COVID-19 Breathalyzer Gets FDA Approval As Alternative For Nose Swabbing
By Alexa Heah, 18 Apr 2022
If you’ve had the uncomfortable experience of having a swab inserted up your nostrils to get a sample for the COVID-19 test, you’ll know how much of a bother it is. Thankfully, the US Food and Drug Administration (FDA) has just announced it has authorized the first breath diagnostic test for emergency use.
By using an instrument that’s about the size of carry-on luggage, doctors can now test patient samples under a qualified, trained operator and provide results on if they’ve been infected with the virus in under three minutes.
The InspectIR COVID-19 Breathalyzer underwent a clinical study with over 2,000 individuals, featuring those with and without any symptoms. It was found to correctly identify 91.2% of positive tests, and 99.3% of negative ones.
How does it work? Well, the machine makes use of gas chromatography gas mass-spectrometry to separate and detect five Volatile Organic Compounds (VOCs) associated with the COVID-19 infection, allowing doctors to have a reasonably accurate preliminary test before the results are further confirmed with a molecular test, such as the ones we’re accustomed to.
It’s believed the breathalyzer test will be able to analyze up to 160 samples per day per machine, with the testing capacity expected to increase by 64,000 samples per month.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health.
“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.
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