Fluorescent Microsphere Test Strip for Vancomycin Detection

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Solution Overview

Problem

Current methods for monitoring vancomycin concentrations, such as Thin Layer Chromatography, Capillary Electrophoresis, and High Performance Liquid Chromatography, are not suitable for large-scale clinical promotion and are costly, failing to meet the increasing demand for clinical monitoring due to their limitations and high costs.

Innovation Solution

A time-resolved fluorescent immunochromatographic test strip is developed, utilizing a vancomycin-bovine serum albumin conjugate and fluorescent microsphere-labeled vancomycin monoclonal antibodies, which includes a preparation method involving redox and coupling reactions to create a vancomycin-bovine serum albumin conjugate and fluorescent microsphere-labeled antibodies, and is applied for detecting vancomycin concentrations in human serum.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional methods such as HPLC, CE, or TLC are used for vancomycin concentration monitoring, then measurement precision can be achieved, but the cost is high and the methods are not suitable for large-scale clinical promotion

Engineering Contradiction:
Improvevancomycin concentration detection accuracyVSAvoidcost-effectiveness and scalability
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent replaces complex mechanical/chemical separation systems (HPLC, CE, TLC) with an immunochromatographic system that uses antibody-antigen specific binding. This substitution maintains detection precision while dramatically reducing equipment requirements and operational complexity, making the system suitable for large-scale clinical use.

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

Solution Approach 2:

The patent introduces fluorescent microspheres as intermediaries to enhance the detection signal. These microspheres carry fluorescent labels that amplify the antibody-antigen binding signal, enabling high-sensitivity detection without requiring the complex separation and detection systems of traditional methods.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If foreign imported immunoassay methods (turbidimetric inhibition, homogeneous enzyme immunoassay, chemiluminescence, fluorescence polarization) are used, then vancomycin detection capability is available, but the cost is high and methods are monopolized by foreign importers

Engineering Contradiction:
Improvevancomycin detection capabilityVSAvoidcost and import dependency
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent changes the detection parameter from traditional optical methods (turbidity, enzyme activity, chemiluminescence) to fluorescent signal detection. This parameter change enables the use of simple fluorescence readers instead of expensive specialized equipment, reducing costs while maintaining detection capability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs disposable test strips with pre-coated antibodies and fluorescent microspheres. These single-use strips eliminate the need for expensive, complex instrumentation and specialized reagents, making the system cost-effective and independent of foreign monopolies.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Ease of operation

If conventional immunochromatographic methods are used, then ease of operation is improved, but detection accuracy and specificity are insufficient for clinical monitoring requirements

Engineering Contradiction:
Improveoperational simplicityVSAvoiddetection accuracy and specificity
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent creates a composite detection system combining fluorescent microspheres, monoclonal antibodies, and immunochromatographic membrane technology. This composite approach integrates the operational simplicity of immunochromatography with the high sensitivity and specificity of fluorescent detection, achieving both ease of use and clinical-grade accuracy.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent uses fluorescent microspheres as intermediaries to bridge the gap between simple immunochromatographic binding and high-precision quantitative detection. The microspheres concentrate and amplify the binding signal, enabling accurate quantification while maintaining the simplicity of the immunochromatographic format.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 a cost-effective, high-accuracy method for vancomycin detection with strong specificity, capable of accurately determining vancomycin concentrations and eliminating interference, thus addressing the limitations of existing methods.

Implementation Method 1

time-resolved fluorescent immunochromatographic test strip

Methodology Applied
Scientific EffectTime-resolved fluorescence: Fluorescence

Implementation Method 2

mixing a sodium periodate aqueous solution with a vancomycin aqueous solution to obtain a vancomycin pre-conjugate by a redox reaction

Methodology Applied
Scientific EffectRedox reaction: Redox Reactions

Data Source

PatentUS11162959B2Time-resolved fluorescent immunochromatographic test strip for detecting vancomycin as well as preparation method and application thereof
Publication Date: 2021.11.02 BEIJING DIAGREAT BIOTECH CO LTD
  • US11162959B2 patent drawing
  • US11162959B2 patent drawing

AI summary

Some embodiments of the disclosure provide a time-resolved fluorescent immunochromato-graphic test strip for detecting vancomycin as well as a preparation method and application thereof. In some embodiments, the test strip includes a bottom plate and a sample absorption pad. A fluorescent microsphere pad, a nitrocellulose membrane coated with a vancomycin-carrier protein conjugate, and an absorbent pad are sequentially overlapped and pasted on the bottom plate. The fluorescent microsphere pad is sprayed with a fluorescent microsphere-labeled vancomycin monoclonal antibody, and the vancomycin monoclonal antibody is prepared by using a vancomycin-bovine serum albumin conjugate as an immunogen.