The FDA Just Approved the First Over-the-Counter COVID-19 Test—And It’ll Give You Results in 15 Minutes

Ellume COVID-19 Home Test
Ellume COVID-19 Home Test

What’s so special about the Ellume test?

The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 that allow for home collection of samples. Last month, the FDA authorized the first prescription COVID-19 test for home use (the Lucira COVID-19 All-In-One Test Kit) in people ages 14 and older who are suspected of having COVID-19. The Lucira test process happens entirely at home, from sample collection to receiving the results. Previously FDA-approved COVID-19 tests allowed at-home sample collection, but still had to be shipped to a lab for processing.

However, the Lucira test requires a doctor's prescription, while the Ellume test doesn't. Additionally, the Ellume test is authorized for anybody ages 2 and older, including those who aren't displaying any symptoms of COVID-19.

How accurate are the results of the Ellume test?

Pretty accurate—the test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms, says the FDA. And in people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.

According to a small study by Stanford Medicine, published July in the Journal of the American Medical Association, at-home test kits are just as accurate as those administered by medical professionals.

Like other antigen tests, a small percentage of results—both positive and negative—from the Ellume test may be false. With that in mind, the FDA recommends that patients who are not displaying COVID-19 symptoms treat positive results as "presumptively positive until confirmed by another test as soon as possible." This is likely to be particularly relevant if there are fewer infections in your community, because false positive results can be more common when antigen tests are used in populations where there is low prevalence of COVID-19.

How and when can I get an Ellume test?

Either online or from a drug store or pharmacy, says NBC News. Availability will be limited initially, but Ellume says it plans to manufacture and deliver about 20 million home COVID-19 tests to the US within the first half of 2021. Bella Zabinofsky, a spokesperson for Ellume, told The New York Times that each kit is expected to cost about $30 or less.

What should I do if I test positive?

Self-isolate immediately, and ask your doctor for further advice. If you test negative but have symptoms of COVID-19—commonly fever or chills, cough, difficulty breathing, headache, and new loss of taste or smell, per the Centers for Disease Control and Prevention (CDC)—you should still follow up with your doctor, possibly for another test performed by a medical professional, because it could be a false negative result.

The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDCWHO, and their local public health department as resources.

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