FDA Authorizes First COVID-19 Breath Test
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- The U.S. Food and Drug Adminstration has granted emergency use authorization to the first COVID-19 test that spots substances in breath that are linked to the infection
- The FDA said the InspectIR COVID-19 Breathalyzer, which is the size of a carry-on luggage, can be used as a portable diagnostic tool in mobile testing sites and medical offices, with results available within minutes
- The device identifies up to five chemical compounds associated with COVID-19 infection. A study that evaluated its effectiveness found that it accurately diagnosed 91% of positive samples and nearly 100% of negative samples
- "It's another tool, and the FDA announcement suggests it's reasonably accurate and a relatively user-friendly tool," Dr. Emily Volk, president of the College of American Pathologists, a board-certified anatomic and clinical pathologist, said Friday
- The FDA, however, added that even if it is widely adopted for rapid COVID-19 evaluation and diagnosis, a follow-up PCR test should be done to confirm the diagnosis of COVID-19