Differentiated Lateral Flow Test Strip Labels for Low-Concentration Detection
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Solution Overview
Problem
Current lateral flow assay strips lack sensitivity for detecting low-concentration analytes and rely on visually similar labels for test and control lines, leading to inaccurate quantification and interpretation errors.
Innovation Solution
The use of conjugatively-labeled detector reagents with analyte-specific labels of larger size or greater signal sensitivity than control-specific labels, along with distinct detectable features, such as different colors, in a lateral flow assay test strip design, allowing for improved detection and quantification through visual and AI-assisted analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the same label size and detectable features are used for both test and control lines, then the device complexity is reduced and manufacturing is simplified, but measurement precision deteriorates due to inability to accurately quantify low-concentration analytes and prone to interpretation errors
Solution Approach 1:
The patent applies local quality by using different label characteristics (size, signal sensitivity, detectable features) specifically for the test line compared to the control line. The analyte-specific label is designed with larger size or greater signal sensitivity than the control-specific label, allowing optimized detection performance for the test analyte while maintaining a simpler control line for reference purposes.
2Reliability
If visually similar labels are used for test and control lines, then the ease of manufacture is improved, but reliability deteriorates due to interpretation errors and difficulty in distinguishing test results
Solution Approach 1:
The patent employs color changes as a detectable feature by using labels with different optical properties for test and control lines. The analyte-specific label has different detectable characteristics (such as color, fluorescence, or other optical signals) compared to the control-specific label, enabling reliable visual or instrumental differentiation of test results while maintaining manufacturing feasibility through established label synthesis methods.
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
Enhances the ability to accurately detect and quantify low-concentration analytes, reducing interpretation errors and providing precise concentration measurements through differentiated visual signals and AI-enhanced analysis.
Implementation Method 1
a conjugatively-labeled detector reagent that specifically binds to the target analyte, the conjugatively-labeled detector reagent having an analyte-specific label covalently-conjugated to an analyte binding reagent
Implementation Method 2
the analyte-specific label is a gold nanoparticle or a gold nanoshell
Implementation Method 3
a lateral flow assay test strip comprising: a sample receiving zone for receiving the test sample; a reaction zone overlapping with or downstream from the sample receiving zone
Data Source
AI summary
A lateral flow assay test strip, device, methods, system and kit for detecting a target analyte in a test sample. The test strip has a sample receiving zone, a reaction zone comprising a conjugatively-labeled detector reagent that specifically binds to the target analyte and a labeled control reagent having a control-specific label, a detection zone comprising a test line region with an immobilized detector capture reagent that specifically binds to the target analyte and a control line region having an immobilized control capture reagent that specifically binds to the labeled control reagent, and an absorbent zone. The conjugatively-labeled detector reagent has an analyte-specific label covalently-conjugated to an analyte binding reagent and such analyte-specific label is of a larger size or a greater signal sensitivity than the control-specific label, and the analyte-specific label has a different detectable characteristic feature than the control-specific label.