A New Covid Breath Test Shows Promising, But Wide Use May Still Be Away


After the Food and Drug Administration, coronavirus infections may soon be marked by a gasp of breath. allowed first breath-based Covid-19 test in the United States on Thursday.

Experts said the emergency use authorization of the InspectIR Covid-19 Breathalyzer is a meaningful milestone in the years-long quest to develop more breath-based diagnostics and innovative new tests for Covid. Experts said it is likely to be the first of many similar breath-based Covid tests.

“I think this is a really exciting development for the whole field of breath analysis,” said Cristina Davis, vice-chancellor of Interdisciplinary Research and Strategic Initiatives at the University of California, Davis, who is developing her own coronavirus test. “This is a big step forward.”

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

According to InspectIR Systems, a small, five-person company based in Frisco, Texas, many instruments will be needed for large-scale scanning, given that each machine can only process about 20 samples per hour.

The company has demonstrated high accuracy rates for its tests, but some experts said they would like to review the data underlying its application to the FDA before approving this testing method.

Additionally, many healthcare environments and mobile testing sites where devices can be used have already adopted other rapid testing that is now widely available. InspectIR officials said final pricing plans have yet to be determined.

John Redmond, co-founder of InspectIR Systems, said Friday that it could take 10 to 12 weeks for the first devices to hit the market. The company said it plans to produce about 100 devices per week. according to the FDAhowever, it was not immediately clear when production would reach this level. D., a pediatric hematologist and bioengineer at Emory University and the Georgia Institute. “We were considering these kinds of tests for the whole pandemic and were waiting for the first to be confirmed,” Wilbur Lam said. Expert in technology and Covid testing.

“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 breathe and have long been the focus of attention. in the development of breath tests For a wide variety of diseases, from lung cancer to liver disease.

As the pandemic began, multiple research teams began trying to identify unique chemical patterns in the breath of Covid patients, and many scientists and companies are developing breath-based coronavirus tests that can be used to quickly and non-invasively screen large groups of people. virus.

Some Covid breath tests have already been tested in pilot programs or authorized for use in other countries, but the InspectIR Breathalyzer will be the first device to come to market in the United States.

To use the device, patients blow into a cardboard straw attached to the chemical analyzer. “A chemistry lab in a box,” said Mr. Redmond. Mr Redmond said he later analyzed the levels of five volatile organic compounds, or VOCs, that together make up a “breath mark” of Covid. (InspectIR said it couldn’t explain what the five compounds were.) The company said results were delivered within three minutes.

“It’s really fast and pretty impressive,” said Nathaniel Hafer, a molecular biologist and tester at the UMass Chan School of Medicine.

It is “really valuable,” he added, to expand the types of samples that can be used to detect the virus. “Not everyone can provide a very easy nose sample.”

In a company-sponsored study of 2,409 asymptomatic people, the sensitivity of the breathalyzer was 91 percent, meaning that of people who tested positive for the virus in a PCR test, the device flagged 91 percent of them as probable positive. Documents published by the FDA It had a specificity of 99 percent, meaning that 99 percent of those who received a negative result from a PCR test did not detect any signs of the virus.

Susan Butler-Wu, a clinical microbiologist at the University of Southern California Keck School of Medicine, said she would like to see more independent data on the device’s performance and more details on exactly which compounds it detects.

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

Scientists noted that some foods and substances can disrupt breath tests. InspectIR Breathalyzer’s instructions state that people should not eat, smoke or use any tobacco product within 15 minutes before taking the test. The company says those who test positive should also have the result confirmed by a PCR or similar test.

Indeed, the most promising way to use breath tests is as a rapid screening tool – a more accurate version of the not-so-reliable temperature displays that have become 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 model that is compatible with the disease.”

InspectIR hopes to lease the analyzers to other businesses, including healthcare facilities and companies that operate mobile or pop-up test sites. It could be used to test passengers at airports or workers in an office building, the co-founders added, adding that there is already interest from professional sports leagues and companies in the travel industry.

“Anywhere they do nasal swabs more than once a day, we’re well-suited,” said Tim Wing, co-founder of the company.

Pricing for the device has yet to be finalized, but the co-founders said Friday they hope to offer licenses or subscriptions that translate to around $10 to $12 per test.

“Yesterday was a big domino for us,” Mr. Wing said on Friday, the day after the device was approved. “All these things are not ready to go, yet to be defined.”

The company says it has raised $2.7 million to date and will be Pfeiffer Vacuum’s first manufacturing partner.



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