Multiple Analyte Immunoassay via Competitive Binding Ratios
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Solution Overview
Problem
Quantitative immunoassays face limitations in specificity and applicability due to constraints on particle movement on the solid phase and competition between related analytes, making it difficult to accurately measure multiple analytes of interest in fluid samples.
Innovation Solution
The method involves using a solid phase assay with sample capture zones and a control capture zone on a lateral or capillary flow apparatus, where analyte binding particles are coated with specific binding agents, allowing for the determination of analyte ratios through capillary action, and optionally subtracting background amounts to enhance accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If solid phase immunoassay is used to detect analytes, then separation of bound and free reagents is facilitated, but particle movement constraints reduce assay specificity and applicability
Solution Approach 1:
The patent introduces a competitive binding mechanism where analyte-coated particles dynamically compete with free analyte in the sample for binding sites on capture antibodies. This dynamic competition allows the system to maintain measurement precision by reflecting the actual analyte concentration through particle displacement, while still benefiting from solid phase separation capabilities.
2Productivity
If solid phase assay is used for multiple analyte detection, then concurrent analysis is enabled, but analyte competition reduces measurement accuracy
Solution Approach 1:
The patent segments the detection system by assigning different capture antibodies specific to each analyte type (e.g., Influenza A, Influenza B, RSV) onto the solid phase. Each analyte-coated particle population is also segmented with unique fluorescent labels, allowing simultaneous detection of multiple analytes without cross-interference, thus maintaining measurement precision while enabling high productivity.
Solution Approach 2:
The patent implements local quality by creating distinct detection zones on the solid phase, each optimized for specific analyte detection with dedicated capture antibodies and particle populations. This localized specialization allows multiple analytes to be detected concurrently with high precision, as each zone operates independently with its own binding equilibrium.
3Adaptability or versatility
If related analytes are detected in the same assay, then comprehensive diagnostic information is obtained, but analyte competition makes correct assessment difficult
Solution Approach 1:
The patent employs fluorescent labels with distinct emission spectra (different colors) on different analyte-coated particle populations. This allows optical detection systems to distinguish and quantify each analyte type independently based on its characteristic fluorescence signal, eliminating assessment ambiguity even when multiple related analytes are present and competing for binding.
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 enables precise measurement of multiple analytes by increasing binding efficiency and specificity, allowing for concurrent analysis of several compounds with improved sensitivity and correction for variations in particle amounts.
Implementation Method 1
The solid phase apparatus includes an application point, two or more sample capture zones (one corresponding to each analyte of interest) and a control capture zone; the sample capture zones and the control capture zone can be sequentially (with respect to the flow of liquid by capillary action) located on the solid phase apparatus
Data Source
AI summary
Methods for measuring the amount of two or more analytes of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods involve determining a ratio of a detected amount of a single analyte of interest, to the sum of a detected amount of each of the analytes of interest plus a detected amount of a control, wherein the amount of each analyte of interest is directly or inversely related to the ratio for each analyte of interest.