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Infectious Diseases

Acceptance of Different Self-sampling Methods for Semiweekly SARS-CoV-2 Testing in Asymptomatic Children and Childcare Workers at German Day Care CentersA Nonrandomized Controlled Trial

Educational Objective
To identify the key insights or developments described in this article

1 Credit CME

JAMA Network Open

Published Online: September 15, 2022

Original Investigation

Article Information and Disclosures

Author Affiliations

¹Department of Pediatrics, University Hospital Wuerzburg, Würzburg, Germany
²Institute for Hygiene and Microbiology, University of Wuerzburg, Würzburg, Germany
³Institute of Clinical Epidemiology and Biometry, University of Wuerzburg, Würzburg, Germany
⁴Leibniz Institute for Natural Product Research and Infection Biology–Hans-Knoell-Institute, Jena, Germany
⁵Department of General Practice, University Hospital Wuerzburg, Würzburg, Germany
⁶Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wuerzburg, Würzburg, Germany
⁷Institute for Virology and Immunobiology, University of Wuerzburg, Würzburg, Germany
⁸Clinical Trial Center Wuerzburg, University Hospital Wuerzburg, Würzburg, Germany

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Key Points

Question What is the acceptance and feasibility of different methods of twice weekly SARS-CoV-2 monitoring in asymptomatic children and childcare workers in day care centers?

Findings In this nonrandomized controlled trial and feasibility study with 452 children and 139 childcare workers, self-sampled surveillance testing via saliva sampling and/or nasal rapid antigen self-test for SARS-CoV-2 was well accepted and provided a high sense of safety.

Meaning These findings suggest that self-sampled continuous testing allowing continued day care for children should be established based on age-adjusted SARS-CoV-2 incidence rates.

Abstract

Importance Closure of day care centers (DCCs) to contain the COVID-19 pandemic has been associated with negative effects on children’s health and well-being.

Objective To investigate the acceptance of self-sampling methods for continuous SARS-CoV-2 surveillance among asymptomatic children and childcare workers (CCWs) in DCCs.

Design, Setting, and Participants This nonrandomized pilot study included children and CCWs at 9 DCCs in Wuerzburg, Germany, from May to July 2021.

Interventions Twice weekly testing for SARS-CoV-2 was conducted by self-sampled mouth-rinsing fluid (saliva sampling [SAL], with subsequent pooled polymerase chain reaction test) plus nasal rapid antigen self-test (RAgT) (group 1), SAL only (group 2), or RAgT only (group 3) in children and CCWs.

Main Outcomes and Measures Main outcomes were rates for initial acceptance and successful (≥60% of scheduled samples) long-term participation. The probability of SARS-CoV-2 introduction into DCCs was modeled as a function of age-adjusted background incidence and DCC size.

Results Of 836 eligible children, 452 (54.1%; 95% CI, 50.7%-57.4%) participated (median [IQR] age: 4 [3-5] years; 213 [47.1%] girls), including 215 (47.6%) in group 1, 172 (38.1%) in group 2, and 65 (14.4%) in group 3. Of 190 CCWs, 139 (73.2%; 95% CI, 66.4%-79.0%) participated (median [IQR] age: 30 [25-46] years; 128 [92.1%] women), including 96 (69.1%) in group 1, 29 (20.9%) in group 2, and 14 (10.1%) in group 3. Overall, SARS-CoV-2 PCR tests on 5306 SAL samples and 2896 RAgTs were performed in children, with 1 asymptomatic child detected by PCR from SAL. Successful long-term participation was highest in group 2 (SAL only; children: 111 of 172 [64.5%]; CCWs: 18 of 29 [62.1%]). Weekly participation rates in children ranged from 54.0% to 83.8% for SAL and from 44.6% to 61.4% for RAgT. Participation rates decreased during the study course (P < .001). The probability of SARS-CoV-2 introduction into a DCC with 50 children was estimated to reach at most 5% for an age-adjusted SARS-CoV-2 incidence below 143.

Conclusions and Relevance Self-sampling for continuous SARS-CoV-2 testing was well accepted, with SAL being the preferred method. Given the high number of negative tests, thresholds for initiating continuous testing should be established based on age-adjusted SARS-CoV-2 incidence rates.

Trial Registration German Registry for Clinical Trials Identifier: DRKS00025546

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Article Information

Accepted for Publication: July 27, 2022.

Published: September 15, 2022. doi:10.1001/jamanetworkopen.2022.31798

Correction: This article was corrected on October 12, 2022, to fix an error in Figure 3.

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Engels G et al. JAMA Network Open.

Corresponding Author: Johannes Liese, MD, MSc, Department of Pediatrics, University Children’s Hospital, Josef-Schneider-Str. 2 / D31, D-97080 Würzburg, Germany (liese_j@ukw.de).

