BioPlex® 2200 System

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Overview

BioPlex™2200 System

Patented Multiplex Detection Magnetic Bead Technology

BioPlex™ 2200 immunoassays use 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 a ligand (i.e., antigen, antibody, analyte, etc.) specific to a particular assay. Bead sets are then mixed together in a single reagent pack, allowing simultaneous detection of multiple analytes from a single sample.

Each microsphere is dyed with a unique combination of 2 colors.

Up to 25
color-coded
microspheres
(bead regions);
can be bound
with a unique
antigen

Example: ANA Screen Kit

The ANA Screen Reagent Pack uses 16 microspheres: 13 assay beads and 3 quality control checks.

13 Assay Microspheres
1 dsDNA
2 Chromatin
3 Ribosomal protein
4 SS-A (52 kD)*
5 SS-A (60 kD)*
6 SS-B
7 Sm
8 Sm/RNP
9 RNP (A)*
10 RNP (68 kD)*
11 Scl-70
12 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.
3 Quality Control Microspheres
A Serum Verification Bead (SVB)
B Internal Standard Bead (ISB)
C Reagent Blank Bead (RBB)
BioPlex™2200 System

Multiplex Chemistry Detection Method

The dual-laser, multiplex flow detection method processes a minimum of 150 individual bead results for each analyte,representing more than 150 assay readings. This enhances the overall quality of each result compared to standardimmunoassays which, rely on a single reading.

Detection 1. A sample of the final reaction mixture is aspirated to the detector.


Detection 2. Bead mixture passes through the detector, where one laser identifies the bead analyte and another measures the analyte concentration.


Detection 3. The system detector performs a minimum of 150 measurements per analyte at the rate of 100,000 measurements per minute.

BioPlex™ 2200 System

Quality Assurance with IQ Bead™ Technology

Every test conducted with the BioPlex™ 2200 also features up to three remarkable internal quality control technologies that dramatically improve the quality and accuracy of assay results:


Serum Verification Bead (SVB)
Confirms the presence of serum or plasma.


Internal Standard Bead (ISB)
Appears in every tube to standardize detector performance.


Reagent Blank Bead (RBB)
Identifies sample problems arising from nonspecific binding

BioPlex™ 2200 System

BioPlex™ 2200 System Profile

A. Sample Processing Module

  • Processes reaction vessels with patient sample and multiplex reagents
  • Inner ring for 37°C incubations
  • Outer ring for magnetic wash and separations
  • Throughput capacity of up to 100 multiplexed patient samples per hour

B. Detector Module

  • Multiplex flow detection
  • Minimum of 200 measurements per analyte

C. Sample Input Area

  • Holds up to 100 primary samples
  • Continuous, random access sample loading

D. STAT Sample Entry

  • On-demand STAT capability

E. On-Board Bulk Reagent Storage

  • On-the-fly loading and unloading of bulk reagents and waste
  • Bulk reagent and waste capacity to process
    up to 800 primary samples

F. Reagent Carousel

  • On-board refrigerated storage
  • Stores up to 20 reagent packs giving the capacity to process up to 2,000 samples
  • Real-time inventory management

G. eFlex™ Software

  • Intuitive touchscreen operation
  • Flexible worklist, testing, and results reporting setup
  • Ability to “Add on” additional test orders for previously run samples
  • Bi-directional LIS interface
  • Includes Medical Decision Support Software (MDSS)

H. Sample Output Area

  • Holds up to 100 primary samples
  • Continuous access sample unloading

I. Central Processing Computer

  • CPU for instrument and software communication

J. Reaction Vessel Storage/Waste

  • Above—hopper for storage of up to 800 reaction vessels
  • Below—waste bin storage
BioPlex™ 2200 System

Disease Panels

Autoimmune Disease Panels


ANA Screen with MDSS

  • ANA Screen*
  • dsDNA
  • Chromatin
  • Ribosomal protein
  • SS-A (52 kD and 60 kD)**
  • SS-B
  • Sm
  • Sm/RNP
  • RNP (A and 68 kD)*
  • Scl-70
  • Jo-1
  • Centromere B

Vasculitis

  • MPO
  • PR3
  • GBM

Gastrointestinal IgG* and IgA*

  • Gliadin
  • tTG
  • ASCA

Anti-Phospholipid Syndrome IgG*** and IgM***

  • Cardiolipin
  • Phosphatidylserine
  • β2-GPI
  • Prothrombin

Rheumatoid Arthritis***

  • Rheumatoid Factor
  • CCP

Other Panels in Development

  • Cardiac
  • Toxicology
  • Diabetes
 

Infectious Disease Panels


EBV IgG and IgM

  • VCA (IgG and IgM)
  • EA-D (IgG)
  • EBNA (IgG)
  • Heterophile (IgM)

Syphilis IgG

  • Treponema pallidum 15 kD**
  • Treponema pallidum 17 kD**
  • Treponema pallidum 47 kD**

Syphilis IgM*

  • T. pallidum 17 kD
  • T. pallidum 47 kD

ToRC IgG* and IgM*

  • Toxoplasma gondii
  • Rubella
  • Cytomegalovirus

Immunity IgG***

  • Mumps
  • Measles
  • Varicella-zoster virus
  • Rubella

Lyme Borreliosis***

  • IgG
  • IgM

HSV***

  • HSV-1 IgG
  • HSV-2 IgG
  • HSV-1/2 IgM


* ANA Screen is a composite roll up of all individual results
** Individual results available outside US only
*** In development

BioPlex™ 2200 System

Customer Training Program

Course Description

Participants will learn:

  • The skills required to operate the instrument on a daily basis
  • Set up and initiate assay run
  • How to procedures and techniques to properly maintain the instrument
  • Techniques to interpret results
  • Skills applicable to troubleshooting

Participant Information

A minimum of two participants is required to conduct a class. Enrollment is limited to eight participants to allow for maximum hands-on instructions.

