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The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to rubella virus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system. The Alinity i Rubella IgG assay is to be used as an aid in the determination of immune status to rubella in individuals including women of child-bearing age. The Alinity i Rubella IgG assay has not been cleared for use in screening blood, plasma, or tissue donors. The performance of this device has not been established for cord blood or neonatal samples. Likewise, performance has not been established for populations of immunocompromised or immunosuppressed individuals.

The Alinity i Rubella IgG assay is an automated, two-step immunoassay for the quantitative determination of anti-rubella IgG in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Sample, partially purified rubella virus-coated paramagnetic microparticles, and assay diluent are combined and incubated. The anti-rubella IgG present in the sample bind to the rubella virus coated microparticles. The mixture is washed. Anti-human IgG acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added. The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of anti-rubella IgG in the sample and the RLU detected by the system optics.

The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age. The LIAISON® Control Rubella IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgM assay. The performance characteristics of LIAISON® Rubella IgM controls have not been established for any other assays or instrument platforms.

The LIAISON® Rubella IgM assay is an in vitro diagnostic device consisting of reagents provided in individual compartments within a plastic container called the Reagent Integral. The assay configuration for the LIAISON® Rubella IgM assay allows for the performance of 100 tests. Reagent Integral Composition: - a. Magnetic particles mouse monoclonal antibody IgG to human IgM - b. Calibrator 1 human serum or defibrinated plasma containing low level of Rubella IqM - c. Calibrator 2 human serum or defibrinated plasma containing high level of Rubella laM - d. Antigen Inactivated rubella viral particles (HPV 77 strain) - c. Specimen diluent buffer with BSA added - d. Conjugate -- mouse monoclonal antibodies to rubella virus conjuqated to an isoluminol derivative The LIAISON® Control Rubella IgM is an in vitro diagnostic device consisting of 2 levels of controls to monitor the performance of the LIAISON® Rubella IgM assay Controls (2 vials of each level): Negative control - human serum or defibrinated plasma non-reactive for Rubella IgM Positive control - human serum or defibrinated plasma reactive for Rubella IgM

For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella. The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.

The MAGO 4S is an automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides. The MAGO 4S is designed to minimize manual operations associated with performing routine laboratory analysis by mechanizing and computerizing the test process.

The BioPlex® 2200 Rubella and CMV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Rubella and Cytomegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma. The BioPlex 2200 Rubella and CMV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a current or recent Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors. Performance characteristics for the Rubella and CMV IgM assays have not been evaluated in immunosupressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities. The BioPlex® 2200 Rubella and CMV IgM Calibrator Set is intended for calibration of the BioPlex 2200 Rubella and CMV IgM Reagent Pack. The BioPlex 2200 Rubella and CMV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex Rubella and CMV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Rubella and CMV IgM Control Set has not been established with any other Rubella or Cytomegalovirus (CMV) IgM antibody assays.

The BioPlex® 2200 Rubella and CMV IgM 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. Rubella and CMV IgM test is to detect antibodies to Rubella and Cytomegalovirus (CMV). Two (2) different populations of dyed beads are coated with cell lysates bearing Rubella or CMV antigens. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel; the mixture is incubated at 37°C. After a wash cycle, anti-human IgM 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 are reported as 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 or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. The instrument is calibrated using a set of three (3) distinct serum based calibrators. A negative and CMV IgM calibrator is used to calibrate CMV assay, and a negrative and rubella IgM calibrator is used to calibrate the rubella IgM assay, The cul-off value and assignment of the calibrators are determined by performing concordance and Receiver Operator Characteristic (ROC) analysis using the Centaur Rubella IgM and VIDAS CMV IgM predicate results as the standard. For Rubella and CMV, results of ≤ 0.8 Al are negative, 0.9 and 1.0 Al are equivocal and results of ≥ 1.1 Al are reported as positive. The BioPlex 2200 Rubella and CMV IgM Control Set includes a negative control as well as a CMV IgM positive control and a Rubella IgM positive control. The BioPlex Rubella and CMV IgM Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex Rubella and CMV IgM Negative Control are manufactured to give negative results, with values below the cut-off for each specific analyte. The recommended frequency for performing quality control is once every 24-hour testing period. Performing quality control is also necessary after each new assay calibration and certain service procedures.

