FDA Grants EUA to Non-Prescription COVID-19 Test That Also Detects Flu, RSV

The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test is the first direct-to-consumer multi-analyte COVID-19 test to be authorized by FDA.

The FDA has granted an Emergency Use Authorization to the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, which is indicated for use without a prescription for individuals with symptoms of respiratory viral infection that are consistent with COVID-19.

The Seasonal Respiratory Virus test can simultaneously identify and differentiate between multiple respiratory viruses. In addition to SARS-CoV-2, the test can detect influenza A and B, as well respiratory syncytial virus (RSV).

The non-prescription test allows people to self-collect a nasal swab sample at home and then send that sample to Labcorp for testing. The results of the test are delivered via an online portal, with follow-up from a health care provider for a positive or invalid 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,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in a press release.

The home sample collection kit can be purchased online or in a store. The test enables consumers to more easily determine whether they are infected with COVID-19, the flu, or RSV. The results can help individuals to better determine whether they need to quarantine and make more informed decisions following consultation with a health care professional, according to the FDA.

The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test is the first direct-to-consumer multi-analyte COVID-19 test to be authorized by FDA.

“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,” Shuren added.

Reference

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV. FDA. News release. May 16, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-available-without-prescription-also