A new test takes the guesswork out of figuring out if you have a viral or bacterial infection. And it could mean that people may no longer receive antibiotics if they don’t need them.
The U.S. Food and Drug Administration (FDA) gave Lumos Diagnostics, a company based in Australia, approval for the test. The purpose of the test is to help healthcare professionals know when a person needs antibiotics or not.
The test, called the FebriDX, is a disposable test to diagnose acute bacterial and respiratory infections. The FDA approval means that the company can market the test in the U.S. Doctors should use it along with their evaluation of clinical symptoms to ensure that people who need antibiotics get them — and those who don’t need them don’t get them. For instance, viral infections don’t respond to antibiotics while bacterial infections do.
When people get antibiotics needlessly, it can impair their ability to respond to antibiotics when they do need them.
Don’t expect a painless mouth or nasal swab, though. The text is a quick finger-prick blood test. It takes about 10 minutes to give a result. The test looks at Myxovirus‐resistance protein A (MxA) and C‐reactive protein (CRP). In a clinical trial, the test accurately diagnosed all people who had bacterial infections like lower respiratory tract infection or pneumonia.
“It is a credit to the regulatory team at Lumos that we have been able to deliver this outcome from our new 510(k) application significantly ahead of our initial expectations,” Doug Ward, the CEO of Lumos Diagnostics said.
“With this clearance in hand, we anticipate securing our first commercial orders in the US before the end of calendar year 2023,” Ward added.
Other countries where FebriDx is already used include the UK, Europe, Canada, the United Arab Emirates, Brazil, Turkey, Pakistan, Singapore, Malaysia and Australia.
Other research teams have come up with tests in recent years to distinguish viral from bacterial infections. Doctors can already use blood tests to tell which is which, but rapid tests will speed up the process.
