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

BioPlex 2200 System - Bio-Rad · The BioPlex® 2200 System combines the diagnostic power of proprietary multiplex chemistry, a state-of-the-art software package, and the benefits

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Page 1: BioPlex 2200 System - Bio-Rad · The BioPlex® 2200 System combines the diagnostic power of proprietary multiplex chemistry, a state-of-the-art software package, and the benefits

Bio-Rad Laboratories B I O P L E X 2 2 0 0 S Y S T E M

Like no other. The first and only fully-automated, random access, multiplex testing platform

BioPlex® 2200 System

Page 2: BioPlex 2200 System - Bio-Rad · The BioPlex® 2200 System combines the diagnostic power of proprietary multiplex chemistry, a state-of-the-art software package, and the benefits

Bio-Rad Laboratories

Forget limitations.Leveraging the power of multiplex testing, the BioPlex® 2200 System brings limitless workflow improvement to your laboratory. You’ve heard about the promise and future potential of multiplex technology…now Bio-Rad has made that promise a reality.

BioPlex® 2200System

FullyAutomated

RandomAccess eFlex

Software™

SuperiorChemistry

MultiplexTechnology

HighThroughput

B I O P L E X 2 2 0 0 S Y S T E M

Page 3: BioPlex 2200 System - Bio-Rad · The BioPlex® 2200 System combines the diagnostic power of proprietary multiplex chemistry, a state-of-the-art software package, and the benefits

Each microsphere is dyed with a uniquecombination of 2 colors

Up to 25color-codedmicrospheres(bead regions),can be bound with a unique antigen

The ANA Screen Reagent Pack uses 16 microspheres: 13 assay beads

and 3 quality control checks

1

5

8

11 13

2

6

9 10

12

3

7

4

A B C

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-70 12 Jo-1 13 Centromere B

13 assay microspheres

3 quality control microspheres

A Serum Verification Bead (SVB) B Internal Standard Bead (ISB) C Reagent Blank Bead (RBB)

Patented Multiplex Detection Magnetic Bead TechnologyBioPlex® 2200 immunoassays use heterogeneous sets

ofmagnetic8µmbeads.Thebeadsareinfusedwith

varyingratiosoffluorescentdyes,creatinguniquebead

sets. Beads within each set are coated with a ligand

(i.e.,antigen,antibody,analyte,etc.)specifictoa

particular assay. Bead sets are then mixed together in

a single reagent pack allowing for simultaneous

detection of multiple analytes from a single sample.Each microsphere is dyed with a uniquecombination of 2 colors

Up to 25color-codedmicrospheres(bead regions),can be bound with a unique antigen

The ANA Screen Reagent Pack uses 16 microspheres: 13 assay beads

and 3 quality control checks

1

5

8

11 13

2

6

9 10

12

3

7

4

A B C

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-70 12 Jo-1 13 Centromere B

13 assay microspheres

3 quality control microspheres

Example: ANAScreenKit

*IndividualSS-AandRNPresultsnot available in theU.S.Reportedas SS-AandRNPfor a total of 11 individual results.

Disease Focused Multiplex Panel MenuCurrently, multiplex panels are available or in development for the following disease-state areas:

•Autoimmune

•Serology/InfectiousDiseases

•SpecialtyImmunoassay

Leveraging the Power of Fully-Automated, Random Access, Multiplex Testing

• UtilizestheconceptofLeanManagementfora more streamlined workflow, improved turn-around times and decreased labor costs in your laboratory

• Reductionoferrorsthroughautomationanddirect connection to your LIS

• Abilitytoprogram3rdparty,Non BioPlex® 2200 controls that uses the same data management module as BioPlex® 2200 Quality Controls

• MultiplexTechnologyallowsforelectronicadd-on, from the same panel, of tests that were not part of the initial request, thus eliminating the need to place the sample back on the system

• Remoteconnectivityforbetterservice,including the monitoring of instrument logs so Bio-Rad can proactively support your system

Page 4: BioPlex 2200 System - Bio-Rad · The BioPlex® 2200 System combines the diagnostic power of proprietary multiplex chemistry, a state-of-the-art software package, and the benefits

Detection MethodThedual-laser,multiplexflowdetectionmethodprocesses

a minimum of 150 individual bead results for each analyte,

representingmorethan150assayreadings.Thisenhances

theoverallqualityofeachresult,whencomparedtostandard

immunoassays which rely on a single reading.

