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

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 nasophary

SUBMITTER: Vogels CBF 

PROVIDER: S-EPMC7836249 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature