Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Authorizes First Covid Breathalyzer Test
A Covid-19 breathalyzer test with the ability to provide diagnostic results in three minutes has won emergency-use authorization from the U.S. Food and Drug Administration, the agency announced Thursday. The test, made by Frisco, Texas-based InspectIR Systems, is authorized for those 18 and older and in settings where samples are both collected and analyzed, such as doctor’s offices, hospitals or mobile testing sites. The device is about the size of a piece of carry-on luggage, the FDA said, and works by detecting chemical compounds in breath samples associated with SARS-CoV-2 infection. (Muller, 4/14)
The test, designed for use in hospitals, doctors offices or mobile testing sites, requires a piece of equipment around the size of a piece of carry-on luggage. The FDA says the company will be able to produce around 100 instruments per week. Each test can evaluate around 160 samples every day. In a study of 2,409 people with and without symptoms, the FDA says the device was able to spot 91.2% of cases — and yielded false positives in only 0.7% of results. The company announced kicking off clinical trials back in 2020, though the FDA says a follow-up study also found the tests had similar accuracy at detecting the Omicron variant. (Tin, 4/14)
The Breathalyzer test uses a technique called gas chromatography gas 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. (Paz, 4/15)
According to InspectIR, the test is performed by exhaling into a tube in a similar manner to blowing up a balloon and produces results within three minutes. (Santucci, 4/14)
