General Description
ViiA 7 Real-Time PCR System can serve various purpose from testing environmental samples, verifying and quantifying bacterial or viral existence, and validating DNA/RNA sequence existence.
Technical Description
Instrument that employs real-time TaqMan® polymerase chain reaction amplification of genes on a peltier-based thermocycling apparatus. The ViiA 7 Real-Time PCR System is available in 384-well, 96-well, Fast 96-well or proprietary TaqMan Array 384-well low volume format.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- Multiple samples, multiple tests/sample per run
- Greater than 750 samples every 2 hours
- The system or device is currently fully automated
- Device or system is intended for multiple detection assays
- 5 or more solutions, buffer, eluents, and/or reagents
- 2 components
- Less than 5 minutes is required for set-up
- 1-2 steps are required for detection
LOGISTICS:
- An afternoon of training and some technical skills required
- Approximately the size of a home dishwasher
- More than 50 kg
- Wired connections are available
- System or device has 110V 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 or device is currently fully autonomous
- The system software is open but modification requires licensing
- The system hardware is open but modification requires licensing
DETECTION:
- Efforts are underway to achieve 510K clearance
- Efforts are underway to achieve FDA approval
- This system does not test liquids
- Superior specificity. System has a false alarm rate approaching zero (~0%)
- Spore lysis not necessary for detection by system
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