Aqueous Stabilizing Composition for Nucleic Acid Preservation

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Solution Overview

Problem

Current methods for collecting, transporting, and storing biological specimens containing nucleic acids face challenges such as degradation at room temperature, requiring refrigeration, and posing safety risks due to the presence of infectious pathogens, which complicates molecular analysis and increases handling costs.

Innovation Solution

A one-step aqueous composition that inactivates pathogens, lyzes cells, and stabilizes nucleic acids, allowing for storage and transport at ambient temperatures without refrigeration, using chaotropes, detergents, chelators, reducing agents, and defoaming agents to maintain nucleic acid integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If nucleic acids are stored at room temperature, then ease of transport and handling is improved, but nucleic acid degradation occurs

Engineering Contradiction:

Improveease of transportVSAvoidnucleic acid stability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent introduces a stabilizing composition containing chaotropic agents (guanidine thiocyanate, guanidine hydrochloride), reducing agents (beta-mercaptoethanol, dithiothreitol), and chelating agents (EDTA, EGTA) as intermediary substances that mediate between the nucleic acids and the environmental conditions. This composition creates a protective chemical environment that allows nucleic acids to remain stable at room temperature without requiring refrigeration, thus resolving the contradiction between ease of transport and nucleic acid stability.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If refrigeration is used to preserve nucleic acids, then nucleic acid stability is improved, but transport complexity and cost increase

Engineering Contradiction:

Improvenucleic acid stabilityVSAvoidtransport requirements

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The stabilizing composition is designed to be self-sufficient, containing all necessary components (chaotropic agents, reducing agents, chelating agents, buffers) to maintain nucleic acid stability independently of external refrigeration. The composition itself provides the protective environment needed, making the system self-service capable and eliminating the need for complex refrigerated transport infrastructure.

Inventive Principle:

Principle #25Self-service

3Loss of information

If infectious pathogens are present in specimens, then diagnostic information is preserved, but safety risks increase

Engineering Contradiction:

Improvediagnostic information integrityVSAvoidpathogen safety risk

Core Design Contradiction:

Loss of informationVSObject-affected harmful factors

Solution Approach 1:

The patent converts the harmful presence of infectious pathogens into a beneficial state by using the same chaotropic agents and reducing agents in the stabilizing composition to simultaneously inactivate pathogens while preserving nucleic acid integrity. The harsh chemical environment that would normally be considered damaging is instead utilized to kill pathogens while the specific composition maintains nucleic acid stability, thus converting a harmful factor into a beneficial dual-function treatment.

Inventive Principle:

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

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 composition effectively stabilizes and preserves nucleic acids, enabling reliable molecular diagnostic analysis by preventing degradation and ensuring safety during transport and storage, reducing the need for refrigeration and enhancing handling safety.

Implementation Method 1

using chaotropes, detergents, chelators, reducing agents, and defoaming agents to maintain nucleic acid integrity

Methodology Applied

Scientific EffectChaotropic effect:

Implementation Method 2

lyzes the biological cells or tissues to free the nucleic acids from cellular debris and extraneous biomolecules

Methodology Applied

Scientific EffectDetergent solubilization: Surfactant

Implementation Method 3

chelators... to maintain nucleic acid integrity

Methodology Applied

Scientific EffectChelation:

Implementation Method 4

reducing agents... to maintain nucleic acid integrity

Methodology Applied

Scientific EffectReduction: Reduction

Data Source

PatentUS10870878B2Aqueous compositions that maintains fidelity of the nucleic acid sequences of a biological specimen

Publication Date: 2020.12.22 LONGHORN VACCINES & DIAGNOSTICS LLC

AI summary

Disclosed are compositions for isolating populations of nucleic acids from biological, forensic, and environmental samples. Also disclosed are methods for using these compositions as one-step formulations for killing pathogens, inactivating nucleases, and releasing polynucleotides from other cellular components within the sample, and stabilizing the nucleic acids prior to further processing or assay. The disclosed compositions safely facilitate rapid sample collection, and provide extended storage and transport of the samples at ambient or elevated temperature without contamination of the sample or degradation of the nucleic acids contained therein. This process particularly facilitates the collection of specimens from remote locations, and under conditions previously considered hostile for preserving the integrity of nucleic acids released from lysed biological samples without the need of refrigeration or freezing prior to molecular analysis.