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CDC teams with NIH to gauge efficacy of at-home COVID-19 testing

Two communities will receive an at-home test, and their data will be compared to that of communities who lack access to tests.

Jeff Lagasse, Associate Editor

(Photo by Halfpoint Images/Getty Images)(Photo by Halfpoint Images/Getty Images)

The U.S. Centers for Disease Control and Prevention is teaming with the National Institutes of Health on an initiative to determine if the widespread use of at-home COVID-19 tests is effective at stemming transmission of the virus.

The program, called Say Yes! COVID Test, will start in two communities, Pitt County, North Carolina, and 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 by themselves 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.

WHAT'S THE IMPACT?

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, 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. The CDC and NIH said that community engagement efforts are underway to ensure that vulnerable and underserved populations are aware of and able to benefit from the initiative.

Participants in the 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 or thoughts about COVID-19 vaccination.

Selection of the two communities was based on local infection rates, the public availability of accurate COVID-19-tracking data, existing community relationships through the NIH Rapid Acceleration of Diagnostics Underserved Populations 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, N.C. – will work with the CDC and NIH to use publicly available COVID-19 case-surveillance data on test-positivity rates, coronavirus-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 provide a basis of comparison. If testing is shown to be effective, then the hope is that at-home testing will be more accepted and widely distributed, potentially introducing a new means of combating the virus.

The test being supplied through the NIH Rapid Acceleration of Diagnostics initiative 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.

It's 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 in Ann Arbor, Michigan, with funding support from NIH, and is customized to be used with the QuickVue test.

The 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.

THE LARGER TREND

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 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 for consumers.

Just a few days ago, retail giant Amazon landed an FDA Emergency Use Authorization for its COVID-19 test kit with at-home sample collection. According to FDA documents, the product is cleared for self-sample collection by nasal swab for individuals aged 18 years and over. 

The kit can be used either under the supervision of a healthcare provider or unsupervised at home. The kit includes a nasal swab, a collection tube, a biohazard bag and instructions for collection and drop-off. The samples are designated to be tested at Amazon subsidiary STS Lab Holdco. The new technology will fit into Amazon's employee-screening program, according to FDA documents.

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com