Ovulation Predictor Test Kit Threshold Detection
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Solution Overview
Problem
Current ovulation predictor kits provide subjective test results due to color intensity comparisons, making it difficult for users to accurately detect the luteinizing hormone (LH) surge, which can lead to missed ovulation predictions.
Innovation Solution
A device with a release medium and a capture medium in fluid communication, featuring a scavenger binding member and a labeled binding member that form a sandwich complex, allowing detection of LH only when the concentration exceeds a predetermined threshold, with visible indicators at both the threshold and result sites, eliminating the need for subjective color matching.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If color intensity comparison is used to determine LH surge, then the test can be performed with simple equipment, but the test result interpretation becomes subjective and difficult
Solution Approach 1:
The patent uses color changes to indicate test results. A test line appears at the result site when LH concentration exceeds the threshold, providing a clear visual indicator. The color change from no line to visible line gives unambiguous positive/negative results without requiring subjective intensity comparison.
Solution Approach 2:
The patent replaces the subjective visual comparison mechanism with an objective threshold-based detection system. Instead of requiring users to compare color intensities, the test uses a scavenger binding member to capture excess LH above the threshold, converting a subjective visual task into an objective binary result (line present/absent).
2Device complexity
If color intensity comparison is required, then the test structure remains simple, but measurement precision deteriorates due to subjective interpretation
Solution Approach 1:
The patent introduces a scavenger binding member as an intermediary component that selectively binds LH above the threshold concentration. This intermediary mechanism objectively separates the detection function from the user's visual interpretation, ensuring precise threshold-based detection without requiring subjective color matching skills.
Solution Approach 2:
The patent substitutes the imprecise visual comparison system with an objective biochemical threshold detection system. The scavenger binding member creates a clear cutoff point where LH concentration above the threshold produces visible test line, replacing subjective measurement with objective detection.
3Device complexity
If subjective color matching is required, then the device remains simple, but reliability deteriorates due to user interpretation errors
Solution Approach 1:
The patent uses color changes to provide unambiguous test results. The appearance of a test line at the result site provides clear positive/negative indication, eliminating the guesswork associated with subjective color matching and improving prediction reliability.
Solution Approach 2:
The patent replaces subjective user interpretation with an objective threshold-based detection system. The scavenger binding member ensures that only LH concentrations above the threshold produce visible results, making the test reliable and independent of user expertise.
4Measurement precision
If threshold-based detection with scavenger binding member is used, then measurement precision and reliability improve, but device complexity increases
Solution Approach 1:
The patent segments the test medium into functional zones: a scavenger binding member region that captures excess LH above the threshold, and a result site that detects the captured LH. This segmentation allows precise threshold-based detection while maintaining a relatively simple overall structure that can be implemented in conventional test strip formats.
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 device provides a clear and non-subjective indication of LH surge, enabling users to accurately predict ovulation by counting visible lines, regardless of color intensity, thus improving the timeliness and reliability of ovulation detection.
Implementation Method 1
a labeled binding member reactive with a first epitope of the analyte to be detected in the biological sample, the labeled binding member being releasably disposed on the release medium and a second binding member capable of directly or indirectly binding to the analyte
Implementation Method 2
a scavenger binding member located on one of the release medium and the capture medium upstream from the result site, the scavenger binding member configured to directly or indirectly bind with a predetermined threshold concentration of the analyte
Implementation Method 3
a release medium formed of a first material, wherein the release medium is configured to receive the biological sample, a capture medium located downstream from the release medium and in fluid communication with the release medium
Data Source
AI summary
The present invention is related to a diagnostic test kit for detecting luteinizing hormone (LH) in a biological sample at a concentration relative to a threshold concentration of LH. The device can include a release medium formed of a first material and including a labeled conjugate with a detectable label and a first binding member reactive with a first epitope of LH and a capture medium formed of a second, different material, in fluid communication with the release medium. The capture medium includes a result site having immobilized thereon a capture component capable of directly or indirectly binding LH that is bound to the labeled conjugate. The device is calibrated such that color development at the result site occurs only when the LH concentration of the liquid sample is greater than the threshold concentration.