AIR (Arrayed Imaging Reflectometry) Bioassay System | Research International, Inc.

General Description
The AIR System performs extremely sensitive label-free, multi-analyte immunoassays (64 to several hundred array elements) on a silicon chip mounted in an injection-molded disposable cartridge. Protein assays typically have 1 pg/mL sensitivity, and a 5 to 6 log detection range. Assay protocols are completely automated and fluidic operations are controlled by an on-board microprocessor. These protocols primarily consist of incubation, wash and optical read-out steps that may be conveniently modified for specific applications or conditions using Windows software. All sample and wash fluids are stored onboard the cartridge after an assay is completed- there is no possibility of post-analysis sample contact. The hardware is currently in its fourth generation. The AIR platform is highly amendable to multiplexing, allowing for rapid, simultaneous quantification of potentially 100’s of analytes with no increase in assay complexity. This robust detection platform is novel in its combination of rapid testing, highly multiplexed capacity and low assay cost. AIR has also been adapted for use in the field and at the point of need.

Technical Description
AIR is a silicon chip-based label-free biosensor platform, which enables the detection and quantification of virtually any probe-target analyte pair with a high degree of sensitivity. Detection occurs via optical sensing of the binding of sub-Angstrom layers to the functionalized substrate surface. As AIR is an essentially reagentless assay, typical target analysis takes under 30 minutes of processing time (limited only by binding kinetics of the probe-target), in contrast to labeled techniques, which require further processing (usually 2-3 additional chemistries after target hybridization) and result in longer test times (>2 hrs) and substantially increased reagent costs.

Evaluation Criteria

THROUGHPUT:

Between 30 and 60 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
0-1 solutions, buffer, eluents, and/or reagents
0 components
Greater than 20 minutes is required for setup
1-2 steps are required for detection

LOGISTICS:

A day of training and technical skills are required
Approximately the size of a toaster
Between 5 and 25 kg
Wireless and wired connections are available
System or device has 110V electrical requirement

OPERATIONS:

Can be used from 25°C to 37°C
Components must be stored at 4°C
Performance is not influenced by relative humidity
Between 6 months and 1 year shelf life
5-10 years expected life
Results cannot be viewed in real-time
The system could be adapted to a fully autonomous system with some effort
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 50 µL
Good specificity. System has a consistently low level of false alarms (2-5%)
10,000-100,000 CFU per mL
10,000-100,000 PFU per mL
1-10 ng per mL
Spore lysis not necessary for detection by system