Testing Strategy

CDC/NIH Team with Local Health Authorities to Promote, Evaluate Home COVID-19 Testing

As the COVID-19 crisis drags on, the primary focus of the federal government’s testing strategy continues to shift from medical diagnosis and treatment to broad testing of the asymptomatic for purposes of screening. The U.S. Centers for Disease Control and Prevention’s (CDC) new “Say Yes! COVID Test” initiative is an innovative program designed to enlist local public health authorities to promote screening at the community level.

The Diagnostic Challenge

Regrettably, COVID-19 infection remains a threat and frequent testing will be essential to make the return to work, school and society as safe as possible. According to the National Institutes of Health (NIH), along with social distancing, vaccination, wearing a mask and regular hand washing, frequent testing offers the best chance of containing the threat posed by the “silent spread” of COVID-19 that occurs when people are infected but do not yet exhibit symptoms.

Although it is accurate, polymerase chain reaction (PCR) molecular testing performed by an offsite laboratory is not suited for such purposes. What is required are rapid tests that can provide reliable results at the point of care, including at home. In a recent study conducted by the NIH RADx initiative, 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 laboratory.

The other major challenges are logistics, test distribution and education. These obstacles will have to be confronted and solved at the local level. Although the federal government can provide general leadership and support, engagement of local public health authorities and government laboratories will be utterly crucial.

The CDC Say Yes! Program

With these principles in mind, the new Say Yes! COVID Test program (Program) is a first of its kind collaboration between the CDC and state and local public health departments, starting in Pitt County, North Carolina, and then Chattanooga, Tennessee. These locations were selected 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) and local infrastructure to support the Program.

As many as 160,000 residents across the two communities will have access to Quidel’s QuickVue At-Home COVID-19 rapid antigen test kits provided by NIH free of charge. The prime targets are individuals who have not yet received the COVID-19 vaccine and/or who are highest risk for exposure to COVID-19, such as those who work or go to school outside the home. Participants may order their test kits online for home delivery or pick them up at a local distribution site.

The Quidel QuickVue At-Home COVID-19 Rapid Antigen Test Kit

The Quidel QuickVue At-Home COVID-19 test used by the Program is a rapid, antigen test that received Emergency Use Authorization from the Food and Drug Administration on March 1. It uses a lateral flow format that individuals can use to rapidly collect their samples at home without having to send them to a laboratory for analysis. The test is authorized for prescription home use with self-collected anterior nasal swabs from individuals 14 years or older and individuals as young as 8 years old with swabs collected by an adult. Quidel claims that the test can return results in 10 minutes and that it showed positive results that agreed with PCR testing 84.8 percent of the time and negative results that agreed with PCR results 99.1 percent of the time. Each kit supports frequent testing of two household members.

Tests require samples from a swab inside each nostril, and results can be read in 10 minutes. Participants can administer the test themselves at home three times a week for one month. 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. with each kit supporting frequent home testing for two household members.

End Game: Determine If Frequent Home Testing Reduces Infection

Participants in the Program 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. NIH will use the data to determine whether frequent self-administered COVID-19 testing helps residents reduce community transmission of SARS-CoV-2.

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.

Takeaway

The Program is a test balloon that may lay the groundwork for much more widespread federal intervention. If self-testing is shown to be effective in reducing COVID019 spread in the selected communities, the expectation is that the CDC and other federal agencies will initiate further projects to ensure wider distribution and acceptance of frequent home testing across the country in the hopes of ultimately providing an easy and accessible new means of stemming the spread of the virus.

“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 in a news release . “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.”

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