{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T19:58:58Z","timestamp":1772135938710,"version":"3.50.1"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,10,26]],"date-time":"2021-10-26T00:00:00Z","timestamp":1635206400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,10,26]],"date-time":"2021-10-26T00:00:00Z","timestamp":1635206400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sci Rep"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Rapid identification of SARS-CoV-2-infected individuals is a cornerstone for the control of virus spread. The sensitivity of SARS-CoV-2 RNA detection by RT-PCR is similar in saliva and nasopharyngeal swabs. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-LAMP assay (EasyCoV) designed for the detection of SARS-CoV2 RNA from fresh saliva samples, compared to nasopharyngeal RT-PCR, to saliva RT-PCR and to nasopharyngeal antigen testing. Overall, 117 of the 1718 participants (7%) tested positive with nasopharyngeal RT-PCR. Compared to nasopharyngeal RT-PCR, the sensitivity and specificity of the RT-LAMP assay in saliva were 34% and 97%, respectively. The Ct values of nasopharyngeal RT-PCR were significantly lower in the 40 true positive subjects with saliva RT-LAMP (Ct 25.9) than in the 48 false negative subjects with saliva RT-LAMP (Ct 28.4) (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.028). Considering six alternate criteria for reference tests, including saliva RT-PCR and nasopharyngeal antigen, the sensitivity of saliva RT-LAMP ranged between 27 and 44%. The detection of SARS-CoV-2 in crude saliva samples with an RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:italic>Registration number<\/jats:italic>\n                    : NCT04578509.\n                  <\/jats:p>","DOI":"10.1038\/s41598-021-00560-8","type":"journal-article","created":{"date-parts":[[2021,10,26]],"date-time":"2021-10-26T06:02:49Z","timestamp":1635228169000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Evaluation of a saliva molecular point of care for the detection of SARS-CoV-2 in ambulatory care"],"prefix":"10.1038","volume":"11","author":[{"given":"J\u00e9r\u00f4me","family":"LeGoff","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Solen","family":"Kern\u00e9is","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Elie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S\u00e9verine","family":"Mercier-Delarue","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nabil","family":"Gastli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laure","family":"Choupeaux","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacques","family":"Fourgeaud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie-Laure","family":"Alby","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Quentin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juliette","family":"Pavie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Brazille","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie Laure","family":"N\u00e9r\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marine","family":"Minier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Audrey","family":"Gabassi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chrystel","family":"Leroy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B\u00e9atrice","family":"Parfait","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Marc","family":"Tr\u00e9luyer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Constance","family":"Delaugerre","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,10,26]]},"reference":[{"key":"560_CR1","doi-asserted-by":"publisher","first-page":"1437","DOI":"10.1001\/jama.2020.3864","volume":"323","author":"JM Sharfstein","year":"2020","unstructured":"Sharfstein, J. M., Becker, S. J. & Mello, M. M. Diagnostic testing for the novel coronavirus. JAMA 323, 1437\u20131438 (2020).","journal-title":"JAMA"},{"key":"560_CR2","doi-asserted-by":"publisher","DOI":"10.7326\/M21-0510","author":"AD Paltiel","year":"2021","unstructured":"Paltiel, A. D., Zheng, A. & Sax, P. E. Clinical and economic effects of widespread rapid testing to decrease SARS-CoV-2 transmission. Ann. Intern. Med. https:\/\/doi.org\/10.7326\/M21-0510 (2021).","journal-title":"Ann. Intern. Med."