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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.