A new Covid breath test is promising, but its widespread use may still be a long way off

Coronavirus infections could soon be marked by a puff of exhaled breath, after the Food and Drug Administration authorized the first Covid-19 breath-based test in the United States on Thursday.

According to experts, the emergency use authorization of the InspectIR Covid-19 breathalyzer is a significant milestone in the research over the years to develop more breath-based diagnoses, as well as new innovative tests for Covid. And it’s likely to be the first of many similar breath-based Covid tests, experts said.

“I think this is a really exciting development for the whole field of breath analysis,” said Cristina Davis, Davis, Associate Vice President for Interdisciplinary Research and Strategic Initiatives. his own coronavirus test. “This is a big step forward.”

But breath tests still pose real-world challenges, and this particular device has several practical limitations, scientists said. The machine needed to perform the tests is large (about the size of a suitcase) and can only be used by trained operators supervised by healthcare professionals.

And many devices would be needed for large-scale screening, as each machine can only process about 20 samples per hour, according to InspectIR Systems, a small, five-person company based in Frisco, Texas.

The company cited high accuracy rates for its testing, but some experts said they wanted to examine the data underlying its application to the FDA before approving this test method.

In addition, many healthcare environments and mobile test sites where devices can be used have already adopted other types of rapid testing, which are now widely available. Inspector officials said final pricing plans had not yet been set.

The first devices could take 10 to 12 weeks to hit the market, John Redmond, co-founder of InspectIR Systems, said Friday. The company said it planned to produce about 100 devices a week, according to the FDA, but it was not immediately clear when production would reach that level.

“We’ve been thinking about this kind of testing throughout the pandemic, and we were waiting for the first one to be cleared,” said Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University and the Georgia Institute. Covid technology and testing expert.

“The devil is in the details to really determine how useful this thing will be,” he said.

Many diseases cause physiological changes that alter the compounds we exhale, and there has long been interest in developing breath tests for a wide range of diseases, from lung cancer to liver disease.

When the pandemic began, numerous research teams began trying to identify unique chemical patterns in the breath of patients with Covid, and many scientists and companies have been developing breath-based coronavirus tests, which could be used to detect quickly and non-invasively large groups of people the virus.

Some Covid breathalyzer tests have already been tested in pilot programs or authorized for use in other countries, but the InspectIR breathalyzer would be the first to hit the United States.

To use the device, patients blow a cardboard straw connected to a chemical analyzer. “It’s a chemistry lab in a box,” Mr. Redmond. The machine then analyzes the levels of five volatile organic compounds, or VOCs, which together form a “breath impression,” Covid said. Redmond. (InspectIR said it could not disclose the five compounds.) The results are delivered in three minutes, the company said.

“This is very fast and quite impressive,” said Nathaniel Hafer, a molecular biologist and testing expert at UMass Chan Medical School.

Extending the types of samples that can be used to detect the virus is “really valuable,” he added. “Not everyone can provide a nasal sample very easily.”

In a company-sponsored study of 2,409 asymptomatic people, alcohol had a sensitivity of 91 percent, meaning that of those who tested positive for the virus on a PCR test, the device scored 91 percent. percent of them as presumptive positive, according to the documents. published by the FDA It had a 99 percent specificity, meaning it did not detect any signs of the virus in 99 percent of those who received a negative PCR test result.

Susan Butler-Wu, a clinical microbiologist at Keck School of Medicine at the University of Southern California, said she wanted to see more independent data on device performance and more details on which compounds she was detecting.

“The use of VOCs is not well developed for the diagnosis of infection,” he said. “I wouldn’t feel comfortable using it to diagnose patients without getting more real-world data.”

Scientists have pointed out that certain foods and substances can cause shortness of breath. And the InspIR breathalyzer instructions state that people should not eat, drink or use any tobacco product for 15 minutes before taking the test. Those who test positive should also confirm the result with a PCR or other similar test, the company says.

In fact, the most promising way to use breath tests is as a quick-detection tool: a more accurate version of unreliable temperature screens that became commonplace during the pandemic, Dr. Lam said. “They don’t really give you a diagnosis,” he said, referring to breath tests. “They give you a biochemical pattern that is consistent with the disease.”

InspectIR expects to rent the analyzers to other companies, including healthcare facilities and companies running mobile or emerging testing sites. They could be used to test airport travelers or office building workers, co-founders said, adding that there has already been interest from professional sports leagues and companies in the travel industry.

“Wherever they do a nasal swab more than once a day, we adapt very well,” said Tim Wing, co-founder of the company.

The price of the device has not yet been determined, but the co-founders said on Friday that they expect to be able to offer licenses or subscriptions that will result in a cost of $ 10 to $ 12 per test.

“Yesterday was a huge domino for us,” Mr. Wing Friday, the day after device authorization. “Not all of this is ready to go, it’s still defined.”

The company said it had raised $ 2.7 million so far and that Pfeiffer Vacuum would be its initial manufacturing partner.

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