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Vogels CBF, Watkins AE, Harden CA, et al. SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity. Med (N Y). 2020;2(3):263-280.e6doi: 10.1016/j.medj.2020.12.010.
Vogels, C. B. F., Watkins, A. E., Harden, C. A., Brackney, D. E., Shafer, J., Wang, J., Caraballo, C., Kalinich, C. C., Ott, I. M., Fauver, J. R., Kudo, E., Lu, P., Venkataraman, A., Tokuyama, M., Moore, A. J., Muenker, M. C., Casanovas-Massana, A., Fournier, J., Bermejo, S., Campbell, M., Datta, R., Nelson, A., Dela Cruz, C. S., Ko, A. I., Iwasaki, A., Krumholz, H. M., Matheus, J. D., Hui, P., Liu, C., Farhadian, S. F., Sikka, R., Wyllie, A. L., & Grubaugh, N. D. (2021). SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity. Med (New York, N.Y.), 2(3), 263-280.e6. https://doi.org/10.1016/j.medj.2020.12.010
Vogels, Chantal B F, et al. "SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity." Med (New York, N.Y.) vol. 2,3 (2021): 263-280.e6. doi: https://doi.org/10.1016/j.medj.2020.12.010
Vogels CBF, Watkins AE, Harden CA, Brackney DE, Shafer J, Wang J, Caraballo C, Kalinich CC, Ott IM, Fauver JR, Kudo E, Lu P, Venkataraman A, Tokuyama M, Moore AJ, Muenker MC, Casanovas-Massana A, Fournier J, Bermejo S, Campbell M, Datta R, Nelson A, Dela Cruz CS, Ko AI, Iwasaki A, Krumholz HM, Matheus JD, Hui P, Liu C, Farhadian SF, Sikka R, Wyllie AL, Grubaugh ND. SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity. Med (N Y). 2021 Mar 12;2(3):263-280.e6. doi: 10.1016/j.medj.2020.12.010. Epub 2020 Dec 26. PMID: 33521748; PMCID: PMC7836249.
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Med (N Y). 2021 Mar 12;2(3):263-280.e6. doi: 10.1016/j.medj.2020.12.010. Epub 2020 Dec 26.

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

Med (New York, N.Y.)

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 F Farhadian, Robby Sikka, Anne L Wyllie, Nathan D Grubaugh

Affiliations

  1. Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  2. Connecticut Agricultural Experimental Station, State of Connecticut, New Haven, CT 06511, USA.
  3. Drug Free Sport International, Kansas City, MO 64108, USA.
  4. Department of Pathology, Yale University School of Medicine, New Haven, CT 06510, USA.
  5. Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06510, USA.
  6. Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06510, USA.
  7. Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06510, USA.
  8. Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
  9. Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
  10. Minnesota Timberwolves, Minneapolis, MN 55403, USA.

PMID: 33521748 PMCID: PMC7836249 DOI: 10.1016/j.medj.2020.12.010

Abstract

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.

© 2020 Elsevier Inc.

Keywords: COVID-19; SARS-CoV-2; molecular testing; population screening; saliva

Conflict of interest statement

A.L.W. has received research funding through grants from Pfizer to Yale and has received consulting fees for participation in advisory boards for Pfizer. N.D.G. and A.L.W. have received research fundi

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