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The DYNEX SmartPLEX MMRV IgG Assay Kit is a multiplex immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended for use with the DYNEX Multiplier Analyzer. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended to be used as an aid in the determination of serological status to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum from adults and pediatrics age above 1 year. This kit is not intended for screening blood or plasma donors. The performance of this device has not been established for use in neonates, pediative patients below 1 year of age, and immunocompromised patients, or for use at point of care facilities.

The DYNEX SmartPLEX MMRV IgG Assay Kit (SmartPLEX MMRV IgG Assay) uses multiplex immunoassay, a methodology that greatly resembles traditional ELISA, while permits simultaneous detection and identification of different antibodies in a single well. The reaction is processed in a 96 well microtiter plate, with six polystyrene beads embedded in each well of the plate. Four (4) different beads are coated with antigens for the detection of IgG antibodies to Measles, Mumps, Rubella and Varicella-Zoster virus in human serum. Two additional beads are included in each reaction well as filler beads. Specimen processing is fully automated on the Multiplier Analyzer. The Multiplier Analyzer adds the patient serum specimen and reagents to each well of the 96well plate, after which the mixture is incubated at 37°C with shaking. After a wash cycle, unbound antibodies from the patient's specimen are removed. Anti-human polyclonal IgG antibody conjugated to horseradish peroxidase (HRP) is added after which the mixture is incubated at 37°C with shaking. A second wash step removes excess conjuqate, then luminol substrate is added to each well. The amount of antibody captured by the antigen is determined by the chemiluminescence triggered by the attached HRP. Raw data is captured as light photons which are converted into relative light intensity units (RLU). The Multiplier software analyzes the image and generates a report that details the mean RLU signal for each target bead (MMRV) by test sample. In every assay a calibrator is run. The DYNEX SmartPLEX MMRV IgG Assay Kit is qualitative and produces a result defined as negative (NEG), equivocal (EQV) or positive (POS) for each target analyte. The result is calculated in the Multiplier software by dividing the test sample RLU values by the mean calibrator RLU value to produce an index value for each target.

The BioPlex® 2200 MMRV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella and Varicella-zoster virus (VZV) in human serum and EDTA or heparinized plasma. The BioPlex 2200 MMRV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the determination of serological status to Measles, Mumps, Rubella, and VZV. This kit is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in neonatal, pediatrics and immunocompromised patients, or for use at point of care facilities.

The BioPlex 2200 MMRV IgG kit uses multiplex flow immunoassay for simultaneous detection and identification of many antibodies in a single tube. Four (4) different populations of magnetic dyed beads are coated with antigens to identify the presence of IgG class antibodies against Measles. Mumps. Rubella and Varicella-zoster. The BioPlex 2200 System combines an aliquot of patient sample diluent, and bead set reagent into a reaction vessel. The mixture is incubated at 37℃. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI). Three additional control beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB), and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel, and the absence of significant non-specific binding in serum. The instrument is calibrated using a set of three (3) distinct calibrator vials, supplied separately by Bio-Rad Laboratories.

The BioPlex™ 2200 MMRV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-zoster virus (VZV) in human serum and EDTA or heparinized plasma. The BioPlex 2200 MMRV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the determination of serological status to Measles, Mumps, Rubella, and VZV. This kit is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in neonates, pediatrics and immunocompromised patients, or for use at point of care facilities.

The BioPlex 2200 MMRV IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Four (4) different populations of dyed beads are coated with antigens to identify the presence of IgG class antibodies associated with Measles, Mumps, Rubella and Varicella-zoster. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead set reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are resuspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI). Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel and the absence of significant non-specific binding in serum. The instrument is calibrated using a set of three (3) distinct calibrator vials, supplied separately by Bio-Rad Laboratories.