TIRF Sense Portable Chem-Biosensor | TIRF Technologies, Inc.

General Description
TIRF Sense is a portable multipurpose chem-bio sensor designed for use in the field and mobile labs. TIRF Sense integrates fluorescence optics, electrochemical system, microfluidics, electronics, software, and nanoengineered bioassays into one portable device. Analyses are performed in the format of real-time microarrays that are capable of parallel detecting up to hundreds of targets. TIRF Sense requires no or minimal sample preparation and is capable of analyzing complex biological fluids. In contrast to traditional microarrays that detect only end-point results, TIRF Sense monitors the entire course of association and dissociation kinetics. Additionally, the sensor measures the dependence of association and dissociation kinetics on electrochemical polarization, which allows for discriminating between perfect targets and their close homologs.

Technical Description
TIRF Sense 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-EC sensor cartridge is engaged into optical, fluidic, and electrochemical subsystems that allow for performing supersensitive TIRF-EC analysis. 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 discrimination between close homologs of target molecules. TIRF-EC microarrays detect unlabeled, unmodified targets. 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. TIRF Sense supports fluorescence assays, Electro-Chemi-Luminescence (ECL), other luminescence assays, as well as luminescence assays immobilized in a hydrogel layer printed at the TIRF-EC surface.

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 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 -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