Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents

doi:10.1016/j.jinf.2022.12.017

. 2023 Mar;86(3):256-308.

doi: 10.1016/j.jinf.2022.12.017. Epub 2022 Dec 21.

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents

Manuel Krone¹, Isabell Wagenhäuser², Kerstin Knies³, Daniela Hofmann³, Geraldine Engels⁴, Regina Taurines⁵, Miriam McDonogh⁶, Sven Flemming⁷, Thomas Meyer⁷, Hartmut Böhm⁸, Agmal Scherzad⁹, Michael Eisenmann¹⁰, Vera Rauschenberger¹¹, Alexander Gabel¹⁰, Nils Petri¹², Julia Reusch², Johannes Forster¹³, Benedikt Weißbrich³, Lars Dölken³, Oliver Kurzai¹⁴, Ulrich Vogel¹¹, Christoph Härtel⁴, Johannes Liese⁴, Oliver Andres⁴

Affiliations

¹ Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany; Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany. Electronic address: krone_m@ukw.de.
² Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany; Department of Internal Medicine I, University Hospital Wuerzburg, Oberdürrbacher Str. 6, Wuerzburg 97080, Germany.
³ Institute for Virology and Immunobiology, University of Wuerzburg, Versbacher Str. 7, Würzburg 97078, Germany.
⁴ Department of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
⁵ Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wuerzburg, Margarete-Höppel-Platz 1, Würzburg 97080, Germany.
⁶ Department of Orthopaedic Trauma, Hand, Plastic and Reconstructive Surgery, University Hospital Wuerzburg, Oberdürrbacher Str. 6, Wuerzburg 97080, Germany.
⁷ Department of General, Visceral, Transplantation, Vascular and Paediatric Surgery, University Hospital Wuerzburg, Oberdürrbacher Str. 6, Wuerzburg 97080, Germany.
⁸ Department of Oral and Maxillofacial Surgery, University Hospital Wuerzburg, Pleicherwall 2, Wuerzburg 97070, Germany.
⁹ Department of Otorhinolaryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, University Hospital Wuerzburg, Josef-Schneider-Str. 11, Wuerzburg 97080, Germany.
¹⁰ Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany.
¹¹ Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany; Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany.
¹² Department of Internal Medicine I, University Hospital Wuerzburg, Oberdürrbacher Str. 6, Wuerzburg 97080, Germany.
¹³ Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany.
¹⁴ Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany; Leibniz Institute for Natural Product Research and Infection Biology - Hans-Knoell-Institute, Beutenbergstraße 13, Jena 07745, Germany.

PMID: 36565725
PMCID: PMC9767879
DOI: 10.1016/j.jinf.2022.12.017

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents

Manuel Krone et al. J Infect. 2023 Mar.

. 2023 Mar;86(3):256-308.

doi: 10.1016/j.jinf.2022.12.017. Epub 2022 Dec 21.

Authors

Affiliations

¹ Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany; Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany. Electronic address: krone_m@ukw.de.
² Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany; Department of Internal Medicine I, University Hospital Wuerzburg, Oberdürrbacher Str. 6, Wuerzburg 97080, Germany.
³ Institute for Virology and Immunobiology, University of Wuerzburg, Versbacher Str. 7, Würzburg 97078, Germany.
⁴ Department of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
⁵ Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wuerzburg, Margarete-Höppel-Platz 1, Würzburg 97080, Germany.
⁶ Department of Orthopaedic Trauma, Hand, Plastic and Reconstructive Surgery, University Hospital Wuerzburg, Oberdürrbacher Str. 6, Wuerzburg 97080, Germany.
⁷ Department of General, Visceral, Transplantation, Vascular and Paediatric Surgery, University Hospital Wuerzburg, Oberdürrbacher Str. 6, Wuerzburg 97080, Germany.
⁸ Department of Oral and Maxillofacial Surgery, University Hospital Wuerzburg, Pleicherwall 2, Wuerzburg 97070, Germany.
⁹ Department of Otorhinolaryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, University Hospital Wuerzburg, Josef-Schneider-Str. 11, Wuerzburg 97080, Germany.
¹⁰ Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany.
¹¹ Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany; Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany.
¹² Department of Internal Medicine I, University Hospital Wuerzburg, Oberdürrbacher Str. 6, Wuerzburg 97080, Germany.
¹³ Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany.
¹⁴ Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2, Wuerzburg 97080, Germany; Leibniz Institute for Natural Product Research and Infection Biology - Hans-Knoell-Institute, Beutenbergstraße 13, Jena 07745, Germany.

PMID: 36565725
PMCID: PMC9767879
DOI: 10.1016/j.jinf.2022.12.017

No abstract available

Keywords: COVID-19 vaccination; Children; Clinical performance evaluation; PCR; Paediatric; SARS-CoV-2 antigen rapid diagnostic test; SARS-CoV-2 virus variants of concern.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest Manuel Krone receives honoraria from Abbott outside the submitted work. None of the other authors has any conflicts of interests to declare.

Figures

Fig 1 — **Fig. 1**
Enrolment of antigen rapid diagnostic test (RDT) results. RDT: Antigen rapid diagnostic test. RT-qPCR: Quantitative reverse transcription polymerase chain reaction.

