A recombinant protein-based enzyme immunoassay for IgM antibody to human cytomegalovirus.

The reliability of an enzyme-linked immunosorbent assay (ELISA) which used recombinant antigen to detect human cytomegalovirus IgM was studied. Serum samples from each of 283 children aged 5 +/- 2 years were studied. In all samples the anti-IgM antibodies were investigated with the ELISA techniques Enzygnost (Behring) and ETI-Cito (Sorin) which were both based on whole viral particles, and OPUS (Behring) based on recombinant antigen. Of the samples, 254 (89.4%) were negative with all three tests. The 29 remaining samples were positive with one or two of the three techniques. The diagnostic efficacy of Enzygnost, ETI-Cito and OPUS, respectively, was for sensitivity of 50%, 66.7% and 50%, and for specificity of 100%, 95.6% and 96%, respectively. The results with each of the three ELISAs did not differ widely and their diagnostic efficacy was similar. The method based on recombinant antigen was not found to be more effective than tests based on whole viral particles.