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Concordance of SARS-CoV-2 Results in Self-collected Nasal Swabs vs Swabs Collected by Health Care Workers in Children and Adolescents

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME
Key Points

Question  Are children and adolescents, aged 4 to 14 years, able to adequately self-collect nasal swabs for SARS-CoV-2 testing after hearing and seeing brief and age-appropriate instructions?

Findings  In a cross-sectional study of 197 symptomatic children and adolescents, self-collected nasal swabs that were positive for SARS-CoV-2 agreed with results from health care worker–collected swabs in 97.8% of participants, while self-collected swabs that were negative agreed with health care worker–collected swabs in 98.1% of participants.

Meaning  SARS-CoV-2 detection in nasal swabs that were self-collected by school-aged children and adolescents, following simple instructions, demonstrated high agreement with results following collection by health care workers.

Abstract

Importance  Despite the expansion of SARS-CoV-2 testing, available tests have not received Emergency Use Authorization for performance with self-collected anterior nares (nasal) swabs from children younger than 14 years because the effect of pediatric self-swabbing on SARS-CoV-2 test sensitivity is unknown.

Objective  To characterize the ability of school-aged children to self-collect nasal swabs for SARS-CoV-2 testing compared with collection by health care workers.

Design, Setting, and Participants  Cross-sectional study of 197 symptomatic children and adolescents aged 4 to 14 years old. Individuals were recruited based on results of testing in the Children’s Healthcare of Atlanta system from July to August 2021.

Exposures  Children and adolescents were given instructional material consisting of a short instructional video and a handout with written and visual steps for self-swab collection. Participants first provided a self-collected nasal swab. Health care workers then collected a second specimen.

Main Outcomes and Measures  The primary outcome was SARS-CoV-2 detection and relative quantitation by cycle threshold (Ct) in self- vs health care worker–collected nasal swabs when tested with a real-time reverse transcriptase–polymerase chain reaction test with Emergency Use Authorization.

Results  Among the study participants, 108 of 194 (55.7%) were male and the median age was 9 years (IQR, 6-11). Of the 196 participants, 87 (44.4%) tested positive for SARS-CoV-2 and 105 (53.6%) tested negative by both self- and health care worker–collected swabs. Two children tested positive by self- or health care worker–collected swab alone; 1 child had an invalid health care worker swab. Compared with health care worker–collected swabs, self-collected swabs had 97.8% (95% CI, 94.7%-100.0%) and 98.1% (95% CI, 95.6%-100.0%) positive and negative percent agreement, respectively, and SARS-CoV-2 Ct values did not differ significantly between groups (mean [SD] Ct, self-swab: 26.7 [5.4] vs health care worker swab: 26.3 [6.0]; P = .65).

Conclusions and Relevance  After hearing and seeing simple instructional materials, children and adolescents aged 4 to 14 years self-collected nasal swabs that closely agreed on SARS-CoV-2 detection with swabs collected by health care workers.

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Corresponding Authors: Wilbur A. Lam, MD, PhD, Emory Children’s Center, 2015 Uppergate Dr NE, Room 448, Atlanta, GA 30322 (wilbur.lam@emory.edu); Greg S. Martin, MD, MSc, Emory University School of Medicine, 49 Jesse Hill Jr Dr SE, Atlanta, GA 30303 (greg.martin@emory.edu).

Accepted for Publication: August 9, 2022.

Published Online: August 26, 2022. doi:10.1001/jama.2022.14877

Author Contributions: Drs Waggoner and Lam had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Waggoner and Vos and Ms Tyburski contributed equally to this work.

Concept and design: Waggoner, Vos, Tyburski, Nguyen, Sullivan, Jerris, Levy, Farmer, Peagler, Wood, Heetderks, Li, Roth, Barcus, Stenzel, Lam.

Acquisition, analysis, or interpretation of data: Waggoner, Vos, Tyburski, Nguyen, Ingersoll, Miller, Griffiths, Stone, Benoit, Benedit, Seitter, Jerris, Levy, Kraft, Farmer, Wood, Westbrook, Morris, Sathian, Roth, Stenzel, Martin, Lam.

Drafting of the manuscript: Waggoner, Vos, Tyburski, Nguyen, Sullivan, Benoit, Benedit, Levy, Farmer, Peagler, Wood, Stenzel, Lam.

Critical revision of the manuscript for important intellectual content: Waggoner, Vos, Ingersoll, Miller, Griffiths, Stone, Benedit, Seitter, Jerris, Levy, Kraft, Westbrook, Morris, Sathian, Heetderks, Li, Roth, Barcus, Stenzel, Martin, Lam.

Statistical analysis: Waggoner, Tyburski, Benedit, Wood, Westbrook, Barcus, Lam.

Obtained funding: Heetderks, Martin, Lam.

Administrative, technical, or material support: Waggoner, Vos, Tyburski, Ingersoll, Miller, Sullivan, Griffiths, Stone, Benoit, Benedit, Seitter, Levy, Kraft, Wood, Sathian, Roth, Barcus, Stenzel, Martin, Lam.

Supervision: Waggoner, Vos, Sullivan, Griffiths, Levy, Kraft, Sathian, Stenzel, Lam.

Conflict of Interest Disclosures: Dr Waggoner reported receiving grants from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) during the conduct of the study. Ms Tyburski reported receiving grants from the National Institutes of Health (NIH; U54 center grant) during the conduct of the study. Dr Levy reported receiving grants from the NIH (1R03TR004022-01) outside the submitted work. Dr Kraft reported serving on the advisory boards of Rebiotix/Ferring and Seres Therapeutic outside the submitted work. Dr Morris reported receiving grants from the NIH (Rapid Acceleration of Diagnostics [RADx] grant funding) during the conduct of the study and having a patent for therapies for the treatment of coronaviruses pending (Emory patent-pending). Dr Martin reported receiving grants from the NIH (to Emory University) during the conduct of the study. Dr Lam reported receiving grants from the NIBIB during the conduct of the study. No other disclosures were reported.

Funding/Support: This work was supported by the NIBIB at the NIH under awards U54 EB027690-03S1 and U54 EB027690-03S2 and the National Center for Advancing Translational Sciences of the NIH under award UL1TR002378.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Additional Contributions: We thank the participants and their families for participation in this study. We acknowledge the contributions of Children’s Healthcare of Atlanta research coordinators Misty McGhee, AS, LPN; Lauren Robinsons, MS; and Rashad Wood, BS, on this project. These individuals did not receive financial compensation specifically for participation on this project. This study was a collaboration between Emory University, Children’s Healthcare of Atlanta, the RADx initiative of the NIH’s NIBIB, and the Food and Drug Administration. We acknowledge the helpful comments and feedback from team members affiliated with each of these entities during all phases of the study. The Children’s Clinical and Translational Discovery Core is supported by Children’s Healthcare of Atlanta and Emory University.

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