bioplex 2200 hsv-1 & hsv-2 igg - bio-rad.com · by detecting and differentiating herpes simplex...
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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
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
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
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%
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
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