The Biden administration on Monday struck a deal to secure 8.5 million rapid at-home COVID-19 tests, which will provide results within minutes. The test, manufactured by Australian company Ellume, is the first Food and Drug Administration–approved antigen test that can be used at home without a prescription and represents a significant development in the country’s broader pandemic response. For months, public-health experts have called for fast, accessible home testing, which would empower people to regularly screen themselves — regardless of whether they have symptoms — and isolate after a positive test.
Here’s what we know about this kind of testing and when you might be able to use it, as well as whether rapid at-home testing is expected to make a difference in curbing the pandemic.
What makes this test different?
While dozens of home-collection kits are currently on the market, they don’t provide immediate results: Users self-administering a swab must send their sample to a lab for processing, and results can take days. Those tests also haven’t been particularly accessible, CNN notes, costing about $100 or more. However, in December, Ellume became one of three fully at-home rapid COVID-19 tests authorized by the FDA, and the only one cleared for over-the-counter use (the other two tests, from BinaxNow and Lucira, require a prescription). Ellume’s test, which is expected to cost about $30, is similar to a home pregnancy test, if somewhat more high-tech: The user collects a sample with a nasal swab and then puts it into a digital analyzer linked to a smartphone app, through which results are delivered 15 minutes later, NPR reports. The test was granted emergency authorization after it showed 96 percent accuracy in a U.S. clinical study, the FDA said, and has been authorized for use on children as young as 2 years old.
One notable difference in Ellume’s technology is that the data can be made available to public-health officials. While other home-test developers were uncertain how capturing and reporting results would work if a lab wasn’t involved, Ellume’s smartphone app “automatically sends data by ZIP code to the cloud — ensuring that regional health officials can learn about positive results while keeping the data confidential,” according to the Washington Post.
What exactly did Biden order, and how many tests will be made available in the U.S. as a result?
Officials from the Department of Defense and the Department of Health and Human Services on Monday announced a $231.8 million agreement with Ellume to ramp up production of its at-home rapid test and create a manufacturing facility in the United States, the Post reports. According to Andy Slavitt, the White House senior adviser for COVID-19 response, Ellume is expected to produce 19 million tests per month by the end of the year, and 8.5 million of those tests have been guaranteed to the U.S. government under the new contract. “The purpose of today’s announcement is to move to mass production and scale,” Slavitt said Monday.
Starting this month, the U.S. will begin receiving batches of 100,000 tests. “That’s good but obviously not where we need to be,” Slavitt said. According to the Post, the deal struck with Ellume won’t increase the scale of expected manufacturing until the company’s U.S. production plant opens, and that isn’t set to happen until the fall. Until then, the availability of Ellume’s tests will be highly limited. Still, Slavitt noted that the agreement is an initial step toward lowering the cost of the test, which is currently too expensive for widespread use. “We know there are efforts to create even lower cost and more innovative approaches and we welcome those,” he said. The move is part of the president’s broader pandemic plan to step up rapid, accessible testing by scaling up testing capacity and investing in the development and production of at-home tests.
Will this make a difference?
Once cheap, quick test results are widely available, they could be a significant tool in combatting the pandemic. “These tests can be our backup. If we get people socialized to using these tests, we don’t have to find ourselves in this position again,” Harvard epidemiologist Michael Mina previously told Intelligencer. More test kits like Ellume’s are expected to be approved in the coming weeks, a development that could help curb viral transmission by giving people more options to confirm they have COVID-19 early on. “Almost all the infections happen from people who don’t know that they’re positive, and so what you need is a widespread testing program that helps people identify when they are infectious so they can stop infecting other people,” according to Brown University’s Ashish Jha.
However, rapid at-home testing presents its own set of issues, among them the potential for incorrect results. “The tradeoff for this simplicity is that these antigen tests have lower sensitivity than the nucleic acid tests, meaning there are more false negatives,” PBS points out. Still, cheap at-home antigen tests could be used as a daily supplement for the general public in addition to diagnostic testing for symptomatic people. “This would be something that you do on a day-to-day basis,” infectious disease expert Amesh Adalja told PBS. “You brush your teeth, test yourself, and then you go out the door.”