Nursing Homes Turn to Abbott Tests Over BD, Quidel as HHS Builds Tracking System for Orders

The Department of Health and Human Services (HHS) is working with the Department of Defense and various distributors to build a tracking system for nursing home orders of new COVID-19 test kits — and the supply for two of the major devices in the government’s nursing home testing initiative “far exceeds the demand from nursing homes,” one of the top coronavirus testing czars said on a call with reporters on Monday.

“We are working right now with the DOD as well as distributors, and should have within just a couple of weeks, the ability to track every single order from every single nursing home and understand when and how they’re being fulfilled, to make sure that not a single nursing home need goes unmet,” HHS assistant secretary for health Adm. Brett Giroir said on Monday’s call.

HHS also issued an update on Monday about shipments of 150 million Abbott BinaxNOW COVID-19 diagnostic tests to U.S. states and territories, an initiative announced in late September.

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The point-of-care antigen tests detect the presence of protein antigens from SARS-CoV-2, and the Abbott tests use a test card to show positive or negative results for COVID-19, rather than requiring instrumentation to test the samples, according to a fact sheet from HHS.

Several states are prioritizing nursing homes and long-term care facilities for distribution of the devices, according to preliminary feedback to HHS from 32 states and the District of Columbia.

The states and territories are receiving BinaxNOW tests in proportion to their populations, according to HHS. Their plans include the following highlights as listed by the department:

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  • D.C. plans to “distribute tests to long term care facilities, group homes, HBCUs [historically black colleges and universities], skilled nursing facilities, and Federal facilities.”
  • Long-term care facilities in Illinois and Indiana were directly sent 198,000 tests and 243,000 tests, respectively. Michigan sent long-term care facilities 45,000 tests, and Minnesota sent its facilities 400,000 tests. Oregon is sending its long-term care facilities 50,000 tests.
  • Iowa plans to “deploy” the tests in 483 long-term care facilities.
  • Long-term care facilities in Mississippi “that are not already receiving tests directly from HHS” will have tests provided by the state.
  • Nebraska sent nursing homes 60% percent of their first shipment.
  • Nevada will distribute 15% of its tests to SNFs and assisted living facilities that have not received direct shipments of tests from HHS.
  • In addition to using them to help with reopening schools, North Dakota intends to send tests to long-term care facilities and opioid treatment programs.
  • “[L]ong term care facilities, skilled nursing facilities and then correctional facilities” will be receiving the tests first in Pennsylvania.
  • Wisconsin, Washington, and South Dakota are all sending unspecified numbers of tests to long-term care facilities. In South Dakota, the tests are being sent directly to long-term care; Wisconsin has sent the tests directly to these facilities. In Washington, SNFs will receive tests after hospitals and federally-funded critical health care facilities.
  • Hawaii plans to use 35% of the Binax tests for “congregate living situations.”

HHS also provided totals of Binax tests going to each state, as well as weekly distribution lists.

The federal government’s original push to distribute point-of-care antigen tests for COVID-19 to nursing homes featured two major medical device firms: BD and Quidel, with HHS shipping out the BD Veritor systems and the Quidel Sofia and Sofia 2 systems.

Unlike the Abbott tests, the BD and Quidel systems require both a processing unit and separate testing kits; operators had expressed concerns about the cost and availability of testing refills after receiving their first free shipments from HHS.

At the time of the announcement in July, Giroir said that the supply chains for these devices would be likely not be fully up and running until October, though 15 million to 20 million tests a month were expected to be available by September.

The BD and Quidel units have also raised concerns about false positives, given their relatively lower sensitivity compared to lab-based polymerase chain reaction (PCR) tests; Giroir and HHS have previously asserted that the prevalence of errors has not exceeded expectations, despite scrutiny from operators and some state-level bans on using the devices.

While Giroir did not have specific numbers on BD and Quidel tests available on Monday’s call, he indicated that “we are tracking nursing home orders, and we are well within the capability of meeting the nursing home orders, based on all the orders that we’re seeing.”

He also suggested that the availability of the Binax test devices — 7.3 million of which have been shipped to nursing homes and over 2.4 million to assisted living facilities — may be affecting demand.

“We think the nursing home orders are probably a little bit less because they’re all getting Binax, and many of them are using Binax instead of Quidel and BD,” Giroir said on the call. “But the the orders from nursing homes, which are in the millions, are easily being fulfilled.”

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