Please login with your free MJA account to view this article in full
Please note: institutional and Research4Life access to the MJA is now provided through Wiley Online Library.
- 1 The Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, VIC
- 2 The Royal Children’s Hospital, Melbourne, VIC
- 3 Melbourne Medical School, University of Melbourne, Melbourne, VIC
- 4 The Royal Women’s Hospital, Melbourne, VIC
- 5 cohealth, Melbourne, VIC
- 6 Cirqit Health, Melbourne, VIC
- 7 The University of Melbourne, Melbourne, VIC
- 8 Public Health Laboratory, University of Melbourne, Melbourne, VIC
- 9 Royal Melbourne Hospital, Melbourne, VIC
- 10 Victorian Infectious Diseases Reference Laboratory, Melbourne Health, Melbourne, VIC
- 11 Melbourne Health, Melbourne, VIC
- 12 Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC), Murdoch Children’s Research Institute, Melbourne, VIC
Our study was supported by a donation from the Isabel and John Gilbertson Charitable Trust. We acknowledge all participants, and the clinical, administrative and laboratory staff who assisted our study at the Royal Children’s Hospital Melbourne, cohealth, Cirqit Health, the Microbiological Diagnostic Unit Public Health Laboratory, Golden Messenger, the Royal Melbourne Hospital, and the University of Melbourne.
No relevant disclosures.
- 1. Public Health Laboratory Network. PHLN guidance on laboratory testing for SARS‐CoV‐2 (the virus that causes COVID‐19), version 1.16. Updated Feb 2021. https://www.health.gov.au/resources/publications/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19 (viewed May 2021).
- 2. Fernandes LL, Pacheco VB, Borges L, et al. Saliva in the diagnosis of COVID‐19: a review and new research directions. J Dent Res 2020; 99: 1435–1443.
- 3. Kivelä JM, Jarva H, Lappalainen M, Kurkela S. Saliva‐based testing for diagnosis of SARS‐CoV‐2 infection: a meta‐analysis. J Med Virol 2021; 93: 1256–1258.
- 4. Khiabani K, Amirzade‐Iranaq MH. Are saliva and deep throat sputum as reliable as common respiratory specimens for SARS‐CoV‐2 detection? A systematic review and meta‐analysis. Am J Infect Control 2021; https://doi.org/10.1016/j.ajic.2021.03.008 [online ahead of print].
- 5. Buban JM, Villanueva PN, Gregorio GEV. Should RT‐PCR of saliva samples be used for diagnosis of COVID‐19? (Philippine COVID‐19 Living Clinical Practice Guidelines). Updated 15 Mar 2021. https://www.psmid.org/wp-content/uploads/2021/05/SALIVA-RT-PCR-CPG-FINAL_031521_MMA.pdf (viewed May 2021).
- 6. Tsang NNY, So HC, Ng KY, et al. Diagnostic performance of different sampling approaches for SARS‐CoV‐2 RT‐PCR testing: a systematic review and meta‐analysis. Lancet Infect Dis 2021; https://doi.org/10.1016/S1473-3099(21)00146-8 [online ahead of print].
- 7. Zhu J, Guo J, Xu Y, Chen X. Viral dynamics of SARS‐CoV‐2 in saliva from infected patients. J Infect 2020; 81: e48–e50.
- 8. Ruggiero A, Sanguinetti M, Gatto A, et al. Diagnosis of COVID‐19 infection in children: less nasopharyngeal swabs, more saliva. Acta Paediatr 2020; 109: 1913–1914.
- 9. Chong CY, Kam KQ, Li J, et al. Saliva is not a useful diagnostic specimen in children with coronavirus disease 2019 [letter]. Clin Infect Dis 2020; https://doi.org/10.1093/cid/ciaa1376 [online ahead of print].
- 10. Han MS, Seong MW, Kim N, et al. Viral RNA load in mildly symptomatic and asymptomatic children with COVID‐19, Seoul, South Korea. Emerg Infect Dis 2020; 26: 2497–2499.
- 11. Yee R, Truong TT, Pannaraj PS, et al. Saliva is a promising alternative specimen for the detection of SARS‐CoV‐2 in children and adults. J Clin Microbiol 2021; 59: e02686–20.
- 12. Huber M, Schreiber PW, Scheier T, et al. High efficacy of saliva in detecting SARS‐CoV‐2 by RT‐PCR in adults and children. Microorganisms 2021; 9: 642.
- 13. Fougère Y, Schwob JM, Miauton A, et al. Performance of RT‐PCR on saliva specimens compared to nasopharyngeal swabs for the detection of SARS‐CoV‐2 in children: a prospective comparative clinical trial [preprint]. medRxiv , 1 Mar 2021. https://doi.org/10.1101/2021.02.27.21252571 (viewed May 2021).
