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Original research
Oral saliva swab reverse transcription PCR for Covid-19 in the paediatric population
  1. Cinta Moraleda1,2,
  2. Sara Domínguez-Rodríguez2,
  3. Juan Miguel Mesa3,
  4. Paula García-Sánchez4,
  5. María de la Serna3,
  6. José Antonio Alonso-Cadenas5,
  7. Amanda Bermejo6,
  8. Gema Sabrido7,
  9. Leticia Martínez-Campos8,
  10. Aránzazu Flavia González-Posada9,
  11. Marta Illán-Ramos10,
  12. Elena Cobos-Carrascosa2,
  13. Álvaro Ballesteros2,
  14. Juan Carlos Galán11,
  15. Francisco Llorente12,
  16. David Aguilera-Alonso13,
  17. Ana Belén Jiménez14,
  18. Pilar Catalán15,
  19. Elias Dahdouh16,
  20. Ignacio Navarro3,
  21. Bárbara Fernández-Garoz17,
  22. Pablo Mendoza18,
  23. Concepción Pérez-Jorge19,
  24. Teresa Cabezas-Fernández20,
  25. Daniel Blázquez-Gamero1,2,21,
  26. Gonzalo Rivas22,
  27. Patricia Gonzalez-Donapetry16,
  28. Elena Sáez23,
  29. Jovita Fernández-Pinero12,
  30. Jesús Lucas-Fernández11,
  31. Elisa Pérez-Ramírez12,
  32. Paloma Merino24,
  33. Sandra Miragaya17,
  34. Jorge Lorente25,
  35. Irene Iglesias12,
  36. Alfredo Tagarro2,3
  37. the EPICO working group
  1. 1 Pediatric Infectious Diseases Unit. Department of Pediatrics, Hospital Universitario 12 de Octubre. Pediatric Research and Clinical Trials Unit (UPIC). RITIP (Translational Research Network in Pediatric Infectious Diseases), Madrid, Spain
  2. 2 Instituto de Investigación 12 de Octubre (imas12), Fundación para la Investigación Biomédica del Hospital 12 de Octubre, Madrid, Spain
  3. 3 Paediatrics Department. Pediatrics Research Group, Hospital Universitario Infanta Sofia, San Sebastian de los Reyes, Madrid, Spain
  4. 4 Emergency Pediatric Department. Instituto Investigación Hospital La Paz (IDIPaz), Hospital Universitario La Paz, Madrid, Spain
  5. 5 Emergency Pediatric Department. Instituto Investigación La Princesa, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
  6. 6 Pediatric Department, Hospital Universitario de Móstoles, Móstoles, Madrid, Spain
  7. 7 Pediatric Department, Hospital Universitario Rey Juan Carlos, Móstoles, Madrid, Spain
  8. 8 Pediatric Infectious Diseases, Materno Infantil. Hospital Universitario Torrecárdenas, Almeria, Spain
  9. 9 Emergency Pediatric Department, Hospital Universitario 12 de Octubre, Madrid, Spain
  10. 10 Pediatrics Department, Hospital Universitario Clínico San Carlos, Madrid, Spain
  11. 11 Microbiology Department, Hospital Universitario Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública (CIBERESP), Madrid, Spain
  12. 12 Centro de Investigacion en Sanidad Animal INIA-CSIC, Valdeolmos, Madrid, Spain
  13. 13 Pediatric Infectious Diseases Unit. Department of Pediatrics, Hospital Universitario Gregorio Marañón. Unidad de Investigación Maternoinfantil Fundación Familia Alonso (UDIMIFFA), Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM). CIBER en Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain
  14. 14 Pediatrics Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
  15. 15 Servicio de Microbiologia Clinica y Enfermedades Infecciosas, Hospital General Universitario Gregorio Marañón, Madrid, Spain
  16. 16 Clinical Microbiology and Parasitology Department, Hospital Universitario La Paz. IdiPAZ, Madrid, Spain
  17. 17 Clinic Analysis Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
  18. 18 Microbiology Department, Hospital Universitario de Móstoles, Mostoles, Madrid, Spain
  19. 19 Microbiology Department, Hospital Universitario Rey Juan Carlos, Mostoles, Madrid, Spain
  20. 20 Microbiology Department, Hospital Universitario Torrecárdenas, Almería, Spain
  21. 21 Universidad Complutense, Madrid, Spain
  22. 22 Microbiology Department, Hospital Universitario 12 de Octubre, Madrid, Spain
  23. 23 Microbiology Department, UR Salud. Hospital Universitario Infanta Sofía. Paediatrics Research Group, San Sebastian de los Reyes, Madrid, Spain
  24. 24 Microbiology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain
  25. 25 Emergency Pediatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain
  1. Correspondence to Dr Cinta Moraleda, Department of Pediatrics, Hospital Universitario 12 de Octubre, Madrid 28041, Spain; cintamoraledaredecilla{at}gmail.com

