After previously being left out of the federal COVID-19 test allocation program, assisted living providers are about to receive a new antigen test cleared last week for emergency use authorization by the Food and Drug Administration.
The federal government is purchasing 150 million new BinaxNow COVID-19 Ag Card tests from Abbott Laboratories with the intention of beginning distribution in mid-September to states and congregate care facilities, including assisted living communities, Admiral Brett P. Giroir, M.D., assistant secretary for health at the U.S. Department of Health and Human Services, said in a call with members of the media on Tuesday.
First in line for distribution will be states coping with natural disasters, including Louisiana, recovering from Hurricane Laura, and western states dealing with wildfires, Giroir said. Distribution to assisted living communities, senior centers, home health staff and nursing homes will follow, with the “overwhelming majority” of tests going to states to help reopen schools and protect first responders, he added.
Giroir said the message is “wrapped up with a bow on it, that everyone who needs to use a point-of-care antigen test” can do so.
The American Health Care Association / National Center for Assisted Living told McKnight’s Senior Living that the announcement was a “positive step in the right direction.”
“We appreciate the federal government’s assistance in supplying point-of-care tests to assisted living communities in addition to the previously announced distribution to all nursing homes nationwide,” the association said in a statement. “Given the vulnerable population we serve, the ability to frequently test residents and staff and receive reliable, rapid results is paramount. Access to testing means that long-term care providers can better identify who has the virus and make tactical decisions to protect residents and staff.”
AHCA / NCAL said it looks forward to working with HHS and the Centers for Medicare & Medicaid Services “to expand this program in the coming weeks and months as well as address questions such as resupply.”
On Monday, HHS issued guidance extending legal protections to healthcare providers who administer point-of-care coronavirus tests to screen asymptomatic individuals in congregate care settings, including assisted living communities, nursing homes and other long-term care facilities. The protections under the Public Readiness and Emergency Preparedness, or PREP, Act, supersede state and local laws prohibiting the use of FDA-authorized tests on symptomatic or asymptomatic individuals in congregate care facilities.
“We’re not going to risk seniors because of paperwork issues or some misunderstandings,” Giroir said.
Last week, the federal government announced a $750 million deal to buy 150 million of Abbott Lab’s rapid point-of-care antigen test. The BinaxNow test is a $5 rapid-results coronavirus antigen test intended for use within the first seven days of symptom onset in individuals suspected of having COVID-19. A healthcare provider twirls a nasal swab sample onto a credit card-sized test device and waits about 15 minutes for a result similar to a pregnancy test; one line indicates a negative result, and two lines signal a positive result.
No equipment is necessary to process samples or read test results, and a complementary smartphone app provides test results to the individual and the healthcare provider, with automatic reporting to public health authorities. Giroir said the test offers “remarkable sensitivity” at 97.1% and specificity at 98.5%.
Antigen tests, in general, are not as sensitive as the more accurate molecular tests and are more likely to deliver a false negative result, according to the FDA.
Find additional coverage of the press conference on our sister site, McKnight’s Long-Term Care News, here.