},{"key":"560_CR3","doi-asserted-by":"publisher","first-page":"2001978","DOI":"10.2807\/1560-7917.ES.2020.26.1.2001978","volume":"26","author":"P Bosetti","year":"2021","unstructured":"Bosetti, P. et al. Impact of mass testing during an epidemic rebound of SARS-CoV-2: A modelling study using the example of France. Euro Surveill. 26, 2001978 (2021).","journal-title":"Euro Surveill."},{"key":"560_CR4","doi-asserted-by":"publisher","first-page":"e184","DOI":"10.1016\/S2468-2667(21)00002-5","volume":"6","author":"Z Du","year":"2021","unstructured":"Du, Z. et al. Comparative cost-effectiveness of SARS-CoV-2 testing strategies in the USA: A modelling study. Lancet Public Health 6, e184\u2013e191 (2021).","journal-title":"Lancet Public Health"},{"key":"560_CR5","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa760","author":"KE Hanson","year":"2020","unstructured":"Hanson, K. E. et al. Infectious Diseases Society of America guidelines on the diagnosis of COVID-19. Clin. Infect. Dis. https:\/\/doi.org\/10.1093\/cid\/ciaa760 (2020).","journal-title":"Clin. Infect. Dis."},{"key":"560_CR6","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1186\/s12916-021-01948-z","volume":"19","author":"S Ricks","year":"2021","unstructured":"Ricks, S. et al. Quantifying the potential value of antigen-detection rapid diagnostic tests for COVID-19: A modelling analysis. BMC Med. 19, 75 (2021).","journal-title":"BMC Med."},{"key":"560_CR7","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(21)00048-7","author":"RW Peeling","year":"2021","unstructured":"Peeling, R. W., Olliaro, P. L., Boeras, D. I. & Fongwen, N. Scaling up COVID-19 rapid antigen tests: Promises and challenges. Lancet Infect. Dis. https:\/\/doi.org\/10.1016\/S1473-3099(21)00048-7 (2021).","journal-title":"Lancet Infect. Dis."},{"key":"560_CR8","first-page":"CD013705","volume":"3","author":"J Dinnes","year":"2021","unstructured":"Dinnes, J. et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst. Rev. 3, CD013705 (2021).","journal-title":"Cochrane Database Syst. Rev."},{"key":"560_CR9","doi-asserted-by":"publisher","first-page":"10519","DOI":"10.1038\/s41598-021-90026-8","volume":"11","author":"Y Takeuchi","year":"2021","unstructured":"Takeuchi, Y. et al. Diagnostic performance and characteristics of anterior nasal collection for the SARS-CoV-2 antigen test: A prospective study. Sci. Rep. 11, 10519 (2021).","journal-title":"Sci. Rep."},{"key":"560_CR10","doi-asserted-by":"publisher","first-page":"2003961","DOI":"10.1183\/13993003.03961-2020","volume":"57","author":"AK Lindner","year":"2021","unstructured":"Lindner, A. K. et al. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with professional-collected nasal versus nasopharyngeal swab. Eur. Respir. J. 57, 2003961 (2021).","journal-title":"Eur. Respir. J."},{"key":"560_CR11","doi-asserted-by":"publisher","first-page":"841","DOI":"10.1093\/cid\/ciaa149","volume":"71","author":"KK-W To","year":"2020","unstructured":"To, K.K.-W. et al. Consistent detection of 2019 novel coronavirus in saliva. Clin. Infect. Dis. 71, 841\u2013843 (2020).","journal-title":"Clin. Infect. Dis."},{"key":"560_CR12","doi-asserted-by":"publisher","first-page":"e45","DOI":"10.1016\/j.jinf.2020.04.005","volume":"81","author":"L Azzi","year":"2020","unstructured":"Azzi, L. et al. Saliva is a reliable tool to detect SARS-CoV-2. J. Infect. 81, e45\u2013e50 (2020).","journal-title":"J. Infect."},{"key":"560_CR13","doi-asserted-by":"publisher","first-page":"e145","DOI":"10.1016\/j.jinf.2020.05.071","volume":"81","author":"S Iwasaki","year":"2020","unstructured":"Iwasaki, S. et al. Comparison of SARS-CoV-2 detection in nasopharyngeal swab and saliva. J. Infect. 81, e145\u2013e147 (2020).","journal-title":"J. Infect."},{"key":"560_CR14","doi-asserted-by":"publisher","first-page":"494","DOI":"10.1056\/NEJMc2016321","volume":"383","author":"Y-P Tu","year":"2020","unstructured":"Tu, Y.