General Description
Incorporating the CANARY® technology, the BioFlash-E® Biological Identifier provides rapid, sensitive and specific identification of up to 21 biological threat agents. The portable and compact BioFlash-E® Biological Identifier offers breakthrough capabilities in sampling performance, reliability and operational cost.
Technical Description
The BioFlash-E® Biological Identifier uses proprietary aerosol collection technology and MIT Lincoln Labs developed CANARY® detection technology to offer a complete, stand-alone solution for biological identification.
Evaluation Criteria
THROUGHPUT:
- 2 minutes or less for detection
- Multiple samples, multiple tests/sample per run
- 95 - 32 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
- 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 carry-on luggage suitcase
- Between 5 and 25 kg
- Wired connections are available
- System or device has 110V electrical requirement
OPERATIONS:
- Can be used from 4°C to 41°C
- Components must be stored at 4°C
- Performance is not influenced by relative humidity
- Between 1 to 6 months shelf life
- 5-10 years expected life
- Results cannot be viewed in real-time
- The system could easily be adapted into a fully autonomous system
- The system software is closed and not available for modification
- The system hardware is closed and not available for modification
DETECTION:
- Not possible for the system to achieve 510K clearance
- Not possible for the system to achieve FDA approval
- Less than 50 µL
- Superior specificity. System has a false alarm rate approaching zero (~0%)
- 1-100 CFU per mL
- 100-1,000 PFU per mL
- Spore lysis not necessary for detection by system