Polymer Protein Label for Lateral Flow Assay Sensitivity
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Solution Overview
Problem
Current lateral flow assays are limited in sensitivity due to the inability to amplify signals beyond one detectable moiety per sample molecule, leading to false negatives when detecting low concentrations of biomolecules, and require additional reagents or hardware for nucleic acid amplification.
Innovation Solution
The development of polymeric molecular constructs and labelled protein constructs with multiple affinity binding sites linked to detectable nanoparticles, allowing each target molecule to be labelled with multiple nanoparticles, thereby increasing signal amplification and sensitivity without the need for additional reagents or hardware.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional lateral flow assays use one detectable moiety per sample molecule, then the assay structure remains simple, but the sensitivity is insufficient leading to false negatives at low concentrations
Solution Approach 1:
The detectable label is segmented into multiple nanoparticles (e.g., 25-70 gold nanoparticles) attached to a single polymeric molecular construct. Each nanoparticle serves as an independent detectable unit, allowing signal amplification where one target molecule produces multiple detectable signals instead of one, thereby increasing measurement precision without requiring complex instrumentation
Solution Approach 2:
The invention uses composite polymeric molecular constructs that combine multiple functional components: affinity binding sites for target recognition, polymeric backbone for structural support, and multiple detectable nanoparticle labels for signal amplification. This composite structure integrates recognition and detection functions in a single molecule, improving sensitivity while maintaining manageable complexity
2Measurement precision
If nucleic acid amplification techniques are used to increase molecule concentration, then detection sensitivity improves, but additional hardware and reagents are required increasing complexity
Solution Approach 1:
The polymeric molecular construct performs self-amplification of the detectable signal without requiring external amplification systems. Each target molecule automatically binds multiple nanoparticles, generating inherent signal amplification (25-70x) that eliminates the need for nucleic acid amplification hardware, enzymes, or additional reagents, thereby maintaining assay simplicity while improving sensitivity
Solution Approach 2:
The polymeric molecular construct acts as an intermediary that bridges the target molecule and the detectable nanoparticles. Instead of using complex amplification systems, this intermediary molecule directly connects one target to multiple detectable units, providing a simplified pathway from target recognition to signal generation that avoids additional hardware requirements
3Measurement precision
If fluorescence detection with labelling is used to increase sensitivity, then detection capability improves, but cost increases due to expensive reagents and instrumentation
Solution Approach 1:
The invention replaces expensive fluorescence labels and detection systems with inexpensive gold nanoparticles that can be detected by simple optical means (light scattering/absorption). The gold nanoparticles serve as durable, reusable detectable units that eliminate the need for costly fluorescent reagents and sophisticated fluorescence detection instrumentation, reducing both material and equipment costs while maintaining high sensitivity through multiplexed labeling
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 enhances the sensitivity of lateral flow assays by amplifying the signal 25-70 times, enabling the detection of small numbers of target molecules in a short time without the need for nucleic acid amplification or expensive instrumentation, and can be applied to various biomolecules including proteins and nucleic acids.
Implementation Method 1
The plurality of detectable nanoparticles may be attached via ligand binding
Implementation Method 2
absorbent material, wherein the absorbent material wicks an aqueous sample across the lateral flow device
Data Source
AI summary
The present invention relates to methods, kits and devices for detecting a quantity of as biological target molecule. The invention is particularly relevant to techniques carried out on a flow based assay device. Each biological target molecule is labelled with a plurality of detectable nanoparticles, and may be detected on the device using an optical read-out.