BioHawk | Research International, Inc.

General Description
The BioHawk is a portable 8-channel bioassay system with automated sample collection capability that is suitable for high-sensitivity monitoring of biological agents. BioHawk can monitor surrounding air for aerosol threats with its built-in air sampler, and periodically transfer a liquid concentrate from the air sampler to the bioidentifier. Assay results are typically available in 20 minutes. The biodetector portion of the instrument will also accept fluids for analysis from other sample collection systems, or will process liquid samples loaded into the instrument manually. Bioassays are performed within a small disposable assay coupon that may be used for up to 10 assays. This capability can substantially reduce life cycle cost. Assay results may be transmitted to users through the touch panel LCD display, an audible alarm, by wireless or RS-232 link to personnel at a remote location. System operation may be remotely controlled in real time virtually.

Technical Description
The BioHawk is an integration of Research International's proven SASS 2300 air sampler technology with an 8-channel bio-identifier. In operation, the SASS 2300 samples air continuously and transfers particulates into a secondary water phase. The water samples are periodically transferred from the air sampler to the bio-identifier. The sample is used for analysis and then may be saved as a confirmatory sample. The BioHawk automatically performs analysis for up to eight agents on the disposable assay coupon. The coupons may be reused up to 10 times before replacement is necessary. Assays are based on 'sandwich format' fluoroimmunoassay reactions taking place on the surface of injection molded polystyrene waveguides. All fluidic and optoelectronic steps associated with the assay are performed automatically.

Evaluation Criteria

THROUGHPUT:

Between 15 and 30 minutes for detection
1 sample, <10 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
2 solutions, buffer, eluents, and/or reagents
0 components
Greater than 20 minutes is required for set-up
Automatic 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
Wireless and wired connections are available
System or device uses batteries
4-8 hours battery life

OPERATIONS:

Can be used from 4°C to 41°C
Components must be stored at room temperature (27°C)
Performance is not influenced by relative humidity
Between 6 months and 1 year shelf life
Greater than 10 years expected life
Results cannot 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 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
Greater than 250 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
10,000-100,000 CFU per mL
Greater than 100,000 PFU per mL
1-10 ng per mL
Spore lysis not necessary for detection by system