FDA Approves First At-Home Test for Detecting COVID, Flu and RSV
The U.S. Food and Drug Administration authorized the first at-home test that can identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B, respiratory syncytial virus and SARS-CoV-2, the virus that causes COVID-19.
“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 Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a written statement.
Labcorp developed the Seasonal Respiratory Virus RT-PCR DTC Test, which allows an individual to self-collect a nasal swab sample at home and send it out to Labcorp for testing. The results are then delivered through an online portal, with a follow-up from a health care provider for positive or invalid test results.
On the Labcorp website, the developers claim the sensitivity of their PCR test is not impacted by the many known COVID-19 variants, and they advise that the test kits cost $169 but can be covered by insurance for those eligible.
The home sample collection kit from Labcorp can be purchased online or in stores and can be self-collected by those 18 years and older, or by those 14 years and older with adult supervision, or through adult assistance for those 2 years and older.
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