General Description
BioThreat Integrated Detection System provides quick, reliable screening and confirmatory analysis of biothreats for both biologists in the laboratory and First Responders in the field. The BioThreat Alert® Reader and BioThreat Alert® strips provide a screening test for 9 different assays (Abrin, Anthrax, Bot Tox, Brucella, Orthopox, Plague, Ricin, SEB, and Tularemia) in less than 20 minutes. The reader is a fully functional ultra-mobile PC designed to enhance the speed and ease of testing. The interface has been designed to be large and simple, accommodating for various PPE worn by First Responders. Tetracore’s T-COR 4TM Handheld Real-Time PCR Thermocycler provides superior confirmatory analysis for samples tested with BioThreat Alert® assays. The device operates connected to the BioThreat Alert® Reader via USB and runs either standard TaqMan® real-time PCR or Isothermal real-time fluorescence based amplification, which delivers confirmatory analysis in 10 minutes. It can process four independent samples and is capable of analyzing two targets per sample. Tetracore produces 18 dry real-time PCR and 4 dry Isothermal Assays for the T-COR 4TM with shelf lives exceeding 18 months at room temperature. The T-COR 4TM is an open system capable of running any customer’s assay in either a wet or dry formulation. Identification of agents in powder samples, agents in environmental samples, bacteria, and viruses has been demonstrated in both devices.
Technical Description
Provides screening and confirmation of biothreat samples. BioThreat Alert® strips are handheld lateral-flow immunochromatographic assays that use colloidal gold labeled antibodies. BioThreat Alert® Reader is a handheld PC coupled with additional hardware and software to allow analysis of the strips. T-COR 4TM is a handheld, battery-powered, peltier-based thermocycler designed for TaqMan® real-time PCR amplification and Isothermal real-time fluorescence based amplification. Designed with a proprietary, modular optical system, it can be modified to suit future requirements. The developed optical technology enables support of nucleic acid detection, polypeptide detection, and environmental sensing.
Evaluation Criteria
THROUGHPUT:
- Between 15 and 30 minutes for detection
- Multiple samples, multiple tests/sample per run
- 95-32 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
- 2 components
- 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
- 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 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 is not capable of autonomy
- The system software is open but modification requires licensing
- The system hardware is open but modification requires licensing
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 250 µL
- Superior specificity. System has a false alarm rate approaching zero (~0%)
- 1-100 CFU per mL
- 1-100 PFU per mL
- 1-10 ng per mL
- Spore lysis not necessary for detection by system