Protein Switch Sensors for Low-Cost High-Specificity Analyte Detection
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Solution Overview
Problem
Current assays for detecting and monitoring analytes in clinical, non-clinical, and point-of-care settings face challenges due to the high cost, requirement for technical expertise, and the need for specialized infrastructure, often lacking sufficient specificity and sensitivity, especially when dealing with small concentrations of analytes.
Innovation Solution
A protein switch comprising a non-naturally occurring polypeptide with an analyte binding domain and an oxidase or dehydrogenase domain that changes activity upon analyte binding, allowing for sensitive detection of analytes like warfarin, cortisol, or triiodothyronine, with specific mutations at defined amino acid positions, and can be used in a sensor system for in vivo monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If capture and/or detection antibodies are used to provide specificity and sensitivity for analyte detection, then the assay can detect target analytes with high specificity and sensitivity, but the production cost increases and technical expertise requirements increase
Solution Approach 1:
The patent replaces expensive, difficult-to-produce antibodies with inexpensive, engineered protein switches that can be produced at scale. These protein switches are designed to be single-use or limited-life sensors that provide the necessary specificity and sensitivity without requiring complex antibody production processes, thereby reducing manufacturing costs while maintaining detection precision.
Solution Approach 2:
The patent substitutes the biochemical recognition system of antibodies with an engineered protein switch system that uses altered oxidases or dehydrogenases. This substitution replaces the complex immunological recognition mechanism with a more manufacturable enzymatic system that responds to analytes through catalytic activity changes, reducing production complexity and cost while preserving measurement precision.
2Measurement precision
If capture and/or detection antibodies are used to provide specificity and sensitivity for analyte detection, then the assay can detect target analytes with high specificity and sensitivity, but the requirement for technical expertise and specialized infrastructure increases
Solution Approach 1:
The patent employs disposable protein switch-based sensors that eliminate the need for complex antibody handling and specialized laboratory infrastructure. These simplified sensors require minimal technical expertise to operate, as they are designed for straightforward deployment and reading, thereby improving ease of operation while maintaining high measurement precision through their engineered specificity.
Solution Approach 2:
The patent replaces the complex immunological assay system requiring specialized infrastructure with a simplified enzymatic protein switch system. This substitution eliminates the need for elaborate biomedical infrastructures and specialized laboratory environments, making the assay easier to operate in diverse settings while preserving analytical precision through the engineered protein switches' specific analyte recognition capabilities.
3Measurement precision
If conventional assays are used for analyte detection in clinical and point-of-care settings, then diagnostic accuracy can be achieved, but the device complexity and infrastructure requirements increase
Solution Approach 1:
The patent segments the complex conventional assay system into simplified protein switch-based detection units that can function independently without elaborate infrastructure. Each protein switch is engineered to perform specific analyte detection tasks autonomously, reducing overall device complexity while maintaining diagnostic accuracy through the cumulative capability of multiple specialized protein switches.
Solution Approach 2:
The patent substitutes complex conventional assay infrastructure with simplified protein switch-based detection systems. This replacement eliminates the need for elaborate biomedical infrastructures typically required for diagnostic assays, reducing device complexity while preserving diagnostic accuracy through the engineered specificity and sensitivity of the protein switches.
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 protein switch provides cost-effective, sensitive, and specific detection of analytes, suitable for widespread application in various settings, including clinical and point-of-care, by changing enzyme activity in response to analyte binding, facilitating accurate health monitoring.
Implementation Method 1
at least one oxidase or dehydrogenase domain having oxidase or dehydrogenase activity and capable of binding or reacting with at least one reactant
Implementation Method 2
the reactant that binds or reacts with the oxidase or dehydrogenase domain
Implementation Method 3
at least one analyte binding domain capable of binding with at least one analyte
Implementation Method 4
when the analyte binds to the analyte binding domain the oxidase or dehydrogenase activity changes
Data Source
AI summary
Compositions of matter, methods, devices, systems and apparatus for detecting analytes are disclosed including, for example, protein switches and their use in an in vivo sensor. The protein switch can be used to determine a level of an analyte that is diagnostic for health and/or well-being of a subject.