The FDA approves the first COVID-19 Breathalyzer test
The FDA approves the first COVID-19 Breathalyzer test

The FDA approves the first COVID-19 Breathalyzer test

Dr. Amy Duckro told 9NEWS, while there are still many questions about its public use, the effort to push for innovation is what makes this development exciting.

COLORADO, USA – There will soon be a new way to check for coronavirus as the FDA has paved the way for the first COVID-19 exhalation test. The Agency announced an emergency use permit for the product last week. The device was created by a company called InspectIR Systems.

At this point, it is too early to say whether Colorado will get any of the tests or where they will be made available.

Kaiser Permanente Dr. Amy Duckro, a specialist in infectious diseases, told 9NEWS that while there are still many questions about its public use, efforts to push for innovation are what make this development exciting.

“We do not know exactly how this test, this particular test, will be used, and yet it is valuable to explore different ways in which we can have new technologies, they can prove to be easier, faster, more accessible to individuals, I do not have normal access to care channels, “Duckro said.

“Focusing on innovation and creating and promoting our science and our understanding of how to use science to help keep our communities and our patients safe and healthy, that’s what I think is the valuable part of this technology,” she said.

How does the COVID test detect?

According to the U.S. Food and Drug Administration (FDA) COVID-19 Breathalyzer uses a technique called gas chromatography mass spectrometry (GC-MS) to separate and identify different chemical mixtures associated with COVID.

How long does it take to get results?

InspectIR systemsthe company that developed the test said the estimated time to get test results is three minutes.

How accurate is the test?

The FDA said the COVID-19 Breathalyzer was proven in a large study of about 2,400 people, including those with and without symptoms. The results showed that the device was 91.2% accurate to identify positive samples. It was 99.3% accurate to identify negative samples.

The FDA said that if a person receives a positive result, it must be confirmed with a PCR test.

“It reports a very good accuracy in terms of false negatives and false positive rates, especially with false positives that are very low,” Duckro said. “However, it is still recommended that these tests be confirmed if they are positive with a PCR test, and this limits to some extent the convenience factor of this.”

Where can the product be used?

The FDA said the test should be performed by a qualified trained operator. It should be done at a doctor’s office, hospital or mobile test site.

When will this be available?

InspectIR expects to produce around 100 Breathalyzer machines per week. They can each run about 160 tests a day. At this production level, the company said that the test capacity using Breathalyzer is expected to increase by about 64,000 samples per month.

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