The Centers for Disease Control and Prevention (CDC), in collaboration with the National Institutes of Health (NIH), has launched an innovative community health initiative called “Say Yes! COVID Test” starting in Pitt County, North Carolina, and coming soon to Chattanooga/Hamilton County, Tennessee. As many as 160,000 residents across the two communities will have access to free, rapid antigen tests that they can administer themselves to use three times a week for one month. NIH will provide the tests (also called a home-test or at-home test) and evaluate the effectiveness of the initiative, which aims to determine if frequent self-administered COVID-19 testing helps residents reduce community transmission of SARS-CoV-2, the virus that causes COVID-19 disease.
“Reliable and widely available testing is a critical part of our efforts to stop the spread of COVID-19. Regular screening with at-home COVID-19 tests can strengthen our prevention efforts,” said CDC Director Rochelle P. Walensky, M.D., M.P.H. “Combined with efforts to increase vaccinations, this important initiative will help us understand how best to utilize these new at-home tests to reduce viral transmission rates in communities.”
The opportunity to participate in the testing program will be offered by local health departments. Participants will be able to order their test kits online for home delivery or pick them up at a local distribution site. A free online tool that also is available as a phone app will be offered to provide testing instructions, information to help understand test results and text message reminders about testing. Strong community engagement efforts are underway to ensure that vulnerable and underserved populations are aware and able to benefit from the opportunity.
“This testing initiative is the first of this scale to attempt to make free, rapid, self-administered tests available community-wide in order to determine their effectiveness in our nation’s comprehensive response to the COVID-19 pandemic,” said NIH Director Francis S. Collins, M.D., Ph.D. “We hope to gain foundational data that can guide how communities can use self-administered tests to mitigate viral transmission during this and future pandemics.”
Participants in the “Say Yes! COVID Test” initiative will also have the option to volunteer in an NIH-supported research study that will collect additional data through surveys. The survey questions are designed to determine whether frequent self-administered testing has made a difference in behavior, knowledge on preventing spread of the virus and thoughts about COVID-19 vaccination.
Selection of the two communities was based on local infection rates, public availability of accurate COVID-19 tracking data, existing community relationships through the NIH Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP)(link is external)external icon and local infrastructure to support the project.
Researchers at NIH-supported University of North Carolina at Chapel Hill, and Duke University and the Duke Clinical Research Institute, both in Durham, North Carolina, will work with the CDC and NIH to use publicly available COVID-19 case surveillance data on test positivity rates, COVID-19-related illness and hospitalizations and measurements of viral particles in sewage wastewater to evaluate viral transmission in the community. At the same time, publicly available data will be reviewed from other communities of similar size that have not received widespread self-administered tests to evaluate the impact of frequent self-administered testing.
“If self-testing is shown to effectively reduce viral spread in the selected communities, the hope is that it will lead to wider distribution and acceptance of frequent home testing across the country—ultimately providing an easy and accessible new means of stemming the spread of the virus,” said Elizabeth A. DiNenno, Ph.D., an associate deputy director for surveillance, epidemiology, and laboratory sciences at the CDC.
The test being supplied through the NIH Rapid Acceleration of Diagnostics (RADxSM) initiativeexternal icon is the QuickVue test developed by San Diego-based diagnostic company Quidel. The test received emergency use authorization for at-home use with a prescription by the U.S. Food and Drug Administration on March 1, 2021. The test is performed with a nasal swab and detects the presence of the SARS-CoV-2 viral antigen within 10 minutes. The companion online tool was developed by CareEvolution, LLC, Ann Arbor, Michigan, with funding support from NIH, and is customized to be used with the QuickVue test.
In a recent study conducted by the NIH RADx initiativeexternal icon, researchers found that rapid antigen testing at least three times per week achieves a viral detection level on par with PCR-based COVID-19 testing processed in a lab. However, a self-administered rapid test produces confidential results at home in minutes, while laboratory processing takes longer and increases cost. The hope is that easier access to tests and faster test results will make frequent testing more desirable and encourage people to protect themselves and others in the community.
“COVID-19 testing has undergone a transformation over the past year to provide optimal approaches for varied circumstances, including self-testing within people’s homes,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the NIH, and leader of the RADx Tech program. “These advances allow more accessible screening and surveillance testing, a powerful approach that complements vaccination and helps prevent infection as the virus mutates.”
“Say Yes! COVID Test” is being conducted in a collaboration with the CDC, state and local public health departments in North Carolina and Tennessee, NIH, research institutions including Duke University, the University of North Carolina, North Carolina Central University, test manufacturer Quidel, healthcare technology company CareEvolution, community engagement partners from RADx-UP, and Community-Campus Partnerships for Health.