General Description
Antigen Capture ELISA kit for detection of biothreat agents; designed to be performed in the lab using a plate washer/reader for quantitative analysis. The kit can be adapted for field use for qualitative analysis with some effort. The kit is designed for environmental samples and the like, and can test samples in many matrices.
Technical Description
ELISA: antigen capture employing capture and detector antibodies; most kits use monoclonal antibodies for detection.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- 1 sample, single test/sample per run
- 95-32 samples every 2 hours
- The system or approach is not amenable to full or semi-automation
- Device or system is designed for a single use
- 5 or more solutions, buffer, eluents, and/or reagents
- 2 components
- No set-up of the system is required
- Greater than 12 steps are required for detection
LOGISTICS:
- A day of training and technical skills are required
- Approximately the size of a soda can
- Less than 1 kg
- This system is not capable of transmitting data
- There is no electrical requirement
OPERATIONS:
- Can be used from 25°C to 37°C
- Components must be stored at 4°C
- Performance is not influenced by relative humidity
- Between 1 to 6 months shelf life
- The system could be adapted to a fully autonomous system\
- The system does not employ any software
DETECTION:
- Possible the system could receive 510K clearance, no current efforts at this time
- Possible the system could receive FDA approval, no current Less than 100 µL
- Excellent specificity. System has occasional false alarms under certain conditions (<2%)
- 10,000-100,000 CFU per mL
- 1-10 ng per mL
- Spore lysis not necessary for detection by system
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