Detection1

Asampleofthefinalreactionmixtureisaspiratedtothedetector.

Quality Assurance with IQ Bead™ TechnologyEverysampleprocessedontheBioPlex® 2200

Systemwillhaveuptothreeremarkable

internalqualitycontrolbeadsaddedto

dramaticallyimprovethequalityandaccuracy

of assay results:

Serum Verification Bead (SVB)*

Confirmsthe presenceofserum/plasma

InternalStandardBead(ISB)*

Appearsineverytubetostandardize

detector performance

Reagent Blank Bead (RBB)*

Identifiessampleproblemsarisingfrom

non-specific binding

* Panel dependent

Detection2

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

Detection3

Thesystemdetectorperformsaminimumof150measurementsper analyte at the rate of 100,000 measurements per minute.

1

A minimum of150

measurementsper analyte100,000

measurementsper minute!

2

3

Page 5: BioPlex 2200 System - Bio-Rad · The BioPlex® 2200 System combines the diagnostic power of proprietary multiplex chemistry, a state-of-the-art software package, and the benefits

The BioPlex® 2200 System combines the diagnostic power of proprietary multiplex chemistry, a state-of-the-art software package, and the benefits of full automation and random access capability…all brought together to bring a new level of flexibility and operational benefits to your laboratory.

System BenefitsFully Automated/Random Access

• Improvedworkflowefficiency

• Decreasedhands-ontime

• Improvedturnaroundtimefortestresults

• Increasedtestingcapacity

• Fewererrorsfromspecimenandreagenthandling

State-of-the-Art eFlex™ Software

• Intuitivetouchscreenuserinterface

• LISConnectivityusingHostQueryor

BroadcastDownload

• Maintenancecalendartotrackdaily,weekly,

monthly and as needed tasks

• ExpansiveQCmoduleforcustomizingQCrules,tracking

BioPlex®2200Systemaswellas3rdpartycontrolsand

evaluatingnewQClotswithacalculationofthemeanandSD

prior to implementation

• RunChecklisttoverifythereareenoughreagentpackson-board

to complete the programmed run

• ExportofQCresultsdirectlytoBio-Rad’sUnityRealTime®

program

Innovative Multiplex Chemistry

• QualityassurancewithintegratedQCtechnologiesineverytest

• Proprietarymagneticbeadchemistryforsuperiorperformance

• Liquid,ready-to-usereagents,calibratorsandcontrols

Page 6: BioPlex 2200 System - Bio-Rad · The BioPlex® 2200 System combines the diagnostic power of proprietary multiplex chemistry, a state-of-the-art software package, and the benefits

For further information, please contact the Bio-Rad office nearest you or visit our website at www.bio-rad.com/diagnostics

Clinical Diagnostics Group

© 2012 Bio-Rad Laboratories, Inc. Printed in USA 08/12 DG12-0974 T-100

Website www.bio-rad.com/diagnostics U.S. 1-800-224-6723 Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium 32-9-385-5511 Brazil 5521-3237-9400 Canada 1-514-334-4372 China 86-21-61698500 Czech Republic 420-241-430-532 Denmark +45-4452-1000 Finland 358-9-804-22-00 France 33-1-47-95-60-00 Germany +49-(0)89-318-840 Greece 30-210-7774396 Hong Kong 852-2789-3300 Hungary +36-1-459-6100 India 1800-180-1224 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-7070 Korea 82-2-3473-4460 Mexico +52 (55) 5488-7670 The Netherlands +31-318-540666 New Zealand 64-9-415-2280 Norway 47-23-38-41-30 Poland 48-22-3319999 Portugal 351-21-472-7700 Russia 7-495-721-14-04 Singapore 65-6415-3170 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland 41-61-717-95-55 Taiwan 886-2-2578-7189 Thailand 662-651-8311 United Kingdom +44-(0)20-8328-2000

