Evaluation of Saliva Self-Collection Devices for SARS-CoV-2 Diagnostics

Abstract

There is an urgent need to expand testing for SARS-CoV-2 and other respiratory pathogens as the global community struggles to control the COVID-19 pandemic. Current diagnostic methods can be affected by supply chain bottlenecks and require the assistance of medical professionals, impeding the implementation of large-scale testing. Self-collection of saliva may solve these problems, as it can be completed without specialized training and uses generic materials. In this study, we observed thirty individuals who self-collected saliva using four different collection devices and analyzed their feedback. Two of these devices, a funnel and bulb pipette, were used to evaluate at-home saliva collection by 60 individuals. All devices enabled the safe, unsupervised self-collection of saliva. The quantity and quality of the samples received were acceptable for SARS-CoV-2 diagnostic testing, as determined by RNase P detection. Here, we demonstrate inexpensive, generic, buffer free collection devices suitable for unsupervised and home saliva self-collection.Funding Information: This work was funded by Tempus Labs, Inc (N.D.G and A.L.W), Yale Center for Clinical Investigation TL1 TR001864 (M.E.P.) and Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University (N.D.G and A.L.W).Declaration of Interests: N.D.G. is a paid consultant for Tempus. The remaining authors declare no competing interests.Ethics Approval Statement: This study was conducted in accordance with an Institutional Review Board protocol reviewed and approved by the Yale University Human Research Protection Program (IRB Protocol ID: 2000028394).