The U.S. Food and Drug Administration has granted an emergency use authorization for the first non-prescription, over-the-counter COVID-19 test kit for at-home use.
The LabCorp Pixel COVID-19 Test Home Collection Kit allows anyone 18 and older to buy the kit and collect nasal swab samples at home, the FDA said in a news release Wednesday. The samples are then sent to a LabCorp facility for testing.
Positive or invalid results are delivered back to the consumer by phone or through a healthcare provider. Users will be notified by email or through an online portal if results are negative.
“While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing,” Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The kit can help individuals understand their COVID-19 status and make decisions about when self-isolation or quarantine may be necessary, the FDA said. It can also help with healthcare decisions after discussions with providers.
“With this authorization, we can help more people get tested, reduce the spread of the virus, and improve the health of our communities,” Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said in a statement.
The new kit is now available through the Pixel by LabCorp website and may soon be available in stores, the company said in a news release.
After buying the test, users register the kit on the website and follow the included instructions.
“Test results are securely delivered to the consumer via the Pixel by LabCorp portal,” LabCorp said. “A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions.”
The company emphasized in its news release that the new COVID-19 at-home testing kit is not a substitute for a doctor’s visit.
FIRST AT-HOME COVID-19 PRESCRIPTION TEST
Last month the FDA issued an EUA for the first self-test for COVID-19 that can provide rapid results at home, but the Lucira COVID-19 All-In-One Test Kit ,a molecular single-use test, is only available by prescription.
The rapid test uses a molecular amplification technology to detect the virus in people with known or suspected COVID-19 and can return results in 30 minutes, the FDA said.
A molecular COVID-19 test searches for signs of the coronavirus’ genetic material.
There are currently two types of diagnostic tests: molecular tests, such as RT-PCR tests, that look for the virus’s genetic material; and antigen tests that detect specific proteins from the virus.
At the time of the EUA for the Lucira test, FDA Commissioner Dr. Stephen Hahn called it a critical development.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn said.
Health and Human Services Secretary Alex Azar also said at the time the test was an important advancement.
“Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options,” Azar said in a statement.
But some health experts urged caution.
“The data is just still emerging,” Tom Bollyky, the director of the global health program and senior fellow for global health, economics, and development at the Council on Foreign Relations, told CNN. “Obviously, with some past emergency use authorizations it pays to be cautious with what the FDA has put out here, but it’s certainly a promising sign.”