First Covid-19 Breath Test Approved

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  • The FDA said the InspectIR Covid-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can be used in medical offices and mobile testing sites.
  • It can give results in less than three minutes.
  • The system separates and identifies chemical mixtures to detect five compounds associated with SARS-CoV-2 infection.
  • However, a positive result should be confirmed with a PCR test, the FDA said.

The US Food and Drug Administration said Thursday that the first Covid-19 test, which detects chemical components linked to the coronavirus in the breath, has been given emergency use authorisation as reported by CNN.

Mobile testing sites 

The FDA said the InspectIR Covid-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can be used in medical offices and mobile testing sites.

It can give results in less than three minutes.

The system separates and identifies chemical mixtures to detect five compounds associated with SARS-CoV-2 infection.

Similar sensitivity was found in another study that focused on the Omicron coronavirus variant.

However, a positive result should be confirmed with a PCR test, the FDA said.

User-friendly tool

“It’s another tool, and the FDA announcement suggests it’s reasonably accurate and a relatively user-friendly tool,” Dr Emily Volk, president of the College of American Pathologists, a board-certified anatomic and clinical pathologist, said Friday.

“It waits to be seen how widely this will be adopted,” Volk said. 

In an email to CNN on Friday, InspectIR Systems said it is not releasing the price of the machine or when it will be available.

The agency’s authorization “is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. 

“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 U.S. for the next public health emergency.”

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Source: CNN

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