LDL Cholesterol Test Strip with POE-POP-POE Block Copolymer

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Solution Overview

Problem

Current methods for measuring low-density lipoprotein (LDL) cholesterol are either complex, require laboratory facilities, or are not compatible with strip technology due to challenges in introducing multiple reagents at critical timings, limiting their effectiveness for on-site, immediate patient assessment.

Innovation Solution

A test strip system incorporating a red blood cell separation layer, a reaction layer with POE-POP-POE block copolymer and surfactant, and a reflectivity changing reactant, which selectively solubilizes non-LDL cholesterol analytes, allowing for direct measurement of LDL cholesterol concentration without the need for laboratory equipment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If two-step reaction methods are used to quantify LDL cholesterol, then measurement accuracy is improved, but device complexity and ease of operation worsen due to the need for multiple reagents and critical timing

Engineering Contradiction:
ImproveLDL cholesterol measurement accuracyVSAvoidreaction system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple reagents (POE-POP-POE block copolymer, surfactant, and reflectivity changing reactant) into a single reaction layer that performs the functions of multiple separate reagents. This single layer simultaneously solubilizes non-LDL cholesterol, enables selective reaction, and provides the measurement signal, eliminating the need for sequential reagent addition and complex timing control.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The reaction layer is designed to perform multiple functions within a single component: it separates red blood cells, solubilizes non-LDL cholesterol analytes, enables the chemical reaction with reflectivity changing reactant, and provides the measurement signal. This multi-functional design simplifies the overall system while maintaining measurement accuracy.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If laboratory-based methods are used for LDL cholesterol measurement, then measurement precision is improved, but loss of time and ease of operation worsen due to facility requirements and delayed results

Engineering Contradiction:
ImproveLDL cholesterol measurement accuracyVSAvoidtime to obtain results
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The test strip is designed as a self-contained, self-service system that performs the complete LDL cholesterol measurement process without requiring external laboratory facilities, equipment, or personnel. The strip automatically separates blood components, performs the chemical reaction, and generates a measurable signal that can be read immediately, enabling point-of-care testing.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The measurement system is segmented into discrete functional layers within the test strip (red blood cell separation layer, reaction layer with embedded reagents), allowing the entire measurement process to be miniaturized and performed in a portable format that does not require laboratory infrastructure.

Inventive Principle:
Principle #1Segmentation

3Ease of manufacture

If conventional surfactants are used to solubilize cholesterol, then ease of manufacture is improved, but measurement precision worsens due to inability to selectively solubilize non-LDL cholesterol

Engineering Contradiction:
Improvetest strip manufacturing simplicityVSAvoidnon-LDL cholesterol selectivity
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent uses a composite material system consisting of POE-POP-POE block copolymer combined with surfactant in the reaction layer. This composite provides both the ease of manufacture associated with conventional surfactants and the selective solubilization capability needed for accurate non-LDL cholesterol measurement, resolving the contradiction between manufacturing simplicity and measurement precision.

Inventive Principle:
Principle #40Composite materials

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

Enables rapid, accurate measurement of LDL cholesterol levels in whole blood samples, providing immediate results that are more accurate than estimation-based methods like the Friedwald equation, especially for non-fasting individuals, and is compatible with dry strip technology.

Implementation Method 1

the POE-POP-POE block copolymers solubilizing essentially only non-LDL cholesterol analytes

Methodology Applied
Scientific EffectMicelle formation: Colloid

Implementation Method 2

the reaction layer including POE-POP-POE block copolymer, a surfactant, and a reflectivity changing reactant

Methodology Applied
Scientific EffectSurfactant action: Surfactant

Implementation Method 3

the non-LDL cholesterol analytes reacting with the reflectivity changing reactant in order to change a reflectivity of the blood sample

Methodology Applied
Scientific EffectColor change reaction: Chemical Bonding

Implementation Method 4

a red blood cell separation layer, the red blood cell separation layer separating red blood cells from a blood sample

Methodology Applied
Scientific EffectPhysical separation: Filter (physical)

Data Source

PatentUS9470698B2Systems and methods for non-fasting LDL cholesterol assays
Publication Date: 2016.10.18 POLYMER TECHNOLOGY SYSTEMS INC
  • US9470698B2 patent drawing
  • US9470698B2 patent drawing
  • US9470698B2 patent drawing

AI summary

In one embodiment, a test strip for testing for cholesterol-related blood analytes in whole blood includes a red blood cell separation layer, the red blood cell separation layer separating red blood cells from a blood sample applied to the test strip as the blood sample flows downward through the red blood cell separation layer. The test strip further includes a reaction layer receiving the blood sample from the red blood cell separation layer, the reaction layer including POE-POP-POE block copolymer, a surfactant, and a reflectivity changing reactant, the POE-POP-POE block copolymers solubilizing essentially only non-LDL cholesterol analytes, the non-LDL cholesterol analytes reacting with the reflectivity changing reactant in order to change a reflectivity of the blood sample.