HHS to Share Best Practices for Point-of-Care COVID-19 Testing

October 05, 2020 - HHS and The Rockefeller Foundation recently signed an agreement to identify and share effective approaches for increasing rapid point-of-care (POC) COVID-19 testing in various communities. 

Under the agreement, a pilot program will specifically focus on safely reopening K-12 schools in select cities in The Rockefeller Foundation’s Testing Solutions Group (TSG). TSG is a network of public officials devoted to scaling COVID-19 testing, tracing, and tracking in their communities. 

"This pilot program will generate real-world evidence, and identify best practices and lessons learned, as well as metrics on how to effectively integrate testing into school opening and reopening for K-12 students and teachers," HHS Assistant Secretary for Health Brett Giroir, MD, said in an announcement last week. 

"Our collaboration with The Rockefeller Foundation will inform states and territories on how to develop their own roadmaps for safely keeping children in the classroom, which is critical for their physical, emotional, mental, and developmental health,” added Giroir.

As part of the initiative, HHS will provide at least 12,000 Abbott BinaxNOW COVID-19 Ag Card POC COVID-19 diagnostic tests to pilot sites, including Louisville, Los Angeles, New Orleans, and Tulsa. Rhode Island was also recently selected as a pilot state. 

The BinaxNOW Ag Card is a COVID-19 antigen test that can provide test results in 15 minutes, according to Abbott.

At the beginning of September, FDA issued an emergency use authorization to Abbott for the antigen test, which does not need the use of an analyzer and is authorized for POC settings, including doctor’s offices, emergency rooms, and some schools. 

The BinaxNOW Ag Card is intended for the qualitative detection of the nucleocapsid protein SARS-CoV-2 antigen, FDA said. The test determines the presence of the antigen using nasal swabs from individuals suspected of having COVID-19. 

HHS will distribute the tests by leveraging the logistics of the Department of Defense (DoD). The Rockefeller Foundation will help communities define problems, set policy goals, explore options, and craft solutions to help fight the pandemic with a scientific approach, HHS said. 

The testing pilot program will also provide data on how testing strategies can be operationalized in laboratories, retail pharmacies, and other communities. 

“The partnership will help build the capacity of communities across the United States to better prepare for future pandemics, especially in low-income and vulnerable communities,” HHS said.

The collaboration between HHS and The Rockefeller Foundation builds upon the Trump Administration's national distribution plan for the BinaxNOW tests to states. This includes sending millions of BinaxNOW rapid tests to all US states and territories over the next few months.

Antigen tests are vital during the COVID-19 pandemic because they generate results faster and are less expensive than standard care tests. They’re more practical to use for a large community of individuals. 

In mid-September, Gauss and Cellex announced an exclusive partnership to launch the first-ever rapid, at-home COVID-19 antigen test.

The test is the first to allow individuals to test themselves for active COVID-19 infection and receive rapid results while at home. 

In early trials, the antigen test showed 90 percent sensitivity and 100 percent specificity. 

Previously, Cellex received FDA emergency use authorization for its rapid COVID-19 antibody test back in April. The company is now in advanced clinical trials with a rapid antigen test that targets the nucleocapsid protein on the SARS-CoV-2 virus.

“The integration of Cellex’s accurate, at-home rapid antigen test with Gauss’s mobile app offers a scalable solution to significantly reduce transmission of COVID-19 and help society mitigate the impacts of the pandemic until a vaccine is widely available,” Gauss founder and CEO Siddarth Satish said in the announcement.