Microfluidic Assay Cartridge Segmentation for Point-of-Care Blood Testing
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Solution Overview
Problem
The in vitro diagnostics (IVD) market faces challenges in developing fast, low-volume, precise, and cost-effective capillary finger stick blood tests with reduced user complexity, hindered by technological limitations in evolving immunoassay IVD towards point-of-care applications.
Innovation Solution
A microfluidic assay system comprising a disposable assay cartridge and associated reading device, featuring microfluidic channels, binding agents, and electrodes, allowing for capillary sample introduction, fluid transport control, and adaptable assay configurations, enabling efficient analyte detection and multiplexing capabilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional immunoassay IVD systems are used, then detection capability is maintained, but device complexity and user complexity remain high
Solution Approach 1:
The system is divided into two main segments: a disposable assay cartridge containing all reagents and microfluidic channels, and a separate reader device for detection. This segmentation allows the cartridge to be simple and easy to use, while the reader can be sophisticated but separate from the user's daily operation.
Solution Approach 2:
The cartridge is designed to be self-contained with all necessary reagents, buffers, and microfluidic pathways pre-configured. The sample automatically flows through the cartridge via capillary action or pressure differential, and the detection is performed automatically by the reader, eliminating complex user intervention.
2Quantity of substance
If capillary finger stick blood testing is implemented, then sample volume is reduced, but manufacturing precision and assay reliability become more difficult to maintain
Solution Approach 1:
The system replaces complex mechanical sampling and handling mechanisms with passive microfluidic flow control. The microfluidic channels use capillary action, pressure differentials, and integrated pumps to precisely control sample and reagent flow, eliminating the need for complex mechanical dosing devices while maintaining manufacturing precision.
Solution Approach 2:
The system optimizes flow rates, temperatures, and contact times within the microfluidic channels to ensure reliable assay results with minimal sample volumes. The microfluidic geometry and material properties are carefully selected to maintain precise control over reaction conditions despite reduced sample quantities.
3Ease of manufacture
If disposable cartridge design is used, then ease of manufacture and cost are improved, but reliability of repeated use may be compromised
Solution Approach 1:
The cartridge is designed as a disposable, single-use component that is inexpensive to manufacture. This allows for high-quality reagents and precise microfluidic fabrication without the need for expensive reusable components. The low cost enables robust quality control and consistent performance across batches.
Solution Approach 2:
By separating the disposable cartridge from the reusable reader device, the system maintains high reliability through consistent, factory-controlled cartridge manufacturing while avoiding the reliability issues associated with cleaning and maintaining complex reusable components. The reader can be sterilized and reused, while the cartridge is discarded after single use.
4Productivity
If microfluidic channels are integrated into the cartridge, then fluid transport control is improved, but device complexity increases
Solution Approach 1:
The microfluidic channels, reagent reservoirs, reaction zones, and detection areas are merged into a single integrated cartridge structure. This integration enables precise fluid transport control through the microfluidic network while the entire cartridge functions as one disposable unit, avoiding the complexity of assembling multiple separate components.
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
The system facilitates rapid, precise, and cost-effective analyte detection with reduced sample volume, enhancing sensitivity and precision, and allowing room temperature stability and storage, thereby expanding market penetration and reducing production costs.
Implementation Method 1
capillary sample introduction
Implementation Method 2
binding agent disposed within said channel(s) for binding any of said analyte within the sample
Data Source
AI summary
The present invention relates to a microfluidic based assay system, comprising a disposable assay cartridge and associated reading device, as well as the individual components themselves. The present invention also relates to methods of conducting assays, using the cartridge and device of the invention, as well as kits for conducting assays.