Clinical Diagnostic Workflow Using Ion Mobility Without Chromatography

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Solution Overview

Problem

Existing mass spectrometry systems face challenges with analyte-surface contact issues, mechanical stress leading to equipment deterioration, and the need for frequent maintenance, especially when analyzing complex biological samples, and lack standardized procedures for reliable and reproducible clinical diagnostics.

Innovation Solution

An automated clinical diagnostic system that integrates a sample preparation station for automated sample processing, including magnetic bead handling and ion mobility units, allowing for high-throughput, low-maintenance, and flexible analyte detection without the need for liquid chromatography units.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If mass spectrometry is combined with chromatographic techniques (HPLC/GC), then analyte separation and detection capability is improved, but mechanical stress on moving parts increases leading to equipment deterioration and frequent maintenance

Engineering Contradiction:
Improveanalyte separation and detection capabilityVSAvoidequipment reliability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent extracts and removes the chromatographic separation component (HPLC/GC) from the mass spectrometry system, eliminating the mechanical moving parts and stationary phases that cause deterioration. The system achieves analyte separation through alternative non-chromatographic methods while maintaining direct coupling with the mass spectrometer for detection.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical chromatographic separation system with a non-mechanical separation approach. Instead of using pumps, columns, and moving mechanical parts for chromatography, the system employs alternative separation techniques that do not rely on mechanical movement, thereby eliminating wear and tear on mechanical components.

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

2Measurement precision

If chromatographic techniques are used for analyte separation, then measurement specificity is improved, but stationary phases and liquid solvents are required increasing system complexity

Engineering Contradiction:
Improvemeasurement specificityVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts and eliminates the stationary phase and liquid solvent components from the separation system. By removing these essential chromatographic elements, the system reduces complexity while maintaining analyte separation capability through alternative methods such as direct injection or non-chromatographic separation techniques.

Inventive Principle:
Principle #2Taking out (Extraction)

3Adaptability or versatility

If manual sample preparation procedures are used, then flexibility in handling different sample types is maintained, but productivity and throughput are reduced

Engineering Contradiction:
Improveflexibility in handling different sample typesVSAvoidsample processing throughput
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The patent implements automated sample preparation systems that perform sample processing tasks autonomously. The system includes automated features for sample intake, preparation, and analysis that reduce or eliminate the need for manual intervention, thereby increasing throughput while maintaining the ability to handle various sample types through programmable flexibility.

Inventive Principle:
Principle #25Self-service

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 efficient, fast, and robust detection of analytes from complex biological samples, reducing manual intervention and enhancing reliability for clinical diagnostics.

Implementation Method 1

a) an ion mobility unit for separating ions based on their mobility by application of DC and/or RF voltages

Methodology Applied
Scientific EffectIon mobility:

Implementation Method 2

a) a first ion fragmentation unit for fragmenting at least a portion of the at least one analyte ion

Methodology Applied
Scientific EffectIon fragmentation:

Implementation Method 3

b) a second ion fragmentation unit for fragmenting at least a portion of the product ion

Methodology Applied
Scientific EffectIon fragmentation:

Data Source

PatentEP4267951B1Automated clinical diagnostic system and method
Publication Date: 2026.03.25 F HOFFMANN LA ROCHE & CO AG
  • EP4267951B1 patent drawingFigure 1
  • EP4267951B1 patent drawingFigure 2
  • EP4267951B1 patent drawingFigure 3

AI summary

The present invention relates to a clinical diagnostic system, a method for determining the presence or level of at least one analyte of interest in a biological sample, a kit and the uses thereof for efficiently and/or robust detection of an analyte of interest.