Closed Nucleic Acid Extraction System for High-Sensitivity Pathogen Detection

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Solution Overview

Problem

Current COVID-19 detection methods face challenges due to limited RNA extraction technology, resulting in low RNA yield from nasal secretions and other specimens, and existing laboratory testing processes are inefficient, exposing medical staff to cross-infection risks and being cost-intensive with long completion times.

Innovation Solution

A method involving a collection device and extraction system that allows for the collection and concentration of large-volume samples (1-40 mL), using a lysis buffer with tris(2-carboxyethyl)phosphine hydrochloride to stabilize nucleic acids, and a closed nucleic acid extraction device to enhance RNA extraction and detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional RNA extraction technology is used, then the extraction process is simple, but the RNA yield is low and sensitivity is limited

Engineering Contradiction:
ImproveRNA extraction sensitivityVSAvoidextraction system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The extraction system is divided into separate functional modules: a lysis buffer system for sample breakdown, a closed extraction device for controlled processing, and a detection system. This segmentation allows each component to be optimized independently, improving overall extraction sensitivity while maintaining manageable complexity through modular design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs tris(2-carboxyethyl)phosphine hydrochloride as a chemical parameter modification to stabilize nucleic acids during extraction. This chemical addition changes the chemical environment to protect RNA from degradation, thereby improving extraction sensitivity and yield without requiring complex mechanical modifications.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If laboratory testing is performed using conventional methods, then detection accuracy is maintained, but cross-infection risks increase and completion time is long

Engineering Contradiction:
Improvedetection reliabilityVSAvoidtesting completion time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary sample collection and stabilization in the field using portable devices, preparing samples before they reach the laboratory. This preliminary action reduces the time samples need to be transported and processed, accelerating overall detection completion time while maintaining reliability through standardized pre-processing protocols.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces complex mechanical laboratory processing systems with simplified field-deployable extraction devices that use chemical stabilization and controlled lysis instead of complex mechanical separation systems. This substitution reduces processing time and eliminates the need for extensive laboratory infrastructure, thereby reducing detection completion time while maintaining accuracy.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Quantity of substance

If large-volume samples are collected, then RNA yield improves, but collection and processing complexity increases

Engineering Contradiction:
ImproveRNA yieldVSAvoidsample processing complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The extraction device is designed to handle multiple sample types and volumes universally. The same closed extraction system can process various sample volumes (from small to large) using standardized protocols, eliminating the need for different processing procedures for different sample sizes. This multi-functionality improves RNA yield from large-volume samples while avoiding increased processing complexity.

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

Solution Approach 2:

The system uses chemical parameter changes through the lysis buffer and stabilization agents to efficiently process large-volume samples. The chemical formulation enables effective nucleic acid extraction and stabilization from large sample volumes without requiring proportionally increased mechanical processing complexity, thereby maintaining simplicity while improving RNA yield.

Inventive Principle:
Principle #35Parameter changes

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 significantly improves RNA extraction sensitivity, reduces cross-infection risks, and enables rapid, cost-effective detection of COVID-19, allowing for bedside monitoring and dynamic cytokine level tracking.

Implementation Method 1

lysing the sample to be tested with a lysis buffer to release the nucleic acids contained in the sample

Methodology Applied
Scientific EffectLysis:

Implementation Method 2

making the lysis buffer and/or washing buffer used in the extraction process contain tris(2-carboxyethyl)phosphine hydrochloride to accelerate and enhance the degradation of proteins or other substances and stabilize nucleic acids

Methodology Applied
Scientific EffectProtein degradation:

Implementation Method 3

extracting the lysis buffer containing nucleic acids through a nucleic acid extraction device to obtain an extract containing host nucleic acids

Methodology Applied
Scientific EffectNucleic acid extraction:

Data Source

PatentUS20230323484A1Method for preparing test solution for pathogen detection purpose,system, kit, detection primer and method thereby
Publication Date: 2023.10.12 TONGLI BIOMEDICAL
  • US20230323484A1 patent drawing
  • US20230323484A1 patent drawing

AI summary

A method for preparing test solution for pathogen detection purpose, system, kit, detection primer and method are provided. The method of preparing a test solution includes lysing the sample to be tested with a lysis buffer to release the nucleic acids contained in the sample to obtain a lysis buffer containing nucleic acids and/or pathogen nucleic acids; extracting the lysis buffer containing nucleic acids through a nucleic acid extraction device to obtain an extract containing host nucleic acids and/or pathogen nucleic acids; preparing the test solution for pathogen detection purposes from the extract. A large volume of samples can be used in the present application and it greatly improves sensitivity and specificity of the assay.