General Description
The MICT system uses a novel detection platform for rapid in-vitro diagnostics by using para magnetic labels to detect a wide range of analytes in a lateral flow format.
Technical Description
The MICT instrument, both bench top and handheld use a disposable cassette to detect analytes by measuring paramagnetic labels that have antibodies attached to them in order to uniquely recognize analytes in a fluid sample. The sample can be blood, plasma, serum, urine, saliva, sewage or a buffer extracted surface swab. The sample is added to a disposable cassette that is inserted into the instrument after development. The labeled analytical capture region within the cassette is measured in a strong magnetic field where the paramagnetic label is magnetized by induction of a 100 kHz, ~1 Tesla AC field. The detector array measures the amount of magnetized material which is proportional to the amount of analyte. The instrument reads a 2D barcode on the cassette that identifies the type of assay, the date of manufacture, the calibration curve for each individual analyte and cassette, eliminating any calibration of the instrument by the user. The cassettes have a shelf life of at least 18 months.
Evaluation Criteria
THROUGHPUT:
- Between 2 and 15 minutes for detection
- Continuous operation with no defined runs
- 349-96 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
- 1 component
- 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
- Wireless and wired connections are available
- System or device has 110V electrical requirement
- 4-8 hours battery life
OPERATIONS:
- Can be used from 4°C to 41°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 is not capable of autonomy
- The system software is open but modification requires licensing
- The system hardware is open but modification requires licensing
DETECTION:
- System currently has 510k clearance
- System currently has FDA approval
- Less than 100 µL
- Excellent specificity. System has occasional false alarms under certain conditions (<2%)
- 1-100 CFU per mL
- 100-1,000 PFU per mL
- Less than 1 ng per mL
- System does not detect spores