The pharma maker will initially produce 150 million of the 5-minute tests.
Immediately after the FDA approved the first 5-minute COVID-19 test that allows results to be read directly from a testing card, the White House said it would work with Abbott Laboratories to make 150 million tests available.
The agency issued an emergency use authorization for the first antigen test with that design, which is similar design to some pregnancy tests. The test, BinaxNow COVID-19 Ag Card, is fast and efficient for healthcare providers and patients and does not need the use of an analyzer, FDA said in a press release.
“This means people will know if they have the virus in almost real-time. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
On August 27, the White House announced the $760 million deal with Abbott to produce 150 million tests, The Washington Post reported.
Abbott said in a post on its web site that it would ship “tens of millions of tests in September, ramping production to 50 million tests a month in October.”
“This is a major development that will help our country to remain open, get Americans back to work, and kids back to school!” White House Press Secretary Kayleigh McEnany tweeted.
However, the government did not say where the tests will be distributed.
Here’s how the test works: a healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result.