FDA approves first COVID-19 test for at home use with quick results

Nov 18 2020, 7:43 am

You may soon be able to test for COVID-19 from the comfort of your home and get rapid results in just half an hour.

On Monday, the US Food and Drug Administration issued an emergency use authorization to the COVID-19 All-In-One Test Kit by California-based company Lucira Health, making it the first coronavirus diagnostic test that will be used for self-testing at home.

Jeff Shuren, the director of the FDA’s Centre for Devices and Radiological Health, said in a statement that an out-of-lab test has long been a major priority for the FDA and that it will work proactively with other test developers to make more at-home tests available.

“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,” said FDA Commissioner Stephen M. Hahn, in a statement.

Lucira’s test, which is currently authorized for prescription use only, works with self-collected nasal swabs that are then swirled in a vial, to then be placed in the test unit powered by two AA batteries.

In 30 minutes (or less), individuals will see the test unit light-up with either a positive or negative result. According to the company, the technology associated with the test has been in development for five years. It is comparable to some of the best molecular tests performed in clinical settings and complex labs.

Lucira Health at-home test

Lucira Health

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The test is available for those 14 and older, by prescription only, and will cost around $50.

It’ll start by being available to patients served by Sutter Health in Northern California and Cleveland Clinic Florida in Miami and Fort Lauderdale. It’s expected to roll out nationwide by early spring 2021, according to Lucira Health. 

“Being able to quickly determine if a person is infected or not has been a global problem,” said John Chou, a principal investigator on Lucira’s Community Testing Study that was submitted to the FDA, in a statement. The study enrolled more than 100 people from a broad range of ages and ethnicities suspected of having the virus, all of which were able to run the test successfully.

“We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic.”

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