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The FDA emergency use authorization allows the nonprescription test to use at-home sample collection with testing performed in a laboratory.
FDA okayed the first direct-to-consumer multi-analyte COVID-19 test that can detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) simultaneously.
The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test is available without a prescription, so people can self-collect a nasal swab sample at home and then send the sample to Labcorp for testing, FDA said in a news release.
Results are delivered through an online portal, with follow up from a healthcare provider for positive or invalid test results.
“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 Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
“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.
The home sample collection kit can be purchased online or in a store.
“This will enable consumers to more easily determine whether they may be infected with COVID-19, flu, or RSV, which can aid in determining if self-isolation (quarantine) is appropriate and to assist with healthcare decisions after discussion with a healthcare professional,” the FDA said.