In November, the Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for an at-home COVID-19 test that people could access in select states with a prescription. Now, a new at-home COVID-19 test has also been granted an EUA—no prescription needed. It’s called the Ellume COVID-19 Home Test, and it’s approved by the FDA to test people age two and up for a COVID-19 infection.
“This is a great step forward in the effort to bring non-prescription cheap, rapid at-home COVID tests to the market,” says infectious disease expert Amesh A. Adalja, M.D., senior scholar at the Johns Hopkins Center for Health Security. “I hope this is the first step in allowing more of these tests to flourish.”
The test, which was developed by Australian company Ellume, is already getting a ton of attention. But how does it work? And is it really accurate? Here’s everything we know so far.
How does the Ellume COVID-19 Home Test work?
The test uses rapid antigen testing technology to look for the presence of SARS-CoV-2, the novel coronavirus that causes COVID-19, in the sample.
The test kit includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on your smartphone, per the Ellume website. The app actually guides you through most of the testing process: It gives step-by-step instructions to perform the test using a self-collecting mid-turbinate swab, to be used in your nose. (With a mid-turbinate swab, the sample is taken further back than a typical nasal swab, but not as far back as nasopharyngeal swabs performed by trained professionals.) The test also comes with a child adapter to help you get an accurate sample from younger people.
The sample is then placed in the processing fluid and analyzed, and the results are sent to your phone through Bluetooth technology. You can even share your results with your doctor.
The fact that it can be done at home—and without a prescription—is a big perk, says Richard Watkins, M.D., an infectious disease physician and professor of medicine at the Northeast Ohio Medical University. “Many people are nervous about leaving the house to get tested, in the fear of getting infected,” he says. “An at-home test is very convenient.”
Does the Ellume COVID-19 Home Test deliver accurate results?
In a clinical trial of 198 people between the ages of two and 82, Ellume’s test detected 96% of the positive coronavirus infections found by P.C.R. testing in people who had symptoms, which is considered the gold standard of testing. It also correctly identified 100% of negative test results in symptomatic people.
It was only slightly less accurate for people who had no symptoms, correctly identifying 91% of the positive cases and 96% of the negative cases from P.C.R. testing.
How long does it take to get results?
Ellume promises results in as little as 15 minutes, although the FDA says it can take up to 20 minutes to get a reading.
How much does the Ellume COVID-19 Home Test cost?
A spokesperson for Ellume confirmed to Prevention that it will cost $30 or less, as it is similar to an average copay at a doctor’s office.
Some experts see the price as a deterrent. “To have a major impact on the pandemic, these tests must be cheaper so they can be used on a frequent basis,” says Dr. Adalja.
While the lack of a prescription makes it easier to access, Dr. Watkins adds that also means insurance companies will likely not cover it.
Where can I buy an Ellume COVID-19 Home Test?
As of this moment, you can’t—but that will change quickly. Ellume has ramped up manufacturing efforts and plans to ship more than 100,000 tests a day, starting next month. Production has already started, a spokesperson confirmed, and the company “will ship the first COVID-19 Home Tests to the U.S. in the first week of January.” The company also says online that it plans to make and deliver 20 million tests to the U.S. within the first half of 2021.
Ellume is hoping to have the tests available in pharmacies, drugstores, and online, and “are in advanced discussions regarding nationwide retail commercialization,” a spokesperson confirmed.
When should you use the Ellume COVID-19 Home Test?
Each kit comes with just one test, making it a little pricy for daily use. “Hopefully, people will use it to know their status when they are ill or when contemplating how to make activities safer,” says Dr. Adalja. Ideally, people would use this kind of test “before any activity,” he says, “but with the cost being relatively high” it’s likely better to use it “before contacts with high-risk individuals,” such as the elderly or immunocompromised.
Bottom line: Experts think this at-home COVID-19 test is promising.
Easier and faster access to testing is a step in the right direction, Dr. Watkins says. “The more people who know they are infected and quarantine, the better it will be for slowing the spread.”
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