing the InspectIR Breathalyzer on Thursday, the FDA has received multiple outside inquiries about the device’s potential to be deployed at large events, said an agency official, speaking on condition of anonymity to discuss agency inquiries.

Officials also said that a noninvasive approach to coronavirus testing could expand the pool of people willing or able to be tested, but cautioned that the breath test is unlikely to be widely adopted in the near future. InspectIR plans to produce only about 100 systems per week, the FDA said, whereas manufacturers of other kinds of coronavirus tests, such as nasal swabs, have produced millions of devices in recent months.

“I’m excited we have another test in our covid response toolbox. I’m most pleased that this new test has a good negative predictive value, meaning people who receive a negative test are truly negative, because it gives us more confidence in identifying a positive coronavirus test as the prevalence of covid goes down,” Beth Linas, a research epidemiologist at RTI International, a nonprofit scientific organization, wrote in an email.

InspectIR, which previously developed devices to test for the presence of opioids or marijuana, did not respond to a request for comment. In a tweet, the company said it would “have a lot to say … in due time.”

Scott Becker, CEO of the Association of Public Health Laboratories, said that the potential of a breath-based test was “exciting” but cautioned that the United States was currently grappling with unrelated, short-term coronavirus testing challenges, such as a shift in testing approach that had hidden the true extent of spread.

“There are so many at-home tests being used” but the results are not being reported to authorities, Becker said. “That’s the blind spot.”