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

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.