On Monday, members of the White House COVID-19 Response Team announced a new partnership to boost production of the first at-home, rapid coronavirus tests authorized by the Food and Drug Administration, securing millions of those kits for the United States.

What You Need To Know

  • The U.S. will provide funding to boost the manufacturing of the first at-home, rapid coronavirus tests approved by the FDA

  • The Ellume test provides results in as little as 15 minutes, and it's completely over-the-counter

  • The new contract guarantees 8.5 million test kits for the U.S., with at least 100,000 set to ship by the end of February

  • The test is expected to cost around $30, but it's possible the price could drop as manufacturing ramps up, officials say

Officials said U.S. agencies have awarded more than $230 million to the Australia-based company Ellume, which makes the test kits, guaranteeing at least 8.5 million kits for the U.S. this year. 

The Ellume test provides results in as little as 15 minutes, and they’re expected to be available for purchase both online and in drugstores like CVS and Walgreens.

Ellume’s at-home test kits were first authorized by the FDA in December, but they’ve yet to reach drugstore shelves. A spokesperson for the company had told Spectrum News they hoped to supply 100,000 test kits per day in January

Each test kit is expected to cost about $30, according to Ellume’s original estimate. On Monday, Andy Slavitt, the senior adviser for the White House COVID Response, wouldn’t say whether the new U.S. contract with Ellume would help reduce the cost for Americans, but he said the first step is to boost production.

"The unit costs will come down only when we can get to that mass production and scale," Slavitt said. "There’s a chicken and egg problem that I think we have taken a step to solve today by creating mass production."

The company has already agreed to begin shipping at least 100,000 test kits per month starting in February, but Slavitt said they hope to boost production quickly with the new funding.

"That's good, but it's obviously not where we will need to be," Slavitt said. "Thanks to this contract, they'll be able to scale their production to manufacture more than 19 million test kits per month by the end of this year, 8.5 million of which are guaranteed to the U.S. government."

The contract is a partnership between the Department of Defense and Department of Health and Human Services.

Ellume's test kit includes a nasal swab and a Bluetooth analyzer, which connects to an Ellume app that provides results. The test is completely over-the-counter and does not require a prescription, which has been a barrier to other at-home tests.

The Ellume test is also authorized for children as young as two years old, meaning it could be useful for parents who want to avoid taking young kids through long testing lines. 

In a clinical study, researchers found that the test is 95% accurate at detecting positive cases and 97% accurate at detecting negative cases.

Because the newly-approved at-home test is not 100% accurate, the Food and Drug Administration advised that people who get a positive result should treat themselves as contagious and follow up with another test to confirm.