Lateral Flow Assay for LH Beta Subunit Detection

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Solution Overview

Problem

Existing hormone diagnostic systems, particularly those using serum-based blood tests, face challenges in accurately measuring reproductive hormones due to their fluctuating nature and circadian rhythms, leading to inaccurate ovulation detection and fertility window estimation.

Innovation Solution

A urine-based lateral flow assay system specifically designed to detect the beta subunit of luteinizing hormone (LH beta) on a standalone basis, using a device with a conjugate pad and a membrane containing binding members with moderate to high affinity for LH beta, allowing for early indication of the fertile window and improved ovulation detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If serum-based blood tests are used to measure reproductive hormones, then the diagnostic system can detect hormone presence, but the measurement accuracy deteriorates due to hormone fluctuation and circadian rhythms

Engineering Contradiction:

Improvehormone measurement accuracyVSAvoiddiagnostic reliability

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent applies preliminary action by detecting LH beta subunit in urine before ovulation occurs, providing early indication of the fertile window. The binding members are pre-positioned on the membrane to capture LH beta as it appears in urine, enabling detection before the actual ovulation event, thus improving both measurement accuracy and diagnostic reliability.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent extracts the beta subunit of luteinizing hormone (LH beta) from the complete LH molecule for standalone detection. By using binding members that specifically bind only to LH beta subunit rather than intact LH, the system isolates the most sensitive indicator for ovulation prediction, improving measurement precision by focusing on the specific hormone component that best indicates fertile window onset.

Inventive Principle:

Principle #2Taking out (Extraction)

2Measurement precision

If intact LH tests are used, then the device can detect luteinizing hormone, but the detection sensitivity deteriorates for early fertile window indication

Engineering Contradiction:

Improveovulation detection accuracyVSAvoidtiming of fertile window detection

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent extracts the beta subunit of luteinizing hormone (LH beta) from the complete LH molecule for standalone detection. By using binding members that specifically bind only to LH beta subunit rather than intact LH, the system isolates the most sensitive indicator for ovulation prediction, enabling earlier detection of the fertile window onset and improving measurement precision by focusing on the specific hormone component that best indicates fertile window opening.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the detection parameter from intact LH to LH beta subunit specifically. This parameter change enables earlier and more sensitive detection of ovulation status because LH beta subunit levels rise and provide detectable signals earlier than intact LH, reducing the time loss in detecting the fertile window onset.

Inventive Principle:

Principle #35Parameter changes

3Measurement precision

If binding members with high affinity for LH beta are used, then the detection sensitivity improves, but the device complexity increases

Engineering Contradiction:

ImproveLH beta detection sensitivityVSAvoidassay system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent uses binding members as intermediaries that specifically mediate between the LH beta subunit and the detection system. These binding members are immobilized on the membrane and serve as the critical intermediary that enables selective and sensitive detection of LH beta without requiring complex sample preparation or additional processing steps, thus improving detection sensitivity while maintaining relatively simple device architecture.

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

The system provides an improved level of accuracy in determining ovulation status and the onset of the fertile window by detecting LH beta levels earlier and with greater sensitivity than traditional intact LH tests, thereby aiding in better timing of intercourse for fertility.

Implementation Method 1

At least one of the conjugate pad and the membrane includes a binding member that exhibits a moderate to high affinity for LH beta and is selectively or preferentially reactive with LH beta

Methodology Applied

Scientific EffectAffinity binding:

Implementation Method 2

A urine-based lateral flow assay system specifically designed to detect the beta subunit of luteinizing hormone (LH beta)

Methodology Applied

Scientific EffectLateral flow:

Data Source

PatentUS20250035652A1Devices, systems and methods for detection of beta subunit of luteinizing hormone

Publication Date: 2025.01.30 MFB FERTILITY INC

AI summary

Provided herein are urine-based lateral flow assays for the detection of the beta subunit of luteinizing hormone (LH), and methods of interpretation and digital quantification thereof. Such assays may be incorporated into ovulation test devices, e.g., for evaluating the onset and quality of ovulation. Also provided are diagnostic systems, and methods of using such devices and systems.