The FDA on Tuesday granted emergency authorization to the first at-home, self-testing coronavirus rapid result kit. The test, Lucira COVID-19 All-In-One Test Kit, is a molecular single-use test designed to detect SARS-CoV-2, which is the virus that causes COVID-19.
The kit, which is authorized for prescription use only, uses nasal swab detection and can produce the results in 30 minutes or less. The results are displayed on the unit’s light-up display and read either positive or negative, according to an FDA press release.
The test is authorized for at-home use in patients over 14 who are suspected of having COVID-19 by their health care provider. Patients under 14 can still be tested using the test, but it must be done so in a point-of-care location such as a doctor’s office or hospital.
Health care providers are required to report all test results they receive from individuals prescribed the test to public health authorities to help track and monitor cases.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic,” FDA Commissioner Dr. Stephen Hahn said. “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
In April, the agency granted authorization to LabCorp’s COVID-19 RT-PCR Test making it the first at-home diagnostic test with a home collection option for COVID-19, but the sample, once collected by the patient, then has to be mailed in a package to a lab for testing. Lucira’s product eliminates the need for the outside lab.
In Tuesday’s announcement, the FDA’s director of the center for devices and radiological health said a coronavirus test that could be fully administered outside of a lab was always a major priority for the agency. Dr. Jeff Shuren said Lucira’s kit will help the public take “immediate action” based on results to help protect themselves and those around them.
As of Wednesday, the U.S. had tallied more than 11.3 million cases of coronavirus and over 248,000 deaths.