The CMV IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is a fluorescence immunoassay for the qualitative detection of IgG and IgM antibodies to Cytomegalovirus (CMV) in human whole blood, serum or plasma. This kit is intended to be used as a screening test and as an aid in the diagnosis of infection with CMV. Any reactive specimen with the CMV IgG/IgM Test Cassette must be confirmed with alternative testing method(s) and clinical findings.