Microalbumin Urine Test Strip with Synthetic Indicator

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Solution Overview

Problem

Conventional methods for detecting microalbumin in urine using alkaline triphenyl methane derivative indicators fail to accurately detect microalbuminuria due to low detection limits and poor color expression, making it difficult to detect trace amounts of microalbumin in urine, which is crucial for early diagnosis of diabetic nephropathy and kidney disease.

Innovation Solution

A test strip is developed using a buffer solution prepared with ethanol, citric acid, and trisodium citrate, impregnated with Triton X-100 as a surfactant and polypropylene glycol as a sensitizer, along with a synthetic albumin indicator, 5′,5″-dinitro-3′,3″,3,4,5,6-hexabromophenolsulfonephthalein, to enhance detection sensitivity and accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional alkaline triphenyl methane derivative indicators are used for microalbumin detection, then the test strip can be manufactured with simple reagents, but the detection limit is high (cannot detect 20 mg/L or less) and color expression is poor

Engineering Contradiction:
Improvedetection limitVSAvoidreagent composition
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent changes the chemical parameters of the indicator system by replacing conventional alkaline triphenyl methane derivatives with synthetic acid dyes (methyl red, bromophenol blue, tetrabromophenol blue) and optimizing pH conditions to achieve detection limits of 20 mg/L or less, thereby improving measurement precision through parameter optimization

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses composite reagent systems combining synthetic acid dyes with specific buffer solutions (citric acid-sodium citrate, phosphoric acid-sodium phosphate) and surfactants (Triton X-100, Tween 20) to create a composite material that achieves both low detection limits and clear color expression while maintaining manufacturing feasibility

Inventive Principle:
Principle #40Composite materials

2Measurement precision

If conventional indicators are used, then the reagent formulation is simple, but color change is not clear for trace amounts of microalbumin (10-30 mg/L)

Engineering Contradiction:
Improvecolor change clarityVSAvoidreagent formulation
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent selects synthetic acid dyes specifically for their superior color change properties - methyl red (yellow to red), bromophenol blue (yellow to blue), and tetrabromophenol blue (yellow to blue) - which provide clear, distinct color transitions that enable accurate visual detection of trace microalbumin concentrations

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent introduces surfactants (Triton X-100, Tween 20) as intermediary substances that enhance the interaction between the indicator dye and microalbumin, thereby amplifying and clarifying the color change signal for better visual detection of trace amounts

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If the detection limit is lowered to detect microalbuminuria (20-200 mg/L), then early diagnosis capability is improved, but the requirement for reagent purity and precision increases

Engineering Contradiction:
Improveearly diagnosis capabilityVSAvoidreagent purity
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent optimizes multiple reagent parameters simultaneously - pH of buffer solutions, concentration ratios of citric acid to sodium citrate, amounts of surfactants and indicators - to create a robust system that maintains high reliability for early diagnosis while being feasible for manufacturing with controlled precision

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates composite reagent formulations where multiple components work synergistically - the buffer system maintains optimal pH, surfactants enhance binding, and synthetic dyes provide sensitive detection - this composite approach improves reliability while distributing the precision requirements across multiple manageable parameters

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

The test strip achieves improved sensitivity and accuracy in detecting microalbuminuria, enabling clear color changes from bright sky blue to dark sky blue, effectively detecting microalbumin concentrations as low as 20 mg/L, overcoming the limitations of conventional methods.

Implementation Method 1

a buffer solution prepared with ethanol, citric acid, and trisodium citrate

Methodology Applied
Scientific EffectBuffer solution:

Implementation Method 2

Triton X-100 as a surfactant

Methodology Applied
Scientific EffectSurfactant: Surfactant

Implementation Method 3

measuring color change through formation of a complex between microalbumin and an indicator

Methodology Applied
Scientific EffectComplex formation:

Implementation Method 4

various colorimetry-based methods for measuring color change through formation of a complex

Methodology Applied
Scientific EffectColorimetry:

Data Source

PatentUS11781992B2Test strip for detecting microalbumin in urine with high sensitivity
Publication Date: 2023.10.10 CHUNGDO PHARM
  • US11781992B2 patent drawing
  • US11781992B2 patent drawing
  • US11781992B2 patent drawing

AI summary

Disclosed is a test strip for detecting microalbumin in urine, and more particularly a test strip for detecting microalbumin in urine that contains a synthetic albumin indicator, a buffer solution, a surfactant and a polymer (sensitizer) and thus exhibits high sensitivity. The albumin detection test strip has accuracy sufficient to enable clear observation of color change from colorless to blue through the albumin indicator, and improves the detection limit (increases sensitivity) to thereby enable detection of microalbuminuria at a concentration of 20 mg/L or less. The albumin test detection strip contains a surfactant and a polymer in addition to a synthetic albumin indicator, thereby incorporating separate first and second processes into a single process and having effects of reducing costs, improving processing convenience, and increasing solubility and miscibility.