The Elecsys Rubella IgM immunoassay is for the in vitro qualitative determination of IgM antibodies to rubella virus in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay may be used as an aid in the presumptive diagnosis of an acute or recent rubella infection in individuals, including women of childbearing age. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. NOTE: This assay has not been cleared/approved by the FDA for blood/plasma donor screening. Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

(1) The Elecsys Rubella IgM Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. The Rubella IgM is composed of a biotin-labeled monoclonal antibody-against-human IgM, a Rubella-like particle and a ruthenium-labeled anti-Rubella antibody. A relationship exists between the concentration of the IgM antibody targets present in a patient sample and the level of signal count detected by the system. The IgM assay is a qualitative test based on a cut-off formula dependent on the negative and positive calibrators. Cut-off index (COI) is based on the ratio of assay signal to cut-off signal (also abbreviated s/co). COI values equal to or greater than 1.0 are considered positive for the presence of anti-Rubella IgM antibody. Results are determined using a 2 point calibration. The test system contains the human serum-based calibrators intended for use with the system. (2) The Elecsys PreciControl Rubella igM contains two levels of human serum. The positive control contains native, inactivated Rubella IgM antibodies.

The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the VIDAS® automated instruments for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.

The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. It is coated with Rubella antigen. The other reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips. The individual kit components are described in detail on the following pages. All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the Rubella antigen fixed onto the interior wall of the SPR to capture the Rubella antibodies present in the sample. After dilution, the sample is incubated with the SPR. Rubella IgG antibodies present in the specimen bind to the Rubella antigen coating the interior of the SPR. Unbound components are eliminated during the preliminary wash step. A second incubation step is then performed using alkaline phosphatase labeled monoclonal anti-human IgG antibodies (mouse), followed by a second wash step. During the final detection step, the substrate (4-Methyl-umbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.

(1) The Elecsys Rubella IgG immunoassay is for the in vitro quantitative determination of IgG antibodies to rubella virus in human serum and Li-heparin, K3-EDTA and sodium citrate plasma. This assay may be used as an aid in the assessment of immune status to rubella in individuals including women of childbearing age. The electrochemiluminescence immunoassay "ECLIA" is intended for use or Elecsys and cobas e immunoassay analyzers. (2) Elecsys PreciControl Rubella IgG is used for quality control of the Elecsys Rubella IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

(1) The Elecsys Rubella IgG Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. The Rubella IgG assay contains: a biotin labeled monoclonal antibody against human IgG, a ruthenium-labeled anti-Rubella antibody fragment , biotin- and ruthenium-labeled Rubella-antigens and a Rubella-like particle. A relationship exists between the concentration of the IgG antibody targets present in a patient sample and the level of signal count detected by the system. The IgG assay is quantitative and is standardized against WHO materials. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. The test kit contains the human serum-based calibrators intended for use with the system. (2) The Elecsys Precicontrol Rubella IgG contains two levels of human serum with Rubella IgG antibodies.

The LIAISON® Rubella IgG uses chemiluminescencc immunoussay (CLIA) technology on the LIAISON Analyzer for the qualitative determination of IgG antibodies to rubella virus in human serum specimens. It is intended for use as an aid in the determination of immune status to rubella in individuals including pregnant women. The performance of this device has not been established for cord blood, neonatal samples, or for any matrices other than human serum. Likewise, performance has not been established for population(s) of immunocompromised or immunosuppressed individuals. The LIAISON® Rubella IgG Tri-Control kit is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgG assay.

The method for qualitative determination of specific IgG to Rubella virus is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with Rubella antigen and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, Rubella virus antibodies present in the calibrators, specimens or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with Rubella virus IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU).

The Zeus Scientific, Inc. AtheNA Multi-Lyte Rubella IgG Test System is intended for the qualitative detection of IgG class antibody to Rubella virus in human sera by microparticle immunoassay testing on the AtheNA Multi-Lyte Instrument. The results of the AtheNA Multi-Lyte Rubella IgG Test System may be used to determine the serological status of individuals including women of childbearing age.

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For in vitro diagnostic use only. The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System. The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.

The VITROS Rubella IgG assay is performed using the VITROS Immunodiagnostic Products Rubella IgG Reagent Pack and VITROS Immunodiagnostic Products Rubella IgG Calibrators on the VITROS Immunodiagnostic System for the qualitative and quantitative determination of rubella IgG antibodies to rubella virus in human serum and plasma. An immunometric technique is used. This involves the reaction of antirubella IgG present in the sample with rubella antigen coated onto the wells. After a wash step a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-human IgG) is added and this complexes with bound anti-rubella IgG. Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the VITROS Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of antirubella IgG present.