WASHINGTON, D.C. — The U.S. Department of Health and Human Services (HHS) this week announced a large-scale procurement of U.S. Food and Drug Administration (FDA) -authorized rapid point-of-care diagnostic test instruments and tests to be distributed to nursing homes in COVID-19 hotspot geographic areas with the United States.
This initiative is a one-time procurement of devices and tests targeted to facilitate on-site testing among nursing home residents and staff. Through this crucial action, nursing homes will be able to augment their current capacity for coronavirus testing, bolstering their response and helping to prevent the spread of SARS-CoV-2, the virus that causes COVID-19.
“Access to rapid point-of-care testing in nursing homes will further protect our Nation’s most vulnerable patients,” said Assistant Secretary for Health ADM Brett P. Giroir, M.D. “With the recent FDA Emergency Use Authorization of the BD Veritor system, combined with the earlier authorization of the Quidel Sofia and Sofia 2 systems, we now have the ability to provide more testing faster. This could not have been possible without the scientific investments made by these companies, advanced regulatory science from the FDA and other investments by the Federal government.”
Distribution will begin next week with nursing homes prioritized by Centers for Medicare & Medicaid Services (CMS) in their continuing effort to protect older adults. Each nursing home will receive one diagnostic test instrument and associated tests.
Following initial distribution, nursing homes can procure additional tests directly from the respective manufacturers. Nursing homes must have the capability to screen and test residents, and test staff on a weekly basis or according to specific guidance by the state and local health departments. This procurement will also enable testing of visitors if appropriate for that facility.
“This new testing initiative is critical for keeping vulnerable older adults safe while delivering the quality of life they deserve,” said CMS Administrator Seema Verma. “It gives nursing homes the ability to swiftly identify residents that need to be isolated and mitigate the spread of the virus. As one more tool in the toolbox, it represents an important step toward the long-awaited reunion of residents with their loves ones.”
Both the Quidel Sofia and Sofia 2 Instruments and BD Veritor Plus Systems use antigen tests that can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs, providing results in minutes.
Antigen tests will play a critical role in the fight against COVID-19 and will be essential to reach the Nation’s goal of testing millions of Americans each day.
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