-P. et al. Swabs collected by patients or health care workers for SARS-CoV-2 testing. N. Engl. J. Med. 383, 494\u2013496 (2020).","journal-title":"N. Engl. J. Med."},{"key":"560_CR15","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02881-20","author":"RA Lee","year":"2021","unstructured":"Lee, R. A., Herigon, J. C., Benedetti, A., Pollock, N. R. & Denkinger, C. M. Performance of saliva, oropharyngeal swabs, and nasal swabs for SARS-CoV-2 molecular detection: A systematic review and meta-analysis. J. Clin. Microbiol. https:\/\/doi.org\/10.1128\/JCM.02881-20 (2021).","journal-title":"J. Clin. Microbiol."},{"key":"560_CR16","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2020.8876","author":"G Butler-Laporte","year":"2021","unstructured":"Butler-Laporte, G. 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. https:\/\/doi.org\/10.1001\/jamainternmed.2020.8876 (2021).","journal-title":"JAMA Intern. Med."},{"key":"560_CR17","doi-asserted-by":"publisher","DOI":"10.7326\/M20-6569","author":"ML Bastos","year":"2021","unstructured":"Bastos, M. L., Perlman-Arrow, S., Menzies, D. & Campbell, J. R. 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. https:\/\/doi.org\/10.7326\/M20-6569 (2021).","journal-title":"Ann. Intern. Med."},{"key":"560_CR18","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.03033-20","author":"M Fern\u00e1ndez-Gonz\u00e1lez","year":"2021","unstructured":"Fern\u00e1ndez-Gonz\u00e1lez, M. et al. Performance of saliva specimens for the molecular detection of SARS-CoV-2 in the community setting: does sample collection method matter?. J. Clin. Microbiol. https:\/\/doi.org\/10.1128\/JCM.03033-20 (2021).","journal-title":"J. Clin. Microbiol."},{"key":"560_CR19","doi-asserted-by":"publisher","DOI":"10.1101\/2021.04.08.21255144","author":"S Kern\u00e9is","year":"2021","unstructured":"Kern\u00e9is, S. et al. Accuracy of antigen and nucleic acid amplification testing on saliva and naopharyngeal samples for detection of SARS-CoV-2 in ambulatory care. MedRxiv https:\/\/doi.org\/10.1101\/2021.04.08.21255144 (2021).","journal-title":"MedRxiv"},{"key":"560_CR20","doi-asserted-by":"publisher","first-page":"104426","DOI":"10.1016\/j.jcv.2020.104426","volume":"128","author":"F Wolters","year":"2020","unstructured":"Wolters, F. et al. Multi-center evaluation of cepheid xpert\u00ae xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic. J. Clin. Virol. 128, 104426 (2020).","journal-title":"J. Clin. Virol."},{"key":"560_CR21","doi-asserted-by":"publisher","first-page":"22349","DOI":"10.1038\/s41598-020-79237-7","volume":"10","author":"P Subsoontorn","year":"2020","unstructured":"Subsoontorn, P., Lohitnavy, M. & Kongkaew, C. The diagnostic accuracy of isothermal nucleic acid point-of-care tests for human coronaviruses: A systematic review and meta-analysis. Sci. Rep. 10, 22349 (2020).","journal-title":"Sci. Rep."},{"key":"560_CR22","doi-asserted-by":"publisher","first-page":"1356","DOI":"10.1080\/22221751.2020.1775133","volume":"9","author":"JH-K Chen","year":"2020","unstructured":"Chen, J.H.-K. et al. Evaluating the use of posterior oropharyngeal saliva in a point-of-care assay for the detection of SARS-CoV-2. Emerg. Microbes Infect. 9, 1356\u20131359 (2020).","journal-title":"Emerg. Microbes Infect."},{"key":"560_CR23","doi-asserted-by":"publisher","first-page":"e01438","DOI":"10.1128\/JCM.01438-20","volume":"58","author":"M Nagura-Ikeda","year":"2020","unstructured":"Nagura-Ikeda, M. et al. Clinical evaluation of self-collected saliva by quantitative reverse transcription-PCR (RT-qPCR), direct RT-qPCR, reverse transcription-loop-mediated isothermal amplification, and a rapid antigen test to diagnose COVID-19. J. Clin. Microbiol. 58, e01438-e1520 (2020).","journal-title":"J. Clin. Microbiol."