FDA Authorizes the First COVID-19 At-Home Test: What You Need to Know

The Food and Drug Administration (FDA) granted an emergency use authorization this week for the first self-administered at-home test kit for COVID-19.

The $50 test, which is called the Lucira COVID-19 All-In-One Test Kit, is designed to detect the presence of SARS-CoV-2, the virus that causes COVID-19. It’s available for home use for people 14 and older through a prescription, according to the FDA

"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," FDA Commissioner Stephen Hahn, MD, said in a statement “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

He added, “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

How It Works

The rapid test uses a molecular amplification technology, which searches for signs of the genetic material of SARS-CoV-2 in people who are suspected of having the virus. It can give results in just 30 minutes, per the FDA.

To use it, a patient will take a swab of the inside of their nose. That sample is then swirled in a vial that’s placed in the test unit. The results can be read directly from the unit’s light-up display that clearly says whether the person is positive or negative for COVID-19.

According to Lucira Health, which makes the test kit, the company’s research has shown that 100% of users aged 14 and up were able to use and administer the kit.

How Accurate Is the Test?

The test has comparable accuracy to rapid tests. Lucira says that, when compared to an FDA-authorized sensitivity test for SARS-CoV-2, Lucira had a 94% positive percent agreement and a 98% negative percent agreement. And, when samples were excluded that had very low levels of the virus that could indicate that there was no longer an active infection, Lucira had a 100% positive percent agreement.

he FDA does stress that people who test negative but are still experiencing symptoms of COVID-19 should follow up with their healthcare provider “as negative results do not preclude an individual from SARS-CoV-2 infection.”

What Experts Think

“We have been waiting for this,” Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo, tells Verywell. “It’s fantastic.”

Richard Watkins, MD, an infectious disease physician in Akron, Ohio, and a professor of internal medicine at the Northeast Ohio Medical University, agrees. “It is good news because there is still a critical need for more testing in the United States,” he tells Verywell. “Testing is a key component for controlling the pandemic.”

Amesh A. Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security, tells Verywell that this is a “good first step forward.” But, he says, it’s not perfect. “It’s still an expensive test that requires a prescription,” he says.

The prescription requirement “could diminish availability” to the general public who may not want to go through the steps of contacting their doctor and picking up a prescription before being tested, Russo says.

He also has concerns that the test could cause false confidence in people. “The test is good for a single point in time,” he says. “But no test is perfect, and what you do afterward matters, too.”

Given that the test isn’t cheap, Adalja says it may be best used in areas like nursing homes where rapid results are needed. It also may gain popularity for at-home use by the general public but, he points out, the cost can be a deterrent to regular use. But Watkins says it may simply be a good option for people to use once in a while. “It could give some reassurance to people traveling or visiting others for the upcoming holidays,” he says.

The Lucira Test Kit is expected to be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, soon By early spring 2021, the company expects it to be available nationally through healthcare providers.

Adalja stresses that, while this is a good option to have, testing in the U.S. still needs to change. “This is a first step to more access to testing, but the technology has to become cheaper and simpler,” he says. “Overall, though, it signals that the paradigm is changing.”