FDA Grants EUA for At-home Triple Test: COVID-19, Influenza, RSV

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An at-home, multianalyte COVID-19 test that can also identify and differentiate influenza A and B and respiratory syncytial virus (RSV) has been granted emergency use authorization (EUA) by the US Food and Drug administration (FDA).

The Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit, the first direct-to-consumer test of its kind to be authorized by the FDA, can be purchased online or at retail, without a prescription, according to an FDA press release.

“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, MD, JD, director of FDA’s Center for Devices and Radiological Health in the press statement.

According to a Labcorp statement, the home collection kit is shipped to an individual’s home overnight via FedEx Priority and includes a prepaid return envelope for submitting the sample, self-collected using a nasal swab. The company notes that the kit can be used to collect samples from individuals as young as age 2 years. Labcorp uses polymerase chain reaction (PCR) testing for analysis.

The test results, Labcorp notes, can be accessed on average 1-2 days after the lab receives the test kit by using an online Labcorp OnDemand account.

All individuals whose test is positive will receive a call from a third-party physician network that will provide detailed next steps as well as access to a free clinician consult.

“With the spike in RSV cases over the last year, the continued presence of COVID-19, and the ever-present threat of flu, testing for all three viruses at once enables individuals and physicians to quickly identify the illness and determine the appropriate treatment,” said Dr. Brian Caveney, chief medical officer and president of Labcorp Diagnostics in the company statement.

“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,” said FDA’s Shuren.

Note: Clinical guidelines for receiving the kit at no upfront cost with insurance include experiencing symptoms, being exposed to someone with COVID-19, or receiving a request to get tested from a health care provider. This test is only intended for individuals experiencing flu-like symptoms.