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The Food and Drug Administration (FDA) has granted emergency use authorization to a new COVID-19 test that can detect infections with only a sample of a patient’s breath, using a device that can yield results in less than three minutes.
The agency says the InspectIR COVID-19 Breathalyzer will only be available for tests “by a qualified, trained operator under the supervision of a health care provider.”
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
“The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”
The test, designed for use in hospitals, doctors’ offices or mobile testing sites, requires a piece of equipment around the size of a piece of carry-on luggage. The FDA says the company will be able to produce around 100 instruments per week. Each test can evaluate around 160 samples every day.
In a study, the InspectIR Breathalyzer accurately identified 91.2% of positive tests and 99.3% of negative tests.
The FDA said that a positive test should be confirmed with a molecular PCR test.
