General Description
The MBio MQ multiplexed assay system delivers quantitative fluorescence immunoassay results for panels of analytes – all from a single drop of blood, plasma, or serum. MQ is a simple reader and disposable cartridge system for point-of-care testing. MQ provides the data quality and multiple results of a clinical laboratory analyzer in an inexpensive format with workflow comparable to single analyte rapid diagnostic tests. Under design for a CLIA-waiver, the simple system uses minimal sample (5 to 10 microliters) and delivers results in less than 30 minutes. The MBio technologies fill an unmet need for near patient disease panels.
Technical Description
MBio’s diagnostic systems are all built on the company’s LightDeckTM technology, a patent-protected fluorescence assay illumination method that is simultaneously simple, inexpensive and robust. It is a variation on planar waveguide technology, an approach that has been used for performing sensitive biological assays for over two decades. MBio’s innovation has been to solve the light coupling reproducibility problem that has limited widespread use of the technology. The MBio MQ incorporates low cost consumer electronics (laser diodes and imagers) to create a robust reader device and for the MQ’s single-use test cartridges.
Evaluation Criteria
THROUGHPUT:
- Between 15 and 30 minutes for detection
- Multiple samples, multiple tests/sample per run
- Less than 32 samples every 2 hours
- The system or device is currently semi-automated
- Device or system is designed for a single use
- 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
- System or device has 110V electrical requirement
- 4-8 hours battery life
OPERATIONS:
- Can be used from 25°C to 37°C
- Components must be stored at room temperature (27°C)
- Performance is not influenced by relative humidity
- Between 6 months and 1 year shelf 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 FDA approval, no current efforts at this time
- Less than 50 µL
- Excellent specificity. System has occasional false alarms under certain conditions (<2%)
- 10,000-100,000 PFU per mL
- 1-10 ng per mL