Coronavirus infections could soon be marked with a breath puff after the Food and Drug Administration approved the first breath-based Covid-19 test in the United States on Thursday.
The emergency clearance 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 say. And it’s likely 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, associate vice chancellor for interdisciplinary research and strategic initiatives at the University of California, Davis, who developed her own coronavirus test. “That’s a giant step forward.”
But breath testing still presents real-world challenges, and this particular device has several practical limitations, 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 under the supervision of medical professionals.
And comprehensive screening would require a lot of equipment, since each machine can only process about 20 samples per hour, according to InspectIR Systems, a small company with five employees based in Frisco, Texas.
The company claimed high accuracy rates for its tests, but some experts said they wanted to examine the data underlying their submission to the FDA before endorsing the testing method.
In addition, many healthcare facilities and mobile testing centers where the devices can be used have already adopted other types of rapid tests that are now widely available. InspectIR officials said final pricing plans have not yet been finalized.
It could take 10 to 12 weeks for the first devices to hit the market, John Redmond, co-founder of InspectIR Systems, said on Friday. The company said it plans to produce about 100 devices a week, according to the FDA, but it wasn’t immediately clear when production would reach that level.
“We’ve been thinking about this type of testing throughout the pandemic and kind of waited for the first one to go through,” said Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University and the Georgia Institute of Technology and an expert in Covid testing.
“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.
When the pandemic began, numerous research teams attempted to identify unique chemical patterns in the breath of Covid patients, and many scientists and companies have developed breath-based coronavirus tests that could quickly and non-invasively screen large groups of people for the virus.
Some Covid breath tests have already been tested in pilot programs or approved for use in other countries, but the InspectIR Breathalyzer would be the first to be launched in the US.
To use the device, patients blow into a cardboard straw attached to a chemical analyzer. “It’s a chemistry lab in a box,” said Mr. Redmond. The machine then analyzes the levels of five volatile organic compounds, or VOCs, which together make up a “breathprint” of Covid, Redmond said. (InspectIR said it couldn’t disclose what the five compounds are.) Results are delivered within three minutes, the company said.
“It’s really fast and pretty 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 easily give a nose sample.”
In a company-sponsored study of 2,409 asymptomatic people, the breathalyzer had a sensitivity of 91 percent, meaning the device flagged 91 percent as presumptive positive of people who tested positive for the virus on a PCR test, according to documents cleared by the FDA It had a specificity of 99 percent, meaning it detected no signs of the virus in 99 percent of those who got 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 would like to see more independent data on the device’s performance and more detail on exactly which compounds it detects.
“The use of VOCs is not well developed for diagnosing infection,” she said. “I wouldn’t feel comfortable using it to diagnose patients without getting more real world data.”
Certain foods and substances can interfere with breath tests, scientists noted. And the instructions for the InspectIR Breathalyzer state that individuals should not eat, drink, or use tobacco products in the 15 minutes prior to the test. Those who test positive should also have the result confirmed 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 not-very-reliable temperature screens that became common during the pandemic, said Dr. lamb “They don’t really give you a diagnosis,” he said, referring to breath tests. “They give you a biochemical pattern consistent with the disease.”
InspectIR hopes to rent the analyzers to other companies, including healthcare facilities and companies running 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 there is already interest from professional sports leagues and companies in the travel industry.
“Anywhere where nasal swabs are done more than once a day, we’re a great fit,” said Tim Wing, a co-founder of the company.
Pricing of the device is yet to be determined, but the co-founders said Friday they hope to offer licenses or subscriptions, which will cost around $10 to $12 per test.
“Yesterday was a huge domino for us,” Mr. Wing said on Friday, the day after the device was approved. “Not all of these things are operational, not defined yet.”
The company said it has raised $2.7 million so far and that Pfeiffer Vacuum will be its first manufacturing partner.
https://www.nytimes.com/2022/04/15/health/covid-breath-test-fda.html A new Covid breath test shows promise, but widespread adoption may still be a long way off