Sample Transport Media Composition for Viscous Swab Processing

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Solution Overview

Problem

Biological samples containing solid or viscous matter, such as mucus or clots, pose challenges in sample processing and analysis due to viscosity issues that complicate liquid handling and automated processing, leading to clogging and inconsistent results.

Innovation Solution

A composition comprising a degradative enzyme, such as a protease, and an anionic detergent, optionally with a buffer and chelator, is used to degrade and solubilize non-nucleic acid components, facilitating efficient nucleic acid isolation and reducing viscosity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If sample transport media is used to stabilize nucleic acids, then nucleic acid preservation is improved, but viscosity reduction and dissolution of solid matter are insufficient

Engineering Contradiction:
Improvenucleic acid stabilityVSAvoidliquid handling ease
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The sample transport media is formulated as a composite composition containing multiple components: a buffer system (phosphate-buffered saline or Good's buffer), an anionic detergent (such as sodium lauryl sulfate or lithium lauryl sulfate), and a degradative enzyme (such as proteinase K, subtilisin, or alcalase). This composite formulation simultaneously achieves nucleic acid stabilization, viscosity reduction, and dissolution of solid particulate matter, resolving the contradiction between stability and ease of operation.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The composition modifies physical-chemical parameters of the sample including pH (maintained at 7.0-8.5 through buffer systems), ionic strength, and enzymatic activity conditions. These parameter changes enable the degradative enzymes to function optimally while maintaining nucleic acid stability and reducing viscosity, thereby improving both stability and ease of operation.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If degradative enzymes and detergents are added to reduce viscosity, then liquid handling ease is improved, but nucleic acid stability may be compromised

Engineering Contradiction:
Improveliquid handling easeVSAvoidnucleic acid stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The buffer system maintains pH within the optimal range (7.0-8.5) for both enzyme activity and nucleic acid stability. The anionic detergent concentration is controlled to effectively reduce viscosity while not denaturing nucleic acids. These parameter optimizations ensure that viscosity reduction does not compromise nucleic acid stability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The buffer system acts as an intermediary that creates a compatible environment for both the degradative enzymes/detergents and the nucleic acids. The buffer mediates between the potentially destabilizing effects of enzymes and detergents and the stability requirements of nucleic acids, allowing both functions to coexist.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If samples containing solid or viscous matter are processed without special composition, then processing simplicity is maintained, but clogging and inconsistent results occur

Engineering Contradiction:
Improveprocessing simplicityVSAvoidprocessing reliability
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The composition performs preliminary actions of viscosity reduction and particulate matter dissolution before downstream processing steps. The degradative enzymes and detergents pre-treat the sample to break down viscous components and solid matter, preventing clogging during automated liquid handling and ensuring consistent results without adding complex processing steps.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The composition enables the sample to self-process viscous and particulate components through the included degradative enzymes and detergents. The sample essentially treats itself, reducing viscosity and dissolving solids without requiring additional external processing steps, thereby maintaining simplicity while improving reliability.

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 composition effectively reduces viscosity, preventing clogging and ensuring consistent liquid handling and downstream analytical processes like nucleic acid amplification and detection, improving processing efficiency.

Implementation Method 1

A composition comprising a degradative enzyme, such as a protease

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 2

degrade and solubilize non-nucleic acid components

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Implementation Method 3

an anionic detergent, optionally with a buffer and chelator

Methodology Applied
Scientific EffectSurfactant action: Surfactant

Data Source

PatentEP4307916B1Use of a composition and method for biological sample processing
Publication Date: 2025.11.19 GEN PROBE INC
  • EP4307916B1 patent drawing
  • EP4307916B1 patent drawing

AI summary

Methods, apparatuses, and systems are provided for processing a biological sample. Exemplary methods comprise transferring a swab associated with an aliquot of the biological sample into a sample transport media. The methods can provide efficient transfer of a target material such as cells or nucleic acid into the sample transport media for extraction, amplification, and detection of the target material.