Evaluation of saliva self-collection devices for SARS-CoV-2 diagnostics
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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.
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SciScore for 10.1101/2021.02.01.21250946: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics: 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).
Consent: Once informed consent was provided, participants received a collection kit containing (1) the four saliva collection devices (Fig. 1a), (2) corresponding collection instructions (Supplement), (3) a biohazard bag, and (4) five alcohol wipes.Randomization Participants self-collected four saliva samples consecutively and in a randomized order. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
… SciScore for 10.1101/2021.02.01.21250946: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics: 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).
Consent: Once informed consent was provided, participants received a collection kit containing (1) the four saliva collection devices (Fig. 1a), (2) corresponding collection instructions (Supplement), (3) a biohazard bag, and (4) five alcohol wipes.Randomization Participants self-collected four saliva samples consecutively and in a randomized order. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Ethics: 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). Human Research Protection Programsuggested: NoneStatistical analysis: Participant, observer, and laboratory survey questions were tested for internal reliability with Cronbach’s alpha using R v.4.0.2 and for significant statistical differences across devices using one-way ANOVA in GraphPad Participants who did not provide a response for all four devices were excluded from the analysis for the corresponding question (maximum of 6 for question 10). GraphPadsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:This study had some limitations. Our sample size was small, and a majority of study participants held a college degree or higher. We did not enroll individuals under the age of 18 and therefore cannot draw conclusions around the usability of these devices in children. The findings of this study are nevertheless important because all thirty participants succeeded in providing four testable saliva samples. We can conclude that the four devices are usable for saliva self-collection and do not inhibit our PCR-based diagnostic assay. We did not compare the self-collection process with the aid of a collection device to the process without a device, and it may be that no device is needed to ensure that true saliva accumulates in the collection tube. Taken together with the participant feedback we received with respect to the size of the collection devices, a wide-mouth collection tube would likely be acceptable in this case. However, wide-mouth tubes are not conducive when sample processing requires the use of a liquid-handling robot, which are necessary for large-scale testing. Therefore, collection devices allow for an easy collection process that does not restrict laboratory procedures. Scaling up the use of saliva self-collection as a routine diagnostic tool would expand access to testing for SARS-CoV-2 and other respiratory pathogens. A major barrier to frequent testing is the need to schedule an appointment at a medical facility staffed with trained personnel. Self-collection ...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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