AIDA: Autonomous Identification Diagnostics and Alert | Prognosys, LLC

General Description
The AIDA™ system is comprised of a multiple pathogens and toxins diagnostic strip, a smart telephone for reading, analyzing and telemetry of the results indicated on the diagnostic strip, and a secure (encrypted) web portal for capturing test data, tracking results, prognosis, decision support, and mapping of identified pathogens and toxins anywhere on the globe. AIDA™ can be used to detect as many as ten pathogens, toxins, chemical threats, and physical conditions (such as temperature, time, and vibration) simultaneously. AIDA™ devices can be configured as qualitative devices or fully quantitative systems with a limit of detection of about 50 ng/mL or 104 CFU, specificity of 95% or better, coefficient of variation of 5% or less, and detection time of less than 10 minutes for all indications on the strip. Prognosys has recently developed multiple pathogen cassettes for B. anthracis spores and PA, C. botulinum toxin, Yersenia pestis, SEB and Ricin, and a number of other diagnostics such as enteric diseases (V. colerae O1, O139, E-coli O157, Salmonella), cardiovascular disease markers (CRP, cTnI, TpP), and a number of kidney disease markers. Developed by Prognosys, LLC as point-of-care diagnostic system, AIDA™ can be used by un-trained individuals at home, in the field, and points of care, without the need for instruments, reagents, and processing. AIDA™ is highly configurable not only for biological threats and medical applications, but also for supply chain tracking and security, tamper detection, and organizational planning and decision support.

Technical Description
Commercially available lateral flow immuno-assays using colloidal gold labeled antibodies, incorporated into barcode diagnostic devices.

Evaluation Criteria

THROUGHPUT:

2 minutes or less for detection
1 sample, >10 tests/sample per run
The system could easily be adapted into a fully automated system
Device or system is intended for multiple detection assays
0-1 solutions, buffer, eluents, and/or reagents
1 component
No set-up is required for setup
1-2 steps are required for detection

LOGISTICS:

An afternoon of training and some technical skills required
Approximately the size of a soda can
Less than 1 kg
Satellite, wireless and wired connections are available
System or device uses batteries
2-4 hours battery life

OPERATIONS:

Can be used from 4°C to 41°C
Components must be stored at 4°C
Device or system has peak performance at normal relative humidity conditions
Between 1 to 3 years shelf life
1-3 years expected life
Results can be viewed in real-time
The system could easily be adapted into a fully autonomous system
The system software is open but modification requires licensing
The system hardware is open but modification requires licensing

DETECTION:

Possible the system could receive 510K clearance, no current efforts at this time
Less than 50 µL
10,000-100,000 CFU per mL
10,000-100,000 PFU per mL
Greater than 10,000 ng per mL
Manual kit not integrated with the system handles spore lysis
> 1x10-3 mg/m3
1 ppb – 1 ppm