Abstract

Objectives To evaluate the performance of oral saliva swab (OSS) reverse transcription PCR (RT-PCR) compared with RT-PCR and antigen rapid diagnostic test (Ag-RDT) on nasopharyngeal swabs (NPS) for SARS-CoV-2 in children.

Design Cross-sectional multicentre diagnostic study.

Setting Study nested in a prospective, observational cohort (EPICO-AEP) performed between February and March 2021 including 10 hospitals in Spain.

Patients Children from 0 to 18 years with symptoms compatible with Covid-19 of ≤5 days of duration were included. Two NPS samples (Ag-RDT and RT-PCR) and one OSS sample for RT-PCR were collected.

Main outcome Performance of Ag-RDT and RT-PCR on NPS and RT-PCR on OSS sample for SARS-CoV-2.

Results 1174 children were included, aged 3.8 years (IQR 1.7–9.0); 73/1174 (6.2%) patients tested positive by at least one of the techniques. Sensitivity and specificity of OSS RT-PCR were 72.1% (95% CI 59.7 to 81.9) and 99.6% (95% CI 99 to 99.9), respectively, versus 61.8% (95% CI 49.1 to 73) and 99.9% (95% CI 99.4 to 100) for the Ag-RDT. Kappa index was 0.79 (95% CI 0.72 to 0.88) for OSS RT-PCR and 0.74 (95% CI 0.65 to 0.84) for Ag-RDT versus NPS RT-PCR.

Conclusions RT-PCR on the OSS sample is an accurate option for SARS-CoV-2 testing in children. A less intrusive technique for younger patients, who usually are tested frequently, might increase the number of patients tested.

  • Covid-19
  • Microbiology
  • Molecular Biology
  • Virology
  • Infectious Disease Medicine

Data availability statement

Data are available on reasonable request. Not applicable.

This article is made freely available for personal use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

https://doi.org/10.1136/archdischild-2021-323712

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    Data availability statement

    Data are available on reasonable request. Not applicable.

