Biomarker Panels for Sample Quality Assessment
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Solution Overview
Problem
Current methods for evaluating the quality of blood samples for biomarker research are limited by pre-analytical sample variation, with crude methods failing to accurately assess the impact of sample handling on analyte concentrations, leading to unreliable measurements due to activation of immune systems and changes in sample composition.
Innovation Solution
The use of biomarker panels comprising proteins sensitive to sample handling, detected through multiplex slow off-rate aptamer-based assays, to assess sample quality by measuring levels of specific biomarkers such as LANC2, PKHM2, ENOA, and others, and determining the duration of sample processing steps like centrifugation and freezing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If visual inspection methods are used to assess sample quality, then the assessment process is simple and quick, but the measurement precision and reliability are insufficient due to inability to detect subtle pre-analytical variations
Solution Approach 1:
The patent introduces an intermediary assessment system that uses multiple biomarkers as mediators to detect pre-analytical variations. Instead of directly measuring sample quality, the system measures changes in biomarker levels (such as fibrinogen, factor V, factor VIII) that serve as indicators of sample handling effects. This intermediary approach enables precise detection of subtle variations without requiring complex direct quality assessment methods.
Solution Approach 2:
The patent creates a universal biomarker panel that can assess multiple aspects of sample quality simultaneously. The same set of biomarkers can evaluate different pre-analytical variables including centrifugation effects, storage conditions, and processing delays. This multi-functional approach allows a single assessment system to provide comprehensive quality evaluation across various sample handling scenarios.
2Productivity
If extended time between sample processing steps is allowed, then operational flexibility increases, but pre-analytical variability increases leading to compromised biomarker reliability
Solution Approach 1:
The patent implements a feedback mechanism where biomarker levels are measured and used to inform decisions about sample suitability. By monitoring changes in biomarker concentrations over time, the system provides feedback on the effects of processing delays. This feedback allows laboratories to adjust processing protocols and identify samples that have undergone unacceptable degradation, thereby maintaining reliability while allowing operational flexibility.
Solution Approach 2:
The patent applies preliminary action by measuring biomarker levels immediately upon sample receipt to establish baseline quality metrics before further processing occurs. This preliminary assessment allows for early identification of samples that may be affected by prior handling issues, enabling corrective actions or exclusions before the samples undergo additional processing steps that could further compromise reliability.
3Reliability
If multiple biomarkers are measured to assess sample quality, then the assessment comprehensiveness improves, but the assay complexity and cost increase
Solution Approach 1:
The patent merges the measurement of multiple biomarkers into a single multiplexed assay platform. Instead of performing separate assays for each biomarker, the system combines detection of multiple proteins (fibrinogen, factor V, factor VIII, and others) into one integrated test. This merging approach maintains comprehensive assessment reliability while reducing the overall complexity compared to multiple separate assays, as it uses a unified protocol and data analysis framework.
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 the identification of suitable samples for biomarker discovery and diagnostic applications by accurately assessing sample quality, reducing the impact of pre-analytical variations and ensuring reliable protein measurements.
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.