Accuracy of saliva and nasopharyngeal sampling for detection of SARS-CoV-2 in community screening: a multicentric cohort study

Solen Kernéis, Caroline Elie, Jacques Fourgeaud, Laure Choupeaux, Séverine Mercier Delarue, Marie-Laure Alby, Pierre Quentin, Juliette Pavie, Patricia Brazille, Marie Laure Néré, Marine Minier, Audrey Gabassi, Aurélien Gibaud, Sébastien Gauthier, Chrystel Leroy, Etienne Voirin-Mathieu, Claire Poyart, Michel Vidaud, Béatrice Parfait, Constance Delaugerre, Jean-Marc Tréluyer, Jérôme LeGoff, Solen Kernéis, Caroline Elie, Jacques Fourgeaud, Laure Choupeaux, Séverine Mercier Delarue, Marie-Laure Alby, Pierre Quentin, Juliette Pavie, Patricia Brazille, Marie Laure Néré, Marine Minier, Audrey Gabassi, Aurélien Gibaud, Sébastien Gauthier, Chrystel Leroy, Etienne Voirin-Mathieu, Claire Poyart, Michel Vidaud, Béatrice Parfait, Constance Delaugerre, Jean-Marc Tréluyer, Jérôme LeGoff

Abstract

Nasopharyngeal sampling for nucleic acid amplification testing (NAAT) is the standard diagnostic test of coronavirus disease 2019. Our objectives were to assess, in real-life conditions, the diagnostic accuracy of a nasopharyngeal point-of-care antigen (Ag) test and of saliva NAAT for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in ambulatory care. This was a prospective cohort study from 19 October through 18 December 2020 in two community COVID-19 screening centers in Paris, France. Two nasopharyngeal swabs and one saliva sample were simultaneously collected. Diagnostic accuracies of nasopharyngeal Ag testing and of three saliva NAAT methods were assessed as compared to nasopharyngeal NAAT. A total of 1452 ambulatory children and adults were included. Overall, 129/1443 (9%) participants tested positive on nasopharyngeal NAAT (102/564 [18%] in symptomatic and 27/879 [3%] in asymptomatic participants). Sensitivity was 94%, 23%, 96%, and 94% for the three different protocols of saliva NAAT and for the nasopharyngeal Ag test, respectively. Estimates of specificity were above 95% for all methods. Diagnostic accuracy was similar in symptomatic and asymptomatic individuals. Diagnostic accuracy of nasopharyngeal Ag testing and of saliva NAAT is similar to that of nasopharyngeal NAAT, subject to compliance with specific protocols for saliva. Registration number: NCT04578509.

Keywords: Antigen test; Diagnostic performances; Nucleic acid amplification testing; SARS-CoV-2; Saliva.

© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Figures

Fig. 1
Fig. 1
Ct values for nasopharyngeal nucleic acid amplification testing (NAAT) and saliva NAAT (method MGI-2) according to the presence of symptoms and timing of testing after symptoms onset. (1A) nasopharyngeal Ct values, (1B) saliva Ct values (MGI-2)
Fig. 2
Fig. 2
(A, B) Ct values for saliva NAAT (method MGI-2) according to the result of the nasopharyngeal NAAT

