Immunoglobulin M antibodies detected by enzyme-linked immunosorbent assay and radioimmunoassay in the diagnosis of cytomegalovirus infections in pregnant women and newborn infants.

Immunoglobulin M (IgM) antibodies were detected by a commercially available enzyme-Linked Immunosorbent Assay (ELISA) in 36 of 49 (73%) pregnant women with primary cytomegalovirus (CMV) infection. A positive ELISA-IgM result occurred in 10 of 13 patients (77%) assessed within 8 weeks of seroconversion. The sensitivity of the radioimmunoassay (RIA) to identify primary infection in pregnant women was comparable, 78% in general and 86% for women tested within 16 weeks of seroconversion. Of the 36 women with primary infection who had detectable IgM antibodies by ELISA, 25 (69%) were delivered of congenitally infected infants, whereas of the 13 with undetectable IgM antibodies, 7 (54%) transmitted the infection in utero. IgM antibodies were detected by ELISA in only 5 of 43 (11%) women who experienced a recurrence of CMV which either did or did not result in congenital infection. RIA was less likely to measure CMV-specific IgM in recurrent infection, inasmuch as 1 of 19 (5.2%) women with proven recurrent infection had detectable IgM antibody, giving RIA a better specificity for primary infection. Specific IgM antibodies were detected by ELISA in 42 of 61 (69%) babies congenitally infected with CMV and in 4 of 70 (5.7%) uninfected control newborn infants. The RIA was superior for diagnosis of congenital CMV infection, with a sensitivity of 89% and a specificity of 100%. The lower sensitivity of the ELISA-IgM occurred in the category of congenitally infected infants born to mothers with recurrent infection (43%), a group that is at the lowest risk of disease or to develop sequelae. This commercially available ELISA-IgM could be used in combination with a CMV-specific IgG test for monitoring women during pregnancy for primary infection.