General Description
Genedrive™ offers rapid detection of NA targets in a fully integrated, compact (12cm x 17cm x 9cm) and lightweight (550g) unit. It can detect multiple targets simultaneously using room temperature stable reagents. Single button operation allows use by untrained operators.
Technical Description
Genedrive™ uses hybrid thermal engine technology which enables rapid thermal cycling within a compact, low power unit.
Notes:
The current version does not integrate sample preparation.
Evaluation Criteria
THROUGHPUT:
- Between 15 and 30 minutes for detection
- 1 sample, >10 tests/sample per run
- Less than 32 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
- 1 component
- No set-up of the system is required
- 1-2 steps are required for detection
LOGISTICS:
- Very brief (minutes-hours) training and minimal technical skills
- Approximately the size of a soda can
- Less than 1 kg
- Wireless and wired connections are available
- System or device uses batteries
- 1-2 hours battery life
OPERATIONS:
- Can be used from < -21°C to > 42°C (All temperatures)
- Components must be stored at room temperature (27°C)
- Between 1 to 3 years shelf life
- 3-5 years expected life
- Results cannot be viewed in real-time
- The system is not capable of autonomy
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- Possible the system could receive 510K clearance, no current efforts at this time
- Possible the system could receive FDA approval, no current efforts at this time
- 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
- Add on capability that is full or semi-automated for spore lysis