A breath test that can detect COVID-19 in three minutes was granted emergency use authorization in the U.S., according to the Food and Drug Administration.
The InspectIR COVID-19 Breathalyzer was authorized by the FDA on Thursday, making it the first breath test approved for the coronavirus.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said 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.”
Here’s what to know about the test.
How does the ‘Breathalyzer’ work?
Patients using the breath test to check for COVID-19 will blow into a tube — “much like blowing up a balloon” — that’s connected to a test kit, according to InspectIR.
The device — “about the size of a piece of carry-on luggage” — is then able to separate, identify and detect five compounds that are associated with coronavirus infections, officials said.
If the Breathalyzer detects any of those compounds in your breath, it will yield a “presumptive” positive test result, according to the FDA news release. This result is considered “unconfirmed” unless and until a molecular test — ones that take samples from the nose or mouth — also says the person is positive for COVID-19.
If the test produces a negative result, authorities say other factors should be considered before ruling out COVID-19. This includes recent viral exposures and related symptoms.
Breathalyzers “do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions,” officials said.
The test — from first breath to a patient’s results — is expected to take “less than three minutes,” according to the news release.
How effective is the breath test?
In a study of 2,409 people — in which some had COVID-19 — the InspectIR COVID-19 Breathalyzer correctly identified 91.2% of positive samples and 99.3% of negative samples, according to the FDA.
“The study also showed that, in a population with only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence,” officials said.
In a similar study focusing on the omicron variant, “the test performed with similar sensitivity,” the FDA says.
Where can I get a COVID-19 breath test?
The InspectIR COVID-19 Breathalyzer can be used at doctor’s offices, mobile testing sites and hospitals, according to the FDA. Specific locations offering the test have not been made publicly available.
“The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests,” officials said.
It will not be available for at-home use.
Is the COVID ‘Breathalyzer’ widely available?
The company producing the COVID-19 breath tests expects it can produce about 100 devices each week, the FDA says, and each instrument can test about 160 samples per day.
“At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month,” according to the FDA.
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