US Covid-19 breathalyser test wins FDA approval

WASHINGTON • A Covid-19 breathalyser test with the ability to provide diagnostic results in three minutes has won emergency-use authorisation from the United States' Food and Drug Administration (FDA), the agency announced on Thursday.

The test, made by Texas-based InspectIR Systems, is authorised for those 18 and older and in settings where samples are both collected and analysed, such as doctors' offices, hospitals or mobile testing sites.

The device is about the size of a piece of carry-on luggage, the FDA said, and works by detecting chemical compounds in breath samples associated with Sars-CoV-2 infection.

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 antigen rapid tests, studies show.

"Today's authorisation is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19," Dr Jeff Shuren, director of the FDA's Centre for Devices and Radiological Health, said in the statement.

The FDA is also supporting the development of more testing capabilities, he said.

Many countries, including Singapore, have been developing breath-based Covid-19 tests.

The Republic's Health Sciences Authority last year gave provisional authorisation for the locally developed Breathonix and TracieX breathalysers, designed to detect Covid-19 within minutes.

InspectIR Systems, which focuses on portable opioid and cannabis detection tools, expects to be able to produce approximately 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.

BLOOMBERG