After the Food and Drug Administration in the United States on Thursday approved the first breath-based Covid-19 test, coronavirus infections could soon be flagged with a single breath.
Experts say the approval of emergency use of the InspectIR Covid-19 Breathalyzer is a significant milestone in the year-long effort to develop more breath-based diagnostics, as well as innovative new tests for Covid. And it could be the first of many similar breath-based covid tests, experts say.
“I think it’s a really exciting development for the whole field of respiratory analysis,” said Christina Davis, associate vice chancellor of the Interdisciplinary Research and Strategic Initiatives at the University of California, Davis, who is developing her own coronavirus test. “It’s a huge step forward.”
But breathing tests still pose real-world challenges, and this particular device has several practical limitations, scientists say. The machine needed to conduct the tests is large – the size of a portable suitcase – and can only be used by trained operators supervised by healthcare professionals.
And according to Inspector IR Systems, a small, five-person company based in Frisco, Texas, each machine will need multiple devices for the given extensive screening, which can process about 20 samples per hour.
The company cites high accuracy rates for its tests, but some experts say they would like to examine the underlying data on its application to the FDA before approving the test method.
Also, many healthcare settings and mobile testing sites where the devices can be used have already adopted other types of rapid testing, which are now widely available. Inspector IR officials said the final pricing plan has not yet been set.
John Redmond, co-founder of InspectIR Systems, said Friday that the first devices could take 10 to 12 weeks to hit the market. The company said it plans to produce about 100 devices a week, according to the FDA, but it was not immediately clear when production would reach that level. Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University and the Georgia Institute, said, “We were thinking of this kind of test for the whole epidemic, and we were waiting for approval for the first one.”
“The devil is in the details to determine how effective this thing will be,” he said.
Many diseases cause physiological changes that alter the compounds we leave behind, and there has long been a growing interest in breathing tests for diseases ranging from lung cancer to liver disease.
As the epidemic began, numerous research teams began trying to detect unique chemical patterns in the respiratory tract of Kovid patients, and many scientists and companies were developing respiratory coronavirus tests that could be used to quickly and non-invasively screen large groups of people. Virus.
While some Covid breathing tests have already been tested in pilot programs or approved for use in other countries, the InspectIR Breathalyzer will be the first in the U.S. market.
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 instrument then analyzes the levels of five volatile organic compounds, or VOCs, which together form a “breath print” of the covid, Mr Redmond said. (Inspector IR said he could not disclose what the five compounds were.) Results were delivered within three minutes, the company said.
“It’s really fast and pretty impressive,” said Nathaniel Huffer, a molecular biologist and test specialist at Eumas Chan Medical School.
Expanding the type of samples that can be used to detect the virus is “really valuable,” he added. “Not everyone can give a nose sample very easily.”
In a company-sponsored study of 2,409 asymptomatic people, the sensitivity of the breathalyzer was 91 percent, meaning that people who tested positive for the virus in a PCR test, the device identified 91 percent of them as approximately positive, according to the document. It had a 99 percent specificity published by the FDA, meaning it did not detect any symptoms of the virus in 99 percent of those who received a negative result from a PCR test.
Susan Butler-U, a clinical microbiologist at the Cake School of Medicine at the University of Southern California, said she wanted to see more independent data on the device’s functionality and more details about exactly what compounds it detects.
“The use of VOCs is not well developed to diagnose infections,” he said. “I wouldn’t feel comfortable using it to diagnose patients without getting some more real-world data.”
Some foods and substances can stop breathing tests, scientists have noted. And the InspectIR Breathalyzer guidelines specify that people should not eat, drink or use any tobacco products within 15 minutes of being tested. Those who test positive should also confirm the results of a PCR or other similar test, the company says.
In fact, the most promising way to use a breath test is a quick screening tool – a more accurate version of non-very reliable temperature screens that have become commonplace during epidemics. Lam says. “They don’t really give you a diagnosis,” he said, referring to a breath test. “They give you a biochemical pattern that is compatible with the disease.”
InspectIR hopes to lease analysts to other businesses, including healthcare facilities and companies that run mobile or pop-up testing sites. These could be used to test travelers at the airport or staff in the office building, the co-founders said, adding that professional sports leagues and organizations are already interested in the travel industry.
“Anywhere they’re sweeping the nose more than once a day, we’re very fit,” said Tim Wing, co-founder of the company.
The price of the device has not yet been finalized, but co-founders said Friday that they will be able to offer a license or subscription that costs around $ 10 to $ 12 per test.
“Yesterday was a huge domino for us,” Mr Wing said Friday, the day after the device was approved. “All of these things are not ready to go, yet defined.”
The company says it has raised $ 2.7 million so far and Pfeiffer Vacuum will be its initial production partner.