At-Home COVID Test Approved by the FDA

The US Food and Drug Administration (FDA) last night granted emergency use authorization (EUA) for an at-home, self-administered test for coronavirus disease 2019 (COVID-19) that will deliver results in 30 minutes.

FDA Commissioner Stephen M. Hahn, MD, said in a press release that “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.”

Lucira Health developed the molecular single use test kit, which is currently available only by prescription. It arrives as the United States confronts a surge of COVID cases that’s increasing hospitalizations and deaths throughout the country. There have been more than 100,000 confirmed cases of COVID-19 each day for the last 2 weeks in the United States, according to Johns Hopkins University. Just yesterday, the country recorded 161,934 cases of COVID-19 with 1707 people dying from the disease. There have been over 11.4 million confirmed cases of COVID-19 in the United States since the pandemic began, and over 248,000 have died from the novel coronavirus.

The at-home test given EUA approval by the FDA—the Lucira COVID-19 All-In-One Test Kit test—provides nasal swabs that can be used for people 14 years old and older who their healthcare provider suspects of having COVID-19. The tests will also be available at hospitals, urgent care centers, doctor’s offices, and emergency rooms.

The test involves collecting a nasal sample and then putting it into a vial. Within 30 minutes or less, a light-up display will show whether the person has tested positive or negative for SARS-CoV-2. Those who test positive should get advice from their healthcare provider, self-isolate.

Jeff Shuren, MD, JD, the director of FDA’s Center for Devices and Radiological Health, said in the press release that the EUA represents “a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them. We look forward to proactively working with test developers to support the availability of more at-home test options.”