The Food and Drug Administration has granted emergency use authorisation to a device that takes a sample of someone’s breath and can identify positive Covid tests in less than three minutes, the agency announced on Thursday.
The InspectIR Covid-19 Breathalyzer, which is only allowed to be operated by a trained professional, returns results faster than common at-home tests, according to its creators.
"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," Dr Jeff Shuren, the FDA’s top COVID-19 testing official, said in a statement.
The marks the first time the agency has approved a breath-based test for use in the US.
The machine is about the size of a carry-on suitcase, and is designed for use in medical settings or at testing sites.
Current capacity suggests 100 InspectIRs can be made a week, with each device able to test up to 160 samples a day.
People being tested use a disposable sanitised straw to blow their sample into the device, using about the same amount of air required to inflate a small balloon, according to InspectIR.
The FDA has been studying the technology since 2020.
A study of the breathalyzer’s effectiveness found that presented with 2,409 samples, a mix of those with and without symptoms, the device spotted more than 90 per cent of cases with a false positive rate lower than 1 per cent.
The agency says breath tests should still be confirmed by a molecular test, mirroring its advice on the radiply proliferating market of at-home Covid tests.
InspectIR, which uses similar technology to screen people for drug use, argues this less-invasive test platform will assist companies in getting back to work.
"In less than three (3) minutes, our device(s) can tell if a person may be actively infected and precluded from entrance/admission to a facility. The only way to ensure a true safety protocol is to understand if people are well enough to be there ‘right now,’" the company’s president wrote in a 2021 post.
Public health officials have faulted the US for its inadequate Covid testing infrastructure and data, and lack of long-term, sustained efforts to monitor the disease.
