The FDA Announced Emergency Approval of the First Covid-19 Self-Test That Can Be Done Fully at Home

It provides results in 30 minutes.
The FDA Announced Emergency Approval of the First Covid-19 Self-Test That Can Be Done Fully at Home
Image credit: Reuters/Brendan McDermid via BI

Grow Your Business, Not Your Inbox

Stay informed and join our daily newsletter now!
2 min read
This story originally appeared on Business Insider

The US Food and Drug Administration (FDA) on Tuesday approved the first at-home COVID-19 test kit for emergency use.

The COVID-19 All-In-One Test Kit, made by biotech company Lucira Health, is the first nasal swab test that can be fully self-administered at home, and it provides results in 30 minutes or less, according to a statement from the government agency.

Once the patient has done the nasal swab, it is then stirred into a vial and placed in a test unit. Within minutes, lights indicate whether the individual is positive, negative, or needs to repeat the test.

Related: The New Pfizer Vaccine Needs Plenty of Cold Storage, but Will There Be Enough Dry Ice?

The single-use test has been approved for people over the age of 14 where their provider suspects they may have coronavirus, the FDA said. It was authorized for prescription use only. 

The kit can also be used in hospitals, urgent care centers, and emergency rooms, but patients under 14 years should have their sample collected by a healthcare provider, the FDA said.

Stephen M. Hahn, FDA commissioner, said in the statement: "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."

The FDA didn't say how much the test would cost, Lucira Health's website says the test is "intended to cost less than $50."

Business Insider has contacted Lucira for comment.

More than 11.4 million people in the US have been infected with coronavirus and more than 248,000 people have died from it, according to the COVID-19 tracker. 

The US has more cases than any other country, and is currently being hit by a third wave of infections.

More from Entrepreneur

Get heaping discounts to books you love delivered straight to your inbox. We’ll feature a different book each week and share exclusive deals you won’t find anywhere else.
Amplify your business knowledge and reach your full entrepreneurial potential with Entrepreneur Insider’s exclusive benefits. For just $5 per month, get access to premium content, webinars, an ad-free experience, and more! Plus, enjoy a FREE 1-year Entrepreneur magazine subscription.
Discover a better way to hire freelancers. From business to marketing, sales, finance, design, technology, and more, we have the freelancers you need to tackle your most important work and projects, on-demand.

Latest on Entrepreneur