References

    1. Paltiel AD, Zheng A, Sax PE. Clinical and economic effects of widespread rapid testing to decrease SARS-CoV-2 transmission. Ann Intern Med [Internet]. 2021 Mar 9 [cited 2021 Mar 16]; Available from: 10.7326/M21-0510
    1. Bosetti P, Kiem CT, Yazdanpanah Y, Fontanet A, Lina B, Colizza V, et al. Impact of mass testing during an epidemic rebound of SARS-CoV-2: a modelling study using the example of France. Euro Surveill. 2021 Jan;26(1).
    1. Du Z, Pandey A, Bai Y, Fitzpatrick MC, Chinazzi M, Piontti AP, y, , et al. Comparative cost-effectiveness of SARS-CoV-2 testing strategies in the USA: a modelling study. Lancet Public Health. 2021;6(3):e184–91. doi: 10.1016/S2468-2667(21)00002-5.
    1. Cheng MP, Papenburg J, Desjardins M, Kanjilal S, Quach C, Libman M, et al. Diagnostic testing for severe acute respiratory syndrome-related coronavirus 2: a narrative review. Ann Intern Med. 2020;172(11):726–734. doi: 10.7326/M20-1301.
    1. Mustafa Hellou M, Górska A, Mazzaferri F, Cremonini E, Gentilotti E, De Nardo P, et al. Nucleic acid amplification tests on respiratory samples for the diagnosis of coronavirus infections: a systematic review and meta-analysis. Clin Microbiol Infect. 2021;27(3):341–351. doi: 10.1016/j.cmi.2020.11.002.
    1. Ricks S, Kendall EA, Dowdy DW, Sacks JA, Schumacher SG, Arinaminpathy N. Quantifying the potential value of antigen-detection rapid diagnostic tests for COVID-19: a modelling analysis. BMC Med. 2021;19(1):75. doi: 10.1186/s12916-021-01948-z.
    1. Peeling RW, Olliaro PL, Boeras DI, Fongwen N. Scaling up COVID-19 rapid antigen tests: promises and challenges. The Lancet Infectious Diseases [Internet]. 2021 Feb 23 [cited 2021 Mar 16];0(0). Available from:
    1. Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020;8:CD013705.
    1. Lee RA, Herigon JC, Benedetti A, Pollock NR, Denkinger CM. Performance of saliva, oropharyngeal swabs, and nasal swabs for SARS-CoV-2 molecular detection: a systematic review and meta-analysis. J Clin Microbiol. 2021 Jan 27;
    1. Butler-Laporte G, Lawandi A, Schiller I, Yao MC, Dendukuri N, McDonald EG, et al. Comparison of saliva and nasopharyngeal swab nucleic acid amplification testing for detection of SARS-CoV-2: a systematic review and meta-analysis. JAMA Intern Med. 2021 Jan 15;
    1. Bastos ML, Perlman-Arrow S, Menzies D, Campbell JR. The sensitivity and costs of testing for SARS-CoV-2 infection with saliva versus nasopharyngeal swabs : a systematic review and meta-analysis. Ann Intern Med. 2021 Jan 12;
    1. Fernández-González M, Agulló V, Rica A de la, Infante A, Carvajal M, García JA, et al. Performance of saliva specimens for the molecular detection of SARS-CoV-2 in the community setting: does sample collection method matter? Journal of Clinical Microbiology [Internet]. 2021 Jan 8 [cited 2021 Mar 16]; Available from:
    1. Bossuyt PM, Cohen JF, Gatsonis CA, Korevaar DA, STARD group STARD 2015: updated reporting guidelines for all diagnostic accuracy studies. Ann Transl Med. 2016;4(4):85.
    1. Griesemer SB, Van Slyke G, Ehrbar D, Strle K, Yildirim T, Centurioni DA, et al. Evaluation of specimen types and saliva stabilization solutions for SARS-CoV-2 testing. J Clin Microbiol. 2021 Mar 5;
    1. Caulley L, Corsten M, Eapen L, Whelan J, Angel JB, Antonation K, et al. Salivary detection of COVID-19. Ann Intern Med. 2021;174(1):131–133. doi: 10.7326/M20-4738.
    1. Hanson KE, Barker AP, Hillyard DR, Gilmore N, Barrett JW, Orlandi RR, et al. Self-collected anterior nasal and saliva specimens versus health care worker-collected nasopharyngeal swabs for the molecular detection of SARS-CoV-2. J Clin Microbiol. 2020 Oct 21;58(11).
    1. Kojima N, Turner F, Slepnev V, Bacelar A, Deming L, Kodeboyina S, et al. Self-collected oral fluid and nasal swabs demonstrate comparable sensitivity to clinician collected nasopharyngeal swabs for coronavirus disease 2019 detection. Clinical Infectious Diseases [Internet]. 2020 Oct 19 [cited 2021 Mar 17];(ciaa1589). Available from: 10.1093/cid/ciaa1589
