A new study that could have immediate implications for COVID-19 testing in schools found that with age-appropriate instructions, school-aged children can successfully use a nasal swab to obtain their own COVID-19 test sample. The study provides data to support self-testing recommendations that can be implemented by schools and other settings where children are tested for COVID-19.
The study was led by a team of clinical investigators from Emory University School of Medicine, Atlanta, and Children’s Healthcare of Atlanta, and funded by the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx®) technology program.
“Having adults collect swab samples from children is not a trivial matter in schools and other group settings,” said Bruce Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and leader of RADx Tech. “The study data may surprise some and will reassure others that children as young as 4 years old can follow simple instructions and collect their own nasal sample for COVID-19 testing.”
The team conducted their study in July and August 2021 at sites in the Atlanta area, enrolling 197 children with COVID-19 symptoms. Before sampling, they showed the children a short (90-second) instructional video designed for a young audience and gave them a handout with written instructions and pictures. The children then proceeded to clean their noses: four rotations of the swab against the inside of each nostril, about a centimeter deep. The health worker then used a second swab to collect a sample by swabing each nostril of each child. All samples were then sent to a clinical laboratory for PCR analysis.
Self-collected swabs and those collected by a healthcare worker matched 97.8% of the time for a positive result and 98.1% of the time for a negative result. The analysis showed that both collection methods identified 44% of symptomatic children who tested positive for COVID-19.
“Seeing how closely the results align between children and trained healthcare workers is a strong indicator that these age groups are fully capable of self-sampling if they receive proper instruction,” says Jesse Wagoner, MD, assistant professor of Infectious Diseases at Emory University School of Medicine and one of the study’s senior authors.
A higher percentage of children aged 8 years and younger needed help, such as more instruction before successfully completing the collection on their own (21.8% compared to 6.1% for children older than 8 years), but SARS-CoV-2 detection between the two age groups did not differ.
The study, published in the Journal of the American Medical Association, provides data that is available to COVID-19 test manufacturers when they submit applications to the U.S. Food and Drug Administration for a diagnostic emergency use authorization (EUA). NIH-backed testing verification hub RADx Tech provided the data late last year, where it has subsequently been referenced by manufacturers in support of the EUA for their COVID-19 PCR diagnostic tests. Prior to this study, the FDA had not authorized self-collection COVID-19 testing for children under 14 years of age. Several FDA co-authors were advisors on the study design, and this study is an example of the unprecedented collaboration between NIH and FDA during the pandemic.
“Pediatric self-testing will support greater access to testing and should make it even easier to test underserved school-aged populations,” said Tim Stenzel, M.D., Ph.D., director of the FDA’s Office of In Vitro Diagnostics. “This study expands our knowledge of the accuracy of testing with these types of samples and provides test manufacturers with data to support their EUA requests to the FDA.”
Traditional medical practice has been for a healthcare worker to collect samples for testing for respiratory tract infection. However, that scenario is challenging when repeat testing is required for children in school or other group settings that are less likely to have trained health care workers available to collect samples. Student sampling, even when samples are sent off-site for testing, could reduce the burden on school staff. The self-swabbing study arose from discussions between researchers at the RADx Tech Testing Verification Core in Atlanta with the NIH RADx Tech program and at the FDA about obtaining data to understand at what age children can self-swab.
“Every minute of a healthcare worker’s time is at a premium,” said senior author Wilbur Lam, MD, a pediatric hematologist and oncologist at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare in Atlanta, a professor in the Department of Pediatrics at Emory University School of Medicine and the Wallace H. Coulter Department of Biomedical Engineering at Georgia Institute of Technology and Emory University, and program director of the Center’s Innovation Catalyst Awards Program. Georgia Clinical and Translational Sciences. “Why not let a child take the sample themselves? It’s a win-win! They’d rather do it themselves and that leaves the healthcare worker free to do other things.” He added that while the study paves the way for lab test developers to add self-collection by children ages 4 to 14, end users should follow the instructions for use of a given device.
This research was supported by funding from President Biden’s American Rescue Plan through the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health (U54 EB027690-03S1 and U54 EB027690-03S2) and also the National Center for Advancing Translational Sciences (UL1 TR002378), both parts of the National Institutes of Health.
Concordance of SARS-CoV-2 results in self-collected nasal swabs and healthcare worker-collected swabs in children and adolescents. Jesse J. Wagoner, Miriam B. Vos, Erika A. Tyburski, Phuong-Vi Nguyen, Jessica M. Ingersoll, Candace Miller, Julie Sullivan, Mark Griffiths, Cheryl Stone, Macarthur Benoit, Laura Benedit, Brooke Seitter, Robert Jerris, Joshua M. Levy, Colleen S. Kraft, Sarah Farmer, Amanda Peagler, Anna Wood, Adrianna L. Westbrook, Claudia R. Morris, Usha N. Sathian, William Heetderks, Li Li, Kristian Roth, Mary Barcus, Timothy Stenzel, Greg S. Martin, Wilbur A. Lam. JAMA. Published online August 26, 2022.
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About the Rapid Acceleration of Diagnostics (RADx®) initiative: The RADx initiative was launched on April 29, 2020 to accelerate innovation in the development, commercialization and deployment of technologies for COVID-19 testing. The initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations and RADx Radical. Leverages existing NIH point-of-care technology research network. The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary for Health, the Department of Defense, the Biomedical Advanced Research and Development Authority, and the U.S. Food and Drug Administration. Learn more about the RADx initiative and its programs: https://www.nih.gov/radx.
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 NIH and its programs, visit https://www.nih.gov/.
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