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The OSOM® Mono Test is intended for the qualitative detection of infectious monomucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.

The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte xtract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result.

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.

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 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. BioPlex 2200 EBV IgM Calibrator Set: The BioPlex 2200 EBV IgM Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgM Reagent Pack. BioPlex 2200 EBV IgM Control Set: 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 2200 EBV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgM Control Set has not been established with any other EBV assays.

The BioPlex 2200 EBV IgM kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional ElA, but permits simultaneous detection and identification of many antibodies in a single tube. Two (2) different populations of dyed beads are coated with proteins associated with infectious mononucleosis. One (1) is coated with an E. coli derived recombinant fusion protein, EBV VCA p18 (40kD), and the other is coated with horse erythrocyte stromal extract (heterophile antigen). The BioPlex 2200 System combines an aliquot of patient sample, sample diluent containing goat anti-human IgG, 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 coniugate 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. 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 respectively. The instrument is calibrated using a set of two (2) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of two (2) vials representing two (2) different antibody concentrations is used for calibration. The result for each of these antibodies is expressed as an antibody index (AI).

The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for health professionals including professionals at point-of-care sites.

The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of heterophile antibodies associated with infectious Mononucleosis in whole blood, serum or plasma. They utilize purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies to infectious Mononucleosis. These tests can be performed without the use of an instrument.

biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis.

biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis. biorapid Mononucleosis uses the same methodology (immunochromatography test) as the predicate OSOM Mono Test.

Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids in the diagnosis of infectious mononucleosis.

Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma.

The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory.

Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells.