- The Trump administration on Monday announced that 6.5 million Abbott BinaxNOW Ag Card rapid tests will be delivered to states this week to help governors reopen their economies and schools.
- Abbott's COVID-19 point-of-care antigen test, which costs $5 and delivers results in 15 minutes, was granted an FDA emergency use authorization on Aug. 26. A day later, HHS awarded Abbott a $760 million contract for 150 million of the tests to be deployed in 2020 to schools and vulnerable populations.
- The World Health Organization also on Monday announced that the Bill & Melinda Gates Foundation has executed separate agreements with Abbott and SD Biosensor to provide 120 million rapid antigen tests over a period of six months to low- and middle-income countries with an initial $50 million from the Global Fund.
The Trump administration has touted Abbott's BinaxNOW test as a quick, easy-to-use and inexpensive diagnostic that can increase the pace of U.S. COVID-19 testing at the point of care.
BD, Quidel and LumiraDx beat Abbott in getting FDA's nod for their antigen tests, all of which provide results in about 15 minutes. However, the Abbott test does not require instrumentation, unlike its competitors, and according to HHS was the only manufacturer with the capability to immediately scale up to meet the urgent need for testing across the country.
Assistant Secretary of Health Brett Giroir said the allocation to states will be based on population data. Trump said that of the total 150 million Abbott tests under the HHS contract, 100 million will ultimately go to states and territories.
Abbott's nasal swab test is not a home test but is authorized during the public health emergency for use by medical personnel or trained operators in certain non-clinical environments, such as schools, operating through a CLIA Certificate of Waiver, Giroir noted.
Giroir said that states have the flexibility to use the Abbott tests as they see fit "but 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-12 schools."
Trump said the remaining 50 million diagnostics will go to protect vulnerable populations, including 18 million for nursing homes, 15 million for assisted living facilities, 10 million for home health and hospice care agencies, as well as nearly 1 million for historically black and tribal nation colleges.
Abbott committed to shipping tens of millions of antigen tests in September and said it will produce 50 million of the diagnostics per month by the beginning of October.
Giroir said that as of Monday the U.S. has performed more than 111 million COVID-19 tests to date.
However, the country needs far more coronavirus testing according to a Sept. 9 report issued by the Rockefeller Foundation.
"A basic screening strategy will require approximately 200 million tests each month for students and staff at the nation’s primary and secondary schools and residents and staff at nursing homes for them to open safely and in stages," the organization wrote.
"But fewer than 25 million COVID-19 tests are now reported monthly in the United States. Even if infection rates decline, the testing needed in just schools and nursing homes exceeds the nation’s entire capacity now."