General Description
JBAIDS is the DoD standard platform used to positively identify specific biological warfare agents in a dual-purpose role: for diagnostic applications in a clinical environment and for environmental and food sample confirmatory testing. JBAIDS provides timely, reliable answers to field commanders and medical laboratory officers to support critical decision making and countermeasures and aid in determining appropriate medical intervention. The JBAIDS is an FDA cleared diagnostic system.
Technical Description
The JBAIDS instrument is a ruggedized, portable real-time PCR instrument using TaqMan PCR amplification for detection of biological threat agents. The instrument is composed of an air thermocycler that amplifies specific DNA and RNA sequences using PCR and a fluorimeter that measures fluorescence signals associated with production of PCR product (amplicon) during the course of the reaction. Analysis of PCR data is achieved by associated software that automatically makes positive or negative calls for 16 biological threat agents.
Notes:
The JBAIDS is a currently fielded DoD system which is scheduled to be replaced with the Next Generation Diagnostic System.
Evaluation Criteria
THROUGHPUT:
- Between 60 minutes and 8 hours for detection
- Multiple samples, multiple tests/sample per run
- 95-32 samples every 2 hours
- The system could be adapted to a semi-automated system
- with some effort
- Device or system is intended for multiple detection assays
- 4 solutions, buffer, eluents, and/or reagents
- 5 or more components
- Less than 5 minutes is required for set-up
- Greater than 12 steps are required for detection
LOGISTICS:
- More than a day of training and significant technical skills
- are required
- Approximately the size of a carry-on luggage suitcase
- Between 5 and 25 kg
- This system is not capable of transmitting data
- System or device has 110V electrical requirement
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
- Greater than 10 years expected life
- Results can be viewed in real-time
- The system is not capable of autonomy
- The system software is open and available for modification
- The system hardware is open and available for modification
DETECTION:
- System currently has 510k clearance
- System currently has FDA approval
- Greater than 250 µL
- Excellent specificity. System has occasional false alarms
- under certain conditions (<2%)
- 100-1,000 CFU per mL
- 1,000-10,000 PFU per mL
- Manual kit not integrated with the system handles spore lysis