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The BioPlex® 2200 EBV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes: Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the BioPlex® 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM). The BioPlex® 2200 EBV IgM kit is intended for use with the Bio-Rad BioPlex® 2200 System. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. The BioPlex® 2200 EBV IgM Calibrator Set is intended for the calibration of the BioPlex® 2200 EBV IgM Reagent Pack. The BioPlex® 2200 EBV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 Instrument and BioPlex® EBV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex® EBV IgM Control Set has not been established with any other EBV IgM antibody assays.

The BioPlex 2200 EBV IgM kit is a multiplexed micro particle bead based immunoassay for the qualitative detection of IgM antibodies to EBV VCA GP125/p18 and Heterophile antigen in human serum using the Luminex flow cytometry technology. The BioPlex 2200 EBV IgM Calibrators set consists of two (2) distinct serum based calibrators. The BioPlex 2200 EBV IgM Control set consists of 2 vials of the BioPlex 2200 EBV IgM Positive Control and 2 vials of the BioPlex 2200 EBV IgM Negative Control. The positive controls are provided in a human serum matrix made from defibrinated plasma with added antibodies to EBV VCA GP125/p18 and Heterophile antigen derived from human disease state plasma. The negative controls are provided in a human serum matrix made from defibrinated plasma.

Focus Diagnostics' Plexus™ EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis. The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkitt's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.

Multiplexed Immunoassay for the Qualitative Detection of Human IgM Antibodies to Epstein-Barr Virus The Focus Diagnostics Plexus™ EBV IgM uses an Antigen Bead suspension that contains two distinct EBV antigen bead types (VCA and Heterophile) and one process control bead type that fluoresce at different wavelengths and/or intensities. The Focus Diagnostics Plexus™ EBV IgM is a three step procedure. 1. Patient sera are diluted, and the diluted sera are incubated with Antigen Beads. If EBV antibodies are present, then the antibodies bind to the corresponding antigen beads. 2. Phycoerythrin-conjugated goat Anti-human IgM (Conjugate) is added, binds to the bound EBV antibody (if present), and forms a Conjugate-EBV antibody-antigen bead sandwich. 3. Fluorescence from each distinct EBV antigen bead type is measured and compared against a Cutoff Calibrator.

The Zeus Scientific, Inc. AtheNA Multi-Lyte® EBV VCA IgM Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte® System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus.

The Zeus Scientific, Inc. AtheNA Multi-Lyte® EBV VCA IgM Test System is a microparticle-based immunoassay.

For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use only.

The SeraQuest VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum. The Calibrators in the SeraQuest VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

1. For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. 2. For in vitro diagnostic use only. 3. A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.

The SeraQuest EB VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum. The Calibrators in the SeraQuest EB VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

The Copalis® EBV-M Assay uses Coupled Particle Light Scattering technology in a microparticle agglutination-based assay for the qualitative detection of IgM antibodies to the EBV VCA antigen. The assay is designed for human serum using the Copalis® I Immunoassay System. The presence of VCA IgM antibodies is used as an aid in the diagnosis of EBV associated mononucleosis when used in conjunction with other EBV serologies in pediatric, adult, transplant donor and transplant recipient populations.

The Copalis® EBV-M Antibody Assay uses Coupled Particle Light Scattering technology in a microparticle agglutination-based assay for the qualitative detection of IgM antibodies to the EBV VCA antigen. The assay is designed for human serum using the Copalis I® Immunoassay System. The presence of VCA IgM antibodies is used as an aid in the diagnosis of EBV associated mononucleosis when used in coniunction with other EBV serologies in pediatric, adult, transplant donor and transplant recipient populations. KIT DESCRIPTION: Coupled Particle Light Scattering (Copalis®) technology provides a rapid method for the measurement of antibodies to specific pathogens. The Copalis® EBV-M Antibody Assay is a microparticle agglutination test using the Copalis® light scattering technology. Polystyrene microparticles are coated with svnthetic VCA antigen and are contained within a special covered reaction well in the test cup. The dried reagent is reconstituted with a reaction buffer on the instrument at the start of the assay. Patient sample is added to the reaction mixture and incubated for 10 minutes. The presence of IgM antibodies specific to the VCA antigen in the patient sample results in agglutination of the monomer microparticles to form aggregates. The reaction mixture is passed through a flow cell and the instrument uses light scattering technology to measure the monomer concentration. The decrease in the monomer population resulting from agglutination is related to the amount of antibody in the sample. The residual monomer concentration in each reaction mixture is compared to a cutoff values to determine sample reactivity and nonreactivity.

ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

Microtiter ELISA kit detecting VCA IgM antibodies