A fee of $5,000 covers lodging and meals. Other expenses, including gratuities, are the responsibility of each individual. Airfare not included.

Course Candidates

  • Users designated as the primary operators who are not familiar with the platform
  • Users designated to train other operators on-site
  • Those who would benefit from a pre-installation course

Course Outline

DAY ONE DAY TWO DAY THREE DAY FOUR DAY FIVE

Introduction

  • Disease States
  • Multiplex Testing

System Overview

  • Hardware
  • Software

Review and Questions

System Overview (cont.)

  • Software
  • Chemistry

Assays

  • Methods Available
  • Assay Preparation
    • Reagent Packs
    • Calibration
    • Quality Control
    • Initiate Calibration and QC Assay Run

Review and Questions

Assays (cont.)

Sample Preparation

Initiate Sample Run

Result Review

  • Medical Decision Software Support (MDSS)
  • Add-on Tests
  • Review
    • Repeat
    • Dilution
    • Releasing Results

Review and Questions

Maintenance

  • Daily
  • Weekly
  • Monthly
  • On Demand
  • As Needed

Review and Questions

Troubleshooting

Review and Questions

Course Exam

The BioPlex® 2200 System is the industry’s first fully automated, random access multiplex testing platform. It combines innovative, reliable automation with the diagnostic power of proprietary multiplex chemistry and state-of-the-art eFlex™ software to bring a new level of flexibility and operational benefits to the laboratory.

Automation
The BioPlex® 2200 improves workflow with random access sampling and priority processing. Performing multiplex analysis on the BioPlex® 2200 is easy: simply load a tray of primary tubes and walk away. The system can automatically process up to 100 samples per hour — for a maximum of 2200 reportable results — with eight hours of walk-away capability. First results are available in approximately 20–45 minutes (assay dependent), with subsequent patient samples completed approximately every 30 seconds.

Patented Multiplex Chemistry
BioPlex® 2200 immunoassays use magnetic 8 µm beads, infused with varying ratios of fluorescent dyes to create unique bead sets. Beads within each set are coated with a ligand (i.e., antigen, antibody, analyte, etc.) specific to a particular assay. Bead sets are then mixed in a single reagent pack, allowing for simultaneous detection of multiple analytes from a single sample. The dual-laser, multiplex flow detection method processes a minimum of 150 individual bead results for each assay.

Powerful eFlex™ Software
Intuitive, touch-screen eFlex™ software allows precise system control and powerful information management. eFlex interfaces with the laboratory information system (LIS) and direct connectivity solutions for troubleshooting, reportable billing and Internet-based QC programs (i.e. Unity™). Order add-on tests from previously processed samples without a patient redraw. Create custom test groups, fine-tune quality control rules to accommodate facility needs and analyze results using interpretive software algorithms (available with certain panels).

BioPlex® 2200 System

660-0000
Fully automated, random access multiplex system for disease-oriented multi-marker assays, includes internal quality control, eFlex™ software

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Sample Racks

660-0800
Box of 30 racks to hold 5 samples each for BioPlex® 2200 System

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Sample Tray

660-0801
1 tray holds up to 10 sample racks for BioPlex® 2200 System

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Instrument Sheath Fluid

660-0817
Fluid to carry sample to detector of BioPlex® 2200 System (20 L) - box of two bottles

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Instrument Wash Buffer

660-0818
Reagent to wash immunoassay samples in preparation for analysis on BioPlex® 2200 System; contains PBS and Tween 20 (10 L)

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Reaction Vessels

660-2003
Bag of 1,000 vessels to hold patient sample and multiplex reagents for multianalyte reactions; to prepare samples for BioPlex® 2200 System

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Instrument Detector Calibration Pack

666-0001
1 pack of calibration beads to load onboard reagent carousel; for detector calibration of the BioPlex® 2200 System

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Instrument Detector Clean Pack

666-0002
1 pack of 70% isopropyl alcohol to load onboard reagent carousel; for cleaning BioPlex® 2200 System

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Instrument Probe Cleaning Solution

666-0003
Empty bottles to hold 1 N NaOH solution to clean instrument probe on BioPlex® 2200 System (4 x 30 mL)

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Number Description Options
T-100 BioPlex 2200 System Brochure Click to download [ Add to Cart (Free) ]
T-101 BioPlex 2200 ANA Screen Brochure Click to download [ Add to Cart (Free) ]
T-106 Bio-Plex 2200 Operator Training Sales Sheet Click to download [ Add to Cart (Free) ]
T-107 Bio-Plex 2200 System Profile Brochure Click to download [ Add to Cart (Free) ]
T-110 BioPlex EBV Brochure Click to download [ Add to Cart (Free) ]
T-115 BioPlex 2200 Syphilis IgG Brochure Click to download [ Add to Cart (Free) ]
T-128 BioPlex 2200 Vasculitis Product Sheet Click to download [ Add to Cart (Free) ]
T-136 BioPlex 2200 Panel Menu Click to download [ Add to Cart (Free) ]
T-145 BioPlex 2200 Syphilis IgM Brochure Click to download [ Add to Cart (Free) ]