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Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV® is intended to be used in screening of patients for serological evidence of previous infection by CMV using manual and semiautomated methods, NEO Iris® and Galileo NEO®.

Capture-CMV® is a Solid Phase Red Cell Adherence System for the detection of IgG and lgM antibodies to Cytomegalovirus (CMV). The CMV assay is to be used with NEO Iris® and the Galileo NEO® instruments. The NEO Iris®/Galileo NEO® is a microprocessor-controlled instrument that fully automates test processing, result interpretation and data management functions for the associated assays. The instrument is designed to automate, in addition to the CMV assay, standard immunohematology assays using a microplate-based platform. The originally cleared Galileo NEO® (BK100033) was updated with the following modifications in the current submission: - The Digi CCD camera module was replaced with an IDS CMOS camera module - Galileo NEO® software was replaced with NEO Iris® Install Set 3.0.1.0 U software and configuration files - Galileo NEO® versions of the files OiBxEngl.dll and GalileoLogo.bmp were installed to preserve Galileo NEO® branding in the User Interface and on Reports

Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV is intended to be used in screening of blood and plasma donors or patients for serological evidence of previous infection by CMV.

Capture-CMV is a solid phase red cell adherence antibody detection system based on procedures of Plapp et al. This procedure is a modification of the mixed agglutination tests for antigen and antibody detection of Coombs et al. and Hogman employing anti-IgG and IgM-coated red cells as the indicator system. Serum or plasma samples are added to the viral-coated wells. The samples are incubated for five minutes; during which antibodies specific for CMV proteins bind to immobilized viral proteins. Unbound immunoglobulins are washed from the wells and replaced with a suspension of anti-IgG plus anti-IgM-coated indicator red cells. Centrifugation brings the indicator red cells in contact with antibodies bound to the immobilized viral proteins. In the case of a positive test, the migration of the indicator cells to the bottom of the well is impeded as the anti-IgG and anti-IgM bridges are formed between the indicator red cells and the viral-bound antibodies. As a consequence, the indicator red cells adhere over the surface of the test well. In contrast, in the absence of viral antigen-antibody interactions (i.e. a negative test) the indicator red cells are not impeded during their migration, and pellet to the bottom of the well as a packed, well-defined cell button. CMV antigen from cytomegalovirus strain AS 169 grown in human foreskin fibroblast cells is inactivated and coated onto microtitration wells and dried.

The Digene Hybrid Capture® CMV DNA Assay is a qualitative, in vitro, diagnostic assay intended for the detection of human cytomegalovirus (CMV) DNA in human peripheral white blood cells isolated from whole blood specimens collected in EDTA. It is indicated for use as an aid in diagnosing CMV infection in solid organ transplant, bone marrow transplant and HIV/AIDS patients. This assay has not been cleared by the FDA for blood/plasma donor screening.

The Hybrid Capture® CMV DNA Assay is a qualitative in vitro diagnostic assay. It is a nucleic acid, signal enhanced, solution hybridization, antibody capture assay that uses chemiluminescent signaling to detect CMV DNA. The assay kit consists of 13 reagents and two accessories. Whole blood specimens are treated with an agent that lyses red blood cells, and the specimen is centrifuged, resulting in a pellet of white blood cells. The white blood cell pellet is then used in the Hybrid Capture CMV DNA Assay. Specimens potentially containing CMV DNA are denatured and then hybridized with a specific CMV RNA probe cocktail. This cocktail contains a probe mixture chosen to eliminate cross-reactivity with human or other herpesvirus sequences. The CMV probe supplied with the Hybrid Capture CMV DNA Assay is complementary to approximately 40,000 base pairs or 17% of the CMV genome (230,000 base pairs). The RNA:DNA hybrids resulting from hybridization are captured on the surface of a tube coated with affinity-purified polyclonal caprine antibodies specific for RNA:DNA hybrids. The immobilized hybrids are then reacted with alkaline phosphatase-conjugated, murine monoclonal antibody to RNA:DNA hybrids, and are detected with a chemiluminescent substrate. Several alkaline phosphatase molecules are conjugated to each antibody. Multiple conjugated antibodies bind to each captured hybrid, resulting in signal enhancement. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted and is measured in Relative Light Units (RLUs) on a standard commercial luminometer. The RLU value of a specimen is compared to a Positive Cutoff Value and to an Equivocal Cutoff Value to determine if the specimen is positive, equivocal, or negative for the presence of CMV DNA.

CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma (EDTA) to determine prior exposure to cytomegalovirus. This product is not FDA cleared for use in screening blood or plasma (EDTA) donors.

CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma (EDTA) to determine prior exposure to cytomegalovirus.

The CopalisTM CMV Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutinationbased immunoassay for the qualitative and semi-quantitative detection of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum using the CopalisTM One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to indicate presence of antibody to CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion or a significant increase in antibody level as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

The Copalis CMV Total Antibody Assay is based on the principle of antibodydependent particle aggregation as detected by measurement of changes in light scattering. Latex particles coated with inactivated CMV antigens aggregate in the presence of antibodies to CMV. After 10 minutes of agitation, the level of aggregation is determined by measurement of the number of reacted and unreacted particles as they flow past a detector. The number of reacted particles is related to the level of CMV antibodies present in the test specimen. Without prior infection, antibody levels are absent or low. After infection, antibody levels rise and usually remain stable (but declining in titer) for years. Reactivity is assessed by the level of aggregation relative to a cutoff value. The Copalis CMV Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.