Microfluidic Assay Cartridge for Portable Pathogen Detection
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Solution Overview
Problem
Diagnostic testing for pathogens often requires complex processing of biological samples using expensive specialized equipment, limiting its availability and hindering timely treatment and infection control.
Innovation Solution
A portable diagnostic testing system using a single-use microfluidic cartridge and a portable analyzer that performs reverse transcriptase loop-mediated amplification (RT-LAMP) followed by fluorescence detection with CRISPR-CAS enzymes, enabling point-of-care testing for various pathogens in a home or low-complexity medical setting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If complex processing of biological samples is performed using specialized equipment in a laboratory setting, then diagnostic testing accuracy is improved, but device complexity and cost increase, limiting availability
Solution Approach 1:
The diagnostic system is segmented into a portable analyzer unit and a disposable microfluidic cartridge. The cartridge contains pre-loaded reagents and microfluidic channels that guide sample processing, while the analyzer provides detection capabilities. This segmentation allows complex diagnostic functions to be distributed across simple, specialized components rather than requiring a single complex laboratory instrument.
Solution Approach 2:
The microfluidic cartridge acts as an intermediary between the biological sample and the detection system. It pre-processes the sample through lysis, nucleic acid extraction, and amplification reactions within integrated microchannels, delivering a prepared analyte to the portable detector. This intermediary handles the complex processing steps that would otherwise require sophisticated laboratory equipment.
2Reliability
If specialized laboratory equipment is used for pathogen detection, then diagnostic capability is improved, but loss of time increases due to limited availability and travel requirements
Solution Approach 1:
The microfluidic cartridge is designed as a self-contained, self-service unit that performs sample processing, reagent mixing, and reaction incubation automatically once the biological sample is introduced. The system requires minimal user intervention beyond sample collection and cartridge insertion, eliminating the need for trained laboratory personnel and reducing time delays associated with sample transport and processing setup.
Solution Approach 2:
The system transitions diagnostic testing from the traditional centralized laboratory dimension to a decentralized point-of-care dimension. By miniaturizing the entire diagnostic workflow into a portable handheld device with integrated microfluidics, the system enables testing in any location without requiring physical access to specialized laboratory facilities.
3Measurement precision
If expensive specialized equipment is deployed for diagnostic testing, then measurement precision is improved, but manufacturing cost increases
Solution Approach 1:
The microfluidic cartridge is designed as a disposable, low-cost single-use component that contains all necessary reagents and processing elements. After one use, the cartridge is discarded, eliminating the need for expensive cleaning, sterilization, and maintenance of reusable components. The low manufacturing cost of each disposable cartridge makes the overall system more affordable than reusable specialized equipment.
Solution Approach 2:
The system changes the scale and integration parameters of diagnostic testing by miniaturizing all components into a handheld format. This parameter change from macro-scale laboratory equipment to micro-scale portable device reduces material requirements, manufacturing complexity, and overall system cost while maintaining detection precision through careful design of microfluidic reaction chambers and detection optics.
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
Facilitates rapid, cost-effective, and accessible pathogen detection at the point of care, allowing for timely treatment and infection control without the need for specialized laboratory equipment.
Implementation Method 1
fluorescence emission triggered by a Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR associated proteins (CAS) enzyme
Data Source
AI summary
Single use cartridges for testing biological samples are provided that include multiple processing channels. A single use cartridge includes an aliquot staging well, a first amplification well, a second amplification well, an actuation port, and a fluid channel control valve assembly. The fluid channel control valve assembly is reconfigurable between a first fluid channel configuration and a second fluid channel configuration.