BioPlex® 2200 MMRV IgG KitThe first and only fully-automated, multiplexed solution for Measles, Mumps, Rubella and Varicella-zoster virus antibody 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 OtherTheBioPlex®2200MMRVIgGkitprovidesafast,

accurateandefficientmethodtodetermineserological

status(immunity)forMeasles,Mumps,Rubellaand

Varicella-zostervirus,simultaneously .

BioPlex® 2200 MMRV IgG kit is a qualitative test for the detection of IgG antibodies to:• Measles(Rubeola)

• Mumps

• Rubella(GermanMeasles)

• Varicella-zostervirus

Efficiency• Multiplexyourworkflow—offeringfourtest

resultssimultaneously

• Multiplexyourinventory—dramaticallyreducing

reagentandcalibratorstoragerequirements

• Multiplexyoursamples—significantlyreducing

yoursamplevolumerequirements

• Multiplexyourtubes—accommodatingserum,

heparinizedplasmaandEDTAtoreduce

laboratorycosts

Throughput• Market-leadingthroughputwithupto400

multiplexedtestresultsperhourtomeet

heavyworkloaddemands

• Randomaccessprocessingensuresresults

areavailablewhenyouneedthem

• Timetofirstresultof45minutesmaximizes

speedandflexibilityinresultreporting

Confidence• Market-leadingprecisionwithwithin-runand

between-run%CVoflessthan10%

• Fullautomationfromprimarytubetofinalresult,

minimizingthechanceofhumanerror

• InternalQualityControlbeadsincludedwitheach

sampletoverifyserumaddition,standardize

detectorperformanceanddetectnon-specific

samplebinding

• Onesystemwithanexpandingmenutomeetyour

autoimmuneandserologytestingneeds

Concordance with EIA MethodClinicalstudiesdemonstrateexcellentsensitivityfortheBioPlex® 2200MMRVIgGkit .

Retrospective Negative Samples for Measles, Mumps, Rubella and Varicella-zoster virusPerformanceoftheMMRVIgGkitwasevaluatedagainst

correspondingcommerciallyavailableMeasles,Mumps,

RubellaandVZVmicroplateEIAsusingretrospective

serumsamples,presumptivelynegative,forantibodies

toMeasles,Mumps,RubellaandVZV .

Retrospective Positive Samples for RubellaPerformanceoftheMMRVIgGkitwasevaluatedagainst

acommerciallyavailableRubellamicroplateEIAusing

retrospectiveserumsamples,presumptivelypositive,

forantibodiestoRubella .

Population Pregnant Women(N = 396)

Pre-employment Screening(N = 393)

Test Ordered(N = 790)

Measles IgGPositive % Agreement

97.6%(359/368)

99.7%(355/356)

98.2%(638/650)

Mumps IgGPositive % Agreement

99.7%(346/347)

100%(341/341)

95.8%(646/674)

Rubella IgGPositive % Agreement

99.5%(362/364)

98.9%(344/348)

97.6%(702/719)

VZV IgGPositive % Agreement

98.9%(348/352)

97.8%(359/367)

96.1%(688/716)

Note: % agreement calculations exclude equivocals.

Assay Negative % Agreement

Measles IgG (N = 93) 100% (93/93)

Mumps IgG (N = 96) 100% (83/83)

Rubella IgG (N = 198) 97.6% (123/126)

VZV IgG (N = 240) 100% (143/143)

Note: % agreement calculations exclude equivocals.

Retrospective Rubella IgG Positive Samples

Positive % Agreement

Low Positive: 10–20 IU/mL (N = 60)

96.0% (48/50)

Positive: > 20 IU/mL (N = 60)

100% (60/60)

Note: % agreement calculations exclude equivocals.

Correlation with CDC Rubella Evaluation PanelTheCentersforDiseaseControl(CDC)providedanevaluationserumpanelforRubellaIgG .

ThispanelwastestedtoevaluatetheperformanceoftheRubellaIgGkitanddoesnotimply

anendorsementoftheBioPlex® 2200MMRVIgGkitbytheCDC .

PrecisionPrecisionwasassessedusingserum,EDTAplasmaandheparinizedplasmasamplesaccordingtotheCLSIEP5-A2

guideline“EvaluationofPrecisionPerformanceofClinicalChemistryDevices .”Inthisstudy,40runswereperformed

ononeBioPlex® 2200Systemover20workingdays(N=80)usingareproducibilitypanelofpatientsamples .

CDC Samples Reference Results BioPlex® 2200Pos (+)

BioPlex® 2200Neg (–)

Rubella IgG Pos(+) 81 1*

Rubella IgG Neg(–) 0 18

* Panel consisted of 100 specimens (50 pairs). There are 9 negative sera, resulting in 18 negative samples and 41 positive sera resulting in 82 positive samples. The discrepant sample was near the cutoff.

Overall Percent Agreement = 99%

Within-Run % CV

Between-Run % CV

Total Precision % CV

Measles IgG 3 .2–10 .1 0 .0–6 .3 3 .2–10 .3

Mumps IgG 1 .9–6 .4 0 .0–3 .9 1 .8–7 .5

Rubella IgG 2 .9–7 .2 0 .0–4 .5 3 .9–7 .6

VZV IgG 2 .1–6 .8 0 .0–4 .2 2 .7–8 .4

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 Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium +32 (3)710-53-00 Brazil +55 (31)3689-6600 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)89-318-840Greece 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 +7-495-721-1404 Singapore 65-6415-3170 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden +46-8-555-127-00 Switzerland +41 (0)26-674-55-05/06 Taiwan 886-2-2578-7189 Thailand 662-651-8311 United Kingdom +44 (0)20-8328-2000

© 2014 Bio-Rad Laboratories, Inc. Printed in USA DG14-0101 T-168INTL Rev. 08/2014 Printed on recycled paper with soy-based inks

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

BioPlex® 2200 MMRV IgG Kit

Ordering InformationCatalog No. Description

665-2450 BioPlex® 2200MMRVIgGReagentPack,100samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1pack

663-2400 BioPlex® 2200MMRVIgGCalibratorSet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1set

663-2430 BioPlex® 2200MMRVIgGControlSet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2sets

MMRV IgG Reagent PackTheMMRVIgGReagentPackcontainsallthenecessaryreagents(samplediluent,beadsandconjugate)toprocess100samplesperpack .

MMRV IgG Control SetThebi-levelpositiveandnegativeMMRVIgGcontrolsaremultiplexedandreadytouse .

MMRV IgG Calibrator SetThetri-levelMMRVIgGkitcalibratorsaremultiplexedandreadytouseoffering30daycalibrationstability .

1. Patientsample(5µL)automaticallyaddedtoreactionvessel

2. Samplediluentandbeads(dilution1:80)addedandincubatedat37ºC

3. Washstep

4. Conjugateaddedandincubatedat37ºC

5. Washstep

6. Beadresuspendedinwashbuffer

7. Flow-based,duallaserdetection