General Description
TIRF Sense Handheld chem-bio sensor is designed for use by first responders and for point-of-care diagnostics. TIRF Sense Handheld integrates fluorescence optics, electrochemical system, microfluidics, electronics, software, and nanoengineered bioassays into one handheld device. Analyses are performed in the format of real-time microarrays that are capable of parallel detecting up to targets. TIRF Sense Handheld requires no or minimal sample preparation and is capable of analyzing complex biological fluids. The sensor is equipped with Wi-Fi, BlueTooth, USB, and cellular connectivity, and a GPS system. In contrast to traditional microarrays that detect only end-point results, TIRF Sense Handheld monitors the entire course of association and dissociation kinetics and its dependence on electrochemical polarization, which allows for discriminating between perfect targets and their close homologs that may be present in the matrix.
Technical Description
TIRF Sense Handheld chem-bio sensor employs synergistic combination of Total Internal Reflection Fluorescence (TIRF) with Electric field Control (TIRF-EC). TIRF-EC sensor chip represents a glass or plastic slide coated with a thin electroconducting transparent layer of indium tin oxide (ITO). TIRF-EC chips are incorporated into cartridges that are available in disposable or reusable formats. TIRF-EC chip carries a microarray of reagentless bioassays printed on the ITO surface. TIRF provides real-time monitoring of the interactions between target molecules and bioassays, while the electric field enables several advantageous functions in TIRF system, including accelerated transport of target molecules to their detection sites and disintegrating cell membranes. TIRF-EC microarrays detect unlabeled, unmodified targets, including DNA, RNA, protein, and metabolite molecular markers, biological and chemical toxins, and chemical agents. Depending on the application, TIRF-EC microarray may contain from a few spots of bioassays in a single flow channel to hundreds of chem-bio assays in two or three separate flow channels.
Evaluation Criteria
THROUGHPUT:
- Detection is instantaneous
- Multiple samples, multiple tests/sample per run
- 349-96 samples every 2 hours
- The system or device is currently semi-automated
- 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
- Automatic detection
LOGISTICS:
- Very brief (minutes-hours) training and minimal technical skills
- Approximately the size of a soda can
- Less than 1 kg
- Wireless and wired connections are available
- System or device uses batteries
- 4-8 hours battery life
OPERATIONS:
- Can be used from -21°C to 41°C
- Components must be stored at room temperature (27°C)
- Device or system has peak performance at normal relative humidity conditions
- Between 1 to 3 years shelf life
- 3-5 years expected life
- Results can be viewed in real-time
- The system could easily be adapted into a fully autonomous system
- 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%)
- 1-100 CFU per mL
- 1-100 PFU per mL
- Less than 1 ng per mL
- < 1x10-6 mg/m3
- < 1 ppb