FDA Authorizes Direct-to-Consumer Test to Detect COVID-19, Influenza, and RSV

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The Food and Drug Administration (FDA) has authorized for emergency use the Labcorp Seasonal Respiratory Virus RT-PCR direct-to-consumer (DTC) Test for use without a prescription by individuals 2 years of age and older with symptoms of respiratory viral infection consistent with COVID-19.

The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test can identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B, respiratory syncytial virus (RSV), and SARS-CoV-2. Sample collection is done using the Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit. The nasal swab specimen is then sent to Labcorp for testing. Results are delivered through an online portal, along with follow-up from a health care provider.

“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, MD, JD, director of FDA’s Center for Devices and Radiological Health.

The LabCorp Seasonal Respiratory Virus RT-PCR DTC Test can be purchased online or in a store. The fact sheet for health care providers can be found here.

Reference

Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test available without a prescription that also detects flu and RSV. News release. US Food and Drug Administration. Accessed May 16, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-available-without-prescription-also

This article originally appeared on MPR

Topics:

COVID19
Diagnostic Agents
Diagnostic Testing
Infectious Disease
Influenza
Respiratory Diseases/Disorders

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