General Description
INT’s Palladium System is an automated field deployable DNA based diagnostic and biological identification system. The unit can be used by first responders or as a point of care diagnostic system. The system utilizes a novel electronic array which allows for identification of multiple nucleic acid sequences within a sample. The current system incorporates sample preparation. It uses PCR to amplify target sequences which provides a high degree of sensitivity and specificity. The system is designed for field use. It is less than nine pounds and is battery powered. Reagents do not need refrigeration. The sample preparation process is versatile and has been used to prepare target material from biological samples, such as blood, tissue, and whole insects, or environmental samples such as air filter washes or soil. Target materials evaluated on the system include DNA and RNA targets from bacteria and viruses. The system integrates all steps from sample preparation to result into a single disposable cartridge which includes all reagents. The unit has GPS and communications capability in order to record time, and location and report results.
Technical Description
INT’s Palladium System utilizes a novel electronic nucleic acid sensor. Target nucleic acids bind to sensors forming a bridge between electrodes. The presence of a target is determined electrically. This approach allows for a multiplexed array of sensors, for simultaneous testing for a number of targets. The system also incorporates a sample preparation process which uses nano- magnetic particles to separate and concentrate target molecules. The sample preparation process works with a wide variety of sample matrixes and with high yields using nucleic acid concentrations from femto-moles to milli-moles. Finally, the system uses a unique revolver disposable cartridge which is low cost and easy to manufacture. The revolver design allows for valving of multiple reagents with only one valve. The design of the cartridge provides flexibility to modify processing steps without the need to rework the cartridge.
Evaluation Criteria
THROUGHPUT:
- Between 30 and 60 minutes for detection
- Multiple samples, multiple tests/sample per run
- 95-32 samples every 2 hours
- The system or device is currently fully automated
- Device or system is intended for multiple detection assays
- 0-1 solutions, buffer, eluents, and/or reagents
- 1 component
- Less than 5 minutes is required for set-up
- 1-2 steps are required for detection
LOGISTICS:
- Very brief (minutes-hours) training and minimal technical skills
- Approximately the size of a toaster
- Between 1 and 5 kg
- Wireless and wired connections are available
- System or device uses batteries
- 4-8 hours battery life
OPERATIONS:
- Can be used from 4°C to 41°C
- Components must be stored at room temperature (27°C)
- Performance is not influenced by relative humidity
- Between 1 to 3 years shelf life
- 5-10 years expected life
- Results cannot be viewed in real-time
- The system could be adapted to a fully autonomous system with some effort
- The system software is open and available for modification
- The system hardware is closed and not available for modification
DETECTION:
- Efforts are underway to achieve 510K clearance
- Efforts are underway to achieve FDA approval
- Less than 250 µL
- Excellent specificity. System has occasional false alarms under certain conditions (<2%)
- 100-1,000 CFU per mL
- 100-1,000 PFU per mL
- Fully automated spore lysis