Corona virus infections will soon be marked by a puff of breath, after the Food and Drug Administration approved the first breath-coded Q-19 test in the United States on Thursday.
Emergency use of the InspectIR Covid-19 Breathalyzer is a meaningful milestone in years of exploration to develop more breath-based diagnostics, as well as advanced new tests for quotients, experts said. And this is likely the first of many similar breath-taking quad tests, experts said.
“I think this is a really exciting development for the entire field of breath analysis,” said Christina Davis, Associate Vice-Chancellor of Interplanetary Research and Strategic Initiatives at the University of California, Davis, who is developing her Corona virus test. General Chat Chat Lounge “This is a big step forward.”
But breath tests still face real-world challenges, and this particular device has many practical limitations, scientists said. The machine needed to test is large – about the size of a carrying suit case – and can only be used by trained operators under the supervision of healthcare professionals.
And many devices will require large-scale screening, given that each machine can process only 20 samples an hour, according to InspectIR Systems, a small, five-person company based in Frisco, Texas.
The company cited high accuracy rates for its tests, but some experts said they would like the FDA to test the basic data of its application before verifying the test.
In addition, many healthcare settings and mobile test sites where the device can be used have already adopted other types of rapid tests, which are now widely available. Inspector officials said the final pricing plans had not yet been determined.
It may take 10 to 12 weeks for the first device to come to market, John Redmond, co-founder of Inspector IR Systems, said on Friday. The company said it planned to produce about 100 devices a week, according to the FDA, but it was not immediately clear if production would ever reach that level. “We are thinking of these types of tests as a whole for epidemic, and we are waiting for the first type,” said Dr. Wilbur Lam, a pediatric hematologist and bio-engineer at Emory University and the Georgia Institute. An expert on technology and code tests.
“The devil is in the details to really determine how effective this thing is,” he said.
Many diseases cause physiological changes that alter the compounds that we exclude, and there is a long interest in developing breath tests for a broad range of diseases, from liver cancer to liver disease. up to.
When the outbreak began, many research teams began to try to identify unique chemical patterns in the patients’ breath, and many scientists and companies were developing breathing coronary virus tests, which rapidly and indirectly interfere with people. Can be used for screening large groups. Virus.
Some Covid breath tests have already been tested in pilot programs or authorized for use in other countries, but the InspectIR Breathalyzer will be the first to hit the market in the United States.
To use the device, patients slip the cardboard steel attached to the 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 form the “breath print” of the cod, Mr Redmond said. (InspectIR said it can’t show what the five compounds are.) The results are delivered within three minutes, the company said.
“It’s really fast and very inspiring,” said Nathaniel Heffer, a molecular biologist and testing specialist at UMass Chan Medical School.
Increasing the types of patterns that can be used to detect viruses is “really valuable,” he added. “Not everyone can easily provide a brownie pattern.”
In a company-sponsored study of 2,409 non-infected people, the sensitivity of the breathalyzer was 91%, meaning that among those who tested positive for the virus on PCR tests, the device marked 91% of them as positive. , According to documents. It had a specificity of 99%, released by the FDA, meaning that it did not detect any signs of the virus in 99% of those who received negative results from the 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 device performance and more details about what compounds it is looking for.
“The use of VOC is not developed for the diagnosis of infection,” he said. “I wouldn’t feel comfortable using it to diagnose patients without getting some more real-world data.”
Certain foods and substances may stop the breath test, scientists note. And the instructions for InspectIR Breathalyzer state that people should not eat, drink or consume any tobacco products within 15 minutes before the test. Those who take a positive test must also have a certified result with a PCR or other similar test, the company says.
In fact, the most promising way to use a breath test is as a rapid screening tool – a more accurate version of the unhealthy temperature screen that became commonplace during the outbreak, Dr. Lam said. “They really don’t diagnose you,” he said, referring to breath tests. “They give you a biochemical model that is disease-friendly.”
InspectIR expects analysts to lease to other businesses, including healthcare facilities and companies that run mobile or popup testing sites. They can be used to test travelers at the airport or in the office building, co-workers said, adding that there has already been interest from professional sports leagues and companies in the travel industry.
“Anywhere they swab more than one brownie a day, we’re a great fit,” said Tim Wing, co-founder of the company.
The price of the device has not yet been finalized, but the co-founder said on Friday that they will be able to offer licenses or subscriptions, which translates into roughly $ 10 to $ 12 per test cost.
“Yesterday was a great domino for us,” Mr. Wing said on Friday, the day after the device was allowed. “Not everything is ready to go, still defined.”
The company said it has collected $ 2.7 million to date and that Pfeiffer Vacuum will be its initial production partner.