Multiple Dataset Analysis for False-Positive-Resistant Analyte Detection

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Solution Overview

Problem

Conventional methods for determining the presence or absence of a target analyte in nucleic acid sequences are prone to false positive and false negative errors due to the challenges in setting an optimal signal threshold, and existing data correction methods can distort normal data and fail to identify all errors.

Innovation Solution

A method involving multiple dataset analysis (MDA) that utilizes a dataset pool comprising different types of datasets and two or more determinative factors to accurately determine the presence or absence of a target analyte, minimizing errors through a novel protocol that includes performing an amplification reaction and evaluating these factors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a single signal threshold is used to determine presence or absence of target analyte, then the determination process is simple, but false positive and false negative errors occur

Engineering Contradiction:
Improvedetermination process simplicityVSAvoiddetermination accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent segments the determination process by using multiple signal thresholds (first threshold and second threshold) instead of a single threshold. This creates distinct decision regions: below the first threshold indicates absence, between the first and second thresholds indicates inconclusive results requiring retesting, and above the second threshold indicates presence. This segmentation resolves the contradiction by maintaining operational simplicity through clear decision rules while significantly improving reliability by eliminating false positives and false negatives through the buffer zone.

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If data correction methods are applied to amplify weak signals, then detection sensitivity improves, but normal data is distorted and errors are introduced

Engineering Contradiction:
Improvedetection sensitivityVSAvoiddata integrity
Core Design Contradiction:
Measurement precisionVSManufacturing precision

Solution Approach 1:

The patent applies parameter changes by using mathematical transformations (logarithmic transformation, derivative calculation) on the amplification curve data to enhance detection sensitivity without distorting normal data. These transformations allow weak signals to be amplified and detected while maintaining the integrity of the underlying biological signal, thus improving measurement precision without compromising data integrity.

Inventive Principle:
Principle #35Parameter changes

3Loss of time

If conventional single-dataset analysis is used, then the analysis process is quick, but false positive errors cannot be eliminated

Engineering Contradiction:
Improveanalysis timeVSAvoiderror rate
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent implements preliminary action by establishing multiple predetermined signal thresholds before analysis begins. The first threshold is set below the detection limit and the second threshold is set above the detection limit, creating a predetermined decision framework. This allows rapid classification of results without requiring complex post-analysis processing, thus maintaining quick analysis time while eliminating false positive errors through the built-in safety margin.

Inventive Principle:
Principle #10Preliminary action

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 MDA method provides error-free analysis by employing multiple datasets and determinative factors, significantly reducing false positive and false negative errors in determining the presence or absence of a target analyte.

Implementation Method 1

employing a signal-generating means for releasing a detectable fluorescent signal in proportion to the amount of target nucleic acid sequences

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Implementation Method 2

amplified a nucleic acid sequence based on the hybridization of a promoter/primer sequence to a target single-stranded DNA

Methodology Applied
Scientific EffectHybridization:

Implementation Method 3

primer extension by a DNA polymerase

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Data Source

PatentEP3353697B1Multiple dataset analysis for determining the presence or absence of target analyte
Publication Date: 2025.11.05 SEEGENE INC
  • EP3353697B1 patent drawingFigure 1
  • EP3353697B1 patent drawingFigure 2
  • EP3353697B1 patent drawingFigure 3

AI summary

The present invention relates to the determination of the presence or absence of a target analyte by a Multiple Dataset Analysis (MDA). The present invention can dramatically reduce errors (particularly, false positive errors) in determination of the presence or absence of a target analyte, by using two or more different types of datasets from an amplification reaction.