Dried Reagent Coating for Biological Sample Stabilization

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Solution Overview

Problem

Current sample collection containers for biological samples, particularly in the field of omics, face challenges in reliably collecting and isolating analyzable targets due to issues with sample quantity and quality, and there is a need for improved stabilization and prolonged shelf-life of reagents, as well as controlled release of stabilizing agents to maintain sample integrity.

Innovation Solution

The development of sample collection containers with a dried reagent coating on the inner surface, comprising a mixture of stabilizer and anticoagulant components, which dissolves and disperses within the sample upon contact, providing enhanced stability and reducing the amount of reagent required, while maintaining sample integrity and allowing for extended storage and transport.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If liquid reagents are used in sample collection containers, then sample stabilization is achieved, but reagent shelf-life is reduced due to evaporation and solvent loss

Engineering Contradiction:
Improvesample stabilizationVSAvoidreagent shelf-life
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The reagent is transformed from liquid to dried solid form through controlled drying processes, fundamentally changing its physical state to eliminate evaporation issues while preserving stabilizing functionality upon sample contact

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The reagent is pre-applied and dried on the container interior surface before sample collection, ensuring immediate stabilization upon sample contact while maintaining reagent stability during storage through the dried state

Inventive Principle:
Principle #10Preliminary action

2Reliability

If conventional amounts of reagent are used, then sample stabilization is maintained, but reagent cost and volume are excessive

Engineering Contradiction:
Improvesample stabilizationVSAvoidreagent amount
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The reagent is applied as a thin coating layer distributed across the interior surface of the container, concentrating the stabilizing function at the sample-reagent interface where it is most needed, rather than using bulk liquid reagent

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The essential stabilizing components are extracted and applied in minimal quantities as a dried coating, removing the excess liquid solvent that would otherwise be required to deliver adequate reagent amounts

Inventive Principle:
Principle #2Taking out (Extraction)

3Duration of action of stationary object

If dried reagent coating is used, then reagent shelf-life is extended and reagent amount is reduced, but manufacturing complexity increases

Engineering Contradiction:
Improvereagent shelf-lifeVSAvoidmanufacturing complexity
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The reagent undergoes controlled drying to transform from liquid to solid coating form, a parameter change that can be achieved through simple evaporation or low-heat processing, integrating smoothly into existing manufacturing workflows

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The reagent coating is applied and dried in advance during container manufacturing, creating a ready-to-use stabilized container that simplifies downstream sample collection processes

Inventive Principle:
Principle #10Preliminary action

4Speed

If liquid reagents are used, then immediate sample contact is achieved, but uncontrolled release of stabilizing agents occurs

Engineering Contradiction:
Improvereagent release speedVSAvoidsample integrity
Core Design Contradiction:
SpeedVSReliability

Solution Approach 1:

The reagent is pre-positioned on the container surface in dried form, ensuring immediate and uniform contact with the sample upon introduction, while the drying process controls the release kinetics to prevent premature or uncontrolled activation

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The physical state change from liquid to dried solid controls the release profile, allowing the reagent to remain stable during storage and only activate upon controlled contact with sample moisture

Inventive Principle:
Principle #35Parameter changes

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

This solution enables the stabilization of biological samples for extended periods, reducing hemolysis and maintaining the quality of analyzable targets like cell-free nucleic acids, and allows for reduced reagent usage, improving the efficiency and reliability of omic analysis.

Implementation Method 1

a dried coating of a reagent... dissolves and disperses within the sample upon contact

Methodology Applied
Scientific EffectDissolution: Solvation

Implementation Method 2

dissolves and disperses within the sample upon contact

Methodology Applied
Scientific EffectDispersion: Dispersion (of waves)

Implementation Method 3

the coating resists delamination from a surface of the container

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 4

stabilization of nucleic acids in plasma or serum... stabilization of cell-free nucleic acids... reducing hemolysis

Methodology Applied
Scientific EffectStabilization: Preservative

Data Source

PatentUS20230302454A1Sample collection containers, processes and collected samples
Publication Date: 2023.09.28 STRECK INC
  • US20230302454A1 patent drawing
  • US20230302454A1 patent drawing
  • US20230302454A1 patent drawing

AI summary

The present teachings relate to a method of making a biological sample collection container, an internally coated biological sample collection container, and uses of the same, particularly for omic analysis. A reagent (or a reagent precursor) is deposited in a liquid state at least partially along at least one side wall of the container. The reagent precursor is dried to form a dried coating having a predefined pattern and topology along at least a portion of the at least one side wall. A container thus results having a coating that includes, in a dried state, a stabilizer agent, or reaction product of a stabilizer agent and an anticoagulant, and upon collection of a sample enables stabilization of any present white blood cells, cell-free nucleic acids, extracellular vesicles, circulating tumor cells, proteins, metabolites, lipids, or any combination thereof, and preserving them in sufficient quantity and quality for omic analysis.