FLASH Reader | Operational Technologies Corporation

General Description
The Fluorescent Assay Sandwich Handheld (FLASH) Reader is a second generation portable fluorometer with epifluorescence optics designed to rapidly and sensitively assess fluorescence emanating from magnetic bead-based sandwich assays. In particular, the FLASH Reader is customized to read OpTech's DNA Aptamer-based magnetic bead sandwich assays for a variety of foodborne pathogens, arboviruses, rickettsia and Leishmania parasites.

Technical Description
The basic technology centers on epifluorescence using a 630 nm red laser and PMT to read DNA aptamer-based magnetic bead sandwich or FRET assays.

Evaluation Criteria

THROUGHPUT:

Between 30 and 60 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
Less than 5 minutes is required for set-up
1-2 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)
Device or system has peak performance at normal relative humidity conditions
Between 1 to 3 years shelf life
Greater than 10 years expected life
Results can be viewed in real-time
The system could be adapted to a fully autonomous system with significant effort
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 FDA approval, no current efforts at this time
Greater than 250 µL
Good specificity. Consistently low level of false alarms (2-5%)
1-100 CFU per mL
100-1,000 PFU per mL
1-10 ng per mL
Spore lysis not necessary for detection by system
3x10-5 - 1x10-4 mg/m3
1 ppm – 100 ppm