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

The Meals and Drug Administration (FDA) has licensed for emergency use the Labcorp Seasonal Respiratory Virus RT-PCR direct-to-consumer (DTC) Take a look at to be used and not using a prescription by people 2 years of age and older with signs of respiratory viral an infection in keeping with COVID-19.

The Labcorp Seasonal Respiratory Virus RT-PCR DTC Take a look at can establish and differentiate a number of respiratory viruses on the similar time, detecting influenza A and B, respiratory syncytial virus (RSV), and SARS-CoV-2. Pattern assortment is completed utilizing the Pixel by Labcorp COVID-19+Flu+RSV Take a look at Dwelling Assortment Equipment. The nasal swab specimen is then despatched to Labcorp for testing. Outcomes are delivered via a web based portal, together with follow-up from a well being care supplier.

“Whereas the FDA has now licensed many COVID-19 assessments and not using a prescription, that is the primary check licensed for flu and RSV, together with COVID-19, the place a person can self-identify their want for a check, order it, accumulate their pattern and ship it to the lab for testing, with out consulting a well being care skilled,” stated Jeff Shuren, MD, JD, director of FDA’s Heart for Gadgets and Radiological Well being.

Proceed Studying

The LabCorp Seasonal Respiratory Virus RT-PCR DTC Take a look at may be bought on-line or in a retailer. The very fact sheet for well being care suppliers may be discovered right here.

Reference

Coronavirus (COVID-19) replace: FDA authorizes first COVID-19 check out there and not using a prescription that additionally detects flu and RSV. Information launch. US Meals and Drug Administration. Accessed Might 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 text initially appeared on MPR