Microfluidic Nucleic Acid Testing for Parallel On-Site Diagnostics

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Solution Overview

Problem

Current in vitro diagnostic analyses are bottlenecked due to the need for specialized equipment, leading to delays and inefficiencies in processing biological samples, as they often require batch processing and are not available on-demand, necessitating shipment and potential mishandling.

Innovation Solution

A diagnostic apparatus comprising modules for simultaneous extraction, amplification, and detection of nucleic acids using microfluidic systems with racks, heaters, magnetic separators, and liquid dispensers, enabling parallel processing and on-site analysis without the need for specialized facilities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If specialized equipment is used for nucleic acid extraction and diagnostic testing, then measurement precision and reliability are improved, but device complexity and cost increase

Engineering Contradiction:
Improvenucleic acid detection accuracyVSAvoidequipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple diagnostic functions (nucleic acid extraction, amplification, and detection) into a single integrated apparatus. The extraction module with magnetic separation, the PCR module with thermal cycling, and the detection module with fluorescence sensing are merged into one system that processes multiple samples simultaneously, reducing the need for separate specialized equipment while maintaining diagnostic accuracy

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The diagnostic apparatus is designed as a multi-functional platform that can perform various nucleic acid-based diagnostic tests on different sample types. The system includes universal components such as the magnetic separator that can handle different extraction protocols, the PCR module that accommodates various amplification reactions, and the detection system that senses multiple fluorescent probes, making it adaptable to different diagnostic requirements without requiring specialized equipment for each test type

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

2Productivity

If batch processing is used for diagnostic analyses, then device complexity is reduced, but productivity and speed deteriorate

Engineering Contradiction:
Improvesample processing throughputVSAvoidprocessing time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The apparatus divides the sample processing into parallel segments using multiple racks that can be loaded simultaneously. Each rack contains multiple holders for individual samples, and the system can process multiple racks in parallel through coordinated operation of the magnetic separator, liquid dispenser, and PCR module. This segmentation allows high-throughput processing without requiring a single complex batch processor

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system maintains continuous productive action by implementing automated workflows where the liquid dispenser continuously transfers liquids between holders, the magnetic separator continuously processes samples through repeated cycles of movement and separation, and the PCR module continuously performs thermal cycling on multiple samples. This continuous operation eliminates idle time between batch completions and maintains high productivity throughout the diagnostic process

Inventive Principle:
Principle #20Continuity of useful action

3Measurement precision

If samples are shipped to specialized facilities for analysis, then measurement precision is improved, but loss of time and loss of substance increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtransportation delay
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The diagnostic apparatus enables self-service capability at the point of care, allowing healthcare providers to perform nucleic acid extraction, amplification, and detection in-house without sending samples to external specialized facilities. The integrated system provides all necessary functions (magnetic separation for extraction, thermal cycling for PCR, fluorescence detection for analysis) in a single device that can be operated with minimal training, eliminating the need for sample shipment while maintaining diagnostic accuracy through standardized automated protocols

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

Facilitates rapid and efficient processing of multiple samples in parallel, reducing delays and costs associated with shipment, and enabling on-site diagnostics, thereby improving healthcare infrastructure efficiency.

Implementation Method 1

a magnetic separator configured to move relative to the process chambers of each holder

Methodology Applied
Scientific EffectMagnetic separation: Magnetism

Implementation Method 2

a heater assembly configured to independently heat each of the process chambers

Methodology Applied
Scientific EffectHeating: Heating

Data Source

PatentUS11845081B2Integrated apparatus for performing nucleic acid extraction and diagnostic testing on multiple biological samples
Publication Date: 2023.12.19 HANDYLAB INC
  • US11845081B2 patent drawing
  • US11845081B2 patent drawing
  • US11845081B2 patent drawing

AI summary

The technology described herein generally relates to systems for extracting polynucleotides from multiple samples, particularly from biological samples, and additionally to systems that subsequently amplify and detect the extracted polynucleotides. The technology more particularly relates to microfluidic systems that carry out PCR on multiple samples of nucleotides of interest within microfluidic channels, and detect those nucleotides.