Time-Resolved Fluorescent Immunochromatographic Test Strip for Paclitaxel Detection

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Solution Overview

Problem

Current methods for monitoring paclitaxel drug concentrations in clinical settings are inadequate due to low sensitivity, high cost, and lack of suitable detection reagents, making it difficult to manage efficacy and adverse reactions effectively.

Innovation Solution

A time-resolved fluorescent immunochromatographic test strip is developed, comprising a test paper with a fluorescent microsphere pad labeled with anti-paclitaxel monoclonal antibodies and a sample diluent, allowing for high sensitivity and specificity in paclitaxel detection with low production costs and simple use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If Turbidimetric Inhibition Immunoassay (TIA) is used for PTX determination, then detection capability is provided, but sensitivity is low and cost is high

Engineering Contradiction:
Improvedetection sensitivityVSAvoidcost-effectiveness
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent replaces the traditional turbidimetric detection system with a fluorescent detection system using time-resolved fluorescent microspheres. This substitution of detection mechanism (from turbidimetric to fluorescent) enables significantly higher sensitivity while reducing reagent costs and improving overall cost-effectiveness for PTX determination

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the detection parameter from turbidimetry to time-resolved fluorescence. By using fluorescent microspheres with specific emission wavelengths and lifetimes, the system achieves enhanced sensitivity and specificity for PTX detection, resolving the contradiction between sensitivity and cost-effectiveness

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If conventional detection methods (TLC, CE, HPLC) are used, then detection capability is provided, but they are not suitable for large-scale clinical promotion

Engineering Contradiction:
Improvedetection capabilityVSAvoidscalability for clinical use
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent segments the complex HPLC/CE/TLC detection process into a simplified immunochromatographic format with discrete functional zones (detection line, control line, sample application area). This segmentation enables parallel processing of multiple samples and simplifies operation, making the system suitable for large-scale clinical promotion while maintaining detection capability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The test strip incorporates all necessary reagents (antibodies, fluorescent microspheres, buffer solutions) directly into the strip structure. The system performs self-contained detection without requiring external complex instrumentation or skilled operators, enabling easy scalability to clinical settings

Inventive Principle:
Principle #25Self-service

3Reliability

If PTX monitoring is not performed, then treatment simplicity is maintained, but efficacy and adverse reactions cannot be effectively managed

Engineering Contradiction:
Improvetreatment management capabilityVSAvoidoperational simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces complex laboratory-based monitoring systems with a simple fluorescent-based immunochromatographic test strip. The time-resolved fluorescent detection provides reliable PTX concentration measurements while maintaining operational simplicity through straightforward sample application and reading procedures

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the monitoring approach from complex multi-step analytical procedures to a single-step fluorescent intensity measurement. By measuring fluorescent signal intensity and comparing it to standards, the system achieves reliable treatment management capability while preserving ease of operation in clinical settings

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

The test strip provides rapid, accurate, and cost-effective detection of paclitaxel with high specificity, capable of analyzing paclitaxel concentrations in clinical samples, improving monitoring and management of the drug's efficacy and adverse reactions.

Implementation Method 1

time-resolved fluorescent immunochromatographic test strip

Methodology Applied
Scientific EffectTime-resolved fluorescence: Fluorescence

Implementation Method 2

fluorescent microsphere-labeled anti-paclitaxel monoclonal antibody

Methodology Applied
Scientific EffectAntibody-antigen binding:

Implementation Method 3

test paper including a bottom plate and a sample absorption pad

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 4

sample diluent

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS11237158B2Time-resolved fluorescent immunochromatographic test strip for detecting paclitaxel drugs as well as preparation method and application thereof
Publication Date: 2022.02.01 BEIJING DIAGREAT BIOTECH CO LTD
  • US11237158B2 patent drawing
  • US11237158B2 patent drawing
  • US11237158B2 patent drawing

AI summary

Some embodiments of the disclosure provide a time-resolved fluorescent immunochromatographic test strip for detecting paclitaxel drugs as well as a preparation method and application thereof. In some embodiments, the test strip includes a test paper and a sample diluent. The test paper includes a bottom plate, a sample absorption pad, a fluorescent microsphere pad, a bonding pad, and an absorbent pad. The sample absorption pad, the fluorescent microsphere pad, the bonding pad, and the absorbent pad are sequentially overlapped on the bottom plate. The fluorescent microsphere pad is sprayed with a fluorescent microsphere-labeled anti-paclitaxel monoclonal antibody. A detection area and a quality control area are immobilized on the bonding pad. The detection area is sprayed with a paclitaxel hapten-carrier protein conjugate. The quality control area is sprayed with a goat anti mouse antibody.