New Iam HSV Provides Rapid Molecular Confirmation Of HSV Infection In Pregnant Women And Neonates

DiaSorin has further strengthened its range of infectious disease diagnostic assays for maternal and neonatal health with the launch of Iam HSV for use with the DiaSorin Liaison Iam analyser. The launch of this new molecular assay provides rapid and reliable differential detection of herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in human cerebrospinal fluid (CSF), vesicle swabs, plasma and whole blood. Together with Iam VZV for the detection of clinically relevant subtypes of Varicella Zoster Virus (VZV), these assays allow the rapid and reliable detection of alphaherpesvirus infections in pregnant women and neonates.

Although neonatal infection with HSV is rare, it is associated with significant morbidity and mortality. The risk of transmission to the neonate is highest if the mother has a primary infection during the peripartum period1.  Complications include viral sepsis, respiratory or hepatic failure, coagulopathies and encephalitis1. Rapid diagnosis and treatment using antiviral and long term suppressive therapy has reduced the mortality rate and improved outcomes in neonatal herpes infections1.

Nucleic acid tests are the method of choice for the diagnosis and characterisation of HSV infection1,2, following baseline serology, offering greater sensitivity than viral culture2. In addition, the ability to differentiate between HSV types can provide important prognostic information, particularly in the diagnosis of genital herpes2,3. Active maternal HSV infection can be diagnosed from swab specimens while neonatal infection is commonly diagnosed from CSF and whole blood4.

“Both HSV and VZV pose a significant threat to neonates when the mother experiences a primary infection during pregnancy. In addition, VZV infection can be life threatening for the pregnant woman during the 2nd and 3rd trimester5,” comments Paul Eros, Global Vice President Molecular, DiaSorin. “Iam HSV and Iam VZV are therefore important additions to the wide range of serology and molecular assays available from DiaSorin for the detection of infectious diseases during pregnancy and in the newborn. Offering excellent specificity and sensitivity, they provide rapid confirmation of viral DNA in the patient sample for a swift diagnosis and early administration of appropriate therapy.”

Like HSV, VZV infection in neonates is a significant cause of morbidity and mortality. The mortality rate of perinatal varicella is as high as 30% when maternal disease develops within 5 days prior to delivery or up to 48 hours post partum5.

Based on the innovative DiaSorin Q-LAMP technology, Iam HSV and Iam VZV are part of an expanding portfolio of infectious disease assays for use on the DiaSorin Liaison Iam analyser. Offering excellent diagnostic sensitivity (>95% for Iam VZV6 and >98.5% for Iam HSV7) and specificity (100% for Iam VZV6 and 100% for Iam HSV7), and with faster time to results than conventional real-time PCR, they provide rapid and accurate molecular confirmation of alphaherpesvirus infections. Furthermore, the small footprint, ease of use and scalable design of the benchtop Liaison Iam Molecular Instrument makes it ideal for use in laboratory facilities of all sizes, including those that are located close to the patient. 

The Iam HSV and Iam VZV assays are CE marked in accordance to IVD Medical Device Directive 98/79 CE.  These kits are available for use outside of the USA and Canada only.