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The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to a first-of-its-kind test that can detect SARS-CoV-2 in the breath in less than 3 minutes. The COVID-19 Breathalyzer test (InspectIR Systems, LLC) will be available only in licensed test settings, therefore it is not currently meant for home use.
That’s one reason why the impact of the test may be limited, said William Schaffner, MD. The manufacturer claims it can produce about 100 testing instruments a week, and “it’s not as though they are producing 10,000,” he said.
Also, the capacity is limited — each testing system can evaluate 160 breath samples per day.
“So this can’t be used at a concert or a big ball game or something like that,” said Schaffner, professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee.
It is more likely the COVID-19 breath test will be used in “an average doctor’s office or clinic…a circumstance where the capacity of the machine would be appropriate,” he said.
“[Thursday’s] authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, stated in a news release.
“The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency,” he said.
The new technology is “fascinating,” Schaffner said. “It’s another advance diagnostically. There are some very clever people out there making better vaccines, therapeutic agents, and diagnostic tests.”
The breath test was evaluated in a study with 2409 people, including participants with and without COVID-19 symptoms.
The test accurately identified 91.2% of positive samples and 99.3% of negative samples, so it has high sensitivity and specificity.
A negative result means people are likely truly negative because the test had a 99.6% negative predictive value, the FDA notes. People who test positive should consider a confirmatory laboratory test. In a separate study specific to the Omicron variant, the test’s performance was similar.
The research that led to the EUA “certainly appears very rigorous,” Schaffner said.
“How much training does it actually take for somebody to run this?” Schaffner asked.
Someone licensed for testing is needed to supervise the testing — which is why this is not a home assay — as well as a technician trained and skilled to run and interpret the results.
Schaffner added, “We’ll just have to see how well it actually works in the real world.”
It remains unknown how much the breath test will cost, whether insurance is likely to cover any or all of the cost, and when the test will likely be available in hospitals, doctors’ offices, or mobile testing sites. Inquiries into the manufacturer were not answered by press time.
Schaffner had no relevant financial disclosures.
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter: @MedReporter.