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

Key TakeawaysThe FDA authorized the first at-home test kit for COVID-19.Results are available in as little as 30 minutes.Experts say it’s a good next step in expanding testing.

Key Takeaways

The FDA authorized the first at-home test kit for COVID-19.Results are available in as little as 30 minutes.Experts say it’s a good next step in expanding testing.

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

At-Home COVID-19 Test Comparable to Clinic Test, Study Finds

“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 CommissionerStephen 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.”

What This Means For YouYou can now test for COVID-19 at home. Lucira’s at-home test kit may not be widely available yet, but if you’re interested in taking it, contact your doctor about getting a prescription and next steps.

What This Means For You

You can now test for COVID-19 at home. Lucira’s at-home test kit may not be widely available yet, but if you’re interested in taking it, contact your doctor about getting a prescription and next steps.

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 toLucira 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.

Currently, there are two types of diagnostic tests: molecular tests, such as RT-PCR tests, that detect the virus’s genetic material, and antigen tests that detect specific proteins from the virus. This kit uses a molecular test, which is more reliable than antigen tests that “usually provide results diagnosing an active coronavirus infection faster than molecular tests, but have a higher chance of missing an active infection,” according to the FDA

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.”

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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.

COVID-19 and Your Health Insurance

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.”

COVID Home Tests: What You Need to Know

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.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.

6 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S. Food and Drug administration.Lucira COVID-19 all-in-one test kit.U.S. Food and Drug Administration.Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home.Lucira Health.Breaking news: Lucira Health receives 1st FDA authorization for COVID-19 self-testing at home.U.S. Food and Drug Administration.Coronavirus disease 2019 testing basics.U.S. Food and Drug Administration.Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home.Lucira Health.FDA authorizes first prescription at home molecular test for COVID-19.

6 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.U.S. Food and Drug administration.Lucira COVID-19 all-in-one test kit.U.S. Food and Drug Administration.Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home.Lucira Health.Breaking news: Lucira Health receives 1st FDA authorization for COVID-19 self-testing at home.U.S. Food and Drug Administration.Coronavirus disease 2019 testing basics.U.S. Food and Drug Administration.Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home.Lucira Health.FDA authorizes first prescription at home molecular test for COVID-19.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

U.S. Food and Drug administration.Lucira COVID-19 all-in-one test kit.U.S. Food and Drug Administration.Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home.Lucira Health.Breaking news: Lucira Health receives 1st FDA authorization for COVID-19 self-testing at home.U.S. Food and Drug Administration.Coronavirus disease 2019 testing basics.U.S. Food and Drug Administration.Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home.Lucira Health.FDA authorizes first prescription at home molecular test for COVID-19.

U.S. Food and Drug administration.Lucira COVID-19 all-in-one test kit.

U.S. Food and Drug Administration.Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home.

Lucira Health.Breaking news: Lucira Health receives 1st FDA authorization for COVID-19 self-testing at home.

U.S. Food and Drug Administration.Coronavirus disease 2019 testing basics.

Lucira Health.FDA authorizes first prescription at home molecular test for COVID-19.

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