Lateral Flow Assay for Urine PdG Detection

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current urine-based tests for detecting progesterone levels, specifically pregnanediol glucuronide (PdG), are inaccurate and not suitable for non-lab environments due to issues with antibody selection, cross-reactivity, and lack of a system for result collection and interpretation, making it difficult to create a lateral flow assay that provides clear, visually interpretable results without specialized equipment.

Innovation Solution

A lateral flow assay using anti-pregnanediol glucuronide antibodies of specific isotypes (IgG1, IgG1 Kappa, IgG2b, or IgG3) conjugated to labels, with PdG conjugated to globulin or Bovine Serum Albumin as a carrier protein, allowing for perceptible results above a PdG threshold of 3-20 μg/ml, and a system for tracking and interpreting results using a mobile device and application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional antibody selection and carrier proteins are used in lateral flow assays, then the test can be performed outside the lab, but the results are inaccurate and not visually interpretable

Engineering Contradiction:

Improvetest usability outside labVSAvoiddetection accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent changes the isotype parameter of the antibody from conventional types to specifically IgG1, IgG1 Kappa, IgG2b, or IgG3 isotypes, which have been shown to provide both visual interpretability and accurate detection of PdG in urine samples outside the lab setting

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses composite materials by conjugating PdG to specific carrier proteins (globulin or Bovine Serum Albumin) at optimized ratios, creating a conjugate that provides both the necessary binding affinity for accurate detection and sufficient color intensity for visual interpretation by non-experts

Inventive Principle:

Principle #40Composite materials

2Measurement precision

If lab-grade electronic readers are used to detect PdG, then high accuracy is achieved, but specialized equipment is required

Engineering Contradiction:

Improveconcentration detection accuracyVSAvoidequipment requirements

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent utilizes color changes as the detection mechanism by optimizing the conjugate to produce sufficient color intensity at the test line that is visually interpretable by the naked eye, eliminating the need for lab-grade electronic readers while maintaining accurate detection capability

Inventive Principle:

Principle #32Color changes

Solution Approach 2:

The patent creates a simplified version of the lab-based detection system by developing a lateral flow assay that replicates the accuracy of electronic readers through optimized chemical conjugates and antibody selection, allowing the same detection function to be performed with simple visual interpretation

Inventive Principle:

Principle #26Copying

3Device complexity

If previous antibody and carrier protein combinations are used, then the test structure is simple, but the results are imperceptible to the naked eye

Engineering Contradiction:

Improvetest structure simplicityVSAvoidcolor intensity for visual detection

Core Design Contradiction:

Device complexityVSIllumination intensity

Solution Approach 1:

The patent changes the carrier protein parameter to specifically globulin or Bovine Serum Albumin and optimizes the conjugate ratio to produce sufficient color intensity that is visually perceptible to the naked eye, while maintaining the simplicity of the lateral flow assay structure

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses the carrier protein-conjugated PdG as an intermediary that bridges the gap between the antibody binding event and the visual signal, ensuring that the color change is intense enough for visual detection while keeping the overall test structure simple

Inventive Principle:

Principle #24Intermediary (Mediator)

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 reliable and reproducible detection of PdG levels in urine, allowing for visual interpretation of results by non-experts without lab equipment, improving the accuracy and usability of progesterone testing.

Implementation Method 1

A lateral flow assay using anti-pregnanediol glucuronide antibodies of specific isotypes (IgG1, IgG1 Kappa, IgG2b, or IgG3) conjugated to labels

Methodology Applied

Scientific EffectAntigen-antibody binding:

Implementation Method 2

allowing for perceptible results above a PdG threshold of 3-20 μg/ml

Methodology Applied

Scientific EffectColorimetric detection:

Data Source

PatentUS20230408512A1System for evaluating urine for the presence or absence of pregnanediol glucuronide and other hormones and analytes

Publication Date: 2023.12.21 MFB FERTILITY INC

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.