MTIDx: Rapid Multiplexed Molecular Diagnostics in a Stand-Alone Low Cost Disposable Platform | Mesa Tech Intl, Inc.

General Description
MITDx is a stand-alone (instrumentation independent), disposable, nucleic acid-based molecular diagnostic platform that integrates nucleic acid extraction, amplification and detection into one simple self-contained device for point of care or resource-limited settings. It does not require elaborate lab infrastructure, expense instrumentation and highly trained personnel. It has capability to detect and differentiate multiple pathogen targets, subtypes, antibiotic resistance from sample-to-answer in <45 minutes. The readout module can either be simple colorimetric Yes or No answers, or digital quantitative readout via the use of a cell phone-sized reader. The data collected from the diagnostic device has the option to be submitted to the remote data processing center via wireless or secure data transferring methods. The device has the option to be run on batteries or regular AC electricity outlets.

Technical Description
The MTIDx platform relies on the novel integration of novel paper chromatography-based passive nucleic acid extraction, robust Oscillating nucleic acid amplification and colorimetric lateral flow-based hybridization detection into one simple cell-phone sized device. It employs greatly simplified engineering solutions that does not requires traditional active valves, pumps, moving parts, Peltier-based thermocycling apparatus etc. The fluid flow is controlled by the combination of gravity and capillary motion via a set of temperature-sensitive valves. The firing of the valves of controlled by a low cost, programmable, micro-controller unit.

Evaluation Criteria

THROUGHPUT:

Between 30 and 60 minutes for detection
1 sample, >10 tests/sample per run
System is continuous and provides real time analysis with no defined tests/samples
The system or device is currently fully automated
Device or system is designed for a single use
0-1 solutions, buffer, eluents, and/or reagents
1 component
No set-up of the system is required
1-2 steps are required for detection

LOGISTICS:

Very brief (minutes-hours) training and minimal technical skills
Approximately the size of a soda can
Less than 1 kg
Wireless and wired connections are available
System or device uses batteries
4-8 hours battery life

OPERATIONS:

Can be used from < -21°C to > 42°C (All temperatures)
Performance is not influenced by relative humidity
Between 6 months and 1 year shelf life
Less than 1 year expected life
Results can be viewed in real-time
The system is not capable of autonomy
The system does not employ any software
The system is single use or this question does not apply to this device

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
Less than 100 µL
Superior specificity. System has a false alarm rate approaching zero (~0%)
1-100 CFU per mL
1-100 PFU per mL
100-1,000 ng per mL
Add on capability that is full or semi-automated for spore lysis