Sampling Wick Porous Matrix Dried Reagent Storage
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Solution Overview
Problem
Existing nucleic acid amplification diagnostic tests, particularly PCR tests, face challenges with storage and supply of reagents, which can require temperature-controlled storage or accurate reconstitution, and also necessitate precise measurement of sample volumes.
Innovation Solution
A method for producing a sampling device using a porous matrix that is impregnated with dried reagents, allowing for accurate and consistent rehydration upon contact with a biological sample, thereby facilitating isothermal nucleic acid amplification assays without the need for precise pipetting or storage requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If reagents are provided in wet form, then they can be used directly in assays, but they require temperature controlled storage
Solution Approach 1:
The reagents are pre-dried and incorporated into the porous matrix during manufacturing, eliminating the need for temperature-controlled storage while maintaining assay functionality. The drying process is performed in advance during production, and the reagents remain stable in the porous structure until used.
Solution Approach 2:
The physical state of the reagents is changed from wet to dried form through controlled drying processes. This parameter change allows the reagents to be stored at room temperature without requiring temperature-controlled storage facilities, while still functioning properly in the assay when rehydrated by the sample.
2Ease of manufacture
If reagents are provided in dried form, then storage is simplified, but accurate reconstitution with measured volume of water is required
Solution Approach 1:
The porous matrix structure itself provides the function of volume measurement and reconstitution control. When the dried matrix is contacted with a liquid sample, the capillary action and porous structure automatically regulate the volume of liquid absorbed, eliminating the need for external volume measurement. The matrix 'services' the reconstitution process itself.
Solution Approach 2:
The porous matrix material provides inherent volume control through its pore structure. The porosity and surface area of the matrix are designed to absorb a specific volume of liquid, ensuring accurate reconstitution without requiring external measurement. The porous structure physically constrains the volume of reagents and sample interaction.
3Ease of manufacture
If lyophilised reagents are used on absorbent matrix, then rehydration occurs, but accurate measurement of sample volume is still required
Solution Approach 1:
The porous matrix is designed to provide self-regulating volume absorption through its capillary structure. The matrix automatically absorbs the correct volume of sample liquid based on its physical properties, eliminating the need for external volume measurement. The rehydration process is self-controlled by the matrix geometry and porosity.
Solution Approach 2:
The physical parameters of the porous matrix (pore size, surface area, porosity) are optimized to control the volume of liquid absorbed during rehydration. By designing the matrix with specific physical parameters, the correct sample volume is automatically achieved without requiring measurement, while maintaining reagent stability.
4Productivity
If continuous manufacturing is implemented, then productivity increases, but manufacturing precision must be maintained
Solution Approach 1:
The porous matrix provides uniform distribution and consistent absorption characteristics throughout the continuous manufacturing process. The homogeneous porous structure ensures that reagents are evenly distributed and absorbed at consistent rates, maintaining manufacturing precision even during continuous production. The matrix acts as a uniform medium that standardizes the rehydration process.
Solution Approach 2:
The drying process parameters (temperature, time, humidity) are optimized to maintain consistent reagent concentration throughout continuous manufacturing. By controlling these physical parameters, the matrix ensures uniform reagent distribution and concentration consistency across all units produced continuously, maintaining precision without sacrificing productivity.
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 method enables the production of sampling devices with consistent reagent concentrations and volumes, ensuring optimal performance in nucleic acid amplification assays while simplifying the manufacturing process and reducing storage and handling complexities.
Implementation Method 1
contacting the matrix with a liquid reaction mix, such that the reaction mix is adsorbed into the matrix
Implementation Method 2
the porous nature of the matrix, the sample will be adsorbed into the matrix
Implementation Method 3
the sample will be adsorbed into the matrix and will rehydrate the dried reaction mix
Data Source
AI summary
A process for producing a sampling device for use in analysis of biological samples is described, the process comprising adsorbing and drying a liquid reaction mix into an elongate porous matrix, and dividing the porous matrix into regular sections.