Multiplex Calibration Reagent for Assay Precision
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Solution Overview
Problem
Current calibration methods for multiplex assays are time-consuming and imprecise due to the need for multiple calibration samples and systematic assay system variability, especially when dealing with different types of molecules like immunoglobulins and non-immunoglobulin biomarkers.
Innovation Solution
A calibration reagent comprising multiple binding molecules, such as chimeric antibodies or peptide/protein biomarkers, is used to create a calibration curve by binding to capturing agents on a solid phase, allowing for simultaneous calibration of various analytes in a single assay, reducing the number of required calibration intervals and improving precision.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple calibration samples are used for each analyte, then calibration precision is improved, but calibration time and complexity increase
Solution Approach 1:
The patent combines multiple calibration samples containing different analytes into a single multiplex calibration sample. This allows simultaneous calibration of multiple analytes in one assay run, reducing the total number of calibration runs needed while maintaining calibration precision through the use of multiple calibration intervals within the single sample.
Solution Approach 2:
The multiplex calibration sample serves multiple functions simultaneously - it calibrates multiple different analytes (immunoglobulins and non-immunoglobulin biomarkers) in a single sample, eliminating the need for separate calibration samples for each analyte type and significantly reducing calibration time.
2Measurement precision
If separate calibration is performed for different analyte types, then calibration accuracy is improved, but systematic assay variability increases
Solution Approach 1:
By merging immunoglobulin and non-immunoglobulin biomarker calibration into a single multiplex calibration sample, the patent reduces the number of separate calibration operations, thereby minimizing the accumulation of systematic variability across multiple separate calibration runs while maintaining accuracy through multiple calibration intervals.
3Measurement precision
If multiple calibration intervals are used, then calibration precision is improved, but the number of required calibration samples increases
Solution Approach 1:
The patent merges multiple calibration intervals for different analytes into a single multiplex calibration sample. This maintains the precision benefits of multiple calibration intervals while eliminating the need for separate physical samples for each interval, thereby reducing overall complexity.
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 approach significantly reduces the time and variability associated with calibration, enabling more efficient and accurate multiplex assays by combining multiple calibration molecules into a single sample, thereby establishing relative interrelations between different binding molecules and minimizing systematic assay system variability.
Implementation Method 1
each binding molecule has a capacity to bind specifically to a capturing agent immobilised on the solid phase
Implementation Method 2
adding a detection molecule which has a capacity to bind to the calibration reagent
Data Source
AI summary
The present invention relates to a method for calibrating a multiplex assay, comprising: adding a calibration reagent to a solid phase on which a plurality of capturing agents are immobilized, adding a detection molecule which has a capacity to bind to the calibration reagent, detecting bound detection molecule, thereby creating a calibration curve, wherein the calibration reagent comprises at least two different binding molecules, wherein each binding molecule has a capacity to bind specifically to a capturing agent immobilized on the solid phase and a capacity to bind to a detection molecule. Further provided is a multiplex assay system comprising such a calibration reagent.