A New Covid Breath Test Holds Promise, but Wide Use May Still Be Far Off

Coronavirus infections could soon be signaled by a whiff of exhaled air, after the Food and Drug Administration (FDA) authorized the first breath-based covid-19 test in the United States on Thursday. .

The emergency use authorization of the InspectIR Covid-19 breathalyzer is a significant milestone in the years-long quest to develop more breath-based diagnostics as well as innovative new tests for Covid, experts said. And it is likely to be the first of many similar breath-based tests for Covid, experts said.

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

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

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

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

Additionally, many healthcare settings and mobile testing sites where the devices can be used have already adopted other types of rapid tests, which are now widely available. InspectIR 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 these types of tests throughout the pandemic, and we were waiting for the first one to be authorized,” said Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University and the Georgia Institute of Technology and an expert in Covid tests.

“The devil is in the details to really determine how useful this thing is going to 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.

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

Some Covid breath 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 market in the United States.

To use the device, patients blow into a cardboard straw attached to a chemical analyzer. “It’s a chemistry lab in a box,” Redmond said. The machine then analyzes the levels of five volatile organic compounds, or VOCs, that together make up a “breathprint” of Covid, Redmond said. (InspectIR said it couldn’t reveal what the five compounds are.) Results are delivered within three minutes, the company said.

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

Expanding 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, the breathalyzer had a sensitivity of 91 percent, meaning that of people who tested positive for the virus in a PCR test, the device flagged 91 percent of them. as presumptive positives, according to the documents. published by the FDA. It had a specificity of 99 percent, meaning that it did not detect any signs of the virus in 99 percent of those who received a negative result from a PCR test.

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

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

Certain foods and substances can disrupt breath tests, the scientists noted. And the instructions for the InspectIR breathalyzer specify that people should not eat, drink or use any tobacco products in the 15 minutes before the test. Those who test positive must 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 rapid screening tool, a more accurate version of the unreliable temperature tests that became commonplace during the pandemic, Dr. Lam said. “They don’t really give you a diagnosis,” he said, referring to the breath tests. “They give you a biochemical pattern that is consistent with the disease.”

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

“Anywhere you get a nasal swab done more than once a day, we’re a perfect fit,” said Tim Wing, co-founder of the company.

Pricing for the device hasn’t been finalized yet, but the co-founders said Friday that they hope to be able to offer licenses or subscriptions that translate to a cost of around $10 to $12 per trial.

“Yesterday was a big domino for us,” Wing said Friday, a day after the device was cleared. “Not all of this is ready to go, it’s not defined yet.”

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

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