Immunoassay Analysis Device with Blank Region Normalization
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Solution Overview
Problem
Existing immunoassay analysis methods are inaccurate when antibodies are non-uniformly fixed in reaction regions, leading to deteriorated relative count values and analysis accuracy.
Innovation Solution
An analysis device and method that includes a configuration with a turntable, optical pickup, and signal processing circuit to accurately analyze detection target substances by using relative count values, even if antibodies are non-uniformly fixed, by forming detection target substance capturing regions and blank regions on the analysis substrate and calculating relative count values based on these regions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If antibodies are fixed in reaction regions for immunoassay analysis, then the detection of detection target substances is enabled, but non-uniform fixation of antibodies causes deterioration of relative count value accuracy and analysis accuracy
Solution Approach 1:
The patent changes the parameter of count value normalization by introducing a reference count value obtained from a blank region. Instead of using absolute count values which are affected by antibody fixation uniformity, the system normalizes measurement count values by dividing them by the reference count value, thereby compensating for variations in antibody fixation across different reaction regions.
Solution Approach 2:
The patent introduces a blank region as an intermediary reference element that does not contain antibodies. This blank region serves as a mediator to establish a reference count value that represents the background signal and fixation variations, which is then used to normalize the count values from regions containing antibodies, thereby eliminating the effect of non-uniform antibody fixation.
2Adaptability or versatility
If multiple antibodies are fixed to different reaction regions for multiplexed detection, then the ability to detect multiple detection target substances is improved, but variations in antibody fixation across regions cause deterioration of quantitative accuracy
Solution Approach 1:
The patent segments the analysis substrate into multiple functional regions including blank regions and multiple detection target substance capturing regions. Each capturing region is assigned a specific antibody for detecting a particular detection target substance. This segmentation allows simultaneous multiplexed detection while the included blank regions provide reference values for normalizing quantitative measurements across all antibody-fixed regions.
Solution Approach 2:
The patent applies parameter transformation by converting absolute count values into relative count values through normalization using reference count values from blank regions. This parameter change enables accurate quantitative comparison across multiple antibody-fixed regions even when antibody fixation amounts vary, thereby maintaining measurement precision in multiplexed detection.
3Device complexity
If relative count values are calculated based on assumption of uniform antibody fixation, then the analysis process is simplified, but the accuracy of analysis deteriorates when antibody fixation is non-uniform
Solution Approach 1:
The patent performs a preliminary action by measuring and storing reference count values from blank regions before conducting the actual analysis. These reference values are obtained in advance and used to normalize the count values from antibody-fixed regions during data processing, thereby compensating for non-uniform antibody fixation without adding significant complexity to the analysis workflow.
Solution Approach 2:
The patent implements a feedback mechanism where reference count values obtained from blank regions are used to adjust and normalize the count values from detection regions. This feedback loop allows the system to automatically compensate for variations in antibody fixation by using the measured reference values to calculate accurate relative count values, thereby maintaining high analysis accuracy.
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 method enables accurate analysis by reducing the influence of in-plane distribution of count values in reaction regions, resulting in a uniform relative count value with less variation, ensuring high accuracy even if antibodies are fixed differently in each reaction region.
Implementation Method 1
an optical pickup 8, the optical pickup 8 irradiating the analysis substrate 30 with a laser beam 82
Implementation Method 2
a fluorescence detector in advance
Data Source
Figure 1
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AI summary
An analysis device (1) includes an analysis substrate (30), an optical pickup (8), a signal processing circuit (10), and a control unit (20). The analysis substrate (30) includes a reaction region (40). The reaction region (40) includes a region (41) fixed with an antibody (A) bound with a detection target substance (43), and a region (42) other than the region (41) in the reaction region (40). The optical pickup (8) irradiates the analysis substrate (30) with a laser beam (82) and receives reflected light to generate a light reception level signal (JS). The signal processing circuit (10) has a computation unit (11) that calculates a count value (Ca) in the region (41) and a count value (Cb) in the region (42). The control unit (20) has a computation unit (21) which calculates a relative count value (Rc) in the reaction region (40) based on the count values (Ca, Cb).