Development of CMV antibody tests and their clinical evaluation

An anti-CMV ELISA was developed in which monoclonal antibodies to immobilize the CMV antigens are used. The test was compared with the IHA test and there was 98.6% agreement. Using the CF test as a referee, sensitivity and specificity of the ELISA were calculated to be 98.6 and 99.0%, respectively. The seroconversion rate among Dutch donors was estimated from the age-related prevalence of anti-CMV antibodies to be about 0.4%. Specific anti-CMV IgM was searched for in a large donor population using an antibody-capture IgM ELISA; 1 of 600 donor sera was found positive. This makes it unlikely that screening for IgM anti-CMV will effectively prevent posttransfusion CMV infections. In order to meet the demand for simpler tests, a one-step ELISA was recently developed, based on the inhibition principle. Preliminary studies with this test indicate a high sensitivity and specificity.