Biomarker Panel Assay for Sample Quality Assessment
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Solution Overview
Problem
Current methods for assessing sample quality in biomarker research are limited by pre-analytical variability, such as sample handling-induced changes in analyte concentrations, which compromise the reliability of biomarker measurements.
Innovation Solution
The use of biomarker panels, including proteins like MCP-3, iC3b, Clusterin, and RIC8A, detected through multiplex slow off-rate aptamer-based assays, to predict and assess sample quality by measuring protein levels and estimating time elapsed between sample processing steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If visual inspection methods are used to assess sample quality, then the method is simple and quick, but the reliability and precision of sample quality assessment is poor
Solution Approach 1:
The patent replaces manual visual inspection with an automated multiplex assay system that uses aptamers to detect biomarker proteins. This substitution of mechanical/visual methods with molecular detection methods enables precise, objective measurement of sample quality parameters while maintaining ease of operation through automated processing.
Solution Approach 2:
The patent shifts from assessing sample quality based on visual parameters (color, cloudiness) to measuring biochemical parameters (concentrations of specific proteins like MCP-3, iC3b, Clusterin, DHI1, and RIC8A). This parameter transformation enables quantitative, precise assessment of sample quality that is not possible with visual inspection alone.
2Reliability
If multiple biomarker proteins are detected using multiplex assays, then the reliability of sample quality assessment is improved, but the device complexity and assay complexity increase
Solution Approach 1:
The patent employs a universal multiplex assay platform that can simultaneously detect multiple biomarker proteins using a single assay system. The aptamer-based platform is designed to handle multiple targets with different proteins in one experiment, reducing the need for separate assays and thereby managing system complexity while improving reliability through comprehensive biomarker profiling.
Solution Approach 2:
The patent combines the detection of multiple biomarker proteins (MCP-3, iC3b, Clusterin, DHI1, RIC8A) into a single multiplex assay. By merging multiple detection functions into one integrated system, the patent improves reliability through comprehensive assessment while avoiding the cumulative complexity that would result from running separate assays for each protein.
3Ease of manufacture
If pre-analytical variability is not accounted for, then the sample processing steps can be simplified, but the measurement precision and reliability of biomarker data are compromised
Solution Approach 1:
The patent performs preliminary assessment of sample quality using the multiplex biomarker panel before proceeding with downstream analyses. By evaluating sample quality in advance and identifying samples affected by pre-analytical variability early in the process, the system can simplify subsequent processing by focusing resources only on high-quality samples, thereby maintaining measurement precision without unnecessary complexity.
Solution Approach 2:
The patent implements feedback mechanisms where the biomarker panel results are used to evaluate and categorize sample quality. This feedback information is then fed back into the workflow to determine which samples are suitable for further analysis and which should be excluded or reprocessed, enabling simplified processing of high-quality samples while maintaining precision through selective analysis.
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
This approach allows for consistent and reliable evaluation of sample quality, enabling accurate protein biomarker discovery, expression analysis, and diagnostic/prognostic methods by identifying and correcting for sample handling inconsistencies.
Implementation Method 1
detecting the biomarkers using a multiplex slow off-rate aptamer-based assay
Data Source
AI summary
Biomarkers, methods, devices, reagents, systems, and kits used to assess the quality of a sample collected from a subject are provided. Such biomarkers, methods, devices, reagents, systems, and kits may be useful in evaluating acceptability of sample handling and/or consistency of sample handling across a plurality of samples.