T-COR 4 Handheld Real-Time PCR Thermocycler | Tetracore, Inc.

General Description
Tetracore’s T-COR 4 Handheld Real-Time PCR Thermocycler can process four independent samples and is capable of analyzing two targets per sample. The T-COR 4 has a footprint of 9” x 7.5” x 3”, weighs 6 pounds, and runs continuously off battery power for 8 hours. The system is capable of running both standard TaqMan® real-time PCR and Isothermal real-time fluorescence based amplification. Isothermal real-time fluorescence based amplification allows for confirmatory analysis in 10 minutes. The user can choose to run the device in either stand-alone mode or connected to a PC. Intuitive software allows the user to set up, run, and analyze an experiment. Easy to learn and simple to use, the T-COR 4 is designed for use by both first responders in the field and biologists in the laboratory. We have demonstrated the identification of agents in powder samples, agents in environmental samples, bacteria, and viruses. Tetracore produces 18 dry real-time PCR and 4 dry Isothermal Assays for the T-COR 4. Dry assays developed for the system are subject to accelerated stability testing at 55 degrees Celsius and 45 degrees Celsius, and to real-time stability testing at room temperature. We have data supporting a shelf life of more than 18 months at room temperature. The T-COR 4 is an open system capable of running any customer’s assay, in either a wet or dry formulation. A handheld, battery powered centrifuge is included with the system.

Technical Description
A handheld, battery powered, peltier-based thermocycler designed for use with TaqMan® real-time PCR amplification and Isothermal real-time fluorescence based amplification. Isothermal real-time fluorescence based amplification allows for confirmatory analysis in 10 minutes. Tetracore has designed a proprietary, modular optical system such that the instrument can be modified to suit future end users requirements. The developed optical technology enables Tetracore to support the fields of biotechnology, such as nucleic acid detection, polypeptide detection, and environmental sensing.

Evaluation Criteria

THROUGHPUT:

Between 2 and 15 minutes for detection
Multiple samples, multiple 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
1 component
No set-up of the system is required
3-5 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
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 1 to 3 years shelf life
5-10 years expected life
Results can be viewed in real-time
The system could be adapted to a fully autonomous system with significant 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 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
Manual kit not integrated with the system handles spore lysis