Objective: To assess the validity of a diagnostic protocol designed to pred
ict the outcome of newborns of mothers suspected to have primary cytomegalo
virus (CMV) infection during the first 4 months of pregnancy.
Study design: Anti-CMV immunoglobulin (Ig) M detection by enzyme immunoassa
y and immunoblot together with the determination of anti-CMV IgG avidity al
lowed us to classify 456 women as (1) uninfected, (2) undergoing either a p
rimary or a recurrent infection, or (3) having an undefined serologic condi
tion. Prenatal diagnosis was carried out at 21 to 23 weeks' gestation for w
omen. The presence of the virus in the amniotic fluid was determined by cul
ture, polymerase chain reaction, and quantitative polymerase chain reaction
, Macroscopic and histologic examinations were undertaken on tissue from ab
orted fetuses, whereas for newborns culture was performed on urine sampled
during the first week of life.
Results: Congenital infections were found exclusively among women undergoin
g a primary infection. The quantitative determination of CMV DNA in the amn
iotic fluid of at least 10(3) genome equivalents gave a 100% certainty of d
etecting an infected fetus. Higher viral loads were associated with fetuses
or newborns with symptoms.
Conclusions: IgM tests and the IgG avidity determination can identify all w
omen at risk of transmitting CMV Furthermore, a high CMV DNA load in amniot
ic fluid could be an indicator of symptomatic congenital infection at a rel
atively early stage of pregnancy.