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The Diagnostic Hybrids, Inc. device, D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit, is intended for use in the qualitative detection and identification of human Cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). This product is not intended for use in testing blood or plasma donors and is not intended for use in direct detection of cytomegalovirus in clinical specimens.

Two murine derived monoclonal antibodies (MAbs) are used in the Diagnostic Hybrids, Inc. (DHI) device, D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit (CMV-IEA ID Kit), and are directed against CMV immediate early antigen (pp 72). The MAbs used in the Kit have been shown to be highly specific, with no cross-reactivity to other cultured viruses. The MAbs have been labeled by DHI using Fluorescein Isothiocyanate (FITC). Kit Components: 1. CMV-IEA DFA Reagent, 10-mL. One dropper bottle containing a mixture of two murine MAbs directed against CMV immediate early antigen (pp 72). The MAbs are both IgG1 (k) isotype. The buffered, stabilized, aqueous solution contains Evans Blue as a counter-stain and 0.1% sodium azide as preservative. 2. CMV Antigen Control Slides, 5-slides. Individually packaged control slides containing wells with cell culture derived positive and negative control cells. Each slide contains one Negative well of uninfected cells and one Positive well of CMV infected cells. Each slide is intended to be stained only one time. 3. Mounting Fluid, 7-mL. One dropper bottle of an aqueous, buffered, stabilized solution of glycerol (ph 8.2 ± 0.2) and 0.1% sodium azide. 4. 40X PBS Concentrate, 25-mL. One bottle containing a 40X concentrate consisting of 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water) in a phosphate buffered saline (PBS) solution. Patient samples are inoculated onto susceptible cell monolayers and cultured. After a defined incubation period, the cells to be tested for the presence of CMV-IEA are fixed in acetone. The CMV-IEA DFA Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35° to 37°C, the stained cells are washed with the supplied PBS Solution (diluted), and a drop of the supplied Mounting Fluid is placed on the prepared cells. The cells are examined using a fluorescence microscope. The cells infected with CMV and expressing the CMV-IEA will have apple-green fluorescent nuclei while uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain. If no fluorescent cells are found, report result as "No cytomegalovirus detected". If fluorescent cells are found in the CMV-IEA DFA Reagent stained monolayer, report result as "Cytomegalovirus isolated by cell culture".

The NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the NucliSens® Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors.

The NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the NucliSens®™ Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors. The NucliSens® CMV pp67 assay is comprised of four separate stages: - Nucleic acid release - Nucleic acid isolation - Nucleic acid amplification - Nucleic acid detection

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 Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay is intended for use in centrifugation enhanced shell vials in the qualitative detection and identification of immediate early antigen- of human CMV.

Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay (CMV DFA) uses the standard laboratory direct immunofluorescence technique for the culture confirmation of cytomegalovirus. The DFA is based on the principle of antigen identification using a detector monoclonal antibody conjugated to fluorescein isothiocyanate. The substrate consists of a slide prepared from the tissue cultured cells from a clinical specimen inoculum. Anti CMV FITC laheled antibody is applied to the substrate. The antibody will bind to specific antigen, if present, in the substrate. The fluorescein conjugated monoclonal antibody allows for visualization of the antigen / antibody complex by flucrescence microscopy. Mouse monoclonal antibody is used as the detector antibody in Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay. The use of monoclonal antibody ensures increased specificity and reduced non-specific interference. The monoclonal antibody is specific for a 68-72 kDa non-structural protein designated as immediate early (IE) antigen of human CMV.