FDA Approves First COVID-19 Test Using Breath Samples

by Suzanne Halliburton
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The FDA gave emergency use authorization Thursday for a test to detect COVID using only samples from a patient’s breath.

And the breath test can detect COVID in only three minutes. But this won’t be an at-home test. Rather, the FDA authorized use for the test in hospitals or clinics, doctors’ offices, or mobile testing sites.

At a Glance

  • The FDA authorized emergency use for a COVID test that uses only a breath sample
  • Name of the new device is InspectIR COVID-19 Breathalyzer
  • Breathalyzer is about as big as a small suitcase
  • You can get the test at hospitals, a doctor’s office or a testing site

Here’s how it works. The test analyzes a person’s breath using “gas chromatography gas mass-spectrometry.” It looks for the presence of five compounds infected people exhale.

This test is far less invasive than the at-home tests, which require a mucus sample from the upper part of each nostril. Those tests can detect COVID within 15 minutes. A person also can go to a mobile testing site. There, you can get a more in-depth PCR test, which usually takes about a day for the results to come back.

InspectIR has worked on this test since the beginning of the COVID pandemic in 2020. CBS reported that it studied the accuracy of its own test on a study of more than 2,400 patients. The FDA said that the breathalyzer was able to detect on 91.2 percent of cases. It had only .7 percent false positives. The FDA said a follow-up analysis showed that the breathalyzer also was accurate in detecting Omicron.

The company said these tests can be useful for employers who need to quickly test employees returning back to the office.

In the last two years, the FDA has authorized tests that can detect COVID in saliva. And, there’s a test that uses a tiny dot of blood from a finger prick.

And, as the FDA authorizes a COVID test using only a sample of your breath, the agency worries about more variants and subvariants.

The Omicron subvariant called BA.2 now accounts for more than 85 percent of new cases in the United States. On Wednesday, the United States reported 53,911 new cases. Those have increased by small percentages, which is why the Biden administration extended the mask mandate on public transportation for another 15 days.

And there are even more subvariants. The New York Times reported this week that cases of BA.2.12 and BA.2.12.1 are circulating throughout the state. These subvariants are more contagious than BA.2. And BA.2 was more contagious than Omicron, which swept through the country earlier this year. New original Omicron cases spiked to 900,000 a day in January. So far, the main subvariant hasn’t caused this kind of spike as most of the country relaxed restrictions.

 

Outsider.com