Fig 2 — **Fig. 2**
RDT performance in comparison to RT-qPCR stratified by age categories, VOC, and COVID-19 symptomatology. Fig. 2 A–C: RDT sensitivity (n = 351), logarithmised viral load (n = 348), and symptomatology (n = 351) in SARS-CoV-2 RNA copies/ml stratified by age categories (first year of life, 1 to 5 years, 6 to 11 years, 12 to 17 years). D portrays the logarithmised viral load in SARS-CoV-2 RNA copies/ml, separated by RDT and COVID-19 symptomatology, n = 339. The viral load of specimen of typically COVID-19 symptomatic children and adolescents exceeded statistically significant the viral load of atypically symptomatic or asymptomatic individuals. E included 346 specimens with either molecularly confirmed or epidemiologically assigned VOC (in case of no molecular VOC diagnostics or, if available, known VOC of the infection source, VOC was assigned based on the VOC corresponding to at least 90% of the German COVID-19 cases at RDT performance).F: Viral load in 306 specimens with known COVID-19 vaccination status stratified by vaccination status only and by vaccination status and RDT result. The viral load threshold of 10⁶ SARS-CoV-2 RNA copies/ml, suggested as infectivity threshold, is added as horizontal dotted line to B,D,F. n: Number of enrolled RDT per group. RDT: Antigen rapid diagnostic test. RT-qPCR: Quantitative reverse transcription polymerase chain reaction. *p < 0.05. ^⁎⁎p < 0.01. ^⁎⁎⁎⁎p < 0.0001.

See this image and copyright information in PMC

References

1. Ladhani S.N. Face masking for children - time to reconsider. J Infect. 2022;85(6):623–624. - PMC - PubMed
1. Forster J., Streng A., Rudolph P., Rücker V., Wallstabe J., Timme S., et al. Feasibility of SARS-CoV-2 surveillance testing among children and childcare workers at German day care centers: a nonrandomized controlled trial. JAMA Netw Open. 2022;5(1) - PMC - PubMed
1. Carbonell-Sahuquillo S., Lázaro-Carreño M.I., Camacho J., Barrés-Fernández A., Albert E., Torres I., et al. Evaluation of a rapid antigen detection test (Panbio™ COVID-19 Ag rapid test device) as a point-of-care diagnostic tool for COVID-19 in a pediatric emergency department. J Med Virol. 2021;93(12):6803–6807. - PMC - PubMed
1. González-Donapetry P., García-Clemente P., Bloise I., García-Sánchez C., MÁ S.C., Romero M.P., et al. Think of the children: evaluation of SARS-CoV-2 rapid antigen test in pediatric population. Pediatr Infect Dis J. 2021;40(5):385–388. - PubMed
1. L’Huillier A.G., Lacour M., Sadiku D., Gadiri M.A., Siebenthal L.D., Schibler M., et al. Diagnostic accuracy of SARS-CoV-2 rapid antigen detection testing in symptomatic and asymptomatic children in the clinical setting. J Clin Microbiol. 2021;59(9):e0099121. - PMC - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information
Miscellaneous
- NCI CPTAC Assay Portal

[1] Ladhani S.N. Face masking for children - time to reconsider. J Infect. 2022;85(6):623–624. - PMC - PubMed

[2] Ladhani S.N. Face masking for children - time to reconsider. J Infect. 2022;85(6):623–624. - PMC - PubMed

[3] Forster J., Streng A., Rudolph P., Rücker V., Wallstabe J., Timme S., et al. Feasibility of SARS-CoV-2 surveillance testing among children and childcare workers at German day care centers: a nonrandomized controlled trial. JAMA Netw Open. 2022;5(1) - PMC - PubMed

[4] Forster J., Streng A., Rudolph P., Rücker V., Wallstabe J., Timme S., et al. Feasibility of SARS-CoV-2 surveillance testing among children and childcare workers at German day care centers: a nonrandomized controlled trial. JAMA Netw Open. 2022;5(1) - PMC - PubMed

[5] Carbonell-Sahuquillo S., Lázaro-Carreño M.I., Camacho J., Barrés-Fernández A., Albert E., Torres I., et al. Evaluation of a rapid antigen detection test (Panbio™ COVID-19 Ag rapid test device) as a point-of-care diagnostic tool for COVID-19 in a pediatric emergency department. J Med Virol. 2021;93(12):6803–6807. - PMC - PubMed

[6] Carbonell-Sahuquillo S., Lázaro-Carreño M.I., Camacho J., Barrés-Fernández A., Albert E., Torres I., et al. Evaluation of a rapid antigen detection test (Panbio™ COVID-19 Ag rapid test device) as a point-of-care diagnostic tool for COVID-19 in a pediatric emergency department. J Med Virol. 2021;93(12):6803–6807. - PMC - PubMed

[7] González-Donapetry P., García-Clemente P., Bloise I., García-Sánchez C., MÁ S.C., Romero M.P., et al. Think of the children: evaluation of SARS-CoV-2 rapid antigen test in pediatric population. Pediatr Infect Dis J. 2021;40(5):385–388. - PubMed

[8] González-Donapetry P., García-Clemente P., Bloise I., García-Sánchez C., MÁ S.C., Romero M.P., et al. Think of the children: evaluation of SARS-CoV-2 rapid antigen test in pediatric population. Pediatr Infect Dis J. 2021;40(5):385–388. - PubMed

[9] L’Huillier A.G., Lacour M., Sadiku D., Gadiri M.A., Siebenthal L.D., Schibler M., et al. Diagnostic accuracy of SARS-CoV-2 rapid antigen detection testing in symptomatic and asymptomatic children in the clinical setting. J Clin Microbiol. 2021;59(9):e0099121. - PMC - PubMed

[10] L’Huillier A.G., Lacour M., Sadiku D., Gadiri M.A., Siebenthal L.D., Schibler M., et al. Diagnostic accuracy of SARS-CoV-2 rapid antigen detection testing in symptomatic and asymptomatic children in the clinical setting. J Clin Microbiol. 2021;59(9):e0099121. - PMC - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents

Affiliations

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents

Authors

Affiliations

Conflict of interest statement

Figures

Similar articles

References

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous