The first Covid-19 breath test machine is available, giving quick results

As you can see, more than two years after the COVID-19 pandemic, many of us are used to nasal PCR tests. Fortunately, American regulators have now approved alternatives that don’t involve torturing our nostrils anymore. With a breath-based Covid-19 test, it can be used to rapidly and non-invasively screen large groups of viruses.

Recently, the US Food and Drug Administration (FDA) has granted emergency use authorization for a new test device that can detect Covid-19 infection with just a sample of a patient’s breath. Delivers results in less than three minutes.

The US FDA agency said that this device, called InspectIR Covid-19 Breathalyze, was directly manufactured by InspectIR Systems. It is about the size of a piece of hand luggage, can be used in medical offices and mobile testing sites, supervised by a qualified, trained operator under supervision. of a health care provider.

According to the study, the test is done by exhaling into a tube connected directly to the machine, in a similar way to blowing up a balloon, and it gives results within three minutes.

A study on InspectIR Covid-19 Breathalyze shows that the InspectIR Covid-19 Breathalyze machine works by analyzing a person’s breath using “gas chromatographic mass spectrometry” (GC-MS) to detect feces. isolation and identification of five compounds present in exhaled breath when a person is infected with SARS-CoV-2.

In a study of 2,409 people with and without symptoms, the FDA said the machine correctly identified 91.2% of positive samples and 99.3% of negative samples. Similar sensitivity was also found in another study focusing on Omicron variation. However, the FDA recommends that positive results returned from this device be further confirmed by molecular biology (PCR) testing, the so-called “gold standard” in COVID-19 screening. , while a negative test may be considered based on epidemiological factors.

Manufacturing company InspectIR Systems is expected to be able to produce around 100 devices per week, each of which can evaluate 160 samples per day, creating a testing capacity of 64,000 samples per month.

“It’s a different tool, and the FDA announcement shows it to be reasonably accurate and a relatively user-friendly tool,” said Dr. Emily Volk, president of the American College of Medicine. , said a board-certified clinical pathologist and pathologist. “It’s going to have to wait and see how widely this will be adopted,” says Volk. “That could be based on how expensive it is.” In an email to CNN, InspectIR Systems said it will not announce the price of the machine or when it will be available on the market.

The agency’s authorization “is another example of the rapid innovation happening with diagnostic tests for COVID-19,” said Dr. Jeff Shuren, director of the FDA’s Center for Radiological Health and Devices. said in a statement. “FDA continues to support the development of new COVID-19 tests with the goal of improving technologies that can help address the current pandemic and better position the United States for emergency health screening testing.” level in the community”.

In other good news, InspectIR Systems is using the same technology in other tests to detect drugs in people’s breath, according to the company’s website.

“I think this is a really exciting development for the whole field of breath analysis,” Cristina Davis, vice dean of the Division of Interdisciplinary Studies and Strategic Initiatives at the University of California, said in a statement. Father. Davis, who is developing his own Covid-19 test, also said. “This is a big step forward”

It is based on the mechanism by which many diseases cause physiological changes that alter the compounds we breathe out, and there has long been interest in developing breath tests for a variety of diseases, from cancer lungs to liver disease, from which the early field of using exhaled breath to diagnose illness has seen other companies pursue tests for COVID-19, including Breathonix, a startup established from the National University of Singapore, they received a temporary domestic marketing license.

Other companies such as Owlstone Medical, the Fierce 15 award-winning brand, have been developing breath-based biopsy tests for cancer and diseases affecting the lungs, liver and digestive system. Owlstone raised $58 million last year after launching the first commercial screening panel to tell the difference between various chronic inflammatory airway conditions including asthma, idiopathic pulmonary fibrosis, and idiopathic pulmonary fibrosis. Chronic obstructive pulmonary disease.