Automated Clinical Mass Spectrometry Without Chromatography

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Solution Overview

Problem

Current mass spectrometry-based clinical diagnostic systems face challenges with sensitivity in analyzing analytes from complex biological matrices, require intensive maintenance, and lack standardized procedures, leading to user-dependent results and limited high-throughput capabilities.

Innovation Solution

A clinical diagnostic system comprising an automated sample preparation station, ion generation station, ion mobility unit for ion separation using electric and radio frequency fields, and ion detection station, along with a data processing station, which eliminates the need for chromatography and enables robust, fast, and low-maintenance detection of analytes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If mass spectrometry is combined with chromatographic techniques (HPLC/GC) for analyzing analytes from complex biological matrices, then separation and analysis capability is improved, but maintenance requirements increase and system complexity increases

Engineering Contradiction:
Improveanalyte detection capabilityVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts and eliminates the chromatography component from the traditional HPLC-MS system, using only mass spectrometry for direct analysis of biological samples. This removes the complex chromatographic separation system while maintaining analyte detection capability through direct MS analysis and data processing.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical chromatographic separation system with a computational approach, using data processing and analysis algorithms to identify and quantify analytes directly from mass spectrometry data without requiring physical separation through chromatography columns and mobile phases.

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

2Measurement precision

If chromatographic techniques with mechanical parts are used for sample separation, then analyte separation is improved, but maintenance requirements increase due to mechanical stress and deterioration

Engineering Contradiction:
Improveanalyte separationVSAvoidmaintenance requirements
Core Design Contradiction:
Measurement precisionVSEase of repair

Solution Approach 1:

The patent replaces mechanical chromatographic separation with a non-mechanical mass spectrometry-based analysis approach. Samples are introduced directly into the MS system without passing through mechanical chromatography columns, pumps, or valves, eliminating wear and maintenance issues associated with these mechanical components.

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

Solution Approach 2:

The patent removes the chromatography subsystem entirely from the analysis platform, eliminating all associated mechanical parts including columns, pumps, and flow control mechanisms that require maintenance due to mechanical stress and deterioration.

Inventive Principle:
Principle #2Taking out (Extraction)

3Adaptability or versatility

If manual sample preparation procedures are used for mass spectrometry analysis, then sample processing flexibility is improved, but productivity decreases and user dependency increases

Engineering Contradiction:
Improvesample processing flexibilityVSAvoidthroughput capability
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The patent implements automated sample preparation systems that perform sample processing tasks autonomously without requiring manual intervention. The system automatically handles sample introduction, preparation, and analysis, reducing user dependency while maintaining flexibility through programmable protocols and increasing throughput through automation.

Inventive Principle:
Principle #25Self-service

4Adaptability or versatility

If standardized procedures are not implemented in mass spectrometry-based clinical diagnostics, then method adaptability is improved, but result reliability decreases due to user-dependent factors

Engineering Contradiction:
Improvemethod adaptabilityVSAvoidresult reproducibility
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent creates a universal, standardized mass spectrometry-based diagnostic platform that can analyze multiple different analytes and sample types through consistent automated procedures. The system uses standardized sample preparation protocols, data processing algorithms, and quality control measures that ensure reproducible results across different users and laboratories while maintaining adaptability to various clinical applications.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 allows for efficient, reliable, and high-throughput analysis of analytes, reducing the need for manual steps and skilled personnel, while providing flexible and rapid processing of samples, including emergency cases, with improved sensitivity and reduced maintenance requirements.

Implementation Method 1

an ion mobility unit for separation ions with respect to their ion mobility using electric and/or radio frequency fields (AC/DC and/or RF) applied to one or more electrodes

Methodology Applied
Scientific EffectIon mobility separation: Electrophoresis

Data Source

PatentUS20230420240A1Automated clinical diagnostic system and method
Publication Date: 2023.12.28 ROCHE DIAGNOSTICS OPERATIONS INC
  • US20230420240A1 patent drawing
  • US20230420240A1 patent drawing
  • US20230420240A1 patent drawing

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.