Luminex 100/200 System | Luminex Corporation

General Description
The Luminex 100/200 System is designed to meet the multiplexing needs of clinical and research laboratory professionals. The System is a versatile multiplexing platform capable of performing qualitative and quantitative analysis of proteins and nucleic acids in a variety of sample matrices. The Luminex 100/200 is a flexible analyzer based on the principles of flow cytometry. The System enables you to multiplex (simultaneously measure) up to 100 analytes in a single microplate well, using very small sample volumes. The System delivers fast and cost-effective bioassay results on many assay formats including nucleic acid assays, receptor-ligand assays, immunoassays and enzymatic assays. The Luminex 100/200 System is the combination of three core xMAP technologies. The first is xMAP microspheres, a family of 100 fluorescently dyed 5.6 micron-sized polystyrene microspheres that act as both the identifier and the solid surface to build the assay. Suspended microspheres give consistent, reproducible results and allow for easy quality control. The second is the flow cytometry-based Luminex 100/200 analyzer, which integrates key xMAP detection components such as lasers, optics, fluidics and high-speed digital signal processors. The third component is the xPONENT software, which is designed for protocol-based data acquisition with robust data regression analysis. The total system includes the Luminex 100/200 instrument, the Luminex XY plate handling platform, and the Luminex SD sheath fluid delivery system, software, and PC. A professional Training Session for one person is included.

Technical Description
The system includes the Luminex 100/200 instrument, the XY plate handling platform, and the SD sheath fluid delivery system, software and PC. The System comprises three core xMAP technologies:

1. The xMAP microspheres, a family of 100 fluorescently dyed 5.6 micron-sized polystyrene microspheres that act as both the identifier and the solid surface to build the assay.
2. The flow cytometry-based Luminex 100/200 analyzer, which integrates key xMAP detection components such as lasers, optics, fluidics and high-speed digital signal processors.
3. The xPONENT® software, which is designed for protocol-based data acquisition with robust data regression analysis.

Notes:
One of several systems that employ bead based xMAP technology.

Evaluation Criteria

THROUGHPUT:

2 minutes or less for detection
Multiple samples, multiple tests/sample per run
349-96 samples every 2 hours
The system or device is currently fully automated
Device or system is intended for multiple detection assays
4 solutions, buffer, eluents, and/or reagents
1 component
Greater than 20 minutes is required for set-up
3-5 steps are required for detection

LOGISTICS:

An afternoon of training and some technical skills required
Approximately the size of a carry-on luggage suitcase
Between 25 and 50 kg
Wired connections are available
System or device has 110V electrical requirement

OPERATIONS:

Can be used from 4°C to 37°C
Components must be stored at 4°C
Device or system has peak performance at normal relative humidity conditions
Between 1 to 3 years shelf life
5-10 years expected life
Results can be viewed in real-time
The system could easily be adapted into a fully autonomous system
The system software is closed and not available for modification
The system hardware is closed and not available for modification

DETECTION:

System currently has 510k clearance
System currently has FDA approval
Less than 50 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
1-100 CFU per mL
1-100 PFU per mL
Less than 1 ng per mL
Manual kit not integrated with the system handles spore lysis