Enable early detection of congenital CMV infection30 January 2024
For over 40 years, DiaSorin Molecular has been developing, producing and commercialising diagnostic tests in a wide range of clinical areas including paediatrics, oncology, women’s health and infectious diseases. The company is about to launch its first Simplexa kit for the detection of congenital human cytomegalovirus (CMV), which poses significant dangers to newborns all across the globe.
As a worldwide manufacturer and distributor of molecular diagnostic products for helping laboratories streamline their workflows and improve patient management, DiaSorin Molecular works from the belief that quality patient treatment begins with effective diagnosis. As such, the company’s products are designed to provide the most accurate diagnosis as quickly as possible.
The DiaSorin Molecular portfolio includes Simplexa kits for infectious diseases and more than 65 primer pairs and general purpose reagents. Most Simplexa kits are developed as direct assays, requiring no sample extraction and providing results in about an hour.
Simplexa products are designed for use on the LIAISON MDX, a real-time PCR instrument that has the capability of running either an 8-well or 96-well disc, providing an ideal platform to accommodate low and high-volume testing needs.
DiaSorin is currently preparing to launch a product for the detection of congenital human cytomegalovirus (CMV), Simplexa Congenital CMV Direct, which will attain CE marking in the coming months. This real-time PCR system enables the direct amplification and detection of CMV DNA from saliva swab specimens or urine from infants less than 21 days old, without the need for nucleic acid extraction.
“Congenital CMV, which occurs when the virus is passed from mother to unborn baby, can lead to severe morbidity and mortality outcomes.”
The leading non-genetic cause of childhood hearing loss
CMV is a member of the human herpes virus family. All herpes viruses establish latent infection and thus remain for life. CMV infection in otherwise healthy individuals is common and usually results in a mild, non-specific illness, but congenital CMV, which occurs when the virus is passed from mother to unborn baby, can lead to severe morbidity and mortality outcomes.
Congenital infection typically occurs when a pregnant woman is infected with CMV for the first time (primary infection), or is infected with a different strain of CMV again during pregnancy. Primary CMV infection in pregnant women results in congenital infection in 30–35% of the foetuses. CMV seroprevalence rates in pregnant women vary by country and are typically >50%. The cases where the woman was previously infected (non-primary infection) gave rise to a congenital infection rate of 1.1–1.7%. Approximately 60,000 neonates are born every year with congenital CMV infection in the US and the EU combined.
Congenital CMV is also the leading non-genetic cause of childhood hearing loss and is a significant cause of neurodevelopmental delays like cognitive deficit and vision impairment. At birth, infected infants can develop both symptomatic and asymptomatic hearing defects, which makes timely diagnosis of congenital CMV critical for disease management and intervention, and perhaps suggests a need for universal screening. The rate of incidence for congenital CMV is similar to the combined incidence of all metabolic or endocrine disorders in the current US core screening panel.
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. PCR testing provides faster turnaround time and improved sensitivity over viral culture.
The Simplexa Congenital CMV Direct kit provides direct detection of cytomegalovirus DNA in saliva swab specimens and urine to enable early detection of congenital CMV infection.
DiaSorin Molecular also provides a comprehensive menu of molecular diagnostic assays including HSV, VZV, Flu A/B & RSV, C. difficile, Group A Streptococcus, Group B Streptococcus and Bordetella.