General Description
The Veriti® Thermal Cycler is a high quality instrument for amplifying target DNA sequences using Polymerase Chain Reaction (PCR). Veriti® Thermal Cyclers are available for research or diagnostic use.
Technical Description
Veriti® performs polymerase chain reaction amplification of genes on a peltier-based thermocycling apparatus.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- Multiple samples, multiple tests/sample per run
- 749-350 samples every 2 hours
- The system could be adapted to a semi-automated system with some effort
- Device or system is intended for multiple detection assays
- 2 solutions, buffer, eluents, and/or reagents
- 2 components
- 5-10 minutes is required for set-up
- 3-5 steps are required for detection
LOGISTICS:
- More than a day of training and significant technical skills are required
- Approximately the size of a toaster
- Between 5 and 25 kg
- Wired connections are available
- System or device has 220V electrical requirement
OPERATIONS:
- Can be used from 4°C to 41°C
- Components must be frozen (-20°C)
- Performance is not influenced by relative humidity
- Between 6 months and 1 year shelf life
- 5-10 years expected life
- Results cannot be viewed in real-time
- The system is not capable of autonomy
DETECTION:
- Efforts are underway to achieve 510K clearance
- System currently has FDA approval
- Less than 50 µL
- Excellent specificity. System has occasional false alarms under certain conditions (<2%)
- 1-100 CFU per mL
- 1-100 PFU per mL
- Manual kit not integrated with the system handles spore lysis