The Department of Health and Human Services has cleared licensed healthcare practitioners to use FDA-authorized antigen test kits to detect COVID-19 at nursing homes as well as assisted-living and long-term care facilities.
In a statement published Monday, the agency said its action preempts state or local laws or requirements that prohibit the use of such point-of-care kits to test symptomatic or asymptomatic individuals for COVID-19 in nursing homes and other "congregate" facilities.
The HHS action follows cautioning by the American Health Care Association (AHCA), a nursing home trade group, that due to the "lower sensitivity and specificity" of antigen tests, some public health departments do not allow them to be used for this purpose. Regional restrictions were a potential obstacle for Trump administration plans to deploy the diagnostics to these facilities nationwide.
In recent months, point-of-care antigen tests, which are designed to in 15 minutes show whether a person is infected with the coronavirus, have emerged as a key component of U.S. plans to reduce deaths due to the virus in nursing homes. HHS accelerated the plan last month when it used the Defense Production Act to compel BD and Quidel to supply 14,000 nursing homes with antigen tests.
AHCA, a U.S. association of long-term and post-acute care providers, flagged the problem with the plan after seeing the details. The trade group advised its members to check with officials to see if state-level guidelines restrict the use of point-of-care antigen tests due to concerns about accuracy.
However, the HHS action appears to eliminate that potential barrier to the use of antigen tests. By extending coverage of the Public Readiness and Emergency Preparedness (PREP) Act to antigen tests in nursing homes, HHS supersedes state-level restrictions. The expansion of the PREP Act also clears healthcare providers to use antigen tests off label to screen asymptomatic individuals.
Through the changes, HHS has set nursing homes up to use antigen tests to periodically screen their staff and residents for COVID-19. Such mass-screening programs could enable nursing homes to find pre- and asymptomatic cases of COVID-19 and act to stop those infected individuals from spreading the virus to other residents and staff members.
Nonetheless, the concerns that led some states to restrict the use of antigen tests mean the screening programs may miss cases. BD won emergency use authorization for its antigen test on the strength of a study that put its sensitivity at 84%, suggesting it misses a significant minority of true positives. The Quidel test performed better, recording a sensitivity of almost 97%.
BD and Quidel entered into the nursing home contracts before Abbott won authorization for its antigen test, which delivers results at the point of care without the need for instrumentation. Abbott landed a $760 million U.S. contract shortly after getting the regulatory OK and will provide 150 million antigen tests to be deployed in 2020 to schools and vulnerable U.S. populations.