},{"key":"560_CR24","doi-asserted-by":"publisher","first-page":"104760","DOI":"10.1016\/j.jcv.2021.104760","volume":"136","author":"W Yamazaki","year":"2021","unstructured":"Yamazaki, W., Matsumura, Y., Thongchankaew-Seo, U., Yamazaki, Y. & Nagao, M. Development of a point-of-care test to detect SARS-CoV-2 from saliva which combines a simple RNA extraction method with colorimetric reverse transcription loop-mediated isothermal amplification detection. J. Clin. Virol. 136, 104760 (2021).","journal-title":"J. Clin. Virol."},{"key":"560_CR25","doi-asserted-by":"publisher","first-page":"410","DOI":"10.1016\/j.jiac.2020.10.029","volume":"27","author":"K Taki","year":"2021","unstructured":"Taki, K. et al. SARS-CoV-2 detection by fluorescence loop-mediated isothermal amplification with and without RNA extraction. J. Infect. Chemother. 27, 410\u2013412 (2021).","journal-title":"J. Infect. Chemother."},{"key":"560_CR26","doi-asserted-by":"publisher","DOI":"10.1101\/2020.05.30.20117291","author":"N L\u2019Helgouach","year":"2020","unstructured":"L\u2019Helgouach, N. et al. EasyCOV: LAMP based rapid detection of SARS-CoV-2 in saliva. MedRxiv https:\/\/doi.org\/10.1101\/2020.05.30.20117291 (2020).","journal-title":"MedRxiv"},{"key":"560_CR27","doi-asserted-by":"publisher","unstructured":"Santos Schneider, F. et al. Comparative Evaluation of Rapid Salivary RT-LAMP Assay for Screening of SARS-CoV-2 Infection. https:\/\/doi.org\/10.2139\/ssrn.3774184, https:\/\/papers.ssrn.com\/abstract=3774184 (2021).","DOI":"10.2139\/ssrn.3774184"},{"key":"560_CR28","doi-asserted-by":"crossref","unstructured":"Yokota, I. et al. A novel strategy for SARS-CoV-2 mass screening with quantitative antigen testing of saliva: A diagnostic accuracy study. Lancet Microbe (2021).","DOI":"10.2139\/ssrn.3719066"},{"key":"560_CR29","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2021.01.017","author":"S Marot","year":"2021","unstructured":"Marot, S., Calvez, V., Louet, M., Marcelin, A.-G. & Burrel, S. Interpretation of SARS-CoV-2 replication according to RT-PCR crossing threshold value. Clin. Microbiol. Infect. https:\/\/doi.org\/10.1016\/j.cmi.2021.01.017 (2021).","journal-title":"Clin. Microbiol. Infect."},{"key":"560_CR30","first-page":"85","volume":"4","author":"PM Bossuyt","year":"2016","unstructured":"Bossuyt, P. M., Cohen, J. F., Gatsonis, C. A., Korevaar, D. A. & STARD Group. STARD 2015: Updated reporting guidelines for all diagnostic accuracy studies. Ann. Transl. Med. 4, 85 (2016).","journal-title":"Ann. Transl. Med."}],"container-title":["Scientific Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41598-021-00560-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-021-00560-8","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-021-00560-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,12,3]],"date-time":"2022-12-03T11:48:34Z","timestamp":1670068114000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41598-021-00560-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10,26]]},"references-count":30,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2021,12]]}},"alternative-id":["560"],"URL":"https:\/\/doi.org\/10.1038\/s41598-021-00560-8","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2021.06.12.21258811","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.3.rs-712544\/v1","asserted-by":"object"}]},"ISSN":["2045-2322"],"issn-type":[{"value":"2045-2322","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,10,26]]},"assertion":[{"value":"13 July 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 October 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 October 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"All authors and persons listed in the Acknowledgments declare no conflict of interest for the submitted work. Outside the submitted work, Solen Kern\u00e9is reports consulting fees, a research grant, honoraria for a lecture and travel expenses from bioM\u00e9rieux (in 2018\u20132019); Jerome LeGoff reports consulting fees from bioM\u00e9rieux and Roche Molecular (in 2018\u20132019); Constance Delaugerre reports to be member of a scientific board for MSD and Gilead ViiV, and a research grant from Gilead ViiV.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"21126"}}