The FDA authorized Labcorp’s seasonal respiratory virus RT-PCR DTC test for use without a prescription.
Individuals with symptoms of respiratory viral infection consistent with COVID-19 can use the seasonal respiratory virus test that can identify and differentiate multiple respiratory viruses at the same time, which marks the first direct-to-consumer, multi-analyte COVID-19 test authorized by FDA.
Users can self-collect a nasal swab sample at home and send it to Labcorp for testing. It can identify and differentiate influenza A and B (the flu), respiratory syncytial virus (RSV) and SARS-CoV-2, the virus causing COVID-19. Results are delivered through an online portal, with healthcare provider follow-up for positive or invalid test results.
Samples can be self-collected by individuals 18 years and older on their own, by those 14 and older with adult supervision, or with adult assistance for individuals aged two years and older.
“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,” FDA CDRH Director Dr. Jeff Shuren said in an FDA release. “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.”