Evaluation of CMV total antibody EIA. An enzyme immunoassay for detection of antibodies to cytomegalovirus.

The performance of an indirect enzyme-immunoassay (CMV Total Antibody EIA, Abbott Laboratories) for the detection of the presence or absence of antibodies to cytomegalovirus (CMV) was evaluated by investigators at five clinical sites. The interassay and intraassay coefficient of variation data showed that the EIA could be performed in a highly reproducible manner at all sites. The investigators tested a total of 2314 clinical samples for antibody to CMV by the CMV Total Antibody EIA and by an indirect hemagglutination assay (IHA). The overall results demonstrated that compared with IHA the sensitivity of the EIA was 97.9% (1096/1120) and the specificity was 93.6% (1096/1171). The clinical samples tested included sera, plasma, and whole blood. These results show a good agreement between the CMV Total Antibody EIA and the IHA. This EIA is a simple, objective, and reproducible method for the detection of antibodies to CMV in sera, plasma, or whole blood samples, and the total procedure is adaptable for batching and automation and takes only 3 hr of elapsed time.