First at-home test for flu, COVID and RSV authorized by the FDA
A new direct-to-consumer test designed to detect a number of different respiratory viruses, including COVID-19 and influenza, has been authorized by the US Food and Drug Administration (FDA). The test is the first of its kind to be approved by the FDA that gives consumers access to these kinds of diagnostics without going through a doctor or needing a prescription.
The COVID-19 pandemic has fundamentally changed how we access diagnostic tests. Rapid antigen tests for COVID-19 allowed people to test for a SARS-CoV-2 infection without going to a doctor. And now the FDA has authorized the first at-home test that can differentiate several respiratory viruses.
The test is from life sciences company Labcorp and looks for traces of influenza A and B, SARS-CoV-2 and respiratory syncytial virus (RSV).
Unlike common rapid antigen tests, this new test uses more traditional PCR (polymerase chain reaction) technology. This means it involves sending a nasal swab out to a lab for analysis.
The kit is called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test and it will be available in stores or online without the need for a prescription. Users will complete a nasal swab at home, send the sample off to the closest Labcorp lab, and access results through an online platform within one to three days of the sample being received at a lab.
“While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a health care professional,” said director of the FDA’s Center for Devices and Radiological Health, Jeff Shuren.
The test obviously won’t be able to return tests fast enough to guide immediate treatment or isolation decisions but knowing whether an infection is either COVID, the flu or even RSV, will be valuable in the long-term.
Shuren said the FDA is looking to expand direct-to-consumer diagnostics such as this one, and in the future it is hoped rapid versions of the tests will be available for people to self-diagnose immediately at home.
“The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home,” said Shuren.
It is unclear how much the test will cost but similar tests from Labcorp cost US$169.
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