New Covid breath test shows promise, but wide use may still be a long way off

Coronavirus infections could soon be signaled by a puff of exhaled breath, after the Food and Drug Administration 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 an important step in the years-long quest to develop more breath-based diagnostics, as well as innovative new tests for Covid, said experts. And it will likely be the first of many similar breath-based Covid tests, experts have said.

“I think this is a really exciting development for the whole field of breath analysis,” said Cristina Davis, associate vice chancellor for interdisciplinary research and strategic initiatives at the University of California. , Davis, who developed his own coronavirus test. “It’s a huge step forward.”

But breath testing still poses challenges in the real world, and this particular device has several practical limitations, the scientists said. The machine needed to perform the tests is large – about the size of a hand-held suitcase – and can only be used by trained operators supervised by medical professionals.

And many devices would be needed for large-scale screening, given that 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 has cited high accuracy rates for its tests, but some experts have said they want to review the data underlying its application to the FDA before approving this testing method.

Additionally, many healthcare facilities and mobile testing sites where the devices may be used have already adopted other types of rapid tests, which are now widely available. InspectIR officials said final pricing plans have yet to be determined.

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

“We’ve been thinking about these kinds of tests throughout the pandemic, and we’ve kind of been waiting for the first one” to be allowed, said Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University and the Georgia Institute of Technology and Covid 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 started, many research teams started trying to identify unique chemical patterns in the breath of Covid patients, and many scientists and companies developed breath-based coronavirus tests, which could be used to quickly and non-invasively screen large groups of people for the virus.

Some Covid breath tests have already been tested in pilot programs or cleared 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,” Mr. Redmond said. The machine then scans for levels of five volatile organic compounds, or VOCs, which together make up a Covid “respiratory fingerprint”, Mr Redmond said. (InspectIR said it could not disclose which five compounds are.) Results are delivered within three minutes, the company said.

“It’s really fast and quite impressive,” said Nathaniel Hafer, a molecular biologist and testing expert at UMass Chan Medical School.

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%, meaning that of those who tested positive for the virus in a PCR test, the device reported 91 % of them as presumptive positive, according to documents published by the FDA It had a specificity of 99%, which means that it detected no signs of the virus in 99% of those who received a negative result from a PCR test.

Susan Butler-Wu, a clinical microbiologist at the University of Southern California’s Keck School of Medicine, said she wants to see more independent data on the device’s performance and more details about the compounds it contains. detected.

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

Certain foods and substances can distort breath tests, the scientists noted. And the instructions for the InspectIR breathalyzer specify that people should not eat, drink or use tobacco products within 15 minutes before the test. Those who test positive should also have the result confirmed by PCR or another similar test, the company says.

Indeed, the most promising way to use breath tests is as a rapid screening tool — a more accurate version of the unreliable temperature screens that have become common 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 consistent with the disease.”

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

“Anywhere they do a nasal swab more than once a day, we’re a great fit,” said company co-founder Tim Wing.

Pricing for the device has yet to be finalized, but the co-founders said on Friday they hoped to be able to offer licenses or subscriptions that would result in a cost of around $10 to $12 per test.

“Yesterday was a huge domino for us,” Mr Wing said on Friday, the day after the device was cleared. “All of this is not ready to go, not yet defined.”

The company said it has raised $2.7 million to date and Pfeiffer Vacuum will be its initial manufacturing partner.


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