Asymmetric Plasma Separation Membrane Reduces Leaching

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Solution Overview

Problem

Conventional plasma separation membranes interfere with plasma sample integrity due to leaching hemolysis-preventing agents, leading to erroneous measurements in assays, especially for calcium and magnesium concentrations, as these agents bind to di-valent cations and affect enzyme reactions.

Innovation Solution

The development of multi-region separation materials with different surface treatments, including anti-hemolytic and anti-coagulant coatings, where the hemolysis-preventing agents are preferentially removed from inner portions or applied in a manner that minimizes contact with the plasma, using materials like single and/or double alkyl chain N-oxides of tertiary amines (NTA) and EDTA derivatives, and employing asymmetric or multi-layer configurations to reduce interference in assays.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a hemolysis-preventing agent coating is applied to the separation membrane surface, then hemolysis is prevented and sample integrity is improved, but the coating leaches into the plasma sample causing erroneous measurements in assays

Engineering Contradiction:

Improvesample integrityVSAvoidassay measurement accuracy

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The patent removes the hemolysis-preventing agent coating from the separation membrane surface through washing steps before plasma separation. This extraction eliminates the source of contamination that causes erroneous assay measurements while preserving the membrane's separation functionality

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies a different coating composition to the separation membrane that is specifically designed to resist leaching into the plasma sample. This preliminary protective action prevents the contamination problem before it occurs during plasma separation

Inventive Principle:

Principle #10Preliminary action

2Reliability

If an anti-hemolytic coating is applied to prevent hemolysis, then red blood cell protection is improved, but interference with calcium and magnesium measurements occurs due to chelating agent binding

Engineering Contradiction:

Improvehemolysis preventionVSAvoidcalcium and magnesium measurement accuracy

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The patent removes chelating agents and other interfering substances from the separation membrane surface through washing steps before plasma separation, eliminating the source of interference with calcium and magnesium measurements

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies different coatings to different regions of the separation membrane - an anti-hemolytic coating on the blood-contacting surface and a different coating composition on the plasma-facing surface that does not interfere with metal ion measurements

Inventive Principle:

Principle #3Local quality

3Adaptability or versatility

If conventional plasma separation membranes are used for large molecule assays, then plasma separation is achieved, but the membranes are limited to specific assay types and cannot be used for smaller metabolite measurements

Engineering Contradiction:

Improveassay type compatibilityVSAvoidmetabolite measurement accuracy

Core Design Contradiction:

Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent applies different coating compositions to different regions of the separation membrane to create selective compatibility - one coating for blood cell protection and another for assay compatibility, enabling use with multiple assay types including metabolite measurements

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent modifies the coating composition parameters of the separation membrane to reduce interference with various assay chemistries, expanding compatibility from only large molecule assays to include smaller metabolite measurements

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 approach significantly reduces the interference of hemolysis-preventing agents in plasma assays, allowing for accurate measurements of smaller metabolites like glucose and calcium, while maintaining the anti-hemolytic benefits, thus enhancing the integrity and reliability of plasma-based assays.

Implementation Method 1

separate solid or semi-solid components from liquid components through the principle of size exclusion

Methodology Applied

Scientific EffectSize exclusion: Filter (physical)

Implementation Method 2

a hemolysis preventing agent typically used with such separation membranes

Methodology Applied

Scientific EffectAnti-hemolytic effect:

Implementation Method 3

NTA, however, is a chelating agent that strongly binds to di-valent cations such as calcium and magnesium ions

Methodology Applied

Scientific EffectChelation:

Data Source

PatentUS10730021B2Systems, devices, and methods for bodily fluid separation materials

Publication Date: 2020.08.04 LABRADOR DIAGNOSTICS LLC

AI summary

In one embodiment described herein, a bodily fluid separation material is provided comprising a formed component capture region and a bodily fluid pass-through region. The pass-through region has structures with a reduced liquid leaching quality relative to than the capture region, wherein during separation material use, bodily fluid enters the capture region prior to entering the pass-through region. Optionally, a bodily fluid pass-through region has a reduced amount of liquid leaching material relative to than the capture region.