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However, existing field-deployable COVID-19 testing methods require the use of uncomfortable swabs and trained providers in PPE, while saliva-based methods must be transported to high complexity laboratories for testing. Here, we report the development and clinical validation of\n                    <jats:underline>H<\/jats:underline>\n                    igh-\n                    <jats:underline>P<\/jats:underline>\n                    erformance\n                    <jats:underline>L<\/jats:underline>\n                    oop-mediated isothermal\n                    <jats:underline>Amp<\/jats:underline>\n                    lification (HP-LAMP), a rapid, saliva-based, SARS-CoV-2 test with a limit of detection of 1.4 copies of virus per \u00b5l of saliva and a sensitivity and specificity with clinical samples of\u2009&gt;\u200996%, on par with traditional RT-PCR based methods using swabs, but can deliver results using only a single fluid transfer step and simple heat block. Testing of 120 patient samples in 40 pools comprised of 5 patient samples each with either all negative or a single positive patient sample was 100% accurate. Thus, HP-LAMP may enable rapid and accurate results in the field using saliva, without need of a high-complexity laboratory.\n                  <\/jats:p>","DOI":"10.1038\/s41598-021-84792-8","type":"journal-article","created":{"date-parts":[[2021,3,9]],"date-time":"2021-03-09T06:03:14Z","timestamp":1615269794000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Field-deployable, rapid diagnostic testing of saliva for SARS-CoV-2"],"prefix":"10.1038","volume":"11","author":[{"given":"Shan","family":"Wei","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hemant","family":"Suryawanshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandre","family":"Djandji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Kohl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Morgan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eldad A.","family":"Hod","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Whittier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Roth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raymond","family":"Yeh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Carlos","family":"Alejaldre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine","family":"Fleck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Ferrara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Hercz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Andrews","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lilly","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristopher A.","family":"Hendershot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua","family":"Goldstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yousin","family":"Suh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahesh","family":"Mansukhani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zev","family":"Williams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,3,9]]},"reference":[{"key":"84792_CR1","doi-asserted-by":"publisher","unstructured":"The COVID-19 testing debacle. Nat Biotechnol 38, 653. https:\/\/doi.org\/10.1038\/s41587-020-0575-3 (2020).","DOI":"10.1038\/s41587-020-0575-3"},{"key":"84792_CR2","doi-asserted-by":"publisher","first-page":"1931","DOI":"10.1126\/scitranslmed.abc1931","volume":"12","author":"R Weissleder","year":"2020","unstructured":"Weissleder, R., Lee, H., Ko, J. & Pittet, M. J. COVID-19 diagnostics in context. Sci Transl Med 12, 1931. https:\/\/doi.org\/10.1126\/scitranslmed.abc1931 (2020).","journal-title":"Sci Transl Med"},{"key":"84792_CR3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2016359","author":"AL Wyllie","year":"2020","unstructured":"Wyllie, A. L. et al. Saliva or nasopharyngeal swab specimens for detection of SARS-CoV-2. N Engl J Med https:\/\/doi.org\/10.1056\/NEJMc2016359 (2020).","journal-title":"N Engl J Med"},{"key":"84792_CR4","doi-asserted-by":"publisher","first-page":"672","DOI":"10.1038\/s41591-020-0869-5","volume":"26","author":"X He","year":"2020","unstructured":"He, X. et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med 26, 672\u2013675. https:\/\/doi.org\/10.1038\/s41591-020-0869-5 (2020).","journal-title":"Nat Med"},{"key":"84792_CR5","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2020.3862","author":"S Lee","year":"2020","unstructured":"Lee, S. et al. Clinical course and molecular viral shedding among asymptomatic and symptomatic patients With SARS-CoV-2 infection in a Community Treatment Center in the Republic of Korea. JAMA Intern Med https:\/\/doi.org\/10.1001\/jamainternmed.2020.3862 (2020).","journal-title":"JAMA Intern Med"},{"key":"84792_CR6","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvaa267","author":"MA Lalli","year":"2020","unstructured":"Lalli, M. A. et al. Rapid and extraction-free detection of SARS-CoV-2 from saliva by colorimetric reverse-transcription loop-mediated isothermal amplification. Clin Chem https:\/\/doi.org\/10.1093\/clinchem\/hvaa267 (2020).","journal-title":"Clin Chem"},{"key":"84792_CR7","unstructured":"L'Helgouach, N. et al. EasyCOV: LAMP based rapid detection of SARS-CoV-2 in saliva. medRxiv, 2020.2005.2030.20117291-20112020.20117205.20117230.20117291 (2020)."},{"key":"84792_CR8","unstructured":"Vogels, C. B. F. et al. SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity. medRxiv pre-print, 2020.2008.2003.20167791-20162020.20167708.20167703.20167791 (2020)."},{"key":"84792_CR9","doi-asserted-by":"publisher","first-page":"24450","DOI":"10.1073\/pnas.2011221117","volume":"117","author":"BA Rabe","year":"2020","unstructured":"Rabe, B. A. & Cepko, C. SARS-CoV-2 detection using isothermal amplification and a rapid, inexpensive protocol for sample inactivation and purification. Proc. Natl. Acad. Sci. 117, 24450\u201324458. https:\/\/doi.org\/10.1073\/pnas.2011221117 (2020).","journal-title":"Proc. Natl. Acad. 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Wei and Williams listed as inventors. Columbia University has entered into a licensing agreement relating to this technology with Sorrento Therapeutics. Drs. Williams is a consultant to Sorrento Therapeutics. Other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"5448"}}