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    Footnotes

    • Twitter @DavidAguileraAl

    • Collaborators EPICO working group: Francisco José Sanz MD, María Isabel Iglesias-Bouzas MD, Jose Antonio Alonso Cadenas MD, Blanca Herrero (Hospital Infantil Universitario Niño Jesús, Madrid, Spain), Teresa del Rosal MD, Ana Méndez-Echevarría MD, Talía Sainz MD, Clara Udaondo MD, Fernando Baquero MD, Cristina Calvo MD, Carlos Grasa MD, Paula R Molino MD, María José Mellado MD, María Ceano MD, Victor Galán MD, Paula Garcia Sanchez MD, Sonsoles San Roman (Hospital Universitario La Paz Madrid, Spain), Alicia Hernanz Lobo MD, Mar Santos MD, Marisa Navarro MD, Elena Rincón MD, David Aguilera-Alonso MD, Begoña Santiago MD, Jesús Saavedra, Jorge Huerta MD, Eduardo Bardón MD, Jorge Lorente MD, Pilar Catalán MD (Hospital Universitario Gregorio Marañón, Spain), Pablo Rojo MD, Daniel Blázquez MD, Luis Prieto MD, Elisa Fernández-Cooke MD, David Torres-Fernández MD, Ángela Manzanares MD, Jaime Carrasco MD, Cristina Epalza MD, Jesús Contreras MD, Sara Domínguez MD, Sara Villanueva MD, Arantxa Gonzalez (Hospital Universitario 12 de Octubre, Madrid, Spain), Cinta Moraleda MD, Alfredo Tagarro MD, Elena Cobos MD, Álvaro Ballesteros MD, Sara Domínguez-Rodriguez (Instituto de Investigación 12 de Octubre, Madrid, Spain), Gemma Pons MD, Silvia Simó MD, Miguel Lanaspa MD, Victoria Fumadó MD, Rosa María Pino MD, María Melé (Hospital Sant Joan de Déu, Barcelon, Spain), María Espiau MD, Jacques G. Rivière MD, Pere Soler-Palacín MD, Antonio Soriano Arandes MD, Natalia Mendoza (Hospital Universitari Vall d’Hebron, Barcelona, Spain), Mercedes Herranz MD, María Urretavizcaya Martínez (Complejo Hospitalario de Navarra, Navarra, Spain), Fernando Cabañas MD, Fátima Ara MD, Marta Baragaño (Hospital Universitario Quirón salud Madrid, Spain), Rut del Valle MD, Ana González-de-Zárate MD, Mónica Pacheco MD, María Luisa Herreros MD, Julia Yebra MD, Beatriz Pérez-Seoane MD, María Fernández MD, Teresa Raga MD, María de la Serna MD, Ane Plazaola MD, Juan Miguel Mesa MD, Rosa Batista MD, Ana Barrios MD, Ignacio Navarro MD, Jana Rizo MD, Teresa Reinoso MD, Alfonso Cañete (Hospital Universitario Infanta Sofía, Madrid, Spain), María Dolores Martín MD, Elena Sáez MD, Olga Nerea Coya MD, Fernando Cava (BR Salud, Madrid, Spain), Enrique Otheo MD, Juan Carlos Galán MD, José Luis Vázquez MD, Carmen Vázquez MD, Victor Quintero (Hospital Universitario Ramón y Cajal, Madrid, Spain), Lola Falcón MD, Olaf Neth MD, Peter Olbrich MD, Walter Goicoechea MD, Cati Márquez MD, Marisol Camacho MD, Inés Marín Cruz (Hospital Universitario Virgen del Rocío, Sevilla, Spain), Laura Martín (Hospital Universitario Regional de Málaga, Málaga, Spain), Lucía Figueroa (Hospital de Villalba, Madrid, Spain), María Llorente (Hospital Universitario del Sureste, Madrid, Spain), María Penin MD, Claudia García MD, María García MD, Teresa Alvaredo (Hospital Universitario Príncipe de Asturias, Madrid, Spain), Mª Inmaculada Olmedo MD, Agustín López MD, María Jose Pérez (Hospital Universitario Puerta de Hierro, Madrid, Spain), Elvira Cobo (Hospital Fundación Alcorcón, Madrid, Spain), Mariann Tovizi (Hospital del Tajo, Madrid, Spain), Pilar Galán (Hospital Universitario de Fuenlabrada, Madrid Spain), Beatriz Soto MD, Sara Guillén (Hospital de Getafe, Madrid, Spain), Adriana Navas (Hospital Universitario Infanta Leonor, Madrid, Spain) M. Luz García (Hospital de Leganés, Madrid, Spain), Sara Pérez (Hospital de Torrejó, Madrid, Spain), Amanda Bermejo MD, Pablo Mendoza (Hospital de Móstoles, Spain), Gema Sabrido (Hospital Rey Juan Carlos, Madrid, Spain), María José Hernández (Hospital Central de la Defensa, Madrid, Spain), Ana Belén Jiménez (Fundación Jiménez Díaz, Madrid, Spain), Arantxa Berzosa MD, José Tomás Ramos MD, Marta Illán (Hospital Clínico San Carlos, Madrid, Spain), Ana López MD, Nerea Gallego (Hospital Universitari Son Espases, Mallorca, Spain), Beatriz Ruiz (Hospital Universitario Reina Sofía, Granada, Spain), Santiago Alfayate MD, Ana Menasalvas MD, Eloísa Cervantes (Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain), María Méndez (Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol, Barcelona, Spain), Ángela Hurtado (Instituto Hispalense de Pediatría, Sevilla, Spain), Cristina García MD, Inés Amich MD, Yolanda Ruiz (Hospital San Pedro, Logroño, Spain), Manuel Oltra MD, Álvaro