Cytomegalovirus (CMV) IgM EIA
For the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum, by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV IgM antibodies and presumptive for the diagnosis of acute or recent CMV infection. These reagents have not received FDA clearance for use in testing blood or plasma donors.
Cytomegalovirus (CMV) has been identified as a major causative agent of congenital abnormalities, including mental retardation and deafness in infants infected in utero. 1,2,3 Subclinical infection may occur in adults as well as overt disease including hepatitis, pneumonitis, and cytomegalovirus induced mononucleosis.4 CMV infection can be transmitted to immunodeficient or immunosuppressed individuals as a result of blood transfusion 5 or organ transplantation.6 In summary, pregnant women, neonates, and immunocompromised individuals are at risk of developing clinically significant disease caused by CMV infection.
The diagnosis of CMV infection is frequently assisted by serological methods. The demonstration of CMV IgM antibodies is indicative of recent or current infection or, in the case of newborns, of congenital infection.
Diluted samples are incubated in antigen-coated wells. Absorbents have been included in the Diluent to neutralize the effects of rheumatoid factor and anti-CMV IgG antibody. CMV antibodies (if present) are immobilized I the wells. Residual sample is eliminated by washing and raining, and conjugate (enzyme-labeled antibodies to human IgM) is added and incubated. If IgM antibodies to CMV are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme-labeled substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end product which is read photometrically. Test performed by VRL Eurofins, 6933 S. Revere Parkway, Centennial, CO 80112. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information.