FDA OKs First Over-the-Counter Home Test for COVID-19

TUESDAY, Dec. 15, 2020 (HealthDay News) -- The first non-prescription COVID-19 test that enables people to collect samples and get results at home has received emergency use authorization from the U.S. Food and Drug Administration.

"This is a great step forward," said Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, in Baltimore. "If people could know their status on any given day, they could change their behavior. I hope that this authorization is just the beginning and will lead to more at-home diagnostics for COVID and other infectious diseases."

Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results.

The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA.

The test uses an analyzer that connects with a smartphone app to help users perform the test and interpret results. Results are delivered by smartphone in as little as 20 minutes.

"Today's authorization is a major milestone in diagnostic testing for COVID-19," FDA Commissioner Dr. Stephen Hahn said in an FDA news release. "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."

As additional tests are authorized for home use, it will help reduce the burden on laboratories and test supplies, and give Americans more testing options from the comfort and safety of their own homes, Hahn said.

But the FDA emphasized that if you have symptoms, a negative test result doesn't necessarily mean you don't have COVID-19, and you still need to see a doctor.

Since the pandemic began, the FDA has authorized more than 225 tests for COVID-19, including more than 25 that allow people to collect samples at home and send them to a lab for analysis.

Last month, the FDA approved the first prescription COVID-19 test for home use and last week it approved the first over-the-counter home test, in which the sample is processed by a lab.

The Ellume COVID-19 Home Test is the first test for SARS-CoV-2 that can be carried out fully at home without a prescription.

According to Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, "This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic."

Because the new test may yield a small percentage of false positives or false negatives, people without symptoms should regard positive results as true until confirmed by another test as soon as possible.

This is especially important if there are fewer infections in a patient's community, because false positives can be more common when antigen tests are used in populations with low COVID-19 rates, according to the FDA.

People who get positive results should self-isolate and contact their health care provider. Those who test negative but have COVID-like symptoms should follow up with their health care provider as negative results don't necessarily mean a person isn't infected.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in people with symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.

Ellume expects to produce more than 3 million tests in January 2021, the FDA said.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19 testing.

SOURCES: Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore; U.S. Food and Drug Administration, news release, Dec. 15, 2020