The first and only fully-automated, multiplexed solution for Measles, Mumps, Rubella and Varicella-zoster virus antibody testing
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1 Bio-Rad Laboratories BioPlex 2200 System BioPlex 2200 MMRV IgG Kit The first and only fully-automated, multiplexed solution for Measles, Mumps, Rubella and Varicella-zoster virus antibody testing
2 Bio-Rad Laboratories BioPlex 2200 System Like No Other The BioPlex 2200 MMRV IgG kit provides a fast, accurate and efficient method to determine serological status (immunity) for Measles, Mumps, Rubella and Varicella-zoster virus, simultaneously. BioPlex 2200 MMRV IgG kit is a qualitative test for the detection of IgG antibodies to: Measles (Rubeola) Mumps Rubella (German Measles) Varicella-zoster virus
3 Efficiency Multiplex your workflow offering four test results simultaneously Multiplex your inventory dramatically reducing reagent and calibrator storage requirements Multiplex your samples significantly reducing your sample volume requirements Multiplex your tubes accommodating serum, heparinized plasma and EDTA to reduce laboratory costs Throughput Market-leading throughput with up to 400 multiplexed test results per hour to meet heavy workload demands Random access processing ensures results are available when you need them Time to first result of 45 minutes maximizes speed and flexibility in result reporting Confidence Market-leading precision with within-run and between-run %CV of less than 10% Full automation from primary tube to final result, minimizing the chance of human error Internal Quality Control beads included with each sample to verify serum addition, standardize detector performance and detect non-specific sample binding One system with an expanding menu to meet your autoimmune and serology testing needs
4 Concordance with EIA Method Clinical studies demonstrate excellent sensitivity for the BioPlex 2200 MMRV IgG kit. Population Pregnant Women (N = 396) Pre-employment Screening (N = 393) Test Ordered (N = 790) Measles IgG 97.6% (359/368) 99.7% (355/356) 98.2% (638/650) Mumps IgG 99.7% (346/347) 100% (341/341) 95.8% (646/674) Rubella IgG 99.5% (362/364) 98.9% (344/348) 97.6% (702/719) VZV IgG 98.9% (348/352) 97.8% (359/367) 96.1% (688/716) Note: % agreement calculations exclude equivocals. Retrospective Negative Samples for Measles, Mumps, Rubella and Varicella-zoster virus Performance of the MMRV IgG kit was evaluated against corresponding commercially available Measles, Mumps, Rubella and VZV microplate EIAs using retrospective serum samples, presumptively negative, for antibodies to Measles, Mumps, Rubella and VZV. 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 Positive Samples for Rubella Performance of the MMRV IgG kit was evaluated against a commercially available Rubella microplate EIA using retrospective serum samples, presumptively positive, for antibodies to Rubella. Retrospective Rubella IgG Positive Samples Low Positive: IU/mL (N = 60) Positive: > 20 IU/mL (N = 60) 96.0% (48/50) 100% (60/60) Note: % agreement calculations exclude equivocals.
5 Correlation with CDC Rubella Evaluation Panel The Centers for Disease Control (CDC) provided an evaluation serum panel for Rubella IgG. This panel was tested to evaluate the performance of the Rubella IgG kit and does not imply an endorsement of the BioPlex 2200 MMRV IgG kit by the CDC. CDC Samples Reference Results BioPlex 2200 Pos (+) BioPlex 2200 Neg ( ) 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% Precision Precision was assessed using serum, EDTA plasma and heparinized plasma samples according to the CLSI EP5-A2 guideline Evaluation of Precision Performance of Clinical Chemistry Devices. In this study, 40 runs were performed on one BioPlex 2200 System over 20 working days (N = 80) using a reproducibility panel of patient samples. Within-Run % CV Between-Run % CV Total Precision % CV Measles IgG Mumps IgG Rubella IgG VZV IgG
6 BioPlex 2200 System BioPlex 2200 MMRV IgG Kit 1. Patient sample (5 µl) automatically added to reaction vessel 2. Sample diluent and beads (dilution 1:80) added and incubated at 37ºC 3. Wash step 4. Conjugate added and incubated at 37ºC 5. Wash step 6. Bead resuspended in wash buffer 7. Flow-based, dual laser detection MMRV IgG Reagent Pack The MMRV IgG Reagent Pack contains all the necessary reagents (sample diluent, beads and conjugate) to process 100 samples per pack. MMRV IgG Calibrator Set The tri-level MMRV IgG kit calibrators are multiplexed and ready to use offering 30 day calibration stability. MMRV IgG Control Set The bi-level positive and negative MMRV IgG controls are multiplexed and ready to use. Ordering Information Catalog No. Description BioPlex 2200 MMRV IgG Reagent Pack, 100 samples...1 pack BioPlex 2200 MMRV IgG Calibrator Set... 1 set BioPlex 2200 MMRV IgG Control Set... 2 sets For further information, please contact the Bio-Rad office nearest you or visit our website at Clinical Diagnostics Group Website Australia Austria Belgium +32 (3) Brazil +55 (31) Canada China Czech Republic Denmark Finland France Germany +49 (0) Greece Hong Kong Hungary India Israel Italy Japan Korea Mexico +52 (55) The Netherlands New Zealand Norway Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland +41 (0) /06 Taiwan Thailand United Kingdom +44 (0) Bio-Rad Laboratories, Inc. Printed in USA DG T-168INTL Rev. 08/2014 Printed on recycled paper with soy-based inks
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