Development of CMV Antibody Tests and Their Clinical Evaluation

Abstract

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.

Prevention of transfusion‐transmitted cytomegalovirus infection

“…By contrast, tests for the screening of blood donations must be capable of identifying all donors harbouring latent CMV infection in PB leucocytes as these cells may support productive viral replication upon transfusion. Current transfusion practice is to use noncompetitive or competitive enzyme immunoassays (EIA) designed to detect CMV‐specific antibody ( Wielaard et al ., 1986 ; Grillner, 1987; Doern et al ., 1994 ; Narvios et al ., 1998 ; Greijer et al ., 1999 ). These techniques are used qualitatively and have several distinct advantages for transfusion services as they are sensitive, specific, rapid and can be automated for high sample throughput.…”