Nucleic Acid Amplification Saturation Detection

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Solution Overview

Problem

Conventional nucleic acid amplification analyzers require advance preparation and complex measurement processes, including calibrator and positive control measurements, every time reagents are exchanged, complicating the determination of amplification reaction success or failure.

Innovation Solution

A method and system that determine the success or failure of nucleic acid amplification by obtaining a measurement value at the saturated state of the amplification reaction, using a nucleic acid amplification unit, detection unit, and control unit to assess the amplified amount of nucleic acid, simplifying the determination process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional nucleic acid amplification analysis is performed using calibrator and positive control measurements, then the reliability of amplification determination is improved, but the preparation complexity and operational complexity increase significantly

Engineering Contradiction:
Improveamplification determination reliabilityVSAvoidpreparation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention extracts and utilizes the saturation state information from the amplification reaction curve itself, rather than requiring separate calibrator and control measurements. By taking out the key diagnostic feature (saturation state) directly from the measurement process, the system achieves reliable amplification determination without the complex preparation of additional controls

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The measurement sample's amplification reaction provides its own reference information through the saturation state. The system uses the inherent characteristics of the amplification curve (the saturation point) as a self-reference, eliminating the need for external calibrators and controls, thereby simplifying preparation while maintaining determination reliability

Inventive Principle:
Principle #25Self-service

2Reliability

If calibrator and positive control measurements are performed every time reagents are exchanged, then amplification reaction success determination is ensured, but the time consumption and operational steps increase

Engineering Contradiction:
Improveamplification reaction success determinationVSAvoidpreparation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention extracts the necessary reference information directly from the amplification reaction curve's saturation state, eliminating the need for separate calibrator and control measurements that consume time. This extraction approach provides determination reliability without the time penalty of multiple measurements

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The system performs preliminary analysis of the amplification curve to identify the saturation state during the normal measurement process itself, rather than requiring additional preliminary measurements of calibrators and controls. This integrates the reference function into the main measurement flow, reducing overall preparation time

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If multiple measurement steps (calibrator, positive control, sample) are performed, then amplification success determination accuracy is improved, but the number of operational steps and ease of operation deteriorates

Engineering Contradiction:
Improveamplification success determination accuracyVSAvoidoperational simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The invention merges the functions of calibrator measurement, control measurement, and sample measurement into a single integrated process. By combining these separate measurement steps and using the saturation state as a unified reference point, the system maintains determination accuracy while significantly improving operational simplicity

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The saturation state parameter serves multiple functions simultaneously: it acts as a reference for determining amplification success, provides information about reaction completeness, and eliminates the need for separate control measurements. This multi-functionality maintains measurement precision while reducing operational complexity

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

Data Source

PatentEP3885451A1Method for determining success or failure of nucleic acid amplification, device for determining success or failure of nucleic acid amplification, and nucleic acid amplification analysis system
Publication Date: 2021.09.29 SYSMEX CORP
  • EP3885451A1 patent drawingFigure 1
  • EP3885451A1 patent drawingFigure 2
  • EP3885451A1 patent drawingFigure 3

AI summary

PROBLEM: To provide a technique for determining the success or failure of nucleic acid amplification, which makes it possible to easily determine the success or failure of the nucleic acid amplification reaction. SOLUTION: The method for determining the success or failure of a nucleic acid amplification according to one aspect of the present invention includes obtaining a measurement value corresponding to the amount of nucleic acid amplified by the nucleic acid amplification reaction of the measurement sample containing nucleic acid in a state in which the nucleic acid amplification reaction has reached a saturated state, and determining the success or failure of the nucleic acid amplification reaction based on the acquired measurement value.