Approved: First Fully At-Home OTC COVID-19 Test

The US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for the first fully at-home, over-the-counter (OTC) COVID-19 test.

This test is called the Ellume COVID-19 Home Test. The FDA approved it to detect the virus in both children and adults. In fact, this test can be used in children as young as 2 years old.

The test requires a nasal swab and can be fully done at home.

Since the start of the pandemic, the FDA has authorized more than 225 COVID-19 tests.

The EUA for the Ellume COVID-19 Home Test comes after the authorization of two other at-home COVID-19 tests:

• Last month, the Lucira COVID-19 All-In-One Test Kit test was granted an EUA. This at-home test can provide results at home (no need to send a sample to a lab); however, it requires a prescription.
• Last week, the FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit. This test does not need a prescription, but the test sample has to be sent to a lab for testing.

The Ellume test is the first that does not require a prescription and can be fully completed at home.

"By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Dr. Stephen M. Hahn in a press release. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes."

This test is an antigen test. That means there is a chance for false positives and false negatives. This type of test is not as sensitive or specific as the molecular tests that are run in a lab, the FDA noted.

However, the fact that this test can be done completely at home offers many Americans more testing options. The results are quick and can free up resources that are needed to combat the pandemic, the agency noted.

The FDA recommended the following:

• For a positive test result, even without symptoms, take the necessary precautions, such as self-isolation, and seek medical care from your health care provider. Take these precautions until the results can be confirmed by another test.
• For a negative test result (with symptoms), seek medical care from your health care provider.

How does the Ellume COVID-19 test work? Following the provided video instructions, the user will collect a nose sample using the provided nasal swab. The sample can then be analyzed using the Bluetooth-connected analyzer.

The analyzer then sends the results to a specific app on the user's smartphone via Bluetooth in as little as 15 minutes.

The test will ask you to enter your zip code and date of birth. This way, the test can provide results to public health authorities for virus monitoring.

Ellume expects to make more than 3 million tests next month.