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FDA approves first at-home test for COVID-19, flu, other respiratory viruses

FDA approves first at-home test for COVID-19, flu, other respiratory viruses
The Food and Drug Administration said Monday it has approved the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription. File Photo by Bill Greenblatt/UPI | License Photo

May 16 (UPI) -- The Food and Drug Administration on Monday approved a new at-home test for respiratory viral infections such as COVID-19 and influenza that can be used without a prescription.

The regulatory agency gave its approval to Labcorp's "Seasonal Respiratory Virus RT-PCR DTC" Test.

"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 Dr. Jeff Shuren, director of FDA's Center for Devices and Radiological Health.

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The home sample collection kit can be purchased online or in a store.

The sample is collected in the same manner as a rapid COVID-19 test using a nasal swab, which is then sent to Labcorp for testing.

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Test results are delivered through an online portal and can identify influenza A and B, respiratory syncytial virus or RSV, along with the novel coronavirus that causes COVID-19.

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The results will allow users to determine whether they need to self-isolate or contact their doctor.

"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," said Shuren.

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