General Description
The MENTOR-100 biodetector is a compact, portable system that uses a patented nucleic-acid based assay (‘NMR Bioassay’) to detect and identify biological agents. Currently the system is capable of detecting liquid, powder and aerosolized agents. The system is fully automated from sample collection to detection, has automated decontamination, and is fully reusable. The results are presented in a simple no threat/threat format that requires no operator interpretation. Clinical samples can be handled by developing and interfacing the appropriate sample processing module. Currently the MENTOR-100 can detect all the bacterial agents and has been blind tested for the biothreats Bacillus anthracis, Francisella tularensis, Yersinia pestis in a multiplex format. Other biothreats including viruses can be added to the system library by developing the appropriate NMR Bioassay. The system is also capable of adapting existing nucleic acid assays developed for other detection platforms. Applications include threat monitoring and biosurveillance, bioprocessing, clinical diagnosis, and food and water safety. The small footprint of the system will allow it to be used in a wide variety of locations, including public buildings, transportation centers, clinics and food processing establishments. The development of the MENTOR-100 has been supported by the Department of Homeland Security (DHS) and the Defense Threat Reduction Agency (DTRA). The MENTOR-100 has successfully detected blind assays at the Edgewood Chemical Biological Center (ECBC).
Technical Description
The MENTOR-100 biodetector uses the properties of paramagnetic nanoparticles to change the nuclear magnetic resonance (NMR) relaxation time of protons in an aqueous solution. Paramagnetic nanoparticles coated with a molecular binding agent together with specialized nucleic acid probes are introduced into the assay and processed. The interaction of the nanoparticles, probes and the target’s nucleic acid causes a change in the NMR relaxation time when the target is present compared to when it is absent. This change in relaxation time is used to indicate the presence of the target.
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 fully automated
- Device or system is intended for multiple detection assays
- 2 solutions, buffer, eluents, and/or reagents
- 0 components
- No set-up of the system is required
- Automatic detection
LOGISTICS:
- Very brief (minutes-hours) training and minimal technical skills
- Approximately the size of a toaster
- Between 5 and 25 kg
- Wireless and wired connections are available
- System or device has 110V electrical requirement
- 4-8 hours battery life
OPERATIONS:
- Can be used from < -21°C to > 42°C (All temperatures)
- Components must be stored at room temperature (27°C)
- Performance is not influenced by relative humidity
- Between 1 to 3 years shelf life
- Greater than 10 years expected life
- Results can be viewed in real-time
- The system or device is currently fully autonomous
- The system software is open and available for modification
- The system hardware is open and 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 10 µL
- Superior specificity. System has a false alarm rate approaching zero (~0%)
- 100-1,000 CFU per mL
- 100-1,000 PFU per mL
- Less than 1 ng per mL
- Fully automated spore lysis