The United States has granted emergency-use permission for a COVID-19 breathalyzer test that can deliver diagnostic findings within three minutes, the Food and Drug Administration (FDA) announced on Thursday.
The test, developed by Frisco, Texas-based InspectIR Systems, is allowed for those over the age of 18 and in places where samples are gathered and processed, such as medical clinics, hospitals, or specialized testing stations.
According to the FDA, the technology is approximately the size of a piece of carry-on baggage and operates by identifying chemical molecules in breath samples linked with the SARS-CoV-2 virus.
The study was confirmed in a survey of 2,409 persons, according to the FDA, and it identified 91.2% of positive samples correctly and 99.3% of negative samples. In follow-up trials concentrating on the omicron variant, it also performed consistently.
The researchers also found that, in a population where just 4.2% are tested for the infection, the test had a negative predictive value of 99.6%, implying that individuals who obtain a negative test result are most likely legitimately negative in places where disease incidence is low.
In the context of the patient's latest exposure levels, history, and the proximity of clinical signs favorable to SARS-CoV-2 infection, negative findings should also be considered.
These findings do not exclude SARS-CoV-2 infection and should not be used as the only criteria for treatment or patient clinical and administrative considerations, along with infection prevention decisions.
The research shows that the response of the breathalyzer is equivalent to that of quick antigen testing.
Jeff Shuren, FDA's Center for Devices and Radiological Health director, said, "Today's authorization is simply another indication of the fast advancement emerging with diagnostic testing for COVID-19."
He also stated that the FDA is assisting in the creation of more diagnostic measures. The administration also emphasized that the test may only be provided by certified, trained clinicians who are authorized by medical experts who have state authority to prescribe procedures.
Frisco, which works primarily on transportable opioid and cannabis diagnostic instruments, anticipates being able to develop roughly 100 of the devices every week, which may be used to examine approximately 160 tests per day.
"At this rate of manufacturing, testing capability through the Breathalyzer is estimated to rise by roughly 64,000 results per month," the agency said.
According to the company's website, the breathalyzer is the first of its kind to be commercially accessible. InspectIR Systems did not reply promptly to questions for more details on its price or estimated level of demand.
