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The CMV Brite™ Turbo Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence using microscopy in isolated peripheral blood leukocytes obtained from ethylenediaminetetraacetic acid (EDTA) or heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human perpheral blood cells aids in the diagnosis of acute or reactivated CMV infection. This product is not FDA cleared (approved) for use in testing (i.e., screening) of blood or plasma donors.

The CMV antigenemia assay has been developed using a cocktail of two monoclonal antibodies (C10/C11) directed against CMV lower matrix protein pp65(6). The assay uses the C10/C11 cocktail in an indirect immunofluorescence staining of cytospin preparations of peripheral blood leukocytes. The CMV Brite™ Turbo antigenemia assay is completed within two hours of blood collection which saves time and means a rapid answer for the clinician. The CMV Brite™ Turbo method consists of: - Direct lysis of peripheral blood erythrocytes a. - Preparation of cytospin slides b. - Fixation and permeabilization C. - Indirect immunofluorescence staining using monoclonal antibodies directed d. against CMV pp65 protein - Reading and evaluation of results e. The first step in the CMV Brite™ Turbo method involves direct lysis of the peripheral blood erythrocytes(22). Following lysis the leukocytes are cytocentrifuged onto a slide, fixed and permeabilized to allow subsequent detection of CMV pp65 antigen. The presence of the CMV pp65 antigen is detected by the C10/C11 antibody cocktail and visualized by means of a specific secondary FITC-labeled antibody. CMV antigenpositive leukocytes exhibit homogeneous yellow-green polylobate nuclear staining when observed using a fluorescence microscope. The number of CMV antigen-positive cells are counted per duplicate stain. The whole procedure can be performed in approximately 2 hours. The total analysis time has been shortened by performing direct erythrocyte lysis on whole blood and avoiding dextran sedimentation. Further time has been saved by shortening individual steps in the protocol so that the whole CMV antigenemia procedure has been reduced in time by more than 50%.

The Biotest EA IgG ELISA is an enzyme immunoassay using recombinant antigens for the qualitative detection of IgG antibodies to the Epstein-Barr Virus Early Antigens (EA) p54 and p138 in human serum or plasma. Results obtained with this test, in conjunction with other clinical and patient data obtained in assays for other Epstein-Barr virus-specific antibodies such as anti-Early Antigen IgM and anti-EBNA-1 IgG, assist in serological diagnosis of EBV infection in pediatric and adult populations.

Using recombinant DNA technology, Biotest has developed three highly purified EBV antigens for use in their ELISA test system. - EBNA-1 p72: Major antigen of the EBNA complex. The recombinant protein does not contain the glycine-alanine copolymer, a structural feature of EBNA-1, which shows cross-reactivities with certain autoantibodies and CMV (IgM response). - EA-D p64: Early antigen. Dominant immunogen of the EA-D complex. - EA p138: Early antigen and major DNA binding protein. This highly reactive antigen is not detectable in EA immunofluorescence assays based on chemically induced Raji cells (deletion within the Raji genome). The EBV immune status will be determined by the detection of specific antibodies directed against EBV proteins according to the principle of the indirect ELISA. The antigens are purified to apparent homogeneity and immobilized on the solid phase (microtest plate, 96 wells). If the patient's serum contains specific antibodies they will bind during the first incubation. Non-specific antibodies are removed by washing steps. During a second incubation the captured IgG or IgM antibodies are labeled. This is performed by addition of murine monoclonal anti-human IgG or IgM antibody-enzyme-conjugates. The final reaction converts a colorless substrate to a colored product. The concentration of color after a definite time is related to the concentration of antibody in the serum sample.

The Biotest EBNA IgG ELISA is an enzyme immunoassay using a recombinant antigen for the qualitative detection of IgG antibodies to the Epstein-Barr Virus (EBV) EBNA-1 (Nuclear Antigen 1) in human serum or plasma. Results obtained with this test, in conjunction with other clinical and patient data obtained in assays for other Epstein-Barr antigens such as Early Antigen IgG and IgM, assist in serological diagnosis of EBV infection in pediatric and adult populations.

Using recombinant DNA technology, Biotest has developed three highly purified EBV antigens for use in their ELISA test system. - EBNA-1 p72: Major antigen of the EBNA complex. The recombinant protein does not contain the glycine-alanine copolymer, a structural feature of EBNA-1, which shows cross-reactivities with certain autoantibodies and CMV (IgM response). - EA-D p64: Early antigen. Dominant immunogen of the EA-D complex. - EA p138: Early antigen and major DNA binding protein. This highly reactive antigen is not detectable in EA immunofluorescence assays based on chemically induced Raji cells (deletion within the Raji genome). The EBV immune status will be determined by the detection of specific antibodies directed against EBV proteins according to the principle of the indirect ELISA. The antigens are purified to apparent homogeneity and immobilized on the solid phase (microtest plate, 96 wells). If the patient's serum contains specific antibodies they will bind during the first incubation. Non-specific antibodies are removed by washing steps. During a second incubation the captured IgG antibodies are labeled. This is performed by addition of murine monoclonal anti-human IgG antibody-enzyme-conjugates. The final reaction converts a colorless substrate to a colored product. The concentration of color after a definite time is related to the concentration of antibody in the serum sample.

The Biotest EA IgM ELISA is an enzyme immunoassay using recombinant antigens for the qualitative detection of IgM antibodies to the Epstein-Barr Virus early antigens (EA) p54 and p138 in human serum or plasma. Results obtained with this test, in conjunction with other clinical and patient data obtained in assays for other Epstein-Barr virus-specific antibodies such as anti-Early Antigen IgG and anti-EBNA-1 IgG, assist in serological diagnosis of EBV infection in pediatric and adult populations.

Using recombinant DNA technology, Biotest has developed three highly purified EBV antigens for use in their ELISA test system. - EBNA-1 p72: Major antigen of the EBNA complex. The recombinant protein does not contain the glycine-alanine copolymer, a structural feature of EBNA-1, which shows cross-reactivities with certain autoantibodies and CMV (IgM response). - EA-D p64: Early antigen. Dominant immunogen of the EA-D complex. - EA p138: Early antigen and major DNA binding protein. This highly reactive antigen is not detectable in EA immunofluorescence assays based on chemically induced Raji cells (deletion within the Raji genome). The EBV immune status will be determined by the detection of specific antibodies directed against EBV proteins according to the principle of the indirect ELISA. The antigens are purified to apparent homogeneity and immobilized on the solid phase (microtest plate, 96 wells). If the patient's serum contains specific antibodies they will bind during the first incubation. Non-specific antibodies are removed by washing steps. During a second incubation the captured IgM antibodies are labeled. This is performed by addition of murine monoclonal anti-human IgM antibody-enzyme-conjugates. The final reaction converts a colorless substrate to a colored product. The concentration of color after a definite time is related to the concentration of antibody in the serum sample.