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. 2022 Sep 13;328(10):935-940.
doi: 10.1001/jama.2022.14877.

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

Jesse J Waggoner  1 , Miriam B Vos  1   2 , Erika A Tyburski  3 , Phuong-Vi Nguyen  1 , Jessica M Ingersoll  1 , Candace Miller  1 , Julie Sullivan  1 , Mark Griffiths  2 , Cheryl Stone  2 , Macarthur Benoit  2 , Laura Benedit  2 , Brooke Seitter  2 , Robert Jerris  2 , Joshua M Levy  1 , Colleen S Kraft  1 , Sarah Farmer  3 , Amanda Peagler  3 , Anna Wood  4 , Adrianna L Westbrook  4 , Claudia R Morris  1   2 , Usha N Sathian  2 , William Heetderks  5 , Li Li  6 , Kristian Roth  6 , Mary Barcus  6 , Timothy Stenzel  7 , Greg S Martin  1 , Wilbur A Lam  1   2   3
Affiliations

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

Jesse J Waggoner et al. JAMA. .

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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Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.. Study Flowchart of Children and Adolescents Enrolled in a Study of Self-swabbing for SARS-CoV-2 Testing
Data were not systematically recorded for all potential callback participants who were not enrolled, including those with incorrect contact information, no-answers, and immediate refusals without listening to the complete telephone script. HCW indicates health care worker; RNase, ribonuclease.
Figure 2.
Figure 2.. Comparison of Nucleocapsid 2 (N2) Cycle Threshold (Ct) Values From Self- and Health Care Worker (HCW)–Collected Swabs
A, Overall distribution of SARS-CoV-2 N2 target Ct values (bars display means and SDs). Ct values compared by 2-sided t test yielding a P value of .65. B, Paired SARS-CoV-2 N2 Ct values for self- and HCW-collected swabs. All displayed results were obtained with the Centers for Disease Control and Prevention’s Emergency Use Authorization real-time reverse transcriptase–polymerase chain reaction (RT-PCR) test and interpreted according to the instructions for use. Ct values are defined as the RT-PCR cycle at which an amplification curve crosses the defined signal threshold. This defines a positive result, with lower Ct values indicating higher concentrations of viral RNA in the sample.
See this image and copyright information in PMC

Comment in

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