Healthcare

‘ Breathalyzer test ‘ to detect Covid is approved in the US; meet

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Coronavirus infections could soon be detected with a puff of exhaled air, after the US Food and Drug Administration (FDA) on Thursday authorized the first Covid-19 test with based on breathing.

The authorization for emergency use of the InspectIR “breathalyzer” is a significant milestone in the multi-year quest for more breath-based diagnostics as well as innovative new tests for Covid-19, experts said. And it is likely to be the first of many similar Covid-19 tests, they say.

“I think this is a really exciting development for the entire field of breath analysis,” said Cristina Davis, Associate Vice Chancellor for Interdisciplinary Research and Strategic Initiatives at the University of California at Davis, who is developing her own coronavirus test. “This is a big step forward.”

But breath tests still present challenges in the real world, and this particular device has several practical limitations. The machine needed to carry out the tests is large – the size of a suitcase – and can only be used by operators trained and supervised by healthcare professionals.

And many devices would be needed for large-scale screening, as each machine can process only about 20 samples an hour, according to InspectIR Systems, a small, five-person company based in Frisco, Texas.

The company cited high accuracy rates in its tests, but some experts wanted to examine the data underlying its application to the FDA before endorsing this method.

It can take 10 to 12 weeks for the first devices to hit the market, John Redmond, co-founder of InspectIR Systems, said Friday. The company said it aims to produce about 100 devices a week, according to the FDA, but it was not immediately clear when production will reach that level.

InspectIR expects to lease the analyzers to other companies, including health clinics and companies that have mobile or “pop-up” testing locations. They could be used to test travelers at airports or workers in an office building, the co-founders said, adding that there has already been interest from professional sports tournaments and companies in the travel industry.

Pricing for the device has yet to be finalized, but the co-founders said on Friday that they hope to offer licenses or subscriptions that will cost roughly $10 to $12 per trial.

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