The Food and Drug Administration (FDA) has authorized the first at-home COVID-19 test which reportedly takes just 15 to 20 minutes to give results.
Unlike another home test approved by the FDA last month, the over-the-counter Ellume COVID-19 Home Test does not require a doctor’s prescription and can be taken by anyone, even if they do not have symptoms of the virus. The test will cost about $30.
“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 said in a statement on Tuesday. “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.”
Initial supplies of the test will be limited, The Associated Press reported. “Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.”
“The kit includes a nasal swab, a chemical solution and a testing strip. The test connects digitally to a smart phone app that displays the results and then helps interpret them. Users can also connect with a health professional via the app,” the AP said.
The Ellume website says “through a secure cloud connection, the Ellume COVID-19 Home Test provides real time reporting of test results and critical data to health authorities, employers and educators, for efficient COVID-19 mapping.”
The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, but those need to be sent to a lab for testing. More tests are in development.
“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them. Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports,” said Dr. Jeff 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.”
The FDA warned, though, that “similar to other antigen tests, a small percentage of positive and negative results from this test may be false. Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible. This is especially true if there are fewer infections in a particular community, as false positive results can be more common when antigen tests are used in populations where there is little COVID-19 (low prevalence).”
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