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May 17, 2022

FDA approves first non-prescription test for Covid-19, flu and RSV

Individuals can self-collect a nasal swab sample at home and send it to the company Labcorp for analysis.

The US Food and Drug Administration (FDA) has approved the first non-prescription test that identifies the respiratory viral infections Covid-19, influenza and respiratory syncytial virus (RSV).

The regulatory approval will enable individuals exhibiting Covid-19 symptoms to buy the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test without a prescription.

Users can then self-collect a nasal swab sample at home and send it to the company Labcorp for analysis. Results will be delivered through an online portal.

According to the FDA statement, the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test can detect influenza A and B, RSV and SARS-CoV-2, which is the virus that causes Covid-19.

FDA Center for Devices and Radiological Health director Jeff Shuren said: “While the FDA has now authorised many Covid-19 tests without a prescription, this is the first test authorised 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.

“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.”

Users can purchase the test online or from a store.

The test can be used by individuals 14 years and older, as well as adults, although they are advised to self-collect swabs under adult supervision.

For individuals two years and older, adult assistance is required.

Recently, the FDA also granted emergency use authorisation (EUA) for Cepheid’s Xpert Xpress CoV-2 plus test.

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