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FDA Authorizes First COVID-19 Test That Also Detects Flu and RSV Without a Prescription
Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Laboratory Corporation of America (Labcorp) Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test.
The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test:
- Is the first COVID-19 direct-to-consumer (DTC) test that also detects and differentiates influenza A and B (flu), and Respiratory Syncytial Virus (RSV), allowing a person to self-collect a nasal sample in their home and then send the sample to Labcorp for testing, all without a prescription.
- Can be used for people with symptoms of respiratory viral infection consistent with COVID-19.
- Can be purchased online or in a store without a prescription.
The test can be used for people:
- Age 18 years and older with a self-collected nasal swab sample.
- Age 14 years and older with a self-collected nasal swab sample under adult supervision.
- Age 2 years and older when an adult collects the nasal swab sample.
Results are delivered through an online portal, with follow-up from a health care provider for positive or invalid test results.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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