The Dragonfly System | Microfluidic Systems

General Description
The Dragonfly System platform offers the precision of molecular diagnostics in an easy to use format that can deliver confirmatory results in 30 minutes or less. The Dragonfly platform is being designed to be a Role 1 CLIA-waived diagnostic device that is highly multiplexed and designed for diagnostic/confirmatory field use by a medically trained operator in a “primary care” setting (Point of Care or Point of Need settings).

Technical Description
The assay format of the Dragonfly platform is TaqMan probe-based chemistry in a single-use disposable cartridge. The Dragonfly platform cartridge system is able to process clinical samples such as blood, urine, saliva, buccal and nasopharyngeal swabs. It is also anticipated that the system will have the ability to process stool samples in subsequent generations of the device. All sample preparation necessary post-collection is performed within the disposable cartridge of the Dragonfly platform system. The Dragonfly platform uses ultrasonic lysis for the rupture of tough cell membranes that are then microfluidically passed through a purification column preferentially binding the nucleic acid in the presence of chaotropic agents. The nucleic acid is washed with multiple steps prior to being eluted into the detection chamber of the instrument. The current time-to-result for the Dragonfly platform is thirty (30) minutes or less, depending on which assay panel is being performed. We anticipate a further reduction in time-to-result in subsequent generations of the system. The Dragonfly platform will be fully automated with radio frequency identification (RFID) chips embedded in each cartridge allowing for efficient, automated, error-free protocol determination by the Platform programming. Required training for the Dragonfly platform will be minimal taking less than 1 hour and utilizing easy to understand simple visual aids. The Dragonfly platform requires no human interpretation and is capable of reporting data out-put (positive/negative) to a local, on-screen digital readout and or electronic data output to a remotely located server.

Evaluation Criteria

THROUGHPUT:

Between 15 and 30 minutes for detection
1 sample, <10 tests/sample per run
Less than 32 samples every 2 hours
The system or device is currently fully automated
Device or system is intended for multiple detection assays
0-1 solutions, buffer, eluents, and/or reagents
0 components
Less than 5 minutes is required for set-up
3-5 steps are required for detection

LOGISTICS:

Very brief (minutes-hours) training and minimal technical skills
Approximately the size of a toaster
Between 5 and 25 kg
Satellite, wireless and wired connections are available
System or device uses batteries
1-2 hours battery life

OPERATIONS:

Can be used from 4°C to 37°C
Components must be stored at room temperature (27°C)
Between 1 to 3 years 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 closed and not available for modification
The system hardware is closed and not available for modification

DETECTION:

Efforts are underway to achieve 510K clearance
Possible the system could receive FDA approval, no current efforts at this time
Less than 250 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
100-1,000 CFU per mL
100-1,000 PFU per mL
1-10 ng per mL
Fully automated spore lysis