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Child getting nasal swab at home

FDA authorizes nonprescription test for COVID, RSV, flu

May 16, 2022

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A new test can detect COVID-19, flu and respiratory syncytial virus (RSV) without a prescription.

The Food and Drug Administration (FDA) has authorized Labcorp’s Seasonal Respiratory Virus RT-PCT DTC Test that allows a consumer to collect a nasal swab sample at home and send it to Labcorp for testing. Results are delivered through an online portal, and a health care provider will follow up on positive or invalid results.

“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,” Jeff Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health, said in a press release.

The tests will be available for purchase online or in a store. Teens ages 14-17 years can collect their own sample with adult supervision. An adult should assist with sample collection for children ages 2 and older.

The authorization comes on the heels of a 76% spike in COVID-19 cases among children during the week ending May 12 compared to two weeks before, according to a report from the AAP and Children’s Hospital Association. Since the start of the pandemic, almost 13.2 million children have tested positive for COVID-19.

Flu activity also is on the rise nationwide at a time when it normally would be winding down, according to the Centers for Disease Control and Prevention. RSV also has seen atypical spikes during the COVID-19 pandemic, including one last summer. All three illnesses have overlapping symptoms.


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