Urine Stabilization Kits for Room-Temperature Biomarker Storage
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Solution Overview
Problem
Existing urine sample collection methods fail to stabilize biomarkers effectively for extended periods at room temperature, hindering non-invasive diagnosis and management of chronic conditions and organ transplantation due to sample instability and improper handling.
Innovation Solution
A kit comprising a vacutainer cup with a piercing hollow channel and pre-packaged urine sample collection tubes containing stabilizing solutions or powders that maintain analytes like cell-free nucleic acid, protein, and other biomarkers stable for at least 5 days at room temperature, ensuring precise sample collection and preservation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If conventional urine sample collection methods are used, then sample collection is simple, but biomarkers become unstable after a short period at room temperature
Solution Approach 1:
The collection tube is pre-packaged with stabilizing solutions or powders before sample collection. The stabilizer is already in place to immediately act on the urine sample upon insertion, preventing biomarker degradation from the start and enabling extended storage at room temperature without requiring complex cold chain logistics.
Solution Approach 2:
A stabilizing agent (formaldehyde, chelator, polyol, or combination) is introduced as an intermediary substance between the urine sample and environmental degradation factors. This stabilizer mediates the interaction by chemically binding to or reacting with substances that would otherwise degrade biomarkers, thereby preserving sample integrity over time.
2Stability of the object's composition
If pre-packaged stabilizers are added to collection tubes, then biomarker stability is improved for extended periods, but device complexity increases
Solution Approach 1:
Multiple stabilizing functions are merged into a single collection tube system. The tube combines the urine collection function with the stabilization function by pre-packaging the stabilizer inside the same tube, eliminating the need for separate stabilization steps or additional containers while achieving comprehensive biomarker preservation.
Solution Approach 2:
The collection tube is designed with multi-functionality, serving both as the urine collection container and as the stabilization system. By integrating the stabilizer within the tube structure, the device performs multiple functions (collection, stabilization, and preservation) in a single component, reducing overall system complexity despite the enhanced capabilities.
3Stability of the object's composition
If formaldehyde and chelators are used as stabilizers, then cell-free nucleic acid and protein stability is improved, but bacterial growth may be promoted
Solution Approach 1:
The stabilizing system uses a composite formulation combining formaldehyde, chelator, and polyol in specific ratios within the collection tube. This composite approach creates a synergistic effect where the combination of substances provides both stabilization of biomarkers and suppression of bacterial growth, overcoming the limitation of individual agents to achieve dual functionality.
Solution Approach 2:
The concentration and ratio of stabilizing agents (formaldehyde, chelator, polyol) are optimized to specific parameters within the collection tube formulation. By carefully controlling these parameters, the system achieves the desired balance where sufficient stabilizer concentration maintains biomarker stability while the specific composition and dosage prevent excessive bacterial growth promotion.
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
The kit enables stable collection and analysis of urine samples for up to 5 days at room temperature, supporting complex biomarker analysis and early detection of conditions like kidney transplant rejection and chronic kidney disease.
Implementation Method 1
the at least one urine sample collection tube has a top configured to form a suction vacuum when pierced by the piercing hollow channel
Data Source
AI summary
Disclosed here are kits comprising pre-packed stabilizing solutions for stabilizing combinations of biomarkers demonstrating sufficient accuracy and specificity for identifying kidney injuries. Such kits can be better adapted for sample collection at a subject's dwelling, thus easing the burdensome requirement of continuous monitoring for kidney injury.