Where to Buy FDA-Authorized Ellume At-home COVID Test and How Much It Costs
On Tuesday, the Food and Drug Administration (FDA) authorized the use of a first-of-its-kind "fully at-home" COVID-19 test kit.
The diagnostic kit, produced by Australian diagnostics company Ellume, is the first coronavirus test in the U.S. that can be operated entirely by the user at home and bought over-the-counter-without a prescription.
The company said in a statement it is "rapidly expanding" its manufacturing efforts and is expecting to ship over 100,000 tests per day from January. It plans to deliver 20 million of the home test kits to the U.S. within the first half of 2021.
They will be available to buy in the U.S. from pharmacies, drug stores and online sites, NBC News reported. The test kit is expected to cost around $30 or less.
According to the FDA, the test kits correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms. In people without symptoms, accuracy was slightly lower, with the tests correctly identifying 91 percent of positive samples and 96 percent of negative samples.
Just like other antigen tests, which provide faster results but are less sensitive than the gold-standard PCR tests, the Ellume kits provide incorrect positive and negative results in small proportion of cases, the FDA said.
As a result, the agency said that people without symptoms who test positive should consider themselves infected and self-isolate, taking another test as soon as possible to confirm the result. In addition, individuals who test negative but experience COVID-like symptoms should "follow up with their health care provider."
How does the at-home COVID test work?
The diagnostic kit is a type of antigen test that detects fragments of proteins from the coronavirus that causes COVID-19 in individuals aged two years and older. Antigens are substances that stimulate an immune response in the body.
Users of the test take a nasal swab, which is then placed into an analyzer that connects to a smartphone through Bluetooth. By using an integrated smartphone app, individuals can view their results, which can be ready in as little as 20 minutes.
The app requires users to enter only their zip code and date of birth, while individuals also have the option to type in their name and email address. Results will be reported to public health authorities when appropriate in order to help track the spread of COVID-19.
Results can also be shared with health care professionals so that users can receive the appropriate treatment where necessary.
FDA Commissioner Stephen Hahn said in a statement on Tuesday: "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."
"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."
Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement: "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."
