Microfluidic-Based POC Device for Detection and Analysis of HIV Directly From Blood
Chipcare, a biotech company specializing in multiplexed Point-of-Care (POC) diagnostics for sexually transmitted infections, approached Gener8 to develop a turnkey sample-to-answer POC device and microfluidic-based cartridge for analyzing blood from HIV patients. The goal was to create a diagnostic device that would allow healthcare providers to perform rapid tests and provide earlier therapy. However, developing a consumable cartridge and an instrument that would work together seamlessly presented significant challenges.
Challenges
With any project consisting of a consumable and an instrument, it’s essential to align the design and development of each in order to deliver a functional and cost-effective product that meets the client’s requirements.
Consumable
- Designing a vertically oriented fluidic cartridge that can perform multiple PCR-based assays on a single platform while storing liquid and lyophilized reagents onboard.
- Creating microfluidic dimensions of 20 µm diameter for sensitive fluorescent detection, with tight tolerances and no low dead volumes.
- Developing a single-source syringe pump to drive rotary valves without causing foaming.
Instrument
- Creating a device that can interface with the disposable cartridge to create a commercial POC medical device, including reagent connectors, heat lysis and thermocycling modules, variable parameter rotary valves, air displacement pumps, solenoid-driven magnetic lever arms, and multiple wavelength laser diodes and optics for fluorescent detection and imaging.
- Developing a functional and cost-effective product that can perform heated sample lysis, amplification, and detection.
- Aligning the design and development of each component to deliver a functional and cost-effective product that meets the client’s requirements.
Solutions
Gener8 fulfilled Chipcare’s demand for a user-friendly and entirely integrated instrument and consumable for their POC applications. We demonstrated the functionality of all cartridge interfaces, including high-speed thermocycling with less than 3 degrees Celsius per second heating and cooling at the sample, and successful optical detection and imaging in a submillimeter imaging channel within the consumable cartridge. We carried out assay development using the prototype and alpha platforms, which were developed in close collaboration with Chipcare. The necessary sensitivity required for precise detection was obtained due to the low dead volume and tight manufacturing tolerances necessary for the assay.
Consumable
- Microfluidics design and testing
- Computational fluid dynamics
- High-volume consumable development
- Mold flow analysis
- Laser welding
Instrument
- Holistic mechanical and system design
- Fluidics design and testing
- Optical and optomechanical development and design
- Thermal simulation and testing
- Electronics design
- Embedded firmware engineering
- Design for manufacturability