- 14. Felix AC, De Paula AV, Ribeiro AC, et al. Saliva as a reliable sample for COVID‐19 diagnosis in paediatric patients [preprint]. medRxiv , 31 Mar 2021. https://doi.org/10.1101/2021.03.29.21254566 (viewed May 2021).
- 15. Al Suwaidi H, Senok A, Varghese R, et al. Saliva for molecular detection of SARS‐CoV‐2 in school‐age children. Clin Microbiol Infect 2021; https://doi.org/10.1016/j.cmi.2021.02.009 [online ahead of print].
- 16. Department of Health and Human Services (Victoria). Assessment and testing criteria for coronavirus (COVID‐19). Updated 9 Apr 2021. https://www.dhhs.vic.gov.au/assessment-and-testing-criteria-coronavirus-covid-19 (viewed May 2021).
- 17. Department of Health and Human Services (Victoria). Coronavirus (COVID‐19). https://www.dhhs.vic.gov.au/coronavirus (viewed May 2021).
- 18. Cohen JF, Korevaar DA, Altman DG, et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open 2016; 6: e012799.
- 19. Williams E, Bond K, Zhang B, et al. Saliva as a noninvasive specimen for detection of SARS‐CoV‐2. J Clin Microbiol 2020; 58: e00776–20.
- 20. Ku CW, Shivani D, Kwan JQT, et al. Validation of self‐collected buccal swab and saliva as a diagnostic tool for COVID‐19. Int J Infect Dis 2021; 104: 255–261.
- 21. Zimba R, Kulkarni S, Berry A, et al; the CHASING COVID Cohort Study Team. Testing, testing: what SARS‐CoV‐2 testing services do adults in the United States actually want? [preprint]. medRxiv, 18 Sept 2020. https://doi.org/10.1101/2020.09.15.20195180 (viewed May 2021).
- 22. Communicable Diseases Network Australia. Coronavirus disease 2019 (COVID‐19): CDNA national guidelines for public health units; version 3.1. Updated 4 June 2020. https://www1.health.gov.au/internet/main/publishing.nsf/Content/cdna-song-novel-coronavirus.htm (viewed May 2021).
- 23. Caulley L, Corsten M, Eapen L, et al. Salivary detection of COVID‐19. Ann Intern Med 2021; 174: 131–133.
- 24. Byrne RL, Kay GA, Kontogianni K, et al. Saliva offers a sensitive, specific and non‐invasive alternative to upper respiratory swabs for SARS‐CoV‐2 diagnosis [pre‐print]. medRxiv, 11 July 2020. https://doi.org/10.1101/2020.07.09.20149534 (viewed May 2021).
- 25. Landry ML, Criscuolo J, Peaper DR. Challenges in use of saliva for detection of SARS CoV‐2 RNA in symptomatic outpatients. J Clin Virol 2020; 130: 104567.
- 26. Vogels CBF, Watkins AE, Harden CA, et al. SalivaDirect: a simplified and flexible platform to enhance SARS‐CoV‐2 testing capacity. Med (NY) 2021; 2: 263–280.
- 27. Ceron JJ, Lamy E, Martinez‐Subiela S,et al. Use of saliva for diagnosis and monitoring the SARS‐CoV‐2: a general perspective. J Clin Med 2020; 9: 1491.


Abstract
Objective: To compare the concordance and acceptability of saliva testing with standard‐of‐care oropharyngeal and bilateral deep nasal swab testing for severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) in children and in general practice.
Design: Prospective multicentre diagnostic validation study.
Setting: Royal Children’s Hospital, and two general practices (cohealth, West Melbourne; Cirqit Health, Altona North) in Melbourne, July–October 2020.
Participants: 1050 people who provided paired saliva and oropharyngeal‐nasal swabs for SARS‐CoV‐2 testing.
Main outcome measures: Numbers of cases in which SARS‐CoV‐2 was detected in either specimen type by real‐time polymerase chain reaction; concordance of results for paired specimens; positive percent agreement (PPA) for virus detection, by specimen type.
Results: SARS‐CoV‐2 was detected in 54 of 1050 people with assessable specimens (5%), including 19 cases (35%) in which both specimens were positive. The overall PPA was 72% (95% CI, 58–84%) for saliva and 63% (95% CI, 49–76%) for oropharyngeal‐nasal swabs. For the 35 positive specimens from people aged 10 years or more, PPA was 86% (95% CI, 70–95%) for saliva and 63% (95% CI, 45–79%) for oropharyngeal‐nasal swabs. Adding saliva testing to standard‐of‐care oropharyngeal‐nasal swab testing increased overall case detection by 59% (95% CI, 29–95%). Providing saliva was preferred to an oropharyngeal‐nasal swab by most participants (75%), including 141 of 153 children under 10 years of age (92%).
Conclusion: In children over 10 years of age and adults, saliva testing alone may be suitable for SARS‐CoV‐2 detection, while for children under 10, saliva testing may be suitable as an adjunct to oropharyngeal‐nasal swab testing for increasing case detection.