Lateral Flow PdG Test Strip for Quantitative Hormone Tracking
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Solution Overview
Problem
Existing hormone and chemical analyte tests, particularly for progesterone metabolites like PdG, are limited by their inability to provide reliable semi-quantitative or quantitative results, often requiring invasive methods, additional devices for result interpretation, and are prone to fluctuations due to pulsatile hormone release, making them inconvenient and expensive.
Innovation Solution
A non-competitive lateral flow assay (LFIA) based test strip or cassette that provides semi-quantitative results through visually identifiable test-line color density, with optional software interpretation using a T/C ratio method to derive quantitative hormone levels, eliminating the need for additional hardware and accounting for ambient interference.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional qualitative hormone tests are used, then the test structure is simple and cost-effective, but reliable semi-quantitative or quantitative results cannot be obtained
Solution Approach 1:
The patent changes the fundamental parameter of the test line response from binary (positive/negative) to continuous (color density intensity). By modifying the lateral flow assay to produce test lines with variable color densities that correspond to different hormone concentrations, the system enables quantitative measurement while maintaining the simplicity of the test strip format. This parameter change allows the same basic test structure to provide both qualitative and quantitative information.
2Measurement precision
If additional devices are used for result interpretation, then quantitative results can be obtained, but the system becomes more complex and expensive
Solution Approach 1:
The test strip performs self-interpretation through its inherent color density variation. The test line automatically provides quantitative information through its visual properties without requiring external reading devices. Users can directly observe and compare color densities against reference standards included with the test, eliminating the need for additional hardware while maintaining quantitative measurement capability.
Solution Approach 2:
The patent utilizes color density changes as the direct readout mechanism. The test line's color intensity varies continuously with hormone concentration, providing a visual quantitative measure that can be interpreted by users without additional devices. This color-based self-reading approach eliminates the need for specialized hardware while maintaining measurement precision.
3Measurement precision
If invasive blood testing is used, then accurate progesterone levels can be measured, but the procedure is inconvenient and expensive
Solution Approach 1:
The patent uses urine as an intermediary medium to indirectly measure progesterone levels. Instead of requiring direct blood sampling, the test detects progesterone metabolites in urine, which serve as a proxy indicator. This intermediary approach maintains measurement accuracy while dramatically improving convenience, allowing users to perform simple self-tests at home without invasive procedures.
Solution Approach 2:
The patent replaces the mechanical invasive blood collection system with a non-invasive urine collection system. The test strip substitutes for complex blood processing equipment, enabling accurate progesterone measurement through a simple dip-test mechanism that can be performed at home, thereby eliminating the need for medical professionals and laboratory infrastructure.
4Productivity
If single-point progesterone testing is used, then the test is simple and quick, but pulsatile hormone release causes fluctuating results that are difficult to analyze
Solution Approach 1:
The patent enables continuous monitoring by allowing multiple tests to be performed at different time points throughout the menstrual cycle. The continuous action of repeated testing generates a time-series dataset that captures the pulsatile nature of progesterone release. This continuity transforms single-point fluctuations into a comprehensive pattern recognition tool, improving both productivity through efficient data collection and reliability through trend analysis.
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 cost-effective, user-friendly, and continuous monitoring of progesterone metabolite levels, facilitating regular data collection and trend analysis, aiding in reproductive health management, early pregnancy detection, and risk assessment for conditions like miscarriage and ectopic pregnancy.
Implementation Method 1
a non-competitive lateral flow assay (LFIA) based test strip or cassette that provides semi-quantitative results through visually identifiable test-line color density
Data Source
AI summary
A test system includes a test device and a calibration chart. The test includes a lateral flow assay that detects the presence of a target analyte. In response to exposure to the target analyte, the results area produces a visually identifiable test-line and a visually identifiable control-line, wherein the visually identifiable test-line increases in darkness according to an increased concentration level of the target analyte. The calibration chart includes a plurality of color blocks, wherein each of the color blocks is representative of a test-line color density that corresponds to a quantitative hormone concentration in the target substance. The test system further includes a user device that derives a quantitative result, tracks the quantitative levels over the time, and compares them to normal hormone trends and threshold values associated with defined risk levels for certain health conditions.