Immunoassay Interferent Detection and Dynamic Range Expansion
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Solution Overview
Problem
Immunoassays face interference from substances that lead to false results due to cross-reactivity, heterophile antibodies, and other interfering factors, limiting their dynamic range and causing the 'hook effect', which complicates the accurate detection of analytes.
Innovation Solution
A kit and method utilizing specific binding members and conjugates with detectable labels that bind to analytes and interfering substances, allowing for simultaneous detection and differentiation of signals to quantify interfering substances and expand the dynamic range of immunoassays.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional immunoassay methods are used, then the assay can detect analytes, but interfering substances cause false results and limit dynamic range
Solution Approach 1:
The patent introduces a third detectable label as an intermediary marker that specifically binds to interfering substances. This intermediary label allows the system to detect and differentiate interfering substances from true analyte signals, enabling correction of false results while maintaining accurate analyte detection through dual-signal analysis
Solution Approach 2:
The patent changes the detection parameter from single-signal measurement to ratio-based dual-signal measurement. By measuring the ratio between the first detectable label (analyte-specific) and the third detectable label (interference-specific), the system can distinguish true analyte concentrations from interfering substance effects, expanding the reliable detection range
2Device complexity
If conventional immunoassay formats are used, then the assay structure is simple, but the dynamic range is limited and hook effect occurs
Solution Approach 1:
The patent makes the immunoassay system multi-functional by enabling it to simultaneously detect both analytes and interfering substances using three different detectable labels. This universal detection capability allows a single assay to perform multiple functions: quantifying analytes, identifying interference, and correcting results, thereby expanding dynamic range without proportionally increasing structural 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
The approach effectively detects interfering substances and enhances the dynamic range of immunoassays, reducing the hook effect and providing more accurate analyte concentration measurements.
Implementation Method 1
specific binding members and conjugates with detectable labels that bind to analytes and interfering substances
Implementation Method 2
fluorescence, chemiluminescence, or other means of generating a signal in response to an analyte
Implementation Method 3
fluorescence, chemiluminescence, or other means of generating a signal in response to an analyte
Data Source
AI summary
The disclosure provides kits and methods for detecting a substance that interferes with detection of an analyte in a sample and for expanding the dynamic range and reducing the hook effect of an immunoassay. The kits and methods employ two conjugates with two different detectable labels, at least one of which is a chemiluminescent compound of Formula (I).