    1. 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. doi: 10.1016/j.jcv.2020.104567.
    1. Miller M, Jansen M, Bisignano A, Mahoney S, Wechsberg C, Albanese N, et al. Validation of a self-administrable, saliva-based RT-qPCR test detecting SARS-CoV-2. medRxiv. 2020 Jun 9;2020.06.05.20122721.
    1. Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a noninvasive specimen for detection of SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8).
    1. Yokota I, Shane PY, Okada K, Unoki Y, Yang Y, Inao T, et al. Mass screening of asymptomatic persons for SARS-CoV-2 using saliva. Clinical Infectious Diseases [Internet]. 2020 Sep 25 [cited 2021 Mar 17];(ciaa1388). Available from: 10.1093/cid/ciaa1388
    1. Pasomsub E, Watcharananan SP, Boonyawat K, Janchompoo P, Wongtabtim G, Suksuwan W, et al. Saliva sample as a non-invasive specimen for the diagnosis of coronavirus disease 2019: a cross-sectional study. Clin Microbiol Infect. 2021;27(2):285.e1–285.e4. doi: 10.1016/j.cmi.2020.05.001.
    1. Antigen rapid tests, nasopharyngeal PCR and saliva PCR to detect SARS-CoV-2: a prospective comparative clinical trial | medRxiv [Internet]. [cited 2021 Mar 17]. Available from: 10.1101/2020.11.23.20237057v1.full
    1. Wyllie AL, Fournier J, Casanovas-Massana A, Campbell M, Tokuyama M, Vijayakumar P, et al. Saliva or nasopharyngeal swab specimens for detection of SARS-CoV-2. N Engl J Med. 2020;383(13):1283–1286. doi: 10.1056/NEJMc2016359.
    1. Rao M, Rashid FA, Sabri FSAH, Jamil NN, Zain R, Hashim R, et al. Comparing nasopharyngeal swab and early morning saliva for the identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical Infectious Diseases [Internet]. 2020 Aug 6 [cited 2021 Mar 16];(ciaa1156). Available from: 10.1093/cid/ciaa1156
    1. Beck ET, Paar W, Fojut L, Serwe J, Jahnke RR. Comparison of the quidel sofia SARS FIA test to the hologic aptima SARS-CoV-2 TMA test for diagnosis of COVID-19 in symptomatic outpatients. J Clin Microbiol. 2021 Jan 21;59(2).
    1. Pollock NR, Jacobs JR, Tran K, Cranston AE, Smith S, O’Kane CY, et al. Performance and implementation evaluation of the Abbott BinaxNOW rapid antigen test in a high-throughput drive-through community testing site in Massachusetts. J Clin Microbiol. 2021 Feb 23;
    1. Merino P, Guinea J, Muñoz-Gallego I, González-Donapetry P, Galán JC, Antona N, et al. Multicenter evaluation of the PanbioTM COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection. Clinical Microbiology and Infection [Internet]. 2021 Feb 16 [cited 2021 Mar 16]; Available from:
    1. Pekosz A, Parvu V, Li M, Andrews JC, Manabe YC, Kodsi S, et al. Antigen-based testing but not real-time polymerase chain reaction correlates with severe acute respiratory syndrome coronavirus 2 viral culture. Clin Infect Dis. 2021 Jan 20;
    1. Al Suwaidi H, Senok A, Varghese R, Deesi Z, Khansaheb H, Pokasirakath S, et al. Saliva for molecular detection of SARS-CoV-2 in school-aged children. Clin Microbiol Infect. 2021 Feb 19;
    1. González-Donapetry P, García-Clemente P, Bloise I, García-Sánchez C, Sánchez Castellano MÁ, Romero MP, et al. Think of the children: evaluation of SARS-CoV-2 rapid antigen test in pediatric population. Pediatr Infect Dis J. 2021 Feb 17;
    1. Zhang K, Shoukat A, Crystal W, Langley JM, Galvani AP, Moghadas SM. Routine saliva testing for the identification of silent coronavirus disease 2019 (COVID-19) in healthcare workers. Infect Control Hosp Epidemiol. :1–5.
    1. Smith DRM, Duval A, Pouwels KB, Guillemot D, Fernandes J, Huynh B-T, et al. Optimizing COVID-19 surveillance in long-term care facilities: a modelling study. BMC Med. 2020;18(1):386. doi: 10.1186/s12916-020-01866-6.

Source: PubMed

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