Integrated Nucleic Acid Testing Modules for Parallel PCR Workflow

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Solution Overview

Problem

Current in vitro diagnostic analyses are bottlenecked by the need for expensive, specialized equipment that is not available on-demand and requires sample transportation, leading to delays and inefficiencies in processing time.

Innovation Solution

A diagnostic apparatus that simultaneously extracts and amplifies nucleic acids from multiple samples using a module with racks, magnetic separators, heaters, and liquid dispensers, and includes a module for real-time PCR and detection systems, enabling high-throughput analysis at the point of care.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

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

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

Solution Approach 1:

The system divides the nucleic acid testing process into separate functional modules: a first module for nucleic acid extraction from multiple samples, and a second module for PCR amplification and detection. Each module performs a specific function, allowing the complex testing process to be broken down into manageable, specialized components that can be operated independently.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The apparatus is designed to handle multiple samples simultaneously through parallel processing capabilities. The first module can extract nucleic acids from multiple samples in parallel, and the second module can amplify and detect multiple samples concurrently, making the system universally applicable to various diagnostic needs without requiring separate specialized equipment for each sample.

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

2Productivity

If batch processing is used, then productivity is improved, but loss of time increases due to waiting for machine availability

Engineering Contradiction:
Improveprocessing throughputVSAvoidsample waiting time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The system enables continuous processing of samples through parallel operations. While one set of samples is being processed in the first module for extraction, another set can be processed simultaneously, and the second module continuously performs PCR amplification and detection. This eliminates idle waiting time between batches and maintains continuous productive action.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The first module performs preliminary nucleic acid extraction from multiple samples before they enter the second module for PCR amplification. This preliminary preparation of multiple samples in parallel ensures that when samples reach the amplification stage, they are ready for immediate processing, reducing waiting time and enabling smoother continuous operation.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If sample transportation to specialized facilities is required, 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 apparatus is designed to perform all nucleic acid testing operations—extraction, amplification, and detection—within a single integrated system at the point of care. This self-contained capability eliminates the need to transport samples to external specialized facilities, allowing the system to serve itself and maintain diagnostic accuracy without transportation-related delays or sample degradation.

Inventive Principle:
Principle #25Self-service

4Productivity

If automated liquid handling is used, then productivity is improved, but device complexity increases

Engineering Contradiction:
Improvesample processing speedVSAvoidautomation system complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The liquid handling automation is segmented into specific functions: the liquid dispenser handles reagent distribution to multiple samples, the magnetic separator performs nucleic acid isolation, and the heater assembly conducts thermal cycling for PCR. By dividing automation into these discrete, specialized components rather than a single complex automated system, the patent achieves high productivity while managing device complexity through functional modularity.

Inventive Principle:
Principle #1Segmentation

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 and efficient nucleic acid testing of multiple samples in under an hour with high throughput, reducing the need for specialized facilities and equipment, and allowing on-demand processing.

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

PatentUS12397295B2Integrated apparatus for performing nucleic acid extraction and diagnostic testing on multiple biological samples
Publication Date: 2025.08.26 HANDYLAB INC
  • US12397295B2 patent drawing
  • US12397295B2 patent drawing
  • US12397295B2 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.