Lateral Flow Device Detecting Kidney Allograft Rejection
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Solution Overview
Problem
Current lateral flow assays for detecting kidney allograft rejection lack sensitivity and accuracy, requiring invasive procedures and inadequate biomarker detection, especially for kidney injury, which limits their effectiveness in monitoring transplant health.
Innovation Solution
A lateral flow device is developed to detect methylated DNA and proteins in urine samples using a membrane with specific detectable moieties that form complexes, providing a non-invasive, sensitive, and accurate method for identifying kidney allograft rejection by adjusting detection thresholds for m-cDNA and protein levels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional lateral flow assays are used for detecting kidney allograft rejection, then the test is simple and rapid, but the sensitivity and limit of detection are poor
Solution Approach 1:
The device segments the detection function into multiple independent capture zones on the membrane, each targeting specific biomarkers (m-cIDNA, CXCL-10, clusterin, total protein). This allows simultaneous detection of multiple analytes with optimized detection thresholds for each, improving overall sensitivity without requiring a completely new device architecture.
Solution Approach 2:
The patent applies parameter changes by establishing specific detection thresholds for different biomarkers (e.g., m-cIDNA ≥25 ng/mL, CXCL-10 ≥100 pg/mL, clusterin ≥50 pg/mL, total protein ≥25 ng/mL). These quantitative thresholds enable sensitive detection and classification of rejection grades while maintaining the simplicity of the lateral flow format.
2Measurement precision
If conventional lateral flow assays are used, then the test is user-friendly and cost-effective, but the results are only qualitative or semi-quantitative
Solution Approach 1:
The device utilizes color changes at different capture zones to indicate the presence and relative concentration of biomarkers. The intensity and position of color development provide semi-quantitative information that can be interpreted by users without complex instrumentation, maintaining ease of operation while improving measurement precision.
Solution Approach 2:
The patent replaces complex electronic detection systems with a simplified optical reading approach. Users can visually interpret results or use simple digital image capture devices to quantify color intensity, eliminating the need for complex electronic readers while achieving quantitative analysis capability.
3Reliability
If invasive procedures are used for monitoring transplant health, then the diagnostic accuracy is high, but the patient comfort and ease of monitoring are reduced
Solution Approach 1:
The device uses urine as an intermediary medium to non-invasively detect biomarkers of kidney injury. By capturing and detecting m-cIDNA, CXCL-10, clusterin, and total protein in urine samples, the system provides diagnostic accuracy comparable to invasive biopsy procedures while eliminating the need for patient discomfort and logistical complexity of tissue sampling.
4Measurement precision
If single biomarker detection is used, then the test is simple, but the sensitivity and specificity for detecting kidney injury are insufficient
Solution Approach 1:
The device merges multiple detection functions into a single integrated lateral flow device by incorporating multiple capture zones on one membrane. Each zone detects a specific biomarker (m-cIDNA, CXCL-10, clusterin, total protein), and the combined results provide high sensitivity and specificity for kidney injury classification, achieving superior performance without requiring multiple separate tests.
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 achieves high sensitivity and specificity in detecting kidney allograft rejection, allowing for reliable monitoring of transplant health without the need for invasive procedures, using a combination of biomarkers like CXCL-10, clusterin, and total protein to generate a composite Q-Score for accurate diagnosis.
Implementation Method 1
a first detectable moiety attached thereto whereby the first detectable moiety specifically binds to a methylated cell free nucleic acid (m-cIDNA) to form a detectable complex
Implementation Method 2
a second detectable moiety attached thereto whereby the second detectable moiety specifically reacts with one or more protein(s)
Implementation Method 3
a flow path from the sample application area to the capture area
Data Source
AI summary
The disclosure provides lateral flow devices for detecting the presence or absence of methylated cIDNA and one or more protein(s) in a biological sample, such as urine or blood.