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FDA gives emergency use authorization for first COVID-19 breath test

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

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

At this point it's too soon to tell if Colorado will get any of the tests or where they would be made available.

Kaiser Permanente Infectious Disease Specialist Dr. Amy Duckro told 9NEWS while there are still many questions about its public usage, the effort to push innovation is what makes this development exciting. 

"We don’t know exactly how this test, this particular test, will be used, and yet it’s valuable to explore different ways where we may have new technologies, they may turn out to be easier, faster, more accessible to persons who don’t have normal access to care channels," Duckro said. 

"The focus on innovation and creating and furthering our science and our understanding of how to use science to help keep our communities and our patients safe and well, that is what I think is the valuable part of this technology," she said.

Credit: InspectIR systems
The breathalyzer device is the size of a suitcase.

How does the test detect COVID?

According to the U.S Food and Drug Administration (FDA) the 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 Systems, the 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 roughly 2,400 people, including those with and without symptoms. The results showed the device was 91.2% accurate at identifying positive samples. It was 99.3% accurate at identifying negative samples.

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

"It reports a very good accuracy in terms of false negative and false positive rates, especially with false positives being very low," Duckro said. "However, it is still recommended that these tests be confirmed if they’re positive with a PCR test and that does limit to some degree the convenience factor of this." 

Where can the product be used? 

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

When will this be available?

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



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