R.A.P.I.D. BioThreat Detection System | BioFire Diagnostics, Inc.

General Description
The Ruggedized Advanced Pathogen Identification Device (R.A.P.I.D.) is a portable real-time PCR system designed to identify biological agents. Because of its rugged design, reliability, and sensitivity it has become the standard for the U.S. DoD and other militaries around the world. The R.A.P.I.D. is the ideal choice for mobile analytical labs and field hospitals. The instrument integrates Idaho Technology’s LightCycler ® Instrument technology into a portable, impact resistant package. Distinctive software allows simple “push-button” use of the R.A.P.I.D. System by military field personnel with minimal training. R.A.P.I.D.’s open platform supports multiple chemistries and sample matrices including environmental and food samples. Used with Idaho Technology’s commercial freeze-dried pathogen test kits or customized reactions, R.A.P.I.D. provides quick, safe, and accurate field identification of pathogens.

Technical Description
R.A.P.I.D. employs real-time Polymerase Chain Reaction (PCR).

Evaluation Criteria

THROUGHPUT:

Between 30 and 60 minutes for detection
Multiple samples, multiple tests/sample per run
Less than 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
Wireless and wired connections are available
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 6 months 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 and available for modification
The system hardware is open and available for modification

DETECTION:

Possible the system could receive 510K clearance, no current efforts at this time
Possible the system could receive approval, no current
efforts at this time
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