Cytomegalovirus IgM ELISA kit is intended for the qualitative determination of IgM class antibodies against CMV in human serum. The cytomegalovirus IgM ELISA kit is a qualitative immunoenzymatic determination of IgM-class antibodies against CMV is based on the ELISA (Enzyme-linked Immunosorbent Assay) technique. Microtiter strip wells of the cytomegalovirus IgM ELISA kit are pre-coated with CMV antigens to bind corresponding antibodies of the specimen. After washing the wells to remove all unbound sample material horseradish peroxidase (HRP) labelled anti-human IgM conjugate is added. This conjugate binds to the captured CMV-specific antibodies. The immune complex formed by the bound conjugate is visualized by adding Tetramethylbenzidine (TMB) substrate which gives a blue reaction product. The intensity of this product is proportional to the amount of CMV specific IgM antibodies in the specimen. Sulphuric acid is added to stop the reaction. This produces a yellow endpoint color. Absorbance at 450 nm is read using an ELISA microwell plate reader.
The reagents of the cytomegalovirus IgM ELISA kit are stable up to the expiry date when stored at 2 to 8 °C. The diagnostic specificity of the cytomegalovirus IgM ELISA kit is defined as the probability of the assay of scoring negative in the absence of the specific analyte. It is >98 %. The diagnostic sensitivity of the cytomegalovirus IgM ELISA kit is defined as the probability of the assay of scoring positive in the presence of the specific analyte. It is 91 %. Interferences with hemolytic, lipemic or icteric sera are not observed up to a concentration of 10 mg/ml hemoglobin, 5 mg/ml triglycerides and 0.2 mg/ml bilirubin for this cytomegalovirus IgM ELISA kit.