Evaluation of saliva self-collection devices for SARS-CoV-2 diagnostics

Abstract

Background 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. Methods We observed 30 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. SARS-CoV-2-spiked saliva samples were subjected to temperature cycles designed to simulate the conditions the samples might be exposed to during the summer and winter seasons and sensitivity of detection was evaluated. Results 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 human RNase P detection. There was no significant difference in SARS-CoV-2 nucleocapsid gene (N1) detection between the freshly spiked samples and those incubated with the summer and winter profiles. Conclusion We demonstrate inexpensive, generic, buffer free collection devices suitable for unsupervised and home saliva self-collection.

SARS-CoV-2 reliably detected in frozen saliva samples stored up to one year

“…This study was in compliance with all research guidelines and due to the nature of residual samples did not require IRB submission. Specimens were collected using the SalivaDirect unsupervised collection kit (Yale School of Public Health, New Haven, CT, USA) [ 5 , 6 ], including a short straw Salimetrics Saliva Collection Aid,(Salimetrics, LLC, Carlsbad, CA, USA, catalog #5016.02) and a sterile 2 mL plastic tube containing 3 ceramic beads. For ease of pipetting, samples were homogenized at 4.5 m/s for 5 seconds using the Omni International Bead Ruptor Elite (Omni International, owned by Perkin Elmer, Kennesaw, GA, USA).…”

Exploring the potential of a saliva-based, RNA-extraction-free PCR test for the multiplexed detection of key respiratory pathogens

“…Nasal swabs were self-collected according to standard diagnostic practice. Saliva samples were self-collected as previously described (Allicock et al, 2022). Singleplex PCR detection of Streptococcus pneumoniae in saliva samples from symptomatic,…”

Evaluation of an immunochromatography-based rapid antigen test, Inspecter Kowa® SARS-CoV-2, using saliva specimens for the detection of SARS-CoV-2

“…However, the acquisition of Np swab specimens is an invasive process that poses a potential risk for SARS-CoV-2 transmission among healthcare workers. In contrast, saliva can be self-collected safely by anyone, including children, and can be used in place of Np swabs to resolve these issues because saliva collection is non-invasive and does not require specialized technical skills [ 5 , 6 ]. There are various reports on the detection sensitivity, specificity, and limitations of saliva-based tests [ [7] , [8] , [9] ].…”