Coronavirus infections may soon be signaled by a sip of exhaled airafter the Food and Drug Administration (FDAfor its acronyms in English) authorized the first breath-based COVID-19 test in the United States on Thursday.
Emergency use authorization The InspectIR COVID-19 breath test is an important step in the multi-year quest to develop more breath-based diagnostics, as well as innovative new tests for COVID, experts said. And it will likely be 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 has developed her own coronavirus test. “It’s a big step forward.”
But breath testing still poses challenges in the real worldand this particular device has several practical limitationssaid the scientists. The machine needed to perform the tests is large, about the size of a hand-held suitcase, and can only be used by operators trained and supervised by medical professionals.
Yes many devices would be needed for large-scale detectionsince each machine can only process about 20 samples per houraccording to InspectIR Systems, a small five-person company based in Frisco, Texas.
The company cited high accuracy rates for its tests, but some experts have said they want to review the data underlying their submission to the FDA before approving this test 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.
The first devices could take between 10 and 12 weeks to reach the marketJohn 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 reach that level.
“We’ve been thinking about these kinds of tests throughout the pandemic, and we hoped the first one would be allowed,” said Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University and the Georgia Institute of Technology and a expert COVID test.
“The devil is in the details to really determine how useful this thing will be”mentioned.
Many diseases cause physiological changes that alter the compounds we exhaleand there has long been an interest in the development of breath tests for a wide range of diseases, from lung cancer to liver disease.
At the start of the pandemic, many research teams started trying to identify unique chemical patterns in the breath of COVID patientsand many scientists and companies have developed breath-based coronavirus tests, which could be used to quickly and noninvasively 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 breath test 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,” Redmond said. The machine then scans for levels of five volatile organic compounds, or VOCs, which together make up a “respiratory fingerprint” of COVID, Redmond said. (InspectIR said it could not reveal which five compounds are.) Results are delivered in three minutesthe company said.
“It’s really fast and quite impressive”said Nathaniel Hafer, a molecular biologist and testing expert at UMass Chan School of Medicine.
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 test had a sensitivity of 91%meaning that of those who tested positive for the virus in a PCR test, the device marked 91% of them as presumptive positive, according to documents released by the FDA. It had a specificity of 99%, meaning it detected no signs of the virus in 99% of those who received a negative PCR test result.
Susan Butler-Wu, a clinical microbiologist at the University of Southern California’s Keck School of Medicine, said I wanted to see more independent data on the performance of the device and more details on which compounds it was accurately detecting.
“The use of VOCs is not well developed for the diagnosis of infections,” he said. “I wouldn’t feel comfortable using it to diagnose patients without getting more real-world data.”
Some foods and substances can alter breath tests, note the scientists. And the instructions for the InspectIR breath test specify that people must not eat, drink or use tobacco products within 15 minutes before the test. Those who test positive must also confirm the result 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 the unreliable temperature tests that have become commonplace 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 plans to rent the analyzers to other companies, including healthcare facilities and companies that run pop-up or mobile 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.
“Wherever a nasal swab is performed more than once a day, we are perfectly suited,” said Tim Wing, co-founder of the company.
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 about $10 to $12 per test.
“Yesterday was a big domino for us,” Wing said Friday, a day after the device was cleaned. “It’s not all ready to go, it’s not defined yet.”
The company said that had raised $2.7 million to date and that Pfeiffer Vacuum would be their initial manufacturing partner.