First COVID-19 exhalation test approved by the FDA
First COVID-19 exhalation test approved by the FDA

First COVID-19 exhalation test approved by the FDA

COVID-19 testing has become more convenient and accessible, but with the pandemic still causing more than 30,000 new infections in the United States on average each week, several ways to detect SARS-CoV-2 may go a long way toward eventually to contain COVID- 19.

On April 14, the US Food and Drug Administration took an important step in that direction approval of the first breathalyzer test for the disease. The test is not designed to serve as a confirmed diagnosis of COVID-19, but as a screening tool to alert people who may be infected in less than three minutes. Anyone who tests positive on the InspectIR system must confirm this result with a PCR-based test.

The test, developed by InspectIR systems, based in Frisco, Tex., analyzes the gases in the breath and captures the specific chemical signature of SARs-CoV-2 infection. Once infected, our cells produce a biological reaction that generates gases that are trapped in the bloodstream and transferred to the lungs and exhaled in the breath. In collaboration with University of North Texas chemistry professor Guido Verbeck, InspectIR’s scientific team identified the exhalation pressure of SARS-CoV-2 by comparing the chemical profiles of exhalation samples from a few dozen people infected with COVID-19 and a similar number that were not. They found 41 differences that served as the basis for the test.

The technology relies on a piece of equipment the size of a piece of hand luggage that acts as a mobile chemistry lab and can perform the automated analysis in about three minutes. The FDA based its approval on a study involving more than 2,400 people, some of whom had COVID-19 symptoms and some did not. The InspectIR test correctly identified 91.2% of the positive samples and 99.3% of the negative tests. These results held even among individuals infected with the Omicron variant.

Tim Wing, co-founder and CEO of InspectIR, expects doctors, hospitals and mobile test sites to use the instrument to provide faster screening of humans than either rapid antigen tests, which take about 15 minutes, or rapid PCR tests, which take a few timer. And because people are simply breathing in a test tube as opposed to getting a cotton swab into their nose, he expects the test will be easier for healthcare professionals to administer and for people to get.

The test must be monitored by a healthcare professional so that it can be performed at a clinic or mobile test site. The instrument performs the chemical analysis and the data is then analyzed by InspectIR, which reports the results back to the health nurse. FDA approval also requires that the positive results be reported to the state health departments; Although the positive results are not confirmed cases, they can be useful in helping states determine when and where cases may be increasing.

For now, because a healthcare professional oversees testing, the instrument is likely limited to locations where mass and rapid testing are critical, such as workplaces and clinics. Tim Wing, co-founder and CEO of the company, says he has also received interested inquiries from travel industry groups, including cruise ship operators and hotels.

However, a handheld breathalyzer test for COVID-19 could have wider application in environments such as workplaces, schools, and sports or entertainment venues, where its mobility could help test more people faster. To that end, other researchers are working on a handheld device similar to the one law enforcement officers wear to detect alcohol among drivers. University of Texas at Dallas bioengineer Shalini Prasad developed one that connects to an app that delivers results in about 30 seconds. Sotech Healtha Texas-based startup that licensed the technology is currently working with the FDA to obtain authorization for the device.

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

John Redmond, co-founder and president of InspectIR, says the smaller instrument loses sensitivity and specificity by detecting SARS-CoV-2 signatures. “The level of resolution and sensitivity is night and day,” he says compared to his company’s instrument.

The FDA will determine if this is true, but so far InspectIR is the only test that can analyze the respiration of COVID-19. The company expects to produce about 100 instruments a week that customers can lease over the coming months, and analyze about 20 tests per hour, with each test costing about the same as fast antigen tests.

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