Double-Window Colloidal Gold Test Paper Delays HOOK in Occult Blood Detection
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Solution Overview
Problem
Colloidal gold detection of fecal occult blood is prone to the HOOK phenomenon, leading to false negatives, and high-concentration samples require repeated dilution, increasing labor and time costs, while single-window detection kits fail to accurately detect hemoglobin concentrations above 5 mg/mL.
Innovation Solution
A colloidal gold test paper with double-window detection using a left and right reagent strip, incorporating a mouse anti-human hemoglobin monoclonal antibody treated with a treatment solution on the nitrocellulose membrane or sample pad to neutralize excessive hemoglobin, preventing competition and improving accuracy by delaying the HOOK phenomenon.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If colloidal gold detection uses a single-window design with double-antibody sandwich method, then the detection is rapid and simple to operate, but the HOOK phenomenon occurs leading to false negative results when hemoglobin concentration is high
Solution Approach 1:
The test strip is divided into two separate detection windows: the first window uses the traditional double-antibody sandwich method for general detection, while the second window uses a blocking antibody method specifically designed to prevent HOOK phenomenon. This segmentation allows each window to optimize for its specific function, maintaining operational simplicity while improving overall reliability through the second window's ability to detect high-concentration samples that would otherwise give false negatives.
Solution Approach 2:
A blocking antibody is introduced as an intermediary element in the second detection window. This blocking antibody specifically binds to hemoglobin at high concentrations, preventing the HOOK phenomenon by blocking the excessive hemoglobin from interfering with the detection reaction. The blocking antibody acts as a mediator that converts the harmful high-concentration condition into a detectable signal, resolving the contradiction between simplicity and reliability.
2Reliability
If repeated dilution is performed for high-concentration samples to avoid HOOK phenomenon, then false negative results are reduced, but labor and time costs increase significantly
Solution Approach 1:
The blocking antibody is pre-loaded onto the test strip in the second detection window during manufacturing. This preliminary action eliminates the need for manual dilution and retesting by clinicians. When a high-concentration sample is applied, the pre-positioned blocking antibody immediately prevents HOOK phenomenon, providing accurate results in a single test operation and significantly reducing the time and labor costs associated with repeated dilution and retesting.
3Device complexity
If single-window detection kit is used, then the device structure is simple, but it cannot accurately detect hemoglobin concentrations above 5 mg/mL
Solution Approach 1:
Two different detection methods are merged into a single test strip device: the first window combines the double-antibody sandwich method with the second window combining the blocking antibody method. Both detection systems are integrated onto one strip, allowing the device to maintain relatively simple structure while achieving the capability to accurately detect hemoglobin across a wide concentration range, including samples above 5 mg/mL that would exceed the capability of a single-window design.
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 detection system enhances accuracy by allowing detection of a wider range of hemoglobin concentrations without repeated dilution, ensuring high sensitivity and rapid, semi-quantitative results.
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
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
Implementation Method 3
the hemoglobin in human feces is detected by color development of a colloidal gold label
Data Source
Figure 1
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.