The FDA just authorized a 10-second breath test for COVID
The breathalyzer can give back results in three minutes, but has to be performed by a health care professional.
Americans will soon be able to detect signs of COVID in mucus, saliva, and breath. On Thursday, the FDA issued an emergency use authorization for a doctor’s office breathalyzer by the drug testing company InspectIR.
To take the test, a patient blows for ten seconds into a sterilized straw attached to the side of the analyzer, which looks like a black plastic box the size of a suitcase. Inside is a mass spectrometer, which can analyze the specific chemicals in a gas. The device will look for five different volatile organic compounds—the type of chemical that creates smells like pine needles or orange rind—emitted by SARS-CoV-2, the virus that causes COVID.
The test will deliver results in three minutes, faster than the typically 15-minute at-home rapid tests, with comparable accuracy. According to the FDA announcement, the breathalyzer correctly identified positive cases 91 percent of the time.
In addition to speed and accuracy, the other advantage is comfort, which may encourage more people to get tested, Yvonne Maldonado, a Stanford University School of Medicine infectious disease researcher, told the New York Times. “The easier we can make it, the better off we are.”
But unlike at-home rapid tests, the breathalyzers will have to be performed “by a qualified, trained operator under the supervision of a health care provider,” according to the FDA. That means that people will likely need to schedule healthcare appointments to access testing—which has been a barrier to equitable COVID care throughout the pandemic. The device could also be used at mobile testing sites, but those are rapidly dwindling as federal funding runs out.
InspectIR said in the FDA announcement that it expects to be able to produce 100 of the analyzers a week, each of which can handle 160 samples a day. If the company manufactures 400 by the end of the month, the new technology would be able to test approximately 64,000 Americans every day. Currently, about 30,000 new COVID cases are diagnosed every day, and several hundred thousand new tests are conducted.