4.1 Article

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

期刊

MED
卷 2, 期 3, 页码 263-+

出版社

CELL PRESS
DOI: 10.1016/j.medj.2020.12.010

关键词

-

资金

  1. NBA
  2. NBPA
  3. Yale community
  4. COVID-19 Sports and Society Working Group
  5. National Basketball Association, US
  6. National Basketball Players Association, US
  7. Huffman Family Donor Advised Fund
  8. Emergent Ventures at the Mercatus Center, George Mason University
  9. Yale Institute for Global Health
  10. Beatrice Kleinberg Neuwirth Fund
  11. NWO Rubicon [019.181EN.004]

向作者/读者索取更多资源

SalivaDirect simplifies saliva-based diagnostic testing for SARS-CoV-2, demonstrating high positive agreement with traditional swab testing. This innovative approach can make large scale testing more accessible and affordable, offering an alternative solution to supply chain issues.
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 dualpiex 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/).

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.1
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

暂无数据
暂无数据