IsoPCR Nucleic Acid Detection Method

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Solution Overview

Problem

Current nucleic acid amplification techniques, such as PCR, face challenges in detecting multiple target sequences simultaneously due to limited sensitivity, time-consuming processes, and the need for thermal cycling, which is problematic in point-of-care settings, especially for diagnosing conditions like sepsis where low copy numbers of nucleic acid sequences are present.

Innovation Solution

A method combining PCR pre-amplification with loop-mediated isothermal amplification, termed 'isoPCR', where a sample is pre-amplified using PCR and then subjected to isothermal amplification using specific primers, allowing for the simultaneous detection of multiple target sequences in a single reaction vessel.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If PCR is used to amplify target nucleic acid sequences, then amplification sensitivity is improved, but the requirement for thermal cycling makes the process time-consuming and difficult to handle

Engineering Contradiction:
Improveamplification sensitivityVSAvoidtime-consuming process
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The invention divides the amplification process into two distinct stages: a PCR pre-amplification stage for initial target enrichment, and an isothermal LAMP amplification stage for rapid exponential amplification. This segmentation allows each stage to optimize for its specific function, resolving the contradiction between sensitivity (achieved through PCR) and time efficiency (achieved through isothermal LAMP).

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The PCR pre-amplification step serves as a preliminary action that enriches the target nucleic acid sequences before the main isothermal amplification process. By performing this enrichment step first, the subsequent isothermal amplification can proceed more efficiently with sufficient target material, reducing the overall time required while maintaining sensitivity.

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If multiplex PCR is used to detect multiple target sequences, then detection capability is improved, but amplification sensitivity is limited due to variability of amplification efficiencies

Engineering Contradiction:
Improvedetection capabilityVSAvoidamplification sensitivity
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The invention separates the detection of multiple targets into distinct isothermal amplification reactions, each optimized for its specific target sequence. By avoiding simultaneous multiplex amplification and instead using sequential or parallel isothermal reactions, each target can be amplified with optimal efficiency, maintaining high sensitivity across all detected targets.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention changes the fundamental parameter of amplification conditions from thermal cycling (PCR) to isothermal conditions (LAMP). This parameter change enables more consistent and predictable amplification efficiencies across different target sequences, as isothermal amplification is less susceptible to the variability that plagues multiplex PCR.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If parallel simplex PCR is used to detect multiple targets, then detection capability is improved, but the limited quantity of target DNA makes the process infeasible

Engineering Contradiction:
Improvedetection capabilityVSAvoidtarget DNA quantity
Core Design Contradiction:
Adaptability or versatilityVSQuantity of substance

Solution Approach 1:

The invention combines multiple target detections into a single isothermal amplification reaction vessel by using partitioned microreactors or spatially separated amplification zones within one container. This merging approach allows simultaneous detection of multiple targets while using the same limited sample volume, as the initial PCR pre-amplification pool serves all subsequent isothermal reactions.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The PCR pre-amplification step creates a pooled enriched sample that contains sufficient target material for multiple subsequent isothermal amplifications. This preliminary enrichment action ensures that even though the original sample has limited DNA quantity, there is enough amplified material to distribute across multiple detection reactions.

Inventive Principle:
Principle #10Preliminary action

4Ease of operation

If isothermal amplification techniques are used to simplify the process, then ease of operation is improved, but amplification sensitivity is insufficient for very low copy numbers

Engineering Contradiction:
Improvesimpler deviceVSAvoidamplification sensitivity
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The invention segments the amplification process into two stages with different sensitivity characteristics: PCR pre-amplification for maximum sensitivity with low copy numbers, followed by isothermal LAMP for ease of operation. This segmentation allows the system to achieve both high sensitivity and operational simplicity by letting each stage perform its strength.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The PCR pre-amplification serves as a preliminary sensitivity-enhancing action that boosts very low copy number targets to detectable levels before the isothermal amplification begins. This preliminary action ensures that even isothermal techniques, which normally have lower sensitivity, can work effectively with the pre-enriched target material.

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

This approach enhances sensitivity and speed, enabling the detection of very low copy numbers of nucleic acid sequences, including multiple targets, and simplifies the process by eliminating the need for thermal cycling, making it suitable for point-of-care diagnostics.

Implementation Method 1

the requirement of a multitude of repeating cycles of thermal cycling (cycles of temperature shifts where different steps in the PCR process are taking place)

Methodology Applied
Scientific EffectThermal cycling:

Implementation Method 2

loop-mediated isothermal amplification of DNA (LAMP)

Methodology Applied
Scientific EffectIsothermal amplification:

Data Source

PatentEP2850205B1Technique combining PCR and loop-mediated isothermal amplification for the detection of nucleic acids
Publication Date: 2019.09.18 W HEALTH LP
  • EP2850205B1 patent drawingFigure 1
  • EP2850205B1 patent drawingFigure 2
  • EP2850205B1 patent drawing

AI summary

The present invention relates to a method and a kit of parts for detecting the presence or absence of one or more target nucleic acid sequences in a sample, the method comprising a sequence of steps for pre-amplifying the sample by means of a polymerase chain reaction, followed by a sequence of steps comprising an isothermal amplification of the pre-amplified sample, wherein the isothermal amplification comprises a pair of primers comprising a forward primer having a 3' part that is substantially complementary to a first part of the target sequence, the presence or absence of which is to be detected, and a 5' part that is substantially homolog to a second part of the target sequence, and a reverse primer comprising a 3' part that is substantially homolog to a fourth part of the target sequence and a 5' part that is substantially complementary to a third part of the target sequence.