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The U.S. Food and Drug Administration (FDA) preliminarily approved the first breath test for covid-19 infections a few days ago.
Proteins present in the breath in the event of infection are used as markers. Accuracy is high, the U.S. agency wrote.
“Today’s approval is just one additional example of the rapid innovations in diagnostic tests for Covid-19, and FDA will continue to support the development of new Covid-19 tests. The goal is technological advances that can better address the current pandemic and put the U.S. in a better position for the next public health emergency,” Jeff Shuren, director of the U.S. Food and Drug Administration’s Division of Medical Technology and Radiology, was quoted as saying in a release.
The approval is an “emergency use authorization” (EUA) as allowed under U.S. drug/medical device law. This is an interim measure to enable faster access to innovation. This was initially used in the US for Covid 19 vaccines during the pandemic.
Results within three minutes
The test procedure originates from the Texas-based medical technology company InspectIR-Systems. It has developed breath analyzers for drug applications as well. The “Covid-19 Breathalyzer” does not directly detect SARS-CoV-2 but combines a gas chromatograph and a mass spectrometry device in a suitcase-sized instrument. Five volatile organic compounds are separated from the air breathed – the test persons blow directly into the device through a disposable tube – (gas chromatography) and then identified by mass spectrometry. The result is available within three minutes. If the test result is positive, PCR testing should then follow.
The test results were good. “The performance of the inspection Covid-19 Breathalyzer was validated in a large study of 2,409 subjects with and without symptoms. In this study, the test demonstrated a sensitivity of 91.2 percent (percent of positive findings correctly identified) and a specificity of 99.3 percent (percent of negative specimens correctly identified),” the FDA wrote. The specificity of such tests also depends on the frequency of positive findings in a group of people. Assuming a 4.2 percent SARS-CoV-2-positive finding (infection rate) in a group of people, the specificity (significance of ruling out infection) increased to 99.6 percent.
The procedure could be an initial push for this technology in the Covid-19 field. Currently, the Texas medical device company has only a limited production capacity of about a hundred such devices per week. They could be used, for example, at airports or in situations where a suspected case needs to be clarified very quickly.
- source: k.at/picture: dallasnews.com
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