D-dimer Assay Calibration Curve Using Deviating Concentration Values
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Solution Overview
Problem
Current calibration methods for coagulation assays, such as the D-dimer assay, are labor-intensive and costly due to the need for establishing a complete calibration curve for each measurement, and existing solutions require linear calibration curves or mathematical assumptions that may not always hold, leading to variations in device-specific and batch-specific results.
Innovation Solution
A method involving a calibrator stock solution with a predetermined D-dimer concentration, where at least two calibrator samples are derived, with assigned concentration values deviating from calculated values, to establish a calibration curve that compensates for batch-to-batch and device model variations, allowing for high-precision measurements with reduced calibration complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a complete calibration curve is established for each measurement, then measurement precision is improved, but productivity deteriorates due to labor and cost intensity
Solution Approach 1:
The patent applies preliminary action by pre-establishing a master calibration curve using a stable calibrator stock solution that can serve as a reference for multiple measurements. Instead of performing complete calibration for each measurement, the method prepares calibration samples in advance from the stock solution, allowing rapid generation of calibration curves without repeated labor-intensive procedures.
Solution Approach 2:
The patent uses copying by creating multiple calibration samples from a single master calibrator stock solution. These copied calibration samples (with known concentration ratios) can be used to generate calibration curves for different measurements, eliminating the need to prepare fresh calibration standards each time while maintaining measurement accuracy through the established reference relationship.
2Productivity
If calibration is simplified using fewer samples, then productivity is improved, but measurement precision deteriorates due to variations in device and batch
Solution Approach 1:
The patent applies parameter changes by assigning corrected concentration values to calibration samples that compensate for device-specific and batch-specific variations. Instead of using only theoretically calculated concentrations, the method introduces correction factors or adjusted concentration parameters that account for real-world deviations, allowing accurate calibration with fewer samples while maintaining precision across different devices and batches.
3Adaptability or versatility
If assigned concentration values deviate from calculated values, then adaptability is improved to compensate for variations, but device complexity increases due to calibration complexity
Solution Approach 1:
The patent reduces complexity through preliminary action by pre-determining the corrected concentration values for calibration samples during the initial calibration phase. These predetermined correction values are stored and reused for subsequent measurements, eliminating the need to perform complex calculations or adjustments during each measurement while maintaining adaptability to device and batch variations.
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 high-precision D-dimer measurements across different devices and batches, ensuring reproducibility throughout the measuring range with fewer calibration samples, reducing labor and costs while maintaining accuracy.
Implementation Method 1
formation of D-dimer/antibody complexes induces agglutination of the latex beads and induces an increase in turbidity of the reaction mixture proportional to the D-dimer concentration
Implementation Method 2
formation of D-dimer/antibody complexes induces agglutination of the latex beads and induces an increase in turbidity of the reaction mixture proportional to the D-dimer concentration
Data Source
Figure 1
AI summary
The present invention relates to a method for providing a calibration curve for an optical D- dimer assay comprising a) providing a calibrator stock solution having a predetermined D- dimer concentration, b) providing at least two calibrator samples, wherein said at least two calibrator samples are derived from said calibrator stock solution, c) determining the value of an optical property of said calibrator samples of b) in said D-dimer assay, d) assigning an assigned concentration value to at least one calibrator sample of b), wherein said assigned concentration value assigned to at least one calibrator sample deviates from the calculated concentration value of said calibrator sample, and e) establishing a calibration curve based on the values of said optical property of c), on the assigned concentration value or the assigned concentration values of d), and on calculated concentration values for calibrator samples to which no assigned concentration value was assigned. The present invention further relates to a method for determining the D-dimer concentration in a sample based on said calibration curve, and to kits, devices, databases, data carriers, and uses related thereto.