Immunochromatography Dual Labeling for Wide Range Detection
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Solution Overview
Problem
Conventional immunochromatography methods have a narrow measurable range, making it difficult to detect both low and high concentrations of test substances, and are prone to false-negative results due to the prozone phenomenon and limitations in signal amplification.
Innovation Solution
The use of two types of labeling substances, one that causes amplification and another that does not, allows for measurement before and after amplification, widening the measurable range and reducing false-negative results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If signal amplification is applied to detect low concentrations, then detection sensitivity is improved, but false-negative results occur in high concentrations due to the prozone phenomenon
Solution Approach 1:
The patent segments the measurement process into two distinct stages: pre-amplification measurement for high concentration samples and post-amplification measurement for low concentration samples. This segmentation allows each measurement stage to be optimized for its specific concentration range, avoiding the prozone phenomenon in high concentrations while maintaining high sensitivity in low concentrations.
Solution Approach 2:
The patent implements a dynamic measurement approach where the system automatically selects between pre-amplification and post-amplification measurement modes based on the detected signal intensity. This dynamic adaptation ensures optimal measurement accuracy across the entire concentration range by adjusting the amplification state according to sample concentration.
2Ease of operation
If conventional immunochromatography is used, then operation simplicity is maintained, but the measurable concentration range is narrow
Solution Approach 1:
The patent makes the immunochromatography system multi-functional by integrating both pre-amplification and post-amplification measurement capabilities into a single device. This allows the same system to handle both high concentration and low concentration samples effectively, expanding the measurable concentration range without requiring separate measurement systems.
Solution Approach 2:
The patent performs preliminary measurement before amplification to assess sample concentration. Based on this preliminary assessment, the system determines whether amplification is necessary, allowing for optimized measurement strategy selection that expands the effective measurable range while maintaining operational simplicity.
3Measurement precision
If amplification is performed to detect ultratrace amounts, then detection sensitivity is improved, but measurement time is excessive
Solution Approach 1:
The patent applies partial amplification only when necessary. By performing preliminary measurement before amplification, the system identifies samples that require amplification (low concentration samples) and applies amplification only to those cases, avoiding unnecessary amplification steps for high concentration samples and thus reducing overall measurement time.
Solution Approach 2:
The patent performs preliminary measurement before amplification to assess whether amplification is necessary. This preliminary action allows the system to skip the amplification step for samples with sufficient signal intensity, significantly reducing measurement time for high concentration samples while maintaining the capability for sensitive detection when needed.
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 approach enables accurate detection across a wider concentration range, allowing for early positive determination in high concentrations and precise measurement in low concentrations without false-negative results.
Implementation Method 1
the first labeling substance is a labeling substance that causes an amplification reaction
Implementation Method 2
a first antibody capable of specifically binding to the analytical target has been immobilized... an immune complex with the analytical target is formed
Data Source
AI summary
It is an object of the present invention to provide an immunochromatography method capable of measuring a sample in a low concentration range and a high concentration range by setting the measurable range of the sample much wider than the conventional measurable range. The present invention provides an immunochromatography method, which comprises: spreading a test substance, a first labeling substance modified with a first binding substance that binds to the test substance, and a second labeling substance modified with the first binding substance that binds to the test substance, which are in a mixed state, on an insoluble carrier; and capturing the test substance, the first labeling substance, and/or the second labeling substance at a reaction site on the insoluble carrier having a substance having ability to bind to the first binding substance that binds to the test substance, so as to detect the test substance, wherein the first labeling substance is a labeling substance that causes an amplification reaction, and the second labeling substance is a labeling substance that does not substantially influence on the amplification reaction.