Villarroya-Villalba MD, Adela Cañete MD, Bienvenida Argiles (Hospital Universitari i Politècnic La Fe, Valencia, Spain), Angustias Ocaña (Hospital La Moraleja, Madrid, Spain), Isabel Romero MD, María Fernanda Guzmán (Hospitales Madrid, Madrid, Spain), M.J. Pascual (Hospital Nisa, Madrid, Spain), Francisco Llorente de Gracia, Jovita Fernández-Pinero, Miguel Ángel Jiménez-Clavero, Pilar Aguilera-Sepúlveda, Cristina Cano-Gómez (Centro de Investigación en Sanidad Animal INIA-CSIC, Valdeolmos, Madrid, Spain), María Sánchez-Códez (Hospital Universitario Puerta del Mar, Cádiz, Spain), Elena Montesinos (Consorci Hospital General Universitari de València, Valencia, Spain), Julia Jensen MD, María Rodríguez (Hospital Universitario Infanta Cristina, Madrid, Spain), Gloria Caro (Hospital Universitario Infanta Elena, Madrid, Spain), Neus Rius MD, Alba Gómez (Hospital Universitari Sant Joan de Reus, Reus, Spain), Rafael Bretón (Hospital Clínico Universitario de Valencia, Valencia, Spain), Margarita Rodríguez MD, Julio Romero MD, Juan Francisco Pascual Gazquez (Hospital Universitario Virgen de las Nieves, Granada, Spain), Ana Campos (Hospital Universitario Sanitas La Zarzuela, Madrid, Spain), Mercedes García (Hospital de Mérida, Mérida, Spain), Rosa María Velasco (Complejo Hospitalario de Toledo, Toledo, Spain), Zulema Lobato Althaia MD, (Xarxa Assistencial Universitària de Manresa, Manresa, Spain), Fernando Centeno MD, Elena Pérez MD, Alfredo Cano (Hospital Universitario Río Hortega, Valladolid, Spain), Paula Vidal (Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain), Corsino Rey MD, Ana Vivanco MD, Maruchi Alonso (Hospital Universitario Central de Asturias, Oviedo, Spain), Pedro Alcalá MD, Javier González de Dios MD, Laura Ureña Horno (Hospital General Universitario de Alicante, Alicante, Spain), Eduard Solé MD, Laura Minguell (Hospital Universitari Arnau de Vilanova, Catalunya, Spain), Itziar Astigarraga MD, Olatz Villate MD, Susana García Obregón (Hospital Universitario de Cruces, Bilbao, Spain), Mª Ángeles Vázquez MD, Miguel Sánchez MD, Leticia Martínez Campos (Hospital Universitario Torrecárdenas, Almería, Spain), Elena Díaz (Hospital Virgen de la Luz, Spain), Eduardo Consuegra MD, Susana Riesco MD, Almudena González MD, Maika Mendoza (Hospital Universitario de Salamanca, Salamanca, Spain), María Cabanillas (Complejo Asistencial Universitario de Palencia, Palencia, Spain), Yeray Novoa-Medina MD, Elena Colino-Gil MD, Ana Reyes-Domínguez MD, Luis Peña-Quintana (Hospital Universitario Materno Infantil de las Palmas, Las Palmas, Spain), Elisa Garrote MD, Maite Goicoechea (Hospital Universitario de Basurto, Basurto, Spain), Irene Centelles (Hospital General Universitari de Castelló, Castelló, Spain), Santiago Lapeña MD, Sara Gutiérrez MD, Soraya Gutiérrez (Complejo Asistencial Universitario de León, León, Spain), Amparo Cavalle (PIUS Hospital de Valls, Valls, Spain), José María Olmos (Hospital Mare de Déu dels Lliris, Catalunya, Spain), Alejandro Cobo MD, Sara Díaz MD, Cristina Martinez Faci MD, Macarena Gonzalez Cruz MD, Beatriz Castro (Hospital Universitario de Canarias, Tenerife, Spain), Beatriz Jiménez MD, Cristina Alvarez Alvarez (Hospital Universitario Marqués de Valdecilla, Santander, Spain), Raúl González (Hospital Sant Joan d’Alacant, Alicante, Spain), Miguel Lafuente MD, Matilde Bustillo (Hospital Infantil de Zaragoza, Zaragoza, Spain), Natividad Pons MD, Julia Morata (Hospital Lluís Alcanyis, Catalunya, Spain), Elsa Segura (Hospital Universitario Son Llatzer de Palma de Mallorca, Spain), María Bernardino (Universidad Europea de Madrid, Spain), Marta Pareja León (Complejo Hospitalario Universitario de Albacete, Albacete, Spain), Ana Domingo Ruiz (Hospital de Manacor, Mallorca, Spain), Eider Oñate MD, Nagore García de Andoin Baran (Hospital Universitario Donostia, Donostia, Spain), Nerea Domínguez-Pinilla (Hospital Virgen de la Salud, Spain), María Teresa Coll Sibina (Hospital General de Granollers, Granollers, Spain), María Jesús García García (Hospital Universitario de Cáceres, Cáceres, Spain), Marta Osuna (Hospital HM Montepríncipe, Madrid, Spain), Raquel Portugal (Hospital Universitario de Burgos, Burgos, Spain), Leonor García Maset (Hospital de Sagunto, Valencia, Spain), Belén Sevilla (Hospital Universitario San Cecilio, Granada, Spain), Noelia Berciano Jiménez (Hospital Virgen Macarena, Sevilla, Spain).

