Integrated Sample Collection and Reaction Cartridge for Point-of-Care Diagnostics

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Solution Overview

Problem

Current molecular diagnostic tests for clinical samples require multiple time-consuming steps and specialized equipment, making them unsuitable for point-of-care settings where rapid and versatile testing is needed.

Innovation Solution

A system comprising a sample collection module and a reaction cartridge that combines sample collection, dilution, filtration, and nucleic acid amplification in a single disposable device, capable of processing diverse clinical samples with minimal equipment and training, using a flexible tube with a filter and a sample buffer containing stabilizing reagents, and a reaction cartridge with multiple chambers for chemical reactions and optical detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple steps are used for sample processing (filtration, lysis, binding, washing, elution), then nucleic acid detection sensitivity is improved, but processing time and operational complexity increase

Engineering Contradiction:
Improvenucleic acid detection sensitivityVSAvoidprocessing time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines multiple sample processing steps (filtration, lysis, binding, washing, elution) into a single integrated cartridge device. The cartridge contains all necessary reagents and components pre-assembled, allowing the user to perform the entire nucleic acid extraction and detection process in one continuous operation without transferring samples between separate devices or steps, thereby reducing processing time while maintaining detection sensitivity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The single cartridge device performs multiple functions: it filters particulate material, lysed cells to release nucleic acids, binds nucleic acids to magnetic beads, washes away contaminants, and elutes purified nucleic acids for detection. This multi-functional integration eliminates the need for separate equipment for each step, reducing both time and operational complexity while preserving analytical sensitivity.

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

2Measurement precision

If multiple steps with transfers are used for sample processing, then detection accuracy is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvedetection accuracyVSAvoidease of operation
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent integrates all sample processing steps within a single cartridge, eliminating the need for operators to transfer measured quantities between separate devices. The cartridge contains pre-assembled components including filtration media, magnetic beads for nucleic acid binding, and washing buffers, all accessible through one device interface, thereby improving ease of operation while maintaining detection accuracy through consistent processing.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The cartridge is designed to perform processing steps automatically through its internal architecture. Magnetic beads self-assemble to bind nucleic acids, and the integrated design allows buffers to flow through predefined paths without requiring operator intervention for transfers or measurements, making the process easier to operate while preserving analytical rigor.

Inventive Principle:
Principle #25Self-service

3Reliability

If expensive equipment and highly trained technicians are used for nucleic acid isolation, then processing reliability is improved, but device complexity and cost increase

Engineering Contradiction:
Improveprocessing reliabilityVSAvoidequipment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs a disposable single-use cartridge that contains all necessary reagents and processing components pre-assembled. This eliminates the need for expensive, complex automated extraction equipment and highly trained technicians, as the cartridge itself provides the reliable processing function. After use, the entire cartridge is discarded, ensuring consistent reliability without requiring maintenance or calibration of expensive equipment.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The cartridge performs nucleic acid isolation automatically through its integrated design, with magnetic beads and buffers working together without human intervention. This self-service capability replaces the need for expensive automated extraction systems and highly trained operators, maintaining processing reliability through standardized, pre-configured reagent and component interactions within the disposable cartridge.

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 rapid, sensitive, and versatile molecular diagnostic testing at the point of care, reducing resource and time requirements while maintaining high sensitivity and rapid turnaround times, suitable for diverse clinical samples without the need for extensive training or specialized equipment.

Implementation Method 1

filtration to remove particulate material

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 2

suspending a small aliquot of the sample in sample buffer

Methodology Applied
Scientific EffectChemical stabilization: Solvation

Implementation Method 3

loop mediated isothermal amplification (LAMP) has proven to be an attractive technology for rapid detection of pathogens

Methodology Applied
Scientific EffectLoop mediated isothermal amplification: Enzyme

Implementation Method 4

optically detecting a plurality of reaction products

Methodology Applied
Scientific EffectOptical detection: Absorption Spectroscopy

Data Source

PatentEP3151965B1Sample collection and analysis devices
Publication Date: 2021.02.24 EDAN INSTR
  • EP3151965B1 patent drawingFigure 1A~1B
  • EP3151965B1 patent drawingFigure 1C
  • EP3151965B1 patent drawingFigure 2A

AI summary

Devices and methods for collecting, processing, and analyzing a sample. A sample collection module is configured for collecting, mixing diluting, and filtering a sample for analysis. A reaction cartridge is configured for processing a sample, mixing it with dried reagents, and conducting a chemical reaction for detecting target analytes.