FDA Authorizes First PCR Test Available Without a Prescription for COVID-19, Flu, RSV

FDA Authorizes First PCR Test Available Without a Prescription for COVID-19, Flu, RSV
Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)
Mimi Nguyen Ly

The U.S. Food and Drug Administration (FDA) has authorized a PCR test that can detect and differentiate between COVID-19, flu, and respiratory syncytial virus (RSV), symptoms of which can be similar, including cough, fever, and runny nose.

The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test can be obtained without a prescription and lets a person take a sample at home and send it to Labcorp for testing. Results are returned through an online portal, and a health care provider will follow up if the results are positive or invalid, the FDA stated in a release on May 16.

The test can enable people to tell what respiratory virus they have, which can help them decide “whether self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional,” the FDA said.

“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.

“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,” he said.

The sample collection kit can be bought online or in a store without a prescription, and can be collected by people aged 18 and over, or people aged 14 and older with adult supervision. Those aged 2 and older can also collect it with adult assistance.