As COVID-19 cases rise among U.S. children, many parents have discovered that, because many COVID-19 testing sites won't perform tests on kids, actually getting a child tested for the virus isn't easy. But an at-home COVID-19 test recently approved by the federal Food and Drug Administration (FDA) is likely to help reduce that obstacle. According to the agency, the Ellume COVID-19 Home Test is an FDA-approved at-home COVID test kids can take.
The FDA announced Tuesday it had granted emergency use authorization to the Ellume COVID-19 Home Test, the first at-home COVID-19 diagnostic test to not require a prescription. The over-the-counter test was described by the FDA as being a "rapid, lateral flow antigen test," meaning it detects protein fragments from the COVID-19 virus via a nasal swab sample. But perhaps the best part for parents is that the test can be done on anyone 2 years old or older.
"Today’s authorization is a major milestone in diagnostic testing for COVID-19," FDA Commissioner Dr. Stephen M. Hahn said in a statement released by the agency. "By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes."
Hahn further characterized the FDA's approval of the Ellume COVID-19 Home Test as an effort to expand access to testing while also reducing the strain on laboratory testing resources. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes," Hahn said.
The FDA's efforts to expand access to COVID-19 testing, especially for children, come as more than 1.6 million children have been diagnosed with the virus in the United States, according to data from the American Academy of Pediatrics and the Children’s Hospital Association. While cases of severe COVID-19 illness remain rare among children, cases have continued to rise among children in recent months, proving they're not completely immune to the virus.
According to the FDA, users of the Ellume COVID-19 Home Test will have their results delivered to them via a smartphone app in as little as 20 minutes. Users are required to submit their zip code and date of birth when using the app to retrieve test results but are not required to give their name or email address.
Now that they've gained FDA approval, Elume is expected to produce more than 3 million tests in January of 2021. A spokesperson for Ellume told the Associated Press the at-home COVID test would cost somewhere around $30 and would be available for sale both online and at pharmacies.
While the Ellume COVID-19 Home Test is the first fully at-home diagnostic test to be approved by the FDA for use without a prescription, it isn't the first at-home COVID-19 test to be approved by the federal agency. In November, the FDA approved the Lucira COVID-19 All-In-One Test Kit. However, that test not only required a prescription but can not be used at home on children under the age of 14.
With the FDA's recent approval of the Ellume COVID-19 Home Test, however, parents of young children will be able to test their child for the novel coronavirus in a familiar, and perhaps more comfortable setting: home.
If you think you’re showing symptoms of coronavirus, which include fever, shortness of breath, and cough, call your doctor before going to get tested. If you’re anxious about the virus’s spread in your community, visit the CDC for up-to-date information and resources, or seek out mental health support. You can find all of Romper’s parents + coronavirus coverage here.