Disposable Test Strip with High Void Substrate for Bodily Fluid Analysis
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Solution Overview
Problem
Current methods for detecting and monitoring constituents in bodily fluids, such as saliva, are invasive, costly, and lack ease of use and economy, limiting widespread accessibility for healthcare monitoring.
Innovation Solution
Development of devices with a carrier substrate having high void volume, incorporating a chromagen formulation and constituent-specific reagents that change color in response to specific analytes like ALT, AST, and cholesterol, enabling non-invasive, rapid, and economical detection and monitoring of bodily fluid constituents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional invasive methods are used for detecting constituents in bodily fluids, then measurement precision is improved, but ease of operation and accessibility deteriorate
Solution Approach 1:
The patent employs disposable test strips with pre-loaded reagents and chromagen formulations. These single-use devices eliminate the need for complex laboratory equipment and invasive procedures, allowing users to perform self-testing at home. The disposable nature ensures reliability while maintaining simplicity and accessibility for end-users.
Solution Approach 2:
The patent replaces complex mechanical and laboratory-based detection systems with a simplified chemical reaction system. The test strip uses chromagen formulations that automatically react with target constituents (ALT, AST, cholesterol) in bodily fluids to produce visible color changes, eliminating the need for sophisticated instrumentation and expert operation.
2Reliability
If traditional detection methods are used, then reliability is improved, but cost and device complexity increase
Solution Approach 1:
The detection system is segmented into distinct functional zones on the test strip: a sample application area, reagent zones containing specific enzymes and chromagen formulations for different analytes (ALT, AST, cholesterol), and a reading area. This segmentation allows each component to perform its specific function reliably while keeping the overall device simple and manufacturable.
Solution Approach 2:
The patent utilizes parameter changes in the form of color intensity and hue variations that correspond to different concentrations of target constituents. The chromagen formulations are designed to produce distinct color changes (e.g., yellow to red for ALT, blue to purple for AST) that can be visually assessed or measured, providing reliable detection without complex instrumentation.
3Productivity
If rapid detection is implemented, then productivity is improved, but measurement precision may deteriorate
Solution Approach 1:
The test strips are prepared in advance with pre-combined reagent systems and chromagen formulations in specific ratios and concentrations. This preliminary preparation ensures that when the sample is applied, the chemical reactions proceed rapidly and reliably without requiring complex timing or additional reagent additions, achieving both speed and accuracy.
Solution Approach 2:
The patent employs composite reagent systems containing multiple components (enzymes, chromagen substrates, buffers, and stabilizers) formulated together in specific matrices on the test strip. These composite formulations are designed to react rapidly with target constituents while maintaining sufficient sensitivity and precision for clinical monitoring applications.
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 solution provides a simplified, rapid, and economical means for detecting and monitoring bodily fluid constituents, facilitating widespread use and improved healthcare access by offering a visual indication of analyte presence and levels, particularly for conditions like NAFLD and liver cancer.
Implementation Method 1
an indicator formulation capable of changing color in response to exposure to the certain constituent to provide a visible indication of the presence and the level of the certain constituent carried by the bodily fluid
Data Source
AI summary
A device is disclosed for conducting a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid. An indicator formulation of the device changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A carrier substrate of the device is constructed of a material having voids providing a high void volume within the substrate. The device is made by applying a chromagen to the carrier substrate to create a chromagen-laden carrier member. Then, a selected reagent having a particular constituent-specific formulation is applied to the chromagen-laden member. The selected reagent then combines with the chromagen thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid.