The Food and Drug Administration approved the first breath-based Covid-19 test in the United States on Thursday.
The emergency use authorization of the Covid-19 Breathalyzer is a significant milestone in the yearslong quest to develop more breath-based diagnostics, as well as innovative new tests for Covid, experts said. Experts said it is likely to be the first of many similar breath-based Covid tests.
The associate vice chancellor of Interdisciplinary Research and Strategic Initiatives at the University of California, Davis, who has been developing her own coronaviruses test, said that she thinks this is a really exciting development for the entire field of breath analysis.
Breath tests still pose real-world challenges, and this particular device has several practical limitations. The machine used to conduct the tests is large and can only be used by trained operators.
According to InspectIR Systems, a small, five-person company based in Texas, many devices would be needed for wide-scale screening, given that each machine can process only about 20 samples an hour.
Some experts wanted to look at the data underlying the application before endorsing the test method.
Many health care settings and mobile test sites where the devices may be used have already adopted other kinds of rapid tests. The final pricing plans have not been set.
John Redmond, a co-founder of InspectIR Systems, said on Friday that it could take 10 to 12 weeks for the first devices to hit the market. According to the F.D.A., the company planned to make about 100 devices a week, but it was not clear when that would happen.
We were waiting for the first one to be authorized to do these types of tests for the entire Pandemic.
The devil is in the details to determine how useful this thing will be.
Breath tests for a wide range of illnesses, from lung cancer to liver disease, have been in the works for a long time.
Many scientists and companies have been developing breath-based coronaviruses tests, which could be used to screen large groups of people for the virus, because many research teams began trying to identify unique chemical patterns in the breath of Covid patients.
The InspectIR Breathalyzer is the first Breathalyzer to be approved for use in the United States and has already been tested in pilot programs.
Patients blow into a cardboard straw to use a chemical analyzer. The levels of V.O.C.s that are analyzed together make up a "breath print" of Covid, according to Mr. Redmond. InspectIR couldn't say what the five compounds are. The company said results are delivered within three minutes.
Nathaniel Hafer is a geneticist and testing expert at the University of Massachusetts Chan Medical School.
It is really valuable to expand the types of samples that can be used to detect the virus.
According to documents released by the company, the breathalyzer had a sensitivity of 91 percent, meaning that of the people who tested positive for the virus on a P.C.R. test, the device flagged 91 percent of them as presumptive positives.
The clinical microbiologist at the University of Southern California wanted to see more independent data on the device's performance and more details on what it was detecting.
She said that the use of V.O.C.s is not well developed for the diagnosis of infections.
Breath tests can be thrown off by certain foods and substances. The instructions for the Breathalyzer state that people should not eat, drink or use tobacco products for 15 minutes before taking the test. The company says that those who test positive should have the result confirmed with a P.C.R.
The most promising way to use breath tests is to use a more accurate version of a temperature screen that became common during the Pandemic.
Health care facilities and companies that run pop-up testing sites are some of the businesses that InspectIR hopes to lease the analyzers to. They could be used to test travelers at airports or workers in an office building, the co-founders said, adding that there has already been interest from professional sports leagues and companies in the travel industry.
Tim Wing, a co-founder of the company, said that they are a great fit.
The price of the device hasn't been decided, but the co-founders said on Friday that they hope to be able to offer licenses or subscriptions that will cost about $10 to $12 per test.
The day after the device was authorized, Mr. Wing said, "Not all this stuff is ready to go."
The company said that it had raised $2.7 million and that Pfeiffer Vacuum would be its initial manufacturing partner.
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