Editor’s Note: This page was updated on June 7, 2021 to include a program update.
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 Testing” that will begin in Pitt County, North Carolina, and soon in Chattanooga/Hamilton County, Tennessee. Up to 160,000 residents of the two communities will have access to free rapid antigen tests that they can administer themselves three times a week for a month. NIH will provide the tests (also called home testing or at-home testing) and evaluate the effectiveness of the initiative, which aims to determine whether 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 testing can strengthen our prevention efforts,” said CDC Director Rochelle P. Walensky, MD, MPH. “Combined with efforts to increase vaccinations, this important initiative will help us understand how best to use these new at-home tests to reduce viral transmission rates in communities.”
Local health departments will offer the opportunity to participate in the testing program. 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 is also 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 of and can benefit from the opportunity.
“This testing initiative is the first of its scale to attempt to make free, rapid, self-administered testing available throughout the community to determine its effectiveness in our nation’s comprehensive response to the COVID-19 pandemic,” said NIH Director Francis S. Collins, MD, Ph.D. “We hope to gain critical data that can guide how communities can use self-administered testing to mitigate viral transmission during this and future pandemics.”
Participants in the “Say Yes! Test COVID” 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-testing has made a difference in behavior, knowledge about preventing the spread of the virus, and thoughts about COVID-19 vaccination.
The selection of the two communities was based on local infection rates, the public availability of accurate COVID-19 tracking data, and existing community relationships through the NIH. Rapid Acceleration of Diagnosis in Underserved Populations (RADx-UP) and local infrastructure to support the project.
Researchers from the 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 CDC and NIH to use publicly available COVID-19 case surveillance data on test positivity rates, COVID-19-related illnesses and hospitalizations, and measurements of viral particles in wastewater to assess viral transmission in the community. At the same time, publicly available data from other communities of similar size that have not received widespread self-testing will be reviewed to evaluate the impact of frequent self-testing.
“If self-testing is shown to effectively reduce viral spread in targeted communities, the hope is that it will lead to greater distribution and acceptance of frequent home testing across the country, ultimately providing a new easy and accessible means to stop the spread of the virus,” said Elizabeth A. DiNenno, Ph.D., CDC’s deputy assistant director for surveillance, epidemiology, and laboratory sciences.
The test is provided through the NIH Rapid Acceleration of Diagnostics (RADxYE) initiative is the QuickVue test developed by San Diego-based diagnostic company Quidel. The test received emergency use authorization for home use (prescription) by the US 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 online companion tool was developed by CareEvolution, LLC, Ann Arbor, Michigan, with financial support from the NIH and is customized for use with the QuickVue test.
In a recent study by the NIH RADx initiative, researchers found that rapid antigen testing at least three times a week achieves a level of viral detection on par with PCR-based COVID-19 tests processed in a laboratory. However, a self-administered rapid test produces confidential results at home in a matter of minutes, while processing in the laboratory takes longer and increases the cost. The hope is that easier access to testing and faster 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 various 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 enable more accessible screening and surveillance testing, a powerful approach that complements vaccination and helps prevent infection as the “virus mutates.”
“Say Yes! COVID Testing” is being conducted in collaboration with the CDC, state and local public health departments in North Carolina and Tennessee, the NIH, research institutions including Duke University, the University of North Carolina, North Carolina Central University, test manufacturer Quidel, health technology company CareEvolution, RADx-UP community engagement partners, and Community-Campus Partnerships for Health.
About the Centers for Disease Control and Prevention (CDC): CDC works 24 hours a day, 7 days a week, protecting the health and safety of the United States. Whether diseases begin at home or abroad, are curable or preventable, chronic or acute, or due to human activity or deliberate attack, CDC responds to America’s most pressing health threats. The CDC is headquartered in Atlanta and has experts located throughout the United States and the world.
About the National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the biological sciences to advance basic research and healthcare. NIBIB supports research and development of emerging technologies within its internal laboratories and through grants, collaborations and training. More information is available on the NIBIB website: https://www.nibib.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures of common and rare diseases. For more information about the NIH and its COVID-19 testing programs, visit https://www.nih.gov/radx.
NIH…Turning Discovery into Health®
###
