Immunoassay Calibration Using Identical Measuring Cells
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Solution Overview
Problem
Existing immunoassay devices require device-specific calibration using adjustment kits containing analyte samples with known concentrations, which are expensive, unstable, and increase the number of samples and time for adjustments, and may lead to inaccurate results if the kits are not available.
Innovation Solution
A method for calibrating immunoassay devices using a batch of identical measuring cells with capture and tracer antibodies, involving signal measurements before and after washing and drying, to calculate device-specific correction factors without requiring analyte-containing samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If device-specific calibration using adjustment kits containing analyte samples with known concentrations is performed, then measurement precision is improved, but cost increases and time for adjustments increases
Solution Approach 1:
The patent applies preliminary action by pre-calibrating measuring cells at the manufacturer's site using analyte-containing calibration solutions. This factory calibration is performed in advance before the device reaches the user, eliminating the need for time-consuming device-specific calibration adjustments at the user's location. The pre-established calibration data is stored in the device, enabling direct use without additional calibration steps.
Solution Approach 2:
The patent uses copying by transferring calibration information from the factory calibration process to the individual device. Instead of performing complete calibration at each device, the system copies essential calibration parameters from master calibration data performed at the manufacturer's site. This allows devices to be calibrated indirectly through data transfer rather than direct measurement, significantly reducing calibration time.
2Measurement precision
If device-specific calibration using adjustment kits containing analyte samples with known concentrations is performed, then measurement precision is improved, but cost increases
Solution Approach 1:
The patent applies preliminary action by pre-calibrating measuring cells at the manufacturer's site using analyte-containing calibration solutions. This factory calibration is performed in advance before the device reaches the user, eliminating the need for time-consuming device-specific calibration adjustments at the user's location. The pre-established calibration data is stored in the device, enabling direct use without additional calibration steps.
Solution Approach 2:
The patent uses copying by transferring calibration information from the factory calibration process to the individual device. Instead of performing complete calibration at each device, the system copies essential calibration parameters from master calibration data performed at the manufacturer's site. This allows devices to be calibrated indirectly through data transfer rather than direct measurement, significantly reducing calibration time.
3Measurement precision
If adjustment kits containing analyte samples with known concentrations are used, then device-specific calibration is achieved, but the number of samples required increases
Solution Approach 1:
The patent applies the extraction principle by removing the analyte component from the calibration process at the user's location. Instead of using analyte-containing calibration samples, the system extracts only the background signal measurement from the calibration kit. The actual analyte calibration data is taken out and performed in advance at the manufacturer's site, leaving only simple background measurements for the individual device.
Solution Approach 2:
The patent applies universality by creating a calibration system that works across all devices of the same model without requiring device-specific analyte samples. The factory calibration creates universal calibration parameters that can be applied to multiple devices, making the calibration process universally applicable rather than individually tailored for each device.
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
Enables accurate device calibration without the need for adjustment kits, reducing costs and time, and ensuring consistent results across devices of the same build.
Implementation Method 1
the analyte is detected using immunoreagents such as antibodies, e.g. in a so-called 'sandwich assay'
Data Source
Figure 1A~1B
Figure 2
Figure 3
AI summary
The present invention relates to a method of calibrating an immunoassay device for determining the concentration of an analyte in a sample. The device can be calibrated without using a calibration standard having a known concentration of the analyte or without using a calibration measuring cell.