FDA Authorizes COVID-19 Test That Also Detects Influenza, RSV

The Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription for people with symptoms of respiratory viral infection consistent with COVID-19. This product is the first direct-to-consumer multi-analyte COVID-19 test authorized by FDA.

This is a non-prescription test that people can 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 at the same time, detecting influenza A and B, respiratory syncytial virus (RSV), along with SARS-CoV-2.

“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, said in a statement.

Test results are delivered through an online portal, with follow-up from a health care provider for positive or invalid test results. This home sample collection kit can be purchased online or in a store.

The samples can be self-collected by individuals ages 18 years and older, self-collected by individuals 14 years and older with adult supervision, or collected with adult assistance for individuals 2 years and older.

“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 said.