Electrochemical Biosensor Diagnostic with Sample Prep
Gener8 designed a disposable cartridge for a client’s IVD point-of-care project, integrating their electrochemical biosensor with a custom reader for sensing and mechanical actuation. The cartridge achieved a sample prep protocol with simple user steps, meeting CLIA waiver requirements, and features a sliding valve for metering the sample and delivering it to a fluid channel that flows the sample over the chip. We also successfully implemented a bubble trap and integrated the cartridge with the instrument with precise alignment features between the biosensor and reader head.
Challenges
- Design a disposable cartridge that could complete a complex sample prep protocol, integrate with the customer’s electrochemical biosensor, and interface with a custom reader for sensing and mechanical actuation
- Achieve the sample prep protocol using simple user steps to meet CLIA waiver requirements
- Integrate the cartridge with the instrument with precise alignment features between the biosensor and reader head
Solutions
- Achieved sample prep protocol in the disposable consisting of metering of whole blood taken from fingerstick, mixing sample with anticoagulant stored onboard, serum separation and metering, mixing with onboard reagent and delivering 5 μl (microliters) to the silicon chip for measurement.
- Protocol achieved with simple user steps, meeting CLIA waiver requirements: prick finger with lancet, deposit the droplet of blood onto the sample pad, close the cap and insert cartridge into the reader.
- Blood is introduced via a sample port with cap. Closing the cap creates the pressure need to drive the sample to the next phase.
- The design features a sliding valve that meters the sample and delivers it to a fluid channel that flows the sample over the chip. Valve is actuated when cartridge is inserted into reader.
- Developed and successfully implemented a bubble trap.
- Integrates with the instrument with precise (6 and 8 μm) alignment features between electrochemical biosensor and reader head.
