Blood Spot Quantification Using Hydrophilic Marker Normalization

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Solution Overview

Problem

Existing methods for quantitative testing of blood and serum specimens, particularly dried blood spot and serum cards, face challenges in accurately determining the quantity of blood or serum, leading to potential errors in analyte level measurements due to variations in specimen volume, which can significantly impact the reliability of test results.

Innovation Solution

The method involves eluting the modified specimen with a liquid, measuring normalizing analytes such as sodium and chloride, and using these measurements to calculate the analyte levels in the original blood specimen, allowing for accurate normalization and determination of analyte levels in the blood.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If blood spot or serum cards are used for self-collection, then ease of operation is improved, but measurement precision deteriorates due to inability to accurately gauge specimen volume

Engineering Contradiction:
Improveself-collection capabilityVSAvoidspecimen volume measurement
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent introduces an intermediary substance (hydrophilic marker such as sodium chloride or glucose) that is added to the blood spot card during self-collection. This marker serves as a reference substance that allows subsequent quantitative determination of the actual blood volume present, thereby enabling accurate measurement without requiring the user to directly measure the volume.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent creates a chemical copy or reference system by adding known amounts of hydrophilic marker substances to the blood specimen. The marker concentrations create a reference profile that can be used to calculate the actual blood volume, effectively copying the volume information in a measurable chemical form.

Inventive Principle:
Principle #26Copying

2Productivity

If quantitative testing is performed on dried blood spot specimens, then productivity is improved through self-testing, but reliability deteriorates due to specimen volume variations

Engineering Contradiction:
Improvetesting throughputVSAvoidtest result reliability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The hydrophilic marker acts as a mediator that bridges the gap between the dried blood spot and accurate volume determination. By measuring the marker concentration in the eluate and comparing it to the known amount added, the system can calculate the actual blood volume and correct the analyte measurements accordingly, maintaining reliability despite volume variations.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent implements a feedback mechanism where the measured marker concentration provides information about the actual specimen volume, which is then used to correct the analyte measurements. This closed-loop approach ensures that volume variations are detected and compensated for, maintaining test reliability.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If normalizing analytes are measured to correct for volume variations, then measurement precision is improved, but device complexity increases

Engineering Contradiction:
Improveanalyte level determinationVSAvoidtesting procedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent changes the approach from directly measuring blood volume (which would require complex volumetric equipment) to measuring the concentration of hydrophilic markers, which can be done using standard analytical techniques. This parameter change simplifies the measurement process while achieving the same goal of volume normalization.

Inventive Principle:
Principle #35Parameter changes

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 enables precise quantification of analyte levels in blood specimens, reducing errors associated with specimen volume variations and enhancing the reliability of test results, particularly for cholesterol and lipid profile measurements.

Implementation Method 1

a modified specimen, preferably a dried blood fluid sample, such as a dried serum or dried whole blood specimen, is eluted (re-solubilized) and then tested for an analyte

Methodology Applied
Scientific EffectElution: Liquid-Liquid Extraction

Data Source

PatentUS7611670B2Quantitative analysis of a biological sample of unknown quantity
Publication Date: 2009.11.03 PWNHEALTH CHICAGO LLC
  • US7611670B2 patent drawing
  • US7611670B2 patent drawing
  • US7611670B2 patent drawing

AI summary

Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.