Flow Cytometry Reagent Calibration System for Lot Variability
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Solution Overview
Problem
Flow cytometry reagents face significant challenges in maintaining consistent median fluorescence intensity (MFI) due to lot-to-lot manufacturing variability, making it difficult to achieve tight MFI control, which is essential for accurate quantitative assessments. Current methods require strict controls at every production step, making the process expensive and inefficient.
Innovation Solution
A system and method for generating calibration factors based on the manufacturing lot of reagents, allowing for numerical adjustment of data to reduce variability, which can be applied to any reagent lot that passes existing quality control specifications, thereby ensuring accurate MFI measurements and extending the shelf-life of reagents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If strict controls are implemented at every production step, then manufacturing precision of MFI is improved, but device complexity and cost increase
Solution Approach 1:
The patent applies preliminary action by generating calibration factors in advance for each reagent lot during manufacturing. These calibration factors are stored and later applied to event data to correct MFI variations. This approach shifts the control mechanism from continuous monitoring during production to pre-characterization of each lot, simplifying the manufacturing process while maintaining precision.
Solution Approach 2:
The patent changes the parameter approach by introducing calibration factors that numerically adjust MFI values. Instead of controlling physical manufacturing parameters tightly, the system measures actual MFI performance and applies mathematical corrections (calibration factors) to compensate for variations, thereby achieving consistent results without strict manufacturing controls.
2Measurement precision
If calibration factors are generated for each reagent lot, then MFI measurement accuracy is improved, but time and resources for calibration increase
Solution Approach 1:
The calibration process is performed in advance during reagent lot manufacturing and characterization. The calibration factors are generated and stored before the reagents are used in actual assays. This preliminary calibration eliminates the need for time-consuming calibration procedures at the point of use, maintaining measurement accuracy while minimizing time loss during actual testing.
3Reliability
If tight MFI control is enforced through manufacturing processes, then product reliability is improved, but productivity decreases due to additional process steps
Solution Approach 1:
The patent replaces mechanical/process-based MFI control with a computational approach. Instead of using complex manufacturing processes to ensure tight MFI control, the system uses calibration factors and mathematical corrections applied to event data. This substitution of physical control mechanisms with computational methods maintains reliability while improving productivity by simplifying the manufacturing process.
Data Source
AI summary
One aspect relates to a method of calibrating event data. The method includes obtaining, via an electronic device including a processor, event data for an assay including a reagent. The reagent is associated with one of a plurality of manufacturing lots of the reagent. The method includes receiving one or more calibration factors for the reagent based on an identifier associated with the one of the plurality of manufacturing lots. The method further includes generating calibrated event data based on an application of the one or more calibration factors to the event data.