May 18, 2022 – A new home test that detects COVID-19, influenza, and respiratory syncytial virus (RSV), just authorized by the FDA, will be available without a prescription.
"In early June, the kit will initially be available online via Labcorp OnDemand," says Jacob Rund, a spokesperson for the test maker, Labcorp.
Users can collect their own nasal sample at home and send it to Labcorp for testing and results. With adult supervision, it can be used on children as young as 2 years.
"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 the FDA's Center for Devices and Radiological Health.
According to the company, the new test detects known COVID-19 variants, including Delta and Omicron.
There is no upfront cost for the new test for those who meet clinical guidelines (such as having an exposure or having symptoms) and have insurance, Labcorp says. Those without insurance would pay $169 for the test.
Previously, Labcorp gained FDA authorization for a home use PCR-based test to detect COVID-19 and influenza A and B. It's available without upfront costs for insured people who meet the same clinical guidelines.
RSV is a common respiratory virus that usually causes mild cold-like symptoms, but it can become a serious infection in infants and older adults, the CDC says. It can lead to pneumonia and other lung issues.
The new test can offer other valuable information, says Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, NY, who reviewed details of the new option.
"In many clinical situations, it is very important to differentiate" the conditions, he says. "And it does offer significant advantages."
But, he says, the cost is significant.