Saliva Sample Collection With Integrated Preservation for Cell Integrity
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Solution Overview
Problem
Current methods for collecting and isolating cells from bodily fluids, particularly saliva and urine, face challenges such as invasive procedures, stigma, high cost, and the inability to maintain cell antigenicity and epigenome integrity, which limits large-scale epigenetic research and biomarker discovery.
Innovation Solution
A sample collection device with a cap and tube configuration that securely houses a preservative solution, allowing easy and safe collection of bodily fluids, and a method for isolating specific cells using chemical fixatives and magnetic beads to maintain cell integrity, followed by downstream analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive blood collection methods are used, then sample quality for epigenetic studies is improved, but patient comfort and participation rates deteriorate
Solution Approach 1:
The patent employs disposable saliva collection devices with integrated preservative solutions that are discarded after single use. This eliminates the need for invasive procedures while maintaining sample quality through chemical preservation, allowing large-scale population studies without compromising participant comfort or sample integrity.
Solution Approach 2:
The patent introduces saliva as an intermediary biological fluid that can be collected non-invasively and contains sufficient cellular material for epigenetic analysis. The integrated preservative solution acts as a mediator to maintain sample integrity, replacing blood as the primary sample source while achieving study objectives.
2Manufacturing precision
If complex cell isolation procedures are used, then cell purity is improved, but processing time and cost deteriorate
Solution Approach 1:
The patent incorporates preservative solutions containing cell-stabilizing agents directly in the collection device before sample collection. This preliminary action preserves cell integrity from the moment of collection, eliminating the need for complex downstream isolation procedures and reducing processing time while maintaining sufficient cell purity for epigenetic analysis.
Solution Approach 2:
The patent changes the chemical parameters of the collection medium by incorporating preservatives and stabilizing agents that maintain cell viability and antigenicity at room temperature. This parameter change eliminates the need for complex cold-chain logistics and sophisticated isolation procedures, simplifying the overall process while maintaining sample quality.
3Quantity of substance
If large-scale population studies are conducted, then statistical power is improved, but sample collection logistics deteriorate
Solution Approach 1:
The patent enables self-collection of saliva samples by participants using integrated collection devices with built-in preservative solutions. Participants can collect and preserve their own samples at home without researcher intervention, dramatically simplifying logistics for large-scale population studies while maintaining sample quality through the self-contained preservation system.
Solution Approach 2:
The patent merges the collection tube and preservative solution into a single integrated device. This combination eliminates the need for separate preservation steps and complex handling procedures, making the device easy to distribute and use in large-scale studies while maintaining sample integrity through the integrated chemical preservation system.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables safe, easy, and efficient collection and preservation of bodily fluids, particularly saliva and urine, with maintained cell antigenicity and epigenome, facilitating large-scale functional genomic and epigenetic studies.
Implementation Method 1
a method for isolating specific cells using chemical fixatives and magnetic beads to maintain cell integrity
Implementation Method 2
a method for isolating specific cells using chemical fixatives and magnetic beads to maintain cell integrity
Data Source
AI summary
The disclosure relates to devices, solutions and methods for collecting and processing samples of bodily fluids containing cells (as well as embodiments for the collection, and processing and/or analysis of other fluids including toxic and/or hazardous substances/fluids). In addition, the disclosure relates generally to function genomic studies and to the isolation and preservation of cells from saliva and other bodily fluids (e.g., urine), for cellular analysis. With respect to devices for collection of bodily fluids, some embodiments include two mating bodies, a cap and a tube (for example), where, in some embodiments, the cap includes a closed interior space for holding a sample preservative solution and mates with the tube to constitute the (closed) sample collection device. Upon mating, the preservation solution flows into the closed interior space to preserve cells in the bodily fluid. The tube is configured to receive a donor sample of bodily fluid (e.g., saliva, urine), which can then be subjected to processing to extract a plurality of cells. The plurality of cells can be further processed to isolate one and/or another cell type therefrom. The plurality of cells, as well as the isolated cell type(s), can be analyzed for functional genomic and epigenetic studies, as well as biomarker discovery.