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

https://www.cell.com/med/fulltext/S2666-6340(20)30076-3

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

Clinical and Translational Resource and Technology Insights|

Highlights

• ●
  SalivaDirect is a simplified saliva-based test for detection of SARS-CoV-2
• ●
  Testing framework is flexible to minimize the risk for supply chain issues
• ●
  SalivaDirect is sensitive, with low rates of invalid and false positive results
• ●
  Laboratories can be designated to use SalivaDirect to increase testing capacity

Summary

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. 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 RT-qPCR 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 RT-qPCR kit. In partnership with the National Basketball Association and Players Association, 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: HYPERLINK "https://publichealth.yale.edu/salivadirect/" \o "https://publichealth.yale.edu/salivadirect/" \h publichealth.yale.edu/salivadirect/.

Funding

This study was funded by the National Basketball Association and Players Association (NDG), Huffman Family Donor Advised Fund (NDG), Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University (NDG), Yale Institute for Global Health (NDG), and Beatrice Kleinberg Neuwirth Fund (AIK). CBFV is supported by NWO Rubicon 019.181EN.004.

Graphical Abstract

Article Info

Publication History

Accepted: December 21, 2020

Received in revised form: December 14, 2020

Received: December 8, 2020

Publication stage

In Press Accepted Manuscript

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