rapid test

At Last, the FDA Has Approved an at-Home Rapid COVID Test

Photo: Pat Greenhouse/Boston Globe via Getty Images

The ability to test oneself for COVID-19 without needing to send the results out to a lab isn’t far off. On Tuesday, the Food and Drug Administration issued an emergency-use authorization to approve the first completely at-home COVID test, which will soon be available by prescription for people age 14 and older.

The test kit, produced by California-based company Lucira Health, is done with a nasal swab in both nostrils that’s then submerged in a vial of chemicals, which is inserted into a reader for processing, according to the New York Times. Results are ready in about 30 minutes on a light-up display. According to Lucira’s website, the kit will cost $50 or less. While other kits that allow people to self-administer a swab before sending it out to a lab for analysis have already received FDA authorization, this is the first test that does not require any outside intervention.

The FDA’s director of the Center for Devices and Radiological Health, Jeff Shuren, said in a statement, “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.” Anyone who tests positive for a test using an at-home kit should notify their health-care provider of the results and isolate.

Like all rapid tests, Lucira’s product is faster than the PCR-based test that requires lab analysis, but it is generally believed to be less accurate. Lucira’s kit instructions say that its study correctly detected 98 percent of individuals not infected with COVID, as well as 94 percent of infections that a PCR test identified. Some scientists have expressed reservations about at-home tests in the past, saying they’re not as good at detecting low-level infections. Notably, Lucira’s at-home test has not been evaluated in asymptomatic people.

NPR reports that Lucira’s test will first be available in limited supply in Florida and California, with plans to expand access more widely by the spring.

At Last, the FDA Has Approved an at-Home Rapid COVID Test