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BioPlex 2200 HSV-1 & HSV-2 IgG The first and only fully-automated, multiplexed solution for Herpes Simplex virus testing Bio-Rad Laboratories BIOPLEX 2200 SYSTEM

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Page 1: BioPlex 2200 HSV-1 & HSV-2 IgG - bio-rad.com · By detecting and differentiating Herpes Simplex Virus type-specific antibodies, the BioPlex ™ 2200 HSV-1 & HSV-2 kit provides laboratories

BioPlex™ 2200 HSV-1 & HSV-2 IgGThe first and only fully-automated, multiplexed solution for Herpes Simplex virus testing

Bio-Rad Laboratories B i o P l e x 2 2 0 0 S y S t e m

Page 2: BioPlex 2200 HSV-1 & HSV-2 IgG - bio-rad.com · By detecting and differentiating Herpes Simplex Virus type-specific antibodies, the BioPlex ™ 2200 HSV-1 & HSV-2 kit provides laboratories

Bio-Rad Laboratories B i o P l e x 2 2 0 0 S y S t e m

Like No OtherBydetectinganddifferentiatingHerpesSimplexVirus

type-specificantibodies,theBioPlex™ 2200HSV-1&HSV-2

kitprovideslaboratorieswithmorediagnosticallyuseful

informationforenhancedpatientmanagementwithhighly

reproducibleresultsandfasterturnaroundtime .

BioPlex™ 2200 HSV-1 & HSV-2 kit reports results for the following:• HSV-1IgG

• HSV-2IgG

Page 3: BioPlex 2200 HSV-1 & HSV-2 IgG - bio-rad.com · By detecting and differentiating Herpes Simplex Virus type-specific antibodies, the BioPlex ™ 2200 HSV-1 & HSV-2 kit provides laboratories

Efficiency• Highthroughput–upto200HSVresultsperhour

forreducedhands-ontimeandlaborcosts

• Multiplexworkflow–twotestresultsavailable

simultaneouslyforimprovedturnaroundtime

• LISConnectivity–Bi-directionalcommunication

forautomatedorderingandreporting

Quality• ExcellentagreementwithEIAandImmunoblot

methodsinthetestingpopulation

• Novelchemistry–onlyfully-automated,random

accessmagneticbeadmultiplexmethod

• Marketleadingprecisionandreproducibility

withCV’slessthan7%

Confidence• Fullautomationfromprimarytubetofinalresult,

minimizingthechanceofhumanerror

• Minimumof150measurementsperanalyte

perreactioncomparedtosinglephotometric

measurementinmicroplatemethods

• InternalQualityControlbeadsincludedwitheach

sampletoverifyserumaddition,standardize

detectorperformanceanddetectsample

problemswithnon-specificbinding

Page 4: BioPlex 2200 HSV-1 & HSV-2 IgG - bio-rad.com · By detecting and differentiating Herpes Simplex Virus type-specific antibodies, the BioPlex ™ 2200 HSV-1 & HSV-2 kit provides laboratories

Comparison with Immunoblot Method

Comparison with ELISA Method

Population

BioPlex™ 2200 HSV-1 IgG BioPlex™ 2200 HSV-2 IgG

% Positive Agreement

% Negative Agreement

% Positive Agreement

% Negative Agreement

Sexually Active Individuals (N = 575)

98.5%(199/202)

CI95 .7%to99 .5%

86.2%(75/87)

CI77 .4%to91 .9%

94.7%(108/114)

CI89 .0%to97 .6%

99.4%(171/172)

CI96 .8%to99 .9%

Expectant Mothers (N = 399)

96.9%(285/294)

CI94 .3%to98 .4%

97.1%(102/105)

CI91 .9%to99 .0%

96.9%(156/161)

CI92 .9%to98 .7%

99.6%(237/238)

CI97 .7%to99 .9%

Low Prevalence: 16–19 years (N = 200)

92.3%(96/104)

CI85 .5%to96 .1%

96.9%(93/96)

CI91 .2%to98 .9%N/A

97.3%(182/187)

CI93 .9%to98 .9%

Population

BioPlex™ 2200 HSV-1 IgG BioPlex™ 2200 HSV-2 IgG

% Sensitivity % Specificity % Sensitivity % Specificity

Sexually Active Individuals (N = 575)

97.6%(400/410)

CI95 .6%to98 .7%

94.5%(155/164)

CI89 .9%to97 .1%

90.7%(223/246)

CI86 .4%to93 .7%

98.8%(325/329)

CI96 .9%to99 .5%

Expectant Mothers (N = 399)

96.3%(287/298)

CI93 .5%to97 .9%

99.0%(100/101)

CI94 .6%to99 .8%

96.9%(157/162)

CI93 .0%to98 .7%

100%(237/237)

