Dual-Region Assay Device Using Single Detection Molecule
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Solution Overview
Problem
Existing assay systems for detecting analytes in samples are difficult to use, manufacture, and store, often produce inaccurate results, and can lead to false negatives or false positives due to their complexity and the need for multiple detection molecules.
Innovation Solution
An assay system comprising a label solution and an assay device with dual detection regions, where a first immobilized molecule binds to either the detection molecule or the analyte to indicate presence or absence, and a second immobilized molecule generates a complex with the analyte, allowing the detection molecule to indicate the presence of a second analyte.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple detection molecules are used to detect multiple analytes, then the detection capability is improved, but the device complexity and difficulty of use increase
Solution Approach 1:
A single detection molecule is designed to perform multiple functions: it can detect both the first analyte directly and the second analyte through complex formation with the first analyte. This multi-functional detection molecule eliminates the need for multiple different detection molecules, thereby reducing device complexity while maintaining the ability to detect multiple analytes.
Solution Approach 2:
The patent combines the detection functions for two different analytes into a single detection molecule system. The detection molecule can bind to either the first analyte or form a complex with the first analyte and second analyte, merging what would traditionally require separate detection molecules into one unified system.
2Adaptability or versatility
If multiple detection molecules are used to detect multiple analytes, then the detection capability is improved, but the ease of operation decreases
Solution Approach 1:
The single detection molecule is designed to automatically perform different detection functions based on what is present in the sample. It can detect the first analyte directly or detect the second analyte through complex formation, eliminating the need for users to manually select or switch between different detection molecules, thereby improving ease of operation.
3Adaptability or versatility
If complex assay systems with multiple detection molecules are used, then multiple analytes can be detected, but the reliability of results decreases due to false negatives or false positives
Solution Approach 1:
The assay system incorporates a control mechanism where the detection molecule's binding behavior provides feedback about the presence of analytes. The detection molecule can bind to the first analyte or form a complex with the first and second analytes, and this binding pattern provides reliable feedback that eliminates false negatives or false positives by confirming the actual presence or absence of target analytes through specific binding patterns.
4Adaptability or versatility
If multiple detection molecules are used, then multiple analytes can be detected, but the manufacturing difficulty increases
Solution Approach 1:
The patent employs a single detection molecule that can detect multiple analytes through different binding mechanisms, eliminating the need to manufacture, quality test, and inventory multiple different detection molecules. This significantly simplifies the manufacturing process while maintaining the capability to detect multiple analytes.
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 simplifies the detection process, reduces false results, and provides clear indications of analyte presence or absence, improving user confidence in health status assessments.
Implementation Method 1
a first immobilized molecule immobilized in one of the first and second detection regions and configured to bind to either the detection molecule or the first analyte to indicate the presence or absence of the first analyte in the sample
Implementation Method 2
a second immobilized molecule immobilized in the other one of the first and second detection regions and configured to bind to the second analyte to generate a complex
Implementation Method 3
the detection molecule is configured to bind to the complex to indicate the presence or absence of the second analyte in the sample
Implementation Method 4
a second detection region in liquid communication with the first detection region and configured to receive the sample from the first detection region in a horizontal direction parallel to the longitudinal axis
Data Source
AI summary
An assay system for detecting the presence or absence of at least a first analyte and a second analyte in a sample is disclosed. The assay system comprises an assay device and a separate label solution comprising a detection molecule. The assay device comprises: a first detection region for receiving the sample in a vertical direction perpendicular to a longitudinal axis; a second detection region for receiving the sample from the first detection region in a horizontal direction parallel to the longitudinal axis; a first immobilized molecule in one of the first and second detection regions configured to bind to either the detection molecule or the first analyte; and a second immobilized molecule in the other one of the first and second detection regions and configured to bind to the second analyte to generate a complex, wherein the detection molecule is configured to bind to the complex.