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U.S. strikes $230 million deal for over-the-counter Covid tests

"Making easier-to-use tests available to every American is a high priority with obvious benefits," White House Covid-19 adviser Andy Slavitt told reporters
Ellume's self-administered rapid coronavirus test.
Ellume's self-administered rapid coronavirus test.Ellume via AP

The Biden administration announced a $230 million deal to ramp up production of the country's first over-the-counter, at-home Covid-19 test.

"These are over-the-counter, self-performed test kits that can detect Covid with roughly 95 percent accuracy within 15 minutes," Andy Slavitt, the White House senior adviser for Covid-19 response, told reporters on Monday.

The Food and Drug Administration granted an emergency use authorization in December for Ellume's tests, which are expected to cost about $30 each.

"Ellume has been ramping up manufacturing and will ship 100,000 test kits per month to the U.S. from February through July," Slavitt said. "That’s good, but it’s obviously not where we will need to be."

Employees work on the production line of a Covid-19 coronavirus home test unit that has been granted an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA), at the production facility of Australian digital diagnostics company Ellume in Brisbane on Dec. 21, 2020.Patrick Hamilton / AFP - Getty Images file

The $230 million deal the departments of Defense and Health and Human Services struck with Ellume will allow the company "to scale the manufacturing base and capacity of this easy-to-use test," Slavitt said. "Thanks to this contract, they’ll be able to scale the production to manufacture over 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 test by Ellume, an Australian digital diagnostics company, does not require sending samples to a lab, is similar to how at-home pregnancy tests work, and is "appropriate for people ages 2 and older," Slavitt said.

He said the test uses a "mid-turbinate nasal swab," which is less invasive than the original deep nasal swabs used at the beginning of the outbreak.

The antigen test involves collecting a sample with a nasal swab that users then place into a Bluetooth-connected analyzer that syncs with a smartphone app.

"After you take the swab, you put the sample into a digital analyzer, which will send a result to your smartphone in about 15 minutes," Slavitt said.

He called the news "exciting," and said he hoped the price would come down when there are more tests in production.

"Making easier to use tests available to every American is a high priority with obvious benefits," Slavitt said.

The at-home test correctly identified 96 percent of positive samples and 100 percent of negative samples in people with symptoms of Covid-19, the FDA said. In people who are not symptomatic, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.

In a statement, the company said the deal "includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility," and that the factory would produce up to 500,000 tests a day. A spokeswoman for the company said the location is still being finalized.

The tests will be available over the counter in pharmacies, drug stores and online, the company told NBC News in an email last month.

Dr. Michael Mina, an epidemiologist at Harvard University and Brigham and Women's Hospital who has studied dozens of types of Covid-19 rapid tests, called the government's investment "a step forward in giving Americans access to at-home rapid testing," but said more needs to be done to turn the tide.

"In order for us to stop the spread of the virus, we need to scale cheap and simple paper-strip antigen tests that a majority of Americans can afford to use frequently," Mina told NBC News.

The Ellume test is one of three at-home tests hitting the market soon.