INFECTIOUS DISEASE

The quality of treatment starts with diagnosis.

Simplexa™ Congenital CMV Direct Kit

Empowering Early Detection for a Healthy FutureDirect detection of cytomegalovirus DNA in saliva swab and urine specimens

Congenital CMV is the leading cause of non-genetic childhood hearing loss

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

Simplexa™ Congenital CMV Direct Kit

Empowering Early Detection for a Healthy FutureA 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.

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.

Rapid and easy congential CMV molecular testing

• Broad coverage: Validated for both saliva swab and urine specimens.

• Sample-to-answer workflow with timely results: CLIA moderate complexity providing results in about an hour - No DNA extraction required.

• High performance: 100% Positive Percent Agreement and 97.6% Negative Percent Agreement.

INFECTIOUS DISEASE

REFERENCES: 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 https://www.cdc.gov/cmv/congenital-infection.html 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. 5. Cannon MJ, Griffiths PD, Aston V, Rawlinson WD. (2014, April 24). Universal newborn screening for congenital CMV infection: what is the evidence of potential benefit? UpToDate. Retrieved on 01/31/2020 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4494732. 6. Boppana, S. B., Ross, S. A., Shimamura, M., Palmer, A. L., Ahmed, A., Michaels, M.G., … Fowler, K. B. (2011). Saliva polymerase-chain-reaction assay for cytomegalovirus screening in newborns. New ENgland Journal of Medicine, 364(22), 2111-2118. 7. MOL2250, Instructions For Use.

Streamlined workflow

Simple and easy workflow enabling the assay to be run on any shift and bypass conventional DNA extraction procedures.

SCAN samples and reagents.

PIPETTE samples and reagents directly onto the disc.

LOAD and press RUN.

Proven performance that you can count onThe Simplexa™ Congenital CMV Direct kit demonstrated high performance with excellent clinical agreement against a composite reference method consisting of PCR/bi-directional sequencing.

Simplexa™ Congenital CMV Direct Clinical Agreement7

SAMPLE TYPE POSITIVE % AGREEMENT NEGATIVE % AGREEMENT

Saliva Swab 100.0% (53/53)93.2% to 100.0%

100.0% (117/117)96.8% to 100.0%

Urine 100.0% (49/49)92.7% to 100.0%

97.6% (121/124)93.1% to 99.2%

Your Solution For Congenital CMV Testing

Ordering information – Simplexa™ Congenital CMV Direct

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2250 Simplexa™ Congenital CMV Direct Kit* 24

MOL2260 Simplexa™ Congenital CMV Positive Control Pack 10 *To be used with Direct Amplification Discs (3 discs, MOL1455).

Other Related Products

Ordering information – Other Simplexa™ Direct Kits

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2750 Simplexa™ Bordetella Direct Kit* 24

MOL3550 Simplexa™ GBS Direct Kit* 24

MOL2150 Simplexa™ HSV 1 & 2 Direct Kit* 24

MOL3650 Simplexa™ VZV Direct Kit* (for CSF) 24

MOL3655 Simplexa™ VZV Swab Direct Kit* 24

*To be used with Direct Amplification Discs (3 discs, MOL1455).

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