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SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity

2020; Elsevier BV; Volume: 2; Issue: 3 Linguagem: Inglês

10.1016/j.medj.2020.12.010

2666-6359

Chantal B. F. Vogels, Anne E. Watkins, Christina A. Harden, Doug E. Brackney, Jared Shafer, Jianhui Wang, César Caraballo, Chaney C. Kalinich, Isabel M. Ott, Joseph R. Fauver, Eriko Kudo, Peiwen Lu, Arvind Venkataraman, Maria Tokuyama, Adam J. Moore, M. Catherine Muenker, Arnau Casanovas‐Massana, John Fournier, Santos Bermejo, Melissa Campbell, Rupak Datta, Allison Nelson, Charles S. Dela Cruz, Albert I. Ko, Akiko Iwasaki, Harlan M. Krumholz, J.D. Matheus, Pei Hui, Chen Liu, Shelli Farhadian, Robby Sikka, Anne L. Wyllie, Nathan D. Grubaugh, Kelly Anastasio, Michael H. Askenase, Maria Batsu, Sean Bickerton, Kristina Brower, Molly L. Bucklin, Staci Cahill, Yiyun Cao, Edward Courchaine, Giuseppe DeIuliis, Rebecca Earnest, Bertie Geng, Benjamin Israelow, Ryan Handoko, William Khoury-Hanold, Daniel Kim, Lynda Knaggs, Maxine Kuang, Sarah Lapidus, Joseph K. Lim, Melissa Linehan, Alice Lu-Culligan, Anjelica Martin, Irene Matos, David McDonald, Maksym Minasyan, Maura Nakahata, Nida Naushad, Jessica Nouws, Abeer Obaid, Camila D. Odio, Ji Eun Oh, Saad B. Omer, Annsea Park, Hong‐Jai Park, Xiaohua Peng, Mary E. Petrone, Sarah Prophet, Tyler Rice, Kadi-Ann Rose, Lorenzo R. Sewanan, Lokesh Sharma, Albert C. Shaw, Denise Shepard, Mikhail Smolgovsky, Nicole Sonnert, Yvette Strong, Codruta Todeasa, Jordan Valdez, Sofia Velazquez, Pavithra Vijayakumar, Elizabeth B. White, Yexin Yang,

Biosensors and Analytical Detection

BackgroundScaling SARS-CoV-2 testing to meet demands of safe reopenings continues to be plagued by assay costs and supply chain shortages. In response, we developed SalivaDirect, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).MethodsWe simplified our saliva-based diagnostic test by (1) not requiring collection tubes with preservatives, (2) replacing nucleic acid extraction with a simple enzymatic and heating step, and (3) testing specimens with a dualplex qRT-PCR assay. Moreover, we validated SalivaDirect with reagents and instruments from multiple vendors to minimize supply chain issues.FindingsFrom our hospital cohort, we show a high positive agreement (94%) between saliva tested with SalivaDirect and nasopharyngeal swabs tested with a commercial qRT-PCR kit. In partnership with the National Basketball Association (NBA) and National Basketball Players Association (NBPA), we tested 3,779 saliva specimens from healthy individuals and detected low rates of invalid (0.3%) and false-positive (<0.05%) results.ConclusionsWe demonstrate that saliva is a valid alternative to swabs for SARS-CoV-2 screening and that SalivaDirect can make large-scale testing more accessible and affordable. Uniquely, we can designate other laboratories to use our sensitive, flexible, and simplified platform under our EUA (https://publichealth.yale.edu/salivadirect/).FundingThis study was funded by the NBA and NBPA (N.D.G.), the Huffman Family Donor Advised Fund (N.D.G.), a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University (N.D.G.), the Yale Institute for Global Health (N.D.G.), and the Beatrice Kleinberg Neuwirth Fund (A.I.K.). C.B.F.V. is supported by NWO Rubicon 019.181EN.004.