At-Home Test for the Flu, RSV, and SARS-CoV-2 Authorized

The U.S. Food and Drug Administration (FDA) announced today it authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19.

This product is the first direct-to-consumer (non-prescription) multi-analyte COVID-19 test enabling an individual to self-collect a nasal swab sample at home and then send that sample to Labcorp for testing.

The test can identify and differentiate multiple respiratory viruses simultaneously, detecting influenza A and B, respiratory syncytial virus (RSV), and the SARS-CoV-2 coronavirus.

Test results are delivered through an online portal, with follow-up from a health care provider for positive or invalid test results.

“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, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, in the press release issued on May 19, 2022.

“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.”

This home sample collection kit can be purchased online or in a store without a prescription.

As of May 13, 2022, about 876 million SARS-CoV-2 tests have been reported to the U.S. CDC during the pandemic.

Note: The FDA announcement was manually curated for mobile readership.