C. Vogels, A. Watkins, C. Harden, D. Brackney, Jared Shafer, Jianhui Wang, C. Caraballo, C. Kalinich, I. Ott, J. Fauver, E. Kudo, P. Lu, A. Venkataraman, M. Tokuyama, A. Moore, M. Muenker, A. Casanovas-Massana, J. Fournier, S. Bermejo, M. Campbell, R. Datta, A. Nelson, C. D. Dela Cruz, A. Ko, A. Iwasaki, H. Krumholz, J. Matheus, P. Hui, Chen Liu, S. Farhadian, R. Sikka, A. Wyllie, N. Grubaugh, Kelly M. Anastasio, M. Askenase, Maria Batsu, S. Bickerton, Kristin I. Brower, Molly L Bucklin, Staci Cahill, Yiyun Cao, Edward M. Courchaine, G. DeIuliis, R. Earnest, B. Geng, Benjamin Goldman-Israelow, Ryan Handoko, William Khoury-Hanold, Daniel J Kim, Lynda Knaggs, Maxine Kuang, S. Lapidus, Joseph Lim, Melissa M Linehan, Alice Lu-Culligan, Anjelica Martin, Irene Matos, D. McDonald, M. Minasyan, M. Nakahata, N. Naushad, J. Nouws, Abeer Obaid, C. Odio, Ji-eun Oh, S. Omer, Annsea Park, Hong-Jai Park, Xiaohua Peng, M. Petrone, Sarah M Prophet, Tyler Rice, K. Rose, L. Sewanan, L. Sharma, A. Shaw, Denise Shepard, Mikhail Smolgovsky, Nicole Sonnert, Yvette Strong, Codruta Todeasa, Jordan Valdez, Sofia E. Velazquez, P. Vijayakumar, Elizabeth B. White, Yexin Yang
Med, 2020
Background Scaling 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). Methods We 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. Findings From 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. Conclusions We 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/ ). Funding This 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.
Cited by 87 publications.
Field of study: Medicine