Lateral Flow Immunoassay for Prediabetes Protein Marker Detection
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Solution Overview
Problem
Current methods for diagnosing type 2 diabetes (T2D) are inadequate as genetic markers are not effective at the prediabetes stage and protein markers are not widely utilized.
Innovation Solution
A diagnostic kit and method utilizing protein markers MLL4, LAMA2, and PLXDC2 for detecting and identifying prediabetes and diabetes, which involves a substrate with specific areas for sample loading, capture antibodies, reagents, and detection antibodies, enabling lateral flow immunoassay.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If genetic markers are used for T2D diagnosis, then reliability is improved, but sensitivity and specificity are limited and they only show up at T2D stage rather than prediabetes stage
Solution Approach 1:
The patent transitions from using genetic markers to using protein markers (MLL4, LAMA2, PLXDC2) as the diagnostic parameter. Protein levels dynamically reflect disease progression and can be detected at the prediabetes stage, thereby improving both sensitivity/specificity while maintaining reliability through the systematic reflection of disease progression.
2Measurement precision
If protein markers are used for diagnosis, then sensitivity and specificity are improved, but they are not widely utilized
Solution Approach 1:
The patent segments the diagnostic approach by identifying specific protein markers (MLL4, LAMA2, PLXDC2) and developing targeted detection methods for each. This segmentation enables systematic utilization of protein markers through specialized assays, making them practically applicable and widely adoptable while maintaining high sensitivity and specificity.
Solution Approach 2:
The patent introduces specific detection reagents and assays as intermediaries between the protein markers and the diagnostic process. These intermediaries (detection antibodies, ELISA reagents, lateral flow assay components) enable the practical utilization of protein markers by providing standardized, easy-to-operate detection systems.
3Reliability
If early prevention and intervention are implemented, then incidence of T2D is reduced, but identification of high-risk subjects before clinical onset is required
Solution Approach 1:
The patent enables preliminary detection of prediabetes through protein marker analysis (MLL4, LAMA2, PLXDC2) before clinical diabetes onset. By detecting elevated protein levels in the prediabetes stage, the system allows early intervention and prevention measures to be implemented, thereby reducing T2D incidence while overcoming the difficulty of early detection.
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 use of MLL4, LAMA2, and PLXDC2 protein markers effectively identifies prediabetes and diabetes with high sensitivity and specificity, as demonstrated by immunoblotting and ROC curve analysis, providing a reliable diagnostic tool.
Implementation Method 1
a capture antibody area, containing capture antibodies immobilized onto the substrate in the capture antibody area to capture prediabetes and diabetes protein markers comprising MLL4, LAMA2, and PLXDC2
Implementation Method 2
a detection antibody area, containing detection antibodies to detect the captured prediabetes and diabetes protein markers comprising the MLL4, LAMA2, and PLXDC2
Implementation Method 3
The diagnostic kit device/apparatus of the invention is optimized for performance by lateral flow immunoassay
Data Source
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AI summary
The invention relates to LAMA2, PLXDC2 and MLL4 as novel biomarkers for prediabetes and diabetes. Specifically, use of a set of probes with specific binding affinities to prediabetes and diabetes protein markers comprising MLL4, LAMA2, and PLXDC2 for screening prediabetes and diabetes for care and/or treatment is disclosed. The set of probes comprises a first probe, a second probe and a third probe having specific binding affinities to the MLL4, LAMA2, and PLXDC2, respectively. A diagnostic kit device/apparatus comprising a set of probes is disclosed. A method for detecting and identifying prediabetes and/or diabetes in a subject in need thereof is also disclosed. The subject in need thereof identified as having prediabetes or diabetes is subject to a care and/or a treatment regime for the prediabetes or diabetes. Also disclosed is a method for identifying prediabetes and/or diabetes protein markers.