Bio-Rad Laboratories BIOPLEX 2200 SYSTEM. BioPlex 2200 System. Workflow: Redefined

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May O’Brien’
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1 BioPlex 2200 System Workflow: Redefined

2 Workflow: Redefined Leveraging the power of multiplex testing, the BioPlex 2200 system brings flexible workflow solutions to your laboratory. Disease Focused Multiplex Menu Autoimmune Infectious Diseases Specialty Immunoassay

Chemistry: Redefined Proprietary Bead Technology Overview BioPlex 2200 immunoassays use Example: ANA Screen Reagent Pack The ANA

Every sample processed on the BioPlex 2200 system has up to three internal quality control beads added which dramatically improves

The beads are infused with varying ratios of fluorescent dyes, creating unique bead sets.

Bead sets are then mixed together in a single reagent pack allowing for simultaneous detection of multiple analytes from a single

3 Quality Control Microsphere (SVB, ISB, RBB) 13 Assay Microspheres: 1 dsdna 2 Chromatin 3 Ribosomal P 4 SS-A (52 kd)* 5 SS-A (60

in the U.S. Reported as SS-A and RNP for a total of 11 individual results.

standardize detector performance Reagent Blank Bead (RBB) Identifies sample problems arising from non-specific binding IgA

Ag-Ab kit * Panel dependent Innovative Multiplex Chemistry Benefits Improve sensitivity with better signal to cutoff ratio using

laminar flow with liquid, ready-to-use reagents, calibrators, and controls Improve turnaround time and report up to 1400* patient

3 Chemistry: Redefined Proprietary Bead Technology Overview BioPlex 2200 immunoassays use Example: ANA Screen Reagent Pack The ANA Screen Reagent Pack uses 16 microspheres: 13 assay beads and 3 quality control checks Quality Assurance with IQ Bead Technology* Every sample processed on the BioPlex 2200 system has up to three internal quality control beads added which dramatically improves the quality and accuracy of assay results: heterogeneous sets of magnetic 8 µm beads. The beads are infused with varying ratios of fluorescent dyes, creating unique bead sets. Beads within each set are coated with an antigen or antibody. Bead sets are then mixed together in a single reagent pack allowing for simultaneous detection of multiple analytes from a single sample. 3 Quality Control Microsphere (SVB, ISB, RBB) 13 Assay Microspheres: 1 dsdna 2 Chromatin 3 Ribosomal P 4 SS-A (52 kd)* 5 SS-A (60 kd)* 6 SS-B 7 Sm 8 Sm/RNP 9 RNP (A)* 10 RNP (68)* 11 Scl Jo-1 13 Centromere B * Individual SS-A and RNP results not available in the U.S. Reported as SS-A and RNP for a total of 11 individual results. Serum Verification Bead (SVB) Confirms the presence of serum/plasma Internal Standard Bead (ISB) Appears in every tube to standardize detector performance Reagent Blank Bead (RBB) Identifies sample problems arising from non-specific binding IgA Verification (AVB) Detects IgA deficiency in the Celiac IgA kit Signal Normalization Bead (SNB) Normalizes assay signals in the HIV Ag-Ab kit * Panel dependent Innovative Multiplex Chemistry Benefits Improve sensitivity with better signal to cutoff ratio using proprietary magnetic bead chemistry Reduce hands-on time and improve workflow efficiency Multiplex Bead Chemistry Beads pass in laminar flow with liquid, ready-to-use reagents, calibrators, and controls Improve turnaround time and report up to 1400* patient results per hour Enhance quality assurance with integrated QC smart bead technology in every test * U.S. Only up to 1200 patient results per hour. Up to 25 color-coded microspheres or antibody can be bound with a unique antigen Sample and beads added to the reaction vessel Multiplex immunoassay reaction Aspiration of processed beads to the detector Red laser classifies the bead type indicating the antigen or antibody bound to it Green laser measures fluorescence from the immunoassay reaction

Laboratory: Redefined The BioPlex 2200 system combines the diagnostic power of proprietary multiplex chemistry, state-of-the-art software, the benefits of full automation and random access capability

