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FDA Issues First EUA for Non-Prescription COVID-19/Flu/RSV Test

NEW YORK – On Monday, The US Food and Drug Administration issued an Emergency Use Authorization to Laboratory Corporation of America's Seasonal Respiratory Virus RT-PCR DTC test for use without a prescription by individuals with symptoms of COVID-19.

The test can detect and differentiate between SARS-CoV-2, influenza A and B, and respiratory syncytial virus and is the first multianalyte direct-to-consumer test authorized by the FDA.

Users self-collect nasal swab samples and then send those samples to Labcorp for testing. The sample kit can be purchased online or in a store without a prescription.

"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," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "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."

The Scan

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