SimplexaTM CMV Kit

Simplexa™ Congenital CMV Direct Kit

Direct detection of cytomegalovirus DNA in saliva swab and urine specimens

KIT for Infectious Diseases



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

Congenital CMV infection occurs when the virus is passed from the mother to her unborn baby.3 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.3

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 30% to 35% of the fetuses, whereas non-primary infection gives rise to a fetal infection rate of about 1.1% to 1.7%.2

Congenital CMV infection is the most common congenital infection worldwide. An estimated incidence in developed countries ranges from 0.6 to 0.7% of all live births, resulting in approximately 60,000 neonates born every year with congenital CMV infection in the United States and the European Union combined.4

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% to 15%) or asymptomatic (85% to 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, and direct detection from these samples can provide a definitive diagnosis.

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.Manickal, S., Emery, V. C., Lazzarotto, T., Boppana, S. B., & Gupta, R. K. (2013). The “silent” global burden of congenital cytomegalovirus. Clinical Microbiology Reviews, 26(1), 86-102.
3.Centers for Disease Control and Prevention. (n.d.). Cytomegalovirus (CMV) and congenital CMV infection. Retrieved from
4.Marsico, C. & Kimberlin, D. W. (2017). Congenital cytomegalovirus infection: advances and challenges in diagnosis, prevention and treatment. Italian Journal of Pediatrics, 43(1): 38.

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.


SimplexaTM CMV Kit

Excellent Clinical Agreement

greater than 97.5% clinical agreement

The Simplexa™ Congenital CMV Direct kit demonstrated high performance with excellent clinical agreement against a composite reference method consisting of PCR/bi-directional sequencing.

SimplexaTM Congenital CMV Direct Clinical Agreement Study
Sample TypeSample Type Positive % Agreement Negative % Agreement
Sample TypeSaliva Swab Positive % Agreement100100% (53/53)
95% CI: 93.2% to 100.0%
Negative % Agreement100100% (117/117)
95% CI: 96.8% to 100.0%
Sample TypeUrine Positive % Agreement100.0% (49/49)
95% CI: 92.7% to 100.0%
Negative % Agreement97.6% (121/124)
95% CI: 93.1% to 99.2%
Broad Coverage

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.

Ordering info

Product Code Reactions

Simplexa Congenital CMV Direct Kit

Code MOL2250 Reactions 24

Simplexa Congenital CMV Positive Control Pack

Code MOL2260 Reactions 10

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