In Vitro Diagnostic Calibration for Metrological Traceability
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Solution Overview
Problem
Existing calibration methods for in vitro diagnostic medical devices suffer from high variance and uncertainty due to individual instrument, hardware, and reagent variations, leading to a less robust calibration process.
Innovation Solution
A method involving a sequence of calibration and adjustment steps, using a leading calibration curve and signal adjustment functions to establish metrological traceability, where each step's outcome depends on the previous step, minimizing overall variance and uncertainty.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple individual and independent calibration steps are performed to account for instrument, hardware, and reagent variations, then the calibration can be adapted to different conditions, but the overall variance and uncertainty of the calibration process increases
Solution Approach 1:
The patent combines multiple independent calibration steps into a single unified calibration function that simultaneously accounts for instrument, hardware, and reagent variations. This integration reduces the cumulative variance that would result from multiple separate calibration operations while maintaining the ability to adapt to different measurement conditions through the comprehensive nature of the unified function.
Solution Approach 2:
The unified calibration function serves multiple purposes: it corrects for instrument-specific variations, hardware component differences, and reagent lot variations all through a single calibration process. This multi-functional approach eliminates the need for separate calibration steps for each variation source, thereby reducing overall uncertainty while maintaining broad adaptability.
2Adaptability or versatility
If multiple independent calibration steps are performed to address various sources of variation, then the calibration can accommodate different instruments and reagents, but the robustness of the calibration process decreases
Solution Approach 1:
By merging multiple calibration steps into one unified function, the patent reduces the number of operations that could potentially fail or introduce errors. The unified calibration function provides a more robust solution because it eliminates the compounding of uncertainties that occurs when multiple independent calibration steps are performed, while still maintaining compatibility across different instruments and reagents.
3Adaptability or versatility
If each calibration function varies in functional parameters to account for individual instrument and reagent differences, then the calibration can be customized for each measurement setup, but the overall uncertainty of the calibration process increases
Solution Approach 1:
The unified calibration function achieves universality by incorporating correction capabilities for instrument, hardware, and reagent variations within a single function. This eliminates the need to create and manage multiple customized calibration functions, each with its own sources of uncertainty. The universal function reduces overall measurement uncertainty while maintaining the ability to adapt to different measurement setups.
Data Source
AI summary
Methods for establishing metrological traceability for at least one in vitro diagnostic medical device (110) are proposed. The methods comprise a sequence of calibration steps and adjustment steps. An outcome of each step depends on the outcome of the previous step. The methods comprises providing a leading calibration curve. The leading calibration curve fp describes a relationship of at least one concentration c of at least one analyte in at least one sample with a signal s of the sample measured with the in vitro diagnostic medical device (110). The leading calibration curve fp is a parametrized function fp(c, {circumflex over (p)}1, . . . , {circumflex over (p)}P) with parameters {circumflex over (p)}1, . . . , {circumflex over (p)}P being a set of parameters of the leading calibration curve and P≥1. In each adjustment step a signal adjustment function or a concentration adjustment function is determined and at least one target concentration value is assigned.