Compact Diagnostic System (model CDS-100) | Resonant Sensors Incorporated

General Description
Resonant Sensors Incorporated (RSI) is developing a new compact photonic biosensor system for real time screening of an array of biotoxins, parasites and/or viruses in biological and environmental samples. Our products include a disposable sensor chip with an associated compact reader unit that can rapidly and simultaneously screen for an array of agents without requiring the use of chemical labels or post processing steps. This differentiating technology provides a new point-of-use diagnostic tool for first responders in the field. Our sensor platform can be applied to monitor an array of bio- or chemical reactions in a variety of matrices (including serum, environmental water samples, and food). Selectivity is imparted on the sensor element using conventional surface chemistries (such as silane) to covalently attach commercially available antibody, aptamer, or DNA layers. As a test begins, the analyte binds to the detection-layer target, and the system monitors instantaneous changes at the sensor surface, thus providing real-time data. Test time is limited only by chemical binding dynamics, and is typically less than 10-15 minutes. Qualitative data is available immediately after sample introduction. The RSI sensor chips are pre-sensitized to detect a target panel of 15 microbials and toxins in a single sample for applications such as infectious disease screening. The biochip will be operated without requiring any post-detection washing steps. This work is being performed in collaboration with our commercial partners at Raytheon ELCAN Optical Technologies in Richardson, Texas.

Technical Description
RSI’s products are based upon guided-mode resonance (GMR) sensor technology that occurs in subwavelength waveguide-gratings. When these sensors are illuminated with a light source, a specific wavelength of light is reflected (with a corresponding transmission null) at a particular angle. Interaction of a target analyte with a biochemical layer on the sensor surface yields measurable angular shifts that directly identify the binding event without additional processing or foreign tags. The GMR sensor surface may be optimized with an array of capture molecules, allowing rapid detection of multiple analytes in a single test.

Evaluation Criteria

THROUGHPUT:

Between 2 and 15 minutes for detection
Multiple samples, multiple tests/sample per run
Greater than 750 samples every 2 hours
The system could easily be adapted into a fully automated system
Device or system is intended for multiple detection assays
0-1 solutions, buffer, eluents, and/or reagents
1 component
Less than 5 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 uses batteries
4-8 hours battery life

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
3-5 years expected life
Results can 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
Excellent specificity. System has occasional false alarms (<2%)
1-100 CFU per mL
1-100 PFU per mL
100-1,000 ng per mL
Manual kit not integrated with the system handles spore lysis