The Food and Drug Administration on Thursday issued an emergency use authorisation for what it said was the first device that can detect Covid-19 in breath samples.
The InspectIR Covid-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites.
The test, which can provide results in less than three minutes, must be used under the supervision of a licensed health care provider.
“Today’s authorisation is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” said Jeff Shuren, director of the FDA’s Centre for Devices and Radiological Health.
The FDA is also supporting the development of more testing capabilities, Mr Shuren said.
The agency said the test was validated in a study of 2,409 people, where it correctly identified 91.2 per cent of positive samples and 99.3 per cent of negative samples.
It performed similarly in follow-up tests focused on the Omicron variant.
The breathalyser’s sensitivity is comparable to that of rapid antigen tests, studies show.
The company, which normally focuses on portable opioid and cannabis detection tools, expects to be able to produce about 100 of the devices each week, which can be used to evaluate about 160 samples a day.
On its website, the company says the breathalyser is the first such device available for commercial use.
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