Sample Preparation Reagent for One-Step Nucleic Acid Extraction

Solution Overview

Problem

Existing nucleic acid amplification techniques are hindered by various inhibitors present in clinical samples, requiring multiple steps for pathogen inactivation, nucleic acid extraction, and purification, which are time-consuming and labor-intensive, and pose safety risks.

Innovation Solution

A Sample Preparation Reagent comprising a quaternary ammonium compound, a denaturing agent, and a precipitating agent is used to prepare samples for nucleic acid amplification, minimizing processing steps and reducing the need for additional equipment, while ensuring rapid inactivation of pathogens and efficient nucleic acid extraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple steps for pathogen inactivation, nucleic acid extraction, and purification are used, then the reliability of nucleic acid amplification is improved, but the time consumption and labor intensity increase

Engineering Contradiction:

Improvereliability of nucleic acid amplificationVSAvoidtime consumption

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent combines pathogen inactivation, nucleic acid extraction, and purification into a single integrated reagent formulation. The reagent simultaneously performs cell lysis, pathogen inactivation, and nucleic acid release without requiring separate processing steps, thereby reducing time consumption while maintaining amplification reliability.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The sample preparation reagent is designed as a multi-functional universal reagent that can handle various sample types (swabs, blood, stool, etc.) and perform multiple functions (lysis, inactivation, extraction) simultaneously, eliminating the need for separate specialized reagents and steps for each function.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If multiple steps for pathogen inactivation, nucleic acid extraction, and purification are used, then the reliability of nucleic acid amplification is improved, but the labor intensity increases

Engineering Contradiction:

Improvereliability of nucleic acid amplificationVSAvoidlabor intensity

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent combines pathogen inactivation, nucleic acid extraction, and purification into a single integrated reagent formulation. The reagent simultaneously performs cell lysis, pathogen inactivation, and nucleic acid release without requiring separate processing steps, thereby reducing time consumption while maintaining amplification reliability.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The reagent is designed to automatically perform all necessary functions without requiring manual intervention for each step. The chemical composition self-regulates to achieve complete lysis, inactivation, and nucleic acid release in a single addition, minimizing personnel hours and operational complexity.

Inventive Principle:

Principle #25Self-service

3Reliability

If multiple steps for pathogen inactivation, nucleic acid extraction, and purification are used, then the reliability of nucleic acid amplification is improved, but the device complexity increases

Engineering Contradiction:

Improvereliability of nucleic acid amplificationVSAvoidequipment requirement

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines pathogen inactivation, nucleic acid extraction, and purification into a single integrated reagent formulation. The reagent simultaneously performs cell lysis, pathogen inactivation, and nucleic acid release without requiring separate processing steps, thereby reducing time consumption while maintaining amplification reliability.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The sample preparation reagent acts as an intermediary substance that mediates the entire sample processing function. Instead of requiring complex equipment for separate inactivation, extraction, and purification steps, the chemical reagent performs all functions in one step, simplifying the equipment requirements to basic mixing and incubation vessels.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Reliability

If conventional sample preparation methods are used, then the pathogen is effectively inactivated, but the safety risk to laboratory personnel increases

Engineering Contradiction:

Improvepathogen inactivationVSAvoidsafety risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The reagent converts the potential harm of requiring multiple handling steps into a benefit by performing all functions in a single step. The integrated formulation ensures pathogen inactivation occurs simultaneously with nucleic acid release, minimizing exposure risk while maintaining effective inactivation.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The reagent is designed to perform pathogen inactivation immediately upon contact with the sample, before any subsequent handling or processing. This preliminary inactivation action occurs simultaneously with nucleic acid extraction, ensuring safety is established first before any potential exposure risk arises during later steps.

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 reagent enables rapid sample preparation in a short time frame, reducing the need for extensive laboratory setup and personnel hours, improving safety and throughput, and maintaining the integrity of nucleic acids for downstream molecular applications.

Implementation Method 1

a quaternary ammonium compound, a denaturing agent and a precipitating agent to form a reaction sample

Methodology Applied

Scientific EffectMembrane disruption:

Implementation Method 2

a quaternary ammonium compound, a denaturing agent and a precipitating agent

Methodology Applied

Scientific EffectDenaturation:

Implementation Method 3

a quaternary ammonium compound, a denaturing agent and a precipitating agent to form a reaction sample

Methodology Applied

Scientific EffectPrecipitation: Precipitation

Implementation Method 4

a quaternary ammonium compound, a denaturing agent and a precipitating agent

Methodology Applied

Scientific EffectDenaturation:

Data Source

PatentUS20250340924A1Sample Preparation Reagents

Publication Date: 2025.11.06 BIOCIFER PTY LTD

AI summary

This invention relates to compositions, methods and kits for preparing samples for the detection of nucleic acids in the samples.