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Sunday, October 2nd, 2022

FDA authorizes first non-prescription test for COVID-19, flu and RSV

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Broadening testing capabilities and achieving a long-term goal, the U.S. Food and Drug Administration (FDA) this week authorized the first COVID-19 test also capable of detecting flu and the respiratory syncytial virus (RSV) without requiring a prescription.

The multifunctional test, the Seasonal Respiratory RT-PCR DTC Test, was developed by Labcorp. It allows users to self-collect nasal swab samples at home, then send them to Labcorp for testing through one of the world’s largest clinical lab networks. Capable of identifying and differentiating between multiple respiratory viruses at the same time, it then delivers results through an online portal for ease of access.

“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,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said. “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.”

While this test will have a cost, it can be purchased online or in-store without authorization from a doctor needed. Anyone at least 18 years old can self-collect samples, while those at least 14 years old can do so with adult supervision. Adult assistance is required for individuals 2 years and older.

Follow-ups are recommended with physicians in the case of positive results.