The Ellume COVID-19 Home Test Is the First FDA-Approved Rapid Test That Doesn’t Need a Prescription
The Pfizer COVID-19 vaccine isn't the only exciting development in the efforts to alleviate the effects of the pandemic. On December 15, the Food & Drug Administration (FDA) issued another emergency use authorization—this time for the nation's first home COVID-19 test that doesn't require a lab or medical provider's prescription.
It comes following increasing pressure on the FDA to authorize home tests to ease the burden on health care providers and labs and to accelerate the entire process. Throughout the pandemic, people taking tests have often faced long lines, slow turnaround times, and high costs. In August, The New York Times reported that many Americans were still having to wait several days for their COVID-19 test results, "effectively rendering those tests useless."
"Today's authorization is a major milestone in diagnostic testing for COVID-19. 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," FDA Commissioner Stephen M. Hahn, MD, said 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."
How does the Ellume COVID-19 test work?
The Ellume COVID-19 Home Test is an antigen test, which means it detects specific proteins on the surface of the coronavirus. (The other type of COVID-19 diagnostic test is the PCR test, which detects the presence of the coronavirus's genetic material using a technique called reverse transcriptase polymerase chain reaction, or RT-PCR.) It's a Nasal mid-turbinate (NMT) test, which basically means it's less invasive than the (very long) Nasopharyngeal (NP) swab that's used when trained a health care provider administers a COVID-19 test.
According to the Ellume website, the test kit includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth® connected "Analyzer," which pairs with an app on your smartphone. Step-by-step video instructions for taking the test are provided on the app. After the sample is analyzed, results are delivered to the user's smartphone via Bluetooth in 15 minutes or less.
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 CDC, WHO, and their local public health department as resources.
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