Cytomegalovirus (CMV) IgG Enzyme Immunoassay Test Kit

Cytomegalovirus (CMV). Sample Type: Serum. # of Samples: 1X96 Assays.
Intended Use: The CMV IgG ELISA is intended for use in evaluating a patient' s serologic status to cytomegalovirus (CMV) infection. Introduction: Cytomegalovirus is a herpes virus and a leading biological factor causing congenital abnormalities and complications among those who receive massive blood transfusions and immunosuppressive therapy. About half the pregnant women who contract a primary infection spread the disease to their fetus. When acquired in-utero the infection may cause mental retardation blindness and/or deafness. Serological tests for detecting the presence of antibody to CMV can diagnose active or recent infection and provide valuable information regarding the history of previous infection. These tests are also useful in screening blood for transfusions in newborns and immuno-compromised recipients. Biotech CMV IgG ELISA is an accurate serologic method to detect CMV IgG antibody for identification of CMV infection. Principle of the test: Purified CMV antigen is coated on the surface of microwells. Diluted patient serum is added to the wells and the CMV IgG specific-antibody if present binds to the antigen. All unbound materials are washed away. HRP-conjugate is added which binds to the antibody-antigen complex. Excess HRP-conjugate is washed off and a solution of TMB Reagent is added. The enzyme conjugate catalytic reaction is stopped at a specific time. The intensity of the color generated is proportional to the amount of CMV IgG-specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrators and controls. Limitation of the Test: 1. Reliable and reproducible results will be obtained when the assay procedure is carried out with a complete understanding of the package insert instructions and with adherence to good laboratory practice. 2. The wash procedure is critical. Insufficient washing will result in poor precision and falsely elevated absorbance readings. 3. Serum samples demonstrating gross lipemia gross hemolysis or turbidity should not be used with this test. 4. The results obtained from the use of this kit should be used only as an adjunct to other diagnostic procedures and information available to the physician. Precision: A study was performed to document typical assay precision with the Biotech CMV IgG EIA product. The mean SD and %CV were calculated for Intra-and Inter-Assay in concentration value (IU/mL).