First FDA-approved COVID-19 breath test

COVID-19 testing has become more convenient and accessible, but with the pandemic still causing an average of more than 30,000 new infections in the United States each week, there are more ways to detect SARS-CoV-2. could go a long way toward finally containing COVID-19.

On April 14, the US Food and Drug Administration took an important step in that direction by allows for first breath-based testing for disease. The test is not designed to serve as a confirmed diagnosis of COVID-19, but as a screening tool to alert those who may be infected, in less than three minutes. Anyone who tests positive on the TestIR system will need to confirm it with a PCR-based test.

Quiz, developed by Test System, based in Frisco, Tex., analyzes the gases in the breath and looks for specific chemical signatures of SARs-CoV-2 infection. Once infected, our cells create a biological response that produces gases that are retained in the blood stream and transported to the lungs and exhaled in the breath. Working with University of North Texas chemistry professor Guido Verbeck, TestIR’s scientific team identified the breath traces of SARS-CoV-2 by comparing the chemical profiles of breath samples from several Dozens of people infected with COVID-19 and a similar number are not infected. They found 41 differences as the basis for the test.

The technology is based on a device the size of a piece of hand luggage, which acts as a mobile chemistry laboratory and can perform automated analysis in about three minutes. The FDA authorized it based on a study involving more than 2,400 people, some of whom had COVID-19 symptoms and some did not. Test The test correctly identified 91.2% of positive samples and 99.3% of negative tests. These results held even in those infected with the Omicron variant.

Tim Wing, co-founder and CEO of TestIR, hopes that doctors, hospitals, and mobile testing sites will use the tool to screen people faster than an antibody test. rapid assay, which takes about 15 minutes, or a rapid PCR test, which takes a few hours. And because people simply breathe into a sample tube rather than stuff a cotton swab into their nose, he predicts the test will be easier for health care providers to perform and for everyone. People.

The test needs to be supervised by a healthcare professional, so it will have to be done in a clinic or mobile testing site. The device performs chemical analysis, and the data is then analyzed by TestIR, which reports the results to a healthcare provider. FDA authorization also requires that positive results be reported to state health departments; While positive results are not confirmed cases, they can be helpful in helping states determine when and where cases may be on the rise.

Currently, because a healthcare professional oversees testing, this device may be limited to places where rapid and mass testing is needed, such as workplaces and clinics. Tim Wing, the company’s co-founder and CEO, said he has also received requests for interest from travel industry groups, including cruise ship and hotel operators.

But the test of a portable ventilator for COVID-19 could be used more widely in settings such as workplaces, schools, and sports or entertainment venues, where its portability could help control. Check more people faster. To that end, other researchers are working on a handheld device similar to that carried by law enforcement officers to detect alcohol levels among motorists. Bioengineer Shalini Prasad of the University of Texas at Dallas has developed a tool that connects to an app that provides results in about 30 seconds. Sotech Healtha Texas-based startup that has licensed the technology, is currently working with the FDA to get the device licensed.

Craig Micklich, founder of Sotech, said: “My vision is to immediately get the device to major hospitals, where there are lines of people waiting to be tested. “But because it is so small, the ultimate goal is to use it as a home diagnostic test. The idea is to make the test affordable to the masses, including third world countries”.

The smaller device loses its sensitivity and specificity in detecting SARS-CoV-2 signatures, said John Redmond, co-founder and president of TestIR. “The level of resolution and sensitivity is night and day, compared to his company’s equipment,” he said.

The FDA will determine if that’s true, but for now, TestIR is the only test that can analyze breath for COVID-19. The company expects to produce around 100 instruments per week, which customers can rent out in the coming months and analyze about 20 tests per hour, with a cost per test comparable to a rapid antigen test. .

Other must-read stories from TIME

Contact us in

Source link


News5s: Update the world's latest breaking news online of the day, breaking news, politics, society today, international mainstream news .Updated news 24/7: Entertainment, the World everyday world. Hot news, images, video clips that are updated quickly and reliably

Related Articles

Back to top button