First COVID-19 Breath Test Authorized by the FDA

COVID-19 testing can be done more easily and more readily. But, given the fact that the US is still experiencing more than 30,000 new cases of infection each week, more options to identify SARS-CoV-2 could help reduce the spread.

The U.S. Food and Drug Administration made an important move in this direction on April 14th by authorizing the first breathalyzer for COVID-19. The test isn’t designed to serve as a confirmed diagnosis of COVID-19, but as a screening tool to alert people who might be infected, in under three minutes. Any person who tests positive for COVID-19 on InspectIR would have to confirm the result using PCR.

InspectIR Systems, based out of Frisco, Texas, created the test. It analyzes breath gases and detects the chemical signature for SARsCoV-2. Our cells can produce a biochemical reaction which creates gasses that are captured by the bloodstream and then transferred to our lungs. These gases then get exhaled through the breath. Working with University of North Texas chemistry professor Guido Verbeck, InspectIR’s scientific team identified the breath print of SARS-CoV-2 by comparing the chemical profiles of breath samples from a few dozen people infected with COVID-19 and a similar number who were not. The test was based on 41 different results.

This technology uses a small piece of equipment that is about the same size as carry-on luggage. It can be used to perform automated analyses in three minutes. The FDA based its authorization on a study involving more than 2400 people, some of whom had COVID-19 symptoms and some who didn’t. InspectIR accurately identified 91.2 percent of positive samples, while 99.3% of those with negative results. Even among Omicron-infected people, these results were valid.

InspectIR CEO Tim Wing is the co-founder of InspectIR. He expects doctors and hospitals to use this instrument for faster screening than rapid antigen testing, which takes about fifteen minutes or rapid PCR tests that take several hours. He believes that the test is easier to administer for both health care professionals and patients, as people breathe directly into the tube instead of having to have a needle inserted in their noses.

This test must be performed at a hospital or on a mobile site. InspectIR analyses the data, then reports the results to the doctor. The FDA authorization also requires that the positive results get reported to state health departments; while the positive results aren’t confirmed cases, they can be useful in helping states determine when and where cases might be increasing.

Because a healthcare professional is overseeing the testing, this instrument may be restricted to those places that require quick and mass testing. Tim Wing, the founder and CEO, said that he received several requests from various travel industries, such as hotel operators and cruise ship operators.

However, a handheld breathalyzer test for COVID-19 might be useful in other settings, such as school and workplaces. This mobility would allow more people to be tested faster. Other researchers have also been working to create a handheld device that is similar to those used by law enforcement officers to identify alcohol in drivers. Shalini Prasad, a bioengineer at the University of Texas at Dallas developed it. It connects with an app and provides results within 30 seconds. Sotech Health is a Texas-based startup which licensed the technology and currently works with FDA to obtain authorization.

“My vision was to immediately get the device out to big hospitals where there were lines of people waiting to get tested,” says Craig Micklich, founder of Sotech. “But since it’s so small, the end goal is to have it used as a home diagnostic test. The idea is for the test to be affordable to the masses, including third world countries.”

John Redmond is co-founder of InspectIR and its president. He claims that the instrument’s smaller size reduces detection accuracy and specificity for SARS-CoV-2 signatures. “The level of resolution and sensitivity is night and day,” he says, in comparison with his company’s instrument.

The FDA will determine if that’s true, but for now, InspectIR is the only test that can analyze breath for COVID-19. Over the next months, the company plans to produce about 100 instruments per week. Clients can rent them. Each test costs about the same price as quick antigen tests.

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