Double-Window Colloidal Gold Test Paper for HOOK Phenomenon Control

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Solution Overview

Problem

Colloidal gold detection methods for fecal occult blood face challenges such as the HOOK phenomenon leading to false negatives, require repeated dilution for accurate results, and are limited in detecting high concentrations of hemoglobin, affecting accuracy and efficiency.

Innovation Solution

A colloidal gold test paper with a double-window design, incorporating a mouse anti-human hemoglobin monoclonal antibody treated with a treatment solution in a new detection window, neutralizes excessive hemoglobin to prevent the HOOK phenomenon and improve accuracy by allowing detection across a wider range of concentrations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If colloidal gold detection is used for fecal occult blood, then detection sensitivity is improved and false negatives are reduced, but the HOOK phenomenon occurs at high hemoglobin concentrations leading to false negatives

Engineering Contradiction:
Improvedetection sensitivityVSAvoidfalse negative rate at high concentration
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The test paper is divided into two independent detection windows: a first detection window for low-concentration hemoglobin and a second detection window for high-concentration hemoglobin. Each window uses antibodies with different concentration thresholds, allowing the system to accurately detect across a wide range of hemoglobin concentrations without experiencing the HOOK phenomenon that plagues single-window systems.

Inventive Principle:
Principle #1Segmentation

2Device complexity

If single-window colloidal gold detection is used, then device simplicity is maintained, but repeated dilution and retesting are required for accurate results at high concentrations

Engineering Contradiction:
Improvetest paper structureVSAvoidrepeated dilution and retesting time
Core Design Contradiction:
Device complexityVSLoss of time

Solution Approach 1:

A single test paper integrates two detection windows with different antibody concentrations, enabling it to universally detect hemoglobin across both low and high concentration ranges. This multi-functional design eliminates the need for separate dilution series and retesting procedures, allowing clinicians to obtain accurate results in a single test regardless of the initial hemoglobin concentration.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Ease of operation

If single-window detection is used, then operation simplicity is maintained, but labor costs increase due to repeated dilution and retesting

Engineering Contradiction:
Improvedetection procedureVSAvoidlabor and time costs
Core Design Contradiction:
Ease of operationVSProductivity

Solution Approach 1:

The detection system is segmented into two parallel detection pathways within a single test paper, each optimized for different concentration ranges. This segmentation allows simultaneous detection of both low and high hemoglobin concentrations without requiring sequential dilution and retesting, thereby maintaining operational simplicity while eliminating repetitive manual procedures and reducing labor costs.

Inventive Principle:
Principle #1Segmentation

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 double-window design enhances detection accuracy by preventing false negatives and reducing the need for repeated dilution, enabling rapid and semi-quantitative detection of hemoglobin concentrations from 100 ng/mL to 5 mg/mL without labor-intensive retesting.

Implementation Method 1

anti-human hemoglobin polyclonal antibody and monoclonal antibody are subjected to colloidal gold labeling to specifically bind to human hemoglobin in feces

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 2

a mouse anti-human hemoglobin monoclonal antibody treated with a treatment solution is added in a test reagent strip in the new window, which plays a neutralizing role before a T2 test line

Methodology Applied
Scientific EffectNeutralization:

Implementation Method 3

the hemoglobin in human feces is detected by color development of a colloidal gold label

Methodology Applied
Scientific EffectColloidal gold color development: Colloid

Data Source

PatentUS20250244322A1Colloidal gold test paper for double-window detection of fecal occult blood and application thereof
Publication Date: 2025.07.31 HANGZHOU ALLTEST BIOTECH CO LTD
  • US20250244322A1 patent drawing

AI summary

Disclosed are colloidal gold test paper for double-window detection of fecal occult blood and an application thereof, and the colloidal gold test paper comprises a left reagent strip and a right reagent strip; the reagent strip is provided with a sample pad, a label pad, a nitrocellulose membrane and a water absorption pad; and the right reagent strip contains a mouse anti-human hemoglobin monoclonal antibody treated with a treatment solution. According to the invention, by double-window detection, the occurrence of HOOK phenomenon can be delayed, and the accuracy of colloidal gold detection can be improved.