Isothermal Nucleic Acid Amplification via Competitive Stem-Loop Structure

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current nucleic acid amplification methods, such as PCR, require complex temperature control and multiple enzymes, making them costly, prone to contamination, and less suitable for detecting short-strand nucleic acids like 5S rRNA, which are important for genetic analysis.

Innovation Solution

A method for synthesizing nucleic acids under constant temperature conditions using a competitive stem-loop structure with specific oligonucleotides and a single enzyme, such as DNA polymerase, to facilitate efficient and specific amplification of short-strand nucleic acids without the need for complex temperature control or multiple enzymes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If PCR method is used for nucleic acid amplification, then amplification sensitivity is improved, but device complexity and operation difficulty increase due to required temperature control system

Engineering Contradiction:
Improveamplification sensitivityVSAvoidtemperature control system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention changes the temperature parameter from variable (PCR) to constant (isothermal), using a single temperature step that maintains the reaction mixture at 37°C throughout the amplification process, thereby eliminating the need for complex temperature cycling equipment

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The reaction system uses endogenous RNA polymerase and reverse transcriptase enzymes that naturally function at 37°C, allowing the reaction to proceed autonomously at constant temperature without external temperature control intervention

Inventive Principle:
Principle #25Self-service

2Reliability

If PCR method is used for nucleic acid amplification, then amplification sensitivity is improved, but cost increases due to multiple enzymes required

Engineering Contradiction:
Improveamplification sensitivityVSAvoidcost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The invention uses a multi-functional enzyme system where RNA polymerase performs both transcription and the generated DNA serves as template for reverse transcription, reducing the need for separate enzymatic steps and reagents required in traditional PCR

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

Solution Approach 2:

The invention extracts and utilizes the natural isothermal functionality of RNA polymerase and reverse transcriptase enzymes, removing the need for thermostable DNA polymerase and other heat-cycling dependent components that increase cost

Inventive Principle:
Principle #2Taking out (Extraction)

3Productivity

If PCR method is used for nucleic acid amplification, then amplification capability is improved, but contamination risk increases due to susceptibility to external contamination

Engineering Contradiction:
Improveamplification capabilityVSAvoidcontamination risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The invention segments the amplification process into distinct isothermal stages using specific primer sets, allowing controlled progression of the reaction and reducing the window of vulnerability to contamination compared to continuous heating cycles

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The method uses short-strand specific oligonucleotide primers that are sequence-specific and short-lived in function, providing built-in containment that prevents amplification of non-target sequences and reduces contamination propagation

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Adaptability or versatility

If conventional methods are used for short-strand nucleic acid detection, then detection capability is limited, but method complexity increases due to requirement for complex temperature control

Engineering Contradiction:
Improvedetection capability for short-strand nucleic acidsVSAvoidtemperature control
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The invention changes from temperature-cycling parameters to constant temperature parameters, enabling detection of short-strand nucleic acids like 5S rRNA using simple isothermal conditions that do not require complex thermal management

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The reaction system self-regulates at 37°C using the natural optimal temperature of the employed enzymes, making the detection process autonomous and independent of external temperature control equipment

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

This method allows for rapid and specific amplification of short-strand nucleic acids, reducing costs and contamination risks, and enabling the detection of target sequences like 5S rRNA, which was previously challenging with existing techniques.

Implementation Method 1

annealing a first oligonucleotide I to the F1c region of the nucleic acid

Methodology Applied
Scientific EffectBase pairing: Chemical Bonding

Implementation Method 2

performing a synthesis step using an F1 region of the first oligonucleotide I as a synthesis starting point

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 3

using the nucleic acid provided in the step 1) as a template to synthesize its own complementary strand

Methodology Applied
Scientific EffectStrand displacement:

Implementation Method 4

a loop can be formed when the Nc region at the 3' end anneals to the N region

Methodology Applied
Scientific EffectIntramolecular base pairing: Chemical Bonding

Data Source

PatentEP3476938B1Method and kit for synthesizing nucleic acid under constant temperature conditions
Publication Date: 2020.05.13 ZHONGKE XINRAY (SUZHOU) BIOLOGICAL TECHNOLOGIES CO LTD
  • EP3476938B1 patent drawingFigure 1
  • EP3476938B1 patent drawingFigure 2
  • EP3476938B1 patent drawingFigure 3~4

AI summary

The invention discloses a method and a kit for synthesizing a nucleic acid under constant temperature conditions, the method comprising the steps of: 1) providing a nucleic acid, wherein the nucleic acid has an Nc region at the 5' end thereof that can anneal to an N region on the same strand and at the same time has an Nc region at the 3' end thereof that can anneal to the N region on the same strand, and the Nc regions at the 5' end and the 3' end of the nucleic acid have a competitive relationship in annealing to the N region on the same strand; 2) using the nucleic acid of the step 1) as a template to synthesize its own complementary strand with the 3' end of the Nc region which has annealed to the N region as a synthetic starting point; and 3) carrying out complementary strand synthesis by using a polymerase to catalyze strand displacement type complementary strand synthesis reaction, so as to displace the complementary strand synthesized in the step 2). The main advantage of the present invention lies in that rapid amplification of a gene can be achieved using a single enzyme thermostatic system for a short-chain nucleic acid fragment (an ideal fragment can be only 60 bp, which is shorter than the minimum ideal fragment 120 bp of LAMP).