General Description
BioSentinel’s BoTest™ Botulinum Neurotoxin (BoNT) Detection Assays offer the most sensitive system available for the routine detection of BoNT serotypes A and E (BoTest™ A/E); and serotypes B, D, F, and G (BoTest™ B/D/F/G). Intended uses include high throughput drug discovery; food, environmental, and water testing; and research. The assay detects and quantifies the activity of BoNT. In addition, the BoTest Matrix A assay can be used to detect botulinum activity in complex matrices.
Technical Description
The BoTest™ Assays utilize fluorescent reporters that give a ratiometric response when specifically cleaved by BoNT. The assay is run in a mix-and-read, 96 – 1536-well plate format. The reporter uses native BoNT substrates for improved enzyme binding and sensitivity and can be coupled to antibody-conjugated magnetic beads to allow for the detection of BoNT in complex matrices. The assays provide up to a 300-fold increase in sensitivity for BoNT activity compared to other co µL commercially available assays. The assays are provided in kits to ensure reagent consistency and reliability.
Notes:
Can determine if toxin is active.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- Multiple samples, single tests/sample per run
- 349-96 samples every 2 hours
- The system could easily be adapted into a fully automated system
- Device or system is intended for multiple detection assays
- 3 solutions, buffer, eluents, and/or reagents
- 5 or more components
- Greater than 20 minutes is required for set-up
- 3-5 steps are required for detection
LOGISTICS:
- An afternoon of training and some technical skills required
- Between 5 and 25 kg
- Wired connections are available
- System or device has 110V electrical requirement
OPERATIONS:
- Can be used from 25°C to 37°C
- Components must be frozen (-20°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 open but modification requires licensing
- The system hardware is closed and not available for modification
DETECTION:
- Not possible for the system to achieve 510K clearance
- Possible the system could receive FDA approval, no current efforts at this time
- Less than 10 µL
- Good specificity. System has a consistently low level of false alarms (2-5%)
- Less than 1 ng per mL