Author Contributions: Drs Liese and Kurzai had full access to all study data and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Engels, Forster, Liese, and Kurzai contributed equally to this work.

Concept and design: Engels, Forster, Streng, Rücker, Pietsch, Schmidt, Jans, Dölken, Heuschmann, Härtel, Gágyor, Liese, Kurzai.

Acquisition, analysis, or interpretation of data: Engels, Forster, Streng, Rücker, Rudolph, Pietsch, J. Wallstabe, L. Wallstabe, Krauthausen, Schmidt, Ludwig, Bauer, Gierszewski, Bendig, Timme, Jans, Weißbrich, Romanos, Gágyor, Figge, Liese, Kurzai.

Drafting of the manuscript: Engels, Forster, Streng, Rudolph, Pietsch, J. Wallstabe, Bendig, Timme, Liese, Kurzai.

Critical revision of the manuscript for important intellectual content: Rücker, J. Wallstabe, L. Wallstabe, Krauthausen, Schmidt, Ludwig, Bauer, Gierszewski, Jans, Weißbrich, Romanos, Dölken, Heuschmann, Härtel, Gágyor, Figge, Liese, Kurzai.

Statistical analysis: Rücker, Rudolph, Schmidt, Bauer, Bendig, Timme, Heuschmann, Figge.

Obtained funding: Romanos, Gágyor, Liese, Kurzai.

Administrative, technical, or material support: Pietsch, J. Wallstabe, L. Wallstabe, Krauthausen, Bendig, Weißbrich, Romanos, Dölken, Härtel, Gágyor, Figge, Liese, Kurzai.

Supervision: Engels, Forster, Streng, Romanos, Heuschmann, Härtel, Figge, Liese, Kurzai.

Conflict of Interest Disclosures: Dr Streng reported receiving grants from GlaxoSmithKline, Janssen-Cilag, Pfizer Pharma, Sanofi Pasteur, and MSD paid to the institution outside the submitted work. Dr Weißbrich reported receiving grants from the Federal Ministry for Education and Science grants during the conduct of the study. Dr Romanos reported receiving grants from Bundesministerium für Bildung und Forschung during the conduct of the study. Dr Heuschmann reported receiving grants from German Ministry of Research and Education, the European Union, the German Parkinson Society, University Hospital Würzburg, Robert Koch Institute, German Heart Foundation, Federal Joint Committee within the Innovationfond, German Research Foundation, Bavarian State (Ministry for Science and the Arts), German Cancer Aid, Charité–Universitätsmedizin Berlin (supported by an unrestricted research grant from Bayer), University Göttingen (supported by an unrestricted research grant from Boehringer-Ingelheim), and grants from University Hospital Heidelberg (supported by an unrestricted research grant from Bayer, BMS, Boehringer-Ingelheim, and Daiichi Sankyo) outside the submitted work. Dr Gágyor reported receiving personal fees from Federal Ministry of Education and Research Germany during the conduct of the study. Dr Liese reported receiving grants from GlaxoSmithKline, Janssen-Cilag, Pfizer, MSD, and Sanofi Pasteur outside the submitted work. Dr Kurzai reported receiving grants from Federal Ministry for Education and Research, Free State of Bavaria, Germany COVID research funds, and the Bavarian Ministry of Health via the Bavarian Office for Health and Food Safety and receiving nonfinancial support from the city of Wuerzburg in the form of vehicles to transport equipment and personnel during the conduct of the study and receiving grants from the Federal Ministry for Education and Research and Bavarian Ministry of Health via the Bavarian Office for Science and Arts outside the submitted work and participating in SARS-CoV-2 expert panels of the city and county of Wuerzburg. No other disclosures were reported.

Funding/Support: The study was funded by the Bavarian State Ministry of Health and Care and the Bavarian Health and Food Safety Authority (GP1i-G8000-2021/278-16) (Dr Liese).

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.

Group Information: See Supplement 3.

Additional Contributions: We thank all participating day care centers and their staff for their friendly support, and all parents, children, and childcare workers for their study participation. We thank the following for their support in organizing the study: Annsophie Amman, Leonie Bode, Inga Enders, Thiemo Frank, Greta Habersack, Viktoria Hamway, Timo Spannagel, Fabian Rothbauer (Institute for Hygiene and Microbiology, University of Wuerzburg); Marianna Abert, Tatjana Durnev, Carolin Glatzle, Antonia Hardung, Katharina Karch, Sebastian Kollert, Tanja Mastorakis, Lena Schregelmann, Victoria Sokalski, Eva-Lotta Tanzberger, Denise Yilmaz, Stefan Zimmerling (Department of Pediatrics, University Hospital Wuerzburg); Brigitte Wehner, Maximilian Siegl (Hematological Laboratory, University Hospital Würzburg). Furthermore, we thank Patricia Niekler, MSc, and Karin Seeger, MPH, for their language support.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.