Covid-19 breath test gets emergency approval from FDA
Silver Spring, Maryland - Breathe out, and three minutes later, results? The US Food and Drug Administration (FDA) has granted emergency approval to a new breath test for Covid-19.
The InspectIR Covid-19 Breathalyzer is about the same size as a carry-on suitcase, the agency announced on Thursday. Users can blow into a tube as if they are inflating a balloon, unlike existing tests which need nasal or throat swabbing.
The test delivers the results in less than three minutes, based on a chemical analysis, and could be used in doctors' surgeries, testing sites, or hospitals, for example. The test must be done with supervision from a licensed health care provider.
The device was able to correctly identify people with coronavirus in 91% of cases, and those without in 99% of cases. The test involved people who were symptomatic and asymptomatic.
"The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant," the FDA said in a statement.
However, the FDA said a positive result should still be confirmed with a follow-up PCR test.
"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 US for the next public health emergency," he added.
Cover photo: Collage: REUTERS