CI98 .4%to100%

Low Prevalence: 16–19 years (N = 200)

93.3%(97/104)

CI86 .7%to96 .7%

97.9%(94/96)

CI92 .7%to99 .4%N/A

97.8%(181/185)

CI94 .6%to99 .2%

Page 5: BioPlex 2200 HSV-1 & HSV-2 IgG - bio-rad.com · By detecting and differentiating Herpes Simplex Virus type-specific antibodies, the BioPlex ™ 2200 HSV-1 & HSV-2 kit provides laboratories

Comparison with CDC Panel

Agreement with CDC PanelTheperformanceoftheBioPlex™ 2200HSV-1&HSV-2IgGkitwasassessedusingamasked,well-characterizedHSV

serumpanelfromtheCDC .Thepanelconsistsof24%HSV-1andHSV-2dual-positivesamples,50%HSV-1positive

and50%HSV-1negativesamplesand48%HSV-2positiveand52%HSV-2negativesamples .TheBioPlex™ 2200had

100%positiveandnegativeagreementwithcommerciallyavailableELISAassaysforeachanalyte .1

1ExcludingEquivocals

BioPlex™ 2200 HSV-1 & HSV-2 DesignBioPlex™ 2200 HSV-1 & HSV-2 Technology

• BioPlex™ 2200HSV-1&HSV-2istypespecific

• TargetsthegG1andgG2antigens

• Targetsthe50%homologythatdifferentiatesHSV-1fromHSV-2

What Differentiates BioPlex™ 2200 HSV-1 & HSV-2?

• UsesrecombinantgG1andsyntheticpeptidep8C:BSA

derivedfromgG2sequence

• SyntheticpeptideisuniquetoHSV-2

(basedonsequenceanalysis)–patented

• Allowstype-specificrecognitionwithoutpotentialnon-specific

cross-reactivity(thatcouldbeseeninothertype-specificproducts)

BioPlex™ 2200 HSV-1 IgG BioPlex™ 2200 HSV-2 IgG

% Positive

Agreement

95% Confidence

Interval

% Negative

Agreement

95% Confidence

Interval

% Positive

Agreement

95% Confidence

Interval

% Negative

Agreement

95% Confidence

Interval

CDC Panel (N = 100)

100%(50/50)

92 .8%to100%

96%(48/50)

86 .5%to98 .9%

100%(50/50)

92 .8%to100%

100%(50/50)

92 .8%to100%

Herpes Simplex Virus

Page 6: BioPlex 2200 HSV-1 & HSV-2 IgG - bio-rad.com · By detecting and differentiating Herpes Simplex Virus type-specific antibodies, the BioPlex ™ 2200 HSV-1 & HSV-2 kit provides laboratories

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

Clinical Diagnostics Group

Website www.bio-rad.com/diagnostics U.S. 1-800-2BIO-RAD 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 86-21-64260808 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 91-124-4029300 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-7070 Korea 82-2-3473-4460 Mexico 52(55)5200-0520 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 65-6415-3188 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland 41-61-717-95-55 Thailand 662-651-8311 United Kingdom +44-(0)20-8328-2000

Printed on recycled paper with soy-based inks © 2009 Bio-Rad Laboratories, Inc. Printed in USA 08/09 DG09-0368 T-164

B i o P l e x 2 2 0 0 S y S t e m

BioPlex™ 2200 HSV-1 & HSV-2 IgG

Ordering InformationCatalog No. Description

BioPlex™ 2200 HSV-1 & HSV-2 IgG

665-3350 BioPlex™ 2200HSV-1&HSV-2IgGReagentPack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1pack

663-3300 BioPlex™ 2200HSV-1&HSV-2IgGCalibratorSet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1set

663-3330 BioPlex™ 2200HSV-1&HSV-2IgGControlSet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1set

HSV-1 & HSV-2 IgG Reagent Pack

Containsallthenecessaryreagents

(samplediluent,beadsandconjugate)

toprocess100samples .

HSV-1 & HSV-2 IgG Control Set

QualityControlsareready-to-useand

multiplexed .Thesetincludesanegative

controlaswellasamuti-analytepositive

controlcontainingantibodiespresentfor

analyteswithintheReagentPack .

HSV-1 & HSV-2 IgG Calibrator Set

Calibratorsareready-to-useand

multiplexed .Apoint-to-pointcurve

fit,usingfourcalibrators,isusedto

calculatequalitativeresults .

1. Patientsample(5µL)automaticallyaddedtoreactionvessel

2. Samplediluentandbeads(dilution1:20)addedandincubatedat37ºC

3. Washstep

4. Conjugateaddedandincubatedat37ºC

5. Washstep

6. Beadresuspendedinwashbuffer

7. Flow-based,duallaserdetection