General Description
The RAMP System is designed to provide First Responders, Military Personnel, and Public Safety Workers with rapid, on-site, reliable diagnostic information for biological testing. The RAMP System is utilized by First Responder Teams world-wide. The RAMP System consists of a portable scanning fluorescence Reader and single-use, disposable test cartridges. To use, a small sample is added to the test cartridge and then inserted into the Reader. RAMP provides a positive or negative result in minutes, with no additional user intervention. Tests are available for anthrax, ricin, botulinum and pox. RAMP is used for testing liquid, powder or invisible surface samples. A suspect surface, powder or liquid is sampled using a swab and then added to the supplied sample buffer. Then a portion of the sample is placed into the Test Cartridge that is then inserted into the RAMP Reader. There is no regular calibration or maintenance required with the RAMP system and the cartridges have an internal standard system that runs concurrently with every assay to eliminate environmental and assay-to-assay variability. This internal standard system is not available in earlier generation flow assays and is unique to the RAMP system. The system has consistently demonstrated to be 100% reliable in detecting anthrax at or above 4,000 spores and does not cross-react with interfering substances, such as baking powder, or with non-pathogenic strains of anthrax.
Technical Description
RAMP is a system for testing the presence of B. anthracis spores, ricin, botulinum toxin and orthopox viruses. The Reader is a scanning immunoassay and data analysis system measuring fluorescence in RAMP cartridges. The Reader can be operated on battery power or AC. The RAMP Test Cartridge is a single-use analyte-specific test used to detect the presence of analyte in a sample. The operator prepares the sample, places an aliquot into the sample well of the Test Cartridge, inserts Cartridge into the RAMP Reader, which analyzes the sample and provides a result.
Evaluation Criteria
THROUGHPUT:
- Between 15 and 30 minutes for detection
- 1 sample, single test/sample per run
- Less than 32 samples every 2 hours
- The system or device is currently semi-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
- Wired connections are available
- System or device uses batteries
- 4-8 hours battery life
OPERATIONS:
- Can be used from 4°C to 37°C
- Components must be stored at room temperature (27°C)
- Performance is not influenced by relative humidity
- Between 1 to 3 years shelf life
- Greater than 10 years expected life
- Results cannot be viewed in real-time
- The system is not capable of autonomy
- 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 100 µL
- Superior specificity. System has a false alarm rate
- approaching zero (~0%)
- 1,000-10,000 CFU per mL
- 10,000-100,000 PFU per mL
- 10-100 ng per mL
- Spore lysis not necessary for detection by system