Comparison of saliva with oral and nasopharyngeal swabs for SARS-CoV-2 detection on various commercial and laboratory-developed assays.

Annie-Claude Labbé, Patrick Benoit, Sarah Gobeille Paré, François Coutlée, Simon Lévesque, Julie Bestman-Smith, Jeannot Dumaresq, Christian Lavallée, Claudia Houle, Philippe Martin, Anton Mak, Philippe Gervais, Stéphanie Langevin, Mariève Jacob-Wagner, Simon Gagnon, Manon St-Hilaire, Nathalie Lussier, Ariane Yechouron, David Roy, Michel Roger, Judith Fafard
Author Information
  1. Annie-Claude Labbé: Service de maladies infectieuses et de microbiologie, Département de médecine spécialisée, Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Ile-de-Montréal, Montréal, Québec, Canada. ORCID
  2. Patrick Benoit: Département de microbiologie, infectiologie et immunologie, Université de Montréal, Montréal, Québec, Canada.
  3. Sarah Gobeille Paré: Service de microbiologie-infectiologie, Centre Hospitalier Universitaire de Québec - Université Laval, Québec, Québec, Canada.
  4. François Coutlée: Département de microbiologie, infectiologie et immunologie, Université de Montréal, Montréal, Québec, Canada. ORCID
  5. Simon Lévesque: Service de microbiologie, Centre Hospitalier Universitaire de Sherbrooke - CIUSSS de l'Estrie, Sherbrooke, Québec, Canada.
  6. Julie Bestman-Smith: Service de microbiologie-infectiologie, Centre Hospitalier Universitaire de Québec - Université Laval, Québec, Québec, Canada.
  7. Jeannot Dumaresq: Département des laboratoires, Hôpital Hôtel-Dieu de Lévis - CISSS de Chaudière-Appalaches, Lévis, Québec, Canada.
  8. Christian Lavallée: Service de maladies infectieuses et de microbiologie, Département de médecine spécialisée, Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Ile-de-Montréal, Montréal, Québec, Canada.
  9. Claudia Houle: Service de microbiologie-infectiologie, Département de médecine spécialisée, Centre hospitalier affilié universitaire régional - CISSS de la Mauricie-Centre-du-Québec, Trois-Rivières, Québec, Canada.
  10. Philippe Martin: Service de microbiologie, Centre Hospitalier Universitaire de Sherbrooke - CIUSSS de l'Estrie, Sherbrooke, Québec, Canada.
  11. Anton Mak: Département de médecine de laboratoire, Hôpital Charles Lemoyne - CISSS Montérégie-Centre, Greenfield Park, Québec, Canada.
  12. Philippe Gervais: Département des laboratoires, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Québec, Canada.
  13. Stéphanie Langevin: Département clinique de médecine de laboratoire, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
  14. Mariève Jacob-Wagner: Service de microbiologie-infectiologie, Centre Hospitalier Universitaire de Québec - Université Laval, Québec, Québec, Canada.
  15. Simon Gagnon: Département de microbiologie, infectiologie et immunologie, Université de Montréal, Montréal, Québec, Canada.
  16. Manon St-Hilaire: Département clinique de médecine de laboratoire, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
  17. Nathalie Lussier: Département de médecine de laboratoire, Hôpital Charles Lemoyne - CISSS Montérégie-Centre, Greenfield Park, Québec, Canada.
  18. Ariane Yechouron: Département clinique de médecine de laboratoire, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
  19. David Roy: Laboratoire de Santé Publique du Québec, Institut national de santé publique du Québec, Ste-Anne-de-Bellevue, Québec, Canada.
  20. Michel Roger: Département de microbiologie, infectiologie et immunologie, Université de Montréal, Montréal, Québec, Canada.
  21. Judith Fafard: Laboratoire de Santé Publique du Québec, Institut national de santé publique du Québec, Ste-Anne-de-Bellevue, Québec, Canada.

