FDA authorizes emergency use of new COVID-19 respiratory sample test
The test, cleared last week, can provide results in as little as three minutes.
Last week, the FDA authorized emergency use of a new test to detect COVID-19 with a breath sample.
According to a Press release, named InspectIR COVID-19 Breathalyzer, the test can provide results in three minutes. It is the size of a carry-on and can be used in medical facilities, including testing sites, under the supervision of a medical professional.
To test the accuracy of the breathalyzer, a study was conducted with 2,409 people. The breathalyzer correctly identified 91.2% of COVID-19 positive samples and correctly identified 99.3% of COVID-19 negative samples. It was then tested on the omicron variant with similar results.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health said in the press release, “The FDA continues to support the development of new COVID-19 tests with the goal of advancing technologies that can help deal with the current pandemic. and better position the United States for the next public health emergency.