Assay Strip Imaging System for Objective Quantification
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Solution Overview
Problem
Existing assay strips provide semi-quantitative results that are subjective and prone to variance due to visual interpretation, with high background colors often leading to incorrect identification of test lines.
Innovation Solution
An assay system comprising a housing with an imager subsystem to capture high-resolution images of assay strips and a processor subsystem for objective evaluation, using pixel transformation, blob analysis, and blob pairing to identify and quantify signal lines, and configurable criteria for accurate analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If visual interpretation is used to read assay strip results, then the method is simple and rapid, but the results are subjective and have high variance between operators
Solution Approach 1:
The patent replaces the mechanical/visual system of human eye interpretation with an automated imaging system. A camera or imager captures images of the assay strip, and software algorithms objectively analyze the signal lines. This substitution eliminates human subjectivity while maintaining ease of operation, as the automated system requires minimal user input beyond inserting the strip and pressing a button.
Solution Approach 2:
The patent creates a digital copy (image) of the assay strip results. Instead of directly interpreting the physical strip, the system captures an image copy and analyzes it through software. This copying approach allows for repeated analysis, archiving, and objective measurement of signal line characteristics without further human subjectivity.
2Illumination intensity
If high background color is present on the assay strip, then the visual signal may be more visible, but it leads to incorrect identification of test lines by operators
Solution Approach 1:
The patent changes the parameters used to detect signal lines from simple visual intensity thresholds to multi-parameter analysis. The software evaluates multiple characteristics including color ratios, signal line morphology, position, and intensity gradients. This multi-parameter approach allows the system to distinguish true positive signals from background color variations, maintaining reliability even when background color is high.
Solution Approach 2:
The system incorporates feedback mechanisms where the imaging system captures the actual appearance of the strip under controlled lighting, and the software adjusts its analysis parameters based on the captured image characteristics. This feedback loop allows the system to adapt to varying background conditions and optimize detection accuracy for each specific assay strip.
3Device complexity
If manual visual assessment is used, then no additional equipment is needed, but quantification of analyte concentration cannot be performed
Solution Approach 1:
The patent replaces the simple visual assessment mechanism with an automated imaging and analysis system. The camera captures quantitative image data, and software algorithms measure signal line intensity, width, and other characteristics to determine analyte concentration. This substitution adds equipment but enables true quantification rather than just qualitative or semi-quantitative assessment.
Solution Approach 2:
The system changes from no measurement parameters to multiple quantitative parameters including signal line intensity, optical density, width, and position. These measurable parameters enable the system to calculate analyte concentration based on the relationship between signal characteristics and known standards, providing actual quantification capability.
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 system enables objective and quantitative analysis of assay strips, reducing human error and providing uniform results across different types and manufacturers, enhancing accuracy and throughput.
Implementation Method 1
an imager subsystem to capture high-resolution images of assay strips
Implementation Method 2
the test fluid and analyte suspended or dissolved therein can flow from the application zone to a detection zone, for example via capillary action
Data Source
AI summary
An assay system includes an optical imager to acquire high resolution images of assay strips (e.g., lateral flow immunochromatographic test strips) and performs image processing to identify individual assay strips and determine results for each assay strip, by quantifies the presence or absence of test signal line(s) and control signal line(s). Assay strips may be in a holder or carrier contained in a specimen container also holding a specimen. The assay system automatically logs all results and data to a database that stores a high resolution image of the original immunochromatographic assay, the values of test line(s) and control line(s), and the test result. A user interface directs an end user through operation.