Reversible Binding Analyte Detection Method for Whole Blood
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Solution Overview
Problem
Current rapid testing methods, such as immunochromatography, have lower analytical sensitivity and precision compared to classic immunoassays, particularly when processing unprocessed whole blood samples, due to sample matrix dependency and limited sample volume.
Innovation Solution
A method utilizing a reversible binding system where a reversible binding partner 1 is immobilized on a solid phase, with an analyte binder reversibly bound via a reversible binding partner 2, allowing for the detection of analytes in biological samples using a detachment buffer that prevents binding between the partners, enabling high sensitivity and precision similar to classic immunoassays.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If immunochromatography is used for rapid testing, then the method can process unprocessed whole blood samples, but the analytical sensitivity and precision are reduced
Solution Approach 1:
The method divides the testing process into distinct functional stages: sample processing phase (using immunochromatography for versatility) and detection phase (using reversible binding system for precision). The reversible binding system separates the analyte binding function from the sample processing function, allowing each to be optimized independently.
Solution Approach 2:
The reversible binding partner acts as an intermediary between the analyte binder and the solid phase. This intermediary enables the analyte binder to maintain high affinity binding for the analyte while allowing controlled release through detachment buffer, thus achieving both rapid processing capability and high measurement precision.
2Measurement precision
If classic immunoassays are used, then high analytical sensitivity and precision are achieved, but the method cannot process unprocessed whole blood samples
Solution Approach 1:
The reversible binding system is designed to perform multiple functions: it can bind analytes from complex matrices like whole blood, maintain high precision through controlled binding/detachment mechanisms, and facilitate rapid testing. The system universally applies to various sample types while maintaining optimal performance.
Solution Approach 2:
The method utilizes parameter changes in the detachment buffer (pH, ionic strength, or other conditions) to reversibly alter the binding between the reversible binding partners. This allows the system to transition from a bound state (for high precision analyte capture) to a released state (for rapid detection), achieving both precision and versatility.
3Measurement precision
If reversible binding system is used, then high analytical sensitivity and precision are achieved, but the device complexity increases
Solution Approach 1:
The reversible binding partners are designed as disposable components that can be easily replaced. The solid phase with immobilized reversible binding partners can be used as single-use test strips or microplates, eliminating the need for complex recovery and reuse mechanisms, thus reducing overall system complexity despite the reversible binding mechanism.
Solution Approach 2:
The reversible binding function is extracted as a separate, modular component from the overall assay system. This allows the binding/detachment mechanism to be optimized independently while keeping the rest of the system simple. The reversible binding partners can be pre-loaded onto solid phases and then disposed of after single use.
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
This method allows for the use of unprocessed whole blood samples, achieving high analytical sensitivity and precision by maintaining or re-establishing the binding of analytes to the analyte binder during and after the detachment process, with the ability to process larger sample volumes, reducing matrix dependency and improving detection accuracy.
Implementation Method 1
a reversible binding system with a reversible binding partner 1, to which an analyte binder is reversibly bound via a reversible binding partner 2 bound to the analyte binder
Implementation Method 2
addition of a detachment buffer which prevents the binding between the reversible binding partners 1 and 2 dissolves
Implementation Method 3
binding of the analyte to the reversibly immobilized analyte binder in the case that the biological sample contains the analyte
Data Source
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AI summary
The present invention relates to a method for detecting analytes of biological samples, said method comprising the following method steps of: a) providing a reversible binding partner 1 which is immobilized on a solid phase and to which an analyte binder is reversibly bound via a reversible binding partner 2 which is bound to the analyte binder, wherein the analyte binder is immobilized by binding the reversible binding partners 1 and 2, b) adding the biological sample and binding the analyte to the reversibly immobilized analyte binder in the event that the biological sample contains the analyte, c) separating the biological sample, d) adding a stripping buffer which dissolves the bond between the reversible binding partners 1 and 2, wherein the bond between the analyte and the analyte binder optionally remains, and e) detecting the analyte in the stripping buffer in the event that the biological sample contains the analyte or determining the absence of the analyte in the event that the biological sample does not contain the analyte.