Multiplex Analysis Control Means for Step Validation
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Solution Overview
Problem
Current multiplex analysis methods lack a simple means to validate each step of the process, particularly in medical diagnostics and blood transfusions, where reliability and traceability are critical, as existing controls only verify the overall method implementation rather than individual steps.
Innovation Solution
The introduction of control means that allow validation of specific steps in the multiplex analysis method, such as sample deposition, detection ligand deposition, washing, and reporter deposition, using two or three controls, ensuring each step is correctly executed without requiring additional equipment or steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional positive control is used to verify overall method implementation, then the analysis method can be validated at a high level, but individual steps of the method cannot be validated
Solution Approach 1:
The control system is segmented into multiple independent control components, each validating a specific step of the multiplex analysis method. This includes a first control for sample deposition, a second control for detection ligand deposition, a third control for washing steps, and a fourth control for reporter deposition. Each control operates independently to validate its specific function, enabling step-by-step validation without requiring a completely new complex system.
Solution Approach 2:
The control components are designed with multi-functionality to validate different steps of the analysis method. Each control can detect multiple analytes and serves multiple validation purposes within the multiplex analysis framework, reducing the need for separate dedicated controls for each function while maintaining comprehensive validation capability.
2Reliability
If multiple control compounds are used on control slide to verify reagent quality, then each reagent can be validated, but the number of control compounds and complexity increases
Solution Approach 1:
The invention extracts and isolates specific control functions from the complex control slide approach. Instead of using multiple control compounds on a control slide, the patent uses discrete control components that can be integrated into the multiplex analysis system. Each control component is extracted to perform a specific validation function, reducing the quantity of control compounds needed while maintaining comprehensive reagent quality validation.
3Reliability
If comprehensive control of all steps is implemented, then reliability and traceability are improved, but the analysis time and complexity increase
Solution Approach 1:
The control components are merged with the multiplex analysis system to validate multiple steps simultaneously. The controls are integrated into the same reaction chamber and are processed together with the analytes during the multiplex analysis, allowing step validation to occur in parallel with the actual analysis rather than requiring separate sequential validation steps.
Solution Approach 2:
The control components are pre-positioned in the reaction chamber before the multiplex analysis begins. The controls are prepared in advance with known analytes and detection ligands, so that when the analysis starts, the validation steps are already in place and can proceed simultaneously with the main analysis, eliminating the need for additional time-consuming validation steps afterward.
Data Source
AI summary
The present invention relates to controls which may be used to secure the results of multiplex analysis methods. The present invention thus relates to solid supports comprising one or several controls and their use in multiplex analysis methods to detect several analytes potentially present in a sample.