Digital Analyte Detection Device with Multi-Sensor Array
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Solution Overview
Problem
Traditional digital pregnancy test devices face challenges in accurately detecting human chorionic gonadotropin (hCG) due to uneven migration of reagents and sample flow, leading to inconsistent test results, which can be attributed to channeling, variations in test strip quality, capture medium porosity, and sample volume, resulting in inaccurate or false interpretations.
Innovation Solution
The implementation of a digital analyte detection device with multiple sensors placed above the test and background regions of a test strip, along with a light source, to enhance detection accuracy by capturing reflectance values from these areas, allowing for more comprehensive analysis and minimizing the impact of channeling and uneven test line development.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a single sensor is used to detect the test region, then the device complexity is low, but the measurement precision deteriorates due to channeling and uneven reagent migration
Solution Approach 1:
The test region is divided into multiple detection zones, each monitored by a separate sensor. This segmentation allows the system to detect spatial variations in reagent migration and channeling effects, improving measurement precision by identifying the most representative zone for analyte detection.
Solution Approach 2:
The invention transitions from a single-point detection approach to a multi-point spatial detection array. By distributing sensors across different locations in the test region, the system captures two-dimensional spatial information about reagent flow and analyte distribution, enabling more accurate detection despite channeling effects.
2Reliability
If multiple sensors are deployed across the test region, then the measurement precision improves, but the device complexity increases
Solution Approach 1:
The test strip is divided into distinct functional zones (test region with multiple sensors, background region with sensors) that can be independently analyzed. This segmentation allows the system to compare signals from different zones and compensate for systematic errors, improving detection consistency and reliability.
Solution Approach 2:
The system uses background region sensors to provide reference signals that feed back into the detection algorithm. By comparing test region sensor signals with background region signals, the system can subtract non-specific background effects and improve the reliability of the final detection result.
3Measurement precision
If background region detection is implemented, then the measurement precision improves through background subtraction, but the device complexity increases
Solution Approach 1:
The background region acts as an intermediary reference that captures non-specific effects such as uneven substrate properties, ambient light variations, and reagent flow artifacts. By measuring this intermediary signal and subtracting it from the test region signal, the system isolates the specific analyte-related signal, improving measurement precision.
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 enables more accurate and consistent detection of analytes, particularly at low levels, by providing additional sensor coverage and processing multiple reflectance values to generate a reliable detection result, reducing false positives and negatives.
Implementation Method 1
a light source placed such that the light source illuminates the test region and the background region once the test strip is received
Implementation Method 2
a first plurality of sensors placed such that the first plurality of sensors are located above the test region once the test strip is received... receive test region signals indicating a quantity of light reflected from the test region
Data Source
AI summary
An improved qualitative or semi-quantitative diagnostic test for measuring low levels of any analyte, such as hCG, in a biological sample, such as urine. The test comprises a test device containing reagents for the detection of the monitored analyte and an electronic reader that measures color development at a detection area of the device. The color development is converted to an electronic or digital signal. Improvements were made to the electronic reader to optimize the coverage of the detection area on the test strip. This improves the detection sensitivity and consistency of the test result while maintaining its reliability and accuracy.