Nucleic Acid Stabilization via Intermediary Carrier Molecules
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Solution Overview
Problem
Current methods for collecting, transporting, and storing biological samples containing nucleic acids face challenges in maintaining sample integrity, particularly in remote or field locations where refrigeration is not available, and there is a risk of pathogen exposure and degradation due to endogenous or exogenous nuclease activity.
Innovation Solution
A one-step formulation that inactivates pathogens, lyzes cells, separates and stabilizes nucleic acids, and uses extra-genomic nonsense RNA carrier molecules as internal positive controls to monitor sample fidelity, allowing for ambient temperature storage and transport without refrigeration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If nucleic acids are stored at room temperature, then ease of operation and portability are improved, but nucleic acid stability and integrity deteriorate due to degradation and denaturation
Solution Approach 1:
The patent introduces a stabilizing composition as an intermediary substance that mediates between the nucleic acid sample and the environmental conditions. This composition contains agents that protect nucleic acids from degradation while allowing storage at ambient temperatures, thus resolving the contradiction between portability and stability.
Solution Approach 2:
The patent changes the chemical and physical parameters of the storage environment by introducing specific buffers, chaotropes, and protective agents in the stabilizing composition. These parameter changes create a microenvironment that maintains nucleic acid integrity even at room temperature, overcoming the need for cold chain storage.
2Stability of the object's composition
If refrigeration is used to maintain nucleic acid stability, then nucleic acid integrity is improved, but device complexity and cost increase due to requirement of refrigerators and freezers
Solution Approach 1:
The stabilizing composition acts as a chemical intermediary that replaces the need for mechanical refrigeration systems. By incorporating nucleic acid-protecting agents, the system achieves stability without requiring complex refrigeration infrastructure, thus resolving the contradiction between integrity and device complexity.
3Measurement precision
If biological samples are kept viable for testing, then measurement precision is improved, but harmful factors increase due to potential pathogen exposure and nuclease activity
Solution Approach 1:
The patent converts the harmful nuclease activity and pathogen viability into beneficial protection by using the same biological components to create a protective environment. The stabilizing composition harnesses natural protective mechanisms while neutralizing harmful effects, allowing sample preservation without pathogen risk.
Solution Approach 2:
The stabilizing composition introduces protective agents as intermediaries that selectively protect nucleic acids while inactivating pathogens and nucleases. This mediator approach maintains diagnostic quality while eliminating safety hazards associated with keeping samples viable.
4Stability of the object's composition
If commercial transport media are used, then nucleic acid protection is improved, but loss of time and flexibility worsen due to limited storage time and temperature requirements
Solution Approach 1:
The patent applies excessive protection by incorporating multiple protective agents in the stabilizing composition at concentrations that provide extended protection beyond what commercial media offer. This excessive action ensures nucleic acid stability over prolonged periods and under varying temperature conditions, overcoming time limitations.
Solution Approach 2:
The stabilizing composition fundamentally changes the storage parameters by enabling long-term stability at ambient temperatures rather than requiring controlled cold storage. This parameter transformation eliminates time and temperature restrictions inherent in commercial transport media.
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 formulation maintains the integrity and stability of nucleic acids, reducing degradation and pathogen risk, enabling high-quality sample preservation for extended periods at various temperatures, facilitating safe and efficient diagnostic analysis.
Implementation Method 1
The formulation maintains the integrity and stability of nucleic acids, reducing degradation and pathogen risk
Implementation Method 2
reducing degradation and pathogen risk
Data Source
AI summary
Disclosed are compositions for collecting, storing, and transporting populations of nucleic acids from biological specimens, and clinical, forensic, or 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. In particular embodiments, the invention provides a single, one-step, sample collection/transport/storage formulation containing a known quantity of a non-genomic, nucleic acid carrier molecule that serves as an internal reference control to monitor the fidelity of the collection/transportation medium, and measure the integrity of nucleic acids subsequently isolated and purified from the processed sample.