Molecular Medicine Israel

FDA Approves New Saliva-Based COVID-19 Test

SalivaDirect, an open-source protocol, avoids many of the supply bottlenecks of other tools and could be offered for as little as $10 a test.

The US Food and Drug Administration has given Emergency Use Authorization to a fifth saliva-based test for COVID-19. The low-cost and noninvasive procedure developed by the Yale School of Public Health requires minimal processing and retains much of the accuracy of traditional nasopharyngeal swabs. 

The United States has struggled to implement consistent and widespread testing throughout the pandemic, making it difficult for public health officials to track the spread of the virus. In addition, the equipment and reagents needed to carry out PCR tests have frequently run low, from the swabs needed to collect the sample to the reagents that extract viral RNA.

In a recent paper, published August 4 on the preprint server medRxiv, a team led by Yale postdoc Chantal Vogels detailed the new tool called SalivaDirect. A team composed of many of the same researchers had previously shown that saliva could be collected in any sterile container and that the saliva remained largely stable even when warm, negating the need for special tubes or preservatives. 

“This is a huge step forward to make testing more accessible,” Vogels said in a recent press release. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health.” …

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