Key result
A newly developed anti-CMV ELISA demonstrated 98.6% sensitivity and 99.0% specificity compared to the CF test, while IgM screening found only 1 positive among 600 donor sera.
Why the study?
Does the newly developed anti-CMV ELISA accurately detect CMV antibodies compared to standard tests in blood donors?
Observational (n=600)
Does the newly developed anti-CMV ELISA accurately detect CMV antibodies compared to standard tests in blood donors?
A newly developed anti-CMV ELISA shows high diagnostic accuracy, but routine IgM screening in donors is unlikely to prevent posttransfusion CMV infections due to very low prevalence.
Supports accurate CMV detection by new ELISA in blood donors; leaves open utility of IgM screening for preventing posttransfusion infections.
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.
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Wielaard et al. (1986) conducted an observational in Cytomegalovirus (CMV) infection (n=600). Anti-CMV ELISA vs. IHA test and CF test was evaluated on Sensitivity and specificity of the anti-CMV ELISA. A newly developed anti-CMV ELISA demonstrated 98.6% sensitivity and 99.0% specificity compared to the CF test, while IgM screening found only 1 positive among 600 donor sera.
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