Dried Blood Spot Metabolite Extraction for ADA-SCID Diagnosis

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Solution Overview

Problem

Current methods for diagnosing severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) or purine-nucleoside phosphorilase (PNP) defects are inadequate as they often require onset of infections for detection, leading to delayed diagnosis and treatment, and existing mass spectrometry methods are ineffective for detecting these metabolites in dried blood spots.

Innovation Solution

A method using a mixture of water and C1-3 linear or branched chain monoalcohol, preferably methanol, to extract Adenosine and Deoxyadenosine from dried blood samples, allowing for concurrent extraction of other metabolites, enabling sensitive and specific detection using mass spectrometry, particularly on Guthrie cards, facilitating early diagnosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional mass spectrometry methods are used on dried blood spots, then other metabolites can be detected, but ADA and PNP deficiency metabolites (Adenosine and Deoxyadenosine) cannot be detected

Engineering Contradiction:
Improvedetection capabilityVSAvoidmetabolite detection coverage
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent changes the extraction parameters by using a water-containing alcohol solution (30-70% v/v water) instead of conventional organic solvents. This parameter change enables the extraction of Adenosine and Deoxyadenosine from dried blood spots while maintaining compatibility with mass spectrometry detection, thereby expanding metabolite detection coverage without compromising reliability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces a specific extraction solution (water-containing alcohol) as an intermediary substance that facilitates the extraction of previously undetectable metabolites. This intermediary enables the transfer of Adenosine and Deoxyadenosine from the dried blood spot matrix to the mass spectrometry detection system, resolving the detection limitation

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If diagnosis is delayed until infection onset, then clinical suspicion can be formulated, but life-saving treatment opportunity is lost

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddiagnosis time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent enables preliminary diagnosis by detecting Adenosine and Deoxyadenosine metabolites in dried blood spots collected at birth or early infancy, before clinical symptoms or infections occur. This preliminary detection allows treatment to be initiated in the preinfection period, maximizing therapeutic effectiveness and preventing severe complications

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent utilizes routinely collected dried blood spots (Guthrie cards) already present in the healthcare system, transforming an existing sample collection practice into a diagnostic tool. This self-service approach enables early detection without requiring additional blood draws or specialized sampling procedures, thus eliminating time loss while maintaining diagnostic accuracy

Inventive Principle:
Principle #25Self-service

3Ease of operation

If ADA activity evaluation is performed, then enzyme function can be assessed, but misleading results occur due to variable residual activity in non-immune cells

Engineering Contradiction:
Improvediagnostic simplicityVSAvoiddiagnosis reliability
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent extracts and measures the end metabolites (Adenosine and Deoxyadenosine) of the enzymatic pathway rather than measuring the enzyme activity itself. This extraction approach bypasses the complexity of ADA activity evaluation and the confounding effect of variable residual activity in different cell types, providing a direct and reliable measure of metabolic dysfunction

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the biochemical assay system (ADA activity measurement) with a mass spectrometry-based metabolite detection system. This substitution eliminates the limitations of enzyme activity measurement, including the influence of residual enzyme activity in non-immune cells, and provides a more accurate reflection of the metabolic defect

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

Enables reliable and reproducible early diagnosis of ADA-SCID at birth, allowing timely treatment and preventing severe complications, with high sensitivity and specificity, and the method can be used during enzyme replacement therapy to monitor treatment efficacy.

Implementation Method 1

A method using a mixture of water and C1-3 linear or branched chain monoalcohol, preferably methanol, to extract Adenosine and Deoxyadenosine from dried blood samples

Methodology Applied
Scientific EffectSolvation: Solvation

Data Source

PatentEP2517016B1Method and kit for determining metabolites on dried blood spot samples
Publication Date: 2013.12.04 AZIENDA OSPEDALIERO UNIVRIA MEYER
  • EP2517016B1 patent drawingFigure 1a
  • EP2517016B1 patent drawingFigure 1b
  • EP2517016B1 patent drawingFigure 1c

AI summary

Is described a method for individuating with high sensitivity and specificity ADA metabolites from dried blood spot. The method described herein can be used to extract Adenosine and Deoxyadenosine from a sample under conditions that permit concurrently extracting other metabolites, such as amino acids, free carnitine, or acylcarnitines. For example, harsh extraction conditions (such as extreme acidity and high temperature) can be avoided. The method can be used, along with other neonatal screenings, on blood samples and preferably on dried blood spots (Guthrie cards) and more preferably on Guthrie cards obtained in the II-IV day of life. The method is reliable and reproducible, easy to perform and gives a definitive response within a short time (1 -2 days). One or more kit for use in the method if the invention are also described.