Viral Nucleic Acid Stabilization via Formaldehyde Release
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Solution Overview
Problem
Current methods for isolating and stabilizing virus particles and nucleic acids from biological samples, particularly blood samples, face challenges such as degradation over time and the need for expensive equipment like ultracentrifuges, leading to inaccurate viral load measurements, especially during transportation between clinics and laboratories.
Innovation Solution
A method using a stabilization composition comprising formaldehyde releasers to stabilize virus particles and nucleic acids, allowing for their effective isolation and preservation, even during prolonged storage and handling, thereby maintaining the integrity of the samples for accurate diagnostic and prognostic analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If EDTA is used as anticoagulant to prevent blood cloting and DNA degradation, then enzymatic reactions are inhibited, but virus particles and viral nucleic acids are not stabilized and remain susceptible to degradation
Solution Approach 1:
The patent introduces a stabilization composition as an intermediary substance that specifically targets and stabilizes virus particles and viral nucleic acids. This composition contains agents that prevent degradation of viral components without interfering with the anticoagulant function of EDTA, thereby adding a new protective layer against degradation that was missing in the original EDTA-only system.
Solution Approach 2:
The patent creates a composite stabilization system by combining EDTA (for anticoagulation) with additional stabilization agents in a single blood collection tube. This composite approach allows simultaneous achievement of multiple functions: preventing blood cloting, inhibiting enzymatic reactions, and specifically stabilizing virus particles and viral nucleic acids against degradation.
2Quantity of substance
If ultracentrifugation is used to enrich viral particles from samples with very low viral concentration, then viral particles are enriched, but expensive equipment and long centrifugation time are required
Solution Approach 1:
The stabilization composition is added to the blood collection tube at the time of sample collection, performing the stabilization action before any processing occurs. This preliminary stabilization prevents viral particle degradation and maintains viral integrity throughout storage and transportation, enabling accurate viral load measurement without requiring complex enrichment procedures.
Solution Approach 2:
The patent employs a disposable blood collection tube containing pre-mixed stabilization composition, eliminating the need for expensive ultracentrifuge equipment. The stabilization agents work effectively during the brief period between collection and processing, providing sufficient stabilization without requiring prolonged or complex processing procedures.
3Ease of operation
If blood samples are transported between clinics and laboratories under normal conditions, then samples can be delivered, but temperature variations, mechanical shocks and delay result in decrease of viral level loads
Solution Approach 1:
The stabilization composition acts as a protective cushioning agent that is activated immediately upon sample collection. It prevents viral particle degradation and maintains viral load stability throughout the transportation period, cushioning against the harmful effects of temperature variations, mechanical shocks, and delivery delays without requiring special transportation conditions.
4Loss of time
If virus particles and viral nucleic acids are stored for prolonged periods, then sample analysis can be performed later, but viral nucleic acid levels decrease substantially over time due to degradation
Solution Approach 1:
The stabilization composition provides continuous protection against degradation throughout the entire storage period. The stabilization agents remain active and continuously prevent viral nucleic acid breakdown, maintaining stable viral load levels from the time of collection through prolonged storage and analysis, eliminating the time-dependent degradation that would otherwise occur.
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 stabilization composition significantly reduces viral nucleic acid degradation, enabling reliable and accurate quantification and analysis, even at room temperature for extended periods, improving the reliability of viral load measurements and diagnostic applications.
Implementation Method 1
a stabilization composition comprising at least one formaldehyde releaser agent, which is a compound which over time releases formaldehyde and/or paraformaldehyde
Implementation Method 2
which is a compound which over time releases formaldehyde and/or paraformaldehyde to stabilize virus particles and viral nucleic acids
Data Source
Figure 1
AI summary
The present disclosure provides methods, compositions and devices for isolating virus particles and/or viral nucleic acids from body samples that were stabiliszed using a stabilizing composition comprising a formaldehyde releaser agent.