Multi-Analyte Diagnostic Device Using Color Intensity Ratios

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Solution Overview

Problem

Current diagnostic methods for female reproductive health, such as ovulation and pregnancy detection, are limited in comprehensiveness and accuracy, often relying on single hormone analysis rather than ratios or differences between multiple analytes, which can lead to missed diagnoses like polycystic ovary syndrome.

Innovation Solution

A diagnostic device and method that analyze the ratio or difference in color intensity between multiple test portions on a reaction unit, using a sample to diagnose pregnancy-related states, including normal and abnormal pregnancy, ovulation, and menopause, by simultaneously measuring hormones like hCG, progesterone metabolites, and estrogen, allowing for more accurate prediction and diagnosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If single hormone analysis is used for diagnosis, then the diagnostic method is simple, but the comprehensiveness and accuracy of diagnosis is limited

Engineering Contradiction:
Improvediagnostic method simplicityVSAvoiddiagnosis accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent combines multiple hormone analysis functions into a single diagnostic device that can simultaneously detect hCG, progesterone metabolites, and estrogen metabolites. This merging of multiple single-hormone test functions into one integrated device allows comprehensive reproductive health assessment while maintaining operational simplicity for the user.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The diagnostic device is designed with multi-functionality to perform various hormone analyses (pregnancy detection via hCG, ovulation monitoring via progesterone and estrogen metabolites, menopause assessment) using a single device platform. This universal design enables one device to replace multiple specialized single-hormone test devices.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If multiple analytes are analyzed simultaneously, then the diagnosis comprehensiveness is improved, but the device complexity increases

Engineering Contradiction:
Improvediagnosis comprehensivenessVSAvoiddevice structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The diagnostic device divides the analysis function into separate test portions, each dedicated to detecting a specific hormone (hCG test portion, progesterone metabolite test portion, estrogen metabolite test portion). This segmentation allows multiple analytes to be analyzed simultaneously through distinct detection zones while maintaining a relatively simple overall device structure that users can easily operate.

Inventive Principle:
Principle #1Segmentation

3Measurement precision

If ratio or difference analysis of color intensity is used, then the diagnostic accuracy is improved, but the measurement complexity increases

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidmeasurement process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The device automatically performs the complex ratio or difference calculations of color intensities between test portions without requiring user intervention. The measurement system self-services by capturing color data from multiple test portions, computing the ratios or differences, and generating diagnostic results autonomously, thus improving accuracy while keeping the user interface simple.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The device incorporates feedback mechanisms where the measured color intensities from multiple test portions are continuously compared and processed. The system uses the ratio or difference of these intensities as feedback to determine diagnostic outcomes, enabling accurate multi-analyte interpretation through automated computational feedback loops.

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 more accurate diagnosis of reproductive health states by analyzing multiple analytes simultaneously, predicting conditions like polycystic ovary syndrome, and providing real-time monitoring through a user-friendly device connected to electronic devices, enhancing healthcare and self-diagnosis capabilities.

Implementation Method 1

a reaction unit receiving a sample therein

Methodology Applied
Scientific EffectImmunochromatography:

Data Source

PatentEP3714797B1Diagnostic device and diagnostic method
Publication Date: 2023.09.20 SUGENTECH INC
  • EP3714797B1 patent drawingFigure 1
  • EP3714797B1 patent drawingFigure 2a
  • EP3714797B1 patent drawingFigure 2b

AI summary

Disclosed is a diagnostic device for diagnosing a state of a subject based on a ratio or a difference between a color intensity of a first test portion and a color intensity of a second test portion in a reaction unit receiving a sample therein, wherein reaction unit includes a sample pad; a conjugate pad; a reaction membrane; and a wicking pad, and wherein the reaction membrane has two or more test portions.