The federal government will release approximately 750,000 point-of-care COVID-19 tests from manufacturer Abbott to nursing homes next week in a separate, parallel initiative that builds on a previously announced push to bring coronavirus tests directly to facilities’ doors.
Initially positioned as a way to ramp up testing in schools, a Department of Health and Human Services (HHS) contract to secure Abbott BinaxNOW COVID-19 Ag Card tests will extend to nursing homes, assistant health secretary Brett Giroir said on a Tuesday evening call with industry leaders.
The initial distribution will target facilities in counties designated as “red” or “yellow” by the Centers for Medicare & Medicaid Services (CMS), meaning the level of community COVID-19 spread requires twice-per-week or weekly testing of all staff members under new regulations announced last month.
The Abbott antigen tests — provided free of charge — will supplement the existing point-of-care antigen machines, manufactured by Becton Dickinson and Quidel, that HHS is in the midst of sending to more than 14,000 facilities across the country.
As of Tuesday, the federal government has distributed more than 13,400 of the BD and Quidel units, Giroir said, with the rest of the machines set to reach operators this week.
Unlike the BD and Quidel systems, the Abbott tests do not require a separate reader; instead, a nasal swab is placed on a testing “card” that can detect the presence of the virus that causes COVID-19, according to HHS. The system is particularly sensitive for people in their first seven days of coronavirus infection, according to Giroir.
The assistant health secretary framed the Abbott tests as a way for operators in COVID-19 hotspots to maintain their testing capacities as BD and Quidel continue to ramp up production of subsequent supplies. In a “red” county, with twice-weekly tests required of all staff, the Abbott cards would help cover approximately half of that testing burden, Giroir said.
“This will provide you an option,” Giroir said. “It will lessen, to a degree, the burden of ordering tests from your facility, and there’s also a theoretical advantage of rotating the types of tests that you use — particularly if you’re in a twice-a-week scenario — between two different types of antigen test.”
As with the BD-Quidel machines, facilities must have a CLIA certificate of waiver in order to perform the Abbott tests, which Giroir indicated could also be used for visitor screening.
“We hope you’ll use this to further protect your seniors — and again, if you have extra testing capacity, there’s no reason you can’t use that for visitors or other reasons to protect our seniors,” he said.
While the government has already sent approximately 4.7 million tests to facilities free of charge as part of the initial point-of-care program, operators will be on the hook to purchase replenishment orders of testing media from BD and Quidel.
The federal government essentially bought out the entire available supply of tests in order to fulfill the initial orders, Giroir said Tuesday, with at least BD set to provide additional testing media as soon as this week.
“I cannot tell you that this will be 100% seamless over the first one to two weeks,” Giroir said. “But we absolutely will be doing our best to make sure that you can be resupplied.”
In response to an audience member’s concern about markups on the replenishment supplies from traditional distributors, Giroir said HHS was aware of the problem and is investigating potential solutions.
“Business is important, but we would certainly like that to be less expensive, and we’re just going to explore our options,” Giroir said.
HHS, in conjunction with the Department of Defense, placed an order for 150 million rapid Abbott BinaxNOW tests for a total of $760 million, the agency announced at the end of August.
The exact distribution pattern for nursing homes remains under development, but Giroir said the direct shipments should continue weekly through November or December — though the Abbott effort will not represent an “indefinite commitment” from the administration. Once HHS runs out, refills will be available for approximately $5 or $6 per test.
“As we transition to the free-market structure, we know you’re going to have a couple of weeks of instability as we get the distribution channels down,” Giroir said. “We’re going to work with you on that, and you have our commitment that we’re going to do what we can to make this seamless.”
This is a developing story. Please check back for updates.