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SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity.
Vogels, Chantal B F; Watkins, Anne E; Harden, Christina A; Brackney, Doug E; Shafer, Jared; Wang, Jianhui; Caraballo, César; Kalinich, Chaney C; Ott, Isabel M; Fauver, Joseph R; Kudo, Eriko; Lu, Peiwen; Venkataraman, Arvind; Tokuyama, Maria; Moore, Adam J; Muenker, M Catherine; Casanovas-Massana, Arnau; Fournier, John; Bermejo, Santos; Campbell, Melissa; Datta, Rupak; Nelson, Allison; Dela Cruz, Charles S; Ko, Albert I; Iwasaki, Akiko; Krumholz, Harlan M; Matheus, J D; Hui, Pei; Liu, Chen; Farhadian, Shelli F; Sikka, Robby; Wyllie, Anne L; Grubaugh, Nathan D.
Afiliación
  • Vogels CBF; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Watkins AE; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Harden CA; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Brackney DE; Connecticut Agricultural Experimental Station, State of Connecticut, New Haven, CT 06511, USA.
  • Shafer J; Drug Free Sport International, Kansas City, MO 64108, USA.
  • Wang J; Department of Pathology, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Caraballo C; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06510, USA.
  • Kalinich CC; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06510, USA.
  • Ott IM; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Fauver JR; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Kudo E; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Lu P; Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Venkataraman A; Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Tokuyama M; Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Moore AJ; Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Muenker MC; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Casanovas-Massana A; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Fournier J; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Bermejo S; Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Campbell M; Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Datta R; Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Nelson A; Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Ko AI; Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Iwasaki A; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT 06510, USA.
  • Krumholz HM; Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Matheus JD; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06510, USA.
  • Hui P; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06510, USA.
  • Liu C; Drug Free Sport International, Kansas City, MO 64108, USA.
  • Farhadian SF; Department of Pathology, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Sikka R; Department of Pathology, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Wyllie AL; Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
  • Grubaugh ND; Minnesota Timberwolves, Minneapolis, MN 55403, USA.
Med ; 2(3): 263-280.e6, 2021 03 12.
Article en En | MEDLINE | ID: mdl-33521748
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: Med Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: Med Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos