Molecular Diagnostic Point-of-Care Microfluidic PCR Cartridge
- Develop a low-cost microfluidic cartridge designed for high-volume manufacturing that automates a PCR assay.
Unique Features and Accomplishments
- Performs sample collection, preparation, amplification (via isothermal PCR), and detection of nucleic acid analytes from clinical samples (including blood, saliva, urine, feces, etc), environmental samples (waste water, soil, spores, etc), and food.
- Multiplexed analysis, testing up to 16 analytes from a single sample
- Microfluidic cartridge functional features include:
- 3 pneumatically actuated diaphragm valves, 1 mechanically actuated pop valve.
- Pneumatic interface with instrument to drive fluid through microfluidic channels.
- Fluid channels and wells created by laminating a heat seal over the top of ridged plastic body.
- Metering and mixing wells using hydrophobic vent membranes, assembled using sonic welding.
- Well used for lysing the cells interfaces with a heating element on the instrument.
- Performs active mixing of stored, dried master mix reagents.
- Sample splitting into 16 wells with optical clarity for florescent detection.
- Reduces an 11 Step Assay Protocol to 2 User Steps, for use in a CLIA waived point-of-care environment:
- Sample collection and deposition using the separate module (pictured)
- Inserting the cartridge into the instrument, which executes an isothermal amplification protocol and fluorescent detection.
- Patent: Sample Collection and Analysis Devices
While all projects benefit from our development process and expertise in design, engineering, and in-house rapid prototyping, this project highlights our expertise in:
- Automating Assays
- Microfluidic Cartridge Design
- Reagent, Buffer Storage and Delivery