BioThreat Alert Reader and BioThreat Alert Strips | Tetracore, Inc.

General Description
This new reader boasts many features designed to enhance the speed and the ease of testing for biological warfare agents. The BioThreat Alert® Reader is a fully functional ultra-mobile PC (UMPC), running Windows and capable of connecting to WiFi and Bluetooth signals. Users can interact with the reader with its touch screen or by connecting via USB with a keyboard/mouse. The user interface has been designed to be large and simple in order to aid First Responders who may be using various forms of PPE. Coupling this new reader with Tetracore’s BioThreat Alert® strips creates a quick, reliable system for biodetection. BioThreat Alert® strips have been on the market for over 10 years and offer assays to detect Abrin, Anthrax, Bot Tox, Brucella, Orthopox, Plague, Ricin, SEB, and Tularemia. These robust handheld assays are capable of testing samples from a variety of matrices (soil, air, liquid, powder) in a matter of 15 minutes. Upon the completion of an assay, the BioThreat Alert® Reader can perform and record an accurate and objective analysis in merely 20 seconds. The software is also capable of generating a detailed report for each sample tested, which includes numerical output and a graphical representation of the results. The report can also be printed directly from the unit.

Technical Description
This detection system consists of two separate parts. The BioThreat Alert® strips are handheld lateral-flow immunochromatographic assays that use colloidal gold labeled antibodies for detection. The BioThreat Alert® Reader is a handheld PC coupled with additional hardware and software to allow for the analysis of the aforementioned strips. A camera attached to the rear of the device analyzes the strips’ surface, measuring the optical density (reflection) and then determining a positive/negative result. The tray attached to the unit is capable of being modified to suit new assay types and designs in the future.

Evaluation Criteria

THROUGHPUT:

Between 2 and 15 minutes for detection
1 sample, single test/sample per run
95-32 samples every 2 hours
The system or device is currently fully automated
Device or system is designed for a single use
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
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 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%)
10,000-100,000 CFU per mL
10,000-100,000 PFU per mL
Spore lysis not necessary for detection by system

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