General Description
The BIOTM-FD is a laser induced florescence (LIF) detector that continuously analyzes air samples for airborne pathogens. The device is capable of alerting or triggering real-time air sample collection if a known and dangerous pathogen is present. This product is designed to be power efficient and operate as a standalone unit with minimal training or interaction. The detector employs a unique technology for determining the threat level based on characterized signatures of florescence vs. size and the statistical distributions for common pathogens. The system is flexible in that it can be trained to adapt to background particulates, look for new pathogens, and ignore known interferents.
Technical Description
The BioTM-FD LIF detector employs a unique design using an air inlet with and integrated aerosol concentrator for enriching the particle stream before interrogating the sampled air. The principle of detection is based on its use of Mie scattering, concurrently examining each particle for the presence of the metabolites NADH and riboflavin, which are necessary intermediates for metabolism of living organisms, such as bacteria and fungi. The detector simultaneously measures particle size and florescence with a single illumination correlating the two resulting signals in real time. The signals generated are processed statistically through maximum likelihood algorithms that compare samples to known bio-agent signatures.
Evaluation Criteria
THROUGHPUT:
- 2 minutes or less for detection
- Continuous operation with no defined runs
- Device or system is intended for multiple detection assays
- 0-1 solutions, buffer, eluents, and/or reagents
- 1 component
- 5-10 minutes is required for set-up
- 1-2 steps are required for detection
LOGISTICS:
- Very brief (minutes-hours) training and minimal technical skills
- Approximately the size of a toaster
- Between 1 and 5 kg
- Wireless and wired connections are available
- System or device has 110V electrical requirement
- 4-8 hours battery life
OPERATIONS:
- Can be used from 4°C to 37°C
- Performance is not influenced by relative humidity
- Greater than 3 years shelf life
- 5-10 years expected life
- Results can be viewed in real-time
- The system or device is currently fully autonomous
- The system software is open but modification requires licensing
- The system hardware is open but modification requires licensing
DETECTION:
- Not possible for the system to achieve 510K clearance
- Not possible for the system to achieve FDA approval
- This system does not test liquids
- 1-100 CFU per mL
- Spore lysis not necessary for detection by system
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