    • Contributors AT, CM, EC-C and JMM designed the study, contributed to the collection and interpretation of the data, drafted the initial manuscript and reviewed the final version. SD-R and AB designed the study, made the statistical analysis and drafted the initial manuscript, and reviewed the final version. FL, JF-P, EP-R and II carried out the viral cultures, and JCG and JL-F carried out the sgRNA analysis. PGS, MdlS, JAA-C, AB, GS, LM-C, AFG-P, MI-R, DA-A, ABJ, PC, ED, IN, BF-G, PM, CP-J, TC-F, DB-G, GR, PG-D, PM, SM, and JL contributed to the collection and interpretation of the data, the creation of the manuscript and reviewed the final version. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work. AT and CM accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

    • Funding The study was funded by: Project PI20/00095, from the Instituto de Salud Carlos III (Ministry of Economy, Industry and Competitiveness) and cofounded by the European Regional Development Fund, by Infanta Sofia University Hospital and Henares University Hospital Foundation for Biomedical Research and Innovation (FIIB HUIS HHEN), and by SERMAS-Fundación para la Investigación Biomédica del Hospital 12 de Octubre. EC-C is supported by the Spanish Society of Paediatrics (Asociación Española de Pediatría); Grant COVID-19 EPICO-AEP 2020. JMM is funded by SERMAS-Fundación para la Investigación Biomédica del Hospital Infanta Sofía y del Henares and by Universidad Europea de Madrid, Spain. MdlS is funded by Grant Cantera de Investigación Santander, Fundación Universidad Europea de Madrid, Spain. ED is funded by the Juan de la Cierva–Incorporación granted by the Spanish Ministry of Science and Innovation. DB-G is funded by the Spanish Ministry of Science and Innovation—Instituto de Salud Carlos III and Fondos FEDER by 'Contratos para la intensificación de la actividad investigadora en el Sistema Nacional de Salud, 2020 (INT20/00086)'.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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