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


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

The regulatory approval will allow people with symptoms of Covid-19 to purchase the Labcorp Seasonal Respiratory Virus RT-PCR DTC test without a prescription.

Users can then collect a nasal swab sample themselves at home and send it to Labcorp for analysis. The results will be delivered via 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.

Director of the FDA Center for Devices and Radiological Health, Jeff Shuren, said: “While the FDA has now authorized many Covid-19 tests without a prescription, this is the first test authorized for influenza and RSV, 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 analysis, without consulting a medical professional.

“Rapid advances in consumer access to diagnostic testing, including the ability to collect your sample at home for influenza and RSV without a prescription, bring us one step closer to testing for these viruses that could be done entirely at home.”

Users can purchase the test online or in a store.

The test can be used by people aged 14 and over, as well as adults, although they are advised to collect swabs themselves under adult supervision.

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

Recently, the FDA also granted an Emergency Use Authorization (EUA) for Cepheid’s Xpert Xpress CoV-2 plus test.

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