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IMMULITE® 2000 CMV IgM is for in vitro diagnostic use with IMMULITE® 2000 Systems analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities. Performance characteristics for this assay have not been established in immunocompromised, immunosuppressed or organ transplant individuals. CMV IgM Controls are assayed, bi-level controls intended for use with the IMMULITE 2000 CMV IgM assay. They are intended as an aid in monitoring day-today assay performance.

IMMULITE 2000 CMV IgM is a solid-phase, enzyme labeled chemiluminescent three-step immunoassay. The solid phase (bead) is coated with inactivated, purified CMV antigen (strain AD-169 from infected cell lysates). The liquid phase consists of two reagents: 1) polyclonal goat anti-human IgG antibody in buffer, and 2) alkaline phosphatase (bovine calf intestine) conjugated to polyclonal goat anti-human IgM antibody in buffer. In the first cycle, the patient sample and polyclonal goat anti-human IgG antibody are incubated together without the bead for 30 minutes. During this time, anti-IgG antibodies block IgG present in the patient's sample. In the second cycle, the pretreated sample and polyclonal goat anti-human IgG antibody are transferred to the second reaction tube. Anti-IgG antibodies block the remaining IgG from the patient's sample from binding to the CMV antigen on the bead. During this time, CMV IgM in the patient sample binds to CMV antigen on the bead. Unbound sample and reagent are then removed by centrifugal washes. In the third cycle, the enzyme conjugated polyclonal goat anti-human IgM antibody is added to the second reaction tube. The enzyme conjugate binds to immobilized IgM to form the antibody sandwich complex. The unbound enzyme conjugate is removed by centrifugal washes. Finally, chemiluminescent substrate is added to the reaction tube and the signal is generated in proportion to the bound enzyme.

ACCURUN™ 146 CMV IgM Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Cytomegalovirus (CMV). This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 146 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to CMV in human serum and plasma.

ACCURUN™ 146 CMV IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to CMV, but is nonreactive for Hepatitis B Surface Antigen (HBsAg) and antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin™ as preservative. This control is supplied as 1 x 1 ml or 1 x 5 ml vial. ACCURUN™ 146 should be stored frozen at -10°C or colder. Once opened, ACCURUN™ 146 should be stored at 2-8°C and discarded after 60 days.