NEW YORK — President Donald Trump on Monday announced the planned national distribution of 150 million of Abbott Laboratories' BinaxNow COVID-19 Ag Card, a low-cost, point-of-care SARS-CoV-2 antigen test that does not require an analyzer.
The $5 test, which received Emergency Use Authorization (EUA) from the US Food and Drug Administration in August, involves applying a nasal swab specimen directly onto a card that has been treated with a reagent. Test results can be read directly on the card within 15 minutes.
Speaking Monday afternoon from the White House Rose Garden, President Trump said that the government had purchased 150 million of the tests, which are being provided free of charge to states, territories, and organizations representing vulnerable populations over the coming weeks.
Specifically, 18 million tests will go to nursing homes, 15 million to assisted living facilities, 10 million to hospice care agencies. Nearly 1 million tests will be provided to historically black colleges and universities, as well as tribal nation colleges. The remaining 100 million tests will be given to US states and territories to support efforts to reopen economies and schools, the president said.
According to HHS Assistant Secretary for Health Brett Giroir, the US awarded Abbott a $760 million contract for the 150 million BinaxNow COVID-19 Ag Cards and awarded Puritan Medical Products a $120 million contract to provide the nasal swabs used with the test.
"We've already shipped 65,000 of these to disaster operations in California, Oregon, Texas, and Louisiana, and we have already shipped 2.1 million tests to 7,600 nursing homes, over 900,000 tests to assisted living, 300,000 tests to the Indian Health Service, and 339,000 tests to historically black colleges and universities," Giroir said during the news conference. "Today, we start the shipment of 100 million tests to governors, beginning with a total of 6.5 million tests … to be shipped this week."
He added that allocation of the tests to states and territories will be based on population size and that governors will oversee distribution within their regions. "We strongly encourage governors to utilize them in settings that are uniquely in need of rapid, low-tech, point-of- care tests, like opening and keeping open our K-through-12 schools; supporting critical infrastructure and first responders; responding to outbreak, specifically in certain demographics or locations; and screening of surveillance in congregate settings," Giroir said.
The rollout of Abbott's test marks the latest move by the federal government to make SARS-CoV-2 tests more widely available in the US. In late August, the US Department of Health and Human Services said it used the Defense Production Act (DPA) to accelerate the acquisition and supply of SARS-CoV-2 rapid antigen tests from Becton Dickinson and Quidel to nursing homes throughout the country. Meanwhile, the FDA has granted EUAs for over 250 different SARS-CoV-2 tests including at least 205 molecular diagnostics and 48 antibody tests, and four antigen tests.
Giroir said that the US has performed over 111 million SARS-CoV-2 tests to date and is now averaging about 920,000 tests per day.
President Trump said that he has invoked the DPA and related authorities more than 100 times and the federal government has distributed $171 million to expand testing production. "And by the end of next month, we will have over 100 million tests available in the market," more than half of which will be for point-of-care use, he added.