Abstract

The accurate laboratory detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a crucial element in the fight against coronavirus disease 2019 (COVID-19). Reverse transcription-polymerase chain reaction testing on combined oral and nasopharyngeal swab (ONPS) suffers from several limitations, including the need for qualified personnel, the discomfort caused by invasive nasopharyngeal sample collection, and the possibility of swab and transport media shortage. Testing on saliva would represent an advancement. The aim of this study was to compare the concordance between saliva samples and ONPS for the detection of SARS-CoV-2 on various commercial and laboratory-developed tests (LDT). Individuals were recruited from eight institutions in Quebec, Canada, if they had SARS-CoV-2 RNA detected on a recently collected ONPS, and accepted to provide another ONPS, paired with saliva. Assays available in the different laboratories (Abbott RealTime SARS-CoV-2, Cobas® SARS-CoV-2, Simplexa™ COVID-19 Direct, Allplex™ 2019-nCoV, RIDA®GENE SARS-CoV-2, and an LDT preceded by three different extraction methods) were used to determine the concordance between saliva and ONPS results. Overall, 320 tests were run from a total of 125 saliva and ONPS sample pairs. All assays yielded similar sensitivity when saliva was compared to ONPS, with the exception of one LDT (67% vs. 93%). The mean difference in cycle threshold (∆C ) was generally (but not significantly) in favor of the ONPS for all nucleic acid amplification tests. The maximum mean ∆​​​​​C was 2.0, while individual ∆C varied importantly from -17.5 to 12.4. Saliva seems to be associated with sensitivity similar to ONPS for the detection of SARS-CoV-2 by various assays.

Keywords

References

  1. N Engl J Med. 2020 Sep 24;383(13):1283-1286 [PMID: 32857487]
  2. Front Med (Lausanne). 2020 Aug 04;7:465 [PMID: 32903849]
  3. Clin Infect Dis. 2020 Nov 19;71(16):2252-2254 [PMID: 32435816]
  4. Clin Infect Dis. 2021 Dec 6;73(11):e3884-e3899 [PMID: 33270107]
  5. Emerg Microbes Infect. 2020 Dec;9(1):1356-1359 [PMID: 32459137]
  6. Clin Infect Dis. 2021 May 4;72(9):e352-e356 [PMID: 32761244]
  7. Int J Oral Sci. 2020 Apr 17;12(1):11 [PMID: 32300101]
  8. J Clin Microbiol. 2020 Oct 21;58(11): [PMID: 32883744]
  9. JAMA Intern Med. 2021 Mar 1;181(3):353-360 [PMID: 33449069]
  10. J Infect. 2020 Jul;81(1):e45-e50 [PMID: 32298676]
  11. J Clin Virol. 2020 Nov;132:104615 [PMID: 32927356]
  12. J Med Virol. 2021 Sep;93(9):5333-5338 [PMID: 33851739]
  13. J Clin Microbiol. 2021 Feb 18;59(3): [PMID: 33262219]
  14. J Clin Microbiol. 2021 Mar 19;59(4): [PMID: 33514627]

MeSH Term

COVID-19
COVID-19 Nucleic Acid Testing
Diagnostic Tests, Routine
Humans
Mouth
Nasopharynx
Quebec
RNA, Viral
SARS-CoV-2
Saliva
Sensitivity and Specificity
Specimen Handling

Chemicals

RNA, Viral

Word Cloud

Created with Highcharts 10.0.0ONPSSARS-CoV-2salivadetectioncoronavirusnasopharyngealvarioustestsLDTassays2COVID-19oralswabsampleconcordancecommerciallaboratory-developedRNAdifferentextractionmethodssimilarsensitivitymean∆Caccuratelaboratorythe severeacuterespiratorysyndromecrucialelementfightdisease2019Reversetranscription-polymerasechainreactiontestingcombinedsuffersseverallimitationsincludingneedqualifiedpersonneldiscomfortcausedinvasivecollectionpossibilitytransportmediashortageTestingrepresentadvancementaimstudycomparesamplesIndividualsrecruitedeightinstitutionsQuebecCanadadetectedrecentlycollectedacceptedprovideanotherpairedAssaysavailablelaboratoriesAbbottRealTimeCobas®Simplexa™DirectAllplex™2019-nCoVRIDA®GENEprecededthreeuseddetermineresultsOverall320runtotal125pairsyieldedcomparedexceptionone67%vs93%differencecyclethresholdgenerallysignificantlyfavornucleicacidamplificationmaximum∆​​​​​C0individualvariedimportantly-175124SalivaseemsassociatedComparisonswabsSARSepidemiologypandemicsresearchanalysisvirusclassification

Similar Articles

Cited By