FDA Authorizes First OTC Covid-19 Test That Also Detects Flu, RSV

The FDA authorized an over-the-counter real-time polymerase chain reaction (RT-PCR) test that can identify not only SARS-CoV-2, the virus that causes Covid-19, but also influenza A and B and respiratory syncytial virus (RSV).

The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test is intended for use by individuals with symptoms of respiratory viral infection consistent with Covid-19 and is the first direct-to-consumer multi-analyte Covid-19 test authorized by FDA.

The test allows an individual to collect a nasal swab sample at home and then send that sample to Labcorp for testing. "Results are delivered through an online portal, with follow-up from a health care provider for positive or invalid test results," the FDA explained.

The test kit can be purchased online or in a store without a prescription. The samples can be self-collected by individuals age 18 and older, self-collected by individuals 14 and older with adult supervision, or collected with adult assistance for individuals 2 years and older.

This at-home self-sampling will let consumers more easily determine whether they might be infected with Covid-19, flu, or RSV. This, in turn, can help determine if self-isolation (quarantine) is appropriate and help with other health care decisions after discussion with a health care professional.

"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," Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, explained in a prepared statement.

"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," Shuren added.