Lyophilized Calibrator Assay Device for Standardized Calibration Curve Storage
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Solution Overview
Problem
Current analytical instruments require time-consuming and resource-intensive calibration processes, with each instrument needing a specific calibration curve, leading to inefficiencies and increased costs due to the need for multiple calibration standards and varied instrument setups.
Innovation Solution
A method for preparing and storing a predetermined standardized calibration curve using lyophilized calibrator compositions in assay devices, which generate optical signals for creating a standardized curve that can be stored on labels or tags, allowing for easy adjustment and normalization across different analyzers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a new calibration curve is generated for each instrument in daily routine, then measurement precision is maintained, but time consumption and resource usage increase significantly
Solution Approach 1:
The calibration curve is pre-generated and stored on the assay device itself (in the well plate or cartridge) before the actual measurement takes place. This preliminary action eliminates the need for time-consuming calibration procedures at each instrument, as the calibration data is already available and can be directly applied during sample analysis
Solution Approach 2:
The calibration curve information is copied onto the assay device (well plate or cartridge) in a machine-readable format (such as barcodes or RFID tags). This copying approach allows multiple instruments to access the same calibration data without requiring physical recalibration, thereby reducing time consumption while maintaining measurement precision across different devices
2Measurement precision
If instrument-specific calibration curves are used, then measurement accuracy is ensured, but device complexity and resource requirements increase
Solution Approach 1:
The assay device is designed to serve multiple functions: it contains both the sample analysis reagents and the calibration curve information. This universal design allows the same device to perform both measurement and calibration reference functions, eliminating the need for separate calibration standards and reducing overall system complexity
Solution Approach 2:
The calibration curve data is merged with the assay device itself (integrated into the well plate or cartridge structure). This merging of calibration information with the measurement device eliminates the need for separate calibration systems, reducing device complexity while ensuring measurement accuracy through the embedded calibration data
3Measurement precision
If multiple calibration standards are prepared, then comprehensive calibration coverage is achieved, but quantity of substances and resource consumption increase
Solution Approach 1:
Multiple calibration standards are pre-prepared and integrated into the assay device in a lyophilized (freeze-dried) state before use. This preliminary preparation allows comprehensive calibration coverage to be achieved without requiring large volumes of liquid calibrators during the actual measurement, as the standards are already in concentrated, space-efficient form
Solution Approach 2:
The calibration standards are converted from liquid to lyophilized (solid) state for storage on the assay device. This phase transition dramatically reduces the volume required to store multiple calibration standards while maintaining their analytical integrity, thereby achieving comprehensive calibration coverage with minimal substance quantity
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 reduces the time and resources required for calibration, allows for a single standardized curve to be used across various instruments, and minimizes the need for multiple calibration standards, thereby enhancing efficiency and cost-effectiveness.
Implementation Method 1
ob, the present disclosure provides a method for preparing and storing a predetermined standardized curve for an assay
Implementation Method 2
obtaining an optical signal for each of the plurality of standard calibrator compositions to generate a plurality of optical signals
Data Source
AI summary
Methods and compositions are disclosed for preparing a predetermined standardized calibration curve, which can be stored on a label, barcode or tag. A lyophilized product containing assay reagents for use in a bioassay and a known amount of analyte. A predetermined calibration curve associated with the lyophilized product. A predetermined calibration curve makes the preparation of a new calibration curve unnecessary. The methods and compositions are useful in bioassays such as a FRET assay, a real-time reverse transcription polymerase (RT-PCR) assay, a chemiluminescence assay, or any other bioassay that elicits a detectable response based on a change in, or appearance of, color, fluorescence, or reflectance.