Lateral Flow Cartridge for Vitamin D Quantification

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Solution Overview

Problem

Current methods for quantifying 25-hydroxyvitamin D, such as LC-MS/MS and CLIA, face challenges in accuracy, cost, and variability, with a lack of quick and accurate fluorescence-based assays using lateral flow cartridges.

Innovation Solution

A method involving a biological sample mixed with a releasing buffer at 32-37°C for 3-7 minutes, followed by a detection buffer with fluorescent-labeled anti-25-hydroxyvitamin D antibodies, loaded into a lateral flow cartridge for 6-10 minutes, allowing fluorescence measurement without pre-treatment and using a test strip with immobilized BSA-25-hydroxyvitamin D and rabbit IgG for accurate quantification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If LC-MS/MS method is used for vitamin D measurement, then measurement accuracy and sensitivity are improved, but instrument cost and complexity increase

Engineering Contradiction:
Improvemeasurement accuracyVSAvoidinstrument cost
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs disposable lateral flow cartridges with pre-immobilized antibodies and reagents, replacing expensive reusable LC-MS/MS instruments. Each cartridge is a single-use device that provides accurate measurement without requiring costly infrastructure, maintenance, or skilled operation, thus resolving the contradiction between measurement precision and device complexity/cost.

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

Solution Approach 2:

The patent replaces the complex mechanical and computational system of LC-MS/MS with a simple optical detection system based on fluorescence measurement. The lateral flow cartridge uses passive capillary action instead of pumps and valves, and fluorescence intensity measurement instead of mass spectrometry, achieving comparable accuracy with dramatically reduced complexity and cost.

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

2Productivity

If CLIA method is used for vitamin D measurement, then quick measurement and high sensitivity are achieved, but result variability and lack of standardization increase

Engineering Contradiction:
Improvemeasurement speedVSAvoidresult consistency
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent pre-immobilizes standardized amounts of capture antibodies and control antibodies on the lateral flow cartridge membrane during manufacturing. This preliminary action ensures that every cartridge starts with identical reagent quantities and positions, eliminating the variability that occurs when reagents are added manually or automatically during CLIA testing, thus achieving both speed and consistency.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the detection parameter from chemical luminescence (CLIA) to optical fluorescence, which can be measured with simpler, more standardized instruments. The fluorescence signal provides a stable, quantifiable parameter that is less susceptible to operator variability and instrument calibration differences, improving result consistency while maintaining quick measurement capability.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If conventional vitamin D assay methods are used, then accurate quantification is achieved, but pre-treatment processes and measurement time increase

Engineering Contradiction:
Improvequantification accuracyVSAvoidmeasurement time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent extracts and pre-processes the necessary reagents (capture antibodies, control antibodies, and blocking agents) during cartridge manufacturing, embedding them directly into the lateral flow structure. This eliminates the need for time-consuming sample preparation steps such as extraction, filtration, or concentration that are required in conventional assays, allowing direct measurement of vitamin D in serum samples while maintaining accuracy.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent performs preliminary immobilization of antibodies and reagents on the cartridge during production, so that when the sample is applied, all necessary components are already in position and ready for immediate reaction. This preliminary preparation eliminates the need for sequential addition of reagents and waiting periods between steps, dramatically reducing total measurement time while preserving quantification accuracy.

Inventive Principle:
Principle #10Preliminary action

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 method enables quick and accurate measurement of 25-hydroxyvitamin D without pre-treatment, providing consistent results across different conditions and instruments, with a range of 8.0 to 70 ng/mL quantification and high correlation with standard instruments.

Implementation Method 1

based on fluorescence measurement using lateral flow cartridge

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Implementation Method 2

fluorescent-labeled anti-25-hydroxyvitamin D antibody

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 3

lateral flow cartridge

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP3401681B1Method for quick quantification assay of vitamin d based on fluorescence measurement using lateral flow cartridge
Publication Date: 2023.03.29 BODITECHMED INC
  • EP3401681B1 patent drawingFigure 1
  • EP3401681B1 patent drawingFigure 2
  • EP3401681B1 patent drawingFigure 3

AI summary

The present invention relates to a method for quick quantification assay of vitamin D based on fluorescence measurement using lateral flow cartridge. According to the method of the present invention, quick and accurate measurement of vitamin D can be achieved since a conventional step for sample pretreatment, which is both time consuming and labor intensive, is not required.