Disposable Test Strip with Control Zone Buffer for Saliva Analysis
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Solution Overview
Problem
Existing disposable test strips for detecting analytes in body liquids, such as alcohol in saliva, lack reliability due to the absence of a control reaction, leading to potential fault results and misinterpretation, and often require invasive sample collection or complex equipment.
Innovation Solution
A disposable enzymatic assay-based test strip device with reactive test and control zones, where the control zone includes a compound buffer that reacts with the biological ink composition upon sample application, providing a visual indication of correct test performance and reducing the likelihood of erroneous results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a control zone is added to the test strip, then reliability is improved, but device complexity increases
Solution Approach 1:
The test strip is divided into distinct functional zones: a test zone containing reagents for analyte detection and a control zone containing a compound buffer for control reaction. This segmentation allows independent optimization of each zone's function while maintaining overall system reliability.
Solution Approach 2:
A compound buffer is introduced as an intermediary substance in the control zone that reacts with the biological ink composition to produce a visual control indication. This intermediary enables the control function without requiring complex electronic or mechanical components.
2Measurement precision
If invasive sample collection is used, then measurement precision is improved, but ease of operation deteriorates
Solution Approach 1:
The test strip is designed as a disposable device that uses non-invasive saliva sampling. The single-use nature ensures freshness and eliminates cross-contamination, maintaining measurement precision while greatly improving ease of operation compared to reusable devices requiring invasive blood sampling.
3Measurement precision
If enzymatic assay with multiple reagents is used, then measurement precision is improved, but manufacturing cost increases
Solution Approach 1:
The test strip utilizes a porous substrate material that can absorb and hold multiple reagents (alcohol oxidase, peroxidase, chromogenic indicator, and compound buffer) within its structure. This porous architecture enables complex multi-reagent chemistry while simplifying the manufacturing process through single-step impregnation techniques.
Solution Approach 2:
The test strip employs composite material structures combining porous substrate, biological ink composition with multiple enzymes and chromogens, and compound buffer layers. These composite materials integrate multiple functions (detection, control, visualization) into a single manufacturable unit, reducing overall manufacturing complexity and cost.
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 offers reliable and cost-effective semi-quantitative detection of analytes in saliva samples, enhancing precision and reducing the possibility of fault responses by incorporating a control reaction within the test strip, while using a simple and non-invasive saliva sample collection method.
Implementation Method 1
Alcohol oxidase functions as a catalyst to convert ethanol present along with ambient oxygen in a liquid sample to acetaldehyde and hydrogen peroxide
Implementation Method 2
Peroxidase, in turn, functions as a catalyst to induce a color change in the hydrogen donor and convert the hydrogen peroxide to water
Implementation Method 3
induce a color change in the hydrogen donor
Implementation Method 4
the compound buffer admixes with the biological ink composition contained in the reactive control zone when the substrate material, defining said reactive control zone or closely adjoining thereto, is supplied with the body liquid sample
Data Source
AI summary
A disposable, enzymatic assay based test strip device for colorimetric detection of an analyte compound, such as ethanol, in a body liquid sample, such as saliva, is provided. The test strip device includes at least one reactive test zone configured to develop a visual indication when the concentration of the analyte compound in the body liquid sample exceeds a predetermined limit, and a reactive control zone configured to develop a visual indication upon being supplied with the body liquid sample. The test strip device further includes a compound buffer, preferably selected from non-volatile alcohols and disposed to closely adjoin the reactive control zone such, that the content of the compound buffer admixes with the reagents provided within the reactive control zone, while the control zone is being supplied with the body liquid sample. Deposition of the reactive zones is preferably implemented by conventional printing methods utilizing biological inks.