Cytomegalovirus, DNA, Saliva

Laboratory assay overview

This test is intended for the in vitro qualitative detection of cytomegalovirus (CMV) DNA from salvia swabs collected in universal transport (UTM) or viral transport media (VTM) from infants <21 days of age. Results from this assay should be used in conjunction with the results of other clinical findings as an aid in the diagnosis of congenital CMV infection. Positive results from a saliva swab are presumptive and should be confirmed with urine.

Laboratory assay overview

Cytomegalovirus (CMV) is the most common congenital infection in newborns, and a leading cause of non-genetic hearing loss and other neurologic complications including microcephaly, developmental delay, and vision impairment. Most infants with congenital CMV (cCMV) infection are asymptomatic at birth. Symptomatic neonates born with hepatosplenomegaly, hepatitis, thrombocytopenia, structural brain malformations, and other abnormalities are recognized and provided appropriate medical care, but asymptomatic infants appear normal at birth, so miss the opportunity for early diagnosis and close monitoring for hearing loss or developmental delay. Infants congenitally infected with CMV may benefit from antiviral therapy, especially if treatment is initiated within the first month of life.