Lateral Flow Assay Reader Alignment for Quantitative Detection

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Solution Overview

Problem

Existing lateral flow assay devices are limited to providing only qualitative or semi-quantitative results, lacking the capability for accurate quantitative analysis, and alignment issues between assay readers and test strips affect reading accuracy.

Innovation Solution

Integration of an electronic reader with a test strip that includes a bibulous material, a porous membrane, and optical components, along with precise alignment markers, to enable accurate quantitative analysis by controlling illumination and detection angles, and using fiducial markers for alignment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If an electronic reader is used to measure the detectable label for determining analyte concentration, then quantitative analysis capability is improved, but alignment precision between the reader and test strip becomes critical and difficult to maintain

Engineering Contradiction:
Improvequantitative analysis capabilityVSAvoidalignment precision
Core Design Contradiction:
Measurement precisionVSManufacturing precision

Solution Approach 1:

Fiducial markers are introduced as intermediary reference elements on the test strip that mediate the alignment between the electronic reader's photodetector and the detection zone. These markers provide a standardized reference framework that enables precise positioning without requiring complex mechanical alignment mechanisms.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces complex mechanical alignment systems with an optical/reference-based system. Instead of using精密 mechanical positioning mechanisms, the invention uses fiducial markers and optical detection to achieve precise alignment, substituting mechanical complexity with a more manageable optical referencing approach.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Use of energy by moving object

If the photodetector is positioned close to the test strip to capture sufficient light signal, then signal intensity is improved, but the device complexity and alignment difficulty increase

Engineering Contradiction:
Improvesignal intensityVSAvoidalignment difficulty
Core Design Contradiction:
Use of energy by moving objectVSDevice complexity

Solution Approach 1:

The test strip design includes integrated fiducial markers that automatically provide alignment reference information to the electronic reader. This self-service mechanism eliminates the need for complex external alignment tools or procedures, allowing the system to self-align using the embedded reference markers.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The fiducial markers utilize optical properties (such as color or reflectivity differences) to provide detectable reference signals. These markers create distinct optical signatures that the photodetector can easily identify and use for precise positioning, making the alignment process simpler and more reliable.

Inventive Principle:
Principle #32Color changes

3Area of stationary object

If a narrow detection zone is used to improve test strip compactness, then device compactness is improved, but the signal captured by the photodetector decreases due to the inverse square law

Engineering Contradiction:
Improvedetection zone widthVSAvoidlight signal captured
Core Design Contradiction:
Area of stationary objectVSUse of energy by moving object

Solution Approach 1:

The patent applies local quality by concentrating the detectable label signal precisely at the detection zone while using fiducial markers to ensure the photodetector is optimally positioned. The narrow detection zone maintains compactness, while the reference markers ensure the photodetector captures maximum signal from this concentrated area.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The fiducial markers provide feedback information to the electronic reader about the relative position between the photodetector and detection zone. This feedback mechanism allows the system to adjust and optimize the positioning to maximize light signal capture despite the narrow detection zone width.

Inventive Principle:
Principle #23Feedback

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

Enables sensitive and accurate quantitative results by minimizing alignment errors and optimizing light capture, allowing for precise measurement of analyte concentration.

Implementation Method 1

Light from a source of electromagnetic radiation, such as a light emitting diode (LED), laser, etc., is directed toward the test strip at the detection (and optionally control) zone and reflected or transmitted or fluoresced light is detected by a photodetector in the reader.

Methodology Applied
Scientific EffectLight emission and detection: Light

Implementation Method 2

reflected or transmitted or fluoresced light is detected by a photodetector in the reader

Methodology Applied
Scientific EffectPhotodetection: Photoelectric Effect

Implementation Method 3

The sample flows along the lateral flow matrix, and one or more analyte components to be detected in the sample react with at least one reagent which is provided in or added to the lateral flow matrix.

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS12372516B2Methods and compositions for lateral flow analyte assays
Publication Date: 2025.07.29 IVD VISION LLC
  • US12372516B2 patent drawing
  • US12372516B2 patent drawing
  • US12372516B2 patent drawing

AI summary

It is an object of the present invention to provide improved lateral flow test devices that can provide sensitive and accurate quantitative test results, and methods for the manufacture thereof.