The U.S. Department of Health and Human Services (HHS) is sending 3,150,000 state-of-the-art Abbott BinaxNOW COVID-19 point of care antigen tests to the State of North Carolina. The rapid point of care tests, which can diagnose coronavirus infection in as little as fifteen minutes, will be distributed at the discretion of Governor Roy Cooper to support testing K-12 students, teachers, nursing home patients and staff, higher education, critical infrastructure, first responders, and other priorities as he deems fit.

The Trump Administration has shipped over 552,000 COVID-19 rapid tests directly to congregate care settings such as North Carolina nursing homes, assisted living facilities and to historically black colleges and universities (HBCUs) in the state. As of October 26 over 1,320,000 BinaxNOW tests have been shipped to North Carolina.

“To facilitate the continued re-opening of North Carolina schools, businesses and economy, the Trump Administration has prioritized scaling up the state’s point of care testing capacity by making this $760 million national investment in BinaxNOW tests,” said Assistant Secretary for Health Admiral Brett Giroir, MD. “Distributing these rapid tests directly to states is consistent with the Trump Administration’s successful, ongoing approach of testing the right person, with the right test at the right time, is working and the effort will continue until the pandemic is under control.”

In preliminary feedback, the State of North Carolina shared the BinaxNOW tests are being sent to counties with >5% positivity rate and allowing their local health departments to determine where tests should be sent. The state is recommending a focus on local schools, outbreaks, and high-risk congregate settings.

Giroir pointed out that testing does not substitute for avoiding crowded indoor spaces, washing one’s hands, or wearing a mask when not able to physically distance. “Combining personal responsibility with smart testing is a foundational pillar of the Administration’s national testing strategy.”

BACKGROUND

The Federal government purchased Abbott BinaxNOW diagnostic tests on August 27, 2020, to ensure equitable distribution of the first 150 million units – one day after an Emergency Use Authorization (EUA) was issued by the Food and Drug Administration (FDA) – to ensure they would be expeditiously distributed to vulnerable populations as quickly as possible. Now that initial distribution of these tests to all 50 states and the District of Columbia is well underway, it ensures the nation’s governors will not have to compete for the initial BinaxNOW shipments, or waste precious time to set up individual purchasing contracts with the manufacturer.

HHS has also provided all CLIA-certified nursing homes over 11 million rapid point of care tests, this includes Abbott BinaxNOW FDA-authorized antigen diagnostic tests and either a Quidel Sofia 2 or Becton, Dickinson and Company (BD) Veritor™ Plus System instrument(s) with associated tests.