FDA Authorizes a Rapid, At-Home COVID Test with Same-Day Results

The Food and Drug Administration has approved the first rapid at-home coronavirus test, which can give users results within the hour.

According to the agency, the Lucira COVID-19 All-In-One Test Kit can be obtained with a prescription for patients 14 or older, and will return results in about 30 minutes. The test can also be administered to patients of all ages at a "point-of-care (POC) setting," such as a hospital or clinic.

"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," FDA Commissioner Stephen M. Hahn, M.D., said in a statement.

The test is done by "swirling the self-collected sample swab in a vial that is then placed in the test unit." After 30 minutes or less, the results appear on the test unit's light-up display that indicates whether a person is positive or negative.

According to NBC, the testing kits — which cost $50 — will first be introduced in California and Florida "in the near future." They will be made available across the country in the spring of 2021.

On their website, Lucira Health states that the tests have a sensitivity (how well it detects positive cases) of about 94.1 percent and a specificity (how well it detects negative cases) of 98 percent.

"We look forward to proactively working with test developers to support the availability of more at-home test options,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, in a statement.

The authorization also comes as Pfizer Inc. recently announced that it submitted a request to the FDA for Emergency Use Authorization approval on their COVID-19 vaccine.

Earlier this month, the pharmaceutical company and its collaborator, BioNTech, announced that preliminary results from trials showed its potential vaccine was at least 90 percent effective. On Wednesday, Pfizer said after its phase three study, the vaccine has proven to be 95 percent effective with "no serious safety concerns observed" in the trial participants.

This could be good news as cases of the coronavirus are on the rise across the country, with experts warning of a third wave hitting around the holidays as people travel and cold weather forces people indoors.

On Tuesday, at least 159,508 new cases of the coronavirus and 1,583 new coronavirus-related deaths were reported in the U.S. As of Wednesday, more than 11,439,000 people in the U.S. have been infected and at least 248,400 have died, according to a New York Times database.

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