General Description
The InSyte is a laboratory based instrument for real-time amplification analysis of nucleic acid samples. It uses independent well control, meaning each vessel is individually monitored and can be controlled as such. The unique ability to perform the PCR process in a sub 15 minute time frame along with laser based optics and photon counting detectors enabling capture of the full plate in under one second. The core technology is applicable to a point of care environment with subsequent further development.
Technical Description
The system relies on ultra-rapid thermal cycling and the real-time PCR process in tandem with fast and sensitive laser and photon counting based optics. This allows the real-time detection of multiple nucleic acid target species in a single diagnostic run.
Evaluation Criteria
THROUGHPUT:
- Between 15 and 30 minutes for detection
- Multiple samples, multiple tests/sample per run
- Greater than 750 samples every 2 hours
- The system could be adapted to a fully automated system with some effort
- Device or system is intended for multiple detection assays
- 3 solutions, buffer, eluents, and/or reagents
- 2 components
- 10-20 minutes is required for set-up
- 3-5 steps are required for detection
LOGISTICS:
- An afternoon of training and some technical skills required
- Approximately the size of a home dishwasher
- Between 25 and 50 kg
- Wireless and wired connections are available
- System or device has 220V electrical requirement
OPERATIONS:
- Can be used from 4°C to 37°C
- Components must be stored at 4°C
- Performance is not influenced by relative humidity
- Between 6 months and 1 year shelf life
- 5-10 years expected life
- Results can be viewed in real-time
- The system could easily be adapted into a fully autonomous system
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- Less than 50 µL
- 1-100 CFU per mL
- 1-100 PFU per mL
- Manual kit not integrated with the system handles spore lysis