General Description
The Cepheid SmartSystem™ is potentially the most sensitive real-time PCR testing platform available on the market. With up to 96 individually programmable reaction sites, it is one of today’s most flexible, easy-to-use systems. No other system is designed for complete portability in the field. The SmartCycler System is highly robust and compact, with no moving components—ideally suited for mobile use in field-testing applications. By automating the entire amplification and detection process, the SmartCycler System can deliver highly accurate and consistent test results from prepared biological samples in 20–40 minutes. Flexible and Expandable Cepheid’s SmartCycler® instrument is the only random access, modular real-time PCR instrument on the market with up to 96 sites that can each run a different protocol. Installation of the SmartCycler System is plug-and-play, and system expansion only requires an additional USB connection. Fast With the SmartCycler System, you can optimize PCR denaturation, annealing and extension temperatures and times in a single run. The SmartCycler System can deliver results in less than half the time of a 96-well plate instrument. High Throughput Two SmartCycler instruments can process an equal or greater number of samples than a 96 well instrument in a single day. Assay Optimization Made Easy Increase Flexibility - random access accommodates varied cycling conditions, with variable amplicon lengths, cycling times, and assay design; Increasing Robustness, Decreasing time to results. Mobile Heavy-duty airline-safe transport case and laptop configuration is available for the SmartCycler System, making it ideal for field work.
Technical Description
The Cepheid SmartSystem™ is potentially the most sensitive real-time PCR testing platform available on the market. With up to 96 individually programmable reaction sites, it is one of today’s most flexible, easy-to-use systems. No other system is designed for complete portability in the field. The SmartCycler System is highly robust and compact, with no moving components—ideally suited for mobile use in field-testing applications. By automating the entire amplification and detection process, the SmartCycler System can deliver highly accurate and consistent test results from prepared biological samples in 20–40 minutes.
Evaluation Criteria
THROUGHPUT:
- Between 30 and 60 minutes for detection
- Multiple samples, multiple tests/sample per run
- 349-96 samples every 2 hours
- The system or device is currently fully automated
- Device or system is designed for a single use
- 0-1 solutions, buffer, eluents, and/or reagents
- 2 components
- No set-up of the system is required
- 1-2 steps are required for detection
LOGISTICS:
- An afternoon of training and some technical skills required
- Approximately the size of a carry-on luggage suitcase
- Between 25 and 50 kg
- This system is not capable of transmitting data
- System or device has 110V electrical requirement
- <1 Hour 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 6 months and 1 year shelf life
- Results can be viewed in real-time
- The system is not capable of autonomy
- The system software is open and 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 100 µL
- Excellent specificity. System has occasional false alarms
- under certain conditions (<2%)
- 100-1,000 CFU per mL
- 100-1,000 PFU per mL
- 10-100 ng per mL
- Fully automated spore lysis
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