One-Point On-Site Calibration of Inline Multi-Sensor Devices
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Solution Overview
Problem
Existing in-situ biomarker monitoring sensors require cumbersome multi-point calibrations that are burdensome for point-of-care devices, especially when multiple sensors are involved, and existing self-calibrating sensors are limited to single analytes and not suitable for inline use with continuous fluid flow.
Innovation Solution
A method for one-point, on-site calibration of sensors involves fluidic inline calibration with variable concentration reference calibrators, followed by a single-concentration calibration, and a translation step to generate accurate calibration data for analyte analysis, incorporating slope, offset, and drift corrections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multi-point calibration is performed to ensure accuracy, then measurement precision is improved, but device complexity and user burden increase
Solution Approach 1:
The calibration process is segmented into two distinct phases: an initial multi-point calibration performed at the factory to establish a calibration curve, and a subsequent single-point calibration performed at the point of care to update the curve. This segmentation allows high accuracy to be achieved through comprehensive initial calibration while simplifying the ongoing user operation to a single easy step.
Solution Approach 2:
The complex multi-point calibration is performed as a preliminary action during manufacturing at the factory, before the device reaches the user. This preliminary comprehensive calibration establishes the baseline accuracy, and the user only needs to perform the simpler single-point calibration at the point of care to maintain accuracy under different conditions.
2Ease of operation
If single-point calibration is used to simplify the process, then ease of operation is improved, but measurement precision deteriorates
Solution Approach 1:
The calibration function is segmented between two locations: the factory performs comprehensive multi-point calibration to establish the initial accuracy, while the point-of-care location performs a simple single-point calibration to maintain accuracy. This segmentation allows each location to optimize for its specific requirements - the factory for comprehensive accuracy and the user for ease of operation.
Solution Approach 2:
The device is designed to perform self-calibration using a single-point method at the point of care, eliminating the need for users to perform complex multi-point calibrations. The device automatically executes the single-point calibration procedure, making the process simple and user-friendly while maintaining sufficient accuracy for clinical use.
3Ease of operation
If self-calibrating sensors are used to reduce user burden, then ease of operation is improved, but adaptability deteriorates due to single analyte limitation
Solution Approach 1:
The calibration method is designed to be universal and can be applied to multiple different analytes using the same single-point calibration approach. The system can calibrate for glucose, pH, and other analytes using the same simplified procedure, making the device adaptable to multi-analyte applications while maintaining ease of operation.
Solution Approach 2:
The system adapts to different analytes by changing the calibration parameters and reference values while maintaining the same single-point calibration methodology. This allows the device to switch between different analytes (glucose, pH, etc.) without requiring a change in the fundamental calibration approach, thus achieving both simplicity and versatility.
4Productivity
If inline calibration with continuous fluid flow is implemented, then productivity is improved, but device complexity increases
Solution Approach 1:
The complex fluidic calibration system is extracted and simplified by performing the multi-point calibration at the factory before delivery to the user. The remaining fluidic system at the point of care only needs to accommodate a single calibrator vial and basic pumping, significantly reducing complexity while maintaining the ability to perform calibration inline with continuous fluid flow.
Solution Approach 2:
The complex fluidic pathways and calibration mechanisms are established as preliminary actions during factory calibration, before the device is deployed. This allows the device to have simplified fluidic systems at the point of care that can still perform effective calibration through the single-point method, improving productivity without requiring complex inline fluidic infrastructure.
Data Source
AI summary
Disclosed herein are systems and methods for a single-point, on-site calibration of one or more sensors in an inline sensor device, the method comprising: calibrating, at a first location, each of the one or more sensors with a plurality of variable concentration reference calibrators to generate multi-point calibration data; calibrating, at a second location, each of the one or more sensors using a single-concentration reference calibrator to generate single-point calibration data; translating, by at least one processor communicatively coupled to a memory, the multi-point calibration data and the single-point calibration data to translated calibration data; and employing, at the second location, the translated calibration data to analyze one or more analytes detected by one or more calibrated sensors in the sensor device.