General Description
Disc-based molecular diagnostic real-time thermocycler intended for use in clinical laboratories. Currently the system utilizes common laboratory specimens, but can be adapted to a wide variety of sample matrices.
Technical Description
Thermocycler with 4-channel detection for use with real-time PCR assays.
Evaluation Criteria
THROUGHPUT:
- Between 30 and 60 minutes per assay
- Multiple samples, multiple tests/sample per run
- 349-96 samples every 2 hours
- The system or device is currently semi-automated
- Device or system is intended for multiple detection assays
- 0-1 solutions, buffer, eluents, and/or reagents
- 0 components
- Less than 5 minutes is required for set-up
- 1-2 steps are required for analysis
LOGISTICS:
- Very brief (minutes-hours) training and minimal technical skills
- Approximately the size of a carry-on luggage suitcase
- Between 5 and 25 kg
- Wireless and wired connections are available
- System or device has 110V electrical requirement
- The device is not intended for portable use
- Is commercially available
OPERATIONS:
- Can be used from 4ºC to 41ºC
- Components must be frozen (-20ºC)
- Performance is not influenced by relative humidity
- Between 1 to 3 years shelf life
- 5-10 years life expectancy
- Results can be viewed in real-time
- System could be adapted to fully autonomous with some effort
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- System currently has 510k clearance
- System currently has FDA approval
- Less than 50 µL per analysis
- Superior specificity. System has a false alarm rate
- approaching zero (~0%)
- 1-100 CFU/mL of original sample
- 1-100 PFU/mL of original sample
- Fully automated spore lysis
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