Biological Sample Stabilization Reagent for Pathogen Inactivation

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Solution Overview

Problem

Biological samples, particularly those containing DNA, RNA, and proteins, are prone to destabilization and degradation during storage and processing, which can affect the integrity and accuracy of analytical results, especially for pathogens like SARS-CoV-2.

Innovation Solution

A reagent comprising a kosmotrope, chaotrope, and viral inactivating agent is used to stabilize biological samples by protecting molecular components from degradation, allowing for prolonged storage and detection without refrigeration, and rapid inactivation of pathogens within seconds.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If biological samples are stored and processed under conventional conditions, then the samples can be maintained for analysis, but the molecular components (DNA, RNA, proteins) undergo destabilization and degradation

Engineering Contradiction:
Improveintegrity of molecular componentsVSAvoidstorage duration
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The reagent is applied to biological samples immediately upon collection, performing preliminary stabilization of molecular components before degradation can occur. This preliminary action preserves DNA, RNA, and protein integrity during subsequent storage and processing, enabling reliable analysis after extended periods without refrigeration

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The reagent contains kosmotropes and chaotropes that fundamentally change the chemical parameters of the storage environment. These agents alter water structure and molecular interactions to create conditions where biological molecules remain stable at ambient temperatures, transforming the storage paradigm from refrigerated to room temperature

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If conventional storage methods are used, then samples can be stored, but analytical sensitivity is reduced due to degradation of molecular components

Engineering Contradiction:
Improveanalytical sensitivityVSAvoidintegrity of molecular components
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

By stabilizing molecular components immediately upon sample collection, the reagent prevents degradation that would otherwise reduce analytical sensitivity. This preliminary protection ensures that DNA, RNA, and proteins remain intact throughout storage and processing, maintaining high detection sensitivity for low-abundance targets

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention replaces the mechanical/physical system of refrigeration with a chemical stabilization system. Instead of using cold temperatures to slow degradation, the reagent uses kosmotropic and chaotropic agents to chemically protect molecular components, enabling sensitive analysis without energy-intensive cooling

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

3Object-affected harmful factors

If viral inactivation is not performed, then sample integrity is maintained, but safety risk increases due to infectious pathogens

Engineering Contradiction:
Improveinfection riskVSAvoidintegrity of biological sample
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The reagent acts as an intermediary that simultaneously performs two functions: it stabilizes molecular components for analysis while also inactivating viral pathogens. The multiple agents in the reagent work together to disrupt viral structures without degrading DNA, RNA, or proteins, resolving the conflict between safety and sample integrity

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The reagent is a composite formulation containing multiple different agents (kosmotropes, chaotropes, viral inactivators) that work synergistically. This composite approach allows simultaneous achievement of molecular stabilization and pathogen inactivation, where each component contributes to one or both functions without interfering with the others

Inventive Principle:
Principle #40Composite materials

4Reliability

If refrigeration is used for storage, then sample stability is maintained, but operational complexity and energy requirements increase

Engineering Contradiction:
Improvesample stabilityVSAvoidstorage conditions
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The reagent fundamentally changes the storage parameters from requiring low temperatures to allowing ambient temperature storage. By chemically stabilizing molecular components through kosmotropic and chaotropic agents, the system eliminates the need for refrigeration infrastructure, simplifying sample collection, transport, and storage operations

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The reagent provides self-service stabilization, where the chemical agents continuously protect molecular components without requiring external energy input or active control systems. This passive stabilization mechanism replaces active refrigeration, enabling straightforward ambient temperature storage that does not require monitoring or energy consumption

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

The reagent effectively maintains the integrity of genetic material, enabling detection at low concentrations and extending the storage duration of biological samples, while ensuring safety by rapidly inactivating viruses, thus improving analytical sensitivity and reducing the risk of infection.

Implementation Method 1

providing a reagent comprising a kosmotrope, a chaotrope, and a viral inactivating agent, the reagent configured to protect a biological molecule in the biological sample from destabilization or degradation

Methodology Applied
Scientific EffectKosmotrope effect:

Implementation Method 2

providing a reagent comprising a kosmotrope, a chaotrope, and a viral inactivating agent, the reagent configured to protect a biological molecule in the biological sample from destabilization or degradation

Methodology Applied
Scientific EffectChaotrope effect:

Implementation Method 3

the reagent further comprises a viral-inactivating agent for inactivating a virus in the biological sample within 30 seconds

Methodology Applied
Scientific EffectViral inactivation:

Data Source

PatentUS20230357825A1Cell preservation reagents and methods of use
Publication Date: 2023.11.09 TRUCKEE APPLIED GENOMICS LLC
  • US20230357825A1 patent drawing

AI summary

Reagents and methods of use thereof for stabilizing a biological sample, including preserving or preventing destruction of a biological molecule within the biological sample, are provided.