Immunochromatographic Test Strip Specimen Detection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Immunochromatographic detection methods struggle to differentiate between samples with and without added specimens, particularly in light-colored specimens like plasma, serum, and urine, leading to incorrect diagnoses due to the control line formation even when only the diluting solution is applied.
Innovation Solution
Incorporating a control component, such as hemoglobin, into the immunochromatographic test strip, which captures a complex with a label and antibodies on an insoluble membrane, allowing for the detection of the presence or absence of the control component to determine if a specimen is present, thereby distinguishing between properly and improperly operated samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a light-colored specimen (plasma, serum, or urine) is diluted at a high dilution factor, then the analyte concentration is adjusted to a suitable level for detection, but it becomes difficult to distinguish the diluted sample from the diluting solution itself, leading to failure to detect specimen absence
Solution Approach 1:
The patent introduces hemoglobin as an intermediary substance that serves as a marker to indicate specimen presence. Hemoglobin is added to the diluting solution at a known concentration, and its detection acts as a mediator to verify whether specimen was properly added. The control component detects hemoglobin levels to distinguish between samples with and without specimen, resolving the inability to detect specimen absence in highly diluted light-colored specimens.
2Ease of operation
If only the diluting solution is dripped onto the test strip due to failure to add specimen, then the control line still forms and indicates successful reaction, but this leads to incorrect negative results or zero concentration determination
Solution Approach 1:
The patent implements a feedback mechanism where the control component provides information about specimen presence by detecting hemoglobin. The system compares the detected hemoglobin level against expected levels to determine whether specimen was properly added. This feedback loop prevents incorrect negative results by alerting operators when specimen absence is detected, thereby improving diagnostic accuracy while maintaining procedural simplicity.
3Reliability
If a control component detecting specimen presence is added to the test strip, then specimen absence can be detected, but the device complexity increases with additional components and detection steps
Solution Approach 1:
The patent merges the specimen presence detection function with the existing control component structure. The control component is designed to perform both its traditional function and the additional function of detecting hemoglobin as a specimen presence marker. By combining these functions into a single integrated component rather than adding separate detection systems, the patent reduces the overall device complexity while maintaining reliable specimen presence detection capability.
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 effectively reduces false negatives and incorrect concentrations by determining if a specimen is added to the diluting solution, ensuring accurate sample detection and reducing errors caused by the absence of specimens in light-colored samples.
Implementation Method 1
an antibody-immobilized insoluble membrane to a which antibody to the control component and antibody to the analyte are immobilized; detecting on the insoluble membrane the complex of the control component and the antibody to the control component
Implementation Method 2
a label to which antibody to the control component is immobilized; detecting on the insoluble membrane the complex of the control component and the antibody to the control component
Data Source
Figure 1
AI summary
An object of the present invention is to provide an immunochromatographic detection method comprising a step of detecting the failure to add a specimen and an immunochromatographic test strip comprising a means for detecting the failure to add a specimen. The inventers provides an immunochromatographic detection method and an immunochromatographic test strip capable of detecting the failure to add a specimen through a step and a means using an antibody solid-phased on an insoluble membrane for capturing the complex of a component (control component) contained in the specimen other than the analyte and a label to which an antibody to the component is immobilized so as to detect the presence or absence of the control component, in an immunochromatographic detection method of detecting an analyte in a sample acquired by diluting the specimen.