BURLINGTON – With COVID-19 cases again on the rise and flu still a threat, Labcorp has received emergency use authorization from the Food and Drug Administration for a new combination at-home test kit that targets not only COVID-19 but infleunza and a respiratory virus that is a threat to children.

The Burlington-based life science giant announced the FDA’s endorsement early Wednesday.

According to Labcorp, the kit “simultaneously detects COVID-19, influenza A/B and respiratory syncytial virus (RSV), a common but contagious respiratory virus often seen in children.”

The kit, known as Pixel, is available now through Labcorp’s online health platform known as Labcorp OnDemand. No prescription is required. It’s intended for use by individuals ages 2 and up, according to the company.

Depending upon a person’s insurance coverage there may be no upfront cost, Labcorp said.

Labcorp has been an industry leader in developing at-home test kits during the COVID-19 pandemic.

“Labcorp’s COVID-19 tests have been trusted by physicians and millions of people throughout the pandemic. This new at-home collection kit makes it easier for consumers to access testing for multiple respiratory viruses – COVID-19, the flu and RSV – that can present similar symptoms,” said Dr. Brian Caveney, chief medical officer and president of Labcorp Diagnostics, in a statement. “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.”

Here’s how the process works according to Labcorp:

  • “The Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit is shipped via FedEx Priority Overnight to an individual’s home. Once collected, the sample is returned to Labcorp via a prepaid return envelope.
  • “Test results are available through an individual’s Labcorp OnDemand account 1-2 days on average after Labcorp receives the completed collection kit.
  • “If a person tests positive, they will receive a call from a third-party physician network with detailed next steps and access to a free clinician consult.
  • “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.”

Labcorp notes that the FDA “has not been FDA cleared or approved and has been authorized by the FDA under an emergency use authorization only for the detection of nucleic acid from SARS-CoV-2, influenza A and/or influenza B, and RSV, not for any other viruses or pathogens” and is “only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency.”