DiaSorin Molecular, Cypress, Calif, has received CE marking for its Simplexa VZV swab direct assay. The new molecular diagnostic enables direct detection of varicella-zoster virus (VZV) DNA from both cutaneous and mucocutaneous swab specimens.
The assay is used with the company’s Liaison MDx instrument and complements the company’s Simplexa HSV 1 & 2 direct kit. DiaSorin Molecular has also submitted the Simplexa VZV swab direct assay to FDA for 510(k) clearance.
VZV infection causes two clinically distinct forms of disease, depending on whether an individual is experiencing a primary (chickenpox) or secondary (shingles) infection. Chickenpox is a highly contagious disease that is usually contracted in early childhood. It can cause health complications especially in older individuals. After initial infection, VZV becomes latent in sensory nerve ganglia and can reactivate later in life to cause shingles (herpes zoster). This is a painful condition that can result in complications such as post-herpetic neuralgia and central nervous system infections.
Although several vaccines for VZV have been available since the 1990s, it is estimated that more than 90% of the population will acquire the disease by the age of 15. The clinical presentation of herpes zoster can often be confused with the dermal manifestation of herpes simplex virus (HSV), which makes it important to detect VZV rapidly for proper patient treatment and management.
“We are committed to expanding our menu of high-quality assays that can be used with our Liaison MDx platform,” says Michelle Tabb, chief scientific officer at DiaSorin Molecular. “Customers are looking to consolidate the testing platforms in their labs. The workflow efficiencies we deliver and our rapidly growing test menu make our platform increasingly attractive and in demand.”
For more information, visit DiaSorin Molecular.