Blood Sample Analysis Using Extraction Markers and Imaging

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Solution Overview

Problem

Current methods for collecting, transporting, and analyzing blood samples face challenges such as user discomfort, high costs, variability in sample collection and analysis, hematocrit bias, chromatographic effects, and inefficient analyte recovery, particularly with dried blood spot (DBS) methods, which lead to inaccurate results and increased labor costs.

Innovation Solution

A system and method utilizing an assay/collection device with absorbent material for capillary action, imaging device for digital image analysis, and computing software to measure sample volume, hematocrit, and analyte concentration, allowing for precise collection, transportation, and analysis of blood samples without refrigeration, and incorporating extraction markers for normalization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If dried blood spot (DBS) method is used for sample collection, then transportation cost and complexity are reduced, but measurement precision deteriorates due to hematocrit bias

Engineering Contradiction:
Improvetransportation complexityVSAvoidanalyte concentration measurement
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent applies preliminary action by incorporating extraction markers into the DBS card during manufacturing, before the actual sample collection. These markers are pre-positioned in known quantities and locations, enabling later calculation of extraction efficiency and hematocrit correction factors without requiring additional actions at the time of sampling.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback by using the extracted markers to calculate extraction efficiency and hematocrit values, which then feed back into the analytical process to correct the measured analyte concentrations. This closed-loop approach allows the system to self-correct for variability introduced by the DBS method.

Inventive Principle:
Principle #23Feedback

2Device complexity

If conventional DBS extraction method is used, then device complexity is reduced, but analyte recovery efficiency deteriorates due to lack of extraction monitoring

Engineering Contradiction:
Improveextraction process complexityVSAvoidanalyte recovery efficiency
Core Design Contradiction:
Device complexityVSProductivity

Solution Approach 1:

The patent uses extraction markers as intermediary substances that facilitate the monitoring of extraction efficiency. These markers serve as a bridge between the extraction process and the analytical measurement, allowing indirect assessment of how effectively the analyte has been extracted without requiring direct measurement of the extraction process itself.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system performs self-service by using the markers to automatically calculate extraction efficiency and apply corrections to the analyte measurements. This eliminates the need for separate quality control samples or manual assessments of extraction efficiency, streamlining the process while maintaining accuracy.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If conventional DBS method is used, then ease of operation is improved for sample collection, but measurement precision deteriorates due to chromatographic effects

Engineering Contradiction:
Improvesample collection easeVSAvoidanalyte concentration measurement
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent replaces mechanical/physical assessment methods with optical detection. Instead of relying on visual inspection or physical measurement of the blood spot characteristics, the system uses imaging devices to capture optical properties of the markers, which are then converted into quantitative data for calculating correction factors.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 system provides a user-friendly, cost-effective, and accurate method for collecting and analyzing blood samples, reducing hematocrit bias and variability, and improving analyte recovery efficiency, leading to more reliable test results and reduced labor costs.

Implementation Method 1

an assay/collection device with absorbent material for capillary action

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP3359697B1Method for analyzing a blood sample
Publication Date: 2024.12.11 MAMENTA EDWARD L
  • EP3359697B1 patent drawingFigure 1~2
  • EP3359697B1 patent drawingFigure 3~5
  • EP3359697B1 patent drawingFigure 6A~6E

AI summary

A system and method for collecting, transporting, and analyzing dried bodily fluid samples using a sample collection device incorporating extraction markers, an imaging device to take images of dried samples on the collection device, and a computing device to analyze data points from the images so as to measure various properties of the collected sample such as the volume of blood initially collected, and the portion of that volume containing plasma and erythrocytes.