General Description
Amplification and Detection of RNA and DNA using NASBA technology of clinical specimens from body fluids.
Technical Description
Not provided.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- Multiple samples, single tests/sample per run
- 349-96 samples every 2 hours
- The system or device is currently fully automated
- Device or system is intended for multiple detection assays
- 0-1 solutions, buffer, eluents, and/or reagents
- 3 components
- Greater than 20 minutes is required for set-up
- 6-8 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 5 and 25 kg
- This system is not capable of transmitting data
- System or device has 110V electrical requirement
OPERATIONS:
- Can be used from 25°C to 37°C
- Components must be stored at 4°C
- Device or system has peak performance at normal relative humidity conditions
- Between 1 to 3 years shelf life
- 3-5 years expected life
- Results can be viewed in real-time
- The system or device is currently fully autonomous
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- Efforts are underway to achieve approval
- Less than 10 µL
- Excellent specificity. System has occasional false alarms under certain conditions (<2%)
- 1-100 CFU per mL
- 100-1,000 PFU per mL
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