Coronavirus infections may soon be marked by exhalation after the Food and Drug Administration approved the first Covid-19 breath-based test in the United States on Thursday.
The permit for emergency use of the InspectIR Covid-19 breathalyzer is a significant milestone in a long-standing drive to develop more breath-based diagnostics as well as innovative new tests for Covid, experts said. And this will probably be the first of many such Covid breath-based tests, experts said.
“I think this is a really exciting development for the whole field of respiratory analysis,” said Christina Davis, vice chancellor of 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 breath tests are still a challenge in the real world, and this particular device has several practical limitations, scientists said. The machine needed to perform the tests is large – the size of a handbag – and can only be used by trained operators supervised by health professionals.
And many large-scale screening devices will be needed, 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 cited high levels of accuracy for its tests, but some experts said they wanted to study the data underlying its application to the FDA before approving the test method.
In addition, many healthcare facilities and mobile test sites where 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 determined.
It could take 10 to 12 weeks before the first devices hit the market, said John Redmond, co-founder of InspectIR Systems, on Friday. The company said it plans to produce about 100 devices a week, according to the FDA, but it is unclear when production will reach that level.
“We were thinking about these types of tests for the whole pandemic, and we were 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 a Covid test expert.
“The devil is in the details to 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 began, many research teams began trying to identify unique chemical patterns in the breathing of Covid patients, and many scientists and companies developed coronavirus-based breath tests that could be used for rapid and noninvasive screening of large groups of people. for the virus.
Some Covid breath tests have already been tested in pilot programs or are approved for use in other countries, but the InspectIR Breathalyzer will be the first to be released 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 analyzed the levels of five volatile organic compounds, or VOCs, which together make up Covid’s “breathprint,” Mr Redmond said. (InspectIR said it could not reveal what the five compounds were.) The 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 percent, which means that of the people who tested positive for the virus in a PCR test, the device rated 91 percent of them as presumed positive, according to documents released. from the FDA. He had a specificity of 99 percent, which means he found no signs of the virus in 99 percent of those who tested negative for PCR.
Susan Butler-Wu, a clinical microbiologist at Keck Medical School at the University of Southern California, said she wanted to see more independent data on the device’s operation and more details on exactly what 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.”
Some foods and substances may reject breath tests, scientists say. And the InspectIR breathalyzer instructions state that people should not eat, drink or use tobacco for 15 minutes before taking the test. Those who test positive should also have a confirmed result with PCR or another similar test, the company said.
Indeed, the most promising way to use breath tests is as a quick screening tool – a more accurate version of the not-so-reliable temperature screens that became common during the pandemic, Dr. Lam said. “They don’t actually give you a diagnosis,” he said, referring to breath tests. “They give you a biochemical model that is consistent with the disease.”
InspectIR hopes to hire analysts to other businesses, including healthcare facilities and companies that run mobile or pop-up testing sites. They can be used to test airport passengers or office workers, co-founders said, adding that there is already interest from professional sports leagues and companies in the tourism industry.
“Wherever a nasal swab is made more than once a day, we are very suitable,” 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 hope to be able to offer licenses or subscriptions that cost around $ 10 to $ 12 per test.
“Yesterday was a huge domino for us,” Mr Wing said on Friday, a day after the device was approved. “Not all of these things are ready to go, it’s still defined.”
The company said it has raised $ 2.7 million to date and that Pfeiffer Vacuum will be its initial manufacturing partner.