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February 01, 2021
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US spends $230M on over-the-counter COVID-19 test kits

The U.S. government will spend $230 million to scale up manufacturing of the first over-the-counter COVID-19 test kit, which can provide results in 15 minutes and is authorized for people aged 2 years or older, a White House official said.

Perspective from Amesh A. Adalja, MD

The test kit, made by Australian-based manufacturer Ellume, was authorized for use in December by the FDA, which reported that it correctly identifies 96% of positive samples and 100% of negative samples in persons with COVID-19 symptoms. Results are reported via a cell phone.

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“Making easier to use tests available to every American is a high priority with obvious benefits,” Andy Slavitt, senior advisor to the White House COVID-19 Response Team, said during a press briefing on Monday.

Ellume was to ship 100,000 test kits per month to the U.S. from February through July. “That’s good, but it’s obviously not where we need to be,” Slavitt said.

The $230 million newly earmarked for Ellume will “scale the manufacturing base and capacity” to allow the company to produce more than 19 million test kits per month by the end of this year, Slavitt said. Of these, 8.5 million kits will be guaranteed to the U.S. government.

“The ability to quickly test to contact trace and quarantine is a linchpin of our national strategy and will be a vital part of maintaining the virus and stopping community spread,” Slavitt said.

The test, which costs around $30, uses mid-turbinate nasal swabs, which are less invasive than nasopharyngeal swabs used in a lot of testing. The swab is inserted into a digital analyzer that comes with the test kits, which transmits results via Bluetooth to an app on the user’s smartphone in roughly 15 minutes.