Urine PdG Test Strip Design for Reliable Ovulation Confirmation
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Solution Overview
Problem
Existing lateral flow assay-based tests are unable to reliably and reproducibly detect progesterone metabolites in urine, particularly pregnanediol-3-glucuronide (PdG), due to the unique chemical structure of PdG, leading to inaccurate and unreliable results, and there is a need for a user-friendly, cost-effective method to confirm ovulation and progesterone levels without laboratory equipment.
Innovation Solution
A specially configured test strip using a combination of specific antibodies and carrier proteins, such as globulin, with colloidal gold or latex beads for color differentiation, allows for the detection of PdG in urine, providing clear visual results and minimizing user interpretation burden.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard lateral flow assay-based tests are used to detect PdG in urine, then the test structure is simple and easy to manufacture, but the detection reliability is poor due to the unique chemical structure of PdG
Solution Approach 1:
The patent applies local quality by making the detection zone antibodies highly specific to PdG's unique chemical structure, while other parts of the test strip maintain standard lateral flow assay characteristics. This localized specialization improves detection reliability without requiring complete redesign of the entire device.
Solution Approach 2:
The patent uses composite materials by combining specific antibody types (IgG, IgM, IgA) with appropriate carrier proteins and colloidal gold labels to create a detection system that reliably binds to PdG's unique structure, while maintaining the overall simplicity of the lateral flow assay format.
2Measurement precision
If standard lateral flow assay-based tests are used, then the manufacturing process is simple, but the measurement precision is insufficient for accurate PdG detection
Solution Approach 1:
The patent changes the critical parameter of antibody specificity to match PdG's unique chemical structure, while maintaining other manufacturing parameters within standard lateral flow assay ranges. This selective parameter optimization achieves precise detection without proportionally increasing manufacturing complexity.
Solution Approach 2:
The patent successfully adapts the proven lateral flow assay design (a copied, reliable format) and modifies only the essential detection components to work with PdG, rather than creating an entirely new test system. This approach maintains ease of manufacture while improving measurement precision.
3Ease of operation
If complex laboratory equipment is used to detect progesterone levels, then the detection accuracy is high, but the ease of operation decreases and requires specialized equipment
Solution Approach 1:
The patent makes the test self-service by using urine as the sample type (no blood draw required) and designing the lateral flow assay to provide automatic visual results without requiring laboratory equipment or specialized training. The test strip itself performs all necessary detection functions.
Solution Approach 2:
The patent replaces complex laboratory mechanical and instrumental systems with a simple lateral flow assay that uses capillary action and visual colorimetric detection. This substitution maintains ease of operation while achieving sufficient measurement precision for fertility tracking.
4Reliability
If existing test methods are used, then the cost is low, but the reproducibility of results is poor
Solution Approach 1:
The patent segments the detection function into highly specific antibodies tailored to PdG's unique structure, separating this critical function from the rest of the test system. This segmentation allows the specific detection component to be optimized for reproducibility while the rest of the device remains simple and cost-effective.
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 solution enables accurate and reproducible detection of PdG levels, confirming ovulation and providing fertility information, allowing users to track their fertile and infertile periods without specialized equipment, thus enhancing pregnancy planning and prevention.
Implementation Method 1
A specially configured test strip using a combination of specific antibodies and carrier proteins, such as globulin, with colloidal gold or latex beads for color differentiation
Implementation Method 2
A specially configured test strip using a combination of specific antibodies and carrier proteins... allows for the detection of PdG in urine
Data Source
AI summary
Embodiments of the invention comprise a test strip configured to detect one or more metabolites of progesterone in urine, and optionally further detect one or more additional metabolites or hormones in urine within the same test strip. Embodiments of the invention are methods of utilizing such a test strip in association with avoidance of pregnancy, detection of menopause, and in association with fertility planning purposes. Embodiments of the invention are associated with the incorporation of a test strip within a testing kit, optionally further comprising a digital reader.