Multilayer CPK Test Strip for Rapid Point-of-Care Measurement

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Solution Overview

Problem

Current methods for measuring Creatine Phosphokinase (CPK) activity, such as mass spectrometry assays, are time-consuming, expensive, and require skilled technicians, making them unsuitable for point-of-care testing.

Innovation Solution

An electrochemical or colorimetric device, referred to as 'CPK Now', which uses a test strip with multiple layers to quantify CPK levels in biological samples, requiring minimal sample volume and providing rapid, cost-effective results without the need for specialized personnel.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If mass spectrometry assays are used to measure CPK activity, then measurement precision is improved, but device complexity and cost increase significantly

Engineering Contradiction:

ImproveCPK measurement precisionVSAvoidassay complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The assay is divided into multiple functional layers on a test strip, each containing specific reagents for different steps of the CPK measurement process. This segmentation allows the complex multi-step enzymatic assay to be performed in a simplified, integrated format that eliminates the need for complex mass spectrometry equipment while maintaining measurement precision.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces intermediary reagents including creatine phosphate substrate, adenosine triphosphate (ATP), and coupling enzymes (creatine kinase, adenosine deaminase, and diaphorase) that mediate the conversion of CPK activity into a measurable colorimetric or electrochemical signal. These intermediaries enable the measurement of CPK activity through simpler detection methods.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If mass spectrometry assays are used to measure CPK activity, then measurement precision is improved, but time consumption increases

Engineering Contradiction:

ImproveCPK measurement precisionVSAvoidtesting time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The test strip is pre-loaded with all necessary reagents including substrates, enzymes, and buffers in their optimal concentrations and configurations. This preliminary preparation allows the assay to proceed through multiple enzymatic steps simultaneously and rapidly, reducing the total testing time from hours to minutes while maintaining precision.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The assay design ensures continuous enzymatic reactions across multiple layers of the test strip, where the product of one enzymatic reaction immediately serves as the substrate for the next reaction. This continuous action eliminates idle time between steps and accelerates the overall measurement process.

Inventive Principle:

Principle #20Continuity of useful action

3Measurement precision

If mass spectrometry assays are used to measure CPK activity, then measurement precision is improved, but ease of operation deteriorates

Engineering Contradiction:

ImproveCPK measurement precisionVSAvoidoperator skill requirement

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The test strip is designed to be self-contained and self-operating, requiring minimal user intervention. The user simply applies the biological sample to the test strip, and the integrated reagents and reaction chambers automatically perform the multi-step enzymatic assay, eliminate the need for skilled technicians while maintaining measurement precision.

Inventive Principle:

Principle #25Self-service

4Measurement precision

If complex laboratory assays are used to measure CPK activity, then measurement precision is improved, but productivity decreases

Engineering Contradiction:

ImproveCPK measurement precisionVSAvoidtesting throughput

Core Design Contradiction:

Measurement precisionVSProductivity

Solution Approach 1:

The complex laboratory assay protocol is copied and replicated in miniaturized form across multiple test strips, each containing the complete assay system. This allows parallel processing of multiple samples simultaneously, dramatically increasing throughput while maintaining the precision of the original laboratory method.

Inventive Principle:

Principle #26Copying

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 device enables fast, reliable, and accurate measurement of CPK levels in biological samples, allowing for point-of-care testing and remote data dissemination, potentially avoiding hospital visits and prompt treatment.

Implementation Method 1

An electrochemical or colorimetric device, referred to as 'CPK Now'

Methodology Applied

Scientific EffectElectrochemical reaction:

Implementation Method 2

An electrochemical or colorimetric device, referred to as 'CPK Now'

Methodology Applied

Scientific EffectColorimetric reaction:

Implementation Method 3

The device comprises a combination of components designed to elicit a measurable electrochemical or colored end-product from the application of a biological sample

Methodology Applied

Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS20250320540A1Point-of-Care Device for the Determination of Creatine Phosphokinase (CPK) in Biological Samples

Publication Date: 2025.10.16 IN VITRO DIAGNOSTIC SOLUTIONS

AI summary

Devices, kits, and methods for testing and monitoring creatine phosphokinase (CPK) in biological samples are provided.