Human cytomegalovirus (CMV) is a member of the human herpes virus family.1 CMV infection in otherwise healthy individuals is common and usually results in a mild, non-specific illness while congenital CMV (cCMV), which occurs when the virus is passed from mother to unborn baby, can lead to severe morbidity and mortality outcomes.2
The virus circulates in the mother’s blood and can cross through the placenta to infect the developing fetus. This typically occurs when a pregnant woman is infected with CMV for the first time (primary infection), or the virus is reactivated during pregnancy.2
Expectant mothers experiencing primary CMV infection present the highest risk of transmitting CMV to the developing fetus. In pregnant women, primary CMV infection results in congenital infection in approximately 40% of the fetuses, whereas non-primary infection gives rise to a fetal infection rate of about 1-2%.2
Congenital CMV infection is the most common congenital infection worldwide. Approximately 1 out of 200 infants are born with cCMV infection in the U.S. every year. Around 1 in 5 babies born with congenital CMV infection will have long-term health problems.2
Congenital CMV is also the leading cause of non-genetic childhood hearing loss and a significant cause of neurodevelopmental delays like cognitive deficit and vision impairment. At birth, infected infants can be symptomatic (10%) or asymptomatic (90%), and in both subgroups, infants can develop hearing defects.2
Timely diagnosis of congenital CMV is critical for disease management and intervention. Antiviral medications such as valganciclovir and ganciclovir, along with appropriate follow-up care may improve congenital CMV related hearing and developmental outcomes.2 Infants with congenital CMV shed high levels of the virus in their urine and saliva. Screening in saliva and confirming in urine can provide a definitive diagnosis for congenital CMV based on testing guidelines.2,3
1. Mocarski, E. S. (1993) Cytomegalovirus biology and replication (p 173-226). In B. Roizman, R. J. Whitley, and C. Lopez (Eds.), The Human Herpesviruses. New York, N.Y: Raven Press.
2. Centers for Disease Control and Prevention. (n.d.). Cytomegalovirus (CMV) and congenital CMV infection. Retrieved from https://www.cdc.gov/cmv/congenital-infection
Why to choose it
A real-time PCR assay for the in vitro qualitative detection of cytomegalovirus (CMV) from saliva swab and urine specimens from infants less than 21 days of age.
Excellent Clinical Agreement
The Simplexa® Congenital CMV Direct assay demonstrated high performance with excellent clinical agreement against a composite reference method consisting of PCR/bi-directional sequencing.
Simplexa® Congenital CMV Direct Clinical Agreement Study*
|Sample TypeSample Type||Positive % Agreement||Negative % Agreement|
|Sample TypeSaliva Swab||Positive % Agreement100100% (53/53)
95% CI: 93% to 100.0%
|Negative % Agreement100100% (117/117)
95% CI: 97% to 100.0%
|Sample TypeUrine||Positive % Agreement100.0% (49/49)
95% CI: 93% to 100.0%
|Negative % Agreement98.4% (122/124)
95% CI: 94% to 99.2%
|*MOL2255 Instructions for Use (IFU) Clinical Agreement (Retrospective Study)|
Broad Coverage for Your Testing Needs
Our Simplexa® Congenital CMV Direct assay provides broad coverage. It is validated for both saliva swab and urine specimens from infants less than 21 days of age.
Simplexa® Congenital CMV Direct Kit*
* Direct Amplification Discs are included with kit
|Code MOL2255||Reactions 24|
Simplexa® Congenital CMV Positive Control Pack
|Code MOL2265||Reactions 10|