Dive Brief:
- HHS has allocated $300 million for the purchase of an additional 60 million Abbott BinaxNOW Ag Card rapid tests or "equivalent" point-of-care COVID-19 testing technology, as the U.S. set a new daily record for the number of coronavirus-related deaths on Thursday.
- White House coronavirus testing czar Brett Giroir left open the possibility that HHS might buy POC antigen tests from Abbott rivals that similarly do not require lab-based instruments for testing samples, he said the 15-minute BinaxNOW diagnostic is a "very sophisticated test in a card-based form for only $5."
- Giroir also referenced antigen tests from other manufacturers including Australia's Ellume, which received an emergency use authorization for the first COVID-19 diagnostic test that can be purchased over the counter and fully performed at home without a prescription. FDA in December also issued an EUA for Abbott's antigen-based BinaxNOW COVID-19 Ag Card Home Test, but it requires a prescription.
Dive Insight:
The purchase of an additional 60 million point-of-care tests is an attempt by the outgoing Trump administration to help bolster the nation's COVID-19 testing capacity.
HHS bought 150 million of Abbott's COVID-19 point-of-care antigen tests under a $760 million contract awarded to the medtech giant in August, a day after it was granted an FDA emergency use authorization. Giroir on Thursday said all of those tests have been distributed as of this week.
That order was followed in December with the purchase of an additional 30 million Abbott BinaxNOW Ag Card rapid tests for nursing homes, assisted living facilities, and other vulnerable groups. HHS last month said states, territories, and tribes would be able to buy those tests at a fixed price through an existing Federal Supply Schedule program.
"Very shortly, we are going to have a system in place that the governors can purchase these on the GSA Schedule over the internet for 5 bucks a test," Giroir said on Thursday.
However, FDA has warned that while antigen tests are "very specific for COVID-19" they are not as sensitive as molecular PCR tests.
"This means that there is a higher chance of false negatives than with many molecular tests. Positive results from antigen tests, while generally highly accurate, may be subject to false positive results especially in areas where there are fewer infections," according to FDA.
Giroir acknowledged that PCR tests are the most sensitive and that antigen tests "will not pick you up as positive when you have very low levels" of the virus. "You could be negative by BinaxNOW or negative by Ellume and positive by PCR," he said.
However, Giroir insisted that "there is no such thing as a perfect test."
"They're a different type of test. But for public health, for finding who's infectious, they work extraordinarily well and they will be the backbone of our system," he added.
Giroir said more than 94 million of Abbott's BinaxNOW Ag Card tests have so far been provided to governors and state public health officials. "We highly advised them to use [the tests] to support school openings," he added, noting that "data continues to show that schools are safe for children to attend" with "very little transmission" in K-12 education settings.
He also pointed to an October memorandum of understanding between HHS and The Rockefeller Foundation to provide 120,000 Abbott BinaxNOW Ag Card tests to pilot sites in Louisville, Los Angeles, New Orleans and Tulsa, Okla., with a focus on reopening K-12 schools.
HHS is also conducting pilots through the Children's Hospital of Philadelphia and Seattle Children's Hospital, including asymptomatic teachers and students on a weekly basis.
Asked on Thursday if he would be resigning like other administration officials in light of Wednesday's mob attack on the U.S. Capitol incited by President Donald Trump, Giroir said he will remain in his position until the Jan. 20 inauguration to ensure a "smooth, professional and seamless transition" to the incoming administration.
