F.D.A authorizes first breath test for COVID-19
The Food and Drug Administration granted emergency use authorization to the first coronavirus test that can detect the coronavirus in a breath sample, within a few minutes and with a high degree of accuracy, the agency said Thursday.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Jeff Shuren, the director of the F.D.A.’s Center for Devices and Radiological Health, said in a statement.
The InspectIR Covid-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can produce results in less than three minutes and can be used in doctor’s offices, hospitals and mobile testing sites by trained operators. A single machine can analyze about 160 samples per day.
Yvonne Maldonado, an infectious disease specialist at Stanford University School of Medicine who is working on another Breathalyzer test, said that having more options to test will only help the transition to the endemic phase of the pandemic.
“If you think back from the original P.C.R., those were pretty horrible,” Ms. Maldonado said. “They were very uncomfortable and seemed to last forever — the easier we can make it, the better off we are.”
The device was tested in a study made up of 2,409 individuals both with and without symptoms of the virus. In the study, the test identified 91 percent of positive samples correctly and 99 percent of negative samples correctly.
The Breathalyzer test uses a combined technique called gas chromatography-mass spectrometry, which separates and identifies chemical mixtures to detect five compounds associated with the coronavirus in exhaled breath. If a test comes back positive on the Breathalyzer, it should be confirmed with a molecular test, such as a P.C.R. lab test.
The F.D.A. warned that negative tests “should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with Covid-19” because they do not completely rule out an infection, and noted that the device “should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.”
InspectIR, the company that produces the breathalyzer, expects to be able to produce about 100 machines per week.