4 Laboratory: Redefined The BioPlex 2200 system combines the diagnostic power of proprietary multiplex chemistry, state-of-the-art software, the benefits of full automation and random access capability bringing a new level of flexibility and operational efficiency to your laboratory. System Benefits Fully Automated/Random Access Instrument Hardware Streamline testing to one area of the laboratory and improve workflow efficiency Eliminate batch testing which improves result turnaround time Decreased specimen and reagent handling reduces errors Connect to Total Laboratory Automation (TLA) Systems with a Point-in-Space design for an improved LEAN laboratory environment State-of-the-Art Software Experience the ease-of-use of an intuitive touchscreen interface Connect to LIS using Host Query or Broadcast Download Track daily, weekly, monthly, on-demand, and user defined tasks with the electronic maintenance Verify on-board reagents and tasks to complete prior to a run using the run checklist Integrated QC Module Customize QC rules, QC tracking, and 3rd party controls with the comprehensive QC Module Generate QC mean and SD prior to new lot implementation Recalculate mean and SD for established data points Export QC results directly to Bio-Rad s Unity Real Time program

BioPlex 2200 System System Specifications Physical Dimensions Height... 4-5 (1.3 m) Width... 4-3 (1.3 m) Depth... 2-10 (0.9 m) Weight Approximately... 1032 lbs.

5 BioPlex 2200 System System Specifications Physical Dimensions Height (1.3 m) Width (1.3 m) Depth (0.9 m) Weight Approximately lbs. (468 kg) Performance Characteristics Maximum Throughput*...Up to ª1400 patient results per hour Sample Capacity...Up to 100 samples per hour Time to First Result...As little as 45 minutes (panel dependant) Sample Tubes... Any CLSI primary sample tubes Sample Tray...10 racks, 5 samples each Sample Volume... As little as 5 ul STAT Capability...Continuous access Walkaway Capacity...8 hours of continuous use Operational Mode... Random and continuous access, priority (STAT) loading Operator Interfaces...Touchscreen monitor, keyboard, trackball mouse Clot Detection...Yes Quality Control... Levey-Jennings, Westgard Rules Sample Barcode Acceptable Symbologies...Code 128, Codabar, Code 39, Interleaved 2 of 5 Sample Types...Serum or Plasma. For more information, refer to BioPlex 2200 assay inserts Sample Dilutions...1:4, 1:10, and 1:100 (panel dependant) Access During Use... Continuous sample input/output, consumables replenishment, and waste disposal without interruption of sample processing LIS Connectivity...Bi-directional: ASTM Standard Total Laboratory Automation (TLA)...Complies with CLSI Auto5A interface standard Power Requirements Input Voltage VAC at Hz, 1000 Watt UPS...Provided Water Requirements Water Quality...CLSI Type II or better Direct Plumbing... Maximum pressure of 50 kpa Installation Requirements Crate Clearance Instrument Operational Requirements Clearance Rear...5 (1.5 m) Rear...6 (0.2 m) Left...4 (1.2 m) Left... 3 (1.0 m) Right...4 (1.2 m) Right...6 (0.2 m) Front...10 (3.0 m) Front... 3 (1.0 m) Vertical...6 (1.8 m) Vertical... 6 (1.8 m) * ANA Throughput ª U.S. Only Up to 1200 patient results per hour Class 2 Laser Product Ordering Information Catalog No. Description BioPlex 2200 System...1 instrument Sample Racks per box Sample Tray...1 tray Instrument Sheath Fluid... 2 per box Instrument Wash Buffer... 1 box Reaction Vessels per bag Instrument Detector Calibration Pack... 1 pack Instrument Detector Clean Pack... 1 pack Instrument Probe Cleaning Solution Bottles... 4 per box Sample/Reagent Probe... 1 each N NaOH... 1 liter For further information, please contact the Bio-Rad office nearest you or visit our website at Clinical Diagnostics Group Website U.S Australia Austria Belgium +32 (3) Brazil +55 (31) Canada China Czech Republic Denmark Finland France Germany +49 (0) Greece Hong Kong Hungary India Israel Italy Japan Korea Mexico +52 (55) The Netherlands New Zealand Norway Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland +41 (0) /06 Taiwan Thailand United Kingdom +44 (0) Bio-Rad Laboratories, Inc. Printed in USA DG T-100 Rev. 09/2015 Printed on recycled paper with soy-based inks

BioPlex 2200 System. Like no other. The first and only fully-automated, random access, multiplex testing platform. Bio-Rad Laboratories

BioPlex 2200 System. Like no other. The first and only fully-automated, random access, multiplex testing platform. Bio-Rad Laboratories Bio-Rad Laboratories BIOPLEX 2200 SYSTEM BioPlex 2200 System Like no other. The first and only fully-automated, random access, multiplex testing platform Bio-Rad Laboratories BIOPLEX 2200 SYSTEM Fully