Disposable Cartridge Sensor Channels for Point-of-Care Diagnostics
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Solution Overview
Problem
Conventional in vitro diagnostic (IVD) equipment is complex, bulky, and requires specialized training, limiting its use to hospital laboratories and preventing its application in medical offices, emergency responses, and point-of-care settings due to its inability to perform multiple tests efficiently and accurately outside a controlled environment.
Innovation Solution
Development of portable point-of-care sensor systems comprising disposable cartridges with integrated sensor channels, reagent storage, and delivery mechanisms, along with a reader that performs on-cartridge sensing, allowing for pneumatic actuation of liquid movement and temperature control, enabling precise and repeatable measurements of analytes in samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional IVD equipment is used, then measurement precision and reliability are maintained, but device complexity and portability are compromised
Solution Approach 1:
The system is divided into two main segments: a reusable reader device and disposable cartridges. The cartridge contains pre-loaded reagents, sample processing components, and sensor channels, separating the complex reagent management and sample preparation functions from the reader. This segmentation allows the reader to remain relatively simple while maintaining measurement precision through the integrated cartridge design.
Solution Approach 2:
The patent employs disposable cartridges that are discarded after a single use. Each cartridge is pre-filled with reagents and contains all necessary components for a complete assay. This disposable approach eliminates the need for complex reagent storage, management, and contamination control systems in the reader, reducing overall device complexity while maintaining measurement precision through factory-prepared, quality-controlled cartridges.
2Measurement precision
If conventional IVD equipment is used, then measurement precision is maintained, but ease of operation and accessibility are reduced
Solution Approach 1:
The cartridge is designed to be self-contained and self-explanatory, with all reagents, buffers, and processing components pre-loaded and pre-configured. The user simply needs to load the sample and insert the cartridge into the reader; all subsequent steps including reagent dispensing, mixing, incubation, and detection are automated within the cartridge and reader system. This self-service design eliminates the need for specialized training while maintaining measurement precision.
3Reliability
If conventional IVD equipment is used, then reliability is maintained, but productivity and versatility for multiple analytes are limited
Solution Approach 1:
The reader device is designed with universal capabilities to accommodate multiple cartridge types and perform various assays. The system can measure multiple analytes simultaneously or sequentially using different sensor channels within a single cartridge or by swapping cartridges. This multi-functionality increases productivity by allowing a single device to replace multiple specialized instruments while maintaining reliability through standardized measurement protocols.
4Measurement precision
If conventional IVD equipment is used, then measurement precision is maintained, but loss of time for sample processing and analysis is increased
Solution Approach 1:
All reagents, buffers, and processing components are pre-loaded into the cartridge during manufacturing. The cartridge is prepared in advance with all necessary materials for the assay, eliminating the need for time-consuming setup steps in the laboratory. When the user receives the cartridge, everything is ready for immediate use, reducing the time from sample collection to result while maintaining measurement precision through factory-prepared, quality-controlled 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
Enables rapid, precise, and cost-effective analysis of multiple analytes in various samples at the point of care, improving clinical decision-making and reducing the need for complex equipment and specialized training, while maintaining performance comparable to laboratory-based systems.
Implementation Method 1
low thermal mass screen printed heaters configured to maintain a sensor channel at a desired temperature
Implementation Method 2
The de-bubbling channel may be covered by a hydrophobic membrane
Implementation Method 3
The cartridge may further include a screen-printed thermocouple configured to provide temperature feedback of the detection channel
Implementation Method 4
The one or more sensors can include two or more screen-printed electrodes. The cartridge can be configured to perform electrochemical enzymatic sensing and electrochemical enzyme-linked immunosorbent assay (ELISA) sensing on a single sample
Data Source
AI summary
Provided are point of care sensor systems that include portable readers and disposable cartridges for receiving and analyzing samples. A cartridge may be equipped with one or more sensor channels, each containing one or more sensors. After providing a sample to a cartridge, the cartridge can be inserted into a reader, which can interact with the cartridge to perform on-cartridge sensing and receive signals indicating the presence and/or quantity of one or more targets in the sample. Examples of cartridges can include cardiac panels, sepsis panels and the like. In some embodiments, the same sensor hardware may be configured for multiple measurements of different targets conducted at different time frames. Also provided herein are novel on-cartridge solid and liquid reagent storage and delivery mechanisms.