Amperometric Test Strip for Rapid Low-Concentration Analyte Detection
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Solution Overview
Problem
Existing assays for detecting analytes in biological and environmental samples require multiple steps and expert analysis, making them impractical for non-clinical settings and layperson use.
Innovation Solution
A system and assay using an enzyme-based amperometric sensor with capture and detector agents to form a detectable complex, enabling rapid detection of target analytes in biological or environmental samples, even by untrained users, with results in under 30 minutes or less.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional assays are used for analyte detection, then detection accuracy is maintained, but the procedure complexity increases and requires multiple steps and expert analysis
Solution Approach 1:
The patent combines multiple assay functions into a single integrated test strip device. The test strip integrates the sample application area, reagent mixing zone, detection zone with capture agents, and electrochemical sensor into one unified structure, eliminating the need for separate preparation steps and equipment while maintaining detection accuracy
Solution Approach 2:
The test strip is designed as a universal platform that can detect multiple different analytes by simply changing the capture agents immobilized on the strip. The same device structure and electrochemical detection method work for various targets including proteins, drugs, and biomarkers, reducing the need for multiple specialized assays
2Reliability
If traditional assays are used for analyte detection, then reliable results are obtained, but the time required for completion increases
Solution Approach 1:
The capture agents are pre-immobilized on the test strip during manufacturing, and the reagents are pre-positioned in their correct locations. When a user applies a sample, all necessary components are already in place to immediately begin the detection reaction, eliminating preparation time while ensuring reliable results through proper reagent placement
Solution Approach 2:
The patent replaces traditional optical detection methods with electrochemical amperometric detection. This substitution enables real-time continuous monitoring of the reaction progress and provides rapid quantification of analyte concentration, significantly reducing the time to obtain reliable results compared to conventional colorimetric or fluorescent assays
3Measurement precision
If traditional assays are used for analyte detection, then detection sensitivity is maintained, but the ease of operation decreases and requires expert analysis
Solution Approach 1:
The test strip performs self-diagnosis and automated detection. The electrochemical sensor automatically measures the analyte concentration by detecting the current generated from the enzymatic reaction, and the device provides direct digital readout of results. This eliminates the need for expert interpretation of complex assay protocols while maintaining high detection sensitivity through precise electrochemical measurement
Solution Approach 2:
The patent introduces an enzymatic reaction as an intermediary step that amplifies the detection signal. The enzyme labeled on the detector agent catalyzes a reaction that produces a measurable electrochemical signal, enhancing detection sensitivity while simplifying the user interface to just sample application and result reading, bridging the gap between complex detection chemistry and simple user operation
4Productivity
If rapid detection is implemented, then the time to result is reduced, but the detection limit for low concentrations may worsen
Solution Approach 1:
The replacement of optical detection with electrochemical amperometric detection enables rapid measurement of low analyte concentrations. The electrochemical method provides continuous real-time signal accumulation that enhances sensitivity for trace analytes while maintaining fast detection speed, overcoming the traditional trade-off between speed and detection limit
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 system allows for reliable detection of low concentrations of target analytes in small sample volumes with high accuracy and sensitivity, suitable for non-clinical settings, providing results in under 1 minute.
Implementation Method 1
the detection device comprises an enzyme-based amperometric sensor comprising at least one electrode
Implementation Method 2
enzyme-based amperometric sensor comprising at least one electrode, wherein the detectable complex forms above the least one electrode or migrates within the system to become located above at least one electrode
Data Source
AI summary
The strip systems, methods, devices and associated kits disclosed herein are used to determine the presence and/or level a target analyte(s) in sample (e.g., a biological sample such as saliva or nasal swab) wherein the target analyte(s) may be a microorganism (e.g., a whole virus) or molecule (e.g., a viral antigen) associated with a healthy state, disease or injury or otherwise altered physiological condition. In certain embodiments, the systems, methods, devices and kits provide one or more improved properties relative to the lateral flow protein and other assays known in the art for the detection, including but not limited to, assay time, ease of use, risk of infection, accuracy, specificity, selectivity, limit of detection of the assay, quantitative detection and the effect of common interferents to the sensor output, cost, simplicity or a combination thereof. In certain embodiments, the systems, assays, methods and kids are multiplexed, i.e., permit detection or monitoring of more than one target analyte (e.g., two different viruses or a virus and a bacterium).