Printed on recycled paper with soy-based inks

BioPlex® 2200 System

Ordering InformationCatalog No. Description

660-0000 BioPlex® 2200System .............................................................................................................................. 1 instrument 660-0800 SampleRacks(30perbox) ................................................................................................................................. 1 box660-0801 SampleTray ......................................................................................................................................................... 1 tray660-0817 InstrumentSheathFluid(2perbox) .................................................................................................................... 1 box660-0818 InstrumentWashBuffer ....................................................................................................................................... 1 box660-2003 ReactionVessels(1000perbag) ........................................................................................................................ 1 bag666-0001 InstrumentDetectorCalibrationPack ............................................................................................................... 1 pack666-0002 InstrumentDetectorCleanPack ....................................................................................................................... 1 pack666-0003 InstrumentProbeCleaningSolutionBottles(4perbox) .................................................................................... 1 box666-0515 Sample/ReagentProbe ..................................................................................................................................... 1 each666-0578 1NNaOH ............................................................................................................................................................. 1 liter

System Specifications

Physical Dimensions

Height....................................................................... 4’-5”(1.3m)

Width........................................................................ 4’-3”(1.3m)

Depth ..................................................................... 2’-10”(0.9m)

Weight Approximately ........................................ 1032lbs.(468kg)

Performance CharacteristicsMaximumThroughput ........... 22 results per sample at 100 samples

per hour, yielding up to 2200 results per hour*TimetoFirstResult ......................20-45minutes(dependingonpanel)SampleTubes ...................................AnyCLSIprimarysampletubesSampleTray ..............................................10 racks, 5 samples eachSampleVolume .................................... 5-50µL(dependingonpanel)STATCapability .................................................. continuous accessWalk–awayCapacity .................................. 8 hours of continuous useOperationalMode ............................ Randomandcontinuousaccess,

priority(STAT)loadingOperatorInterfaces ...................................... Touchscreenmonitor,

keyboard, trackball mouseAspirationCapability ................RoboticprecisionwithclotdetectionQualityControl ............................. Levey-Jennings,WestgardRulesSampleBarCodeAcceptableSymbologies .....Code128,Codabar,

Code39,Interleaved2of5SampleTypesSerumorPlasma ........ Formoreinformation,referto

BioPlex® 2200 assay insertSampleDilutions .............1:4,1:10,and1:100(dependingonpanel)AccessDuringUse ....................... Continuoussampleinput/output,

consumables replenishment, and waste disposal without interruption of sample processing

LISConnectivity ...............................Bi-directional:ASTMStandardLaboratoryAutomationSolution(LAS) .............................AdaptableClass2LaserProduct

Power Requirements

InputVoltage ........................100-240VACat50-60Hz,1000Watt

UPS ................................................................................Provided

Water Requirements

WaterQuality ................................................ CLSITypeIIorbetter

DirectPlumbing ................................ Maximumpressureof50kPa

Installation Requirements

Crate Clearance Requirements Instrument Operational Clearance

Rear .......................5’(1.5m) Rear ...........................6”(0.2m)

Left ........................4’(1.2m) Left ............................ 3’(1.0m)

Right ......................4’(1.2m) Right ..........................6”(0.2m)

Front ....................10’(3.0m) Front .......................... 3’(1.0m)

Vertical ...................6’(1.8m) Vertical ....................... 6’(1.8m)*TypicalThroughput