The U.S. Government has awarded a $231 million contract to ramp up production of the first over-the-counter antigen COVID-19 test, according to the White House Coronavirus task force.
The test kits, which can be used at home and give results in as little as 20 minutes, according to the company’s data, was approved by the FDA for emergency use in mid-December.
On Monday, Andy Slavitt, a senior advisor to the White House on the COVID-19 response, said the Australia-based company Ellume, will be awarded $231 million to produce these kits. They would be made available, initially, for $30 each, he said.
When asked about the price and equity issues, Slavitt said this first step was to increase the amount of tests available, to hopefully be able to bring the cost down and increase accessibility.
The test uses a nasal swab, and can be used when a person has symptoms or not. The swab is put into a digital analyzer and results are sent to a user’s phone.
“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,” Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health said in Decemberwhen the FDA gave the test emergency use authorization.
The FDA admits there is a small percentage of positive and negative results from this test that may be false, as with other antigen tests. And they encourage anyone without symptoms who receives a positive test should act like they are presumptively positive until it is confirmed by another test.
The Ellume antigen test is one of three COVID-19 tests people can use themselves, and is the only one available without a doctor’s prescription.
Ellume said it would use the money from the U.S. contract to build a manufacturing plant in the U.S., according to the Associated Press, and plans to deliver 8.5 million tests for federal use.
